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The U.S. Food and Drug Administration (FDA) has authorized the emergency use of the investigational product Pfizer-BioNTech COVID-19 Vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) in individuals 16 years of age and older. The vaccine has not been approved, but is authorized under an Emergency Use Authorization only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the vaccine under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Pfizer-BioNTech COVID-19 Vaccine
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Pfizer-BioNTech COVID-19 Vaccine Quick Finder
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To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:
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You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or www.fda.gov/MedWatch