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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
Impact of COVID-19The information below is intended solely to help educate healthcare providers about COVID-19. It is not a statement of vaccine efficacy or effectiveness. Example Text

Burden of Disease

COVID-19 & Flu Impact

Risk Factors

Tab Number 4

Tab Number 5

The information below is intended solely to help educate healthcare providers about COVID-19. It is not a statement of vaccine efficacy or effectiveness.
Example TextUncovering the Burden of DiseaseKeeping eligible people up to date with COVID-19 vaccination is important to help protect against
COVID-19 and potential severe outcomes1-3*The United States Centers for Disease Control and Prevention (CDC) defines severe outcomes of COVID-19 as hospitalization, admission to the intensive care unit (ICU), intubation or mechanical ventilation, or death.4COVID-19 continues to cause severe outcomes in some people2,5 Note: The United States Centers for Disease Control and Prevention (CDC) defines severe outcomes of COVID-19 as hospitalization, admission to the intensive care unit (ICU), intubation or mechanical ventilation, or death.4 The National Center for Health Statistics uses data from death certificates to produce provisional COVID-19 death counts for the 50 states and Washington, DC, based on ICD-10 code U07.1 (including confirmed and probable cases). Provisional counts may differ from other sources and typically lag 1 to 2 weeks behind due to the time required to complete death certificates and delays in testing or state reporting. Provisional data may be incomplete and subject to revision, and should not be compared across states due to differing reporting practices.6 For more detailed technical information about provisional death counts, please visit https://www.cdc.gov/nchs/nvss/vsrr/covid19/tech_notes.htmThe National Center for Health Statistics uses data from death certificates to produce provisional COVID-19 death counts for the 50 states and Washington, DC, based on ICD-10 code U07.1 (including confirmed and probable cases). Provisional counts may differ from other sources and typically lag 1 to 2 weeks behind due to the time required to complete death certificates and delays in testing or state reporting. Provisional data may be incomplete and subject to revision, and should not be compared across states due to differing reporting practices.6 For more detailed technical information about provisional death counts, please visit https://www.cdc.gov/nchs/nvss/vsrr/
covid19/tech_notes.htm < Back Home Page Loading
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 COVID-19 & Flu Impact LoadingICD=International Classification of Diseases.
TitleExample Text
The information below is intended solely to help educate healthcare providers about COVID-19. It is not a statement of vaccine efficacy or effectiveness. 
The information below is intended solely to help educate healthcare providers about COVID-19. It is not a statement of vaccine efficacy or effectiveness. 
Example TextCOVID-19 & Flu ImpactCOVID-19 & Flu |  2023-2024

COVID-19–associated hospitalizations continue to be a year-round risk2,7

RESP-NET rates of weekly
COVID-19–associated or flu-associated hospitalizations in the US

Laboratory-confirmed hospitalizations associated with COVID-19 or influenza in adults from October 1, 2023, to September 28, 2024 (per 100,000 people)2,7

2023-2024

 NOTES
  • RESP-NET also reports other pathogens not represented here2,7
  • Source: Respiratory Virus Hospitalization Surveillance Network (RESP-NET)7
  • Additional information available at: https://www.cdc.gov/resp-net/dashboard/index.html
  • Data are collected for all ages through a network of acute care hospitals in select counties or county equivalents in 13 states for COVID-19 surveillance and 14 states for influenza surveillance. COVID-NET covers more than 34 million people and includes an estimated 10% of the US population. The COVID-19 surveillance area is generally similar to the US population by demographics, however, COVID-NET data might not be generalizable to the entire country2,7
  • Data are preliminary and subject to change as more data become available. In particular, case counts and rates for recent hospital admissions are subject to lag. Data may be affected by potential reporting delays; caution should be taken when interpreting these data2,7
  • Incidence rates of respiratory virus-associated hospitalizations (per 100,000) are calculated using the US Census vintage 2023 unbridged-race postcensal population estimates for the counties or county equivalents included in the surveillance area2,7
  • These rates are likely to be underestimated as some RESP-NET–associated hospitalizations might be missed because of undertesting, differing provider or facility testing practices, and diagnostic test sensitivity. Rates presented do not adjust for testing practices, which may differ by pathogen, age, race and ethnicity, and other demographic criteria2,7
  • Surveillance for COVID-19– and influenza-associated hospitalizations is typically conducted between October 1 and April 30, but recent years have seen COVID-NET and FluSurv-NET conduct surveillance past April 30 due to observed pathogen-specific trends in activity. As per RESP-NET, the surveillance season for COVID-19 is extended through September 30, 2024, while the influenza surveillance season is extended to "present." The data shown in the graph reflect information through September 28, 20242,7
COVID-19 & Flu |  2024-2025

COVID-19–associated
hospitalizations continue to be a year-round risk2,7

RESP-NET rates of weekly COVID-19–associated
or flu-associated hospitalizations in the US

Laboratory-confirmed hospitalizations associated with COVID-19 or influenza in adults from October 1, 2024, to February 1, 2025 (per 100,000 people)2,7

2024-2025

 NOTES
  • RESP-NET also reports other pathogens not represented here2,7
  • Source: Respiratory Virus Hospitalization Surveillance Network (RESP-NET)7
  • Additional information available at: https://www.cdc.gov/resp-net/dashboard/index.html
  • Data are collected for all ages through a network of acute care hospitals in select counties or county equivalents in 13 states for COVID-19 surveillance and 14 states for influenza surveillance. COVID-NET covers more than 34 million people and includes an estimated 10% of the US population. The COVID-19 surveillance area is generally similar to the US population by demographics, however, COVID-NET data might not be generalizable to the entire country2,7
  • Data are preliminary and subject to change as more data become available. In particular, case counts and rates for recent hospital admissions are subject to lag. Data may be affected by potential reporting delays; caution should be taken when interpreting these data2,7
  • Incidence rates of respiratory virus-associated hospitalizations (per 100,000) are calculated using the US Census vintage 2023 unbridged-race postcensal population estimates for the counties or county equivalents included in the surveillance area2,7
  • These rates are likely to be underestimated as some RESP-NET–associated hospitalizations might be missed because of undertesting, differing provider or facility testing practices, and diagnostic test sensitivity. Rates presented do not adjust for testing practices, which may differ by pathogen, age, race and ethnicity, and other demographic criteria2,7
  • Surveillance for COVID-19– and influenza-associated hospitalizations is typically conducted between October 1 and April 30, but recent years have seen COVID-NET and FluSurv-NET conduct surveillance past April 30 due to observed pathogen-specific trends in activity. As per RESP-NET, the surveillance season for COVID-19 is extended through September 30, 2024, while the influenza surveillance season is extended to "present." The data shown in the graph reflect information through February 1, 20252,7
 CDC recommendations for COVID-19 vaccination include eligible adults, but the vaccination rate remains low1,8

Estimated vaccination rates for 2024-2025 formula 

COVID-19 vaccine and influenza vaccine
September 2024 to February 20258 | In adults 18 years of age and older8: 

Estimated vaccination rates for 2024-2025 formula COVID-19 vaccine and influenza vaccine
September 2024 to February 20258 | In adults 18 years of age and older8: 

  COVID-19  Influenza

COVID-19 Vaccination Rate

Influenza Vaccination Rate

 Source: National Immunization Survey-Adult COVID Module (NIS-ACM). These data are weekly estimates of COVID-19 vaccination coverage and intent for vaccination among adults and are calculated from the NIS-ACM.8
Despite high rates of infection in the fall and winter months, these two potentially serious respiratory illnesses have low vaccination rates1,8,9
COVID-19 vaccination coverage estimates presented represent uptake or intent for uptake of the 2024-2025 COVID-19 vaccine. Vaccination coverage estimates are based on all interviews through the current week and represent approximately the cumulative percent vaccinated by mid-week. Each week, estimates for prior weeks are recalculated using the additional interviews conducted that week, combined with all previous interviews. Estimates for vaccination intent are based on interviews conducted that week and are adjusted to the cumulative vaccination coverage estimate for that week.8

The NIS-ACM adult flu vaccination coverage estimates for prior season(s) are based on interviews conducted during each analysis period and can increase or decrease over time due to random sampling variation.8

According to the CDC, routine simultaneous administration* of all age-appropriate vaccines is recommended if there are no contraindications at the time of the visit.10†

 Special considerations apply to coadministration of orthopoxvirus vaccines. Refer to CDC clinical guidance for information.10Simultaneous administration is defined as administering more than 1 vaccine on the same clinic day, at different anatomic sites, and not combined in the same syringe.11 < Back
Burden of Disease
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UMCs & Risk Factors
LoadingCDC=Centers for Disease Control and Prevention; COVID-NET=Coronavirus Disease 2019 (COVID-19) Hospitalization Surveillance Network; FluSurv-NET=Influenza Hospitalization Surveillance Network.
The information below is intended solely to help educate healthcare providers about COVID-19. It is not a statement of vaccine efficacy or effectiveness. 
The information below is intended solely to help educate healthcare providers about COVID-19. It is not a statement of vaccine efficacy or effectiveness. 
Example TextSelect Underlying Medical Conditions and Risk Factors

According to the CDC, routine simultaneous administration* of all age-appropriate vaccines is recommended if there are no contraindications at the time of the visit.10†

The United States Centers for Disease Control and Prevention (CDC) defines severe outcomes of COVID-19 as hospitalization, admission to the intensive care unit (ICU), intubation or mechanical ventilation, or death.4 List is not a complete list or in order of risk.

To see a complete list of the factors that increase the risk of severe illness from COVID-19, click here.

 By clicking this link, you will be redirected to a website that is neither owned nor controlled by Pfizer. Pfizer is not responsible for the content or services of this site.
By clicking this link, you will be redirected to a website that is neither owned nor controlled by Pfizer. Pfizer is not responsible for the content or services of this site.
Example Text According to COVID-NET, a case is defined as laboratory-confirmed SARS-CoV-2 in a person residing in a COVID-NET surveillance area who tests positive within 14 days before or during hospitalization. COVID-NET covers 185 counties and county equivalents in 13 states nationwide. It includes an estimated 10% of the US population and is generally similar to the US population by demographics, though data might not be generalizable to the entire country. The COVID-NET surveillance season begins on Week 40 of the calendar year (on or around October 1) and continues through Week 39 of the following calendar year (on or around September 30). Surveillance for the 2023-2024 season began on October 1, 2023; additional data points are added as data are available.2 Additional information available at: https://www.cdc.gov/covid/php/covid-net/index.html The United States Centers for Disease Control and Prevention (CDC) defines severe outcomes of COVID-19 as hospitalization, admission to the intensive care unit (ICU), intubation or mechanical ventilation, or death.4According to COVID-NET, a case is defined as laboratory-confirmed SARS-CoV-2 in a person residing in a COVID-NET surveillance area who tests positive within 14 days before or during hospitalization. COVID-NET covers 185 counties and county equivalents in 13 states nationwide. It includes an estimated 10% of the US population and is generally similar to the US population by demographics, though data might not be generalizable to the entire country. The COVID-NET surveillance season begins on Week 40 of the calendar year (on or around October 1) and continues through Week 39 of the following calendar year (on or around September 30). Surveillance for the 2023-2024 season began on October 1, 2023; additional data points are added as data are available.2 Additional information available at: https://www.cdc.gov/covid/php/covid-net/index.html

Please refer to https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covid-net/purpose-methods.html for the most current information related to CDC data collection.

 By clicking this link, you will be redirected to a website that is neither owned nor controlled by Pfizer. Pfizer is not responsible for the content or services of this site.
By clicking this link, you will be redirected to a website that is neither owned nor controlled by Pfizer. Pfizer is not responsible for the content or services of this site.
Example Text < Back COVID-19 & Flu Impact Loading
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 About COMIRNATY LoadingCDC=Centers for Disease Control and Prevention; COPD=chronic obstructive pulmonary disease;
COVID-NET=Coronavirus Disease 2019 (COVID-19) Hospitalization Surveillance Network; SARS-CoV-2=severe acute respiratory syndrome coronavirus 2.
 References:Staying up to date with COVID-19 vaccines. Centers for Disease Control and Prevention. Updated June 6, 2025. Accessed June 18, 2025. https://www.cdc.gov/covid/vaccines/stay-up-to-date.htmlCOVID-NET interactive dashboard. Centers for Disease Control and Prevention. Accessed June 17, 2025. https://www.cdc.gov/covid/php/covid-net/index.htmlLong COVID basics. Centers for Disease Control and Prevention. Updated February 3, 2025. Accessed June 27, 2025. https://www.cdc.gov/covid/long-term-effects/index.htmlUnderlying conditions and the higher risk for severe COVID-19. Centers for Disease Control and Prevention. Updated February 6, 2025. Accessed February 11, 2025. https://www.cdc.gov/covid/hcp/clinical-care/underlying-conditions.htmlProvisional mortality statistics, through last week results. Deaths occurring through February 15, 2025, as of February 23, 2025. WONDER online database. Centers for Disease Control and Prevention. https://wonder.cdc.gov/mcd-icd10-provisional.htmlProvisional COVID-19 mortality surveillance. Centers for Disease Control and Prevention. Updated June 12, 2025. Accessed June 17, 2025. https://www.cdc.gov/nchs/nvss/vsrr/covid19/index.htmRespiratory virus hospitalization surveillance network (RESP-NET). Centers for Disease Control and Prevention. Updated February 28, 2025. Accessed June 17, 2025. https://www.cdc.gov/resp-net/dashboard/index.htmlVaccination trends. Centers for Disease Control and Prevention. Updated February 21, 2025. Accessed June 17, 2025. https://www.cdc.gov/respiratory-viruses/data/vaccination-trends.htmlGetting your immunizations for the 2024-2025 fall and winter virus season. Centers for Disease Control and Prevention. Updated September 27, 2024. Accessed June 17, 2025. https://www.cdc.gov/ncird/whats-new/getting-your-immunizations-for-the-2024-2025-fall-and-winter-virus-season.htmlInterim clinical considerations for use of COVID-19 vaccines in the United States. Centers for Disease Control and Prevention. Updated May 1, 2025. Accessed June 17, 2025. https://www.cdc.gov/covid/hcp/vaccine-considerations/index.htmlTiming and spacing of immunobiologics. Centers for Disease Control and Prevention. Updated July 24, 2024. Accessed June 17, 2025. https://www.cdc.gov/vaccines/hcp/imz-best-practices/timing-spacing-immunobiologics.htmlImpact of COVID-19 References:Staying up to date with COVID-19 vaccines. Centers for Disease Control and Prevention. Updated June 6, 2025. Accessed June 18, 2025. https://www.cdc.gov/covid/vaccines/stay-up-to-date.htmlCOVID-NET interactive dashboard. Centers for Disease Control and Prevention. Accessed June 17, 2025. https://www.cdc.gov/covid/php/covid-net/index.htmlLong COVID basics. Centers for Disease Control and Prevention. Updated February 3, 2025. Accessed June 27, 2025. https://www.cdc.gov/covid/long-term-effects/index.htmlUnderlying conditions and the higher risk for severe COVID-19. Centers for Disease Control and Prevention. Updated February 6, 2025. Accessed February 11, 2025. https://www.cdc.gov/covid/hcp/clinical-care/underlying-conditions.htmlProvisional mortality statistics, through last week results. Deaths occurring through February 15, 2025, as of February 23, 2025. WONDER online database. Centers for Disease Control and Prevention. https://wonder.cdc.gov/mcd-icd10-provisional.htmlProvisional COVID-19 mortality surveillance. Centers for Disease Control and Prevention. Updated June 12, 2025. Accessed June 17, 2025. https://www.cdc.gov/nchs/nvss/vsrr/covid19/index.htmRespiratory virus hospitalization surveillance network (RESP-NET). Centers for Disease Control and Prevention. Updated February 28, 2025. Accessed June 17, 2025. https://www.cdc.gov/resp-net/dashboard/index.htmlVaccination trends. Centers for Disease Control and Prevention. Updated February 21, 2025. Accessed June 17, 2025. https://www.cdc.gov/respiratory-viruses/data/vaccination-trends.htmlGetting your immunizations for the 2024-2025 fall and winter virus season. Centers for Disease Control and Prevention. Updated September 27, 2024. Accessed June 17, 2025. https://www.cdc.gov/ncird/whats-new/getting-your-immunizations-for-the-2024-2025-fall-and-winter-virus-season.htmlInterim clinical considerations for use of COVID-19 vaccines in the United States. Centers for Disease Control and Prevention. Updated May 1, 2025. Accessed June 17, 2025. https://www.cdc.gov/covid/hcp/vaccine-considerations/index.htmlTiming and spacing of immunobiologics. Centers for Disease Control and Prevention. Updated July 24, 2024. Accessed June 17, 2025. https://www.cdc.gov/vaccines/hcp/imz-best-practices/timing-spacing-immunobiologics.html

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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.