FDA Releases Tougher Vaccine EUA Guidance Despite White House Holdup

Despite the White House reportedly blocking the FDA’s tighter requirements for COVID-19 vaccine Emergency Use Authorizations (EUAs), the agency has opted to release them.

The new guidelines explain that the agency wants to see a median of two months of follow-up data after vaccination of trial participants, which will almost certainly push any granting of a vaccine EUA beyond the Nov. 3 presidential election.

“Being open and clear about the circumstances under which the issuance of an EUA for a COVID-19 vaccine would be appropriate is critical to building public confidence and ensuring the use of COVID-19 vaccines once available,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER) in releasing the guidance yesterday.

In addition, the agency said it “does not expect to be able to make a favorable benefit-risk determination that would support an EUA” without data from a phase 3 trial that includes “well over 3,000 vaccine recipients” followed for serious adverse events and adverse events of special interest for at least one month after completion of the vaccination regimen.

The guidance will be a key discussion document for the upcoming Oct. 22 meeting of the FDA’s advisory committee on vaccines, which will consider COVID-19 vaccine standards, but which is not expected to issue a recommendation to the agency about any specific vaccine.

Currently, Pfizer’s candidate appears to be the farthest ahead in the race for an EUA, with Pfizer CEO Albert Bourla writing in an early October letter to his colleagues that the company could have enough trial data to file for an EUA this month. Bourla has vowed to resist political pressure to either speed up or slow down its EUA application (DID, Oct. 5).

“The FDA has already communicated with individual manufacturers about its expectations, data the agency intends to consider and what we expect to see in a request for an EUA to demonstrate safety and efficacy,” an FDA spokesperson said.

The FDA isn’t alone in backing off a more aggressive vaccine EUA timeline. Moncef Slaoui, co-leader of the Operation Warp Speed initiative, said during a vaccines symposium Tuesday, hosted by Johns Hopkins University and the University of Washington, that the government has asked companies to hold off on filing for an EUA if they don’t have a sizeable amount of vaccine doses available for deployment.

“The one learning message that we came to … was to recommend to the companies that we are supporting that if they achieve efficacy demonstration while there are no vaccine doses available at industrial scale … to be able to immunize at least a relevant fraction of the population, that they should refrain, or at least consider refraining, from filing for EUA,” he said.

The president claimed Monday following his discharge from Walter Reed National Military Medical Center that “vaccines are coming momentarily,” though health experts have previously disagreed with his timelines and said that a vaccine may not be widely available until the late spring or summer of 2021.

Read the new EUA guidelines here: www.fdanews.com/10-06-20-EUAVaccinesPreventCOVID19.pdf. — James Miessler