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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Vaccine Presentation for eligible individuals 12 years of age and older1

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

  • Please verify that the single dose 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.

COMIRNATY (COVID-19 Vaccine, mRNA) 2024-2025 Formula
Single Dose Glass Prefilled Syringes

Refrigerated Storage Time: Up to 8 months,* DO NOT FREEZE

The total time out of refrigeration [at temperatures between 8°C and 25°C (46°F and 77°F)] must not exceed 12 hours.

Dose:  0.3 mL

Each 0.3 mL dose of COMIRNATY (2024-2025 Formula) is formulated to contain 30 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 Omicron variant lineage KP.2.

Single Dose Syringe

Do not shake. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.1 

*When stored in a refrigerator, single dose glass prefilled syringes should be used within 8 months from date of manufacture, until the expiration date printed on the carton and syringe labels. Store COMIRNATY glass prefilled syringes refrigerated at 2°C to 8°C (35°F to 46°F). DO NOT FREEZE. Regardless of storage condition, the vaccine should not be used after the expiration date printed on the prefilled syringes and cartons.

COMIRNATY® (COVID-19 Vaccine, mRNA) 2024-2025 Formula glass prefilled syringes

Dose preparation and administration1†

For additional information, please see Full Prescribing Information and Patient Information.

Step 1:  Verify Glass Prefilled Syringes1

Verify that the COMIRNATY single dose glass syringe label states “2024-2025 Formula.” Verify that the label is for the indicated age group of 12 years of age and older.

  • Glass prefilled syringes are supplied in a carton containing 10 syringes
  • Each glass prefilled syringe contains a single 0.3 mL dose

Storage and Expiration


Store COMIRNATY single dose glass prefilled syringes refrigerated at 2°C to 8°C (35°F to 46°F).


DO NOT FREEZE. If COMIRNATY single dose glass prefilled syringes have been frozen, discard.


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


Verify that product has not expired. Glass prefilled syringes should be used within 8 months from date of manufacture. The vaccine should not be used after the expiration date printed on the prefilled syringes and cartons.


Received Refrigerated and Stored in Refrigerator

  • Store single dose glass prefilled syringe refrigerated at 2°C to 8°C (35°F to 46°F)

The total time out of refrigeration at temperatures between 8°C and 25°C (46°F and 77°F) must not exceed 12 hours.


Step 2:  Preparation1

  • Do not shake
  • Remove tip cap by slowly turning the cap counterclockwise while holding the Luer lock and attach a sterile needle​. Use immediately.
  • If it cannot be used immediately, it must be used within 4 hours​

Step 3:  Administration1

  • Visually inspect for particulate matter and discoloration prior to administration (whenever solution and container permit)​
  • Vaccine will be a white to off-white suspension​
  • DO NOT ADMINISTER if vaccine is discolored or contains particulate matter
  • For the prefilled syringe, administer the entire volume to deliver a single 0.3 mL dose intramuscularly immediately after preparation

†For detailed instructions and information related to product handling, please see Full Prescribing Information.

Ensuring the authenticity of COMIRNATY® (COVID-19 Vaccine, mRNA) (2024-2025 Formula)

  • Pfizer is committed to patient safety and ensuring that people have accurate information about COMIRNATY, including how it is accessed and administered. We are actively monitoring for fraudulent offers of illegitimate COMIRNATY to protect patients from products that might be dangerous and lead to serious and life-threatening harm
    • COMIRNATY is only administered intramuscularly by government-authorized healthcare professionals
    • COMIRNATY is not taken orally and is not available in a capsule or tablet form
    • Authentic COMIRNATY, manufactured by Pfizer or BioNTech, will include the COMIRNATY name on the label and can be visually verified via this page.
  • COMIRNATY is not available for private purchase. COMIRNATY is NOT sold online. Any sales of COMIRNATY over the internet, including from online pharmacies, are not legitimate
    • The authenticity of products acquired outside of the legitimate supply chain cannot be verified by Pfizer

If you suspect the vaccine you have purchased may be counterfeit, contact us at 1-800-438-1985 or visit https://www.pfizer.com/products/product-contact-information.

To learn more, visit https://www.pfizer.com/products/medicine-safety/counterfeiting.

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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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.

For more information

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Call 1-800-879-3477
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Call 1-800-666-7248
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Pfizer Customer Service

Including General
Product Questions.

Call 1-800-879-3477

Information Icon

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