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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
About COMIRNATY®

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 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, double-blind, efficacy (Phase 2/3) study in a diverse population of approximately 46,000 people 12 years of age or older, of whom approximately 22,000 received COMIRNATY 
Multiple real-world studies on different formulas of COMIRNATY have been published and are generally supportive of the effectiveness of COMIRNATY against COVID-19 and severe disease5,6The results from one real-world study associated with the 2023-2024 Formula of COMIRNATY are presented in Real-World Evidence. < Back Impact of COVID-19 Loading
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 mRNA Technology LoadingmRNA=messenger ribonucleic acid.
mRNA Technology

Supporting the development of COMIRNATY (COVID-19 Vaccine, mRNA)

COMIRNATY: The first FDA-approved, mRNA-based COVID-19 vaccine2

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 1990s3,4,7,8

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-198

Updating the formula of COVID-19 vaccines to more closely match predominant circulating strain(s) of SARS-CoV-2 can help restore protection that may have decreased since previous COVID-19 infection or vaccination5,9,10

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 virus4,11

1. COMIRNATY contains a spike protein mRNA segment surrounded by a protective lipid coat for delivery. After vaccination, the mRNA enters the cells.4,11

2. mRNA provides the cell instructions to build copies of spike proteins found on the surface of the virus that causes COVID-19.4,11

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.4,11

Note: These graphical representations are intended for illustrative purposes only.4,11 < Back Introduction Loading
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 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 (COVID-19 Vaccine, mRNA)

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 vaccines1
  • The safety and immunogenicity data of previous formulas of COMIRNATY are pertinent to the 2024-2025 Formula 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 fainting. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to COMIRNATY1
To see Important Safety Information, expand tray below. More information

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

Prescribing Information Loading < Back mRNA Technology Loading
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 Pivotal Trial LoadingmRNA=messenger ribonucleic acid.
Example
Pivotal Trial Data (Study 2)

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

Note: Data from clinical studies were added to the full Prescribing Information in 2023 to support use of a single dose of COMIRNATY in individuals ≥12 years of age.1
See dosage and administration for COMIRNATY
 Dosage & Administration Loading Dosage & Administration Loading
Over 46,000 participants

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-2.1,13At 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 at least 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 participants 16 years of age and olderPrimary efficacy endpoint: First COVID-19 occurrence from 7 days after dose 2 in participants 16 years of age and older1Title91.1% vaccine efficacy (95% CI: 88.8, 93.1) among 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 of age
    94.5% vaccine efficacy
    (95% CI: 88.3, 97.8)
    (COMIRNATY, n=4,192)1
Title90.9% vaccine efficacy (95% CI: 88.5, 92.8) among participants with or without evidence of prior SARS-CoV-2 infection (COMIRNATY, n=20,533)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.10Vaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original).1Secondary efficacy endpoint: First severe COVID-19 occurrence from 7 days ​after dose 2 in participants 16 years of age 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)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)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.10Defined 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.1NOTES
  • The vaccine efficacy was observed during a period of time before the Omicron variant was the predominant strain of SARS-CoV-21,14
  • ​​​​​​​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
  • Vaccine effectiveness will naturally wane over time and may be impacted by the emergence of new or different variants10
  • Confirmed cases were determined by reverse transcription polymerase chain reaction (RT-PCR) 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
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 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 2-dose series, 3 weeks apart (referred to as a primary series) and subsequent doses referred to as booster doses1
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COMIRNATY encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original).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), authorized as Pfizer-BioNTech COVID-19 Vaccine, Bivalent.1Influenza Vaccine (Afluria Quadrivalent).1The safety of a 2-dose primary series of the original monovalent COMIRNATY was evaluated in Study 21An overview of most commonly reported adverse reactions (≥8 and ≥10) following any dose in participants receiving a 2-dose primary series of COMIRNATY1Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.1
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This safety data is pertinent to 2024-2025 Formula of COMIRNATY because these vaccines are manufactured using a similar process.1Most commonly reported adverse reactions ≥8%.1Most commonly reported adverse reactions ≥10%.1 < Back Pivotal Trial Loading
Up next >
 Real-World Evidence LoadingmRNA=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 Real-World Evidence LoadingReferences:COMIRNATY® (COVID-19 Vaccine, mRNA). Prescribing Information. BioNTech Manufacturing GmbH and Pfizer Inc.; June 25, 2025.FDA approves first COVID-19 vaccine. FDA news release. US Food and Drug Administration. Published August 23, 2021. Accessed March 8, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccineQin 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 March 8, 2025. https://www.cdc.gov/covid/vaccines/how-they-work.htmlTartof SY, Slezak JM, Frankland TB, et al. Estimated effectiveness of the BNT162b2 XBB vaccine against COVID-19. JAMA Intern Med. 2024;184(8):932-940. doi:10.1001/jamainternmed.2024.1640Tartof 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/ofae3702020 COVID-19 and related vaccine development and research. History of COVID-19: outbreaks and vaccine timeline. Mayo Clinic. Accessed April 4, 2025. 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.2022.844039Niazi SK. RNA therapeutics: a healthcare paradigm shift. Biomedicines. 2023;11(5):1275. doi:10.3390/biomedicines11051275Pooley 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/s40121-022-00753-2Understanding COVID-19 mRNA vaccines. National Human Genome Research Institute Fact Sheet. National Institutes of Health. Updated August 30, 2021. Accessed March 8, 2025. https://www.genome.gov/about-genomics/fact-sheets/Understanding-COVID-19-mRNA-VaccinesStudy 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 March 8, 2025. https://clinicaltrials.gov/study/NCT04368728Bajema 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.2020.7976Zambrano 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.mm7315a2

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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.