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6 Months – 11 Years of Age
12+ Years of Age

Emergency Use Authorization1

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) 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 6 months through 11 years of age. 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.

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 (2023-2024 Formula).

Verify the vial cap color and label are for the respective authorized age group.

Expiry Information

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

Learn More

Formulation/Presentation Guide

Refer to the information outlined below for select information about the formulation and presentations.

Formulation/Presentation Guide

For Eligible Individuals 6 Months Through 4 Years of Age

Expand All

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula)
6 MONTHS THROUGH 4 YEARS* OF AGE, DILUTE BEFORE USE

Yellow Cap1

Dosing Information

Dose

3 mcg†

Dose volume

0.3 mL†

Dilution‡

1.1 mL‡

Doses per vial

Multiple-Dose Vial§:
3 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)]

12 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

After first puncture
[2°C to 25°C (35°F to 77°F)]

Discard 12 hours after the first puncture**

* For individuals turning from 4 to 5 years of age during the vaccination series, administer all doses with Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) supplied in vials with yellow caps and labels with yellow borders.

† After dilution, each 0.3 mL dose is formulated to contain 3 mcg of modRNA encoding Omicron variant lineage XBB.1.5 (Omicron XBB.1.5).

‡ 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 are not required for multiple dose vial (MDV).

||If the amount of vaccine in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume. Do not pool excess vaccine from multiple vials.

Regardless of storage condition, the vaccine should not be used after the expiration date printed on the vial and cartons. Expiry information can be found at: https://lotexpiry.cvdvaccine.com/.

#Once vials are thawed, they should not be refrozen.

**After dilution, multiple dose vials should be held between 2°C to 25°C (35°F to 77°F). Multiple dose vials should be discarded 12 hours after dilution.

For Eligible Individuals 5 Through 11 Years of Age

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula)
5 THROUGH 11 YEARS* OF AGE, DO NOT DILUTE

Blue Cap1

Dosing Information

Dose

10 mcg†

Dose volume

0.3 mL†

Dilution

DO NOT DILUTE

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)]

12 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 use‡§

After puncture
[2°C to 25°C (35°F to 77°F)]

Use immediately; discard vial and any excess volume

* For individuals turning from 4 to 5 years of age during the vaccination series, administer all doses with Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) supplied in vials with yellow caps and labels with yellow borders.

† Each 0.3 mL dose is formulated to contain 10 mcg of modRNA encoding Omicron variant lineage XBB.1.5 (Omicron XBB.1.5).

‡ Low dead-volume syringes and/or needles are not required for single dose vial (SDV).

§ Regardless of storage condition, the vaccine should not be used after the expiration date printed on the vial and cartons. Expiry information can be found at: https://lotexpiry.cvdvaccine.com/.

Once vials are thawed, they should not be refrozen.

Shipping & Handling Resources

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Reference
  1. Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula). Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers)  (6 months to 11 years of age), Pfizer and BioNTech; September 11, 2023.

Eligible healthcare providers can order COVID-19 vaccines directly
from Pfizer*

Learn about ordering vaccines through Pfizer Prime online or by calling 1-800-533-4535.

*If preferred, orders may be placed with your facility’s wholesaler.

IMPORTANT SAFETY
INFORMATION

 

AUTHORIZED USE

Indication & Authorized Use

IMPORTANT SAFETY INFORMATION

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Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) 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 through 11 years of age.

Important Safety Information

Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine or to individuals who had a severe allergic reaction (e.g., anaphylaxis) following a previous dose of a Pfizer-BioNTech COVID-19 vaccine.

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.

Monitor Pfizer-BioNTech COVID-19 Vaccine 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 data with authorized or approved 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.

Limitation of Vaccine Effectiveness

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

Adverse Reactions

Solicited adverse reactions included:

  • 6 months through 23 months of age: Injection site redness; swelling and tenderness; decreased appetite; drowsiness; fever; irritability.
  • 2 through 11 years of age: Injection site pain; redness and swelling; chills; diarrhea; fatigue; fever; headache; new or worsened joint pain; new or worsened muscle pain; vomiting.

Vaccination providers must report all vaccine administration errors, all serious adverse events, cases of myocarditis, cases of pericarditis, cases of Multisystem Inflammatory Syndrome (MIS), and cases of COVID-19 that result in hospitalization or death following administration of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) 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 (2023-2024 Formula) 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 https://
www.pfizersafetyreporting.com/

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

AUTHORIZED USE

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) 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 through 11 years of age.


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Emergency Use Authorization
(EUA)

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) 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 6 months through 11 years of age. 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.

NOW AUTHORIZED: Effective 09/11/23

PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA) IS NOW AUTHORIZED FOR EMERGENCY USE 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 THROUGH 11 YEARS OF AGE.

Click to view the EUA Fact Sheet for Vaccination Providers.

Important Reminder:

Previous COVID-19 vaccines, including original monovalent COVID-19 vaccines and bivalent (original and Omicron BA.4/BA.5) COVID-19 mRNA vaccines are no longer authorized for use in the United States.

FDA and CDC guidance is to check inventory and dispose of previous COVID-19 vaccines according to state and local regulations.

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

  • Please verify that vial labels state Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula)
  • 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

. . .

1 EMERGENCY USE AUTHORIZATION

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) 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 through 11 years of age.

The Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula), which is supplied in multiple dose vials with yellow caps and labels with yellow borders and in single dose vials with blue caps and labels with blue borders, is not licensed for any use.

. . .

Information Regarding Available Alternative Vaccines for the Prevention of COVID-19 in Individuals 6 Months Through 11 Years of Age

There may be clinical trials or availability under EUA of other COVID-19 vaccines, including vaccines that contain or encode the spike protein of the SARS-CoV-2 Omicron variant lineage XBB.1.5 (Omicron XBB.1.5).

2 DOSAGE AND ADMINISTRATION

For intramuscular injection only.

2.1 Preparation for Administration

There are 2 presentations of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula):

Vial Cap and Vial Label Border Color

Yellow

Age of Recipient

6 months through
4 years of age

Vial Type

Multiple dose

Dilution Required

Yes

Vial Cap and Vial Label Border Color

Blue

Age of Recipient

5 through 11 years of age

Vial Type

Single dose

Dilution Required

No

Pfizer-BioNTech COVID-19 Vaccine vials contain a frozen suspension that does not contain a preservative and must be thawed prior to administration.

Preparation Instructions

  • If vials are frozen, they must be thawed prior to use [for thawing instructions, see How Supplied/Storage and Handling (16)].
  • Prior to use, mix by inverting thawed vial gently 10 times. Never shake the vials or vaccine.
  • Check the contents of the vaccine during preparation and right before use. The liquid should be clear to slightly opalescent with no visible particles. Do not use if liquid is discolored or if other particles are observed.

For multiple dose vials with yellow caps and labels with yellow borders:

  • Dilute prior to use:
    • Add 1.1 mL of sterile 0.9% Sodium Chloride Injection, USP into the vaccine vial.
    • Before removing the needle from the vial, equalize vial pressure by withdrawing air into the empty diluent syringe.
    • Record the date and time of dilution on the vial label.
    • Store at 2°C to 25°C (35°F to 77°F) and discard after 12 hours.
  • After dilution, multiple-dose vials contain 3 doses of 0.3 mL each.
  • If the amount of vaccine in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume. Do not pool excess vaccine from multiple vials.

For single dose vials with blue caps and labels with blue borders:

  • Do Not Dilute.
  • Withdraw a single 0.3 mL dose.
  • Discard vial and any excess volume.

2.2 Administration

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The vaccine should be clear to slightly opalescent suspension. Do not administer if vaccine is discolored or contains particulate matter.

Administer a single 0.3 mL dose intramuscularly.

2.3 Dose and Schedule

Individuals 6 Months Through 4 Years of Age by Pfizer-BioNTech COVID-19 Vaccination Status

Pfizer-BioNTech COVID-19 Vaccine, (2023-2024 Formula)
Vial Cap and Label Border Color

Yellow

Number of Previous Doses of Pfizer-BioNTech COVID-19 vaccine(s)*

0‡

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula)
Dosing Regimen, Dose and Schedule†

3 doses§, 0.3 mL each Dose 1: Week 0 Dose 2: Week 3 Dose 3: ≥8 weeks after Dose 2

Number of Previous Doses of Pfizer-BioNTech COVID-19 vaccine(s)*

1

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula)
Dosing Regimen, Dose and Schedule†

3 doses†, 0.3 mL each 2 doses§, 0.3 mL each Dose 1: 3 weeks after receipt of the previous dose of Pfizer-BioNTech COVID-19 vaccine* Dose 2: ≥8 weeks after Dose 1

Number of Previous Doses of Pfizer-BioNTech COVID-19 vaccine(s)*

2 to 4

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula)
Dosing Regimen, Dose and Schedule†

Single dose, 0.3 mL ≥8 weeks after receipt of the last previous dose of Pfizer-BioNTech COVID-19 vaccine*

*Previous doses of Pfizer-BioNTech COVID-19 vaccine(s) refers to doses with Pfizer-BioNTech COVID-19 Vaccine (Original monovalent) and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5). These vaccines are no longer authorized for use in the United States.

†For individuals with certain kinds of immunocompromise previously vaccinated with Pfizer-BioNTech COVID-19 vaccines, see text below tables for dosing information.

‡Not previously vaccinated with any COVID-19 vaccine.

§For individuals turning from 4 to 5 years of age during the vaccination series, administer all doses with Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) supplied in vials with yellow caps and labels with yellow borders.

Individuals 5 Years Through 11 years of Age Irrespective of COVID-19 Vaccination Status

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula)
Vial Cap and Label Border Color

Blue

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula)
Dosing Regimen, Dose and Schedule*

Single dose, 0.3 mL If previously vaccinated, ≥2 months after receipt of the last previous dose of COVID-19 vaccine†

*For individuals with certain kinds of immunocompromise, see text below tables for dosing information.

†COVID-19 vaccine refers to the monovalent COVID-19 vaccines that encode the spike protein of the original SARS-CoV-2 and the bivalent COVID-19 vaccines encoding the spike protein of original SARS-CoV-2 and of the Omicron-variant lineages BA.4 and BA.5 that are no longer authorized for use in the United States.

Individuals 6 Months Through 11 Years of Age with Certain Kinds of Immunocompromise

Individuals 6 months through 11 years of age with certain kinds of immunocompromise* should complete at least a 3-dose series with an age-appropriate dose and dosing schedule†‡ of a COVID-19 vaccine. At least 1 dose should be with a COVID-19 vaccine (2023-2024 Formula).

  • If previously not vaccinated, complete the 3-dose series with age-appropriate doses of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula).
  • If previously vaccinated with 1 or 2 dose(s) of Pfizer-BioNTech COVID-19 Vaccine (Original monovalent) and/or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent, complete the remaining dose(s) in the 3-dose series with age-appropriate doses of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula).
  • If previously vaccinated with 3 or more doses, administer a single age-appropriate dose of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) at least 2 months following the last previous dose.§||

An age-appropriate additional dose of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) may be administered at least 2 months following the last dose of a COVID-19 vaccine (2023-2024 Formula).¶# Age-appropriate additional doses of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) may be administered at the discretion of the healthcare provider, taking into consideration the individual’s clinical circumstances. The timing of the additional doses may be based on the individual’s clinical circumstances.

*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.

†Dosing schedule for individuals 6 months through 4 years of age for Pfizer-BioNTech COVID-19 vaccines: Dose 1: Week 0; Dose 2: Week 3; Dose 3: ≥8 Weeks after Dose 2. For individuals turning from 4 to 5 years of age during the vaccination series, complete the series with doses of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) supplied in vials with yellow caps and labels with yellow borders.

‡Dosing schedule for individuals 5 through 11 years of age for Pfizer-BioNTech COVID-19 vaccines: Dose 1: Week 0; Dose 2: Week 3; Dose 3: ≥4 weeks after Dose 2. Individuals turning from 11 to 12 years of age during the vaccination series may complete the series with doses of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) supplied in vials with blue caps and labels with blue borders.

§For immunocompromised individuals 6 months through 4 years of age, the last previous dose refers to the last dose of Pfizer-BioNTech COVID-19 Vaccine (Original monovalent) or Pfizer-BioNTech COVID-19 Vaccine, Bivalent, which are no longer authorized for use in the U.S.

||For immunocompromised individuals 5 through 11 years of age, the last previous dose refers to the last dose of a COVID-19 vaccine (Original monovalent) or bivalent COVID-19 vaccine, which are no longer authorized for use in the U.S.

For immunocompromised individuals 6 months through 4 years of age, the last dose of a COVID-19 vaccine (2023-2024 Formula) refers to a dose with Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula).

#For immunocompromised individuals 5 through 11 years of age, the last dose of a COVID-19 vaccine (2023-2024 Formula) refers to a dose with Moderna COVID-19 Vaccine (2023-2024 Formula) or Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula).

3 DOSAGE FORMS AND STRENGTHS

Pfizer-BioNTech COVID-19 Vaccine is a suspension for injection.

A single dose is 0.3 mL.

4 CONTRAINDICATIONS

Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine [see Description (11)] or to individuals who had a severe allergic reaction (e.g., anaphylaxis) following a previous dose of a Pfizer-BioNTech COVID-19 vaccine.

. . .

6 ADVERSE REACTIONS

. . .

The safety data accrued with the Pfizer-BioNTech COVID-19 Vaccine (Original monovalent, no longer authorized for use in the U.S.), 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)] and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron, BA.4/BA.5) [no longer authorized for use in the U.S.] are relevant to Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) because these vaccines are manufactured using the same process.

. . .

11 DESCRIPTION

The Pfizer-BioNTech COVID-19 Vaccine does not contain preservative. The vial stoppers are not made with natural rubber latex.

Multiple Dose Vials with Yellow Caps and Labels with Yellow Borders

The Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) in multiple dose vials with yellow caps and labels with yellow borders is supplied as a frozen suspension; each vial must be diluted with 1.1 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine.

After dilution, each 0.3 mL dose is formulated to contain 3 mcg of nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 Omicron variant lineage XBB.1.5 (Omicron XBB.1.5).

Each 0.3 mL dose also includes the following ingredients: lipids (0.04 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.005 mg 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 0.01 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.02 mg cholesterol), 9.4 mg sucrose, 0.02 mg tromethamine, and 0.12 mg tromethamine hydrochloride. The diluent (sterile 0.9% Sodium Chloride Injection, USP) contributes 1.88 mg sodium chloride per dose.

Single Dose Vials with Blue Caps and Labels with Blue Borders

The Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) in single dose vials with blue caps and labels with blue borders is supplied as a frozen suspension. This presentation does not need to be diluted.

Each 0.3 mL dose is formulated to contain 10 mcg of a modRNA encoding the viral spike (S) glycoprotein of SARS-CoV-2 Omicron variant lineage XBB.1.5 (Omicron XBB.1.5).


Each 0.3 mL dose also includes the following ingredients: lipids (0.14 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.02 mg 2[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 0.03 mg 1,2-distearoyl-sn-glycero-3-phosphocholine, and 0.06 mg cholesterol), 31 mg sucrose, 0.06 mg tromethamine, and 0.4 mg tromethamine hydrochloride.

. . .

14 CLINICAL STUDIES

The effectiveness of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) for individuals 6 months through 11 years of age is based on:

  • effectiveness of the Pfizer-BioNTech COVID-19 Vaccine (Original monovalent) in individuals 6 months of age and older, and
  • immunogenicity of Pfizer-BioNTech COVID-19 Vaccine, Bivalent in individuals 6 months through 4 years of age.

. . .

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula): multiple dose vials with yellow caps and labels with yellow borders

NDC 59267-4315-2

Carton of 10 multiple dose vials

NDC 59267-4315-1

Multiple dose vial containing 3 doses of 0.3 mL (after dilution)

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula): single dose vials with blue caps and labels with blue borders

NDC 59267-4331-2

Carton of 10 single dose vials

NDC 59267-4331-1

One vial contains 1 dose of 0.3 mL (Do Not Dilute)

During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Do not refreeze thawed vials.

Vial Storage Prior to Use

Cartons of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) may arrive frozen at ultra-cold conditions in thermal containers with dry ice.

Once received, frozen vials may be immediately transferred to the refrigerator [2°C to 8°C (35°F to 46°F)], thawed and stored for up to 10 weeks, not to exceed the expiration date printed on the vial and cartons. The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer. Cartons of multiple dose vials with yellow caps and labels with yellow borders and cartons of single dose vials with blue caps and labels with blue borders may take up to 2 hours to thaw at this temperature.

Alternatively, frozen vials may be stored in an ultra-low temperature freezer at -90°C to -60°C (-130°F to -76°F) until the expiration date printed on the vials and cartons. Do not store vials at -25°C to -15°C (-13°F to 5°F). Once vials are thawed, they should not be refrozen.

If cartons of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) are received at 2°C to 8°C (35°F to 46°F), they should be stored at 2°C to 8°C (35°F to 46°F). Check that the carton has been updated to reflect the 10-week refrigerated expiry date, not to exceed the expiration date printed on the vial and cartons.

Vial Storage During Use

If not previously thawed at 2°C to 8°C (35°F to 46°F), allow Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) multiple dose vials or single dose vials to thaw at room temperature [up to 25°C (77°F)] for 30 minutes.

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) may be stored at room temperature [8°C to 25°C (46°F to 77°F)] for a total of 12 hours prior to the first puncture. After dilution, multiple dose vials should be held between 2°C to 25°C (35°F to 77°F). Multiple dose vials should be discarded 12 hours after dilution.

Transportation of Vials

If local redistribution is needed, multiple dose vials and single dose vials may be transported at -90°C to -60°C (-130°F to -76°F) or 2°C to 8°C (35°F to 46°F).

Expiry Information

When stored at ULT, yellow and blue cap vials should be used within 12 months. Regardless of storage condition, the vaccine should not be used after the expiration date printed on the vials and cartons.


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

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