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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 AnalysesRWE Study Design: 2023-2024 Formula of COMIRNATY in Individuals 18 Years and Older2023-2024 Formula of COMIRNATY RWEAdditional RWE InformationDosing & AdministrationResourcesResourcesLinks & 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 PrimePediatric Information (5 years & older)
Has been the most administered COVID-19 vaccine* every year in the US† since 2020 in individuals 12 years of age and older5-7

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.5.5-7The US consists of 48 contiguous states, Alaska and Hawaii, District of Columbia, and 12 jurisdictions.8Data are for individuals aged ≥12 years. Data reflective of deductions for returned vaccine doses.5-7

Your recommendation matters
Discussing COVID-19 vaccination with eligible individuals can be an important first step in helping to prevent COVID-19 with COMIRNATY.3
Learn About COMIRNATY
Learn About COMIRNATY
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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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LoadingGo to Patient ProfilesLoadingOrdering 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.

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Learn MoreLoadingCOVID-19=coronavirus disease 2019; SARS-CoV-2=severe acute respiratory syndrome coronavirus 2.References:COMIRNATY® (COVID-19 Vaccine, mRNA). Prescribing Information. BioNTech Manufacturing GmbH and Pfizer Inc.; August 27, 2025.Underlying conditions and the higher risk for severe COVID-19. Centers for Disease Control and Prevention. Updated February 6, 2025. Accessed September 12, 2025. https://www.cdc.gov/covid/hcp/clinical-care/underlying-conditions.htmlFor health care providers. US Department of Health and Human Services. Updated February 20, 2025. Accessed September 12, 2025. https://www.hhs.gov/risk-less-do-more/for-health-care-providers/index.htmlData on file. BioNTech Manufacturing GmbH and Pfizer Inc.; April 18, 2025.COVID-19 vaccinations in the United States, jurisdiction. Centers for Disease Control and Prevention. Updated May 12, 2023. Accessed September 12, 2025. https://data.cdc.gov/Vaccinations/COVID-19-Vaccinations-in-the-United-States-Jurisdi/unsk-b7fc/about_dataIQVIA National Prescription Audit, retail (September 2023-August 2025).IQVIA National Prescription Audit and Drug Distribution Data (September 2023-August 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 September 12, 2025. https://data.cdc.gov/api/views/unsk-b7fc/files/cec0661b-25b0-4fd8-9988-c138b4f2ad16
Data on file. BioNTech Manufacturing GmbH and Pfizer Inc.; June 7, 2025.

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COVID-19 vaccines from BioNTech and Pfizer, which are based on BioNTech proprietary mRNA technology, were developed by both BioNTech and Pfizer.

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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).

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 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 ReactionsMost 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. 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.