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Emergency uses of the vaccines have not been approved or licensed by the U.S. Food and Drug Administration (FDA), but have been authorized by the FDA, under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 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.
The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is a vaccine for use in individuals 6 months of age and older to prevent COVID-19. The FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent under an EUA.
The Pfizer-BioNTech COVID-19 Vaccine, Bivalent encodes the spike protein of the Original SARSCoV2 and the Omicron BA.4/BA.5 SARS-CoV-2.
Comirnaty [monovalent], Pfizer-BioNTech COVID-19 Vaccine [monovalent], or Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original/Omicron BA.4/BA.5)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
COVID-19 Vaccines (Pfizer/BioNTech) Quick Finder
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Contact Pfizer Medical Information to speak with a professional regarding your medical question on a Pfizer prescription product: (800) 438-1985
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
(800)-332-1088.