Comirnaty 2026-2027 (12Y Up) (COVID vaccine 2026-2027 (12 yrs up) (Pfizer)/PF)

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There is no enhanced messaging for this drug.

Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

Non-Live Or Non-Replicating Vaccines/Efalizumab

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Efalizumab-induced immunosuppression may prevent proper immune response to the vaccine.(1)

CLINICAL EFFECTS: The use of vaccines in patients who have recently received efalizumab may be ineffective.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Patients should receive all appropriate immunizations prior to beginning efalizumab therapy. The use of vaccines in patients who have recently received efalizumab may be ineffective.(1) Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2)

DISCUSSION: In a small study with intravenous efalizumab, a single dose of 0.3 mg/kg of efalizumab given before primary immunization with a neoantigen decreased the secondary immune response, and a dose of 1 mg/kg almost completely ablated it. (This dose has comparable pharmacodynamic effects to the recommended subcutaneous dose of 1 mg/kg.) In chimpanzees treated with greater than 10 times the normal clinical exposure level of efalizumab, antibody responses were decreased following immunization with tetanus toxoid compared with untreated control animals.(1)

Non-Live, Non-Replicating Vaccine/Rebisufligene Etisparvovec

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Rebisufligene etisparvovec therapy may decrease the effectiveness of vaccines. The mechanism is not known.(1)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The US manufacturer of rebisufligene etisparvovec states that vaccines should be avoided 30 days prior to rebisufligene etisparvovec administration.(1)

DISCUSSION: Rebisufligene etisparvovec therapy may decrease the effectiveness of vaccines.(1)

Vaccines/Pariglasgene Brecaparvovec

SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient.

MECHANISM OF ACTION: Pariglasgene brecaparvovec therapy may decrease the effectiveness of vaccines. The mechanism is not known.(1)

CLINICAL EFFECTS: The expected serum antibody response may not be obtained.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The US manufacturer of pariglasgene brecaparvovec states that vaccines should be avoided for 1 month prior to pariglasgene brecaparvovec administration.(1)

DISCUSSION: Pariglasgene brecaparvovec therapy may decrease the effectiveness of vaccines.(1)

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Non-Live Or Non-Replicating Vaccines/Teplizumab

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Teplizumab may cause lymphopenia and alter the immune system's response to vaccines.(1)

CLINICAL EFFECTS: Administration of a non-live vaccine within the 2 weeks prior to, during, or for 6 weeks following teplizumab therapy may result in decreased effectiveness of the vaccine.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating teplizumab therapy. The manufacturer of teplizumab states that non-live vaccines (e.g., inactivated or mRNA vaccines) are not recommended within the 2 weeks prior to, during, or for 6 weeks after stopping teplizumab therapy.(1) The immune response to non-live vaccines should be monitored in patients who receive teplizumab within these time frames. The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2) For COVID-19 vaccines, the CDC advises planning for vaccination at least 2 weeks before starting or resuming immunosuppressive therapy. Patients should be offered and given a COVID-19 vaccine even if the use and timing of immunosuppressive agents cannot be adjusted. The CDC states that an age-appropriate mRNA COVID-19 vaccine is preferred over the Janssen COVID-19 vaccine for the primary and booster doses for immunocompromised patients. All immunocompromised patients over 5 years of age should receive at least 1 booster dose if eligible. See the CDC's Interim Clinical Considerations for Use of COVID-19 Vaccines for age- and product-specific recommendations.(3)

DISCUSSION: Vaccinations may be less effective if administered within 2 weeks before, during, and for 6 weeks following teplizumab therapy.(1)

Moderate Interaction: Assess the risk to the patient and take action as needed.

Covid-19 Vaccines/Covid-19 Monoclonal Antibodies

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: COVID-19 monoclonal antibodies such as tixagevimab-cilgavimab and pemivibart may prevent the immune system from properly responding to the COVID-19 vaccine.(1-3)

CLINICAL EFFECTS: Administration of a COVID-19 monoclonal antibody such as tixagevimab-cilgavimab and pemivibart, soon after receipt of a COVID-19 vaccine may interfere with vaccine-induced immune responses and impair the efficacy of the vaccine.(1-3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: In individuals who have received a COVID-19 vaccine, a COVID-19 monoclonal antibody (such as tixagevimab-cilgavimab and pemivibart) should be administered at least two weeks after vaccination.(2,3) Patients who previously received a COVID-19 monoclonal antibody may be vaccinated against COVID-19 at any time.(1)

DISCUSSION: There is no data on the safety or efficacy of COVID-19 vaccines in patients who subsequently receive COVID-19 monoclonal antibodies. Given a lack of data, the CDC recommends that tixagevimab-cilgavimab be temporarily deferred for 2 weeks in patients who previously received COVID-19 vaccines.(1)

Covid-19 Vaccines/Immunosuppressives; Immunomodulators

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Immunosuppressants and immunomodulators may prevent the immune system from properly responding to the COVID-19 vaccine.(1-3)

CLINICAL EFFECTS: Administration of a COVID-19 vaccine with immunosuppressants or immunomodulators may interfere with vaccine-induced immune response and impair the efficacy of the vaccine. However, patients should be offered and given a COVID-19 vaccine even if the use and timing of immunosuppressive agents cannot be adjusted.(1-3)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The Centers for Disease Control and Prevention (CDC),(1) Infectious Diseases Society of America (IDSA),(2) and the American College of Rheumatology (ACR)(3) have published guidances for COVID-19 vaccination in patients on immunosuppressants. The CDC states that all immunocompromised patients over 6 months of age should receive at least 1 dose of COVID-19 vaccine if eligible. See the CDC's Interim Clinical Considerations for Use of COVID-19 Vaccines for specific recommendations based on age, vaccination history, and vaccine manufacturer.(1) The CDC advises planning for vaccination at least 2 weeks before starting or resuming immunosuppressive therapy.(1) IDSA recommends timing COVID-19 vaccination at least 2 weeks before starting or at least 3 months after completing immunosuppressive therapy.(2) The ACR states that in general, immunosuppressants and immunomodulators should be held for 1-2 weeks after each vaccine dose.(3) Patients should be offered and given a COVID-19 vaccine even if the use and timing of immunosuppressive agents cannot be adjusted, though the immune response will likely be blunted. COVID-19 vaccines should not be delayed in patients taking immunosuppressive therapies.(1-2) See below for specific recommendations for certain agents. B-cell depleting agents, including rituximab: The CDC states that the utility of B-cell quantification to guide clinical care is not known and is not recommended. Patients who receive B-cell depleting therapy on a continuing basis should receive COVID-19 vaccines about 4 weeks before the next scheduled dose. For patients who received 1 or more doses of COVID-19 vaccine during treatment with B-cell-depleting therapies that were administered over a limited period (e.g., as part of a treatment regimen for certain malignancies), revaccination may be considered according to the current CDC recommendations for unvaccinated patients. The suggested interval to start revaccination is about 6 months after completion of the B-cell-depleting therapy.(1) IDSA recommends waiting for at least 3-6 months after the last infusion of B-cell depleting therapy before administering COVID-19 vaccines.(2) The ACR recommends consulting with the rheumatologist to determine optimal timing of COVID-19 vaccination. Measuring CD19 B cells may be considered to determine need for a booster vaccine dose. If B cell levels are not measured, a supplemental vaccine dose 2-4 weeks before the next scheduled dose of rituximab is recommended.(3) Recipients of hematopoietic cell transplant or CAR-T-cell therapy who received one or more doses of COVID-19 vaccine prior to or during treatment should undergo revaccination following the current CDC recommendations for unvaccinated patients. Revaccination should start at least 3 months (12 weeks) after transplant or CAR-T-cell therapy.(1,2) The CDC includes abatacept, cyclophosphamide, and TNF-alpha and cytokine inhibitors in their general recommendation to hold therapy for at least 2 weeks following vaccination (1) while the ACR provides different recommendations:(3) *Abatacept: - Subcutaneous abatacept should be withheld for 1-2 weeks after each vaccine dose, as disease activity allows. - For intravenous abatacept, time administration so that vaccination will occur 1 week before the next abatacept infusion. *Cyclophosphamide: When feasible, administer cyclophosphamide 1 week after each COVID-19 vaccine dose. *TNF-alpha inhibitors and cytokine inhibitors: The ACR was not able to reach consensus on whether to modify dosing or timing of these agents with COVID-19 vaccination.

DISCUSSION: IDSA recommendations are based on cohort and case control studies in immunocompromised patients that found low to modest vaccine effectiveness (37-61%) but lower risks of COVID-19 association hospitalization, COVID-19 related mortality, and critical illness.(2) The ACR convened a COVID-19 Vaccine Guidance Task Force to provide guidance on optimal use of COVID-19 vaccines in rheumatology patients. These recommendations are based on limited clinical evidence of COVID-19 vaccines in patients without rheumatic and musculoskeletal disorders and evidence of other vaccines in this patient population.(3) The ACR recommendation for rituximab is based on studies of humoral immunity following receipt of other vaccines. These studies have uncertain generalizability to vaccination against COVID-19, as it is unknown if efficacy is attributable to induction of host T cells versus B cell (antibody-based) immunity.(3) The ACR recommendation for mycophenolate is based on preexisting data of mycophenolate on non-COVID-19 vaccine immunogenicity. Emerging data suggests that mycophenolate may impair SARS-CoV-2 vaccine response in rheumatic and musculoskeletal disease and transplant patients.(3) The ACR recommendation for methotrexate is based on data from influenza vaccines and pneumococcal vaccines with methotrexate.(3) The ACR recommendation for JAK inhibitors is based on concerns related to the effects of JAK inhibitors on interferon signaling that may result in a diminished vaccine response.(3) The ACR recommendation for subcutaneous abatacept is based on several studies suggesting a negative effect of abatacept on vaccine immunogenicity. The first vaccine dose primes naive T cells, naive T cell priming is inhibited by CTLA-4, and abatacept is a CTLA-4Ig construct. CTLA-4 should not inhibit boosts of already primed T cells at the time of the second vaccine dose.(3)

Covid-19 Vaccines/Orthopoxvirus Vaccines

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Both the COVID-19 vaccines and orthopoxvirus vaccines have been reported to cause myocarditis and pericarditis.(1,2)

CLINICAL EFFECTS: Concurrent use of COVID-19 vaccines and orthopoxvirus vaccines may increase the risk of myocarditis and pericarditis.(1,2)

PREDISPOSING FACTORS: Myocarditis and pericarditis have been reported more frequently in adolescent and young adult males after the 2nd dose of COVID-19 vaccines and within a week of vaccination.(1) Patients with pre-existing heart disease or 3 or more cardiac risk factors (hypertension, diabetes, hypercholesterolemia, family history of heart disease, and smoking) have a theoretical risk for myopericarditis with the smallpox-mpox vaccine.(2)

PATIENT MANAGEMENT: While there is no required minimum interval between receiving the COVID-19 vaccine and the smallpox or smallpox-mpox vaccine, patients who are predisposed to developing myocarditis or pericarditis may consider waiting 4 weeks between vaccines. However, if an orthopoxvirus vaccine is recommended in the setting of an outbreak, or a patient's risk for severe COVID-19 disease is high, administration of both vaccines should not be delayed. The smallpox-mpox vaccine is preferred over the smallpox vaccine when coadministering with a COVID-19 vaccine.(1,2)

DISCUSSION: Myocarditis and pericarditis have been reported rarely after COVID-19 vaccination in the United States, but available evidence both in the US and internationally supports a causal relationship.(1) After primary vaccination with the smallpox vaccine, there is an estimated rate of myocarditis of 5.7 per 1,000 patients. Myocarditis has not been reported with the smallpox-mpox vaccine, but since the mechanism for myocarditis with the smallpox vaccine is believed to be immune-mediated, there is a possibility that antigens in the smallpox-mpox vaccine may precipitate myopericarditis.(2)

Non-Live Or Non-Rep Vaccines/Systemic Corticosteroids; Acth

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Corticosteroids and corticotropin suppress the immune system and may alter the immune system's response to vaccines.(1)

CLINICAL EFFECTS: Vaccines administered during or within 2 weeks prior to therapy with corticosteroids or corticotropin may result in decreased effectiveness of the vaccine.(1)

PREDISPOSING FACTORS: Patients receiving immunosuppressive doses of corticosteroids or corticotropin for equal to or greater than 14 consecutive days.(1)

PATIENT MANAGEMENT: The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed, including those who are receiving or have received high-dose, systemic steroids for greater than or equal to 14 consecutive days. When initiating immunosuppressives doses of corticosteroids, wait 2 weeks after a non-live vaccines is administered. However, if patients require therapy for chronic inflammatory conditions, do not delay therapy due to past vaccines.(1) The immune response to non-live vaccines should be monitored in patients receiving corticosteroids. Vaccinations given during corticosteroid therapy may need to be repeated.(1) Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(1)

DISCUSSION: Vaccinations given during and within 2 weeks prior to corticosteroid therapy may be less effective. However they are considered safe to administer.(1) Many clinicians consider a dose equivalent to either 2 mg/kg of body weight or a total of 20 mg/day of prednisone as sufficiently immunosuppressive to raise safety concerns about live-virus vaccines.(1) Immunization procedures may be undertaken in patients receiving corticosteroids when the therapy is short term (less than 2 weeks); low to moderate dose; long-term, alternate-day treatment with short-acting preparations; maintenance physiologic doses (replacement therapy); or administered topically (skin or eyes), by aerosol, or by intra-articular, bursal, or tendon injection.(1)

Non-Live Or Non-Replicating Vaccines/Etrasimod

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Etrasimod is an immunosuppressant and may alter the immune system's response to vaccines.(1)

CLINICAL EFFECTS: Administration of a vaccine during and for up to 5 weeks after discontinuation of etrasimod therapy may result in decreased effectiveness of the vaccine. Etrasimod treatment should be paused 5 weeks prior and for 4 weeks after vaccination.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating etrasimod therapy. The immune response to non-live vaccines should be monitored in patients receiving etrasimod or who have received etrasimod in the previous 5 weeks. Vaccinations given during and for up to 5 weeks after discontinuation of etrasimod therapy may need to be repeated.(1) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2)

DISCUSSION: Vaccinations may be less effective if administered during and for up to 5 weeks after etrasimod treatment.(1) However they are considered safe to administer.

Non-Live Or Non-Replicating Vaccines/Fingolimod

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Fingolimod is an immunosuppressant and may alter the immune system's response to vaccines.(1)

CLINICAL EFFECTS: Administration of a vaccine during and for 2 months following fingolimod therapy may result in decreased effectiveness of the vaccine.(1,2)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating fingolimod therapy. The immune response to non-live vaccines should be monitored in patients receiving fingolimod or who have received fingolimod in the previous two months. Vaccinations given during and for 2 months after stopping fingolimod therapy may need to be repeated.(1,2) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(3)

DISCUSSION: Vaccinations may be less effective during and for 2 months following fingolimod therapy(1) however they are considered safe to administer.(2)

Non-Live Or Non-Replicating Vaccines/Ozanimod

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Ozanimod is an immunosuppressant and may alter the immune system's response to vaccines.(1)

CLINICAL EFFECTS: Administration of a vaccine during and for up to 3 months after discontinuation of ozanimod therapy may result in decreased effectiveness of the vaccine. Ozanimod treatment should be paused 3 months prior and for 1 month after vaccination.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating ozanimod therapy. The immune response to non-live vaccines should be monitored in patients receiving ozanimod or who have received ozanimod in the previous 3 months. Vaccinations given during and for up to 3 months after discontinuation of ozanimod therapy may need to be repeated.(1) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2)

DISCUSSION: Vaccinations may be less effective if administered during and for up to 3 months after ozanimod treatment.(1) However they are considered safe to administer.

Non-Live Or Non-Replicating Vaccines/Ponesimod

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Ponesimod is an immunosuppressant and may alter the immune system's response to vaccines.(1)

CLINICAL EFFECTS: Administration of a vaccine during and for up to 2 weeks after discontinuation of ponesimod therapy may result in decreased effectiveness of the vaccine. Ponesimod treatment should be paused 1-2 weeks prior and for 4 weeks after vaccination.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating ponesimod therapy. The immune response to non-live vaccines should be monitored in patients receiving ponesimod or who have received ponesimod in the previous 2 weeks. Vaccinations given during and for up to 2 weeks after discontinuation of ponesimod therapy may need to be repeated.(1) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(2)

DISCUSSION: Vaccinations may be less effective if administered during and for up to 2 weeks after ponesimod treatment.(1) However they are considered safe to administer.

Non-Live Or Non-Replicating Vaccines/Siponimod

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Siponimod is an immunosuppressant and may alter the immune system's response to vaccines.(2)

CLINICAL EFFECTS: Administration of a vaccine during and for up to 1 month after discontinuation of siponimod therapy may result in decreased effectiveness of the vaccine. Siponimod treatment should be paused 1 week prior and for 4 weeks after vaccination.(2)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Ideally, administer vaccines prior to initiating siponimod therapy. The immune response to non-live vaccines should be monitored in patients receiving siponimod or who have received siponimod in the previous week. Vaccinations given during and for up to 1 month after discontinuation of siponimod therapy may need to be repeated.(2) The Centers for Disease Control's (CDC) Advisory Committee on Immunization Practices (ACIP) states that non-live vaccines should be used with caution in patients who are severely immunosuppressed. Patients who are vaccinated within the 14 days prior to initiating immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after immunosuppressive therapy is discontinued when immune competence is restored.(3)

DISCUSSION: Vaccinations may be less effective if administered during and for up to 1 month after siponimod treatment(2) however they are considered safe to administer.(1)

Vaccines/Hepatitis B Vaccine (Fendrix)

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: No data is available on the concurrent administration of the hepatitis B vaccine Fendrix and other vaccines.(1)

CLINICAL EFFECTS: It is unknown if concurrent administration of the hepatitis B vaccine Fendrix and other vaccines will affect the efficacy of either vaccine.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The Swedish manufacturer of Fendrix states that since there is no data available for the concurrent administration of Fendrix with other vaccines, the administration of Fendrix and other vaccines should be separated by 2 to 3 weeks.(1)

DISCUSSION: No data is available on the concurrent administration of the hepatitis B vaccine Fendrix with other vaccines.(1)

*Known history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.

There are no contraindication contraindications for this drug.

• Myocarditis
• Pericarditis

There are no moderate contraindications for this drug.

The most commonly reported adverse reactions (>=10%) in participants 12 years of age and older receiving Comirnaty(R) were pain at the injection site (up to 90.5%), fatigue (up to 77.5%), headache (up to 75.5%), chills (up to 49.2%), muscle pain (up to 45.5%), joint pain (up to 27.5%), fever (up to 24.3%), injection site swelling (up to 11.8%), and injection site redness (up to 10.4%).

The most commonly reported adverse reactions (>=5%) in participants 5 through 11 years of age receiving Comirnaty(R) were pain at the injection site (up to 83.8%), fatigue (up to 51.9%), headache (up to 38.4%), injection site redness (up to 25.9%), injection site swelling (up to 20.0%), muscle pain (up to 18.1%), chills (up to 13.3%), fever (up to 7.8%), and joint pain (up to 7.6%).

Rare or Very Rare

• Anaphylaxis
• Angioedema
• Appendicitis
• Hypersensitivity drug reaction
• Myocarditis
• Pericarditis

More Frequent

• Arthralgia
• Chills
• Fatigue
• Headache disorder
• Injection site pain
• Myalgia

Less Frequent

• Fever
• Injection site erythema
• Irritability
• Localized edema
• Malaise
• Nausea

Rare or Very Rare

• Anorexia
• Bell's palsy
• Diarrhea
• Dizziness
• Extensive limb swelling after injection
• Facial palsy
• Gynecomastia
• Hyperhidrosis
• Hypoesthesia
• Insomnia
• Lethargy
• Lymphadenopathy
• Migraine
• Night sweats
• Pain in extremities
• Paresthesia
• Pruritus of skin
• Skin rash
• Syncope
• Vomiting

No enhanced messaging available.

Pfizer-BioNTech COVID-19 vaccine, mRNA (2026-2027 Formula) is FDA-labeled for use in children 5 years of age or older.

In a randomized, placebo-controlled study in which pregnant women 18 years of age or older received 2 doses of the Original Monovalent formulation of COVID-19 vaccine, mRNA (Pfizer-BioNTech) approximately 21 days apart (first dose administered at 24 to 34 weeks' gestation), major or minor congenital anomalies or chromosomal abnormalities were reported in 6.4% of infants born to women in the vaccine group compared with 4.4% of infants born to women in the placebo group. However, the available data from this study are insufficient to establish or exclude a vaccine-associated risk of congenital anomalies because the vaccine was not administered in the first trimester, the period when such anomalies is highest.

In a reproductive and developmental toxicity study, 0.06 mL of a vaccine formulation containing the same quantity of mRNA (30 mcg) and other ingredients included in a single human dose of the Pfizer-BioNTech COVID-19 vaccine was administered IM to female rats on 4 occasions (21 and 14 days prior to mating and on gestation days 9 and 20. No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported in the study.

Available data suggest that, while the absolute risk is low, pregnant and recently pregnant women with COVID-19 are at increased risk of severe illness, including illness resulting in hospitalization, admission to an intensive care unit, mechanical ventilation, extracorporeal membrane oxygenation (ECMO), or death compared with women who are not pregnant. Additionally, pregnant women with COVID-19 are at increased risk of preterm birth and may be at increased risk of adverse pregnancy complications and outcomes, such as preeclampsia, coagulopathy, and stillbirth.

Surveillance safety data are accumulating regarding COVID-19 vaccination during pregnancy. Early data from VAERS, v-safe active surveillance, and v-safe pregnancy registry have not identified any safety concerns in pregnant women who were vaccinated late in their pregnancy or in their infants; additional evidence has not found an increased risk for miscarriage following receipt of an mRNA vaccine before 20 weeks gestation. There is some evidence that pregnant women who receive an mRNA vaccine (Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine) during pregnancy have immune responses comparable to those observed in individuals who are not pregnant and may develop anti-SARS-CoV-2 antibody titers greater than those observed in women diagnosed with SARS-CoV-2 infection during pregnancy.

ACIP states that vaccination against COVID-19 is recommended for pregnant women. These experts state that evidence regarding the safety and efficacy of COVID-19 vaccines available from both animal and human studies indicates that the benefits of vaccination against COVID-19 during pregnancy outweigh any known or potential risks.

The American College of Obstetricians and Gynecologists (ACOG) also recommends that all pregnant women be vaccinated against COVID-19. Vaccination may occur in any trimester and as soon as possible to maximize maternal and fetal health.

It is not known whether COVID-19 vaccine (Pfizer-BioNTech) is distributed into milk. Data are not available to assess whether the vaccine administered to a woman who is breast-feeding has any effects on the breast-fed infant or milk production.

The benefits of breast-feeding and the importance of the Pfizer-BioNTech COVID-19 vaccine to the woman should be considered along with any potential adverse effects on the breast-fed child from the vaccine or from the underlying maternal condition (i.e., susceptibility to SARS-CoV-2 infection).

ACIP and ACOG recommend COVID-19 vaccination in all lactating individuals.

Individuals >=65 years of age have been included in clinical trials evaluating COVID-19 vaccine (Pfizer-BioNTech), and data from such individuals contribute to the overall assessment of safety and efficacy of the vaccine.

Data from a phase 1/2/3 clinical trial indicate that, as of March 13, 2021, 20.7% of the total number of individuals who received a 2-dose primary series of the initial (Original strain; no longer authorized for use in the US) monovalent vaccine were >=65 years of age and 4.2% were >=75 years of age. No overall differences in safety or effectiveness were observed between those >=65 years of age and younger recipients of the vaccine.