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Ex. FED-186 Order Primary source read

Emergency Use Authorization letter: Moderna COVID-19 Vaccine (Dec. 18, 2020; reissued thereafter)

Letter of Authorization, Moderna COVID-19 Vaccine

Food and Drug Administration, HHS · United States (Federal)

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The COVID Project

The record

Jurisdiction
United States
Level
Federal
Authority
FD&C Act § 564
Issued
2020-12-18 Dec. 18, 2020
Effective
2020-12-18
End
BLA approval (Spikevax) Jan. 31, 2022; EUA continued for other formulations (read as 2022-01-31)
In force
Dec. 18, 2020 to Jan. 31, 2022
Quarters
2020 Q42021 Q12021 Q22021 Q3
Limitation types
Health care ordersOther
Addressees
  • ModernaTX, Inc.; vaccination providers
Functions reached
  • context
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 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

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.

Retrieval note

context; saved letter is a later reissuance.

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.