What will FDA's experts review at their first COVID-19 vaccine hearing? Agency documents set the tone

The countdown to the FDA's first coronavirus vaccine hearing has begun.

More than seven months into the COVID-19 pandemic, with several vaccines in late-stage testing and developers preparing to file for widespread use, the FDA unveiled its plan for a Thursday advisory panel confab.

Unlike a typical AdComm meeting, this one won't revolve around a particular product or products. Instead, it's laying the groundwork for specific vaccine reviews to come.

The FDA's working to ensure a “level playing field” for all of the developers, a briefing document, released Tuesday, says. Already, the agency has unveiled vaccine guidelines and recommendations covering everything from manufacturing specifics to data requirements, plus post-approval safety monitoring and more.

During Thursday's meeting, the agency plans to seek its expert panel's advice on the gamut of development topics. The meeting will start at 10 a.m. ET and could run until the evening, according to an agenda posted on the agency’s website.

It’ll include presentations on vaccine confidence, distribution, safety monitoring and more. Expecting a large audience, the FDA has unveiled plans to stream it live on YouTube.

In the coming months, the FDA will likely decide on COVID-19 vaccine approvals or emergency use authorizations (EUA) or both. An EUA could allow vaccine distribution to millions of people, so the agency will require detailed manufacturing info to ensure “quality and consistency," the briefing document says.

The agency will also need enough data to ensure that benefits outweigh risks from “at least one well-designed Phase 3 clinical trial that demonstrates the vaccine’s safety and efficacy in a clear and compelling manner."

Decisions about vaccines will be made on a “case-by-case basis considering the target population, the characteristics of the product, the preclinical and human clinical study data on the product, and the totality of the available scientific evidence relevant to the product,” the document says.

Looking forward, the agency will require a separate meeting of the committee for each COVID-19 vaccine application that comes through.

After reading the FDA’s briefing doc, Cantor Fitzgerald analyst Louise Chen wrote in a note that there were “no big surprises” in the Tuesday release. The committee could convene later this year to review vaccines from Pfizer/BioNTech and Moderna, she added.

Vaccines from Pfizer, Moderna, Johnson & Johnson, AstraZeneca and Novavax are in late-stage tests, but the J&J and AZ vaccines have faced trial pauses in the U.S. due to illnesses in participants.

After those vaccine tests were paused, FDA commissioner Stephen Hahn told Bloomberg they aren’t a cause for alarm. Instead, they show the system is working as planned, he said.

Oct 20, 2020


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