Something went wrong

We encountered an unexpected error, we encourage you to try again later.

We're here to help

Should you have additional questions please contact PfizerPro customer service.

Representatives are available:
Monday-Friday 8:00am to 9:00pm Eastern time

Call 1 (800) 505-4426

PP-UNP-USA-5796
Order samples Unable to confirm your eligibility

Unfortunately, your registration is incomplete and we are unable to confirm your eligibility for sample ordering.

To gain access please enter your professional information within your account.

Open your account We're here to help

Should you need further support updating your account information, please contact PfizerPro customer service.

Representatives are available:
Monday-Friday 8:00am to 9:00pm Eastern time

Call 1 (800) 505-4426

​​​​​​​PP-UNP-USA-5796
Order samples
Thank you for expressing interest in Pfizer samples. Currently there are no samples available to order. Samples renew periodically, we encourage you to check back soon.
 We're here to help

Should you have additional questions please contact PfizerPro customer service.

Representatives are available:
Monday-Friday 8:00am to 9:00pm Eastern time

Call 1 (800) 505-4426

​​​​​​​PP-UNP-USA-5796
Order samples

All samples available online to you are included below. Availability is updated periodically.

PP-UNP-USA-5796
Important Notice

Savings cards will be shipped with Product Samples, if applicable.

Signature

Use your mouse, finger, or stylus to sign below.

Legal Notice

I certify that I am a licensed prescriber, eligible to request and receive the drug samples listed in the quantities indicated. I am also confirming that these samples will be used exclusively for the medical treatment of my patients in conformity with all relevant state and/or local prescribing and dispensing requirements. My signature will also serve as confirmation of my receipt of these medications, if delivered by a company representative, or my intention to acknowledge them upon delivery to my medical office if shipped via common carrier. I understand that these samples cannot be sold, traded, bartered returned for credit or utilized to seek or obtain reimbursement.

Your order has been placed

We have received your order and are getting it ready

More to explore Patient assistance

Download available co-pay cards and patient savings offers across select Pfizer products.

Explore patient assistance Loading Vaccines

Find out more about the diseases, treatments and prevention methods that are impacted by our Pfizer Vaccine portfolio.

Explore Vaccines Loading
PP-UNP-USA-5796
Leave ordering?

Changes you have made will not be saved.

This site is intended for U.S. healthcare professionals.

For patient resources and support click HERE

Menu

Close

Sign InLog OutTherapy AreasProductsOrder VaccinesOrder SamplesOrderMaterialsCo-pay Cards & Patient Savings OffersRequest SamplesHospital ProductsVaccinesPatient AssistancePfizer Oncology TogetherPfizer RxPathwaysPfizer Dermatology Patient AccessExplore ContentEventsMaterialsVideosContact
Search

Menu

Close

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)
About COMIRNATY®
(COVID-19 Vaccine, mRNA)
Introduction
mRNA
Technology
Clinical Trial
Overview
Pivotal Trial
Select
Safety Data
The effectiveness and safety of COMIRNATY have been evaluated in multiple randomized controlled trials in individuals 12 years of age
and older1COMIRNATY: The First Approved COVID-19 Vaccine1,2 COMIRNATY is an mRNA COVID-19 vaccine approved to prevent COVID-19 in individuals1:
 
  • 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
 
The pivotal study (Study 2) of COMIRNATY was one of the largest clinical trials Pfizer has ever conducted1
  • It is the main study to support the safety and efficacy of COMIRNATY
  • A multicenter, multinational, randomized, placebo-controlled, observer-blind, efficacy (Phase 2/3) study in a diverse population of approximately 46,000 vaccine-naïve people 12 years of age or older, of whom approximately 23,000 received COMIRNATY
COMIRNATY is supported by select real-world studies involving ~190,000 participants, of which ~20,000 received COMIRNATY variant-adapted formulas3-6*Learn more about Real-World EvidenceReferencesBased on 4 real-world, test-negative case-control studies from 2023 through 2025 evaluating BNT162b2 vaccine effectiveness during Omicron sub-lineage circulation, including 3 studies of variant-adapted BNT162b2 vaccine formulations. Out of 196,673 population across the studies, 19,804 received BNT162b2.3-6 < Back Impact of COVID-19 Loading
Up next >
 mRNA Technology LoadingReferencesmRNA=messenger ribonucleic acid; RCT=randomized controlled trial; RWE=real-world evidence.
mRNA TechnologySupporting the development of COMIRNATY

In development since the 1960s, mRNA technology has been explored across various diseases. Studies evaluating use of mRNA as a vaccine platform began in the 1990s7-10

mRNA technology, used by mRNA COVID-19 vaccines including COMIRNATY, has the potential to streamline vaccine development.
This helps to allow for a timely response to FDA-directed formula updates/strain(s) selection for circulating strains of the virus that causes COVID-1910

Updates to the vaccine's encoded spike protein sequence to more closely match circulating SARS‑CoV‑2 variants while using the same manufacturing platform and process.10-12

How COMIRNATY Works
COMIRNATY helps train the immune system to recognize and help fight the virus that causes COVID-19, without exposing the body to the virus8,13

1. COMIRNATY contains a spike protein mRNA segment surrounded by a protective lipid coat for delivery. After vaccination, the mRNA enters the cells.8,13

2. mRNA provides the cell instructions to build copies of spike proteins found on the surface of the virus that causes COVID-19.8,13

3. The spike proteins are presented on the surface of the cell and train the immune system. The resulting immune response, which includes antibodies, is what recognizes and helps protect against COVID-19 if the body is exposed again in the future.8,13

Note: These graphical representations are intended for illustrative purposes only.8,13 < Back Introduction Loading
Up next >
 Clinical Trial Overview LoadingFDA=Food and Drug Administration; mRNA=messenger ribonucleic acid; SARS-CoV-2=severe acute respiratory syndrome coronavirus 2.
Clinical Trial Overview

Supporting the development of COMIRNATY

COMIRNATY overview
  • COMIRNATY effectiveness and safety have been evaluated in multiple randomized controlled trials1
  • Analyses of prespecified immunogenicity endpoints were also studied1
  • Pfizer is committed to ongoing monitoring of the safety and effectiveness of our vaccines
  • The safety and immunogenicity data of previous formulas of COMIRNATY are pertinent to the updated formulas of COMIRNATY because previous formulas of the vaccine are manufactured using a similar process, with differences only in the mRNA that encodes the viral spike protein1
  • COMIRNATY should not be administered to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of COMIRNATY. Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of COMIRNATY1
  • Postmarketing data with authorized or approved mRNA COVID-19 vaccines demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following vaccination. For COMIRNATY, the observed risk is highest in males 12 through 24 years of age1
  • Syncope (fainting) may occur in association with administration of injectable vaccines, including COMIRNATY. Procedures should be in place to avoid injury from fainting1
  • Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to COMIRNATY1
To see Important Safety Information (ISI), expand the ISI tray at the bottom of the page.
 More information

Read the full Prescribing Information for additional information on effectiveness, immunogenicity, and safety of COMIRNATY.

Prescribing Information Loading < Back mRNA Technology Loading
Up next >
 Pivotal Trial LoadingmRNA=messenger ribonucleic acid.
Example
Pivotal Trial Data (Study 2)Efficacy of Two-Dose Series (Original Monovalent) in Vaccine-Naïve Individuals 12 Years of Age and Older

The efficacy and safety of a 2-dose primary series of COMIRNATY compared with placebo (randomized 1:1) was studied in a large pivotal trial (Study 2)—one of the largest clinical trials Pfizer has ever conducted—and is the main study supporting the approval of COMIRNATY1

The COMIRNATY pivotal study took place when much of the US population had not yet been infected with or vaccinated against SARS-CoV-2, and the results may not be generalizable given widespread population immunity and currently circulating variants.1,2

Note: Data from clinical studies supporting the single-dose regimen were added to the full Prescribing Information in 2023.1
See dosage and administration for COMIRNATY
 Dosage and Administration Loading Dosage and Administration Loading
Over 46,000 participants

Over 46,000 vaccine-naïve individuals 12 years of age and older were randomized to COMIRNATY or placebo in the pivotal trial (Study 2)1

The COMIRNATY pivotal study took place when much of the US population had not yet been infected with or vaccinated against SARS-CoV-2.1,15At the time of the analysis of the ongoing study with a data cutoff of March 13, 2021, a total of 25,651 participants 16 years of age and older were followed for ≥4 months after the second dose.1At the time of the analysis of the ongoing study with a data cutoff of September 2, 2021, there were 
1,559 adolescents 12 to 15 years of age followed for ≥4 months after the second dose.1Participants were also monitored for unsolicited adverse events throughout the study (from Dose 1 through 1 month [all unsolicited AEs] or 6 months [serious AEs] after the last vaccination).1Participants were planned to be followed for up to 24 months, for assessments of safety and efficacy against COVID-19.1Study 2 EfficacyPrimary series with COMIRNATY—Efficacy in vaccine-naïve participants 16 years of age and olderPrimary vaccine efficacy endpoint: First COVID-19 occurrence from 7 days after dose 2 in participants 16 years and older, by Age Subgroups1Title91.1% vaccine efficacy (95% CI: 88.8, 93.1) among all participants without evidence of prior SARS-CoV-2 infection (COMIRNATY, n=19,711)1
  • 16-64 years of age
    90.5% vaccine efficacy
    (95% CI: 87.9, 92.7)
    (COMIRNATY, n=15,519)1
  • 65 years and older
    94.5% vaccine efficacy
    (95% CI: 88.3, 97.8)
    (COMIRNATY, n=4192)1
ReferencesVaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original).1Title90.9% vaccine efficacy (95% CI: 88.5, 92.8) among all participants with or without evidence of prior SARS-CoV-2 infection (COMIRNATY, n=20,533)1ReferencesVaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original).1Please see updated vaccine efficacy information presented in Prescribing Information, Table 14 for additional details.1TitleIMPORTANT NOTE: The vaccine effectiveness noted above was evaluated in the clinical trial. Vaccine effectiveness will naturally wane over time and may also be impacted by the emergence of new variants.10Secondary efficacy endpoint: First severe COVID-19 occurrence from 7 days ​after dose 2 in participants 16 years and older1Title95.3% vaccine efficacy (95% CI: 70.9, 99.9) for first severe COVID-19 occurrence (severe disease as defined in the protocol),# with or without evidence of prior SARS-CoV-2 infection (COMIRNATY, N=20,540)1ReferencesVaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original).1Title100% vaccine efficacy (95% CI: 87.6, 100) for first severe COVID-19 occurrence (severe disease as based on the CDC definition),** with or without evidence of prior SARS-CoV-2 infection (COMIRNATY, N=20,513)1#TitleIMPORTANT NOTE: The vaccine effectiveness noted above was evaluated in the clinical trial. Vaccine effectiveness will naturally wane over time and may also be impacted by the emergence of new variants.10ReferencesVaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original).1Defined as confirmed COVID-19 and ≥1 of the following: clinical signs at rest indicative of severe systemic illness, respiratory failure, evidence of shock, significant acute renal, hepatic, or neurological dysfunction, admission to an intensive care unit, or death.1Defined as confirmed COVID-19 and ≥1 of the following: hospitalization, admission to an intensive care unit, intubation or mechanical ventilation, or death.1Please see updated vaccine efficacy information presented in Prescribing Information, Table 14 for additional details.1A descriptive efficacy analysis of Study 2: In participants 12-15 years of age1Participants meeting the endpoint100% vaccine efficacy (95% CI: 86.8, 100) for first COVID-19 occurrence without evidence of prior SARS-CoV-2 infection (COMIRNATY cases [N=1057; n=1043])1ReferencesVaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original).1Participants at risk for meeting the endpoint100% vaccine efficacy (95% CI: 87.5, 100) for first COVID-19 occurrence with or without evidence of prior SARS-CoV-2 infection (COMIRNATY cases [N=1119; n=1098])1ReferencesVaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original).1Please see updated vaccine efficacy information presented in Prescribing Information, Table 16 for additional details.TitleIMPORTANT NOTE: The vaccine effectiveness noted above was evaluated in the clinical trial. Vaccine effectiveness will naturally wane over time and may also be impacted by the emergence of new variants.16NOTES
  • The vaccine efficacy was observed during a period of time before the Omicron variant was the predominant strain of SARS-CoV-21,17,18
  • SARS-CoV-2 variants of concern identified from COVID-19 cases from this data cutoff included B.1.1.7 (Alpha) and B.1.351 (Beta)1
  • Confirmed cases were determined by reverse transcription-polymerase chain reaction and symptom(s) including fever, new or increased cough, new or increased shortness of breath, chills, new or increased muscle pain, new loss of taste or smell, sore throat, diarrhea, or vomiting1
 More information

To learn about the clinical study data supporting the safety and effectiveness of COMIRNATY in individuals 12 through 15 years of age.

Prescribing Information Loading < Back Clinical Trial Overview Loading
Up next >
 Select Safety Data LoadingAE=adverse event; CDC=Centers for Disease Control and Prevention; HBV=hepatitis B virus; HCV=hepatitis C virus; HIV=human immunodeficiency virus; modRNA=nucleoside-modified mRNA; mRNA=messenger ribonucleic acid; NAAT=nucleic acid amplification test; PCR=polymerase chain reaction; SARS-CoV-2=severe acute respiratory syndrome coronavirus 2.
Select Safety Data from Clinical StudiesAn overview of clinical studies contributing to the safety assessment of COMIRNATY1Participants in these clinical studies received a single dose or a 2-dose series administered 3 weeks apart (referred to as a primary series) and subsequent doses referred to as booster doses1
Scroll left to view table
Scroll left to view table
Table with data from clinical studies contributing to the safety assessment of COMIRNATY.
COMIRNATY encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original, 30 mcg modRNA).1Received COMIRNATY during placebo-control period.1Vaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original) and Omicron variant lineages BA.4 and BA.5 (Omicron BA.4/BA.5), previously authorized as Pfizer-BioNTech COVID-19 Vaccine, Bivalent (30 mcg modRNA).1Influenza Vaccine (Afluria® Quadrivalent).1COMIRNATY encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original, 10 mcg modRNA).1Vaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original) and Omicron variant lineages BA.4 and BA.5 (Omicron BA.4/BA.5), previously authorized as Pfizer-BioNTech COVID-19 Vaccine, Bivalent (10 mcg modRNA).1COMIRNATY encoding the viral spike (S) glycoprotein of SARS-CoV-2 Omicron XBB.1.5 (10 mcg modRNA).1Serious Adverse Events by Age in Clinical StudiesStudy 21
  • Ages 16-55:

Participants 16 through 55 years of age in Study 2 who had received at least 1 dose of vaccine or placebo (COMIRNATY, N=12,995; placebo, N=13,026) reported serious adverse events from Dose 1 up to the participant unblinding date in ongoing follow-up as follows: 103 (0.8%) COMIRNATY recipients and 117 (0.9%) placebo recipients. 



In a similar analysis, in participants 56 years of age and older (COMIRNATY, N=8931; placebo, N=8895), serious adverse events were reported by 165 (1.8%) COMIRNATY recipients and 151 (1.7%) placebo recipients who received at least 1 dose of COMIRNATY or placebo, respectively.

  • Ages 12-15:

In Study 2, among participants 12 through 15 years of age who had received at least 1 dose of vaccine or placebo (COMIRNATY, N=1131; placebo, N=1129), serious adverse events from Dose 1 up to the participant unblinding date in ongoing follow-up were reported by 10 (0.9%) COMIRNATY recipients and 2 (0.2%) placebo recipients.

Study 31
  • Ages 5-11:

In analyses of participants 5 through 11 years of age, 3109 participants received COMIRNATY, and 1538 participants received placebo.



Serious adverse events from administration of Dose 1 to the participant unblinding date were reported in 8 (0.3%) COMIRNATY recipients and in 2 (0.1%) placebo recipients.

Most Commonly Reported Adverse Reactions with COMIRNATY
  • Ages 12 & older:
12 years of age and older adverse reactions (≥10%, after a dose): 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%).
  • Ages 5-11:
5 through 11 years of age adverse reactions (≥5%, following any dose): 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 20.0%), muscle pain (up to 18.1%), chills (up to 13.3%), fever (up to 7.8%), and joint pain (up to 7.6%). This safety data is pertinent to the updated formulas of COMIRNATY because these vaccines are manufactured using a similar process.1 To see Important Safety Information (ISI), expand the ISI tray at the bottom of the page. < Back Pivotal Trial Loading
Up next >
 Real-World Evidence LoadingmodRNA=nucleoside-modified mRNA; mRNA=messenger ribonucleic acid; SARS-CoV-2=severe acute respiratory syndrome coronavirus 2.
About COMIRNATY Learn about Real-World Evidence

Learn about COMIRNATY published data from real-world settings.

 View RCTs & RWE LoadingReferences:COMIRNATY® (COVID-19 Vaccine, mRNA). Prescribing Information. BioNTech Manufacturing GmbH and Pfizer Inc.; August 27, 2026.FDA approves first COVID-19 vaccine. FDA news release. US Food and Drug Administration. Published August 23, 2021. Accessed August 10, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccineAppaneal HJ, Lopes VV, Nguyen, JL, et al. BNT162b2 LP.8.1 early vaccine effectiveness against COVID-19 emergency department, urgent care, and outpatient visits. Nat Commun. 2026;17(1):6912. doi:10.1038/s41467-026-73798-3.Tartof SY, Slezak JM, Puzniak L, et al. Effectiveness of BNT162b2 XBB vaccine against XBB and JN.1 sublineages. Open Forum Infect Dis. 2024;11(7):ofae370. doi:10.1093/ofid/ofae370Appaneal HJ, Lopes VV, Puzniak L, et al. Early effectiveness of the BNT162b2 KP.2 vaccine against COVID-19 in the US Veterans Affairs Healthcare System. Nat Commun. 2025;16(1):4033. doi:10.1038/s41467-025-59344-7Tartof SY, Frankland TB, Slezak JM, et al. Effectiveness and durability of the BNT162b2 KP.2 vaccine against COVID-19 hospitalization and emergency department or urgent care encounters in US adults. Open Forum Infect Dis. 2026;13(2):ofag019. doi:10.1093/ofid/ofag019Qin S, Tang X, Chen Y, et al. mRNA-based therapeutics: powerful and versatile tools to combat diseases. Signal Transduct Target Ther. 2022;7(1):166. doi:10.1038/s41392-022-01007-wCOVID-19 vaccine basics. Centers for Disease Control and Prevention. Updated September 3, 2024. Accessed August 10, 2026. https://www.cdc.gov/covid/vaccines/howtheywork.html2020 COVID-19 and related vaccine development and research. History of COVID-19: outbreaks and vaccine timeline. Mayo Clinic. Accessed August 10, 2026. https://www.mayoclinic.org/diseases-conditions/history-disease-outbreaks-vaccine-timeline/covid-19Sparrow E, Hasso-Agopsowicz M, Kaslow DC, et al. Leveraging mRNA platform technology to accelerate development of vaccines for some emerging and neglected tropical diseases through local vaccine production. Front Trop Dis. 2022;3:844039. doi:10.3389/fitd.2022.844039COVID-19 vaccines (2025-2026) for use in the United States beginning in fall 2025. US Food and Drug Administration. Published May 22, 2025. Accessed August 10, 2026. https://www.fda.gov/vaccines-blood-biologics/industry-biologics/covid-19-vaccines-2025-2026-formula-use-united-states-beginning-fall-2025  Niazi SK. RNA therapeutics: a healthcare paradigm shift. Biomedicines. 2023;11(5):1275. doi:10.3390/biomedicines11051275 Understanding COVID-19 mRNA vaccines. National Human Genome Research Institute Fact Sheet. National Institutes of Health. Updated August 30, 2021. Accessed August 10, 2026. https://www.genome.gov/about-genomics/fact-sheets/Understanding-COVID-19-mRNA-Vaccines Study to describe the safety, tolerability, immunogenicity, and efficacy of RNA vaccine candidates against COVID-19 in healthy individuals. ClinicalTrials.gov identifier: NCT04368728. Updated February 28, 2023. Accessed August 10, 2026. https://clinicaltrials.gov/study/NCT04368728 Bajema KL, Wiegand RE, Cuffe K, et al. Estimated SARS-CoV-2 seroprevalence in the US as of September 2020. JAMA Intern Med. 2021;181(4):450-460. doi:10.1001/jamainternmed.2020.7976Pooley N, Abdool Karim SS, Combadière B, et al. Durability of vaccine-induced and natural immunity against COVID-19: a narrative review. Infect Dis Ther. 2023;12(2):367-387. doi:10.1007/s40121-022-00753-2Zambrano LD, Newhams MM, Simeone RM, et al. Durability of original monovalent mRNA vaccine effectiveness against COVID-19 Omicron–associated hospitalization in children and adolescents — United States, 2021–2023. MMWR Morb Mortal Wkly Rep. 2024;73:330-338. doi:10.15585/mmwr.mm7315a2CDC museum COVID-19 timeline. Centers for Disease Control and Prevention. Update July 8, 2024. Accessed August 10, 2026. https://www.cdc.gov/museum/timeline/covid19.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

Pfizer for Professionals 1-800-505-4426

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.

© 2026 Pfizer Inc. All rights reserved.

PP-CMR-USA-0603
You are now leaving PfizerPro

You are now leaving a Pfizer-operated website. Links to all outside sites are provided as a resource to our visitors. Pfizer accepts no responsibility for the content of sites that are not owned and operated by Pfizer.

PP-MCL-USA-0367

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.