Full Prescribing Information & EUA Fact Sheets

FDA EUA Letter Full Prescribing Information (FDA Approved - 16 Years & Up) EUA Fact Sheet for Vaccination Providers (12 Years & Up) – DILUTE BEFORE USE, Purple Cap EUA Fact Sheet for Vaccination Providers (12 Years & Up) – DO NOT DILUTE, Gray Cap EUA Fact Sheet for Vaccination Providers (5 to <12 Years Old) – DILUTE BEFORE USE, Orange Cap EUA Fact Sheet for Recipients and Caregivers - 12 Years & Up EUA Fact Sheet for Recipients and Caregivers (5 to <12 Years Old)

Three vaccine presentations are now available with different preparation and storage guidelines.
See immediately below for information on Gray Cap and Orange Cap vials.

For dosing, preparation, and storage guidelines for Ages 12 years and older DO NOT DILUTE Gray Cap presentation:

View the EUA Fact Sheet for Vaccination Providers

Click here for expiry information.

For dosing, preparation, and storage guidelines for Ages 5 through 11 years DILUTE BEFORE USE Orange Cap presentation:

View the EUA Fact Sheet for Vaccination Providers

Click here for expiry information.

Unless otherwise specified, the remainder of the website applies only to the Ages 12 & Up DILUTE BEFORE USE Purple Cap Presentation.

Mandatory Requirements for Vaccine Administration Under Emergency Use Authorization2

In order to mitigate the risks of using this unapproved product under EUA and to optimize the potential benefit of the vaccine, the following items are required. Use of unapproved vaccine for active immunization to prevent COVID-19 under this EUA is limited to the following (all requirements must be met):
  1. The vaccine is authorized for use in individuals 12 years of age and older.
  2. The vaccination provider must communicate to the individual receiving the vaccine or their caregiver, information consistent with the “Vaccine Information Fact Sheet for Recipients and Caregivers” prior to the individual receiving the vaccine.
  3. The vaccination provider must include vaccination information in the state/local jurisdiction's Immunization Information System (IIS) or other designated system.
  4. The vaccination provider is responsible for mandatory reporting of the following to the Vaccine Adverse Event Reporting System (VAERS):
    • vaccine administration errors whether or not associated with an adverse event,
    • serious adverse events (irrespective of attribution to vaccination),
    • cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and
    • cases of COVID-19 that result in hospitalization or death.

    Complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS, call 1-800-822-7967. The reports should include the words “the vaccine EUA” in the description section of the report.

  5. The vaccination provider is responsible for responding to FDA requests for information about vaccine administration errors, adverse events, cases of MIS in adults and children, and cases of COVID-19 that result in hospitalization or death following administration of the vaccine to recipients.

Serious adverse events are defined as:

Other Adverse Event Reporting to VAERS and Pfizer Inc.

Vaccination providers may report to VAERS other adverse events that are not required to be reported using the contact information above.

To the extent feasible, report adverse events to Pfizer Inc. using the contact information below or by providing a copy of the VAERS form to Pfizer Inc.

Website: www.pfizersafetyreporting.com

Fax number: 1-866-635-8337

Telephone number: 1-800-438-1985

Vaccination providers administering COMIRNATY® (COVID-19 Vaccine, mRNA) must adhere to the same reporting requirements.2

Important Safety Information

  • Do not administer to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of the vaccine.

  • 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, in particular in adolescents. 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.

  • Primary Series Adverse Events:
    In clinical studies (30 mcg modRNA) 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 (30 mcg modRNA) 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 (30 mcg modRNA) of adolescents 12 through 15 years of age, adverse reactions following the administration of the primary series 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%).

  • In a clinical study (10 mcg modRNA) in children 5 through 11 years of age, adverse reactions following administration of any primary series dose included pain at the injection site (84.3%), fatigue (51.7%), headache (38.2%), injection site redness (26.4%), injection site swelling (20.4%), muscle pain (17.5%), chills (12.4%), fever (8.3%), joint pain (7.6%), lymphadenopathy (0.9%), nausea (0.4%), rash (0.3%), malaise (0.1%), and decreased appetite (0.1%).

  • Booster Dose Adverse Events:
    In a clinical study (30 mcg modRNA) of participants 18 through 55 years of age, adverse reactions following administration of a booster dose were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), joint pain (25.3%), lymphadenopathy (5.2%), nausea (0.7%), decreased appetite (0.3%), rash (0.3%), and pain in extremity (0.3%).

  • Before administration of the vaccine, please click to see
    Fact Sheets and Prescribing Information for individuals 12 years of age and older
    Full Prescribing Information (16 years of age and older)
    EUA Fact Sheet for Vaccination Providers (12 years of age and older), DILUTE BEFORE USE, Purple Cap
    EUA Fact Sheet for Vaccination Providers (12 years of age and older), DO NOT DILUTE, Gray Cap
    Recipients and Caregivers Fact Sheet (12 years of age & older)
    Fact Sheets for individuals 5 through 11 years of age
    EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap
    Recipients and Caregivers Fact Sheet (5 through 11 years of age)


  • Important Safety Information

    Indication & Authorized Use

    Important Safety Information

    • Do not administer to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of the vaccine.

    • 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, in particular in adolescents. 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.

    • Primary Series Adverse Events:
      In clinical studies (30 mcg modRNA) 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 (30 mcg modRNA) 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 (30 mcg modRNA) of adolescents 12 through 15 years of age, adverse reactions following the administration of the primary series 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%).

    • In a clinical study (10 mcg modRNA) in children 5 through 11 years of age, adverse reactions following administration of any primary series dose included pain at the injection site (84.3%), fatigue (51.7%), headache (38.2%), injection site redness (26.4%), injection site swelling (20.4%), muscle pain (17.5%), chills (12.4%), fever (8.3%), joint pain (7.6%), lymphadenopathy (0.9%), nausea (0.4%), rash (0.3%), malaise (0.1%), and decreased appetite (0.1%).

    • Booster Dose Adverse Events:
      In a clinical study (30 mcg modRNA) of participants 18 through 55 years of age, adverse reactions following administration of a booster dose were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), joint pain (25.3%), lymphadenopathy (5.2%), nausea (0.7%), decreased appetite (0.3%), rash (0.3%), and pain in extremity (0.3%).

    • Before administration of the vaccine, please click to see
      Fact Sheets and Prescribing Information for individuals 12 years of age and older
      Full Prescribing Information (16 years of age and older)
      EUA Fact Sheet for Vaccination Providers (12 years of age and older), DILUTE BEFORE USE, Purple Cap
      EUA Fact Sheet for Vaccination Providers (12 years of age and older), DO NOT DILUTE, Gray Cap
      Recipients and Caregivers Fact Sheet (12 years of age & older)
      Fact Sheets for individuals 5 through 11 years of age
      EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap
      Recipients and Caregivers Fact Sheet (5 through 11 years of age)

    Indication & Authorized Use

    The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the 2 EUA-authorized formulations of Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older, when prepared according to their respective instructions for use, can be used interchangeably.


    COMIRNATY® (COVID-19 Vaccine, mRNA) and the 2 formulations of Pfizer-BioNTech COVID-19 Vaccine intended for individuals 12 years of age and older should not be used for individuals 5 through 11 years of age because of the potential for vaccine administration errors, including dosing errors.


    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

    The Pfizer-BioNTech COVID-19 Vaccine has received Emergency Use Authorization (EUA) from FDA to prevent COVID-19 in individuals 5 years of age and older to provide:

    • a 10 mcg modRNA 2-dose primary series to individuals 5 through 11 years of age
    • a 30 mcg modRNA 2-dose primary series to individuals 12 years of age and older
    • a 30 mcg modRNA third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
    • a 30 mcg modRNA single booster dose to individuals 18 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®
    • a 30 mcg modRNA single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. The dosing interval for the heterologous booster dose is the same as that authorized for a booster dose of the vaccine used for primary vaccination

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

    • a 30 mcg modRNA 2-dose primary series to individuals 12 through 15 years of age
    • a 30 mcg modRNA third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
    • a 30 mcg modRNA single booster dose to individuals 18 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®
    • a 30 mcg modRNA single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. The dosing interval for the heterologous booster dose is the same as that authorized for a booster dose of the vaccine used for primary vaccination
References
  1. COMIRNATY® (COVID-19 Vaccine, mRNA). Prescribing Information. Pfizer and BioNTech; August 23, 2021.
  2. Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers). Pfizer and BioNTech; October 20, 2021.

For more information

Pfizer Customer Service
Call 1-800-879-3477.

Medical Information
Visit PfizerMedicalInformation.com or call 1-800-438-1985.

General Product Inquiries
Call 1-877-829-2619.

Shipment Support
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Call 1-800-666-7248.