CBER’s COVID-19 Vaccine EUA Guidance Expected This Week

The FDA’s planned guidance on Emergency Use Authorization (EUA) of COVID-19 vaccines may be released as soon as this week and could include standards making an EUA unlikely before the Nov. 3 presidential election.

The agency announced earlier this month that the guidance was on its way. FDA Commissioner Stephen Hahn said on Twitter that it would expand on the agency’s guidance issued in late June on the development of COVID-19 vaccines and will “provide sponsors of requests for EUAs with recommendations regarding the data and information necessary to support issuance of an EUA” (DID, Sept. 14).

The guidance is expected to set a higher bar than the standards previously met for EUAs for convalescent plasma and hydroxychloroquine. For example, the agency will likely expect vaccine manufacturers pursuing an EUA to track phase 3 trial participants for at least two months after they’re given a second vaccine dose. It would also require at least five severe COVID-19 cases and some cases in older patients in a trial’s placebo group as a signal of efficacy.

It is viewed as a response to widespread accusations that the FDA will bow to political pressure from the Trump administration to speed up approval of a vaccine before the election.

Three COVID-19 vaccines are in phase 3 clinical testing, and President Trump continues to assert that a COVID-19 vaccine may be ready as soon as October.

The FDA has spent much of this month assuring the public that its decisions to authorize or approve a COVID-19 vaccine will be based on science with Hahn and Peter Marks, director of the Center for Biologics Evaluation and Research, both vowing to resign rather than approve a vaccine under pressure. — Jordan Williams and James Miessler