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COMIRNATY® (COVID-19 Vaccine, mRNA)
is available in two age-appropriate
vaccine presentations1:
COMIRNATY® (COVID-19 Vaccine, mRNA) is available in two age-appropriate vaccine presentations1:
Single-dose vialCOMIRNATY single-dose vials are approved for individuals 5 through 11 years of age with at least 1 underlying condition that puts them at high risk for severe outcomes from COVID-19.1
View dosing information
LoadingSingle-dose prefilled syringeCOMIRNATY single-dose prefilled syringes are approved for individuals 12 through 64 years of age with at least 1 underlying condition that puts them at high risk for severe outcomes from COVID-19, or ≥65 years of age.1
View dosing information
LoadingYour recommendation matters2Discussing COVID-19 vaccination with parents and caregivers of eligible individuals can be an important first step in helping to protect them against COVID-19.
Orders for COMIRNATY 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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*If preferred, orders may be placed with your facility’s wholesaler.
References:COMIRNATY® (COVID-19 Vaccine, mRNA). Prescribing Information. BioNTech Manufacturing GmbH and Pfizer Inc.; August 27, 2026.Adult immunization standards. Centers for Disease Control and Prevention. Updated August 9, 2024. Accessed August 3, 2026. https://www.cdc.gov/vaccines-adults/hcp/imz-standards/index.html
Manufactured for
BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz, Germany
Marketing Authorization Holder
Manufactured by
Pfizer Inc.
New York, NY 10001
The formulation of COMIRNATY, which is based on BioNTech proprietary mRNA technology, was developed by BioNTech and Pfizer.
This site is intended only for U.S. healthcare professionals. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only.
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INDICATIONCOMIRNATY® (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).
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.
Important Safety InformationDo 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.govPlease click for COMIRNATY Full Prescribing Information and Patient Information.IndicationCOMIRNATY 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.