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Emergency Use Authorization1

Pfizer-BioNTech COVID-19 Vaccine, Bivalent has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals aged 6 months of age and older. The emergency use of this product is 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.

6 months  -  4 years of age

Pfizer-BioNTech COVID-19 Vaccine, Bivalent
(Original and Omicron BA.4/BA.5)

EUA Fact Sheet
5  -  11 years of age

Pfizer-BioNTech COVID-19 Vaccine, Bivalent
(Original and Omicron BA.4/BA.5)

EUA Fact Sheet
12+ years of age

Pfizer-BioNTech COVID-19 Vaccine, Bivalent
(Original and Omicron BA.4/BA.5)

EUA Fact Sheet

Select Important Vial Information

To prevent vaccine administration errors, prior to preparation and administration:

  • Please verify that vial labels state Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)
  • Verify the vial cap color and label for the respective authorized age group

Expiry Information

Expiry information for vaccine vials can be found at https://lotexpiry.cvdvaccine.com/

Important Authorization Update

Monovalent mRNA COVID-19 vaccines are no longer authorized for emergency use in the United States. FDA and CDC guidance is to check inventory and dispose of monovalent mRNA vaccines according to state and local regulations.

Formulation/
Presentation Guide

Refer to the information outlined below for select information about the formulations and presentations of the vaccines.

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For individuals 6 months through 4 years of age

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)
6 MONTHS THROUGH 4 YEARS OF AGE, DILUTE BEFORE USE

Maroon Cap1

Dosing Information

Dose
3 mcg

Dose volume
0.2 mL

Amount of diluent needed per vial*
2.2 mL

Doses per vial
10 doses per vial (after dilution)†

For eligibility, dosing schedule, and other important information, please see EUA Fact Sheet.

STORAGE CONDITIONS

Ultra-low-temperature (ULT) freezer
[-90°C to -60°C (-130°F to -76°F)]
18 months‡

Freezer
[-25°C to -15°C (-13°F to 5°F)]
DO NOT STORE

Refrigerator§
[2°C to 8°C (35°F to 46°F)]
10 weeks

Room temperature§
[8°C to 25°C (46°F to 77°F)]
12 hours prior to first puncture
(including any thaw time)

After first puncture
[2°C to 25°C (35°F to 77°F)]
Discard after 12 hours||

*ONLY use sterile 0.9% Sodium Chloride Injection, USP as the diluent. Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent.

†Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial.

‡Regardless of storage conditions, maroon cap, orange cap, and gray cap vaccines should not be used after 18 months from the date of manufacture printed on the vial and cartons. Expiry information can be found at: https://lotexpiry.cvdvaccine.com/.

§Do not refreeze thawed vials.

||After first puncture, the vial should be held between 2°C to 25°C (35°F to 77°F). Vials should be discarded 12 hours after first puncture.

For individuals 5 through 11 years of age

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)
5 THROUGH 11 YEARS OF AGE, DILUTE BEFORE USE

Orange Cap1

Dosing Information

Dose
10 mcg

Dose volume
0.2 mL

Amount of diluent needed per vial*
1.3 mL

Doses per vial
10 doses per vial (after dilution)†

For eligibility, dosing schedule, and other important information, please see EUA Fact Sheet.

STORAGE CONDITIONS

Ultra-low-temperature (ULT) freezer
[-90°C to -60°C (-130°F to -76°F)]
18 months‡

Freezer
[-25°C to -15°C (-13°F to 5°F)]
DO NOT STORE

Refrigerator§
[2°C to 8°C (35°F to 46°F)]
10 weeks

Room temperature§
[8°C to 25°C (46°F to 77°F)]
12 hours prior to first puncture
(including any thaw time)

After first puncture
[2°C to 25°C (35°F to 77°F)]
Discard after 12 hours||

*ONLY use sterile 0.9% Sodium Chloride Injection, USP as the diluent. Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent.

†Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial.

‡Regardless of storage conditions, maroon cap, orange cap, and gray cap vaccines should not be used after 18 months from the date of manufacture printed on the vial and cartons. Expiry information can be found at: https://lotexpiry.cvdvaccine.com/.

§Do not refreeze thawed vials.

||After first puncture, the vial should be held between 2°C to 25°C (35°F to 77°F). Vials should be discarded 12 hours after first puncture.

For individuals 12 years of age and older

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)
12 YEARS OF AGE AND OLDER, DO NOT DILUTE

Gray Cap1

Dosing Information

Dose
30 mcg

Dose volume
0.3 mL

Amount of diluent needed per vial
NO DILUTION

Doses per vial
Multiple dose vial: 6 doses per vial*
Single dose vial: 1 dose per vial

For eligibility, dosing schedule, and other important information, please see EUA Fact Sheet.

STORAGE CONDITIONS

Ultra-low-temperature (ULT) freezer
[-90°C to -60°C (-130°F to -76°F)]
18 months†

Freezer
[-25°C to -15°C (-13°F to 5°F)]
DO NOT STORE

Refrigerator‡
[2°C to 8°C (35°F to 46°F)]
10 weeks

Room temperature‡
[8°C to 25°C (46°F to 77°F)]
12 hours prior to first puncture
(including any thaw time)

After first puncture
[2°C to 25°C (35°F to 77°F)]
Discard after 12 hours§

*Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract 6 doses from a single vial.

†Regardless of storage conditions, maroon cap, orange cap, and gray cap vaccines should not be used after 18 months from the date of manufacture printed on the vial and cartons. Expiry information can be found at: https://lotexpiry.cvdvaccine.com/.

‡Do not refreeze thawed vials.

§After first puncture, the vial should be held between 2°C to 25°C (35°F to 77°F). Vials should be discarded 12 hours after first puncture.

Reference:
  1. Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5). Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (6 months of age and older), Pfizer and BioNTech; April 28, 2023.

Authorized Use

Indication & Authorized Use

Important Safety Information

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Important Safety Information

 

AUTHORIZED USE

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), hereafter referred to as Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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, Bivalent to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of Pfizer-BioNTech COVID-19 Vaccine, Pfizer-BioNTech COVID-19 Vaccine, Bivalent, or COMIRNATY® (COVID-19 Vaccine, mRNA).

Management of Acute Allergic Reactions

Appropriate medical treatment 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, Bivalent.

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

Myocarditis and Pericarditis

Postmarketing safety data with Pfizer-BioNTech COVID-19 Vaccine are relevant to Pfizer-BioNTech COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process.

Postmarketing data with authorized or approved monovalent mRNA COVID-19 vaccines demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following vaccination. For the Pfizer-BioNTech COVID-19 Vaccine, 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. Procedures should be in place to avoid injury from fainting.

Altered Immunocompetence

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

Limitation of Vaccine Effectiveness

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

Adverse Reactions

The safety of Pfizer-BioNTech COVID-19 Vaccine, Bivalent in individuals 6 months of age and older is based on the safety data accrued from the formulations described below because these vaccines are manufactured using the same process:

  • safety data from clinical trials which evaluated primary and booster vaccination with Pfizer-BioNTech COVID-19 Vaccine (monovalent formulation is no longer authorized for use in the United States),
  • safety data from clinical trials which evaluated booster vaccination with Pfizer-BioNTech COVID-19 Vaccine, Bivalent,
  • safety data from a clinical study which evaluated a booster dose of bivalent vaccine (Original and Omicron BA.1), [not authorized or approved in the U.S., hereafter referred to as bivalent vaccine (Original and Omicron BA.1)] and
  • postmarketing safety data with Pfizer-BioNTech COVID-19 Vaccine (monovalent formulation is no longer authorized for use in the United States) and Pfizer-BioNTech COVID-19 Vaccine, Bivalent

Solicited adverse reactions include:

  • 6 months through 23 months of age:
    Injection site redness, swelling, and tenderness; decreased appetite, drowsiness, fever, irritability.
  • 2 years of age and older:
    Injection site pain, redness, and swelling; chills, diarrhea, fatigue, fever, headache, new or worsened joint pain, new or worsened muscle pain, vomiting.

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

Vaccination providers enrolled in the federal COVID-19 Vaccination Program must report all vaccine administration errors and all serious adverse events to the Vaccine Adverse Event Reporting System (VAERS) by submitting 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 “Pfizer‑BioNTech COVID‑19 Vaccine, Bivalent EUA” in the description section of the report. To the extent feasible, report adverse events to Pfizer 1-800-438-1985 or provide a copy of the VAERS form to Pfizer www.pfizersafetyreporting.com

Please click for Pfizer-BioNTech COVID-19 Vaccine, Bivalent Vaccination Provider and Recipient and Caregiver EUA Fact Sheets


For More Information

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Call 1-800-879-3477

Medical Information

Medical Information

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

Medical Information

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Call 1-800-666-7248

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Information Updates

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Emergency Use Authorization

Pfizer-BioNTech COVID-19 Vaccine, Bivalent has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals aged 6 months of age and older. The emergency use of this product is 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.

Updated Authorization Effective 04/18/23; Reissued 04/28/23 with Additional Authorization

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) Emergency Use Authorization now has updated uses for eligible individuals 6 months of age and older according to the below vaccination schedule

Monovalent mRNA COVID-19 vaccines are no longer authorized for emergency use in the United States. FDA and CDC guidance is to check inventory and dispose of monovalent mRNA vaccines according to state and local regulations.

Click to view the EUA Fact Sheet for Vaccination Providers

To prevent vaccine administration errors, prior to preparation and administration:

  • Please verify that vial labels state Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)
  • Verify the vial cap color and label for the respective authorized age group

Please see the Formulation/Presentation Guide for more details.

Changes include but are not limited to the following sections: New Language in Teal

2.3 Dose and Schedule

Individuals 6 months of age and older not previously vaccinated with a COVID-19 vaccine

Age Pfizer-BioNTech COVID-19 Vaccine, Bivalent Vial Cap and Label Border Color Dosing Regimen, Dose and Schedule
6m-4y* Maroon 3 doses, 0.2 mL each
Dose 1: Week 0
Dose 2: Week 3
Dose 3: ≥8 weeks after Dose 2
5-11y Orange Single dose, 0.2 mL
12-64y Gray Single dose, 0.3 mL
Gray Single dose, 0.3 mL

One additional dose, 0.3 mL, may be administered ≥4 months after first dose of an authorized bivalent COVID-19 vaccine
*

Notwithstanding the age limitations for use of the vaccine, individuals turning from 4 to 5 years of age during the vaccination series should receive all doses with Pfizer-BioNTech COVID-19 Vaccine, Bivalent supplied in vials with maroon caps and labels with maroon borders.

Individuals 6 months through 4 years of age previously vaccinated with the monovalent Pfizer-BioNTech COVID-19 Vaccine†

Age Number of Previous Doses of Pfizer-BioNTechPfizer-BioNTech COVID-19 Vaccine Pfizer-BioNTechPfizer-BioNTech COVID-19 Vaccine, BivalentVaccine, Bivalent Vial Cap and Label Border Color Dosing Regimen, Dose and Schedule
6m-4y 1 previous dose Maroon 2 doses,‡ 0.2 mL each

Dose 1:

3 weeks after receipt of Pfizer-BioNTech COVID-19 Vaccine

Dose 1:
3 weeks after receipt of Pfizer-BioNTech COVID-19 Vaccine

Dose 2:

≥8 weeks after Dose 1

Dose 2:
≥8 weeks after Dose 1
6m-4y 2 previous doses Maroon Single dose, 0.2 mLSingle dose, 0.2 mL
≥8 weeks after receipt of second dose of Pfizer-BioNTech COVID-19 Vaccine
6m-4y 3 previous doses Maroon Single dose, 0.2 mL
≥2 months§ after receipt of third dose of Pfizer-BioNTech COVID-19 Vaccine
†

The monovalent Pfizer-BioNTech COVID-19 Vaccine is no longer authorized for use in the United States.

‡

Notwithstanding the age limitations for use of the vaccine, individuals turning from 4 to 5 years of age during the vaccination series should receive 2 doses with Pfizer-BioNTech COVID-19 Vaccine, Bivalent supplied in vials with maroon caps and labels with maroon borders.

§

For individuals with certain kinds of immunocompromise previously vaccinated with three doses of the monovalent Pfizer-BioNTech COVID-19 Vaccine, see text below the following table for dosing interval.

Individuals 5 years of age and older previously vaccinated with 1 or more doses of a monovalent COVID-19 vaccineII

Age Pfizer-BioNTechPfizer-BioNTech COVID-19 Vaccine, Bivalent Vial Cap and Label Border Color Dosing Regimen, Dose and Schedule
5-11y Orange Single dose, 0.2 mL
≥2 months after monovalent COVID-19 vaccine
12-64y Gray Single dose, 0.3 mL
≥2 months after monovalent COVID-19 vaccine
Gray Single dose, 0.3 mL

≥2 months after monovalent COVID-19 vaccine

One additional dose, 0.3 mL, may be administered ≥4 months after first dose of an authorized bivalent COVID-19 vaccine

Individuals with Certain Kinds of Immunocompromise
For individuals with certain kinds of immunocompromise 6 months through 4 years of age who have received three 0.2 mL doses (Pfizer‑BioNTech COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine, Bivalent), a fourth dose (0.2 mL) with Pfizer-BioNTech COVID-19 Vaccine, Bivalent may be administered at least 1 month following the most recent dose; additional doses of Pfizer-BioNTech COVID-19 Vaccine, Bivalent may be administered at the discretion of the healthcare provider, taking into consideration the individual’s clinical circumstances.

For individuals with certain kinds of immunocompromise 5 years of age and older, a single additional age-appropriate dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent may be administered at least 2 months following the initial dose of a bivalent COVID-19 vaccine; additional age-appropriate doses of Pfizer-BioNTech COVID-19 Vaccine, Bivalent may be administered at the discretion of the healthcare provider, taking into consideration the individual’s clinical circumstances.

||

Monovalent refers to a COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2.

Certain kinds of immunocompromise refers to individuals who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

. . .

6 ADVERSE REACTIONS

The safety data accrued with the Pfizer-BioNTech COVID-19 Vaccine (no longer authorized for use in the U.S.) and Pfizer-BioNTech’s bivalent COVID-19 vaccine (Original and Omicron BA.1) [not authorized or approved in the U.S., hereafter referred to as bivalent vaccine (Original and Omicron BA.1)] are relevant to Pfizer-BioNTech COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process.

The safety of Pfizer-BioNTech COVID-19 Vaccine, Bivalent in individuals 6 months of age and older is based on:

  • safety data from clinical studies which evaluated primary and booster vaccination with Pfizer-BioNTech COVID-19 Vaccine,
  • safety data from clinical studies which evaluated booster vaccination with Pfizer-BioNTech COVID-19 Vaccine, Bivalent,
  • safety data from a clinical study which evaluated a booster dose of bivalent vaccine (Original and Omicron BA.1), and
  • postmarketing safety data with Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

. . .


14 CLINICAL STUDIES

The effectiveness of Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 6 months of age and older is based on:

  • effectiveness of Pfizer-BioNTech COVID-19 Vaccine in individuals 6 months of age and older,
  • immunogenicity of the bivalent vaccine (Original and Omicron BA.1) in individuals greater than 55 years of age, and
  • immunogenicity of Pfizer-BioNTech COVID-19 Vaccine, Bivalent in individuals 6 months through 4 years of age.

. . .

14.11 Effectiveness of a Single Dose of Pfizer-BioNTech COVID-19 Vaccine in Individuals with Evidence of Prior SARS-CoV-2 Infection

Seroprevalence surveys estimate that almost all of the U.S. population 5 years of age and older now have antibodies (from vaccination and/or infection) against SARS-CoV-2 (Centers for Disease Control and Prevention. COVID Data Tracker. Atlanta, GA: US Department of Health and Human Services, CDC; 2023, March 31. https://covid.cdc.gov/covid-data-tracker).

Powell et al. conducted an observational test-negative study including symptomatic individuals aged 12 to 17 years of age with SARS-CoV-2 polymerase-chain-reaction (PCR) testing results in England from August 9, 2021 to March 31, 2022 (Powell et al. Protection against symptomatic infection with delta (B.1.617.2) and omicron (B.1.1.529) BA.1 and BA.2 SARS-CoV-2 variants after previous infection and vaccination in adolescents in England, August, 2021—March, 2022: a national, observational, test-negative, case-control study. Lancet Infectious Diseases. April 2023). Among 1,161,704 SARS-CoV-2 PCR tests linked to COVID-19 vaccination status, there were 390,467 SARS-CoV-2 PCR confirmed positive tests during Delta variant predominance and 212,433 SARS-CoV-2 positive tests during Omicron variants BA.1 and BA.2 predominance. Among adolescents who had received only 1 dose of Pfizer-BioNTech COVID-19 Vaccine, those who had evidence of previous infection with Alpha, Delta, or Omicron variants had increased protection against symptomatic Omicron infection compared with those with no evidence of previous infection. At 2 to 14 weeks following 1 dose of Pfizer-BioNTech COVID-19 Vaccine, the estimated vaccine effectiveness was 18.8% (95% CI: 17.2%, 20.3%), 81.5% (95% CI: 80.0%, 82.9%), 78.8% (95% CI: 77.9, 79.5%), and 79.6% (95% CI: 44.9%, 92.4%) for individuals with no evidence of prior infection, and evidence of prior Alpha, Delta, and Omicron infection, respectively.

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.

Read the Important Safety Information below and check back for further updates.

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