0.3 mL (30 mcg) IM for 2 doses administered 3 weeks apart.[66080]
0.3 mL (30 mcg) IM for 2 doses administered 3 weeks apart. Of note, Emergency Use Authorization is based on extrapolation of adult safety and efficacy data.[66080]
0.5 mL (100 mcg) IM for 2 doses administered 1 month apart.[66120]
0.3 mL/dose IM for Pfizer-BioNTech COVID-19 vaccine; 0.5 mL/dose IM for Moderna COVID-19 vaccine.
0.3 mL/dose IM for Pfizer-BioNTech COVID-19 vaccine; 0.5 mL/dose IM for Moderna COVID-19 vaccine.
16 to 17 years: 0.3 mL/dose IM for Pfizer-BioNTech COVID-19 vaccine; safety and efficacy have not been established for Moderna COVID-19 vaccine.
13 to 15 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
† Off-label indicationThe COVID-19 vaccine is an investigational vaccine that contains messenger RNA (mRNA) 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 16 years of age and older (Pfizer-BioNTech COVID-19 vaccine) and 18 years of age and older (Moderna COVID-19 vaccine).[66080][66120] There are many clinical trials underway for various COVID-19 vaccines. Within the United States, phase 3 clinical trials currently include mRNA vaccines, viral vector-based vaccines, and protein-based 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] In phase 1a of the vaccination program for COVID-19, the Advisory Committee on Immunization Practices (ACIP) recommends that both health care personnel and residents of long-term care facilities are the first to be offered the vaccine. Next, in phase 1b, frontline essential workers and persons aged 75 years and older will be offered vaccination. Phase 1c will consist of persons aged 65 to 74 years, persons aged 16 to 64 years with high-risk medical conditions, and essential workers not recommended for vaccination in Phase 1b. In the final phase (phase 2), all persons aged 16 years and older not previously recommended for vaccination are eligible.[66165]
Pfizer-BioNTech Vaccine Trial Data
Efficacy data for the Pfizer-BioNTech COVID-19 vaccine included 36,621 patients who did not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose. Of the study participants who received the Pfizer-BioNTech COVID-19 vaccine (n = 18,242), 51.1% were male and 48.9% were female, 82.8% were White, 8.9% were Black or African American, 4.5% were Asian, 0.6% were American Indian or Alaska Native, 0.3% were Native Hawaiian or other Pacific Islander, and 2.9% were either multiracial or not reported. Additionally, 72.7% were not Hispanic or Latino, 26.8% were Hispanic or Latino, and 0.6% were 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 and breast-feeding women. Patients with pre-existing stable disease, defined as diseases not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, were included as were participants with known stable infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV). In an interim analysis, there were 8 confirmed COVID-19 cases in the Pfizer-BioNTech COVID-19 vaccine group and 162 cases in the placebo group. The overall efficacy of the Pfizer-BioNTech COVID-19 vaccine was 95% in patients without evidence of prior SARS-CoV-2 infection. In patients 16 to 64 years and 65 years and older, the efficacy was 95.1% and 94.7%, respectively. There were no significant clinical differences in overall vaccine efficacy in 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).[66080]
Moderna Vaccine Trial Data
Efficacy data for the Moderna COVID-19 vaccine included 28,207 patients who did not have evidence of prior infection with SARS-CoV-2 through 14 days after the second dose. Of the study participants, 52.6% were male and 47.4% were female, 79.5% were White, 9.7% were Black or African American, 4.6% were Asian, and 2.1% were other. Additionally, 19.7% were Hispanic or Latino. Patients who were immunocompromised were excluded, along with pregnant and breast-feeding women. Patients with pre-existing stable disease, defined as diseases not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment, were included as were participants with known stable infection with human immunodeficiency virus (HIV). In the primary efficacy analysis, there were 11 confirmed COVID-19 cases in the Moderna COVID-19 vaccine group and 185 cases in the placebo group. The overall efficacy of the Moderna COVID-19 vaccine was 94.1% in patients without evidence of prior SARS-CoV-2 infection (95% CI, 89.3% to 96.8%; p less than 0.001). In patients 18 to 64 years and 65 years and older, the efficacy was 95.6% and 86.4%, respectively. Vaccine efficacy was also similar across other subgroups including presence of risk for severe COVID-19, sex, and race and ethnic group. A secondary endpoint of vaccine efficacy at preventing COVID-19 14 days after the first dose was 95.2%. The vaccine efficacy in the population that included patients who were SARS-CoV-2 seropositive at baseline was 93.6%. There were 30 cases of severe COVID-19 all occurring in patients who received placebo.[66120][66199]
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:
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]
Storage and Handling Prior to Thawing (Pfizer-BioNTech COVID-19 vaccine)
Storage and Handling Prior to Thawing (Moderna COVID-19 vaccine)
Pfizer-BioNTech COVID-19 vaccine
Thawing
Dilution
Intramuscular Injection
Moderna COVID-19 vaccine
Thawing
Preparation
Intramuscular Injection
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] After Pfizer-BioNTech COVID-19 vaccine administration, pain (84.1%), erythema or redness (9.5%), and swelling (10.5%) at the injection site were the most common reactions in patients 16 years and older. Most local reactions resolved within 3 days, but some patients reported symptoms for up to 36 days. About one-third (28.3% to 32%) of patients 18 to 55 years who received the vaccine reported pain that either interfered with daily activity or prevented it; the percentage of patients reporting this degree of pain (15.2% to 18.5%) was lower in patients 56 years and older. The largest difference occurred in the incidence of redness in patients 56 years and older (7.2% after dose 2, 4.7% after dose 1).[66080] 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 (8.9% after dose 2, 3% after dose 1) and swelling or hardness (12.6% after dose 2, 6.7% after dose 1) were reported in patients 18 to 64 years. Similar numbers of erythema or redness (7.5% after dose 2, 2.3% after dose 1) and swelling or hardness (10.8% after dose 2, 4.4% after dose 1) were reported in patients 65 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 2 to 3 days. Delayed reactions, occurring 8 or more days after administration, occurred in 0.8% and 0.2% of patients after the first and second dose, respectively, and usually resolved over 4 to 5 days.[66120] [66199]
During clinical trials, fatigue (62.9% to 70%), headache (55.1% to 64.7%), and malaise (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] In patients 18 to 55 years of age who received the Pfizer-BioNTech COVID-19 vaccine, moderate fatigue (causing some interference with activity) was reported in majority of patients experiencing fatigue (33.7% after dose 2, 19.9% after dose 1). In patients 56 years and older, moderate fatigue was also reported by more patients after the second dose (26.6% after dose 2, 13.3% after dose 1). Headache was more common after the second dose in both age groups (18 to 55 years: 51.7% after dose 2, 41.9% after dose 1 and 56 years and older: 39% after dose 2, 25.2% after dose 1).[66080] 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 67.6% reporting any fatigue, 10.7% reporting fatigue that prevented daily activities, and 1 patient reporting fatigue that required an emergency room visit or hospitalization. Headache was more common after the second dose in both age groups (18 to 64 years: 62.8% after dose 2, 35.3% after dose 1 and 65 years and older: 46.2% after dose 2, 24.5% after dose 1).[66120]
Musculoskeletal adverse reactions reported during COVID-19 vaccine clinical trials include muscle pain or myalgia (38.3% to 61.5%) and/or joint pain or arthralgia (23.6% to 46.4%).[66080] [66120] In patients 18 to 55 years of age, new or worsened muscle pain was reported in about one-third of patients (37.3%) after the second Pfizer-BioNTech COVID-19 vaccine dose compared to 21.3% after the first dose. A similar number of patients 56 years or older reported new or worsened muscle pain (28.7% after dose 2, 13.9% after dose 1). Moderate to severe muscle pain (causing some interference with daily activities or preventing activities) was reported after dose 2 in 21.7% of patients 18 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 both age groups (18 to 55 years: 21.9% after dose 2, 11% after dose 1 and 56 years and older: 18.9% after dose 2, 8.6% after dose 1).[66080] During Moderna COVID-19 clinical trials, myalgia was more common after the second dose in both age groups (18 to 64 years: 61.6% after dose 2, 23.7% after dose 1 and 65 years and older: 47.1% 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: 45.5% after dose 2, 16.6% after dose 1 and 65 years and older: 35% 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: 3.3% 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.[66120]
Diarrhea, nausea, and vomiting were reported during COVID-19 vaccine clinical trials.[66080] [66120] During clinical trials in patients 16 years and older, nausea (1.1%) was reported after administration of the Pfizer-BioNTech COVID-19 vaccine. Diarrhea was reported by 10.4% to 11.1% of patients 18 to 55 years and 8.3% of patients 56 years and older. Vomiting was reported in 1.2% to 1.9% of patients 18 to 55 years and 0.5% to 0.7% of patients 56 years and older.[66080] 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 (11.8% 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]
Lymphadenopathy was reported in 0.3% of patients 16 years and older during Pfizer-BioNTech COVID-19 vaccine clinical trials. From dose 1 through 20 days after dose 2, lymphadenopathy was reported in more patients in the vaccine group (n = 64) than in the placebo group (n = 6).[66080] During Moderna COVID-19 vaccine clinical trials, lymphadenopathy-related events were reported in 1.1% of patients who received the vaccine compared to 0.6% of patients who received placebo. These events included lymphadenopathy, lymphadenitis, lymph node pain, vaccination-site lymphadenopathy, injection-site lymphadenopathy, and axillary mass.[66120]
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 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.[66120]
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 Moderna COVID-19 vaccine clinical trials, there were 3 reports of Bell's palsy in the vaccine group (n = 15,185) compared to 1 patient in the placebo group (n = 15,166). Onset of facial paralysis occurred 22, 28, and 32 days after vaccination in the vaccine group and 17 days after vaccination in the placebo group. In the United States, it is estimated that between 25 and 35 in 100,000 people are affected with Bell's palsy. Currently available information is insufficient to determine a causal relationship between appendicitis or Bell's palsy with the vaccine.[66080] [66120] [66184]
During clinical trials, chills (31.9% to 45.4%) and fever (14.2% to 15.5%) 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] In patients 18 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 (6.4% after dose 2, 1% 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% of patients after dose 2 compared to 0.3% of patients after dose 1. In patients 18 to 55 years old, chills were reported by more patients after the second Pfizer-BioNTech COVID-19 vaccine dose (35.1% after dose 2, 14% after dose 1). A similar difference in the incidence of chills was seen in patients 56 years and older (22.7% after dose 2, 6.3% after dose 1).[66080] 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 (10% after dose 1, 0.3% after dose 2). 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 (48.6%).[66120]
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 of any severity to a previous dose of an mRNA COVID-19 vaccine or any of its components, including polyethylene glycol (PEG), or to polysorbate (due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG) a contraindication to COVID-19 vaccination. Patients with a previous reaction to components of the COVID-19 vaccine, including PEG, or polysorbate should not receive COVID-19 vaccination unless they have been evaluated by an allergist-immunologist. 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. Patients with an immediate allergic reaction to the first COVID-19 vaccine dose should not receive additional doses of the vaccine. 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 and patients with a history of anaphylaxis due to any cause. A 15 minute observation period is recommended for patients with an allergic reaction (but not anaphylaxis) to oral medications, food, pet, insect, venom, environmental, latex, or other allergy and in those with a family history of anaphylaxis.[66175]
Immunocompromised patients, including patients with immunosuppression or receiving immunosuppressive therapy, may not have an adequate immune response to the COVID-19 vaccine.[66080] [66120] 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. When vaccinating immunocompromised patients, observe patients for 15 minutes after vaccine administration.[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.[65107] Re-vaccination is not recommended after immune competence is regained in patients who received mRNA COVID-19 vaccines 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 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.[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.[65107] [66080] [66120] 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. When vaccinating immunocompromised patients, observe patients for 15 minutes after vaccine administration. Re-vaccination is not recommended after immune competence is regained in patients who received mRNA COVID-19 vaccines during chemotherapy or treatment with other immunosuppressive drugs.[66175]
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. 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] 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. When vaccinating immunocompromised patients, observe patients for 15 minutes after vaccine administration.[66175]
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]
Available data are insufficient to inform vaccine-associated risks during pregnancy. It is unknown whether administration of the COVID-19 vaccine can cause fetal harm or affect the reproductive system.[66080] [66120] The American College of Obstetricians and Gynecologists (ACOG) recommends that women eligible for the COVID-19 vaccine be offered the vaccine regardless of pregnancy status. Women planning to become pregnant who are eligible for the COVID-19 vaccine are encouraged to complete their vaccination series prior to conception to ensure maximal protection prior to pregnancy. If a woman becomes pregnant after the first dose, administer the second dose as indicated. If a woman becomes pregnant within 30 days of receipt of the vaccine, encourage participation in the CDC's V-SAFE program.[66179] When vaccinating pregnant women, observe patients for 15 minutes after vaccine administration.[66175] 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. In a developmental toxicity study, when the same quantity of mRNA (100 mcg) and other ingredients included in a single human dose of Moderna COVID-19 vaccine was administered to female rats by the IM route on 4 occasions, no vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported.[66120]
There are no data regarding use of the COVID-19 vaccine during breast-feeding and its excretion in human breast milk is unknown.[66080] [66120] The American College of Obstetricians and Gynecologists (ACOG) recommends that breast-feeding women eligible for the COVID-19 vaccine be offered the vaccine.[66179] When vaccinating a breast-feeding woman, observe patients for 15 minutes after vaccine administration.[66175] 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]
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]
Revision Date: 12/18/2020, 09:51:00 PMThe COVID-19 vaccine is administered intramuscularly. Vaccination does not ensure immunity.[66080][66120]
Affected cytochrome P450 isoenzymes: none
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 geometric mean titers (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]
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]
Available data are insufficient to inform vaccine-associated risks during pregnancy. It is unknown whether administration of the COVID-19 vaccine can cause fetal harm or affect the reproductive system.[66080] [66120] The American College of Obstetricians and Gynecologists (ACOG) recommends that women eligible for the COVID-19 vaccine be offered the vaccine regardless of pregnancy status. Women planning to become pregnant who are eligible for the COVID-19 vaccine are encouraged to complete their vaccination series prior to conception to ensure maximal protection prior to pregnancy. If a woman becomes pregnant after the first dose, administer the second dose as indicated. If a woman becomes pregnant within 30 days of receipt of the vaccine, encourage participation in the CDC's V-SAFE program.[66179] When vaccinating pregnant women, observe patients for 15 minutes after vaccine administration.[66175] 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. In a developmental toxicity study, when the same quantity of mRNA (100 mcg) and other ingredients included in a single human dose of Moderna COVID-19 vaccine was administered to female rats by the IM route on 4 occasions, no vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported.[66120]
There are no data regarding use of the COVID-19 vaccine during breast-feeding and its excretion in human breast milk is unknown.[66080] [66120] The American College of Obstetricians and Gynecologists (ACOG) recommends that breast-feeding women eligible for the COVID-19 vaccine be offered the vaccine.[66179] When vaccinating a breast-feeding woman, observe patients for 15 minutes after vaccine administration.[66175] 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]