{"id":"FED-186","kind":"order","level":"federal","jurisdiction":"United States","state":"","metro":"","industry":"","agency":"","eco":"","issuer":"Food and Drug Administration, HHS","authority":"FD\u0026C Act § 564","instrument":"Emergency Use Authorization letter: Moderna COVID-19 Vaccine (Dec. 18, 2020; reissued thereafter)","title":"Letter of Authorization, Moderna COVID-19 Vaccine","dateIssued":"2020-12-18","effective":"2020-12-18","end":"BLA approval (Spikevax) Jan. 31, 2022; EUA continued for other formulations","startDate":"2020-12-18","endDate":"2022-01-31","quarters":["2020Q4","2021Q1","2021Q2","2021Q3"],"types":["HC","OTHER"],"addressees":["ModernaTX, 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 Moderna COVID19 Vaccine... for the prevention of COVID-19, as described in the Scope of Authorization section (Section II) and subject to the terms of this authorization.","enforcement":"Conditions of authorization","functions":["context"],"notes":"CONTEXT ONLY. The live FDA letter is the 2024-2025 reissuance (it names the 2023-2024 and 2024-2025 formulas); the December 18, 2020 original date is recited in its history.","sourceUrl":"https://www.fda.gov/media/144636/download","snapshot":"","fileExists":true,"fileBytes":466592,"grade":"primary","character":"","description":"","collection":"FED-A","url":"/library/FED-186","exhibitUrl":"/exhibit/FED-186","citation":"Food and Drug Administration, HHS, Emergency Use Authorization letter: Moderna COVID-19 Vaccine (Dec. 18, 2020; reissued thereafter) (Ex. FED-186)","stateName":"","related":["FED-187"]}