{"id":"FED-187","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: Janssen COVID-19 Vaccine (Feb. 27, 2021; reissued thereafter; revoked June 1, 2023)","title":"Letter of Authorization, Janssen COVID-19 Vaccine","dateIssued":"2021-02-27","effective":"2021-02-27","end":"revoked June 1, 2023 (not verified here)","startDate":"2021-02-27","endDate":"2023-06-01","quarters":["2021Q1","2021Q2","2021Q3"],"types":["HC","OTHER"],"addressees":["Janssen Biotech, Inc.; vaccination providers"],"clause":"For the February 27, 2021 authorization for individuals 18 years of age and older, FDA reviewed safety and efficacy data from an ongoing phase 3 trial which enrolled 43,783 participants... 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 the Janssen COVID19 Vaccine for the prevention of COVID-19","enforcement":"Conditions of authorization","functions":["context (the April 13-23, 2021 federal pause of the Janssen vaccine is a fact and circumstance of 2021Q2; not verified here)"],"notes":"CONTEXT ONLY.","sourceUrl":"https://www.fda.gov/media/146303/download","snapshot":"","fileExists":true,"fileBytes":1088949,"grade":"primary","character":"","description":"","collection":"FED-A","url":"/library/FED-187","exhibitUrl":"/exhibit/FED-187","citation":"Food and Drug Administration, HHS, Emergency Use Authorization letter: Janssen COVID-19 Vaccine (Feb. 27, 2021; reissued thereafter; revoked June 1, 2023) (Ex. FED-187)","stateName":"","related":["FED-186"]}