2024-2025 FORMULA OF COMIRNATY® (COVID-19 Vaccine, mRNA) FDA APPROVED: Effective 08/22/24

COMIRNATY IS APPROVED FOR ACTIVE IMMUNIZATION TO PREVENT COVID-19 CAUSED BY SARS-CoV-2 IN INDIVIDUALS 12 YEARS OF AGE AND OLDER.

COMIRNATY Single Dose Glass Prefilled Syringes are stored in the refrigerator and are refrigerator-stable for up to 8 months from date of manufacture to the expiration date printed on the carton and on the syringe labels. If a glass prefilled syringe has been frozen, discard.

Click to view the full Prescribing Information and Patient Information.

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

  • Please verify that the glass prefilled syringe states "COMIRNATY® (COVID-19 Vaccine, mRNA) 2024-2025 Formula”
  • Verify the glass prefilled syringe and label are for the appropriate age group

Please see the Vaccine Presentation Guide for more details.

Important Reminder:

Previous COVID-19 vaccines are no longer available 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.

Regardless of storage condition, the vaccine should not be used after the expiration date printed on the glass prefilled syringes and cartons.

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

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Your recommendation matters

Discussing COVID-19 vaccination with eligible patients can be an important first step in helping to protect them against COVID-192

Help protect eligible patients 12 years of age & older against COVID-19 with COMIRNATY® (COVID-19 Vaccine, mRNA)1

  • The first and only mRNA COVID-19 vaccine that has never been frozen and is stored at refrigerated temperature
  • Available in a single dose glass prefilled syringe
  • May be stored for up to 8 months in refrigerator from date of manufacture
COMIRNATY® (COVID-19 Vaccine, mRNA) packaging and glass prefilled syringes

Store COMIRNATY glass prefilled syringes refrigerated at 2°C to 8°C (35°F to 46°F). DO NOT FREEZE1

Find Out About Dosing

COVID-19=coronavirus disease 2019; SARS-CoV-2=severe acute respiratory syndrome coronavirus 2.

Ordering available through Pfizer Prime*

Orders for 2024-2025 formula COVID-19 vaccines by BioNTech and Pfizer can be placed by eligible
healthcare professionals directly with Pfizer through Pfizer Prime online or by calling 1-800-533-4535.

Visit Pfizer Prime

*Eligible healthcare providers can order COVID-19 vaccines directly from
Pfizer. If preferred, orders may be placed with your facility’s wholesaler.

IMPORTANT SAFETY INFORMATION

Do not administer COMIRNATY® (COVID-19 Vaccine, mRNA) to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of COMIRNATY 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 must be immediately available to manage potential anaphylactic reactions following administration of COMIRNATY.

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 COMIRNATY, 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 Centers for Disease Control and Prevention (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, including COMIRNATY. 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 COMIRNATY.

Limitation of Vaccine Effectiveness

COMIRNATY may not protect all vaccine recipients.

Adverse Reactions

The most commonly reported adverse reactions (≥10%) after a dose of COMIRNATY were pain at the injection site (up to 90.5%), fatigue (up to 77.5%), headache (up to 75.5%), chills (up to 49.2%), muscle pain (up to 45.5%), joint pain (up to 27.5%), fever (up to 24.3%), injection site swelling (up to 11.8%), and injection site redness (up to 10.4%).

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or https://www.pfizersafetyreporting.com or VAERS at 1-800-822-7967 or http://vaers.hhs.gov

Please click for COMIRNATY Full Prescribing Information and Patient Information.

INDICATION

COMIRNATY® (COVID-19 Vaccine, mRNA) 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 12 years of age and older.

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Pfizer Customer Service

Including General
Product Questions.

Call 1-800-879-3477

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Medical Information

Visit
PfizerMedicalInformation.com

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Shipment Support US Trade Customer Service

Call 1-800-666-7248

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References:Reference:
  1. COMIRNATY® (COVID-19 Vaccine, mRNA). Prescribing Information. BioNTech Manufacturing GmbH and Pfizer Inc.; August 22, 2024.
  2. Talking with patients about COVID-19 vaccination: an introduction to motivational interviewing for healthcare professionals. Centers for Disease Control and Prevention. Accessed August 16, 2024. https://www.cdc.gov/vaccines/covid-19/hcp/engaging-patients.html