CBER Plans Updated Guidance on Emergency Use Authorizations for COVID-19

As hopes increase for a COVID-19 vaccine by year’s end, the FDA is planning to issue a new guidance on Emergency Use Authorizations (EUA).

FDA Commissioner Stephen Hahn said via Twitter Friday that the new guidance will expand on the agency’s previous guidance issued in late June on development of COVID-19 vaccines (DID, July 1), and will “provide sponsors of requests for EUAs with recommendations regarding the data and information necessary to support issuance of an EUA.”

In a joint statement issued Friday, Hahn and Center for Biologics Evaluation and Research  Director (CBER) Peter Marks said that an EUA may be appropriate for a vaccine with adequate manufacturing information if the vaccine has been shown to be safe and effective but before the sponsor submits all of the data required and/or the agency has completed a formal review of the biologics license application.

CBER did not include a release date for the EUA guidance in its newly updated guidance agenda for 2020 that was published Friday.

The FDA has scheduled an Oct. 22 meeting of its Vaccines and Related Biologics Advisory Committee to discuss the development of COVID-19 vaccines in general. Hahn and Marks said that while the committee is not expected to discuss specific vaccine candidates, the agency is ready to “rapidly” schedule additional meetings of the committee in case any applications or EUA requests come in.

The possibility of an EUA before year’s end has raised concerns that the FDA is responding to pressure from the Trump administration to rush the approval process. President Trump, who is trying to get reelected on Nov. 3, has suggested on more than one occasion that a COVID-19 vaccine may be ready as soon as October.

For his part, Hahn has frequently said that the agency will make any decision on a vaccine approval or EUA based strictly on science (DID, Sept. 1). — Jordan Williams