An October surprise?

WASHINGTON—The FDA is scheduling a meeting of its Vaccines and Biologics Products Advisory Committee for Oct. 22, and the topic is Covid-19 vaccine development.

There has been much speculation about the process the FDA would use to review — and possibly approve — one or more of the Covid-19 vaccines currently in phase 3 trials. In a presidential election year, the Covid-19 pandemic has become a point of contention, and the meeting will come 12 days before the Nov. 3 vote.

In the statement released late in the day Aug. 28, FDA Commissioner Stephen M. Hahn, MD, said “The agency is also prepared to rapidly schedule additional meetings of this committee upon submission of any applications as appropriate. I want to assure the American people that the process and review for vaccine development will be as open and transparent as possible. A discussion with this committee, made up of outside scientific and public health experts from around the country, will help ensure clear public understanding regarding clinical development of these vaccines indicated to prevent Covid-19 and the data needed to facilitate their authorization or licensure. It is critical for people to see FDA’s expectations for data to support safety and effectiveness.”

Hahn’s announcement came just five days after a Sunday-evening White House press conference at which he announced that the FDA was issuing an emergency use authorization for convalescent plasma. At that press event, Hahn overstated the findings of a Mayo Clinic study, which has not yet been peer-reviewed or published. Hahn was roundly criticized for his statements, and in less than 24 hours he Tweeted an erratum.

The FDA said the October 22 meeting will be available via webcast from 10 a.m. to 5 p.m. Additionally, the FDA will have briefing documents and the full committee roster available on its website “not later than two business days before the meeting.”

FDA advisory committees, or “adcomms,” as they are known, are routinely conducted for the review of new drug applications as well as for review of safety concerns that arise for already approved drugs or devices. At the end of such meetings, members of the committees vote on a series of questions including whether or not to recommend FDA approval, recommendations for label restrictions or special use guidance, and requirements for additional studies after approvals.

Peggy Peck, Editor-in-Chief, BreakingMED™

Cat ID: 190

Topic ID: 79,190,730,933,190,926,192,927,148,150,590,725,928