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FDA Commissioner Stephen Hahn 'cautiously optimistic' about coronavirus vaccine

'It will be the beginning of the end when a vaccine is authorized'
Posted at 1:45 PM, Jul 23, 2020

WEST PALM BEACH, Fla. — The head of the Food and Drug Administration said Thursday he's hopeful that a coronavirus vaccine could be ready by the end of the year.

FDA Commissioner Dr. Stephen Hahn told WPTV NewsChannel 5 anchor Kelley Dunn in an exclusive interview that a vaccine will be "a really important tool" in the fight against COVID-19.

"It will be the beginning of the end when a vaccine is authorized, based upon the data and when it's administered to people," Hahn said.

Hahn said clinical trials will be starting next week, including in Florida.

Dr. Larry Bush, an infectious disease specialist in Wellington, said Wednesday he is helping to start one such trial in the state.

"One promise we have to the American people is that we will make the right decision for them based upon this data," Hahn said.

Hahn said he is "cautiously optimistic" that there could be a vaccine by the end of 2020 or early next year.


"So far the vaccine looks safe and that these vaccines are stimulating an immune response," he said. "Ultimately, we have to wait for the Phase 3, the final data, to come through in large numbers of people, but that will ultimately tell us whether it's safe and effective. But I do remain cautiously optimistic. This has been done at record speed."

As for children, they may have to wait a little longer if, in fact, a vaccine is approved.

"We believe that children will not be included in the initial trial," Hahn said.

However, Hahn said the FDA won't prejudge the data.

"We will make that based upon the data and science that comes to us," he said.

Hahn also tried to alleviate any concern for those who might be wary of a vaccine being rushed into production. He said the FDA has "very rigorous criteria to make this decision," citing the FDA's 34-page guidance on conducting clinical trials.

Although the trials are being accelerated, Hahn said the FDA is "not cutting corners."

"Typically, you do a Phase 1 trial, wait some time, look at the data, go to Phase 2, wait some time, go to Phase 3, and that could take years," Hahn said. "And we're not doing that. We're putting that together, looking at it almost immediately."

Hahn also noted that many manufacturers are producing vaccines at-risk, "meaning they're paying for it, knowing that the decision from the FDA hasn't come through yet."