FDA May Give EUA for Covid Vaccine on Early Data: Hahn

As several Covid-19 vaccines move into final safety-efficacy demonstrations, FDA commissioner Stephen Hahn says it is possible that an emergency use authorization (EUA) could be granted before Phase 3 clinical trials are completed. In an interview with the Financial Times, Hahn said such actions will be transparent, grounded in science, and not for any political gain.

“It is up to the sponsor [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application,” Hahn said in the 8/30-published interview. “If they do that before the end of Phase 3, we may find that appropriate. We may find that inappropriate, we will make a determination.” Hahn said such an EUA action would be for certain groups rather than a blanket approval, presumably meaning the vaccine’s use would be directed at those most at risk. “Our emergency use authorization is not the same as a full approval,” he said. “The legal, medical and scientific standard for that is that the benefit outweighs the risk in a public health emergency.” Hahn insisted, according to the Financial Times, that he would not rush a vaccine to benefit the president’s desire to have one available by election day.

Hahn has had a rocky last several months, leaving many FDA watchers worried that the agency has become too politicized. In June, FDA had to revoke an EUA that allowed for chloroquine phosphate and hydroxychloroquine sulfate to be used to treat certain hospitalized patients, which many saw as Hahn’s move to appease the president. And just last week after Trump complained about “deep state” FDA employees delaying Covid-19 vaccine progress (see story), Hahn announced an EUA for convalescent plasma while exaggerating its effectiveness, which had to be walked back the next day.

The bad taste left by the impression of political interference at FDA has caused some experts to worry about the public’s willingness to get vaccinated, some calling for an independent commission to review data from coronavirus vaccine trials before a vaccine is approved or authorized. This perception is bolstered by a new Harris/STAT poll that found 78% of Americans are worried that the Covid-19 vaccine approval process is being driven more by politics than science. The poll also found that only 67% of those surveyed said they would get a vaccine as soon as one is available. Health experts fear that this vaccine uncertainty could hamper the objective to reach herd immunity offering more Covid-19 protection.