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HomeImpact of COVID-19Impact of
COVID-19Uncovering the Burden of DiseaseCOVID-19 & Flu ImpactSelect UMCs & Risk FactorsAbout COMIRNATYAbout COMIRNATYIntroductionmRNA TechnologyCOMIRNATY Clinical Trial OverviewCOMIRNATY Pivotal TrialSelect Safety DataRWEReal-World EvidenceRCTs and RWE AnalysesStudy Design: 2023-2024 Formula RWEEffectiveness Data: 2023-2024 Formula RWEAdditional RWE InformationDosing & PreparationResourcesResourcesLinks & SupportCOMIRNATY Health Plan CoverageMaterialsHypothetical Patient ProfilesSusan is 68 years oldMike has asthmaMaria has coronary artery diseaseTom has type 2 diabetes
IndicationPrescribing InformationPatient InformationPatient SiteOrder on Pfizer PrimeEUA Vaccine Option for 6 Mo to 11 Years of Age
Inclusive of US-administered vaccine doses from formulas encoding the SARS-CoV-2 spike protein for Wuhan-Hu-1 strain (Original), Omicron XBB.1.5, and Omicron KP.2. Also, inclusive of administered COVID-19 vaccine doses encoding the spike proteins for Wuhan-Hu-1 strain (Original) and Omicron BA.4/BA.5. Previous formulas of COVID-19 vaccines are no longer available in the US.1-4The US consists of 48 contiguous states, Alaska and Hawaii, District of Columbia, and 12 jurisdictions.5Data are for individuals aged ≥12 years. Data reflective of deductions for returned vaccine doses.1-3COMIRNATY: The first FDA-approved COVID-19 vaccine6

COMIRNATY: The first FDA-approved 
COVID-19 vaccine6

The first and only mRNA
COVID-19 vaccine available from the manufacturer at REFRIGERATED TEMPERATURE supplied in a single dose glass prefilled syringe4,7,8

May be stored for up to 8 months in refrigerator from date of manufacture. Do not exceed the expiration date printed on the carton and syringe.4,8

Help protect eligible individuals against COVID-19 with COMIRNATY4

Dosing & Preparation LoadingYour recommendation mattersDiscussing COVID-19 vaccination with eligible individuals can be an important first step in helping to protect them against COVID-19.9Learn About COMIRNATY Impact of COVID-19

Learn about the disease burden and risk factors for severe outcomes from COVID-19.

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Learn about the disease burden and risk factors for severe outcomes from COVID-19.

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Learn about the effectiveness and safety data for COMIRNATY in individuals 12 years of age and older.

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Learn about the disease burden and risk factors for severe outcomes from COVID-19.

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Find out about COMIRNATY dose preparation and administration.


Dosing & PreparationLoading Impact of COVID-19

Learn about the disease burden and risk factors for severe outcomes from COVID-19.

 Button LoadingHypothetical Patient ProfilesExplore examples of hypothetical patients with certain underlying medical conditions or risk factors for COVID-19, and learn how to protect them against COVID-19 and potential severe outcomes.Go to Patient ProfilesLoadingGo to Patient ProfilesLoadingOrdering 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 PrimeLoading

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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Learn MoreLoadingCOVID-19=coronavirus disease 2019; FDA=Food and Drug Administration; SARS-CoV-2=severe acute respiratory syndrome coronavirus 2.References:COVID-19 vaccinations in the United States, jurisdiction. Centers for Disease Control and Prevention. Updated May 12, 2023. Accessed April 16, 2025. https://data.cdc.gov/Vaccinations/COVID-19-Vaccinations-in-the-United-States-Jurisdi/unsk-b7fc/about_dataIQVIA National Prescription Audit, retail (September 2023-January 2025).IQVIA National Prescription Audit and Drug Distribution Data (September 2023-January 2025).COMIRNATY® (COVID-19 Vaccine, mRNA). Prescribing Information. BioNTech Manufacturing GmbH and Pfizer Inc.; June 25, 2025.CDC COVID-19 vaccine administration and distribution data. Jurisdiction abbreviations: COVID-19 vaccinations in the United States, jurisdiction. Centers for Disease Control and Prevention. Updated May 4, 2023. Accessed April 28, 2025. https://data.cdc.gov/api/views/unsk-b7fc/files/cec0661b-25b0-4fd8-9988-c138b4f2ad16FDA approves first COVID-19 vaccine. US Food and Drug Administration. Updated August 23, 2021. Accessed April 16, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccineModerna COVID-19 vaccine summary. Centers for Disease Control and Prevention. Updated August 28, 2024. Accessed April 15, 2025. https://www.cdc.gov/vaccines/php/info-by-product/moderna-COVID-19-summary.htmlPfizer COVID-19 vaccine summary. Centers for Disease Control and Prevention. Updated August 28, 2024. Accessed April 15, 2025. https://www.cdc.gov/vaccines/php/info-by-product/pfizer-covid-19-summary.htmlAdult immunization standards. Centers for Disease Control and Prevention. Updated August 9, 2024. Accessed June 26, 2025. https://www.cdc.gov/vaccines-adults/hcp/imz-standards/index.html

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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.

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 ReactionsAppropriate 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.

SyncopeSyncope (fainting) may occur in association with administration of injectable vaccines, including COMIRNATY. Procedures should be in place to avoid injury from fainting.Altered ImmunocompetenceImmunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to COMIRNATY.Limitation of Vaccine EffectivenessCOMIRNATY may not protect all vaccine recipients.Adverse ReactionsThe 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 https://vaers.hhs.govPlease 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.