EsteéoconteúdodoDrugInformationdaElsevier
SARS-CoV-2 Virus (COVID-19) Adenovirus Vector Vaccine
Indications/Dosage
Labeled
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]
- There is no data available on administration of the Janssen COVID-19 vaccine after an mRNA COVID-19 vaccine to complete the primary vaccination series. In exceptional situations where patients received the first dose of a mRNA COVID-19 vaccine but are unable to complete the primary series with either the same or different mRNA vaccine (e.g., due to contraindication), a single dose of Janssen COVID-19 vaccine may be considered at a minimum interval of 28 days after the mRNA COVID-19 vaccine dose. Patients who receive the Janssen COVID-19 vaccine after a dose of a mRNA COVID-19 vaccine should be considered to have received a valid, single-dose Janssen vaccination (not a mixed vaccination series).[66175]
- Patients 18 years and older who received a single dose Janssen COVID-19 primary series should receive a single COVID-19 booster dose at least 2 months after completing their Janssen primary series. Use of a mRNA COVID-19 vaccine for the booster dose is preferred, when available. Patients 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] 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.[66374]
- In patients who are moderately or severely immunocompromised, administer a second (additional) dose using a mRNA vaccine at least 4 weeks after the first dose. If the Moderna COVID-19 vaccine is used, administer a 100 mcg dose. A single booster dose is recommended at least 2 months after the second additional dose, for a total of 3 doses (1 Janssen COVID-19 vaccine dose followed by 1 additional mRNA vaccine dose, then 1 booster dose). mRNA vaccines are preferred for the booster dose. If the Moderna COVID-19 vaccine is used, administer a 50 mcg dose. A second mRNA booster dose may be given at least 4 months after the first booster dose (total of 4 doses).[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 Janssen 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 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
- prevention of coronavirus disease 2019 (COVID-19)
INVESTIGATIONAL USE: For the prevention of coronavirus disease 2019 (COVID-19)†
NOTE: Use is only recommended in patients for whom other FDA-authorized or approved vaccines are not accessible or clinically appropriate and in patients who elect to receive the Janssen COVID-19 vaccine because they would not otherwise receive a vaccine.[66374]
for the primary vaccination series
Intramuscular dosage (Janssen COVID-19 vaccine)
Adults
0.5 mL (5 x 1010 vp) IM once.[66374]
for booster dosing
Intramuscular dosage (Janssen COVID-19 vaccine)
Adults
0.5 mL (5 x 1010 vp) IM at least 2 months after completing the primary series.[66374]
Therapeutic Drug Monitoring
Maximum Dosage Limits
- Adults
0.5 mL/dose IM.
- Geriatric
0.5 mL/dose IM.
- Adolescents
Safety and efficacy have not been established.
- Children
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 indicationReferences
How Supplied
ad26.cov2.s Suspension for injection
Janssen COVID-19 50,000,000,000vp/0.5mL Vaccine Suspension for Injection (59676-0580) (Janssen Biotech, Inc.) null
Description/Classification
Description
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 COVID-19 vaccine is an investigational vaccine that contains a recombinant replication-incompetent adenovirus type 26 vector encoding the viral spike glycoprotein (S) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The COVID-19 vaccine is not an FDA-approved vaccine; however, the vaccine has been authorized for use under an Emergency Use Authorization (EUA) for active immunization for the prevention of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in patients 18 years of age and older for whom other FDA-authorized or approved vaccines are not accessible or clinically appropriate, and in patients 18 years and older who elect to receive the Janssen COVID-19 vaccine because they would not otherwise receive a vaccine.[66374] There are many clinical trials underway for various COVID-19 vaccines.[66083] Adenoviruses are often used for viral vector vaccines because they elicit a robust immune response. Adenovirus vector vaccines are easy to design and can be produced on a mass scale, making them well suited for pandemic response.[66375] In clinical trials, adenovirus COIVD-19 vaccines have been found to be safe and well-tolerated. The most commonly reported adverse drug reactions include injection site pain, headache, fatigue, and muscle pain. The Janssen COVID-19 vaccine is a single dose vaccine.[66374]
Janssen Vaccine Trial Data
Efficacy data for the Janssen COVID-19 vaccine included 39,321 patients. Of the study participants who received the Janssen COVID-19 vaccine (n = 19,630), 55.6% were male and 44.3% were female, 62.1% were White, 17.2% were Black or African American, 8.4% were American Indian or Alaska Native, 3.7% were Asian, 0.3% were Native Hawaiian or other Pacific Islander, 5.3% were multiracial, and 3% were unknown or not reported. Additionally, 52.7% were not Hispanic or Latino, 44.8% were Hispanic or Latino, and 2.5% were unknown or not reported. Patients who were immunocompromised and those who had a previous clinical or microbiological diagnosis of COVID-19 disease were excluded, along with pregnant women. Patients with pre-existing stable disease, defined as diseases not requiring significant change in therapy or hospitalization for worsening disease during the 12 weeks before enrollment, were included as were participants with known stable infection with human immunodeficiency virus (HIV). In an interim analysis, there were 116 confirmed moderate to severe/critical COVID-19 cases in the Janssen COVID-19 vaccine group and 348 cases in the placebo group with onset at least 14 days after vaccination (vaccine efficacy of 66.9%). There were 66 confirmed moderate to severe/critical COVID-19 cases in the Janssen COVID-19 vaccine group and 193 cases in the placebo group with onset at least 28 days after vaccination (vaccine efficacy of 66.1%). In general, vaccine efficacy was similar among patients at risk of severe COVID-19 disease including those with 1 or more comorbidities that increase the risk of severe COVID-19 disease (e.g., asthma, BMI 30 kg/m2 or more, chronic pulmonary disease, diabetes mellitus, hypertension). A lower vaccine efficacy against moderate to severe/critical COVID-19 with onset at least 28 days after vaccination was observed for the subgroup of patients 60 years of age and older with comorbidities compared to the overall population, but with an observed trend of increasing vaccine efficacy as the number of cases included in the analysis increased.[66374][66447]
Classifications
- General Anti-infectives Systemic
- Vaccines
- Pure Vaccines
- SARS-CoV-2 (Covid-19) Vaccines
- Pure Vaccines
- Vaccines
References
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 cases of COVID-19 that result in hospitalization or death after administration of the vaccine.[66374]
Route-Specific Administration
Injectable Administration
- Administer intramuscularly. Do not administer intravenously, intradermally, or subcutaneously.
- Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. The Janssen COVID-19 vaccine is a colorless to slightly yellow, clear to very opalescent suspension.[66374]
- 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.
- Do not delay the 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]
- 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
Janssen COVID-19 vaccine
Preparation
- If vials are frozen upon receipt, thaw at 2 to 8 degrees C (36 to 46 degrees F). If needed immediately, thaw at room temperature (max temperature of 25 degrees C/77 degrees F). At room temperature, a carton of 10 vials will take approximately 4 hours to thaw and an individual vial will take approximately 1 hour to thaw. Do not refreeze once thawed.
- Before withdrawing each dose, swirl vial gently in an upright position for 10 seconds. Do NOT shake.
- Withdraw each 0.5 mL dose using a new sterile needle and syringe.
- Storage before vial has been needle-punctured: Store between 2 and 8 degrees C (36 to 46 degrees F) and protect from light; do not store frozen. Vaccine may also be stored between 9 and 25 degrees C (44 to 77 degrees F) for up to 12 hours.
- Storage after vial has been needle-punctured: Store between 2 and 8 degrees C (36 to 46 degrees F) and use within 6 hours or at room temperature (max temperature of 25 degrees C/77 degrees F) for up to 2 hours from the time the needle punctures the vial to withdraw initial dose. Discard remaining vaccine if not used within these times.[66374]
Intramuscular Injection
- After withdrawing the dose, administer immediately as an intramuscular injection.[66374]
Clinical Pharmaceutics Information
From Trissel's 2‚Ñ¢ Clinical Pharmaceutics DatabaseReferences
Adverse Reactions
Mild
- diarrhea
- fatigue
- fever
- headache
- hypoesthesia
- injection site reaction
- myalgia
- nausea
- paresthesias
- tinnitus
- urticaria
- vomiting
Moderate
- erythema
- lymphadenopathy
- thrombocytopenia
Severe
- anaphylactoid reactions
- angioedema
- capillary leak syndrome
- Guillain-Barre syndrome
- pulmonary embolism
- seizures
- thrombosis
- thrombosis with thrombocytopenia syndrome
Local injection site reaction was the most commonly reported adverse reaction after COVID-19 vaccine administration during clinical trials. After Janssen COVID-19 vaccine administration, injection pain (33.3% to 58.6% vs. 15.6% to 17.4% placebo), erythema (4.6% to 9% vs 3.2% to 4.3% placebo), and swelling (2.7% to 7% vs 1.6% placebo) at the injection site were the most common reactions. One patient reported severe pain in the injected arm at the time of vaccination that was not responsive to analgesics and was ongoing 74 days after vaccination. All local adverse reactions were reported more frequently in the younger (18 to 59 years) patients compared to the older (60 years and older) patients.[66374]
During clinical trials, headache (30.4% to 44.4% vs. 22.1% to 24.8% placebo) and fatigue (29.7% to 43.8% vs. 20.8% to 22% placebo) occurred after administration of the Janssen COVID-19 vaccine. One patient reported severe generalized weakness, fever, and headache, with onset on the day after vaccination and resolution 3 days after vaccination.[66374]
Musculoskeletal adverse reactions reported during COVID-19 vaccine clinical trials include myalgia (24% to 39.1% vs. 12.1% to 13.7% placebo).[66374]
Nausea (12.3% to 15.5% vs. 8.9% to 10.8% placebo) was reported during COVID-19 vaccine clinical trials.[66374]
During clinical trials, fever (3.1% to 12.8% vs. 0.5% to 0.7% placebo) occurred after administration of the COVID-19 vaccine.[66374]
Serious allergic reactions, including anaphylactoid reactions, have been reported in Janssen COVID-19 vaccine clinical trials. One case of anaphylaxis was reported in an ongoing, open-label study. Urticaria (all non-serious) was reported in 5 patients receiving the Janssen COVID-19 vaccine and in 1 patient who received placebo in the 7 days after vaccination. Additionally, 1 patient vaccinated with the Janssen COVID-19 vaccine reported urticaria beginning 2 days after vaccination and angioedema of the lips with no respiratory distress beginning 4 days after vaccination.[66374]
An increased risk of Guillain-Barre syndrome (GBS) has been observed under emergency use authorization during the 42 days after Janssen COVID-19 vaccination. The patient population at highest risk for GBS are patients aged 40 to 64 years. Additionally, paresthesias and hypoesthesia have been reported during postmarketing reports.[66175] [66374]
Thromboembolic events were reported during Janssen COVID-19 vaccine clinical trials. In vaccinated patients, 6 events of deep vein thrombosis (2 serious; 5 within 28 days of vaccination) were reported compared to 2 events (1 serious; 2 within 28 days of vaccination) with placebo. Four events of pulmonary embolism (3 serious; 2 within 28 days of vaccination) were reported in vaccinated patients compared to 1 event (serious; within 28 days of vaccination) in a placebo patient. One event of transverse sinus thrombosis with thrombocytopenia (serious; with the onset of symptoms 8 days after vaccination) occurred in a vaccinated patient compared to none in patients receiving placebo. A causal relationship of these events to the Janssen COVID-19 vaccine could not be determined based on the clinical trial; however, based on current evidence, a causal relationship between thrombosis with thrombocytopenia and the Janssen COVID-19 vaccine is plausible. Capillary leak syndrome, thrombosis with thrombocytopenia syndrome (TTS), and immune thrombocytopenia (ITP) have been reported after Janssen COVID-19 vaccine administration under the emergency use authorization. The risk of ITP is greatest during the 42 days after vaccination. Symptoms of TTS usually occur approximately 1 to 2 weeks after vaccination and have been reported primarily in females ages 18 through 49 years; some have been fatal. In women 18 to 49 years, TTS reporting rates to VAERS were 7 cases per million Janssen COVID-19 vaccine doses administered compared to 0.9 per million in women 50 years and older. Thrombosis involving large blood vessels, including the cerebral venous sinuses, portal vein and splenic vein, lower extremity veins, and pulmonary artery, combined with thrombocytopenia have been reported. Specific risk factors are under investigation. Advise patients who develop shortness of breath, chest pain, leg pain or swelling, persistent abdominal pain, nausea and vomiting, back pain, neurological symptoms (including severe or persistent headaches or blurred vision), petechiae beyond the site of vaccination, easy bruising, or bleeding 4 to 30 days after Janssen COVID-19 vaccination to seek immediate medical attention. The clinical course shares features with autoimmune heparin induced thrombocytopenia (HIT). If TTS is suspected, perform immediate CBC with platelet count, imaging for thrombosis based on signs and symptoms, platelet factor-4 (PF4) enzyme-linked immunosorbent (ELISA) assay, and fibrinogen and D-dimers. In patients with a thrombotic event and thrombocytopenia after Janssen COVID-19 vaccination, an urgent consult from hematologist with expertise in hemostasis is recommended. Do not treat patients with thrombotic events and thrombocytopenia after vaccination with heparin unless HIT testing is negative. Initiate non-heparin anticoagulants and high-dose intravenous immune globulin (IVIG) pending PF4 ELISA results if there are signs/symptoms of serious thrombosis and at least 1 of the following: positive imaging or low platelets. Patients presenting with thrombosis and a normal platelet count post-vaccination may be in an early stage of TTS. Patients who develop TTS after their initial Janssen COVID-19 vaccine should not receive a Janssen COVID-19 booster dose.[59117] [66175] [66374] [66657]
In patients vaccinated with the Janssen COVID-19 vaccine, 4 events of seizures (1 serious; 4 within 28 days of vaccination) were reported compared to 1 event (0 serious; 0 within 28 days of vaccination) in patients receiving placebo. A causal relationship of these events to the COVID-19 vaccine cannot be determined.[66374]
In patients vaccinated with the Janssen COVID-19 vaccine, 6 events of tinnitus (0 serious; 6 within 28 days of vaccination, including 3 within 2 days of vaccination) were reported; no events were reported in patients receiving placebo. Tinnitus has also been noted in postmarketing reports. A causal relationship of these events to the COVID-19 vaccine cannot be determined.[66374]
Lymphadenopathy, diarrhea, and vomiting have been reported with postmarketing use of the Janssen COVID-19 vaccine.[66374]
References
Contraindications/Precautions
Absolute contraindications are italicized.
- thrombosis with thrombocytopenia syndrome
- acquired immunodeficiency syndrome (AIDS)
- agammaglobulinemia
- anticoagulant therapy
- breast-feeding
- chemotherapy
- coagulopathy
- corticosteroid therapy
- females
- hemophilia
- heparin-induced thrombocytopenia (HIT)
- human immunodeficiency virus (HIV) infection
- hypogammaglobulinemia
- immunosuppression
- laboratory test interference
- neoplastic disease
- pregnancy
- radiation therapy
- renal failure
- severe combined immunodeficiency (SCID)
- syncope
- thrombocytopenia
- thrombosis
- 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 polysorbate allergy is a contraindication to the Janssen COVID-19 vaccine. Polyethylene glycol (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, adenovirus) have a precaution to the other (i.e., mRNA). 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. 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. 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.[66175][66374] 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.[66374] 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. Counsel patients about the unknown vaccine safety profile and effectiveness in immunocompromised patients, the potential for reduced immune responses, and the need to continue following precautions to avoid exposure to the SARS-CoV-2 virus.[66175] Immunosuppressed persons may include patients with severe combined immunodeficiency (SCID), hypogammaglobulinemia, agammaglobulinemia, or an immune system compromised by drug therapy (i.e., corticosteroid therapy with greater than physiologic doses). Short-term (less than 2 weeks) corticosteroid therapy or intra-articular, bursal, or tendon injections with corticosteroids should not be immunosuppressive. COVID-19 vaccines may be administered without regard to timing of corticosteroid treatment, including topical or intraarticular treatment, bursal, or tendon injection.[65107] [66175] Ideally, COVID-19 vaccination should be completed at least 2 weeks before initiation of immunosuppressive therapies. When it is not possible to administer the COVID-19 vaccine in advance, people on immunosuppressive therapy can still receive COVID-19 vaccination. Antibody testing is not recommended to assess for immunity after COVID-19 vaccination. Re-vaccination is not recommended after immune competence is regained in patients who received the COVID-19 vaccine during treatment with immunosuppressive drugs. 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 COVID-19 vaccines. Administration of the COVID-19 vaccine 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.[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. Data suggest immune response to COVID-19 vaccination may be reduced in patients receiving chemotherapy for cancer, patients with hematologic cancers (i.e., chronic lymphocytic leukemia), patients receiving stem cells or organ transplants, and in patients receiving certain medications that may blunt the immune response to vaccination (e.g., mycophenolate, rituximab, azathioprine, anti-CD20 monoclonal antibodies, Bruton tyrosine kinase inhibitors).[65107] [66175] [66374] Counsel patients about the unknown vaccine safety profile and effectiveness in immunocompromised patients, the potential for reduced immune responses, and the need to continue following precautions to avoid exposure to the SARS-CoV-2 virus. Ideally, complete COVID-19 vaccination 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 neutrophil 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]
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.[66374] Counsel patients about the unknown vaccine safety profile and effectiveness in immunocompromised patients, the potential for reduced immune responses, and the need to continue following precautions to avoid exposure to the SARS-CoV-2 virus.[66175]
The Janssen COVID-19 vaccine is contraindicated in patients with a history of thrombosis with thrombocytopenia after the Janssen COVID-19 vaccine or any other adenovirus-vectored COVID-19 vaccine. Thrombosis with thrombocytopenia syndrome (TTS), which may be life-threatening, and immune thrombocytopenia (ITP) has been reported after Janssen COVID-19 vaccine administration under the emergency use authorization. The risk of ITP is greatest during the 42 days after vaccination. The TTS clinical course shares features with autoimmune heparin-induced thrombocytopenia (HIT). Reports suggest an increased risk of thrombosis at sites usual for a thrombus (i.e, cerebral vein, visceral artery or vein, extremity artery, central artery or vein) or in an extremity vein or pulmonary artery in combination with thrombocytopenia and positive platelet factor-4 (PF4) enzyme-linked immunosorbent (ELISA) assay in patients with no recent known heparin exposure. Symptoms usually occur approximately 1 to 2 weeks after vaccination and have been reported in males and females 18 years and older, with the highest rate (approximately 8 case per 100,000 doses administered) in females ages 30 to 49 years; 15% of TTS cases have been fatal. Specific risk factors are under investigation, but based on current evidence, a causal relationship between thrombosis with thrombocytopenia and the Janssen COVID-19 vaccine is plausible. Advise patients who develop shortness of breath, chest pain, leg pain or swelling, persistent abdominal pain, nausea and vomiting, back pain, neurological symptoms (including severe or persistent headaches or blurred vision), petechiae beyond the site of vaccination, easy bruising, or bleeding 4 to 30 days after Janssen COVID-19 vaccination to seek immediate medical attention. If TTS is suspected after vaccination, perform immediate CBC with platelet count, imaging for thrombosis based on signs and symptoms, PF4 ELISA assay, and fibrinogen and D-dimers. In patients with a thrombotic event and thrombocytopenia after Janssen COVID-19 vaccination, an urgent consult from hematologist with expertise in hemostasis is recommended. Do not treat patients with thrombotic events and thrombocytopenia after vaccination with heparin unless HIT testing is negative. Initiate non-heparin anticoagulants and high-dose intravenous immune globulin (IVIG) pending PF4 ELISA results if there are signs/symptoms of serious thrombosis and at least 1 of the following: positive imaging or low platelets. Patients presenting with thrombosis and a normal platelet count postvaccination may be in an early stage of TTS. If patients have a history of an episode of an immune-mediated syndrome characterized by thrombosis and thrombocytopenia, such as HIT, and it has been less than 90 days after resolution of their illness, they should be offered another FDA-authorized COVID-19 vaccine (i.e., mRNA vaccine). After 90 days, patients may be vaccinated with any FDA-authorized COVID-19 vaccine. Experts believe that patients with risk factors for VTE (e.g., inherited or acquired thrombophilia including Factor V Leiden, prothrombin gene 20210A mutation, antiphospholipid syndrome, protein C, protein S or antithrombin deficiency), or a prior history of other types of thromboses (including CVST) not associated with thrombocytopenia are unlikely to be at increased risk for TTS. Additionally, although the risk of thrombosis is increased in pregnant women, during the postpartum period, and with certain hormonal contraceptives, experts believe that these factors do not make patients more susceptible to TTS after Janssen COVID-19 administration. Patients taking routine aspirin or anticoagulants do not need to stop these medications prior to Janssen COVID-19 vaccination. Counsel females younger than 50 years of age on the increased risk for TTS after Janssen COVID-19 vaccination and the availability of other FDA-authorized COVID-19 vaccines. Advise patients with a history of ITP to discuss the risk of ITP and the potential need for platelet monitoring after vaccination with their healthcare provider.[59117] [66175] [66374] [66657] 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] [66374]
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] 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] The adenovirus vector used in the Janssen COVID-19 vaccine has been used in other vaccines where patients were vaccinated during any trimester, including a large-scale Ebola vaccine trial. No adverse pregnancy or infant outcomes were determined to be related to the vaccine in these trials.[66864] Manage potential post vaccination fever with acetaminophen. There is no current evidence that COVID-19 vaccines cause fertility problems in woman or men.[66863] [66864] Thrombosis with thrombocytopenia syndrome (TTS) has been reported after Janssen COVID-19 vaccine administration under the emergency use authorization. Although the risk of thrombosis is increased during pregnancy and the postpartum period, experts believe that these factors do not make patients more susceptible to TTS after Janssen COVID-19 administration. However, 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). Counsel female patients younger than 50 years of age on the rare risk of TTS after Janssen COVID-19 vaccination and the availability of other FDA-authorized COVID-19 vaccines (i.e, mRNA vaccines).[66175] A pregnancy exposure registry is available that monitors pregnancy outcomes in women exposed to Janssen COVID-19 vaccine during pregnancy. Encourage women vaccinated with the Janssen COVID-19 vaccine to enroll in the registry by visiting https://c-viper.pregistry.com. Additionally, pregnant women should be encouraged to enroll in the CDC's V-SAFE program by going to vsafe.cdc.gov.[66175] [66374]
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, it's 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] 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.
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]
Injectable vaccines, including the Janssen COVID-19 vaccine, have been associated with episodes of syncope and fainting. Prior to administration, ensure procedures are in place to prevent falls and manage syncopal reactions.[66374]
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]
References
Mechanism of Action
The Janssen COVID-19 vaccine is a monovalent vaccine composed of a recombinant replication-incompetent human adenovirus type 26 (Ad26) vector, constructed to encode the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) spike (S) protein. After binding of the Ad26 vector to cellular receptors and transduction of the cell, episomal vector DNA drives cellular production of the transgene encoded S protein. The S protein is then expressed on the cell membrane resulting in humoral and cellular immune responses directed against the SARS-CoV-2 S protein.[66374][66470]
Revision Date: 02/27/2021, 10:16:10 PMReferences
Pharmacokinetics
The COVID-19 vaccine is administered intramuscularly. Vaccination does not ensure immunity.[66374]
Affected cytochrome P450 isoenzymes: none
Route-Specific Pharmacokinetics
Intramuscular Route
Neutralizing antibody titers against wild-type virus were detected in 96% of participants aged 18 to 55 years and 96% of participants aged 65 years and older by Day 29. Neutralizing antibody concentrations were maintained in patients aged 18 to 55 years up to at least Day 85 and up to at least Day 87 for patients 65 years and older.[66470]
References
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] 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] The adenovirus vector used in the Janssen COVID-19 vaccine has been used in other vaccines where patients were vaccinated during any trimester, including a large-scale Ebola vaccine trial. No adverse pregnancy or infant outcomes were determined to be related to the vaccine in these trials.[66864] Manage potential post vaccination fever with acetaminophen. There is no current evidence that COVID-19 vaccines cause fertility problems in woman or men.[66863] [66864] Thrombosis with thrombocytopenia syndrome (TTS) has been reported after Janssen COVID-19 vaccine administration under the emergency use authorization. Although the risk of thrombosis is increased during pregnancy and the postpartum period, experts believe that these factors do not make patients more susceptible to TTS after Janssen COVID-19 administration. However, 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). Counsel female patients younger than 50 years of age on the rare risk of TTS after Janssen COVID-19 vaccination and the availability of other FDA-authorized COVID-19 vaccines (i.e, mRNA vaccines).[66175] A pregnancy exposure registry is available that monitors pregnancy outcomes in women exposed to Janssen COVID-19 vaccine during pregnancy. Encourage women vaccinated with the Janssen COVID-19 vaccine to enroll in the registry by visiting https://c-viper.pregistry.com. Additionally, pregnant women should be encouraged to enroll in the CDC's V-SAFE program by going to vsafe.cdc.gov.[66175] [66374]
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, it's 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] 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.
References
Interactions
Level 3 (Moderate)
- Abatacept
- Abemaciclib
- Abrocitinib
- Acalabrutinib
- Adalimumab
- Ado-Trastuzumab emtansine
- Afatinib
- Alectinib
- Alemtuzumab
- Alpelisib
- Altretamine
- Aminolevulinic Acid
- Amivantamab
- Anakinra
- Anifrolumab
- Antithymocyte Globulin
- Arsenic Trioxide
- Asciminib
- Asparaginase Erwinia chrysanthemi
- Avacopan
- Avapritinib
- 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
- 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
- Deucravacitinib
- Dexamethasone
- Dinutuximab
- Docetaxel
- Dostarlimab
- Doxorubicin
- Doxorubicin Liposomal
- Dupilumab
- 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
- Irinotecan
- Irinotecan Liposomal
- Isatuximab
- Ivosidenib
- Ixabepilone
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- 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
- Obinutuzumab
- Ocrelizumab
- Ofatumumab
- Olaparib
- Olaratumab
- Omacetaxine
- Omalizumab
- Osimertinib
- Oxaliplatin
- Ozanimod
- Paclitaxel
- Palbociclib
- Panitumumab
- Panobinostat
- Pazopanib
- Pegaspargase
- Pegcetacoplan
- 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
- Spesolimab
- 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
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- Ustekinumab
- Vandetanib
- Vedolizumab
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- Venetoclax
- Vinblastine
- Vincristine
- Vincristine Liposomal
- Vinorelbine
- Vismodegib
- Voclosporin
- Vorinostat
- Zanubrutinib
- Ziv-Aflibercept
References
Monitoring Parameters
- laboratory monitoring not necessary
US Drug Names
- Janssen COVID-19 Vaccine
