Emergency Use Authorization letter: Janssen COVID-19 Vaccine (Feb. 27, 2021; reissued thereafter; revoked June 1, 2023)

The record

Jurisdiction

United States

Level

Federal

Authority

FD&C Act § 564

Issued

2021-02-27 Feb. 27, 2021

Effective

2021-02-27

End

revoked June 1, 2023 (not verified here) (read as 2023-06-01)

In force

Feb. 27, 2021 to June 1, 2023

Quarters

2021 Q12021 Q22021 Q3

2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3

Limitation types

Health care ordersOther

Addressees

• Janssen Biotech, Inc.; vaccination providers

Functions reached

• context (the April 13-23, 2021 federal pause of the Janssen vaccine is a fact and circumstance of 2021Q2; not verified here)

Collection

Federal health, safety and transport layer FED-A

Operative words

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

Notes