FDA Adviser: Not Realistic To Expect A COVID-19 Vaccine In 2020

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A medical worker draws blood at a free coronavirus antibody testing event in Los Angeles on Wednesday.

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You wrote an op-ed for The New York Times in June and expressed some concern that the president could announce a vaccine prematurely. Do you think the administration has been racing ahead too quickly?

The way this process has worked so far is fine. As long as you do a phase 3 trial, then you have proven that the vaccine is safe, at least in, say, 15,000 or 20,000 people, and that it’s effective at least for a certain length of time, which is reasonable. That’s as big as many vaccines trials are.

What you don’t want to have happen is you don’t want the administration to reach their hand into the «warp speed bucket, where there are tens of millions of doses, pull out one or more vaccines and say, look, it’s been tested in a few thousand people, we know it induces an immune response without knowing whether or not it’s effective, and then putting it out into the American public. That would be a mistake.

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What could happen?

Well, what could happen is that the vaccine is far less effective than you think it is, in which case you’ve shaken what is a fragile vaccine confidence in this country, or that it has a safety problem that would have been picked up in 15,000 or 20,000 people but wasn’t picked up in only a few thousand people.

Peter Granitz and Martha Wexler produced and edited the audio version of this story. Christianna Silva adapted it for the web.