Full Prescribing Information & EUA Fact Sheets

FDA EUA Letter (12 Years & Up) Full Prescribing Information (FDA Approved - 16 Years & Up) EUA Fact Sheet for Vaccination Providers - 12 Years & Up EUA Fact Sheet for Recipients and Caregivers - 12 Years & Up

Clinical Efficacy & Safety

In individuals 16 years of age and older1

Please see the full Prescribing Information to see the clinical trial design and efficacy (Section 14 - pg. 15) and safety (Section 6 - pg. 6).1

In individuals 12 through 15 years of age2

Please see the EUA Fact Sheet for Vaccination Providers to see the clinical trial design and efficacy (Section 18 - pg. 34) and safety (Section 6 - pg. 21).2


  • Important Safety Information

    Indication & Authorized Use

    Important Safety Information

    • Known history of a severe allergic reaction (eg, anaphylaxis) to any component of COMIRNATY® is a contraindication.
    • Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the vaccine.

      Monitor vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).

    • Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose.
    • Syncope (fainting) may occur in association with administration of injectable vaccines, including this vaccine. Procedures should be in place to avoid injury from fainting.
    • Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine.
    • The vaccine may not protect all vaccine recipients.
    • In clinical studies of participants 16 through 55 years of age, the most commonly reported adverse reactions (≥10%) were pain at the injection site (88.6%), fatigue (70.1%), headache (64.9%), muscle pain (45.5%), chills (41.5%), joint pain (27.5%), fever (17.8%), and injection site swelling (10.6%).
    • In clinical studies of participants 56 years of age and older, the most commonly reported adverse reactions (≥10%) were pain at the injection site (78.2%), fatigue (56.9%), headache (45.9%), muscle pain (32.5%), chills (24.8%), joint pain (21.5%), injection site swelling (11.8%), fever (11.5%), and injection site redness (10.4%).
    • In a clinical study evaluating administration of a booster dose in participants 18 through 55 years of age, the most commonly reported adverse reactions (≥10%) following the dose were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), and joint pain (25.3%).
    • In a clinical study of adolescents 12 through 15 years of age, the most commonly reported adverse reactions included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%).
    • Before administration of the vaccine, please see full Prescribing Information (16+ years of age), EUA Fact Sheet for Vaccination Providers (12+ years of age), and Recipients and Caregivers Fact Sheet (12+ years of age).
    • Patients should always ask their healthcare providers for medical advice about adverse events. You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit https://vaers.hhs.gov/reportevent.html or call 1-800-822-7967.

    Indication & Authorized Use

    The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.


    Indication

    COMIRNATY® is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.

    Authorized Use

    COMIRNATY® (COVID-19 Vaccine, mRNA) is also authorized for emergency use to provide:

    • a two-dose primary series to individuals 12 through 15 years
    • a third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
    • a single booster dose to the following individuals who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®:
      • 65 years of age and older
      • 18 through 64 years of age at high risk of severe COVID-19
      • 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
    • a single booster dose to eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine. The eligible population(s) 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

    The Pfizer-BioNTech COVID-19 Vaccine has received Emergency Use Authorization (EUA) from FDA to prevent COVID-19 in individuals 12 years of age and older to provide:

    • a two-dose primary series to individuals 12 years of age and older
    • a third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
    • a single booster dose to the following individuals who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®:
      • 65 years of age and older
      • 18 through 64 years of age at high risk of severe COVID-19
      • 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
    • a single booster dose to eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine. The eligible population(s) 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
References
  1. COMIRNATY® (COVID-19 Vaccine, mRNA). Prescribing Information. Pfizer and BioNTech; 2021.
  2. Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers). Pfizer and BioNTech; 2021.

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