9 Companies Pledge Not To Submit Coronavirus Vaccine To FDA Until It's Proved Safe To reassure the public, nine companies issued a joint statement Tuesday saying they won't seek government approval for their coronavirus vaccines until full safety and effectiveness data are in hand.
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9 Companies Pledge Not To Submit Coronavirus Vaccine To FDA Until It's Proved Safe

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9 Companies Pledge Not To Submit Coronavirus Vaccine To FDA Until It's Proved Safe

9 Companies Pledge Not To Submit Coronavirus Vaccine To FDA Until It's Proved Safe

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  • <iframe src="https://www.npr.org/player/embed/910788743/910788744" width="100%" height="290" frameborder="0" scrolling="no" title="NPR embedded audio player">
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AILSA CHANG, HOST:

The rush to make a COVID-19 vaccine widely available in record time has made some people nervous about cutting corners. To calm consumers, nine companies working on vaccines have made an unusual pledge. NPR pharmaceuticals correspondent Sydney Lupkin reports.

SYDNEY LUPKIN, BYLINE: Drugmakers are pledging not to submit their vaccines for FDA review unless large clinical trials show safety and efficacy. Pfizer CEO Albert Bourla talked about the pledge on the "Today" show, calling it historic.

(SOUNDBITE OF TV SHOW, "TODAY")

ALBERT BOURLA: With increasing public concerns about the processes that we are using to develop these vaccines and, even more importantly, the processes that will be used to evaluate these vaccines, we saw it as critical to come out and reiterate our commitment.

LUPKIN: It's a commitment to science. The pledge comes after President Trump said this.

(SOUNDBITE OF ARCHIVED RECORDING)

PRESIDENT DONALD TRUMP: So we're going to have a vaccine very soon, maybe even before a very special date. You know what date I'm talking about.

LUPKIN: Most assume he's talking about Election Day. Ameet Sarpatwari is the assistant director of the Program on Regulation, Therapeutics and Law at Harvard Medical School. He says the pledge by vaccine makers is unprecedented.

AMEET SARPATWARI: I think it reflects an acknowledgment of the widespread concern that FDA decisions are currently being guided by politics and not science.

LUPKIN: He cited the hydroxychloroquine debacle as an example of this. The FDA authorized the drug for emergency use in the fight against COVID-19 in March but revoked the status in June. Now the agency cautions against using it. He says a vaccine pledge is an attempt to calm fears about a repeat of that scenario. It doesn't include a promise to wait until those large clinical trials are complete before seeking FDA review. The companies could still use partial data and argue it's enough to show safety and efficacy. The pledge also doesn't include a promise to share study data with the public in a timely manner, Sarpatwari says.

SARPATWARI: In the grand scheme of things, I don't think it moves the needle that much.

LUPKIN: Bourla, Pfizer's CEO, said there's a 60% chance we'd know whether Pfizer's vaccine is safe and effective by Election Day. But that doesn't mean the public will receive the vaccine by then. Moncef Slaoui, who leads the Trump administration's effort to develop a vaccine, told NPR that it's extremely unlikely a vaccine would be ready by Election Day. But the CDC is preparing to distribute one by then anyway just in case.

Sydney Lupkin, NPR News.

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