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HomeCOVID-19 ImpactCOVID-19
Impact Burden of DiseaseUMCs & Risk FactorsDiscussing VaccinationAbout COMIRNATYAbout COMIRNATYIntroductionmRNA TechnologyCOMIRNATY Clinical Trial OverviewCOMIRNATY Pivotal TrialSelect Safety DataRCTs & RWERandomized Controlled Trials & Real-World EvidenceRCTs and RWE Considerations24-25 Appaneal Study Design24-25 Appaneal VE AnalysisDosingDosing & AdministrationIntroduction & FAQsCOMIRNATY Dosing for ≥12 YearsCOMIRNATY Dosing for 5-11 YearsPatient ProfilesPatient
ProfilesHypothetical Patient ProfilesSusan is 68 years oldClaire has chronic kidney diseaseMike has asthmaHypothetical Patient ProfilesSusan is 68 years oldClaire has chronic kidney diseaseMike has asthmaMaria has coronary artery diseaseTom has type 2 diabetesMaria has coronary artery diseaseTom has type 2 diabetesResourcesResourcesLinks & 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)
Help protect your eligible patients against COVID‑19 and severe outcomes2
COMIRNATY is approved for use in individuals who are2:
• 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
COMIRNATY is approved for use in individuals who are2:
• 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
#1 administered

Learn more about COMIRNATY for eligible people.

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500+ scientific publications

COMIRNATY is supported by more than 500 peer-reviewed scientific publications, including reported clinical trial results.

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RCTs and RWE

View select RCTs and real-world studies about the effectiveness of COMIRNATY.

 Go to RCTs and RWE studiesLoadingBased on a three-month rolling analysis of cumulative COVID-19 vaccine doses administered to individuals aged ≥12 years in the United States.4 ​Based on data available on VIEW-hub, a global vaccine data platform maintained by the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health. Calculation includes publications from 2020 to 2025. Data on this site is updated on an ongoing basis.5​Not available for the 2026-2027 formula of COMIRNATY.3 
COMIRNATY dosing options for eligible individuals
Prefilled syringe

COMIRNATY single-dose prefilled syringes are approved for individuals aged ≥65 or 12-64 years with at least 1 underlying medical condition (UMC) that puts them at high risk for severe outcomes from COVID-19.2

 View dosing information LoadingSingle-dose vial

COMIRNATY single-dose vials are approved for individuals aged 5 through 11 years with at least 1 UMC that puts them at high risk for severe outcomes from COVID-19.2

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Discuss COVID-19 vaccination
Clear recommendations matter to your patients at risk.6
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 Button LoadingOrder with Pfizer Prime*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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HCP=healthcare professional; RCT=randomized controlled trial.References:Underlying conditions and the higher risk for severe COVID-19. Centers for Disease Control and Prevention. Updated February 6, 2025. Accessed July 22, 2026. https://www.cdc.gov/covid/hcp/clinical-care/underlying-conditions.html COMIRNATY® (COVID-19 Vaccine, mRNA). Prescribing Information. BioNTech Manufacturing GmbH and Pfizer Inc.; August 27, 2026.Modjarrad K. 2026-2027 COVID-19 vaccine formula: Pfizer/BioNTech supportive data. Vaccines and Related Biological Products Advisory Committee. US Food and Drug Administration. Presented May 28, 2026. Accessed July 22, 2026. https://www.fda.gov/media/192765/download  IQVIA National Prescription Audit, Drug Distribution Data, & Longitudinal Access and Adjudication Data (September 2025 - June 2026)International Vaccine Access Center (IVAC), Johns Hopkins Bloomberg School of Public Health. VIEW-hub. Accessed August 10, 2026. https://view-hub.org/vaccine/covid/?field_covid_studies_vaccine_all=101&field_covid_studies_vaccine_all=301&field_covid_studies_vaccine_all=106&field_covid_studies_vaccine_all=302&field_covid_studies_vaccine_all=603&field_covid_studies_vaccine_all=606&field_covid_studies_vaccine_all=607&field_covid_studies_vaccine_all=610&field_covid_studies_vaccine_all=652&field_covid_studies_vaccine_all=657Adult immunization standards. Centers for Disease Control and Prevention. Updated August 9, 2024. Accessed July 22, 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.  

The formulation of COMIRNATY, which is based on BioNTech proprietary mRNA technology, was developed by BioNTech and Pfizer.  

To report an adverse event, please call 1-800-438-1985

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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.