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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
Real-World Evidence

RCTs and RWE Analyses

Study Design

Effectiveness Data

Additional RWE Information

Tab Number 5

Select Real-World Analysis of Vaccine Effectiveness Associated with COMIRNATY
RCTs: Gold Standard
RCTs | Interventional studies
  • Gold standard for evaluating efficacy and safety of new drug treatments according to the FDA1,2
  • Designed to eliminate systematic biases when comparing drug treatments1
RCTs | Limitations
  • Due to highly specific inclusion and exclusion criteria, RCT results may not be generalizable to the broader patient population in clinical practice2
  • May not be able to address questions that require large patient populations or when ethical or time constraints exist1,2
RWE: May Complement RCT Findings
RWE | Observational, non-interventional
  • May use data from routine clinical practice3
  • RWE is clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of real-world data. Real-world data are data related to patient health status and/or delivery of health care3,4
  • May include a broader, more heterogeneous patient population and, therefore, may be more generalizable1,3,5,6
RWE | Limitations
  • Unable to determine causality3,6
  • Biases related to treatment selection and unobserved variables cannot be fully addressed1,3
  • Other limitations include limited internal validity, potential data quality, and/or methodology issues1,3,5,6
Review results from the pivotal trial (Study 2) for COMIRNATY
 Pivotal Trial Results LoadingObservational RWE analyses are not intended for direct comparison with clinical trials and may introduce bias.3,5Potential Limitations of RWE Studies in Vaccine Effectiveness8,9

Overall, limitations of an RWE analysis provide important contextual information and highlight the need for cautious interpretation of findings, as limitations may affect the reliability and generalizability of vaccine effectiveness estimates. VE findings should be interpreted as the added benefit provided by COVID-19 vaccination in a population with a high prevalence of vaccine- and infection-induced immunity at the start of the 2023-2024 respiratory virus season.

This study has several limitations that healthcare professionals should consider in evaluating results to potentially complement RCT data:

  • The primary analysis included the use of healthcare encounter data from a single healthcare system.  Reliance on data from one healthcare system may limit external validity due to potential biases or lack of heterogeneity of study populations
  • Residual Confounding from Test Negative Design: Differences in exposure risk and disease severity between vaccinated and unvaccinated individuals may not have been fully accounted for, potentially impacting the study's conclusions on vaccine effectiveness
  • Short Follow-Up Period: The median follow-up after receiving a 2023-2024 Formula COMIRNATY vaccination was 58 days, which may not capture long-term vaccine effectiveness or associated durability of protection
  • Potential misclassification of a patient hospitalized with a positive SARS-CoV-2 test as being hospitalized for severe COVID-19 when SARS-CoV-2 infection was incidental to but not the reason for hospitalization. Inclusion of patients hospitalized for other reasons can result in underestimation of VE
  • Missing genotype information and potential for misclassification of SARS-CoV-2 sublineages: Lack of complete genotype data or misclassification can limit the ability to differentiate and assess the vaccine's effectiveness against specific SARS-CoV-2 sublineages
  • Information on Prior Infection: Misclassification of previous infections, particularly unreported or undocumented cases due to at-home testing or decreases in testing rates, potentially affecting the reliability of study results. Limited data on prior infections and high rates of prior SARS-CoV-2 infection may confound vaccine effectiveness estimates
  • COMIRNATY Uptake: Low vaccination rates with COMIRNATY among participants, or vaccination rates with significant differences between groups (eg, elderly or individuals with comorbidities), may impact results, potentially impacting generalizability and resulting in underestimation of vaccine effectiveness
  • Misclassification of Vaccination Status: There is a risk of errors in documenting previous COVID-19 vaccination status, which could affect study results

Note: Vaccine effectiveness will naturally wane over time and may also be impacted by the emergence of new variants.10

VE should be interpreted as the added benefit of 2023–2024 COVID-19 vaccination in a population with high levels of infection-induced immunity, vaccine-induced immunity, or both.11,12

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SARS-CoV-2=severe acute respiratory syndrome coronavirus 2.

Study Design: 2023-2024 Formula Real-World EvidenceNotes
  • “Estimated effectiveness of the BNT162b2 XBB vaccine against COVID-19” by Tartof et al was a test-negative, case-control study that evaluated estimates of the COMIRNATY 2023-2024 Formula against COVID-19–associated hospital admissions and ED or UC encounters8
  • This test-negative, case-control vaccine effectiveness (VE) analysis assessed the VE against XBB and JN.1 sublineages of COVID-19 during the 2023-2024 season8,9
  • Cases included those presenting with an acute respiratory illness who had a positive SARS-CoV-2 PCR test; while controls had an acute respiratory illness but tested negative for SARS-CoV-2 (and had no encounters, in any setting, with a positive SARS-CoV-2 test in the prior 90 days)8,9
  • Hospitalization is a widely recognized measure of severe COVID-19. The limitations of this measure as a marker of severe disease include the challenge in distinguishing hospitalizations due to COVID-19 from hospitalizations in which SARS-CoV-2 infection is incidentally identified, which can lead to differences in vaccine effectiveness estimates generated across various platforms7
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PCR=polymerase chain reaction; RCT=randomized controlled trial; RWE=real-world evidence; SARS-CoV-2=severe acute respiratory syndrome coronavirus 2.

Effectiveness Data: 2023‑2024 Formula RWE

Observed estimated vaccine effectiveness (VE)

Primary outcome

Note: Due to high rates of prior infection, VE estimates are evaluated as an incremental or relative benefit beyond what individuals may have from prior infection(s), vaccination(s), or both (hybrid immunity).14


*Those who did not receive an XBB.1.5–adapted vaccine included participants who received wild-type boosters, variant-adapted vaccines (eg, BA.1 or BA.4/5 bivalent vaccines), or unvaccinated individuals.8

NOTE: Vaccine effectiveness will naturally wane over time and may also be impacted by the emergence of new variants.10< Back Study DesignLoading
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RCT=randomized controlled trial; RWE=real-world evidence.

Additional RWE InformationThis select real-world analysis of 2023-2024 Formula of COMIRNATY included the following publications8,9:The interim analysis

was published in JAMA Internal Medicine and covered the time period from October 10, 2023, through December 10, 2023.8

[Tartof 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.2024.1640]

The full analysis

was published in Open Forum Infectious Diseases and covered the time period from October 10, 2023, through February 29, 2024.9

[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/ofae370]

Note: Numerous studies and analyses have been conducted to evaluate the effectiveness of COVID-19 vaccines, yielding varying results across different populations, settings, and study designs. These variations may be attributed to differences in factors such as the timing of vaccine administration, the emergence of new viral variants, and demographic characteristics of study participants. Healthcare professionals should consider the context and specific conditions of individual studies when interpreting vaccine effectiveness data.7,8,15,16

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JAMA=Journal of the American Medical Association; RCT=randomized controlled trial; RWE=real-world evidence.

Real-World EvidenceReferences:Designing sound clinical trials that incorporate real-world data. Food and Drug Administration. Updated August 19, 2022. Accessed June 13, 2025. https://www.fda.gov/drugs/regulatory-science-action/designing-sound-clinical-trials-incorporate-real-world-dataZabor EC, Kaizer AM, Hobbs BP. Randomized controlled trials. Chest. 2020;158(1S):S79-S87. doi:10.1016/j.chest.2020.03.013Klonoff DC. The expanding role of real-world evidence trials in health care decision making. J Diabetes Sci Technol. 2020;14(1):174-179. doi:10.1177/1932296819832653Considerations for the use of real-world data and real-world evidence to support regulatory decision-making for drug and biological products: guidance for industry. Food and Drug Administration. Updated August 30, 2023. Accessed June 13, 2025. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-real-world-data-and-real-world-evidence-support-regulatory-decision-making-drugKim HS, Lee S, Kim JH. Real-world evidence versus randomized controlled trial: clinical research based on electronic medical records. J Korean Med Sci. 2018;33(34):e213. doi:10.3346/jkms.2018.33.e213Kim HS, Kim JH. Proceed with caution when using real world data and real world evidence. J Korean Med Sci. 2019;34(4):e28. doi:10.3346/jkms.2019.34.e28Vaccine effectiveness studies. Centers for Disease Control and Prevention. Updated July 12, 2024. Accessed June 13, 2025. https://www.cdc.gov/covid/php/surveillance/vaccine-effectiveness-studies.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/ofae370Pooley 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/s40121-022-00753-2Link-Gelles R. Effectiveness of COVID-19 (2023-2024 Formula) vaccines. National Center for Immunization and Respiratory Diseases. Published June 27, 2024. Accessed June 13, 2025. https://www.fda.gov/media/179140/downloadLink-Gelles R. Effectiveness of COVID-19 vaccines. National Center for Immunization and Respiratory Diseases. Published October 23, 2024. Accessed March 8, 2025. https://www.cdc.gov/acip/downloads/slides-2024-10-23-24/04-COVID-Link-Gelles-508.pdfCOMIRNATY® (COVID-19 Vaccine, mRNA). Prescribing Information. BioNTech Manufacturing GmbH and Pfizer Inc.; June 25, 2025. Link-Gelles R, Britton A, Fleming-Dutra KE; CDC COVID-19 Vaccine Effectiveness Team. Building the U.S. COVID-19 vaccine effectiveness program: past successes and future directions. Vaccine. 2024;42 Suppl 3(Suppl 3):125492. doi:10.1016/j.vaccine.2023.12.002Agampodi S, Tadesse BT, Sahastrabuddhe S, Excler JL, Kim JH. Biases in COVID-19 vaccine effectiveness studies using cohort design. Front Med (Lausanne). 2024;11:1474045. doi:10.3389/fmed.2024.1474045Young M, Crook H, Scott J, Edison P. Covid-19: virology, variants, and vaccines. BMJ Med. 2022;1(1):e000040. doi:10.1136/bmjmed-2021-000040

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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.