EUA Fact Sheets for Vaccination Providers

FACT SHEETS FOR
VACCINATION
PROVIDERS

Updated FDA Fact Sheet (12 & Older)
EFFECTIVE: 08/31/2022

Updated FDA Fact Sheet

(12 & Older)

EFFECTIVE: 08/31/2022

The FDA has granted Emergency Use Authorization for Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), as a single booster dose for eligible people 12 years of age and older.

It is now available as a single booster dose administered at least 2 months after:

  • Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine; or
  • Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine

The vaccine may not protect everyone.

Monovalent refers to any authorized or approved COVID-19 vaccine that contains or encodes the spike protein of only the original SARS-CoV-2.


Emergency Use Authorization

Emergency uses of Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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 aged 12 years 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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REPORT VACCINE SIDE EFFECTS

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Report an adverse event to the FDA/CDC Vaccine Adverse
Event Reporting System (VAERS).

Report to VAERS*
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Report an adverse event to
Pfizer Inc.

Report to Pfizer

Report an adverse event to the FDA/CDC Vaccine Adverse Event Reporting System (VAERS).

Report to VAERS*

Report an adverse event to
Pfizer Inc.

Report to Pfizer
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VACCINE AUTHENTICITY:

WHAT YOU NEED TO KNOW

WHAT YOU NEED
TO KNOW

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Around the world, Pfizer and BioNTech are working in partnership with government agencies to safely and efficiently distribute the vaccine. There are currently no legitimate COVID-19 vaccines produced by any manufacturer that are available for purchase by individuals.


We urge everyone to be wary of any offers for COVID-19 vaccinations that do not come from an authorized source—meaning, from anyone other than a healthcare provider or local government health agency.

The vaccine:

  • Is NOT sold online. Any sales of COVID-19 vaccines over the Internet, including from online pharmacies, are not legitimate
  • Cannot be purchased in individual doses
  • Is not taken by mouth and is not available in a capsule or tablet form
  • Can only be administered by licensed healthcare professionals at government-authorized vaccination centers—such as doctors’ offices, authorized pharmacies, outpatient clinics, community vaccination locations, and hospitals
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FOR MORE INFORMATION

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Call your healthcare provider with any additional questions.

General Product Inquiries

Call 1-877-829-2619

Medical Information

Visit PfizerMedicalInformation.com or call 1-800-438-1985

*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.