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Ex. FED-185 Order Primary source read

Emergency Use Authorization letter: Pfizer-BioNTech COVID-19 Vaccine (Dec. 11, 2020; reissued and amended thereafter)

Letter of Authorization, Pfizer-BioNTech COVID-19 Vaccine

Food and Drug Administration, HHS (Center for Biologics Evaluation and Research) · United States (Federal)

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The COVID Project

The record

Jurisdiction
United States
Level
Federal
Authority
FD&C Act § 564; HHS declaration of Mar. 27, 2020 (FED-184)
Issued
2020-12-11 Dec. 11, 2020
Effective
2020-12-11
End
superseded by BLA approval (Comirnaty) Aug. 23, 2021 for ages 16+; EUA continued for other uses (read as 2021-08-23)
In force
Dec. 11, 2020 to Aug. 23, 2021
Quarters
2020 Q42021 Q12021 Q22021 Q3
Limitation types
Health care ordersOther
Addressees
  • Pfizer Inc.; vaccination providers
Functions reached
  • 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)
Collection
Federal health, safety and transport layer FED-A

Operative words

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

Notes

CONTEXT ONLY (facts and circumstances). The live FDA letter is the latest reissued version, which recites the December 11, 2020 original authorization.

Retrieval note

context; the saved letter is a later reissuance; cite the original date from its recital.

A record of The COVID Project. The instrument's text is the source's; the summary fields are The COVID Project's reading of it. Not legal advice.