[Federal Register Volume 89, Number 199 (Tuesday, October 15, 2024)]
[Notices]
[Pages 83021-83023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23637]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0335]


Revocation of Emergency Use of a Biological Product During the 
COVID-19 Pandemic; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the revocation of the Emergency Use Authorization (EUA) (the 
Authorization) issued to Janssen Biotech, Inc. (Janssen), for the 
Janssen COVID-19 Vaccine. FDA revoked the Authorization on June 1, 
2023, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The 
revocation, which includes an explanation of the reasons for the 
revocation, is reprinted in this document.

DATES: The Authorization is revoked as of June 1, 2023.

ADDRESSES: Submit written requests for a single copy of the revocation 
to the Office of Communication, Outreach and Development, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. 
Send one self-addressed adhesive label to assist that office in 
processing your request or include a Fax number to which the revocation 
may be sent. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the Authorization.

FOR FURTHER INFORMATION CONTACT: Tami Belouin, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to 
strengthen the public health protections against biological, chemical, 
nuclear, and radiological agents. Among other things, section 564 of 
the FD&C Act allows FDA to authorize the use of an unapproved medical 
product or an unapproved use of an approved medical product in certain 
situations. On February 27, 2021, FDA issued an Authorization (EUA 
27205) to Janssen for the Janssen COVID-19 Vaccine, subject to the 
terms of the Authorization. Notice of the issuance of the Authorization 
was published in the Federal Register on May 27, 2021 (86 FR 28608), as 
required by section 564(h)(1) of the FD&C Act. Subsequent updates to 
the Authorization were made available on FDA's website. The 
authorization of a biological product for emergency use under section 
564 of the FD&C Act may, pursuant to section 564(g)(2) of the FD&C Act, 
be revoked when the criteria under section 564(c) of the FD&C Act for 
issuance of such authorization are no longer met (section 564(g)(2)(B) 
of the FD&C Act), or other circumstances make such revocation 
appropriate to protect the public health or safety (section 
564(g)(2)(C) of the FD&C Act).

II. EUA Revocation Request

    In a request received by FDA on May 22, 2023, Janssen requested 
withdrawal of, and on June 1, 2023, FDA revoked, the Authorization for 
the Janssen COVID-19 Vaccine. Janssen notified FDA that the last lots 
of the Janssen COVID-19 Vaccine purchased by the U.S. Government have 
expired, that there is no demand for new lots of the Janssen COVID-19 
Vaccine in the United States, and that it does not intend to update the 
strain composition of this vaccine to address emerging variants. Based 
on FDA's understanding that Janssen does not intend to offer the 
Janssen COVID-19 Vaccine in the United States under the EUA anymore and 
Janssen's request that FDA revoke the EUA for the Janssen COVID-19 
Vaccine, FDA has determined that it is appropriate to revoke this 
Authorization to protect the public health or safety.

III. The Revocation

    Having concluded that the criteria for revocation of the 
Authorization under section 564(g)(2)(C) of the FD&C Act are met, FDA 
has revoked the EUA for the Janssen COVID-19 Vaccine. Although FDA 
revoked the Authorization for the Janssen COVID-19 Vaccine on June 1, 
2023, as was publicly announced on the Agency's website, publication of 
notice of this revocation in the Federal Register was inadvertently 
delayed. The revocation in its entirety follows and provides an 
explanation of the reasons for revocation, as required by section 
564(h)(1) of the FD&C Act.

IV. Electronic Access

    An electronic version of this document and the full text of the 
Authorizations and revocation are available on the internet at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.
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    Dated: September 27, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-23637 Filed 10-11-24; 8:45 am]
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