The FDA plans to toughen coronavirus vaccine standards
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President Trump and FDA commissioner Stephen Hahn. Photo: Pete Marovich/Getty Images
The Food and Drug Administration plans to toughen the requirements for a coronavirus vaccine emergency authorization, which would make it more difficult for one to be ready by the election, the Washington Post reported Tuesday.
Why it matters: Public skepticism of an eventual vaccine keeps increasing as President Trump keeps making promises that are at odds with members of his own administration.
- This skepticism is bad. A rushed, unproven vaccine would be even worse.
Driving the news: The new FDA guidance would be much more rigorous than what was used to provide emergency authorization to hydroxychloroquine or convalescent plasma. Both authorizations were controversial.
- The agency is expected to ask vaccine manufacturers to monitor late-stage clinical trial participants for a median of at least two months, beginning after the participants receive their second shot.
- It will also be looking for at least five severe coronavirus cases in each trial's placebo group, along with cases in older people, to further indicate that the vaccine works.
Between the lines: The new standards, combined with other elements of the authorization process, would make it very unlikely than any vaccine will be ready for administration before Nov. 3.
The other side: Some critics say that an emergency authorization — versus a full approval — shouldn't be used at all for a vaccine.
- "Things are so revved up right now that there is quite a possibility that the American public won't accept a vaccine because of all the things that are going on," Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine, told the Post.
What they're saying: "The FDA has previously noted that the agency intends to issue additional guidance shortly to provide sponsors of requests for Emergency Use Authorization for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an EUA," the agency said in a statement.
