FDA Will Consider OK'ing COVID-19 Vaccine Before End Of Phase 3 Trials

The head of the FDA says he’d consider bypassing the usual approval process to get a coronavirus vaccine out as soon as possible.
Posted at 6:30 PM, Aug 31, 2020

The head of the Food and Drug Administration says he’d consider bypassing the usual approval process to get a coronavirus vaccine out as soon as possible. The American Medical Association is cautioning against rushing.

In an interview with the Financial Times, Stephen Hahn said the FDA could grant something called EUA, or emergency use authorization. 

With it, a vaccine maker could get permission to distribute covid shots before Phase 3 clinical trials were complete. Those trials are  widely viewed as critical to making sure vaccines are safe and work. 

Hahn’s comments come a week after President Donald Trump claimed, without proof, that the FDA is slowing vaccine development to hurt his re-election chances.

Hahn insists he’d follow the science — not the politics  —  saying “We have a convergence of the COVID-19 pandemic with the political season, and we're just going to have to get through that and stick to our core principles.” 

"I don't believe that the physicians in the United States would accept anything that had gone through wide scale Phase 3 trials," Dr. Susan Bailey, president of American Medical Association told Newsy.

American Medical Association President Dr. Susan Bailey tells Newsy many patients already don’t trust a COVID-19 vaccine. A Gallup poll found 35% of Americans — one in three — would not get a free, FDA-approved vaccine if ready today.

"Vaccine hesitancy is a significant problem. And we have to listen to our patients very carefully to make sure that we hear what their concerns are and make sure they are addressed. And a rushed vaccine is...we're not going to be able to allay their fears," she said.

Right now, three American coronavirus vaccine candidates are in phase 3 trials, one is just beginning. Officials with Operation Warp Speed, the federal government’s COVID-19 vaccine program, say they still need half of the patients necessary for the two studies that are furthest along. Three more vaccine phase 3 clinical trials are expected in the next month or so.