FDA Convenes Experts for Advice on COVID Vaccine — Then Ignores Their Warnings

When the U.S. Food and Drug Administration (FDA) convened a panel of outside experts Oct. 22 to advise it on potential coronavirus vaccines, members of the advisory committee expressed several serious concerns about the testing and approval process.

One medical doctor warned of the potential for “a total disaster.” Another complained of “hugely missed opportunities.”

What the FDA heard — or chose to hear — is another matter.

At the end of the daylong meeting, an FDA official summarized the discussion in a way that seemed to minimize, mischaracterize, or gloss over some of the outside experts’ warnings.

“I heard that the general … principles and the standards that we are applying are right on the money, and that there is really buy-in for that,” the FDA official, Marion F. Gruber, said in part.

The acting chairman of the advisory committee — whose past relationships with companies developing coronavirus vaccines the Project On Government Oversight (POGO) documented in a recent report — endorsed the FDA official’s description.

“I fully agree with your summary,” Dr. Arnold Monto said.

The conclusion of the meeting left this reporter wondering: Did we just listen to the same discussion?

Other observers have reacted similarly.

“If FDA officials like Gruber walk away from adcomms [advisory committees] just deciding in their own minds what they heard and not what was actually said, what’s the point? And what damage did her closing remarks just do?” Donna Young, who covers pharmaceuticals and biotech for S&P Global News, tweeted. …

The roster the FDA posted of experts participating in the meeting named a long list of doctors. It didn’t say anything about spin doctors.

Both the FDA official and the acting chairman of the advisory committee offered a bit more nuance in their closing remarks on Oct. 22. But, as they framed what the FDA would or should take away from the meeting, neither seemed to do justice to feedback and advice committee members provided.

The public meeting, live-streamed on YouTube, came as the FDA was trying to restore public trust after appearing to bow to political pressure by issuing so-called Emergency Use Authorizations (EUA) for unproven coronavirus treatments.

At the meeting, some speakers presented research showing that members of the public are deeply skeptical about and disinclined to use potential vaccines. Other speakers warned that if the FDA approves a coronavirus vaccine that turns out to be dangerous, it could shatter faith in coronavirus vaccines generally and undermine efforts to fight the pandemic….


Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.