FDA Head Says Any Approved COVID-19 Vaccine Will Be Safe

TUESDAY, Aug. 11, 2020 (HealthDay News) -- Dr. Stephen Hahn, the head of the U.S. Food and Drug Administration, said Monday that the agency will not compromise safety when approving COVID-19 vaccines, CNN reported.

That assurance was given during a video briefing with the American Medical Association.

Because of how fast the FDA is working, some have questioned if the agency will weaken its usual rigor when it reviews data from clinical trials.

"Let me assure you that we will not cut corners," Hahn said. "All of our decisions will continue to be based on good science and the same careful deliberative processes we have always used when reviewing medical products."

Many Americans are wary of a vaccine. Hahn said he has seen surveys that show that many people will be reluctant to get vaccinated.

In May, a CNN poll found one-third of Americans wouldn't get a COVID-19 vaccine even if it is widely available and inexpensive.

Hahn urged doctors to get their patients to take the vaccine when it's approved.

"We hope that you will urge your patients to take an approved vaccine so that we can seek to establish widespread immunity," he said.

More than 200 trials are underway, Hahn said, but no one knows when the results of those trials will be ready.

"I can promise you that when the data are available, FDA will review them, using its established rigorous and deliberative scientific process. We all understand that only by engaging in an open review process and relying on good science and sound data can the public, and you as providers, have confidence in the integrity of our decisions," he said.

Despite claims by President Donald Trump that a vaccine will be ready in November, experts say that's not possible.

"I don't see how that would be possible," Dr. Paul Offit, a vaccinologist at Children's Hospital of Philadelphia, told CNN.

Before a trial can start, Moderna, a company that's ahead of most in developing a vaccine, needs to finish enrolling patients in late-stage trials. That might happen by the end of September. Then the volunteers have to have their first shots, wait 28 days, and then give a second shot. After that, researchers have to wait two weeks to see if the vaccine is effective.

Dr. Peter Hotez, a vaccinologist at Baylor College of Medicine in Houston, told CNN "there's just no way" a vaccine will be available by Nov. 3. It's more likely a vaccine will be available in 2021, he added.

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