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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 AnalysesRWE Study Design: 2023-2024 Formula of COMIRNATY in Individuals 18 Years and Older2023-2024 Formula of COMIRNATY RWEAdditional RWE InformationDosing & AdministrationResourcesResourcesLinks & SupportHealth 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)
Impact of COVID-19
Burden of Disease
COVID-19 & Flu Impact
Risk Factors
Tab Number 4
Tab Number 5
Example 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.
Uncovering the Burden of DiseaseCOVID-19 continues to cause severe outcomes in some people1,2Note: 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.3 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). The 2019-2020 season began on March 1, 2020. Surveillance for the 2023-2024 season began on October 1, 2023; additional data points are added as data are available. Data is for the 2024-2025 respiratory season (which is still ongoing).6
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.7 For more detailed technical information about provisional death counts, please visit https://www.cdc.gov/nchs/nvss/vsrr/covid19/tech_notes.htm
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). The 2019-2020 season began on March 1, 2020. Surveillance for the 2023-2024 season began on October 1, 2023; additional data points are added as data are available. Data is for the 2024-2025 respiratory season (which is still ongoing).6
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.7 For more detailed technical information about provisional death counts, please visit 
https://www.cdc.gov/nchs/nvss/vsrr/covid19
/tech_notes.htm
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 COVID-19 & Flu Impact Loading
COVID-NET=Coronavirus Disease 2019 (COVID-19) Hospitalization Surveillance Network; ICD=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 |  2024-2025COVID-19–associated hospitalizations continue to be a year-round risk1,6
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 September 28, 2024, to June 30, 2025 (per 100,000 people)1,6

2024-2025

 NOTES
  • RESP-NET also reports other pathogens not represented here1,6
  • Source: Respiratory Virus Hospitalization Surveillance Network (RESP-NET)1
  • 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 country1,6
  • 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 data1,6
  • 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 area1,6
  • 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 criteria1,6
  • 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 June 30, 20251,6
  • Rates reflect previous CDC recommendations
COVID-19 & Flu |  2023-2024COVID-19–associated hospitalizations continue to be a year-round risk1,6

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)1,6
2023-2024 NOTES
  • RESP-NET also reports other pathogens not represented here1,6
  • Source: Respiratory Virus Hospitalization Surveillance Network (RESP-NET)1
  • 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 country1,6
  • 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 data1,6
  • 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 area1,6
  • 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 criteria1,6
  • 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, 20241,6
COVID-19 & Flu |  2024-2025Cumulative COVID-19 and flu hospitalization rates, by age1,6

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

Cumulative rates of respiratory virus–associated hospitalizations for ages 
65 to 74, from September 28, 2024, to June 30, 2025 (per 100,000 people)1,6

2024-2025

 Hospitalization rates due to COVID-19 or influenza (by age group)1
The vaccination rate for COVID-19 in individuals aged ≥65 years continues to be low8,9

Estimated vaccination rates for 2024-2025 formula
COVID-19 vaccine and influenza vaccine
September 2024 to April 20258,9 | In adults 65 years of age and older8,9:
 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.8,9
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. 
Example TextSelect Underlying Medical Conditions and Risk Factors 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.3List 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.
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.6 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.3According 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.6 Additional information available at: https://www.cdc.gov/covid/php/covid-net/index.html
Please refer to https://www.cdc.gov/covid/php/covid-net/index.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
Up next >
 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:RESP-NET interactive dashboard. Centers for Disease Control and Prevention. Accessed September 12, 2025. https://www.cdc.gov/resp-net/dashboard/index.htmlCDC COVID data tracker: trends in cases and deaths by race/ethnicity, age, and sex. Centers for Disease Control and Prevention. Accessed September 12, 2025. https://covid.cdc.gov/covid-data-tracker/#demographicsovertimeUnderlying conditions and the higher risk for severe COVID-19. Centers for Disease Control and Prevention. Updated February 6, 2025. Accessed September 12, 2025. https://www.cdc.gov/covid/hcp/clinical-care/underlying-conditions.htmlMonthly COVID-19 death rates per 100,000 population by age group, race and ethnicity, sex, and region with double stratification. Centers for Disease Control and Prevention. Updated July 21, 2025. Accessed September 12, 2025. https://data.cdc.gov/Public-Health-Surveillance/Monthly-COVID-19-Death-Rates-per-100-000-Populatio/exs3-hbne/about_data
CDC data tracker death data as of July 24, 2025. Centers for Disease Control and Prevention. Updated July 24, 2025. Accessed September 12, 2025. https://data.cdc.gov/Public-Health-Surveillance/Monthly-COVID-19-Death-Rates-per-100-000-Populatio/exs3-hbne/about_data
COVID-NET interactive dashboard. Centers for Disease Control and Prevention. Accessed September 12, 2025. https://www.cdc.gov/covid/php/covid-net/index.htmlProvisional COVID-19 mortality surveillance. Centers for Disease Control and Prevention. Updated June 12, 2025. Accessed September 12, 2025. https://www.cdc.gov/nchs/nvss/vsrr/covid19/index.htmCOVID-19 vaccination coverage and intent for vaccination, adults 19 years and older, United States. Centers for Disease Control and Prevention. Updated May 7, 2025. Accessed September 12, 2025. https://www.cdc.gov/covidvaxview/weekly-dashboard/adult-vaccination-coverage.htmlInfluenza vaccination coverage and intent for vaccination, adults 19 years and older, United States. Centers for Disease Control and Prevention. Updated May 7, 2025. Accessed September 12, 2025. https://www.cdc.gov/fluvaxview/dashboard/adult-coverage.htmlInterim clinical considerations for use of COVID-19 vaccines in the United States. Centers for Disease Control and Prevention. Updated May 1, 2025. Accessed September 12, 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 September 12, 2025. https://www.cdc.gov/vaccines/hcp/imz-best-practices/timing-spacing-immunobiologics.htmlStaying up to date with COVID-19 vaccines. Centers for Disease Control and Prevention. Updated June 6, 2025. Accessed September 12, 2025. https://www.cdc.gov/covid/vaccines/stay-up-to-date.htmlImpact of COVID-19 References:RESP-NET interactive dashboard. Centers for Disease Control and Prevention. Accessed September 12, 2025. https://www.cdc.gov/resp-net/dashboard/index.htmlCDC COVID data tracker: trends in cases and deaths by race/ethnicity, age, and sex. Centers for Disease Control and Prevention. Accessed September 12, 2025. https://covid.cdc.gov/covid-data-tracker/#demographicsovertimeUnderlying conditions and the higher risk for severe COVID-19. Centers for Disease Control and Prevention. Updated February 6, 2025. Accessed September 12, 2025. https://www.cdc.gov/covid/hcp/clinical-care/underlying-conditions.htmlMonthly COVID-19 death rates per 100,000 population by age group, race and ethnicity, sex, and region with double stratification. Centers for Disease Control and Prevention. Updated July 21, 2025. Accessed September 12, 2025. https://data.cdc.gov/Public-Health-Surveillance/Monthly-COVID-19-Death-Rates-per-100-000-Populatio/exs3-hbne/about_data
CDC data tracker death data as of July 24, 2025. Centers for Disease Control and Prevention. Updated July 24, 2025. Accessed September 12, 2025. https://data.cdc.gov/Public-Health-Surveillance/Monthly-COVID-19-Death-Rates-per-100-000-Populatio/exs3-hbne/about_data
COVID-NET interactive dashboard. Centers for Disease Control and Prevention. Accessed September 12, 2025. https://www.cdc.gov/covid/php/covid-net/index.htmlProvisional COVID-19 mortality surveillance. Centers for Disease Control and Prevention. Updated June 12, 2025. Accessed September 12, 2025. https://www.cdc.gov/nchs/nvss/vsrr/covid19/index.htmCOVID-19 vaccination coverage and intent for vaccination, adults 19 years and older, United States. Centers for Disease Control and Prevention. Updated May 7, 2025. Accessed September 12, 2025. https://www.cdc.gov/covidvaxview/weekly-dashboard/adult-vaccination-coverage.htmlInfluenza vaccination coverage and intent for vaccination, adults 19 years and older, United States. Centers for Disease Control and Prevention. Updated May 7, 2025. Accessed September 12, 2025. https://www.cdc.gov/fluvaxview/dashboard/adult-coverage.htmlInterim clinical considerations for use of COVID-19 vaccines in the United States. Centers for Disease Control and Prevention. Updated May 1, 2025. Accessed September 12, 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 September 12, 2025. https://www.cdc.gov/vaccines/hcp/imz-best-practices/timing-spacing-immunobiologics.htmlStaying up to date with COVID-19 vaccines. Centers for Disease Control and Prevention. Updated June 6, 2025. Accessed September 12, 2025. https://www.cdc.gov/covid/vaccines/stay-up-to-date.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).

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.