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Jun.21.2022
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SARS-CoV-2 Virus (COVID-19) mRNA Vaccine

Indications/Dosage

Labeled

  • prevention of coronavirus disease 2019 (COVID-19)

General Dosing Information

  • The mRNA COVID-19 vaccines are preferred, when available, over the Janssen COVID-19 vaccine due to the risk of thrombosis with thrombocytopenia syndrome (TTS) after Janssen COVID-19 vaccination.[66175]
  • The Pfizer-BioNTech COVID-19 vaccine (Comirnaty) is FDA-approved for the 2-dose primary series in patients 16 years and older; use in patients 6 months to 15 years and the recommended third dose for immunocompromised patients is covered under an Emergency Use Authorization (EUA). Additionally, a first booster dose has been authorized in patients 5 years and older under the EUA and a second booster dose has been authorized under the EUA in patients 50 years and older and in immunocompromised patients 12 years and older.[66080][66904][67085][67688] The Moderna COVID-19 vaccine (Spikevax) is FDA-approved for the 2-dose primary series in patients 18 years and older. Use in patients 6 months to 17 years, the recommended third dose for immunocompromised patients and both booster doses (first for all patients 18 years and older and second for patients 50 years and older and immunocompromised patients 18 years and older) have been authorized under an EUA.[66120][67339][67491][67691][67692]
  • There is no data available on the interchangeability of the COVID-19 vaccines to complete the primary vaccination series. Patients who have received 1 dose of Pfizer-BioNTech COVID-19 or Moderna COVID-19 vaccine should receive a second dose of the same vaccine to complete the primary vaccination series.[66080][66120] The FDA-approved mRNA COVID-19 vaccines, Comirnaty and Spikevax, have the same formulation as the FDA-authorized Pfizer-BioNTech COVID-19 vaccine and Moderna COVID-19 vaccine, respectively, and can be used interchangeably.[66120][66175] In exceptional situations (e.g., first dose of vaccine product cannot be determined or is no longer available), any available mRNA COVID-19 vaccine may be administered at a minimum interval of 28 days between doses. In situations where the same mRNA COVID-19 vaccine is temporarily unavailable, it is recommended to delay the second dose to receive the same product. If 2 doses of different COVID-19 vaccine products are administered in these situations or inadvertently administered, no additional doses of either product are recommended.[66175]
  • Administer the second dose as close to the recommended interval as possible; do not schedule the second dose appointment earlier than the recommended dosing interval. Patients receiving a second dose up to 4 days before or any time after the recommended date can be considered fully vaccinated. If the second dose of a vaccine is given earlier than the 4-day grace period (less than 17 days for the Pfizer COVID-19 vaccine or less than 24 days for the Moderna COVID-19 vaccine), the second dose should be repeated. Space the repeat dose the recommended minimum interval after the dose given in error.[66175]
  • A third dose of the mRNA vaccine may be administered at least 28 days after the 2-dose regimen in individuals who have undergone solid organ transplantation, or who are diagnosed with a condition that is considered to have an equivalent level of immunocompromise.[66080][66120] The additional mRNA COVID-19 vaccine dose should be the same vaccine product as the initial 2-dose primary vaccine series, unless it is unavailable, and then the other mRNA COVID-19 product may be administered. If the additional dose is given fewer than 24 days after the second dose, the additional dose should be repeated. The repeat dose should be spaced after the dose given in error by the recommended minimum intervals.[66175]
  • It is recommended that all patients 18 years and older (Pfizer-BioNTech COVID-19 vaccine and Moderna COVID-19 vaccine) receive the first booster dose of the COVID-19 vaccine; for patients 12 to 17 years old (Pfizer-BioNTech COVID-19 vaccine) base the decision to administer the first booster dose on individual benefits and risks.[66080][66120][66175] Moderately to severely immunocompromised patients 12 years and older (Pfizer-BioNTech COVID-19 vaccine) and 18 years and older (Pfizer-BioNTech COVID-19 vaccine and Moderna COVID-19 vaccine) who received a 2-dose mRNA primary series and an additional mRNA dose (3 total mRNA vaccine doses) are eligible for the first COVID-19 booster dose after completing their third mRNA vaccine dose.[66175][67010] Patients 50 years and older and immunocompromised patients 12 years and older (Pfizer-BioNTech COVID-19 vaccine) or 18 years and older (Pfizer-BioNTech COVID-19 vaccine and Moderna COVID-19 vaccine) who received a first booster dose, may receive a second booster dose.[66080][66904][66120][66175][67339][67491] Patients 18 to 49 years who are not moderately or severely immunocompromised and who received Janssen COVID-19 vaccine as both their primary series dose and booster dose may receive a second booster dose using an mRNA COVID-19 vaccine at least 4 months after the first Janssen booster dose.[66175] A different authorized or approved COVID-19 vaccine than the 1 used for the primary series may be used for the booster dose in patients 18 years and older; however, use of a mRNA COVID-19 vaccine for the booster dose is preferred, when available. The eligible populations and dosing interval for the heterologous booster dose are the same as those authorized for a booster dose of the vaccine used for primary vaccination.[66080][66120][66175]
  • The COVID-19 vaccine may be administered with other vaccines without regard to timing. If multiple vaccines are given at a single visit, administer each injection in a different injection site; separate injection sites by 1 inch or more, if possible. Administer the COVID-19 vaccines and vaccines that may be more likely to cause a local reaction in different limbs, if possible.[66175]
  • The influenza season will coincide with the continued or recurrent circulation of SARS-CoV-2. Influenza vaccination of patients 6 months and older may reduce symptoms that might be confused with those of COVID-19. Additionally, prevention and reduction of influenza severity could decrease hospitalizations and intensive care unit admissions and alleviate stress on the health care system.[63436]
  • Do not delay the mRNA COVID-19 vaccine because of testing for tuberculosis (TB) infection. Testing for TB infection, using the tuberculin skin test (TST) or interfero-gamma release assay (IGRA), can be done before, after, or during the same visit as vaccine administration.[66175]

 

Vaccination in cases of SARS-CoV-2 infection or exposure

  • Defer treatment with tixagevimab/cilgavimab for at least 2 weeks in patients who previously received a COVID-19 vaccine. Otherwise, prior receipt of a mRNA COVID-19 vaccine should not affect treatment decisions (including use of monoclonal antibodies, convalescent plasma, antiviral treatment, or corticosteroid administration) or timing of treatments if patients subsequently develop COVID-19. Administration of an antiviral drug at any interval before or after vaccination is unlikely to impair the development of a protective antibody response.
  • Offer vaccination regardless of history of prior symptomatic or asymptomatic SARS-CoV-2 infection. Defer vaccination of patients with known SARS-CoV-2 infection until acute illness has resolved and criteria for discontinuing isolation have been met. Information about the optimal timing between SARS-CoV-2 infection and vaccination is insufficient to inform guidance.
  • Patients who recently had SARS-CoV-2 infection may consider delaying their first or second COVID-19 vaccine booster dose by 3 months from symptom onset or positive test. Studies have shown that increased time between infection and vaccination may result in an improved immune response to vaccination.
  • Patients with a history of multisystem inflammatory syndrome in children (MIS-C) or in adults (MIS-A) may choose to be vaccinated. Considerations for vaccination may include clinical recovery from MIS-C or MIS-A, including return to normal cardiac function; personal risk of severe acute COVID-19; level of COVID-19 community transmission and personal risk of reinfection; lack of safety data of COVID-19 vaccines after these illnesses; and timing of any immunomodulatory therapies. Patients with a history of MIS-C or MIS-A should consider delaying vaccination until they have recovered from their illness and for 90 days after the date of diagnosis. Consider referring patients who develop MIS-C or MIS-A that is associated with a confirmed SARS-CoV-2 infection, but occurs after COVID-19 vaccine administration, to a specialist in infectious disease, rheumatology, or cardiology.
  • For patients who received antibody products (anti-SARS-CoV2 monoclonal antibodies or convalescent plasma) as part of COVID-19 treatment, post-exposure prophylaxis, or pre-exposure prophylaxis, COVID-19 vaccination does not need to be delayed and may be administered at anytime.
  • Patients in congregate healthcare settings (e.g., long-term care facilities) or other congregate settings (e.g., correctional and detention facilities, homeless shelters) with a known SARS-CoV-2 exposure may receive vaccination at any time.[66175]

 

Patients vaccinated for COVID-19 as part of a clinical trial

  • Patients who received the full series of an active COVID-19 vaccine that is not authorized for use by FDA, but is listed for emergency use by the World Health Organization (WHO) do NOT need any additional primary series doses.
  • Patients who received the full series of an active COVID-19 vaccine that is neither authorized for use by FDA nor emergency use by the WHO, but vaccine efficacy has been independently confirmed (e.g., by a data and safety monitoring board or equivalent), do NOT need any additional primary series doses.
  • Patients who completed the primary series as part of a clinical trial with an FDA-authorized or FDA-approved COVID-19 vaccine may receive an additional mRNA dose or a booster dose if they are eligible.[66175]

 

Patients vaccinated outside the United States

  • Patients who were vaccinated outside the United States with a currently FDA-approved or FDA-authorized COVID-19 vaccine or a vaccine that has been authorized for emergency use by the WHO and have received all the recommended doses do NOT need any additional doses for the primary series. It is recommended that these patients receive an additional mRNA primary dose and booster dose if they are eligible.
  • Patients who received the first dose of an FDA-approved or FDA-authorized COVID-19 vaccine that requires 2 doses do NOT need to restart the vaccine series in the United States, but should receive the second dose as close to the recommended time as possible to complete the primary series. It is recommended that these patients receive an additional mRNA primary dose and booster dose if they are eligible.
  • Patients who are partially vaccinated with a COVID-19 vaccine series authorized for emergency use by WHO do NOT need to restart a primary vaccine series in the United States. It is recommended that these patients receive a single dose of the mRNA COVID-19 vaccine at least 28 days after the last dose of vaccine to be considered fully vaccinated as well as an additional mRNA primary dose and booster dose if they are eligible.
  • Patients who have completed or partially completed a COVID-19 vaccine series with a vaccine that is NOT approved or authorized by FDA or NOT authorized for emergency use by WHO should start the primary series at least 28 days after the last dose of vaccine. Once the primary series is complete, it is recommended that these patients receive an additional mRNA primary dose and booster dose if they are eligible.[66175]

Off-Label

    † Off-label indication

    For the prevention of coronavirus disease 2019 (COVID-19)

    for the primary vaccination series

    Intramuscular dosage (Pfizer-BioNTech COVID-19 vaccine)

    Adults

    0.3 mL (30 mcg) IM for 2 doses administered 3 weeks apart.[66904] Consider an 8-week interval between the 2 doses, especially in males 18 to 39 years, to decrease the risk of myocarditis. Patients who are moderately to severely immunocompromised, 65 years and older, or who need rapid protection due to increased concern about community transmission or risk of severe disease should still receive a shorter 3-week interval.[66175]

    Adolescents 16 to 17 years

    0.3 mL (30 mcg) IM for 2 doses administered 3 weeks apart.[66904] Consider an 8-week interval between the 2 doses, especially in adolescent males, to decrease the risk of myocarditis. Patients who are moderately to severely immunocompromised or who need rapid protection due to increased concern about community transmission or risk of severe disease should still receive a shorter 3-week interval.[66175]

    Children and Adolescents 12 to 15 years†

    0.3 mL (30 mcg) IM for 2 doses administered 3 weeks apart.[66080] Consider an 8-week interval between the 2 doses, especially in males, to decrease the risk of myocarditis. Patients who are moderately to severely immunocompromised or who need rapid protection due to increased concern about community transmission or risk of severe disease should still receive a shorter 3-week interval.[66175]

    Children 5 to 11†

    0.2 mL (10 mcg) IM for 2 doses administered 3 weeks apart.[67085]

    Infants and Children 6 months to 4 years†

    0.2 mL (3 mcg) IM for 3 doses. Administer the first 2 doses 3 weeks apart, followed by a third dose at least 8 weeks after the second dose. Patients who turn from 4 years to 5 years between any doses in the primary series may receive a 2-dose primary series with 0.2 mL (10 mcg) for patients 5 to 11 years (orange caps/label with orange border), a 3-dose primary series with 0.2 mL (3 mcg) IM for 3 doses (maroon cap), or a 3-dose primary series with 0.2 mL (10 mcg) used for patients 5 to 11 years (orange caps/label with orange border).[67688]

    Intramuscular dosage (Moderna COVID-19 vaccine)

    Adults

    0.5 mL (100 mcg) IM for 2 doses administered 1 month apart.[67339] Consider an 8-week interval between the 2 doses, especially in males 18 to 39 years, to decrease the risk of myocarditis. Patients who are moderately to severely immunocompromised, 65 years and older, or who need rapid protection due to increased concern about community transmission or risk of severe disease should still receive a shorter 1-month interval.[66175]

    Children and Adolescents 12 to 17 years†

    0.5 mL (100 mcg) IM for 2 doses administered 1 month apart.[67339]

    Children 6 to 11 years†

    0.5 mL (50 mcg) IM for 2 doses administered 1 month apart.[67691]

    Infants and Children 6 months to 5 years†

    0.25 mL (25 mcg) IM for 2 doses administered 1 month apart.[67692]

    additional primary dose for patients with certain kinds of immunocompromise†

    Intramuscular dosage (Pfizer-BioNTech COVID-19 vaccine)

    Adults

    0.3 mL (30 mcg) IM may be administered as a third dose at least 28 days after the second dose.[66080]

    Children and Adolescents 12 to 17 years

    0.3 mL (30 mcg) IM may be administered as a third dose at least 28 days after the second dose.[66080]

    Children 5 to 11 years

    0.2 mL (10 mcg) IM may be administered as a third dose at least 28 days after the second dose.[67085]

    Intramuscular dosage (Moderna COVID-19 vaccine)

    Adults

    0.5 mL (100 mcg) IM may be administered as a third dose at least 1 month after the second dose.[66120]

    Children and Adolescents 12 to 17 years†

    0.5 mL (100 mcg) IM may be administered as a third dose at least 1 month after the second dose.[66120]

    Children 6 to 11 years†

    0.5 mL (50 mcg) IM may be administered as a third dose at least 1 month after the second dose.[67691]

    Infants and Children 6 months to 5 years†

    0.25 mL (25 mcg) IM may be administered as a third dose at least 1 month after the second dose.[67692]

    for first booster dose†

    Intramuscular dosage (Pfizer-BioNTech COVID-19 vaccine)

    Adults

    0.3 mL (30 mcg) IM at least 5 months after completing the primary series.[66080] An interval of at least 3 months after completing the primary series is recommended by the CDC in moderately or severely immunocompromised patients.[66175]

    Children and Adolescents 12 to 17 years

    0.3 mL (30 mcg) IM at least 5 months after completing the primary series.[66080] An interval of at least 3 months after completing the primary series is recommended by the CDC in moderately or severely immunocompromised patients.[66175]

    Children 5 to 11 years

    0.2 mL (10 mcg) IM at least 5 months after completing the primary series.[67085]

    Intramuscular dosage (Moderna COVID-19 vaccine)

    Adults

    0.25 mL (50 mcg) [red vial cap, label with light blue border] or 0.5 mL (50 mcg) [dark blue vial cap, label with purple border] IM at least 5 months after completing the primary series.[66120] [67491] An interval of at least 3 months after completing the primary series is recommended by the CDC in moderately or severely immunocompromised patients.[66175]

    for second booster dose†

    Intramuscular dosage (Pfizer-BioNTech COVID-19 vaccine)

    Adults 50 years and older

    0.3 mL (30 mcg) IM at least 4 months after receipt of a first booster dose.[66080]

    Adults 18 years and older with certain kinds of immunocompromise

    0.3 mL (30 mcg) IM at least 4 months after receipt of a first booster dose.[66080]

    Children and Adolescents 12 to 17 years with certain kinds of immunocompromise

    0.3 mL (30 mcg) IM at least 4 months after receipt of a first booster dose.[66080]

    Intramuscular dosage (Moderna COVID-19 vaccine)

    Adults 50 years and older

    0.25 mL (50 mcg) [red vial cap, label with light blue border] or 0.5 mL (50 mcg) [dark blue vial cap, label with purple border] IM at least 4 months after receipt of a first booster dose.[66120] [67491]

    Adults 18 years and older with certain kinds of immunocompromise

    0.25 mL (50 mcg) [red vial cap, label with light blue border] or 0.5 mL (50 mcg) [dark blue vial cap, label with purple border] IM at least 4 months after receipt of a first booster dose.[66120] [67491]

    Therapeutic Drug Monitoring

    Maximum Dosage Limits

    • Adults

      0.3 mL/dose (30 mcg) IM for Pfizer-BioNTech COVID-19 vaccine; 0.5 mL/dose (100 mcg) IM for Moderna COVID-19 vaccine.

    • Geriatric

      0.3 mL/dose (30 mcg) IM for Pfizer-BioNTech COVID-19 vaccine; 0.5 mL/dose (100 mcg) IM for Moderna COVID-19 vaccine.

    • Adolescents

      0.3 mL/dose (30 mcg) IM for Pfizer-BioNTech COVID-19 vaccine; 0.5 mL/dose (100 mcg) IM for Moderna COVID-19 vaccine.

    • Children

      12 years: 0.3 mL/dose (30 mcg) IM for Pfizer-BioNTech COVID-19 vaccine; 0.5 mL/dose (100 mcg) IM for Moderna COVID-19 vaccine.

      6 to 11 years: 0.2 mL/dose (10 mcg) IM for Pfizer-BioNTech COVID-19 vaccine; 0.5 mL/dose (50 mcg) IM for Moderna COVID-19 vaccine.

      5 years: 0.2 mL/dose (10 mcg) IM for Pfizer-BioNTech COVID-19 vaccine; 0.25 mL/dose (25 mcg) IM for Moderna COVID-19 vaccine.

      1 to 4 years: 0.2 mL/dose (3 mcg) IM for Pfizer-BioNTech COVID-19 vaccine; 0.25 mL/dose (25 mcg) IM for Moderna COVID-19 vaccine.

    • Infants

      6 to 11 months: 0.2 mL/dose (3 mcg) IM for Pfizer-BioNTech COVID-19 vaccine; 0.25 mL/dose (25 mcg) IM for Moderna COVID-19 vaccine.

      1 to 5 months: Safety and efficacy have not been established.

    • Neonates

      Safety and efficacy have not been established.

    Patients with Hepatic Impairment Dosing

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Patients with Renal Impairment Dosing

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    † Off-label indication
    Revision Date: 06/21/2022, 03:50:06 PM

    References

    63436 - Grohskopf LA, Alyanak E, Ferdinands JM, et al. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices - United States, 2021-2022 Influenza Season. MMWR 2021;70(No. RR-5):1-28.66080 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 12 years of age and older. Purple cap and purple border. Retrieved June 17, 2022.66120 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 12 years and older. Red cap and light blue border. Retrieved June 17, 2022.66175 - Center for Disease Control and Prevention. Interim clinical considerations for use of COVID-19 vaccines currently approved or authorized in the United States. Updated April 25, 2022. Accessed April 22, 2022. Available at: https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html.66904 - Comirnaty (COVID-19) injection package insert. New York, NY: Pfizer, Inc; 2021 Aug.67010 - Centers for Disease Control and Prevention (CDC). Underlying medical conditions associated with high risk for severe COVID-19: information for healthcare providers. Accessed Sept 28, 2021. Available on the World Wide Web at: https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html.67085 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 5 to 11 years of age. Orange cap and orange border. Retrieved June 17, 2022.67339 - Spikevax (COVID-19) injection package insert. Cambridge, MA: Moderna US, Inc.; 2022 Jan.67491 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for booster dose only. Dark blue cap and purple border. Retrieved June 17, 2022.67688 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 6 months to 4 years of age. Maroon cap and Maroon border. Retrieved June 17, 2022.67691 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 6 to 11 years. Dark blue cap and purple border. Retrieved June 17, 2022.67692 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 6 months to 5 years. Dark blue cap and magenta border. Retrieved June 17, 2022.

    How Supplied

    Nucleoside-modified messenger RNA (modmRNA) of SARS-CoV-2 Suspension for injection

    Pfizer-BioNTech COVID-19 Vaccine for 6 Months Through 4 Years of Age Dilute Before Use (Maroon Cap/Maroon Border) (59267-0078) (Pfizer Manufacturing Belgium NV) null

    Nucleoside-modified messenger RNA (modmRNA) of SARS-CoV-2 Suspension for injection

    Pfizer-BioNTech COVID-19 Vaccine for 5 Years to 11 Years of Age Dilute Before Use (Orange Cap) (59267-1055) (Pfizer Manufacturing Belgium NV) null

    Nucleoside-modified messenger RNA (modmRNA) of SARS-CoV-2 Suspension for injection

    COMIRNATY COVID-19 Vaccine Suspension for Injection (00069-1000) (Pfizer Injectables) null

    Nucleoside-modified messenger RNA (modmRNA) of SARS-CoV-2 Suspension for injection

    Pfizer-BioNTech COVID-19 Vaccine for 12 Years of Age and Older Dilute Before Use (Purple Cap) (59267-1000) (Pfizer Manufacturing Belgium NV) null

    Nucleoside-modified messenger RNA (modmRNA) of SARS-CoV-2 Suspension for injection

    Pfizer-BioNTech COVID-19 Vaccine for 12 Years of Age and Older Do NOT Dilute (Gray Cap) (59267-1025) (Pfizer Manufacturing Belgium NV) null

    Synthetic messenger RNA (mRNA) of SARS-CoV-2, Cholesterol, SM-102, 1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE, PEG2000-DMG Suspension for injection

    Moderna COVID-19 25mcg/0.25mL Vaccine for 6 Months to 5 Years (Dark Blue Cap/Teal Border Label) (80777-0279) (Moderna US, Inc) null

    Synthetic messenger RNA (mRNA) of SARS-CoV-2, Cholesterol, SM-102, 1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE, PEG2000-DMG Suspension for injection

    Moderna COVID-19 50mcg/0.5mL Booster Vaccine (Dark Blue Cap/Purple Border Label) (80777-0275) (Moderna US, Inc) null

    Synthetic messenger RNA (mRNA) of SARS-CoV-2, Cholesterol, SM-102, 1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE, PEG2000-DMG Suspension for injection

    Moderna COVID-19 50mcg/0.5mL Vaccine for 6 Years to 11 Years (Dark Blue Cap/Magenta Border Label) (80777-0277) (Moderna US, Inc) null

    Synthetic messenger RNA (mRNA) of SARS-CoV-2, Cholesterol, SM-102, 1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE, PEG2000-DMG Suspension for injection

    Moderna COVID-19 100mcg/0.5mL Vaccine (Red Cap/Light Blue Border Label) (80777-0273) (Moderna US, Inc) null

    Synthetic messenger RNA (mRNA) of SARS-CoV-2, Cholesterol, SM-102, 1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHOCHOLINE, PEG2000-DMG Suspension for injection

    spikevax COVID-19 mRNA 0.20mg/mL Vaccine (80777-0100) (Moderna US, Inc) null

    Description/Classification

    Description

    The COVID-19 vaccine is a vaccine that contains messenger RNA (mRNA) encoding the viral spike glycoprotein (S) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is used for active immunization for the prevention of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2. While Comirnaty (Pfizer-BioNTech COVID-19 vaccine) has received full FDA-approval for the 2-dose primary series in patients 16 years and older, use in patients 6 months to 15 years and the recommended third dose for immunocompromised patients continues to be covered under the Emergency Use Authorization (EUA). Additionally, a first booster dose has been authorized in patients 5 years and older under the EUA and a second booster dose has been authorized under the EUA in patients 50 years and older and in immunocompromised patients 12 years and older.[66080][66904][67085][67688] Spikevax (Moderna COVID-19 vaccine) has received full FDA-approval for the 2-dose primary series in patients 18 years and older. Use in patients 6 months to 17 years, the recommended third dose for immunocompromised patients, and both booster doses (first for all patients 18 years and older and second for patients 50 years and older and immunocompromised patients 18 years and older) have been authorized under an EUA.[66120][67339][67491][67691][67692] The mRNA COVID-19 vaccines are preferred, when available, over the Janssen COVID-19 vaccine due to the risk of thrombosis with thrombocytopenia syndrome (TTS) after Janssen COVID-19 vaccination.[66175] There are many clinical trials underway for various COVID-19 vaccines.[66083] One of the advantages of mRNA vaccines is that they can be rapidly manufactured. The process is cell-free and can be scaled, allowing quick responses to large outbreaks and epidemics, such as the COVID-19 pandemic. Additionally, mRNA vaccines offer a different technology; unlike other vaccines, RNA-based vaccines introduce an mRNA sequence coded for a disease-specific antigen, which elicits a robust innate immune response when presented to the immune system.[66084][66093] In clinical trials, RNA-vaccines and RNA-based therapeutic agents have been found to be safe and well-tolerated. The most commonly reported adverse drug reactions include injection site pain, fever, chills, fatigue, muscle pain, and headache. Serious allergic reactions and anaphylaxis have been reported in patients outside of clinical trials during mass vaccination.[66084][66080][66120][67085]

    Classifications

    • General Anti-infectives Systemic
      • Vaccines
        • Pure Vaccines
          • SARS-CoV-2 (Covid-19) Vaccines
    Revision Date: 06/17/2022, 06:56:34 PM

    References

    66080 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 12 years of age and older. Purple cap and purple border. Retrieved June 17, 2022.66083 - World Health Organization. Draft landscape of COVID-19 candidate vaccines. Updated November 3, 2020. Accessed November 5, 2020. Available at: https://www.who.int/publications/m/item/draft-landscape-of-covid-19-candidate-vaccines.66084 - Mulligan MJ, Lyke KE, Kitchin N, et al. Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults. Nature 2020; 586:589-593.66093 - jackson NA, Kester KE, Casimiro D, et al. The promise of mRNA vaccines: a biotech and industrial perspective. npj Vaccines. 2020; 5:1166120 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 12 years and older. Red cap and light blue border. Retrieved June 17, 2022.66175 - Center for Disease Control and Prevention. Interim clinical considerations for use of COVID-19 vaccines currently approved or authorized in the United States. Updated April 25, 2022. Accessed April 22, 2022. Available at: https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html.66904 - Comirnaty (COVID-19) injection package insert. New York, NY: Pfizer, Inc; 2021 Aug.67085 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 5 to 11 years of age. Orange cap and orange border. Retrieved June 17, 2022.67339 - Spikevax (COVID-19) injection package insert. Cambridge, MA: Moderna US, Inc.; 2022 Jan.67491 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for booster dose only. Dark blue cap and purple border. Retrieved June 17, 2022.67688 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 6 months to 4 years of age. Maroon cap and Maroon border. Retrieved June 17, 2022.67691 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 6 to 11 years. Dark blue cap and purple border. Retrieved June 17, 2022.67692 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 6 months to 5 years. Dark blue cap and magenta border. Retrieved June 17, 2022.

    Administration Information

    General Administration Information

    For storage information, see the specific product information within the How Supplied section.

     

    Under the Emergency Use Authorization (EUA), healthcare providers are required to communicate to the patient, parent, or caregiver information consistent with the "Fact Sheet for Recipients and Caregivers" prior to the patient receiving the vaccine, including:

    • FDA has authorized the emergency use of this vaccine, which is not an FDA-approved vaccine.
    • The recipient or caregiver has the option to accept or refuse the COVID-19 vaccine.
    • The significant known and potential risks and benefits of the COVID-19 vaccine, and the extent to which such potential risks and benefits are unknown.
    • Available alternative vaccines in clinical trials or approved for use under other EUA and the risks and benefits of those alternatives.

    Under the EUA, vaccination providers enrolled in the federal COVID-19 Vaccination Program are required to report all vaccination administration errors, all serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and cases of COVID-19 that result in hospitalization or death after administration of the vaccine.[66080][67085]

     

    Storage and Handling Prior to Thawing (Pfizer-BioNTech COVID-19 vaccine with purple caps and labels for 12 years and older)

    • Cartons of Pfizer-BioNTech COVID-19 vaccine vials with purple caps and labels arrive in thermal containers with dry ice. Once received, vials should be immediately transferred from the thermal container and preferably stored in an ultra-low temperature freezer between -90 to -60 degrees C (-130 to -76 degrees F) until the expiration date printed on the label.
    • Alternatively, Pfizer-BioNTech COVID-19 vaccine vials may be stored frozen at -25 to -15 degrees C (-13 to 5 degrees F) for up to 2 weeks. These vials may be returned 1 time to the recommended storage condition of -90 to -60 degrees C (-130 to -76 degrees F). Total cumulative time the vials are stored at -25 to -15 degrees C (-13 to 5 degrees F) should be tracked and should not exceed 2 weeks.
    • Protect from light until ready to use.
    • If an ultra-low temperature freezer is not available for storage of the Pfizer-BioNTech COVID-19 vaccine, the thermal container in which the vaccine arrives may be used as temporary storage when consistently refilled to the top with dry ice. The thermal container maintains a temperature range of -90 to -60 degrees C (-130 to -76 degrees F). Storage of the vials between -96 to -60 degrees C (-141 to -76 degrees F) is not considered an excursion from the recommended storage condition. Refer to the re-icing guidelines included in the original container for instructions regarding use for temporary storage.
    • Transportation of frozen vials: If local redistribution is needed and cartons containing vials cannot be transported at -90 to -60 degrees C (-130 to -76 degrees F), vials may be transported at -25 to -15 degrees C (-13 to 5 degrees F). Any hours used for transport at -25 to -15 degrees C (-13 to 5 degrees F) count against the 2-week limit for storage at -25 to -15 degrees C (-13 to 5 degrees F). Frozen vials transported at -25 to -15 degrees C (-13 to 5 degrees F) may be returned 1 time to the recommended storage condition of -90 to -60 degrees C (-130 to -76 degrees F).[66080][66904]

     

    Storage and Handling Prior to Thawing (Pfizer-BioNTech COVID-19 vaccine with gray caps and labels for 12 years and older; orange caps and labels for 5 to 11 years; maroon caps and labels for 6 months to 4 years)

    • Cartons of Pfizer-BioNTech COVID-19 vaccine vials arrive in thermal containers with dry ice. Once received, vials may be immediately transferred from the thermal container to the refrigerator, stored between 2 to 8 degrees C (35 to 46 degrees F), thawed, and stored for up to 10 weeks. Record the 10-week refrigerated expiration date on the carton at the time of transfer. A carton of 10 vials may take up to 6 hours to thaw.
    • Alternatively, Pfizer-BioNTech COVID-19 vaccine vials may be stored in an ultra-low temperature freezer at -90 to -60 degrees C (-130 to -76 degrees F). Do NOT store vials at -25 to -15 degrees C (-13 to 5 degrees F). Once vials are thawed they should not be refrozen.
    • Cartons of Pfizer-BioNTech COVID-19 vaccine vials may also arrive at 2 to 8 degrees C (35 to 46 degrees F). Check that the carton has been updated to reflect the 10-week refrigerated expiration date.
    • Regardless of storage conditions, vaccines should NOT be used after 12 months from the date of manufacture printed on the vial and cartons.
    • Transportation of frozen vials: If local redistribution is needed, vials may be transported at -90 to -60 degrees C (-130 to -76 degrees F) or at 2 to 8 degrees C (35 to 46 degrees F).[67085][67215][67688]

     

    Storage and Handling Prior to Thawing (Moderna COVID-19 vaccine)

    • Store vaccine vials frozen between -50 to -15 degrees C (-58 to 5 degrees F) until ready to use. Keep in the original container to protect from light. Do not store on dry ice or below -50 degrees C (-58 degrees F).
    • Transportation of vials: If transport at -50 to -15 degrees C (-58 to 5 degrees F) is not feasible, available data support transportation of 1 or more thawed vials for up to 12 hours at 2 to 8 degrees C (35 to 46 degrees F) when shipped using shipping containers which have been qualified to maintain 2 to 8 degrees C (35 to 46 degrees F) and under routine road and air transport conditions with shaking and vibration minimized. Once thawed and transported at 2 to 8 degrees C (35 to 46 degrees F), vials should not be refrozen and should be stored at 2 to 8 degrees C (35 to 46 degrees F) for up to 30 days until use.[66120][67339][67491][67692]

    Route-Specific Administration

    Injectable Administration

    • Administer intramuscularly. Do not administer intravenously, intradermally, or subcutaneously.
    • Due to the potential for errors, separation of the different formulations during storage is recommended. Additionally, ensure proper labeling for individual syringes prior to administration.[67102][67188]
    • Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. Prior to dilution (purple, orange, or maroon cap) or mixing (gray cap), the Pfizer-BioNTech COVID-19 vaccine is a white to off-white suspension and may contain white to off-white opaque amorphous particles. The diluted (purple, orange, or maroon cap) or mixed (gray cap) Pfizer-BioNTech COVID-19 vaccine is an off-white suspension and should not contain particulate matter.[66080][67085][67215][67688] The Moderna COVID-19 vaccine is a white to off-white suspension. It may contain white or translucent product-related particles.[66120][67339]
    • There is no available information on coadministration of the COVID-19 vaccine with other vaccines; do not mix with other vaccines or products in the same syringe.[66080][66120]
      • The COVID-19 vaccine may be administered with other vaccines without regard to timing. If multiple vaccines are given at a single visit, administer each injection in a different injection site; separate injection sites by 1 inch or more, if possible. Administer the COVID-19 vaccines and vaccines that may be more likely to cause a local reaction in different limbs, if possible. For patients 11 years and older, the deltoid muscle may be used for more than 1 intramuscular injection administered at different sites in the muscle. For children 5 to 10 years receiving more than 2 vaccines in a single limb, the vastus lateralis muscle of the anterolateral thigh is the preferred site.
      • Do not delay the mRNA COVID-19 vaccine because of testing for tuberculosis (TB) infection. Testing for TB infection, using the tuberculin skin test (TST) or interferon-gamma release assay (IGRA), can be done without regard to timing of COVID-19 vaccination.[66175]
    • A 30 minute observation period after vaccination is recommended for the following patient populations:
      • History of an immediate allergic reaction of any severity to a vaccine or injectable therapy
      • History of anaphylaxis due to any cause
      • A contraindication to a different COVID-19 vaccine than the 1 they are receiving
    • A 15 minute observation period after vaccination is recommended for all other patients.[66175]

    Intramuscular Administration

    Pfizer-BioNTech COVID-19 vaccine

    Thawing (Pfizer-BioNTech COVID-19 vaccine with purple caps and labels for 12 years and older)

    • The Pfizer-BioNTech COVID-19 vaccine contains a volume of 0.45 mL, supplied as a frozen suspension that is preservative-free. Each vial must be thawed prior to dilution.
    • During storage, minimize exposure to room light and avoid exposure to direct sunlight and ultraviolet light. Do NOT refreeze thawed vials.
      • Thawing under refrigeration: Vials may be thawed and stored in the refrigerator [2 to 8 degrees C (35 to 46 degrees F)] for up to 1 month. A carton of 25 or 195 vials may take up to 2 or 3 hours, respectively, to thaw in the refrigerator; fewer vials will require less time to thaw.
      • Transportation of vials thawed under refrigeration: Available data support transportation of 1 or more vials thawed under refrigeration at 2 to 8 degrees C (35 to 46 degrees F) for up to 12 hours.
      • Thawing at room temperature: For immediate use, frozen vials may be thawed at room temperature [up to 25 degrees C (77 degrees F)] for 30 minutes. Undiluted vials may be stored at room temperature for no more than 2 hours.

    Dilution

    • Thawed vials must reach room temperature before dilution and must be diluted within 2 hours.
    • Before dilution, gently invert vial 10 times to mix. Do NOT shake.
    • Inspect liquid in the vial prior to dilution. The liquid should be a white to off-white suspension and may contain white to off-white amorphous particles.
    • Dilute the vaccine suspension in its original vial with 1.8 mL of 0.9% Sodium Chloride Injection. Do NOT use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent. Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL of air into the empty diluent syringe. Do not add more than 1.8 mL of diluent
    • After dilution, gently invert vial 10 times to mix. Do NOT shake.
    • Each vial contains up to 6 doses of 0.3 mL. Vial labels and cartons may state that after dilution, a vial contains 5 doses of 0.3 mL. The information on the EUA fact sheet and product labeling supersedes the number of doses stated on vial labels and cartons.
    • Low dead-volume syringes and/or needles are preferred to extract up to 6 doses from a single vial. If using standard syringes and needles, the volume may not be sufficient to extract a sixth dose from a single vial. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and content; do not pool excess vaccine from multiple vials.
    • Record the date and time of dilution on the vial label.
    • Storage after dilution: Store between 2 and 25 degrees C (35 to 77 degrees F) and use within 6 hours from the time of dilution. Discard any vaccine remaining in vials after 6 hours.[66080][66904]

     

    Thawing (Pfizer-BioNTech COVID-19 vaccine with gray caps and labels for 12 years and older)

    • The Pfizer-BioNTech COVID-19 vaccine contains a volume of 2.25 mL, supplied as a frozen suspension that is preservative-free. Each vial must be thawed prior to administration.
    • During storage, minimize exposure to room light and avoid exposure to direct sunlight and ultraviolet light. Do NOT refreeze thawed vials.
      • Thawing under refrigeration: Vials may be thawed and stored in the refrigerator [2 to 8 degrees C (35 to 46 degrees F)] for up to 10 weeks. A carton of 10 vials may take up to 6 hours to thaw.
      • Thawing at room temperature: Allow vials to thaw at room temperature [up to 25 degrees C (77 degrees F)] for 30 minutes.
      • Thawed vials may be stored at room temperature [up to 25 degrees C (77 degrees F)] for up to 12 hours prior to use.

    Do NOT dilute

    • Before administration, gently invert vial 10 times to mix. Do NOT shake.
    • Prior to mixing, inspect liquid in the vial. The thawed vaccine may contain white to off-white opaque amorphous particles.
    • After mixing, the vaccine should appear as a white to off-white suspension. Do not use if it is discolored or contains particulate matter.
    • Each vial contains up to 6 doses of 0.3 mL.
    • Low dead-volume syringes and/or needles are preferred to extract up to 6 doses from a single vial. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and content; do not pool excess vaccine from multiple vials.
    • Record the date and time of first vial puncture on the vial label.
    • Storage after vial puncture: Store between 2 and 25 degrees C (35 to 77 degrees F) and use within 12 hours from the time of first vial puncture. Discard any vaccine remaining in vials after 12 hours.[67215]

     

    Thawing (Pfizer-BioNTech COVID-19 vaccine with orange caps and labels for 5 to 11 years)

    • The Pfizer-BioNTech COVID-19 vaccine contains a volume of 1.3 mL, supplied as a frozen suspension that is preservative-free. Each vial must be thawed prior to dilution.
    • During storage, minimize exposure to room light and avoid exposure to direct sunlight and ultraviolet light. Do NOT refreeze thawed vials.
      • Thawing under refrigeration: Vials may be thawed and stored in the refrigerator [2 to 8 degrees C (35 to 46 degrees F)] for up to 10 weeks. A carton of 10 vials may take up to 4 hours to thaw.
      • Thawing at room temperature: Allow vials to thaw at room temperature [up to 25 degrees C (77 degrees F)] for 30 minutes.
      • Thawed vials may be stored at room temperature [up to 25 degrees C (77 degrees F)] for up to 12 hours prior to use.

    Dilution

    • Before dilution, gently invert vial 10 times to mix. Do NOT shake.
    • Inspect liquid in the vial prior to dilution. The liquid should be a white to off-white suspension and may contain opaque amorphous particles.
    • Dilute the vaccine suspension in its original vial with 1.3 mL of 0.9% Sodium Chloride Injection.
    • Equalize vial pressure before removing the needle from the vial by withdrawing 1.3 mL of air into the empty diluent syringe. Do not add more than 1.3 mL of diluent.
    • After dilution, gently invert vial 10 times to mix. Do NOT shake.
    • The vaccine will be a white to off-white suspension. Do not use if it is discolored or contains particulate matter.
    • Each vial contains up to 10 doses of 0.2 mL.
    • Low dead-volume syringes and/or needles are preferred to extract up to 10 doses from a single vial. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 mL, discard the vial and content; do not pool excess vaccine from multiple vials.
    • Record the date and time of first vial puncture on the vial label.
    • Storage after dilution: Store between 2 and 25 degrees C (35 to 77 degrees F) and use within 12 hours from the time of dilution. Discard any vaccine remaining in vials after 12 hours.[67085]

     

    Thawing (Pfizer-BioNTech COVID-19 vaccine with maroon caps and labels for 6 months to 4 years)

    • The Pfizer-BioNTech COVID-19 vaccine contains a volume of 0.4 mL, supplied as a frozen suspension that is preservative-free. Each vial must be thawed prior to dilution.
    • During storage, minimize exposure to room light and avoid exposure to direct sunlight and ultraviolet light. Do NOT refreeze thawed vials.
      • Thawing under refrigeration: Vials may be thawed and stored in the refrigerator [2 to 8 degrees C (35 to 46 degrees F)] for up to 10 weeks. A carton of 10 vials may take up to 2 hours to thaw.
      • Thawing at room temperature: Allow vials to thaw at room temperature [up to 25 degrees C (77 degrees F)] for 30 minutes.
      • Thawed vials may be stored at room temperature [up to 25 degrees C (77 degrees F)] for up to 12 hours prior to use.

    Dilution

    • Before dilution, gently invert vial 10 times to mix. Do NOT shake.
    • Inspect liquid in the vial prior to dilution. The liquid should be a white to off-white suspension and may contain opaque amorphous particles.
    • Dilute the vaccine suspension in its original vial with 2.2 mL of 0.9% Sodium Chloride Injection.
    • Equalize vial pressure before removing the needle from the vial by withdrawing 2.2 mL of air into the empty diluent syringe. Do not add more than 2.2 mL of diluent.
    • After dilution, gently invert vial 10 times to mix. Do NOT shake.
    • The vaccine will be a white to off-white suspension. Do not use if it is discolored or contains particulate matter.
    • Each vial contains up to 10 doses of 0.2 mL.
    • Low dead-volume syringes and/or needles are preferred to extract up to 10 doses from a single vial. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 mL, discard the vial and content; do not pool excess vaccine from multiple vials.
    • Record the date and time of first vial puncture on the vial label.
    • Storage after dilution: Store between 2 and 25 degrees C (35 to 77 degrees F) and use within 12 hours from the time of dilution. Discard any vaccine remaining in vials after 12 hours.[67688]

     

    Intramuscular Injection

    • Prior to vaccine administration, verify the patient's age and the vaccine(s) they have requested; ensure the age-appropriate formulation is used. Involve the parent or caregiver in reading the label to confirm the correct vaccine. Only bring the labeled vaccine syringe(s) for 1 patient into the vaccination area. Document the lot number and date of manufacture prior to vaccine administration with additional documentation after vaccine administration.[67188]
    • After withdrawing the dose, administer immediately as an intramuscular injection.[66080][66904][67085][67215][67688]

     

    Moderna COVID-19 vaccine

    Thawing

    • The Moderna COVID-19 vaccine contains a frozen suspension that is preservative-free and must be thawed prior to use.
      • 2.5 mL vial:
        • Thawing in the refrigerator: Vials may be thawed and stored in the refrigerator [2 to 8 degrees C (36 to 46 degrees F)] for 2 hours. Allow vial to remain at room temperature for 15 minutes prior to administration.
        • Thawing at room temperature: Frozen vials may be thawed at room temperature [15 to 25 degrees C (59 to 77 degrees F)] for 45 minutes.
      • 5.5 mL vial:
        • Thawing in the refrigerator: Vials may be thawed and stored in the refrigerator [2 to 8 degrees C (36 to 46 degrees F)] for 2 hours 30 minutes. Allow vial to remain at room temperature for 15 minutes prior to administration.
        • Thawing at room temperature: Frozen vials may be thawed at room temperature [15 to 25 degrees C (59 to 77 degrees F)] for 1 hour.
      • 7.5 mL vial:
        • Thawing in the refrigerator: Vials may be thawed and stored in the refrigerator [2 to 8 degrees C (36 to 46 degrees F)] for 3 hours. Allow vial to remain at room temperature for 15 minutes prior to administration.
        • Thawing at room temperature: Frozen vials may be thawed at room temperature [15 to 25 degrees C (59 to 77 degrees F)] for 1 hour 30 minutes.
      • Do NOT refreeze thawed vials.
      • Thawed vials can be handled in room light conditions; however, minimize exposure to room light during storage.

     

    Preparation

    • Swirl vial gently after thawing and between each withdrawal. Do NOT shake. Do NOT dilute.
    • Withdraw each 0.25 mL or 0.5 mL dose using a new sterile needle and syringe to prevent transmission of infection between patients. Pierce the stopper at a different site each time.
    • The 2.5 mL vial contains five 0.5 mL doses or ten 0.25 mL doses.
    • The 5.5 mL vial contains a maximum of 11 primary series doses with a range of 10 to 11 doses. A maximum of 20 doses may be extracted for booster doses or a combination of primary series and booster doses.
    • The 7.5 mL vial contains a maximum of 15 primary series doses with a range of 13 to 15 doses. A maximum of 20 doses may be extracted for booster doses or a combination of primary series and booster doses.
    • If the vial stopper has been punctured 20 times, discard the vial and contents. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.25 mL or 0.5 mL, discard the vial and content; do not pool excess vaccine from multiple vials.
    • Storage before vial has been needle-punctured:
      • Storage in refrigerator: Store between 2 and 8 degrees C (36 to 46 degrees F) for up to 30 days. Do NOT refreeze.
      • Storage outside refrigerated conditions: Vials may be stored between 8 and 25 degrees C (46 to 77 degrees F) for a total of 24 hours.
    • Storage after vial has been needle-punctured: Store between 2 and 25 degrees C (36 to 77 degrees F) and use within 12 hours from the time the needle punctures the vial to withdraw initial dose. Do NOT refreeze.[66120][67339][67491][67691][67692]

     

    Intramuscular Injection

    • Prior to vaccine administration, verify the patient's age and the vaccine(s) they have requested; ensure the age-appropriate formulation is used. Involve the parent or caregiver in reading the label to confirm the correct vaccine. Only bring the labeled vaccine syringe(s) for 1 patient into the vaccination area. Document the lot number and date of manufacture prior to vaccine administration with additional documentation after vaccine administration.[67188]
    • After withdrawing the dose, administer immediately as an intramuscular injection.[66120][67339][67491][67691][67692]

    Clinical Pharmaceutics Information

    From Trissel's 2‚Ñ¢ Clinical Pharmaceutics Database
      Revision Date: 06/20/2022, 04:57:44 PM

      References

      66080 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 12 years of age and older. Purple cap and purple border. Retrieved June 17, 2022.66120 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 12 years and older. Red cap and light blue border. Retrieved June 17, 2022.66175 - Center for Disease Control and Prevention. Interim clinical considerations for use of COVID-19 vaccines currently approved or authorized in the United States. Updated April 25, 2022. Accessed April 22, 2022. Available at: https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html.66904 - Comirnaty (COVID-19) injection package insert. New York, NY: Pfizer, Inc; 2021 Aug.67085 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 5 to 11 years of age. Orange cap and orange border. Retrieved June 17, 2022.67102 - Institute for Safe Medication Practices (ISMP). Adult and pediatric COVID-19 vaccine mix-ups are predictable. Acute Care ISMP Medication Safety Alert 2021;26(22):1-4.67188 - Institute for Safe Medication Practices (ISMP). National Alert Network (NAN Alerts) Age-related COVID-19 vaccine mix-ups. Retrieved on Dec 6, 2021.67215 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 12 years of age and older. Gray cap and gray border. Retrieved June 17, 2022.67339 - Spikevax (COVID-19) injection package insert. Cambridge, MA: Moderna US, Inc.; 2022 Jan.67491 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for booster dose only. Dark blue cap and purple border. Retrieved June 17, 2022.67688 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 6 months to 4 years of age. Maroon cap and Maroon border. Retrieved June 17, 2022.67691 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 6 to 11 years. Dark blue cap and purple border. Retrieved June 17, 2022.67692 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 6 months to 5 years. Dark blue cap and magenta border. Retrieved June 17, 2022.

      Adverse Reactions

      Mild

      • anorexia
      • arthralgia
      • chills
      • diarrhea
      • fatigue
      • fever
      • headache
      • injection site reaction
      • malaise
      • myalgia
      • nausea
      • pruritus
      • rash
      • urticaria
      • vomiting

      Moderate

      • erythema
      • lymphadenopathy

      Severe

      • anaphylactoid reactions
      • angioedema
      • appendicitis
      • Bell's palsy
      • myocarditis
      • pericarditis

      Local injection site reaction was the most commonly reported adverse reaction after COVID-19 vaccine administration during clinical trials. In general, the rates and severity of the reactions were slightly higher after the second dose compared to after the first.[66080] [66120] [66904] [67085] [67339] After Pfizer-BioNTech COVID-19 vaccine administration, pain (66.1% to 86.2%), erythema or redness (5% to 18.5%), and swelling (4.9% to 16.4%) at the injection site were reported during clinical trials. About one-third of patients 12 to 55 years (30.9% to 44.7%) who received the vaccine reported pain that either interfered with daily activity or prevented it; the percentage of patients reporting this degree of pain was lower in patients 5 to 11 years (15.2% to 18.1%) and 56 years and older (14.9% to 19.2%). Redness and swelling occurred more frequently in patients 5 to 11 years (14.7% to 18.5% and 10.5% to 16.4%, respectively) compared to patients 12 years and older (5% to 7.2% and 4.9% and 7.8%, respectively). The mean duration of pain at the injection site after dose 2 was 2.3 to 2.5 days (range 1 to 70 days), for redness 2.2 to 3 days (range 1 to 34 days), and for swelling 1.9 to 2.6 days (range 1 to 34 days). After the booster dose, the mean duration of pain at the injection site for patients 5 to 11 years was 2.4 days (range 1 to 35 days), for redness 2.3 days (range 1 to 12 days), and for swelling 2.3 days (range 1 to 9 days). After the booster dose, the mean duration of pain at the injection site for patients 18 to 55 years was 2.6 days (range 1 to 8 days), for redness 2.2 days (range 1 to 15 days), and for swelling 2.2 days (range 1 to 8 days).[66080] [66904] [67085] After Moderna COVID-19 vaccine administration, pain at the injection site was reported in 92% of patients. The highest rates of pain were in patients 18 to 64 years after dose 2, with 89.9% reporting pain and 4.6% reporting that it prevented daily activity and required the use of pain relievers. Erythema or redness (2.4% to 9%) and swelling or hardness (4.5% to 12.7%) were reported in patients 18 years and older. Axillary swelling or tenderness was more common after the second dose in both age groups (18 to 64 years: 16.2% after dose 2, 11.6% after dose 1 and 65 years and older: 8.5% after dose 2, 6.1% after dose 1). Most local reactions lasted 1 to 3 days.[66120] [66199] [67339] Patients who have received dermal fillers may develop swelling at or near the site of filler injection (usually face or lips) after mRNA COVID-19 vaccine administration. It appears to be temporary and can resolve with medical treatment, including corticosteroid therapy. These patients may receive mRNA COVID-19 vaccines without additional precautions; however, they should be advised to contact their health care provider if they develop swelling at or near the site of dermal filler after vaccination.[66175]

      During clinical trials, fatigue (33.6% to 67.8%), headache (22.4% to 64.5%), and malaise (0.1% to 0.5%) occurred after administration of the COVID-19 vaccine. The rates and severity of the reactions were generally higher after the second dose compared to the first dose.[66080] [66120] [66904] [67085] [67339] In patients who received the Pfizer-BioNTech COVID-19 vaccine, fatigue was more frequently reported in patients 12 to 55 years (49.4% to 66.2%) compared to patients 5 to 11 years (33.6% to 39.4%) and patients 56 years and older (33.7% to 51%). Mild fatigue (not interfering with activity) was more frequent in patients 5 to 11 years (21.4% to 22% vs. 11.3% to 17.3% moderate) and patients 56 years and older (20.7% to 21% vs. 8.2% to 12.9% moderate). In contrast, patients 12 to 55 years reported moderate fatigue (causing some interference with activity) more frequently (12 to 15 years: 34.1% to 42.7% vs. 21.1% to 24.7% mild; 16 to 55 years: 21.7% to 35.4% vs. 20.8% to 26.2% mild). Headache was also more common in patients 12 to 55 years (43.5% to 64.5%) compared to patients 5 to 11 years (22.4% to 28%) and patients 56 years and older (25% to 39.4%). The incidence of fatigue and headache after a booster dose of the Pfizer-BioNTech COVID-19 vaccine in patients 5 to 11 years (45.6% and 34%, respectively) and 18 to 55 years (63.7% and 48.4%, respectively) was similar to that seen after the second dose of the primary series.[66080] [66904] [67085] In Moderna COVID-19 vaccine clinical trials, fatigue (70%) was the most frequently reported systemic adverse reaction. The highest incidence of fatigue was reported by patients 18 to 64 years after the second dose, with 67.8% reporting any fatigue, 10.7% reporting fatigue that prevented daily activities, and 1 case requiring an emergency room visit or hospitalization. Headache was reported by approximately twice as many patients after the second dose in both age groups (18 to 64 years: 63% after dose 2, 35.3% after dose 1 and 65 years and older: 46.3% after dose 2, 24.5% after dose 1). The incidence of fatigue and headache after a booster dose of the Moderna COVID-19 vaccine (53.5% to 67.7% and 39.5% to 56.1%, respectively) was similar to that seen after the second dose of the primary series.[66120] [67339]

      Musculoskeletal adverse reactions reported during COVID-19 vaccine clinical trials include muscle pain or myalgia (9.1% to 61.7%) and/or joint pain or arthralgia (3.3% to 45.6%).[66080] [66120] [66904] [67085][67339] New or worsened muscle pain (9.1% to 11.7%) and joint pain (3.3% to 5.2%) were reported less frequently in patients 5 to 11 years compared to patients 16 years and older. In patients 12 to 15 years of age, new or worsened muscle pain was reported in about one-third of patients (32.4%) after the second Pfizer-BioNTech COVID-19 vaccine dose compared to 24.1% after the first dose. A similar number of patients 16 to 55 years (39.3% after dose 2, 22.9% after dose 1) and 56 years or older (28.9% after dose 2, 13.6% after dose 1) reported new or worsened muscle pain. Moderate to severe muscle pain (causing some interference with daily activities or preventing activities) was reported after dose 2 in 18.5% of patients 12 to 15 years, 22.9% of patients 16 to 55 years, and 16.6% of patients 56 years and older. New or worsened joint pain was reported in approximately twice as many patients after the second dose compared to the first dose in patients 12 years and older (12 to 15 years: 15.8% after dose 2, 9.7% after dose 1; 16 to 55 years: 23.8% after dose 2, 11.8% after dose 1; and 56 years and older: 19% after dose 2, 8.7% after dose 1). The incidence of myalgia and arthralgia after a booster dose of the Pfizer-BioNTech COVID-19 vaccine in patients 5 to 11 years (18.3% and 6.7%, respectively) and 18 to 55 years (39.1% and 25.3%, respectively) was similar to that seen after the second dose of the primary series.[66080] [66904] [67085] During Moderna COVID-19 clinical trials, myalgia was more common after the second dose in both age groups (18 to 64 years: 61.7% after dose 2, 23.7% after dose 1 and 65 years and older: 47.2% after dose 2, 19.7% after dose 1). Myalgia that prevented daily activity was reported in significantly more patients after the second dose (18 to 64 years: 10.1% after dose 2, 0.6% after dose 1 and 65 years and older: 5.6% after dose 2, 0.5% after dose 1). Similar to myalgia, arthralgia was more common after the second dose in both age groups (18 to 64 years: 45.6% after dose 2, 16.6% after dose 1 and 65 years and older: 35.1% after dose 2, 16.4% after dose 1). Arthralgia that prevented daily activity was reported in significantly more patients after the second dose (18 to 64 years: 5.9% after dose 2, 0.4% after dose 1 and 65 years and older: 3.4% after dose 2, 0.3% after dose 1). One case of arthralgia requiring an emergency room visit or hospitalization was reported in the vaccine group. The incidence of myalgia and arthralgia after a booster dose of the Moderna COVID-19 vaccine (39.5% to 41.9% and 47.4% to 49.6%, respectively) was similar to that seen after the second dose of the primary series.[66120] [67339]

      During clinical trials, chills (4.6% to 48.7%) and fever (1.3% to 19.6%) occurred after administration of the COVID-19 vaccine. The rates and severity of the reactions were generally higher after the second dose compared to the first dose.[66080] [66120] [66904] [67085] [67339] In patients 5 to 15 years, fever of 101.2 degrees F (38.4 degrees C) or higher was reported in 3 times more patients after the second Pfizer-BioNTech COVID-19 vaccine dose (5 to 11 years: 3.1% after dose 2, 1% after dose 1; 12 to 15 years: 9.9% after dose 2, 3.6% after dose 1). In patients 16 to 55 years, fever of 101.2 degrees F (38.4 degrees C) or higher was reported in 6 times more patients after the second Pfizer-BioNTech COVID-19 vaccine dose (6.9% after dose 2, 1.2% after dose 1). In patients 56 years and older, fever of 101.2 degrees F (38.4 degrees C) or higher was reported in 3.3% of patients after dose 2 compared to 0.1% of patients after dose 1. In patients who received the Pfizer-BioNTech COVID-19 vaccine, chills were more frequently reported in patients 12 to 55 years (16.5% to 41.5%) compared to patients 5 to 11 years (4.6% to 9.8%) and patients 56 years and older (6.5% to 23.4%).[66080] [66904] [67085] After Moderna COVID-19 vaccine administration, fever was reported in more patients 18 to 64 years after dose 2 (17.4%) compared to dose 1 (0.9%). A fever of 102.1 degrees F (38.9 degrees C) or higher was reported by 1.7% of patients after dose 2 compared to less than 0.1% after dose 1. Significantly more patients 65 years and older also reported fever after the second dose (9.9% after dose 2, 0.3% after dose 1). A fever of 102.1 degrees F (38.9 degrees C) or higher was reported by 0.5% of patients after dose 2 compared to less than 0.1% after dose 1. The greatest incidence of chills occurred after dose 2 in patients 18 to 64 years (48.7%).[66120] [67339] The incidence of chills and fever after a booster dose of the Pfizer-BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine was similar to that seen after the primary series.[66080] [66120] [67085]

      Adverse gastrointestinal (GI) reactions have been reported during COVID-19 vaccine trials.[66080] [66120] [66904] [67085] [67339] Diarrhea (5.3% to 10.7%), nausea (0.4% to 1.2%), and vomiting (0.5% to 2.8%) were reported during Pfizer-BioNTech COVID-19 vaccine clinical trials. Anorexia (decreased appetite) was reported by 0.1% of patients 5 to 11 years old.[66080] [66904] [67085] During Moderna COVID-19 vaccine clinical trials, nausea and/or vomiting was reported in twice as many patients 18 to 64 years after dose 2 (21.4%) compared to dose 1 (9.4%). A similar difference was seen in patients 65 years and older (11.9% after dose 2; 5.2% after dose 1). One case of intractable nausea and vomiting requiring hospitalization was reported as a serious adverse reaction in the vaccine group.[66120] [67339] The incidence of GI adverse reactions after a booster dose of the Pfizer-BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine was similar to that seen after the primary series.[66080] [66120] [67085]

      Rare cases of myocarditis and pericarditis have been reported after mRNA COVID-19 vaccination, particularly in adolescents and young adults. The observed risk is greater for males younger than 40 years of age than for females and older males and the risk is highest in males 12 to 17 years of age (Pfizer-BioNTech COVID-19 vaccine) and in males 18 to 24 years of age (Moderna COVID-19 vaccine). Onset typically has been within 7 days after vaccination, occurring more often after the second dose. The risk of myocarditis may be reduced by extending the interval to 8-weeks between the first and second dose in patients 12 years and older, especially males 12 to 39 years. According to evidence from multiple sources, the risk of myocarditis and pericarditis is higher in males under 40 after Moderna COVID-19 vaccination compared to other authorized or approved COVID-19 vaccines. From May 1 through June 11, 2021, there were 40.6 cases of myocarditis per million second doses of mRNA COVID-19 vaccines administered to males aged 12 to 29 years and 2.4 cases per million second doses administered to males aged 30 years and older; reporting rates among females were 4.2 and 1 cases per million second doses, respectively. Although postmarketing data is limited, available evidence suggests a lower risk after administration of a mRNA booster dose compared to the risk after the second dose in the primary series. No cases of myocarditis were reported in patients aged 5 to 11 years (n = 3,082) in Pfizer-BioNTech COVID-19 trials with at least 7 days of follow-up after dose 2, although the study was not powered to assess the risk for myocarditis. Consider myocarditis and pericarditis in adolescents and young adults with acute chest pain, shortness of breath, or palpitations. Most patients require hospitalization, but have experienced resolution of acute symptoms. Although data from short-term follow-up suggests that most patients have resolution of acute symptoms, information is not yet available about long-term sequelae. It is unclear if patients who develop myocarditis or pericarditis after a first dose of mRNA COVID-19 vaccine are at an increased risk of further adverse cardiac effects after a subsequent dose of vaccine; until additional information is available, a subsequent dose should generally be avoided. If the decision is made to receive a subsequent dose, the episode of myocarditis or pericarditis should be resolved. Considerations for subsequent vaccination include myocarditis or pericarditis was considered unrelated to mRNA COVID-19 vaccination (e.g., due to SARS-CoV-2 or other viruses, diagnosis was made more than 3 weeks after vaccination), personal risk of severe acute COVID-19 (e.g., age, underlying conditions), level of COVID-19 community transmission and personal risk of infection, or timing of any immunomodulatory therapies. Patients with a history of myocarditis or pericarditis prior to COVID-19 vaccination should not receive a mRNA vaccine dose until their episode of myocarditis or pericarditis has completely resolved, which incudes no evidence of ongoing heart inflammation or sequelae. For men 18 years and older who develop myocarditis or pericarditis after a dose of mRNA COVID-19 vaccine and chose to receive a subsequent dose of COVID-19 vaccine, consider administration of the Janssen COVID-19 vaccine instead of a mRNA COVID-19 vaccine, taking into account the risk of thrombosis with thrombocytopenia syndrome. In a retrospective study of 139 patients (mostly white male; median age of 15.8 years), suspected myocarditis was reported in 131 (94.2%) patients receiving the Pfizer-BioNTech vaccine, with the majority of cases occurring after the second dose 128 (91.4%). Five cases (3.6%) were reported after the Moderna COVID-19 vaccine, 1 case (0.7%) occurred after the Janssen COVID-19 vaccine, and the brand was unknown in 2 patients. Median onset of symptoms was 2 days after vaccination and the most common symptom was chest pain (99.3%). Patients were treated with nonsteroidal anti-inflammatory drugs (81.3%), intravenous immunoglobulin (21.6%), glucocorticoids (21.6%), colchicine (7.9%), or no anti-inflammatory therapies (8.6%). Twenty-six patients (18.7%) were in the ICU, but only 2 patients were treated with inotropic/vasoactive support, and none required ECMO or died. The median hospital stay was 2 days (0 to 10 days).[66080] [66120] [66175] [66698] [66770] [66904] [67172]

      Serious allergic reactions or anaphylactoid reactions have been reported in patients outside of clinical trials during mass vaccination. During phase 2/3 Pfizer-BioNTech COVID-19 vaccine clinical trials, a subset of patients in the vaccinated group had hypersensitivity-related adverse reactions, possibly representing allergic reactions (0.63% vs. 0.51%, placebo).[66080] [66175] During mass vaccination with the Pfizer-BioNTech COVID-19 vaccine outside of clinical trials, severe allergic reactions, including anaphylaxis and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema), have been reported.[66080] During this time, 21 cases of anaphylaxis were identified (a rate of 11.1 anaphylaxis cases per million doses administered). Of those, 17 patients had a documented history of allergies or allergic reaction and 7 patients had a history of anaphylaxis. Median time to symptom onset was 13 minutes (range = 2 to 150 minutes). Twenty patients were available for follow-up and all had recovered or been discharged home. An additional 83 nonanaphylaxis allergic reactions were reported; symptoms included pruritus, rash, itchy and scratchy sensation in the throat, and mild respiratory symptoms. Median time to symptom onset was 12 minutes (range = less than 1 minute to 20 hours). In most patients (85%), symptoms occurred within 30 minutes. For 67% of patients, a past history of allergies or allergic reactions was documented. Rash was reported in patients 5 to 11 years old (0.3%) and in patients after administration of the booster dose (0.3%).[66397] [67085] During Moderna COVID-19 clinical trials, hypersensitivity related adverse reactions were reported in 1.5% of vaccine recipients compared to 1.1% of placebo recipients. Hypersensitivity reactions included injection site rash and injection site urticaria. Rash was also reported in 1.8% of patients after administration of the booster dose.[66120] During mass vaccination with the Moderna vaccine, 10 cases of anaphylaxis were identified (a rate of 2.5 anaphylaxis cases per million doses administered). Of those, 9 patients had a documented history of allergies or allergic reaction and 5 patients had a history of anaphylaxis. Median time to symptom onset was 7.5 minutes (range = 1 to 45 minutes). Eight patients were available for follow-up and all had recovered or been discharged home. An additional 43 nonanaphylaxis allergic reactions were reported; symptoms included pruritus, rash, itchy and scratchy sensation in the throat, sensations of throat closure, and mild respiratory symptoms. Median time to symptom onset was 15 minutes (range = less than 1 minute to 24 hours). In most patients (73%), symptoms occurred within 30 minutes. For 60% of patients, a past history of allergies or allergic reactions was documented.[66398]

      Lymphadenopathy was reported in 0.3% to 0.9% of patients 5 years and older during Pfizer-BioNTech COVID-19 vaccine clinical trials and in 2.5% and 5.2% of patients 5 to 11 years and 18 to 55 years, respectively, after the booster dose. From dose 1 through 30 days after dose 2, lymphadenopathy was reported in more patients in the vaccine group than in the placebo group (5 to 11 years: 13 vs. 1; 12 to 15 years: 7 vs. 1; 16 years and older: 64 vs. 6).[66080] [66904] [67085] During Moderna COVID-19 vaccine clinical trials, lymphadenopathy-related events were reported in 1.7% of patients who received the vaccine compared to 0.8% of patients who received placebo. These events included lymphadenopathy, lymphadenitis, lymph node pain, vaccination-site lymphadenopathy, injection-site lymphadenopathy, and axillary mass.[66120] [67339]

      During Pfizer-BioNTech COVID-19 vaccine clinical trials, appendicitis was reported as a serious adverse reaction in 8 patients receiving vaccine (n = 18,801) vs. 4 receiving placebo (n = 18,785). Bell's palsy (facial paralysis) was reported by 4 patients in the Pfizer-BioNTech COVID-19 vaccine group (n = 18,801) compared to none of the patients in the placebo group. Onset of facial paralysis occurred on day 37 after dose 1 (patient did not receive dose 2) and days 3, 9, and 48 after dose 2. During the blinded portion of Moderna COVID-19 vaccine clinical trials, there were 8 reports of facial paralysis (including Bell's palsy) in the vaccine group compared to 3 patients in the placebo group. In the 28-day follow-up period, there were 2 cases of facial paralysis in the vaccine group (occurring on 8 and 22 days, respectively, after vaccination) compared to 1 in the placebo group (occurring 17 days after vaccination). In the United States, it is estimated that between 25 and 35 in 100,000 people are affected with Bell's palsy. During the blinded portion of Moderna COVID-19 vaccine clinical trials, there were 50 reports of herpes zoster in the vaccine group compared to 23 patients in the placebo group. In the 28-day follow-up period, there were 22 cases of herpes zoster in the vaccine group compared to 15 in the placebo group. Currently available information is insufficient to determine a causal relationship between appendicitis, Bell's palsy, or herpes zoster with the vaccine.[66080] [66120] [66184] [67339]

      Revision Date: 06/17/2022, 06:53:19 PM

      References

      66080 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 12 years of age and older. Purple cap and purple border. Retrieved June 17, 2022.66120 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 12 years and older. Red cap and light blue border. Retrieved June 17, 2022.66175 - Center for Disease Control and Prevention. Interim clinical considerations for use of COVID-19 vaccines currently approved or authorized in the United States. Updated April 25, 2022. Accessed April 22, 2022. Available at: https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html.66184 - National Organization for Rare Disorders (NORD). Bell's Palsy. Accessed December 18, 2020. Available on the World Wide Web at https://rarediseases.org/rare-diseases/bells-palsy/.66199 - Baden LR, El Sahly HM, Essink B, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. [published online ahead of print, 2020 Dec 30]. N Engl J Med. Doi: 10.1056/NEJMoa2035389.66397 - Centers for Disease Control and Prevention. Allergic reactions including anaphylaxis after receipt of the first dose of Pfizer-BioNTech COVID-19 vaccine - United States, December 14-23, 2020. MMWR 2021;70:1-6.66398 - Centers for Disease Control and Prevention. Allergic reactions including anaphylaxis after receipt of the first dose of Moderna COVID-19 vaccine - United States, January 10, 2021. MMWR 2021;70(4):125-129.66698 - Centers for Disease Control and Prevention (CDC). Clinical considerations: myocarditis and pericarditis after receipt of mRNA COVID-19 vaccines among adolescents and young adults. Accessed May 28, 2021. Available at: https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html?ACSTrackingID=USCDC_425-DM58530&ACSTrackingLabel=Clinical%20Considerations%3A%20Myocarditis%20and%20Pericarditis%20after%20Receipt%20of%20mRNA%20COVID-19%20Vaccines&deliveryName=USCDC_425-DM58530.66770 - Gargano JW, Wallace M, Hadler SC, et al. Use of mRNA COVID-19 vaccine after reports of myocarditis among vaccine recipients: update from the Advisory Committee on Immunization Practices, June 2021. MMWR Morb Mortal Wkly Rep. ePub: 6 July 2021. DOI: http://dx.doi.org/10.15585/mmwr.mm7027e1.66904 - Comirnaty (COVID-19) injection package insert. New York, NY: Pfizer, Inc; 2021 Aug.67085 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 5 to 11 years of age. Orange cap and orange border. Retrieved June 17, 2022.67172 - Truong DT, Dionne A, Muniz JC, et al. Suspected myocarditis after COVID-19 vaccination. Circulation. 2021; Online ahead of print.67339 - Spikevax (COVID-19) injection package insert. Cambridge, MA: Moderna US, Inc.; 2022 Jan.67491 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for booster dose only. Dark blue cap and purple border. Retrieved June 17, 2022.67688 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 6 months to 4 years of age. Maroon cap and Maroon border. Retrieved June 17, 2022.67691 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 6 to 11 years. Dark blue cap and purple border. Retrieved June 17, 2022.67692 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 6 months to 5 years. Dark blue cap and magenta border. Retrieved June 17, 2022.

      Contraindications/Precautions

      Absolute contraindications are italicized.

      • acquired immunodeficiency syndrome (AIDS)
      • agammaglobulinemia
      • anticoagulant therapy
      • breast-feeding
      • chemotherapy
      • coagulopathy
      • corticosteroid therapy
      • heart transplant
      • hemophilia
      • human immunodeficiency virus (HIV) infection
      • hypogammaglobulinemia
      • immunosuppression
      • infection
      • kidney transplant
      • laboratory test interference
      • liver transplant
      • lung transplant
      • neoplastic disease
      • organ transplant
      • pregnancy
      • radiation therapy
      • renal failure
      • severe combined immunodeficiency (SCID)
      • syncope
      • thrombocytopenia
      • vitamin K deficiency

      The COVID-19 vaccine is contraindicated in patients with a history of a severe allergic reaction to any component of the vaccine. The CDC considers an immediate allergic reaction (occurring within 4 hours of administration) of any severity to a previous dose of COVID-19 vaccine or any of its components or a severe allergic reaction (i.e., anaphylaxis) after a previous dose or to a component of the COVID-19 vaccine a contraindication to COVID-19 vaccination. A known polyethylene glycol (PEG) allergy is a contraindication to the mRNA COVID-19 vaccines. PEG is an ingredient in both mRNA COVID-19 vaccines and polysorbate 80 is an ingredient in the Janssen COVID-19 vaccine; cross-reactive hypersensitivity between these compounds may occur. Patients with a contraindication to 1 type of COVID-19 vaccine (i.e, mRNA) have a precaution to the other (i.e., adenovirus). However, because of potential cross-reactive hypersensitivity between the ingredients in both vaccines, consider evaluation by an allergist-immunologist in patients with a known allergy to these ingredients before they receive COVID-19 vaccination. Patients with a history of an immediate allergic reaction to a vaccine or injectable therapy that contains multiple components, 1 or more of which is a component of a COVID-19 vaccine, have a precaution to vaccination with that COVID-19 vaccine, even if the specific component responsible for the allergic reaction is unknown. Administration of antihistamines is not recommended for allergic reaction prophylaxis prior to vaccination as they can mask cutaneous symptoms and delay the diagnosis and management of anaphylaxis. Delayed-onset local reactions (e.g., erythema, induration, pruritus), which are sometimes quite large, have been reported beginning a few days through the second week after the first mRNA COVID-19 vaccine dose in some patients. Patients with only a delayed-onset local reaction around the injection site area after the first vaccine dose are not thought to be at risk for anaphylaxis when receiving the second dose and do not have a contraindication or precaution to the second dose. These patients should still receive the second dose using the same vaccine product as the first dose and at the recommended interval, preferably in the opposite arm. As with any biologic product, the prescriber or healthcare professional should have procedures in place to manage allergic reactions. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and immediately discontinue administration of the vaccine. The healthcare professional should have immediate availability of epinephrine (1 mg/mL) injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction to the vaccine.[66080][66120][66175] When vaccinating patients with allergies, a 30 minute observation period is recommended for patients with a history of an immediate allergic reaction of any severity to a vaccine or injectable therapy, patients with a history of anaphylaxis due to any cause, or patients with a contraindication to a different COVID-19 vaccine than the 1 they are receiving. A 15 minute observation period is recommended for all other patients.[66175]

      Immunocompromised patients, including patients with immunosuppression or receiving immunosuppressive therapy, may not have an adequate immune response to the COVID-19 vaccine. An additional third dose of the same mRNA vaccine administered at least 28 days after the 2-dose regimen and a second booster dose have been authorized for individuals who have undergone solid organ transplantation (e.g., heart transplant, kidney transplant, liver transplant, lung transplant, or other organ transplant), or are diagnosed with a condition that is considered to have an equivalent level of immunocompromise. Patients at increased risk include, but are not limited to, those who have received a solid-organ transplant and are taking immunosuppressive therapy, those who are receiving active treatment with high-dose corticosteroids (i.e., 20 mg or more of prednisone or equivalent per day when administered for 2 weeks or more), transplant-related immunosuppressive drugs, and other biologic agents that are immunosuppressive or immunomodulatory, and patients with moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome). Administration of a third dose appears to be only moderately effective in increasing antibody titers; counsel patients to maintain physical precautions to avoid exposure to the SARS-CoV-2 virus.[66080] [66120] [66175] [66904] [67491] Immunosuppressed persons may also include patients with severe combined immunodeficiency (SCID), hypogammaglobulinemia, or agammaglobulinemia. Short-term (less than 2 weeks) corticosteroid therapy or intra-articular, bursal, or tendon injections with corticosteroids should not be immunosuppressive.[65107] [66175] Ideally, complete COVID-19 vaccination (including the primary series and an additional dose) at least 2 weeks before initiation or resumption of immunosuppressive therapies, but timing of COVID-19 vaccination should take into consideration current or planned immunosuppressive therapies and optimization of both the patient's medical condition and response to vaccine. Serologic testing or cellular immune testing to assess for immunity after COVID-19 vaccination, outside the context of research studies, is not recommended. Re-vaccination after immune competence is regained in patients who received mRNA COVID-19 vaccines during treatment with immunosuppressive drugs is not recommended. For patients receiving antibody therapies not specific to COVID-19 treatment (e.g., intravenous immunoglobulin, RhoGAM), there is no recommended minimum interval between these therapies and administration of mRNA COVID-19 vaccines. Administration of mRNA COVID-19 vaccines either together or at any interval before or after receipt of an antibody-containing product is unlikely to substantially impair the development of a protective antibody response. During clinical trials, no imbalances were noted in the occurrence of symptoms consistent with autoimmune conditions or inflammatory disorders in patients who received the COVID-19 vaccine compared to placebo. Patients with autoimmune conditions may receive the COVID-19 vaccine.[66175]

      Patients with altered immune states due to generalized neoplastic disease or an immune system compromised by radiation therapy or chemotherapy may not have an adequate immune response to the COVID-19 vaccine. An additional third dose of the same mRNA vaccine administered at least 28 days after the 2-dose regimen and a second booster dose have been authorized for individuals who have undergone solid organ transplantation, or are diagnosed with a condition that is considered to have an equivalent level of immunocompromise. Patients at increased risk include, but are not limited to, those receiving active treatment for solid tumor and hematologic malignancies, receipt of chimeric antigen receptor (CAR) T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppression therapy), and active treatment with alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor-necrosis (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory. Administration of a third dose appears to be only moderately effective in increasing antibody titers; counsel patients to maintain physical precautions to avoid exposure to the SARS-CoV-2 virus.[65107] [66080] [66120] [66175] [66904] [67491] Ideally, complete COVID-19 vaccination (including the primary series and an additional dose) at least 2 weeks before initiation or resumption of immunosuppressive therapies, but timing of COVID-19 vaccination should take into consideration current or planned immunosuppressive therapies and optimization of both the patient's medical condition and response to vaccine. Serologic testing or cellular immune testing to assess for immunity after COVID-19 vaccination, outside the context of research studies, is not recommended.[66175] Delay vaccination for at least 3 months after hematopoietic cell transplantation (HCT) or engineered cellular therapy (e.g. CAR-T cells) to maximize vaccine efficacy.[66335] Revaccinate patients who received 1 or more doses of COVID-19 vaccine (i.e., complete primary vaccination and any recommended additional or booster doses) prior to or during HCT or CAR-T-cell therapy for any doses administered before or during treatment starting at least 3 months after transplant or CAR-T-cell therapy. An mRNA COVID-19 vaccine is recommended for revaccination doses.[66175] For patients with hematologic malignancies receiving intensive cytotoxic chemotherapy (e.g., cytarabine/anthracycline-based induction regimens for AML), delay vaccination until absolute neutrophile count (ANC) recovery. For patients with solid tumor malignancies undergoing major surgery, separate date of surgery from vaccination by at least a few days to allow symptoms (e.g. fever) to be correctly attributed to surgery vs. vaccination. For more complex surgeries (e.g. splenectomy or surgery that may lead to an immunosuppressive state) surgeons may recommend a wider window (+/- 2 weeks) from the time of surgery.[66335]

      Postponing vaccination with the COVID-19 vaccine is recommended in patients with an acute moderate to severe illness or infection, both before the first vaccine or before the second vaccine if infection develops after the first vaccine administration. Patients who have active tuberculosis (TB) disease or an illness that is being evaluated as active TB disease can receive an mRNA COVID-19 vaccine. If vaccination is not deferred, observe the patient for 15 minutes after vaccine administration.[66175]

      Clinical trials for the vaccine were expanded to include patients with chronic, stable human immunodeficiency virus (HIV) infection. Efficacy information for the COVID-19 vaccine is not yet available in this patient population and although patients with HIV infection or acquired immunodeficiency syndrome (AIDS) could have a diminished response, the COVID-19 vaccine should be offered to patients with chronic, stable HIV.[65107] [66080] [66086] [66120] [66904] An additional third dose of the same mRNA vaccine administered at least 28 days after the 2-dose regimen and a second booster dose have been authorized for individuals who have undergone solid organ transplantation, or are diagnosed with a condition that is considered to have an equivalent level of immunocompromise. Patients at increased risk include, but are not limited to, those with advanced or untreated HIV infection (people with HIV and CD4 counts less than 200/mm3, history of AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV infection). Administration of a third dose appears to be only moderately effective in increasing antibody titers; counsel patients to maintain physical precautions to avoid exposure to the SARS-CoV-2 virus.[66080] [66120] [66175] [67491]

      The COVID-19 vaccine is administered by intramuscular (IM) injection only. Carefully consider the risks and benefits in patients at increased risk for bleeding after an intramuscular injection, such as thrombocytopenia, bleeding disorders (e.g., hemophilia), coagulopathy, vitamin K deficiency, and those receiving anticoagulant therapy. Caution and appropriate precautions to minimize the risk of bleeding or hematoma formation are advised.[65107] [66080] [66120] [66904]

      COVID-19 vaccination is recommended in all eligible women regardless of pregnancy status (including those who are pregnant, trying to get pregnant, or may become pregnant in the future). Pregnant and recently pregnant patients (for at least 42 days after the end of pregnancy) with COVID-19 are at increased risk for severe illness compared to patients who are not pregnant.[66175] [66179] [66863] If a woman becomes pregnant after the first dose, administer the second dose as indicated. Manage potential post vaccination fever with acetaminophen.[66863] [66864] A growing body of evidence suggests that benefits of COVID-19 vaccination outweigh any known or potential risk of vaccination during pregnancy. Recent studies have also shown that antibodies produced after COVID-19 vaccination during pregnancy are transferred to the newborn, and COVID-19 vaccination in pregnant patients reduces the risk of COVID-19 hospitalization in infants younger than 6 months.[66175] Data analyzed from 3 vaccine safety-related databases (VAERS, the v-safe active surveillance system, and the v-safe pregnancy registry) did not identify safety concerns for pregnant patients who were vaccinated late in their pregnancy or their infants. Analysis of current data from the V-SAFE pregnancy registry did not find an increased risk of miscarriage among approximately 2,500 pregnant women who received an mRNA COVID-19 vaccine before 20 weeks of pregnancy. Miscarriage rates in this population were 13%, compared to 11% to 16% of pregnancies in the general population. There is no current evidence that COVID-19 vaccines cause fertility problems in woman or men.[66175] [66863] [66864] In a prospective cohort study of 131 mRNA COVID-19 vaccine recipients (84 pregnant, 31 lactating, and 16 non-pregnant), vaccine-induced antibody titers were equivalent in pregnant and lactating women compared to non-pregnant women. All titers were significantly higher than those induced during SARS-CoV-2 infection during pregnancy. Vaccine-generated antibodies were present in all umbilical cord blood samples; neutralizing antibody titers were lower in umbilical cord compared to maternal sera, although statistical significance was not reached. No differences in reactogenicity were noted between the groups.[66558] A pregnancy exposure registry is available that monitors pregnancy outcomes in women exposed to Comirnaty (Pfizer-BioNTech COVID-19 vaccine) during pregnancy. Encourage women vaccinated during pregnancy to enroll in the registry by going to https://mothertobaby.org/ongoing-study/covid19-vaccines/.[66904] A pregnancy exposure registry is available that monitors pregnancy outcomes in women exposed to Moderna COVID-19 vaccine during pregnancy. Encourage women vaccinated with Moderna COVID-19 vaccine to enroll in the registry by calling 1-866-663-3762. Additionally, encourage pregnant women to enroll in the CDC's V-SAFE program by going to vsafe.cdc.gov.[66120] [66864]

      COVID-19 vaccination is recommended in all eligible women, including those who are breast-feeding.[66179] [66864] There are limited data regarding use of the COVID-19 vaccine during breast-feeding, its effect on milk production, and its excretion in human breast milk. However, the COVID-19 vaccines cannot cause infection in either the lactating patient or the infant.[66175] Recent reports suggest mothers who have received mRNA COVID-19 vaccines have antibodies in their breast milk, which may help protect their babies.[66864] In a prospective cohort study of 131 mRNA COVID-19 vaccine recipients (84 pregnant, 31 lactating, and 16 non-pregnant), vaccine-induced antibody titers were equivalent in pregnant and lactating women compared to non-pregnant women. All titers were significantly higher than those induced during SARS-CoV-2 infection during pregnancy. Vaccine-generated antibodies were present in all breast milk samples. No differences in reactogenicity were noted between the groups.[66558] If a breast-feeding infant experiences an adverse event possibly related to a maternally administered vaccine, health care providers are encouraged to report the adverse event to the FDA.[66080] [66904]

      Injectable vaccines, including the Pfizer-BioNTech COVID-19 vaccine, have been associated with episodes of syncope and fainting, especially in adolescents. Prior to administration, ensure procedures are in place to prevent falls and manage syncopal reactions. Patients should remain seated or lying down during the observation period to decrease the risk for injury. If syncope develops, observe patients until symptoms resolve.[66080] [66175] [66904]

      Data suggest immune response to COVID-19 vaccination may be reduced in patients with renal failure receiving hemodialysis. Counsel hemodialysis patients about the potential for reduced immune responses and the need to continue following precautions to avoid exposure to the SARS-CoV-2 virus.[66175]

      The use of the COVID-19 vaccine has resulted in laboratory test interference with the Bio-Rad Laboratories BioPlex 2200 Syphilis Total and Rapid Plasma Reagin (RPR) kit. False reactivity may occur for at least 5 months after COVID-19 vaccination. It is unknown if other RPR tests may also be affected. Treponemal testing for syphilis such as Treponema pallidum particle agglutination (TP-PA) and treponemal immunoassays do not appear to be impacted. Retest patients who receive a positive result using the Bio-Rad BioPlex 2200 Syphilis Total and RPR kit for syphilis with another test to confirm results. For patients with a negative treponemal test, but reactive RPR result using the Bio-Rad BioPlex 2200 Syphilis Total and RPR kit, repeat RPR testing is not necessary unless otherwise clinically indicated. For patients previously treated for syphilis, whose treponemal testing will remain persistently positive, and are being evaluated for a possible new syphilis infection, interpret a reactive RPR in the context of the patient's medical history, risk factors, and clinical presentation. If the Bio-Rad BioPlex 2200 Syphilis Total and RPR kit was used and the clinical presentation does not support syphilis reinfection, then confirm reactive results with a RPR test from another manufacturer.[67201]

      Revision Date: 04/06/2022, 04:54:27 PM

      References

      65107 - Kroger A, Bahta L, Hunter P. General Best Practice Guidelines for Immunization. Best Practices Guidance of the Advisory Committee on Immunization Practices (ACIP). Available on the world wide web at https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.pdf. Accessed on July 26, 202166080 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 12 years of age and older. Purple cap and purple border. Retrieved June 17, 2022.66086 - Protocol C4591001. A phase 1/2/3, placebo-controlled, randomized, observer-blind, dose-finding study to evaluate the safety, tolerability, immunogenicity, and efficacy of SARS-COV-2 RNA vaccine candidates against COVID-19 in healthy individuals. Accessed Nov 5, 2020. https://pfe-pfizercom-d8-prod.s3.amazonaws.com/2020-09/C4591001_Clinical_Protocol.pdf66120 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 12 years and older. Red cap and light blue border. Retrieved June 17, 2022.66175 - Center for Disease Control and Prevention. Interim clinical considerations for use of COVID-19 vaccines currently approved or authorized in the United States. Updated April 25, 2022. Accessed April 22, 2022. Available at: https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html.66179 - The American College of Obstetricians and Gynecologists' Immunization, Infectious Disease, and Public Health Preparedness Expert Work Group. Vaccinating pregnant and lactating patients against COVID-19. Public advisory, December 2020. Accessed December 15, 2020. Available at: https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2020/12/vaccinating-pregnant-and-lactating-patients-against-covid-1966335 - National Comprehensive Cancer Network. Cancer and COVID-19 vaccination preliminary recommendations of the NCCN COVID-19 vaccination advisory committee. Updated January 22, 2021. Accessed January 22, 2021. Available at: https://www.nccn.org/covid-19/pdf/COVID-19_Vaccination_Guidance_V1.0.pdf.66558 - Gray KJ, Bordt EA, Atyeo C, et al. COVID-19 vaccine response in pregnant and lactating women: a cohort study. American Journal of Obstetrics and Gynecology (2021), doi: https://doi.org/10.1016/j.ajog.2021.03.023.66863 - Center for Disease Control and Prevention. New CDC data: COVID-19 vaccination safe for pregnant people. Released August 11, 2021. Accessed August 11, 2021. Available at: https://www.cdc.gov/media/releases/2021/s0811-vaccine-safe-pregnant.html.66864 - Center for Disease Control and Prevention. COVID-19 vaccines while pregnant or breastfeeding. Updated August 11, 2021. Accessed August 11, 2021. Available at: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/pregnancy.html.66904 - Comirnaty (COVID-19) injection package insert. New York, NY: Pfizer, Inc; 2021 Aug.67201 - Food and Drug Administration. FDA Drug Safety Communication: Possible false RPR reactivity with BioPlex 2200 Syphilis total and RPR test kit following a COVID-19 vaccine - letter to clinical laboratory staff and health care providers. Retrieved Dec 20, 2021. Available on the World Wide Web at: https://www.fda.gov/medical-devices/letters-health-care-providers/possible-false-rpr-reactivity-bioplex-2200-syphilis-total-rpr-test-kit-following-covid-19-vaccine?utm_medium=email&utm_source=govdelivery67491 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for booster dose only. Dark blue cap and purple border. Retrieved June 17, 2022.

      Mechanism of Action

      The Pfizer-BioNTech COVID-19 vaccine contains nucleoside-modified messenger RNA (modRNA) and the Moderna COVID-19 vaccine is made up of a synthetic messenger RNA (mRNA), both encoding the viral spike glycoprotein (S) of SARS-CoV-2. The RNA is encapsulated in lipid nanoparticles, which enables entry into host cells, expression of the S protein, and elicitation of both antibody and cellular immune responses.[66080][66120][66904][67339]

      Revision Date: 02/01/2022, 12:43:08 PM

      References

      66080 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 12 years of age and older. Purple cap and purple border. Retrieved June 17, 2022.66120 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 12 years and older. Red cap and light blue border. Retrieved June 17, 2022.66904 - Comirnaty (COVID-19) injection package insert. New York, NY: Pfizer, Inc; 2021 Aug.67339 - Spikevax (COVID-19) injection package insert. Cambridge, MA: Moderna US, Inc.; 2022 Jan.

      Pharmacokinetics

      The COVID-19 vaccine is administered intramuscularly. Vaccination does not ensure immunity.[66080][66120][66904]

       

      Affected cytochrome P450 isoenzymes: none

      Route-Specific Pharmacokinetics

      Intramuscular Route

      After Pfizer-BioNTech COVID-19 vaccine administration, the highest neutralization titers were measured on day 28 (i.e., 7 days after the second dose) or on day 35 (i.e., 14 days after the second dose). The 50% neutralizing geometric mean titers (GMTs) on day 28 or 35 ranged from 1.7 to 3.8 times the GMT of the convalescent serum panel in patients 18 to 55 years of age and from 1.6 to 2.2 times the GMT of the convalescent serum panel in patients 65 to 85 years of age.[66103][66104]

       

      After 2 Moderna COVID-19 vaccinations, seroconversion occurred in all patients by day 15. All GMTs exceeded those seen in convalescent serum by day 57. At day 43, neutralizing activity against SARS-CoV-2 was seen in all evaluated patients.[66185]

      Special Populations

      Pediatrics

      An analysis of SARS-CoV-2 50% neutralizing titers 1 month after the second dose in a randomly selected subset of patients demonstrated non-inferior immune responses (within 1.5-fold) when comparing patients 12 to 15 years to patients 16 to 25 years of age.[66080]

      Geriatric

      The Pfizer-BioNTech COVID-19 vaccine generally elicited lower antigen-binding IgG and virus-neutralizing responses in patients 65 to 85 years of age compared to patients 18 to 55 years of age. However, on day 28 (i.e., 7 days after the second dose) and on day 35 (i.e., 14 days after the second dose), the 50% and 90% neutralizing geometric mean titers (GMTs) elicited in older adults exceeded those of the convalescent serum panel.[66103][66104]

      Revision Date: 08/24/2021, 01:25:54 PM

      References

      66080 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 12 years of age and older. Purple cap and purple border. Retrieved June 17, 2022.66103 - Walsh EE, Frenck RW, Falsey AR, et al. Safety and immunogenicity of two RNA-based Covid-19 vaccine candidates. NEJM 2020; DOI: 10.1056/NEJMoa2027906.66104 - Walsh EE, Frenck RW Jr, Falsey AR, et al. Supplementary appendix: Safety and immunogenicity of two RNA-based Covid-19 vaccine candidates. N Engl J Med. DOI:10.1056/NEJMoa2027906. Available on the World Wide Web at: https://www.nejm.org/doi/suppl/10.1056/NEJMoa2027906/suppl_file/nejmoa2027906_appendix.pdf66120 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 12 years and older. Red cap and light blue border. Retrieved June 17, 2022.66185 - Jackson LA, Anderson EJ, Rouphael NG, Roberts PC, et al. An mRNA vaccine against SARS-CoV-2 - preliminary report. N Engl J Med 2020; 383: 1920 - 1931.66904 - Comirnaty (COVID-19) injection package insert. New York, NY: Pfizer, Inc; 2021 Aug.

      Pregnancy/Breast-feeding

      pregnancy

      COVID-19 vaccination is recommended in all eligible women regardless of pregnancy status (including those who are pregnant, trying to get pregnant, or may become pregnant in the future). Pregnant and recently pregnant patients (for at least 42 days after the end of pregnancy) with COVID-19 are at increased risk for severe illness compared to patients who are not pregnant.[66175] [66179] [66863] If a woman becomes pregnant after the first dose, administer the second dose as indicated. Manage potential post vaccination fever with acetaminophen.[66863] [66864] A growing body of evidence suggests that benefits of COVID-19 vaccination outweigh any known or potential risk of vaccination during pregnancy. Recent studies have also shown that antibodies produced after COVID-19 vaccination during pregnancy are transferred to the newborn, and COVID-19 vaccination in pregnant patients reduces the risk of COVID-19 hospitalization in infants younger than 6 months.[66175] Data analyzed from 3 vaccine safety-related databases (VAERS, the v-safe active surveillance system, and the v-safe pregnancy registry) did not identify safety concerns for pregnant patients who were vaccinated late in their pregnancy or their infants. Analysis of current data from the V-SAFE pregnancy registry did not find an increased risk of miscarriage among approximately 2,500 pregnant women who received an mRNA COVID-19 vaccine before 20 weeks of pregnancy. Miscarriage rates in this population were 13%, compared to 11% to 16% of pregnancies in the general population. There is no current evidence that COVID-19 vaccines cause fertility problems in woman or men.[66175] [66863] [66864] In a prospective cohort study of 131 mRNA COVID-19 vaccine recipients (84 pregnant, 31 lactating, and 16 non-pregnant), vaccine-induced antibody titers were equivalent in pregnant and lactating women compared to non-pregnant women. All titers were significantly higher than those induced during SARS-CoV-2 infection during pregnancy. Vaccine-generated antibodies were present in all umbilical cord blood samples; neutralizing antibody titers were lower in umbilical cord compared to maternal sera, although statistical significance was not reached. No differences in reactogenicity were noted between the groups.[66558] A pregnancy exposure registry is available that monitors pregnancy outcomes in women exposed to Comirnaty (Pfizer-BioNTech COVID-19 vaccine) during pregnancy. Encourage women vaccinated during pregnancy to enroll in the registry by going to https://mothertobaby.org/ongoing-study/covid19-vaccines/.[66904] A pregnancy exposure registry is available that monitors pregnancy outcomes in women exposed to Moderna COVID-19 vaccine during pregnancy. Encourage women vaccinated with Moderna COVID-19 vaccine to enroll in the registry by calling 1-866-663-3762. Additionally, encourage pregnant women to enroll in the CDC's V-SAFE program by going to vsafe.cdc.gov.[66120] [66864]

      breast-feeding

      COVID-19 vaccination is recommended in all eligible women, including those who are breast-feeding.[66179] [66864] There are limited data regarding use of the COVID-19 vaccine during breast-feeding, its effect on milk production, and its excretion in human breast milk. However, the COVID-19 vaccines cannot cause infection in either the lactating patient or the infant.[66175] Recent reports suggest mothers who have received mRNA COVID-19 vaccines have antibodies in their breast milk, which may help protect their babies.[66864] In a prospective cohort study of 131 mRNA COVID-19 vaccine recipients (84 pregnant, 31 lactating, and 16 non-pregnant), vaccine-induced antibody titers were equivalent in pregnant and lactating women compared to non-pregnant women. All titers were significantly higher than those induced during SARS-CoV-2 infection during pregnancy. Vaccine-generated antibodies were present in all breast milk samples. No differences in reactogenicity were noted between the groups.[66558] If a breast-feeding infant experiences an adverse event possibly related to a maternally administered vaccine, health care providers are encouraged to report the adverse event to the FDA.[66080] [66904]

      Revision Date: 04/06/2022, 04:54:27 PM

      References

      66080 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 12 years of age and older. Purple cap and purple border. Retrieved June 17, 2022.66120 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Moderna COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 12 years and older. Red cap and light blue border. Retrieved June 17, 2022.66175 - Center for Disease Control and Prevention. Interim clinical considerations for use of COVID-19 vaccines currently approved or authorized in the United States. Updated April 25, 2022. Accessed April 22, 2022. Available at: https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html.66179 - The American College of Obstetricians and Gynecologists' Immunization, Infectious Disease, and Public Health Preparedness Expert Work Group. Vaccinating pregnant and lactating patients against COVID-19. Public advisory, December 2020. Accessed December 15, 2020. Available at: https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2020/12/vaccinating-pregnant-and-lactating-patients-against-covid-1966558 - Gray KJ, Bordt EA, Atyeo C, et al. COVID-19 vaccine response in pregnant and lactating women: a cohort study. American Journal of Obstetrics and Gynecology (2021), doi: https://doi.org/10.1016/j.ajog.2021.03.023.66863 - Center for Disease Control and Prevention. New CDC data: COVID-19 vaccination safe for pregnant people. Released August 11, 2021. Accessed August 11, 2021. Available at: https://www.cdc.gov/media/releases/2021/s0811-vaccine-safe-pregnant.html.66864 - Center for Disease Control and Prevention. COVID-19 vaccines while pregnant or breastfeeding. Updated August 11, 2021. Accessed August 11, 2021. Available at: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/pregnancy.html.66904 - Comirnaty (COVID-19) injection package insert. New York, NY: Pfizer, Inc; 2021 Aug.

      Interactions

      Level 3 (Moderate)

      • Abatacept
      • Abemaciclib
      • Abrocitinib
      • Acalabrutinib
      • Adalimumab
      • Ado-Trastuzumab emtansine
      • Afatinib
      • Alectinib
      • Alefacept
      • Alemtuzumab
      • Alpelisib
      • Altretamine
      • Aminolevulinic Acid
      • Amivantamab
      • Anakinra
      • Anifrolumab
      • Antithymocyte Globulin
      • Arsenic Trioxide
      • Asciminib
      • Asparaginase Erwinia chrysanthemi
      • Atezolizumab
      • Avacopan
      • Avapritinib
      • Avelumab
      • Axicabtagene Ciloleucel
      • Axitinib
      • Azacitidine
      • Azathioprine
      • Belantamab mafodotin
      • Belatacept
      • Belimumab
      • Belinostat
      • Belumosudil
      • Bendamustine
      • Benralizumab
      • Betamethasone
      • Bevacizumab
      • Bexarotene
      • Binimetinib
      • Bleomycin
      • Blinatumomab
      • Bortezomib
      • Bosutinib
      • Brentuximab vedotin
      • Brexucabtagene Autoleucel
      • Brigatinib
      • Brodalumab
      • Budesonide
      • Budesonide; Formoterol
      • Budesonide; Glycopyrrolate; Formoterol
      • Busulfan
      • Cabazitaxel
      • Cabozantinib
      • Calaspargase pegol
      • Canakinumab
      • Capecitabine
      • Capmatinib
      • Carboplatin
      • Carfilzomib
      • Carmustine, BCNU
      • Cemiplimab
      • Ceritinib
      • Certolizumab pegol
      • Cetuximab
      • Chlorambucil
      • Ciltacabtagene Autoleucel
      • Cisplatin
      • Cladribine
      • Clofarabine
      • Cobimetinib
      • Copanlisib
      • Corticosteroids (systemic)
      • Cortisone
      • Crizotinib
      • Cyclophosphamide
      • Cyclosporine
      • Cytarabine, ARA-C
      • Dabrafenib
      • Dacarbazine, DTIC
      • Daclizumab
      • Dacomitinib
      • Dactinomycin, Actinomycin D
      • Daratumumab
      • Daratumumab; Hyaluronidase
      • Dasatinib
      • Daunorubicin
      • Daunorubicin Liposomal
      • Daunorubicin Liposomal; Cytarabine Liposomal
      • Decitabine
      • Decitabine; Cedazuridine
      • Deflazacort
      • Denileukin Diftitox
      • Denosumab
      • Dexamethasone
      • Dinutuximab
      • Docetaxel
      • Dostarlimab
      • Doxorubicin
      • Doxorubicin Liposomal
      • Dupilumab
      • Durvalumab
      • Duvelisib
      • Eculizumab
      • Efgartigimod Alfa
      • Elotuzumab
      • Emapalumab
      • Enasidenib
      • Encorafenib
      • Enfortumab vedotin
      • Entrectinib
      • Epirubicin
      • Erdafitinib
      • Eribulin
      • Erlotinib
      • Estramustine
      • Etanercept
      • Etoposide, VP-16
      • Everolimus
      • Fam-Trastuzumab deruxtecan
      • Fedratinib
      • Fingolimod
      • Floxuridine
      • Fludarabine
      • Fludrocortisone
      • Fluorouracil, 5-FU
      • Fostamatinib
      • Gefitinib
      • Gemcitabine
      • Gemtuzumab Ozogamicin
      • Gilteritinib
      • Glasdegib
      • Golimumab
      • Guselkumab
      • Hydrocortisone
      • Hydroxyurea
      • Ibritumomab Tiuxetan
      • Ibrutinib
      • Idarubicin
      • Idecabtagene Vicleucel
      • Idelalisib
      • Ifosfamide
      • Imatinib
      • Immunosuppressants
      • Inebilizumab
      • Infigratinib
      • Infliximab
      • Inotuzumab Ozogamicin
      • Iobenguane I 131
      • Ipilimumab
      • Irinotecan
      • Irinotecan Liposomal
      • Isatuximab
      • Ivosidenib
      • Ixabepilone
      • Ixazomib
      • Ixekizumab
      • L-Asparaginase Escherichia coli
      • Lapatinib
      • Larotrectinib
      • Leflunomide
      • Lenvatinib
      • Lisocabtagene Maraleucel
      • Lomustine, CCNU
      • Loncastuximab Tesirine
      • Lorlatinib
      • Lurbinectedin
      • Lutetium Lu 177 dotatate
      • Margetuximab
      • Mechlorethamine, Nitrogen Mustard
      • Melphalan
      • Melphalan Flufenamide
      • Mepolizumab
      • Mercaptopurine, 6-MP
      • Methotrexate
      • Methoxsalen
      • Methylprednisolone
      • Midostaurin
      • Mitomycin
      • Mitotane
      • Mitoxantrone
      • Mobocertinib
      • Mogamulizumab
      • Moxetumomab pasudotox
      • Mycophenolate
      • Nanoparticle Albumin-Bound Paclitaxel
      • Nanoparticle Albumin-Bound Sirolimus
      • Natalizumab
      • Naxitamab
      • Necitumumab
      • Nelarabine
      • Neratinib
      • Nilotinib
      • Niraparib
      • Nivolumab
      • Nivolumab; Relatlimab
      • Obinutuzumab
      • Ocrelizumab
      • Ofatumumab
      • Olaparib
      • Olaratumab
      • Omacetaxine
      • Omalizumab
      • Osimertinib
      • Oxaliplatin
      • Ozanimod
      • Paclitaxel
      • Palbociclib
      • Panitumumab
      • Panobinostat
      • Pazopanib
      • Pegaspargase
      • Pegcetacoplan
      • Pembrolizumab
      • Pemetrexed
      • Pemigatinib
      • Pentostatin
      • Pertuzumab
      • Pertuzumab; Trastuzumab; Hyaluronidase
      • Pexidartinib
      • Plicamycin
      • Polatuzumab Vedotin
      • Ponatinib
      • Ponesimod
      • Porfimer
      • Pralatrexate
      • Pralsetinib
      • Prednisolone
      • Prednisone
      • Procarbazine
      • Radium-223 Dichloride
      • Ramucirumab
      • Ravulizumab
      • Regorafenib
      • Reslizumab
      • Ribociclib
      • Ribociclib; Letrozole
      • Rilonacept
      • Ripretinib
      • Rituximab
      • Rituximab; Hyaluronidase
      • Romidepsin
      • Rucaparib
      • Ruxolitinib
      • Sacituzumab Govitecan
      • Sarilumab
      • Secukinumab
      • Selinexor
      • Selpercatinib
      • Selumetinib
      • Siltuximab
      • Siponimod
      • Sirolimus
      • Sonidegib
      • Sorafenib
      • Sotorasib
      • Streptozocin
      • Sunitinib
      • Tacrolimus
      • Tafasitamab
      • Tagraxofusp
      • Talazoparib
      • Talimogene Laherparepvec
      • Tazemetostat
      • Tebentafusp
      • Temozolomide
      • Temsirolimus
      • Teniposide
      • Tepotinib
      • Teriflunomide
      • Tezepelumab
      • Thioguanine, 6-TG
      • Thiotepa
      • Tisagenlecleucel
      • Tisotumab Vedotin
      • Tivozanib
      • Tocilizumab
      • Tofacitinib
      • Topotecan
      • Tositumomab
      • Trabectedin
      • Tralokinumab
      • Trametinib
      • Trastuzumab
      • Trastuzumab; Hyaluronidase
      • Tretinoin, ATRA
      • Triamcinolone
      • Trifluridine; Tipiracil
      • Trilaciclib
      • Tucatinib
      • Umbralisib
      • Upadacitinib
      • Ustekinumab
      • Vandetanib
      • Vedolizumab
      • Vemurafenib
      • Venetoclax
      • Vinblastine
      • Vincristine
      • Vincristine Liposomal
      • Vinorelbine
      • Vismodegib
      • Voclosporin
      • Vorinostat
      • Zanubrutinib
      • Ziv-Aflibercept
      Abatacept: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Abemaciclib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Abrocitinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Acalabrutinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Adalimumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Ado-Trastuzumab emtansine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Afatinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Alectinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Alefacept: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Alemtuzumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Alpelisib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Altretamine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Aminolevulinic Acid: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Amivantamab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Anakinra: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Anifrolumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Antithymocyte Globulin: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Arsenic Trioxide: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Asciminib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Asparaginase Erwinia chrysanthemi: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Atezolizumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Avacopan: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Avapritinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Avelumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Axicabtagene Ciloleucel: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Axitinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Azacitidine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Azathioprine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Belantamab mafodotin: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Belatacept: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Belimumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Belinostat: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Belumosudil: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Bendamustine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Benralizumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Betamethasone: (Moderate) Patients receiving corticosteroids in greater than physiologic doses may have a diminished response to the SARS-CoV-2 virus vaccine. Counsel patients receiving corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Bevacizumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Bexarotene: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Binimetinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Bleomycin: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Blinatumomab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Bortezomib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Bosutinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Brentuximab vedotin: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Brexucabtagene Autoleucel : (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Brigatinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Brodalumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Budesonide: (Moderate) Patients receiving corticosteroids in greater than physiologic doses may have a diminished response to the SARS-CoV-2 virus vaccine. Counsel patients receiving corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Budesonide; Formoterol: (Moderate) Patients receiving corticosteroids in greater than physiologic doses may have a diminished response to the SARS-CoV-2 virus vaccine. Counsel patients receiving corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Budesonide; Glycopyrrolate; Formoterol: (Moderate) Patients receiving corticosteroids in greater than physiologic doses may have a diminished response to the SARS-CoV-2 virus vaccine. Counsel patients receiving corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Busulfan: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Cabazitaxel: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Cabozantinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Calaspargase pegol: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Canakinumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Capecitabine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Capmatinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Carboplatin: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Carfilzomib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Carmustine, BCNU: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Cemiplimab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Ceritinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Certolizumab pegol: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Cetuximab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Chlorambucil: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Ciltacabtagene Autoleucel: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Cisplatin: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Cladribine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Clofarabine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Cobimetinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Copanlisib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Corticosteroids (systemic): (Moderate) Patients receiving corticosteroids in greater than physiologic doses may have a diminished response to the SARS-CoV-2 virus vaccine. Counsel patients receiving corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Cortisone: (Moderate) Patients receiving corticosteroids in greater than physiologic doses may have a diminished response to the SARS-CoV-2 virus vaccine. Counsel patients receiving corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Crizotinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Cyclophosphamide: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Cyclosporine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Cytarabine, ARA-C: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Dabrafenib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Dacarbazine, DTIC: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Daclizumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Dacomitinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Dactinomycin, Actinomycin D: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Daratumumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Daratumumab; Hyaluronidase: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Dasatinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Daunorubicin Liposomal: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Daunorubicin Liposomal; Cytarabine Liposomal: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Daunorubicin: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Decitabine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Decitabine; Cedazuridine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Deflazacort: (Moderate) Patients receiving corticosteroids in greater than physiologic doses may have a diminished response to the SARS-CoV-2 virus vaccine. Counsel patients receiving corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Denileukin Diftitox: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Denosumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Dexamethasone: (Moderate) Patients receiving corticosteroids in greater than physiologic doses may have a diminished response to the SARS-CoV-2 virus vaccine. Counsel patients receiving corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Dinutuximab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Docetaxel: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Dostarlimab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Doxorubicin Liposomal: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Doxorubicin: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Dupilumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Durvalumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Duvelisib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Eculizumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Efgartigimod Alfa: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Elotuzumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Emapalumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Enasidenib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Encorafenib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Enfortumab vedotin: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Entrectinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Epirubicin: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Erdafitinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Eribulin: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Erlotinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Estramustine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Etanercept: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Etoposide, VP-16: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Everolimus: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Fam-Trastuzumab deruxtecan: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Fedratinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Fingolimod: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Floxuridine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Fludarabine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Fludrocortisone: (Moderate) Patients receiving corticosteroids in greater than physiologic doses may have a diminished response to the SARS-CoV-2 virus vaccine. Counsel patients receiving corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Fluorouracil, 5-FU: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Fostamatinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Gefitinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Gemcitabine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Gemtuzumab Ozogamicin: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Gilteritinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Glasdegib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Golimumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Guselkumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Hydrocortisone: (Moderate) Patients receiving corticosteroids in greater than physiologic doses may have a diminished response to the SARS-CoV-2 virus vaccine. Counsel patients receiving corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Hydroxyurea: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Ibritumomab Tiuxetan: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Ibrutinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Idarubicin: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Idecabtagene Vicleucel: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Idelalisib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Ifosfamide: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Imatinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Immunosuppressants: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Inebilizumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Infigratinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Infliximab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Inotuzumab Ozogamicin: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Iobenguane I 131: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Ipilimumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Irinotecan Liposomal: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Irinotecan: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Isatuximab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Ivosidenib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Ixabepilone: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Ixazomib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Ixekizumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Lapatinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Larotrectinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] L-Asparaginase Escherichia coli: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Leflunomide: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Lenvatinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Lisocabtagene Maraleucel: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Lomustine, CCNU: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Loncastuximab Tesirine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Lorlatinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Lurbinectedin: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Lutetium Lu 177 dotatate: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Margetuximab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Mechlorethamine, Nitrogen Mustard: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Melphalan Flufenamide: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Melphalan: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Mepolizumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Mercaptopurine, 6-MP: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Methotrexate: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Methoxsalen: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Methylprednisolone: (Moderate) Patients receiving corticosteroids in greater than physiologic doses may have a diminished response to the SARS-CoV-2 virus vaccine. Counsel patients receiving corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Midostaurin: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Mitomycin: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Mitotane: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Mitoxantrone: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Mobocertinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Mogamulizumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Moxetumomab pasudotox: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Mycophenolate: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Nanoparticle Albumin-Bound Paclitaxel: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Nanoparticle Albumin-Bound Sirolimus: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Natalizumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Naxitamab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Necitumumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Nelarabine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Neratinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Nilotinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Niraparib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Nivolumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Nivolumab; Relatlimab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Obinutuzumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Ocrelizumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Ofatumumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Olaparib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Olaratumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Omacetaxine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Omalizumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Osimertinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Oxaliplatin: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Ozanimod: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Paclitaxel: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Palbociclib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Panitumumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Panobinostat: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Pazopanib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Pegaspargase: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Pegcetacoplan: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Pembrolizumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Pemetrexed: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Pemigatinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Pentostatin: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Pertuzumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Pertuzumab; Trastuzumab; Hyaluronidase: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Pexidartinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Plicamycin: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Polatuzumab Vedotin: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Ponatinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Ponesimod: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Porfimer: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Pralatrexate: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Pralsetinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Prednisolone: (Moderate) Patients receiving corticosteroids in greater than physiologic doses may have a diminished response to the SARS-CoV-2 virus vaccine. Counsel patients receiving corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Prednisone: (Moderate) Patients receiving corticosteroids in greater than physiologic doses may have a diminished response to the SARS-CoV-2 virus vaccine. Counsel patients receiving corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Procarbazine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Radium-223 Dichloride: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Ramucirumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Ravulizumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Regorafenib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Reslizumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Ribociclib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Ribociclib; Letrozole: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Rilonacept: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Ripretinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Rituximab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Rituximab; Hyaluronidase: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Romidepsin: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Rucaparib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Ruxolitinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Sacituzumab Govitecan: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Sarilumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Secukinumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Selinexor: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Selpercatinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Selumetinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Siltuximab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Siponimod: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Sirolimus: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Sonidegib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Sorafenib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Sotorasib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Streptozocin: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Sunitinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Tacrolimus: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Tafasitamab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Tagraxofusp: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Talazoparib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Talimogene Laherparepvec: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Tazemetostat: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Tebentafusp: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Temozolomide: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Temsirolimus: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Teniposide: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Tepotinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Teriflunomide: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Tezepelumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Thioguanine, 6-TG: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Thiotepa: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Tisagenlecleucel: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Tisotumab Vedotin: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Tivozanib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Tocilizumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Tofacitinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Topotecan: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Tositumomab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Trabectedin: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Tralokinumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Trametinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Trastuzumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Trastuzumab; Hyaluronidase: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Tretinoin, ATRA: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Triamcinolone: (Moderate) Patients receiving corticosteroids in greater than physiologic doses may have a diminished response to the SARS-CoV-2 virus vaccine. Counsel patients receiving corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Trifluridine; Tipiracil: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Trilaciclib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Tucatinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Umbralisib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Upadacitinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Ustekinumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Vandetanib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Vedolizumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Vemurafenib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Venetoclax: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Vinblastine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Vincristine Liposomal: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Vincristine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Vinorelbine: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Vismodegib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Voclosporin: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Vorinostat: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Zanubrutinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080] Ziv-Aflibercept: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to the SARS-CoV-2 virus vaccine. When feasible, administer indicated vaccines prior to initiating immunosuppressant medications. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure to SARS-CoV-2 virus after receiving the vaccine. [65107] [66080]
      Revision Date: 03/22/2022, 02:27:00 AM

      References

      65107 - Kroger A, Bahta L, Hunter P. General Best Practice Guidelines for Immunization. Best Practices Guidance of the Advisory Committee on Immunization Practices (ACIP). Available on the world wide web at https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.pdf. Accessed on July 26, 202166080 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Pfizer-BioNTech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) for 12 years of age and older. Purple cap and purple border. Retrieved June 17, 2022.

      Monitoring Parameters

      • laboratory monitoring not necessary

      US Drug Names

      • COMIRNATY COVID-19
      • Moderna COVID-19
      • Pfizer-BioNTech COVID-19
      • spikevax COVID-19 mRNA
      ;