{"id":"FED-185","kind":"order","level":"federal","jurisdiction":"United States","state":"","metro":"","industry":"","agency":"","eco":"","issuer":"Food and Drug Administration, HHS (Center for Biologics Evaluation and Research)","authority":"FD\u0026C Act § 564; HHS declaration of Mar. 27, 2020 (FED-184)","instrument":"Emergency Use Authorization letter: Pfizer-BioNTech COVID-19 Vaccine (Dec. 11, 2020; reissued and amended thereafter)","title":"Letter of Authorization, Pfizer-BioNTech COVID-19 Vaccine","dateIssued":"2020-12-11","effective":"2020-12-11","end":"superseded by BLA approval (Comirnaty) Aug. 23, 2021 for ages 16+; EUA continued for other uses","startDate":"2020-12-11","endDate":"2021-08-23","quarters":["2020Q4","2021Q1","2021Q2","2021Q3"],"types":["HC","OTHER"],"addressees":["Pfizer Inc.; vaccination providers"],"clause":"Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of Pfizer-BioNTech COVID19 Vaccine for the prevention of COVID-19, as described in the Scope of Authorization section of this letter (Section II) and subject to the terms of this authorization.","enforcement":"Conditions of authorization","functions":["context: vaccine availability dates behind the 2021 reopening and vaccination-proof orders (Dec. 11, 2020 first EUA; general adult eligibility in most States by April 19, 2021)"],"notes":"CONTEXT ONLY (facts and circumstances). The live FDA letter is the latest reissued version, which recites the December 11, 2020 original authorization.","sourceUrl":"https://www.fda.gov/media/144412/download","snapshot":"","fileExists":true,"fileBytes":221977,"grade":"primary","character":"","description":"","collection":"FED-A","url":"/library/FED-185","exhibitUrl":"/exhibit/FED-185","citation":"Food and Drug Administration, HHS (Center for Biologics Evaluation and Research), Emergency Use Authorization letter: Pfizer-BioNTech COVID-19 Vaccine (Dec. 11, 2020; reissued and amended thereafter) (Ex. FED-185)","stateName":"","related":[]}