“It’s a lesser review, it’s a lower-quality review, and when you’re talking about vaccinating a large chunk of the American population, that’s not acceptable,” said one vaccine expert.
Epidemiologists and vaccine experts are alarmed by Food and Drug Administration Commissioner Stephen Hahn’s recent assertion that he will consider approving a coronavirus vaccine before the completion of late-stage clinical trials.
On Aug. 23, President Trump called a press conference to announce an EUA for convalescent plasma to treat COVID-19, which was controversial in its own right, but the people who might receive it are already sick; vaccines by definition are given to healthy people.
Story continuesIn an interview with the Financial Times over the weekend, Hahn insisted that if he determines a vaccine is safe enough for an EUA, it will be a “science, medicine, data decision. This is not going to be a political decision.” “There was never a controlled study [of convalescent plasma], so that’s the second example of something that has not been shown to work that has now been approved by the FDA under EUA, and you have the president standing up there saying, ‘This is a breakthrough therapy,’ which it’s not,” Offit said. “I think people can reasonably worry [about political pressure] now.
Offit said that because all the vaccines now being tested are being developed with novel strategies that have never been used commercially before, it is that much more critical to collect data in large-scale trials before a vaccine is “put out there to a group that is going to [initially] consist of mostly healthy [essential workers] who are unlikely to die from this virus” even if they did contract it.
Dr. George Rutherford, an epidemiologist at the University of California, San Francisco, said there have been devastating side effects to vaccines in the past that have not surfaced until after clinical trials have finished.
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