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.

( printed page 83022)

89 FR 83021