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Pfizer-BioNTech COVID-19 Vaccine Medical Data

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Welcome to the Pfizer-BioNTech Vaccines Medical Data website. New medical content will be added on a rolling basis.

  • Vaccine & COVID-19 related Topics
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  • Clinical Trials
  •  Vaccine Efficacy
  •  Vaccine Safety
  • Real World Evidence
  •  Vaccine Effectiveness
  •   Omicron
  •   Boosters
  •   Pediatrics
  •   Special Populations
  •  Vaccine Safety
  •   Myo/pericarditis

Emergency uses of the Pfizer-BioNTech COVID-19 Vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 6 months of age and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

Welcome to Pfizer-BioNTech COVID-19 Vaccines Medical Data

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Emergency uses of the Pfizer-BioNTech COVID-19 Vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 6 months of age and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

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Pfizer-BioNTech COVID-19 Vaccine Medical Data

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Prescribing Information and Fact Sheets

EUA Fact sheet for Vaccination Providers ( 12 years & Up), BIVALENT (Original and Omicron BA.4/BA.5), DO NOT DILUTE, Gray Cap

EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), BIVALENT (Original and Omicron BA.4/BA.5), DILUTE BEFORE USE, Orange Cap.

Full Prescribing Information (12 years of age and older), DO NOT DILUTE BEFORE USE, Gray Cap

EUA Fact Sheet for Vaccination providers (12 years of age and older), DO NOT DILUTE, Gray Cap.

EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap

EUA Fact Sheet for Vaccination Providers (6 months through 4 years of age), DILUTE BEFORE USE, Maroon Cap

Prescribing Information and Fact Sheets

EUA Fact sheet for Vaccination Providers ( 12 years & Up), BIVALENT (Original and Omicron BA.4/BA.5), DO NOT DILUTE, Gray Cap

EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), BIVALENT (Original and Omicron BA.4/BA.5), DILUTE BEFORE USE, Orange Cap.

Full Prescribing Information (12 years of age and older), DO NOT DILUTE BEFORE USE, Gray Cap

EUA Fact Sheet for Vaccination providers (12 years of age and older), DO NOT DILUTE, Gray Cap.

EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap

EUA Fact Sheet for Vaccination Providers (6 months through 4 years of age), DILUTE BEFORE USE, Maroon Cap

Prescribing Information and Fact Sheets

EUA Fact sheet for Vaccination Providers ( 12 years & Up), BIVALENT (Original and Omicron BA.4/BA.5), DO NOT DILUTE, Gray Cap

EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), BIVALENT (Original and Omicron BA.4/BA.5), DILUTE BEFORE USE, Orange Cap.

Full Prescribing Information (12 years of age and older), DO NOT DILUTE BEFORE USE, Gray Cap

EUA Fact Sheet for Vaccination providers (12 years of age and older), DO NOT DILUTE, Gray Cap.

EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap

EUA Fact Sheet for Vaccination Providers (6 months through 4 years of age), DILUTE BEFORE USE, Maroon Cap

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Links to external websites are provided as a resource to the viewer. These external websites are neither owned, endorsed, nor controlled by Pfizer Inc.
Pfizer accepts no responsibility for the content or services of a linked site. Any opinions, claims, or comments expressed on external sites should not be attributed to Pfizer.
You are now leaving the Pfizer-BioNTech Medical Data website.
Links to external websites are provided as a resource to the viewer. These external websites are neither owned, endorsed, nor controlled by Pfizer Inc.
Pfizer accepts no responsibility for the content or services of a linked site. Any opinions, claims, or comments expressed on external sites should not be attributed to Pfizer.