COVID-19 Vaccine: FDA Considers Skipping Phase 3 of Clinical Trials
The head of the U.S. Food and Drug Administration says they may consider allowing a COVID-19 vaccine to be put on the market before finishing all phases of clinical trials.
In the U.S., two vaccines are in phase three clinical trials right now, which is the step determining whether a vaccine is effective and safe.
Now the FDA says they will consider allowing drug makers to put vaccines on the market without completing that phase.
But experts are concerned about rushing a vaccine to market before clinical trials are complete.
Harvard Global Health Institute Director Dr. Ashish Jha says, “If you’re going to give it to millions of people who are otherwise healthy, you have to have a much higher bar, and so what I would like to see is really robust data, ideally a full review before we go ahead and authorize any kind of a vaccine.”
Drug makers are also dealing with a lack of trust in the vaccine from the public. The FDA says they are working to reassure the public about the safety of future vaccines.
When FDA Commissioner Dr. Stephen Hahn was asked what he would do if he felt pressured to make a vaccine available before it’s ready to use, he said, “I can tell you our decision at FDA will not be made on any other criteria than the science and data associated with these clinical trials.”
Hahn insisted he has not felt pressured politically.
“I have not been pressured politically to make an incorrect decision,” Hahn said.
But he did acknowledge the pandemic itself brings its own kind of pressure.
“So we have felt, I mean, there’s been pressure throughout this pandemic…and I think anybody who doesn’t acknowledge that would be kidding themselves,” Hahn said.
Former FDA Commissioner Dr. Scott Gottlieb says even if some vaccine doses are made available in the fall, widespread use is not expected until next year.