Dosing and Administration

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Impact of COVID-19

Impact of
COVID-19

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About COMIRNATY

Introduction

mRNA Technology

COMIRNATY Clinical Trial Overview

COMIRNATY Pivotal Trial

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RWE

Real-World Evidence

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RWE Study Design: 2023-2024 Formula of COMIRNATY in Individuals 18 Years and Older

2023-2024 Formula of COMIRNATY RWE

Additional RWE Information

Dosing & Administration

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Pediatric Information (5 years & older)

Dosing and administration

Learn about proper preparation and administration for the 2025-2026 Formula of COMIRNATY, with two age-appropriate dosing presentations¹:

COMIRNATY is supplied as follows:

COMIRNATY single-dose glass prefilled syringes (labeled with gray borders) for individuals 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, and for individuals 65 years of age and older
COMIRNATY single-dose vials (blue caps and labeled with blue borders) for individuals 5 through 11 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19

Quick links

View information for patients 12 years of age and older

Explore the following vaccine sections for the COMIRNATY 2025-2026 Formula:

Dosing chart >

Administration >

View information for pediatric patients 5-11 years of age

Explore the following vaccine sections for the COMIRNATY 2025-2026 Formula:

Dosing chart >

Administration >

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Vaccine presentation for eligible individuals 12 years of age and older¹

Verify the single-dose glass prefilled syringes (labeled with gray borders) prior to preparation for administration to help avoid vaccine administration errors. 

Please see the Vaccine Presentation Guide for more details.

COMIRNATY 2025-2026 Formula

Single-Dose Glass Prefilled Syringes

Dosing 12 Years and Older

Dose Preparation and Administration^‡

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

Dosing 12 Years and Older

Step 1: Verify Single-Dose Glass Prefilled Syringes¹

Verify that the label on the prefilled syringe states 2025-2026 Formula
Glass prefilled syringes are supplied in a carton containing 10 syringes
Single-dose syringes for individuals 12 years and older are labeled with gray borders
If prefilled syringe has been frozen, discard

Step 2: Preparation¹

If prefilled syringe has been frozen, discard
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 COMIRNATY cannot be used immediately, it must be used within 4 hours

Step 3: Administration Information¹

Visually inspect for particulate matter and discoloration prior to administration
For the prefilled syringe, the vaccine will be a white to off-white suspension
Do not administer if vaccine is discolored or contains particulate matter

Step 4: Administration¹

Administer the 0.3 mL dose intramuscularly
For the prefilled syringe, administer the entire volume to deliver a single 0.3 mL dose
For individuals previously vaccinated with any COVID-19 vaccine, administer the dose of COMIRNATY at least 2 months after the last dose of COVID-19 vaccine

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

Vaccine presentation for eligible individuals 5-11 years of age¹

Verify the single-dose vials (blue caps and labeled with blue borders) prior to preparation for administration to help avoid vaccine administration errors.

Please see the Vaccine Presentation Guide for more details.

COMIRNATY 2025-2026 Formula
Single-Dose Vials

Dosing 5 Through 11 Years

Dose Preparation and Administration^¶

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

Dosing 5 Through 11 Years

Step 1: Verify Vials¹

COMIRNATY (2025-2026 Formula) is a suspension for injection, for intramuscular use only.

During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.

Single-dose vials for individuals 5 through 11 years of age have blue caps and labels with blue borders
Blue cap vials are supplied in a carton of 10 singIe-dose vials
Each single-dose vial contains 1 dose of 0.3 mL (no dilution required)

During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.

5 years through 11 years of age
DO NOT DILUTE

Step 2: Confirm Formula and Thaw Vials¹

Verify that the label on the vial states 2025-2026 Formula
Take out of refrigerator or thaw
If vial is frozen, thaw vial in the refrigerator (2ºC to 8ºC [35ºF to 46ºF] for up to 2 hours) or at room temperature (up to 25ºC [77ºF] for 30 minutes)

Step 3: Preparation¹

Prior to use, mix by inverting vial gently 10 times. Do not shake
Withdraw a single 0.3 mL dose using a sterile needle and syringe
Discard vial and any excess volume

Step 4: Administration¹

Visually inspect for particulate matter and discoloration prior to administration
The vaccine will be clear to slightly opalescent suspension
Do not administer if vaccine is discolored or contains particulate matter
Administer the 0.3 mL dose intramuscularly immediately after preparation
COMIRNATY is administered as a single dose for individuals 5 years through  11 years of age
For individuals previously vaccinated with any COVID-19 vaccine, administer the dose of COMIRNATY at least 2 months after the last dose of COVID-19 vaccine

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

Authenticity of
COMIRNATY 2025-2026 Formula

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 about how Pfizer is working to fight counterfeit medicines, visit https://www.pfizer.com/products/medicine-safety/counterfeiting

Ordering available through Pfizer Prime*

Orders for 2025-2026 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.

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.

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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

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References

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

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Provider Resources

References:

COMIRNATY® (COVID-19 Vaccine, mRNA). Prescribing Information. BioNTech Manufacturing GmbH and Pfizer Inc.; August 27, 2025.

Data on file. BioNTech Manufacturing GmbH and Pfizer Inc.; April 18, 2025.

Data on file. BioNTech Manufacturing GmbH and Pfizer Inc.; June 7, 2025.

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Manufactured by
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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 from use of authorized or approved mRNA COVID-19 vaccines, including COMIRNATY, have demonstrated increased risks of myocarditis and pericarditis, with onset of symptoms typically in the first week following vaccination. The observed risk has been highest in males 12 years through 24 years of age.

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

Most commonly reported adverse reactions after a dose:

12 years of age and older (≥10%) 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%).
5 years through 11 years of age (≥5%) were pain at the injection site (up to 83.8%), fatigue (up to 51.9%), headache (up to 38.4%), injection site redness (up to 25.9%), injection site swelling (up to 20%), muscle pain (up to 18.1%), chills (up to 13.3%), fever (up to 7.8%), and joint pain (up to 7.6%).

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 https://vaers.hhs.gov

Please click for COMIRNATY Full Prescribing Information and Patient Information.

Indication

COMIRNATY 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).

COMIRNATY is approved for use in individuals who are:
• 65 years of age and older, or
• 5 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.