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EUA Approval

6 months through
4 years of age

FDA AUTHORIZED FOR EMERGENCY USE1

Emergency uses of the vaccines have not been approved or licensed by FDA but have been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older for the Pfizer-BioNTech COVID-19 Vaccine and 5 years and older for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

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IMPORTANT MAROON CAP VIAL INFORMATION: 6 MONTHS THROUGH 4 YEARS OF AGE, DILUTE BEFORE USE, MAROON CAP

The vial labels may state “Age 2y to < 5y” or “Age 6m to < 5y” and carton labels may state “For age 2 years to < 5 years” or “For age 6 months to < 5 years”. Vials with either printed age range can be used for individuals 6 months through 4 years of age.

The Pfizer-BioNTech COVID-19 Vaccine is available in a 6 months through 4 years of age (Maroon Cap) presentation with different dosing, preparation, administration, and storage requirements than for the other three presentations (Purple Cap, Gray Cap, and Orange Cap).1-4

AGES 6 MONTHS THROUGH 4 YEARS, DILUTE BEFORE USE

6 MONTHS THROUGH 4 YEARS OF AGE DILUTE BEFORE USE
(MAROON CAP)

Storage & Handling Dosing & Preparation Resources
References
  1. Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (6 months through 4 years of age), DILUTE BEFORE USE, Maroon Cap. Pfizer and BioNTech; August 31, 2022.
  2. Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap. Pfizer and BioNTech; October 12, 2022.
  3. Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (12 years of age and older), DILUTE BEFORE USE, Purple Cap. Pfizer and BioNTech; October 18, 2022.
  4. Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (12 years of age and older), DO NOT DILUTE, Gray Cap. Pfizer and BioNTech; August 31, 2022.

Indication & Authorized Use

Indication & Authorized Use

Important Safety Information

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Important Safety Information

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Indication & Authorized Use


Authorized Use

Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older.


Important Safety Information

Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of the vaccine.

Management of Acute Allergic Reactions

Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 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).

Myocarditis and Pericarditis

Myocarditis and pericarditis have been reported following administration of Pfizer-BioNTech COVID-19 Vaccine.

Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is highest in males 12 through 17 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).

Syncope

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.

Altered Immunocompetence

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to Pfizer-BioNTech COVID-19 Vaccine.

Limitation of Effectiveness

Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

Adverse Reactions

In a clinical study (3 mcg modRNA) in participants 6 through 23 months of age, adverse reactions following administration of any dose included irritability (68.4%), decreased appetite (38.6%), tenderness at the injection site (26.4%), injection site redness (17.8%), fever (14.4%), injection site swelling (7.3%), and lymphadenopathy (0.2%).

In a clinical study (3 mcg modRNA) in participants 2 through 4 years of age, adverse reactions following administration of any dose included pain at the injection site (47.0%), fatigue (44.8%), injection site redness (18.9%), fever (10.5%), headache (8.7%), injection site swelling (8.4%), chills (5.7%), muscle pain (5.0%), joint pain (2.4%), and lymphadenopathy (0.1%).

Post Authorization Experience

Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (eg, rash, pruritus, urticaria, angioedema), diarrhea, vomiting, pain in extremity (arm), and syncope have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine.

Myocarditis and pericarditis have been reported following administration of Pfizer-BioNTech COVID-19 Vaccine.

Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of Pfizer-BioNTech COVID-19 Vaccine.


Before administration of Pfizer-BioNTech COVID-19 Vaccine, please click to see

EUA Fact Sheet for Vaccination Providers (6 months through 4 years of age),
DILUTE BEFORE USE, Maroon Cap and the respective
Recipients and Caregivers Fact Sheet


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Medical Information Medical Information

Medical Information

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

Shipment Support US Trade Customer Service Shipment Support US Trade Customer Service

Shipment Support
US Trade Customer Service

Call 1-800-666-7248

General Product Inquiries General Product Inquiries

General Product Inquiries

Call 1-877-829-2619

Pfizer Customer Service Pfizer Customer Service

Pfizer Customer Service

Call 1-800-879-3477

Medical Information Medical Information

Medical Information

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

General Product Inquiries General Product Inquiries

General Product Inquiries

Call 1-877-829-2619

Shipment Support US Trade Customer Service Shipment Support US Trade Customer Service

Shipment Support
US Trade Customer Service

Call 1-800-666-7248

Pfizer Customer Service Pfizer Customer Service

Pfizer Customer Service

Call 1-800-879-3477

Now Authorized: Effective 12/08/22

Pfizer-BioNTech COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) IS NOW AUTHORIZED FOR EMERGENCY USE AS DOSE 3 IN A THREE-DOSE PRIMARY SERIES IN ELIGIBLE INDIVIDUALS 6 MONTHS THROUGH 4 YEARS OF AGE

Click to view the EUA Fact Sheet for Vaccination Providers, Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) (6 months through 4 years of age), DILUTE BEFORE USE, Maroon Cap

Emergency Use Authorization

Emergency uses of Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent have not been approved or licensed by FDA but have been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older as appropriate. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see EUA Fact Sheets at www.cvdvaccine-us.com.

Changes include but are not limited to the following sections:

New Language in Teal

1 Authorized Use

Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) are authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older.

This EUA Prescribing Information pertains only to Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), hereafter referred to as Pfizer-BioNTech COVID-19 Vaccine, Bivalent, supplied in multiple dose vials with maroon caps and labels with maroon borders, which are authorized for use in individuals 6 months through 4 years of age.

2.3 Vaccination Schedule

The Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 6 months through 4 years of age are supplied in multiple dose vials with maroon caps and labels with maroon borders and after dilution are administered intramuscularly as a 3-dose (0.2 mL each) primary series as follows:
Dose 1: Pfizer-BioNTech COVID-19 Vaccine
Dose 2: Pfizer-BioNTech COVID-19 Vaccine
Dose 3: Pfizer-BioNTech COVID-19 Vaccine, Bivalent

Dose 1 and Dose 2 (Pfizer-BioNTech COVID-19 Vaccine) are administered 3 weeks apart. Dose 3 (Pfizer-BioNTech COVID-19 Vaccine, Bivalent) is administered at least 8 weeks after the Dose 2.

Individuals who will turn from 4 years to 5 years of age between any doses in the primary series may receive either:

  • a 3-dose primary series comprised of Pfizer-BioNTech COVID-19 Vaccine (supplied in multiple dose vials with maroon caps and labels with maroon borders) for Doses 1 and 2 and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (supplied in multiple dose vials with maroon caps and labels with maroon borders) for Dose 3, or
  • a 2-dose primary series with the Pfizer-BioNTech COVID-19 Vaccine authorized for use for individuals 5 through 11 years of age (supplied in multiple dose vials with orange caps and labels with orange borders).

6 OVERALL SAFETY SUMMARY

. . .

The safety of Pfizer-BioNTech COVID-19 Vaccine for the first and second dose of the primary series in individuals 6 months through 4 years of age is based on:

  • safety data from a clinical study which evaluated primary vaccination with Pfizer-BioNTech COVID-19 Vaccine in individuals 6 months through 4 years of age,
  • safety data from clinical studies which evaluated primary vaccination with Pfizer-BioNTech COVID-19 Vaccine in individuals 5 years of age and older, and
  • postmarketing safety data with the Pfizer-BioNTech COVID-19 Vaccine.

The safety of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for the third dose of the primary series in individuals 6 months through 4 years of age is based on:

  • safety data from a clinical study which evaluated a booster dose with Pfizer BioNTech’s bivalent COVID-19 vaccine (Original and Omicron BA.1), not authorized or approved, hereafter referred to as bivalent vaccine (Original and Omicron BA.1) in individuals greater than 55 years of age,
    • The safety data accrued with the bivalent vaccine (Original and Omicron BA.1) and with the Pfizer-BioNTech COVID-19 Vaccine are relevant to the Pfizer-BioNTech COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process.
  • safety data from clinical studies which evaluated primary vaccination with Pfizer-BioNTech COVID-19 Vaccine in individuals 6 months of age and older and
  • safety data from clinical studies which evaluated booster vaccination with Pfizer-BioNTech COVID-19 Vaccine (previously, but no longer, authorized) in individuals 5 years of age and older, and
  • postmarketing safety data with the Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

In a clinical study (Study 3) in participants 6 through 23 months of age who received Pfizer-BioNTech COVID-19 Vaccine containing 3 mcg of a nucleoside-modified messenger RNA encoding the spike (S) glycoprotein of SARS-CoV-2 (3 mcg nucleoside modified messenger RNA (modRNA)), adverse reactions following administration of any dose included irritability (68.4%), decreased appetite (38.6%), tenderness at the injection site (26.4%), injection site redness (17.8%), fever (14.4%), injection site swelling (7.3%), and lymphadenopathy (0.2%).

In a clinical study (Study 3) in participants 2 through 4 years of age who received Pfizer-BioNTech COVID-19 Vaccine (3 mcg modRNA), adverse reactions following administration of any dose included pain at the injection site (47.0%), fatigue (44.8%), injection site redness (18.9%), fever (10.5%), headache (8.7%), injection site swelling (8.4%), chills (5.7%), muscle pain (5.0%), joint pain (2.4%), and lymphadenopathy (0.1%).

The clinical study that evaluated a booster dose of the bivalent vaccine (Original and Omicron BA.1) included participants greater than 55 years of age. The bivalent vaccine (Original and Omicron BA.1) contained 15 mcg of modRNA encoding the S-glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original) and 15 mcg of modRNA encoding the S-glycoprotein of SARS-CoV-2 Omicron variant lineage BA.1, for a total of 30 mcg modRNA per dose. Adverse reactions following administration of the bivalent vaccine (Original and Omicron BA.1) as a second booster dose included pain at the injection site (58.1%), fatigue (49.2%), headache (33.6%), muscle pain (22.3%), chills (13.0%), joint pain (11.3%), injection site redness (7.0%), injection site swelling (6.6%), fever (5.0%), lymphadenopathy (0.3%), nausea (0.3%), and malaise (0.3%).

Expiry Update: Effective 12/08/22

Expiry dates included in product labeling for maroon cap, orange cap, and gray cap presentations of Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) have been updated from 12 to 18 months after the date of manufacture printed on the vials and cartons.

Verify the vials (including labels) prior to preparation and administration to help avoid dosing errors. Check gray cap, orange cap, and maroon cap vial labels to ensure that the name on the vial states “Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5).” Please see the Formulation/Presentation Guide for more details.

Formulation/
Presentation Guide
Expiry Information

Regardless of storage condition, the maroon cap, orange cap, and gray cap vaccines should not be used after 18 months from the date of manufacture printed on the vials and cartons.

I acknowledge that this website is being updated on an ongoing basis. I have read the Important Safety Information below. I will check back for further updates.

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