Biden says full FDA approval of COVID-19 vaccines could come by fall 2021

COUNTY OF SAN DIEGO HEALTH & HUMAN SERVICES AGENCY (KUSI) – Millions of Americans have already gotten their COVID-19 vaccinations as the medical community urges it’s the best way to end the pandemic once and for all. However, all three vaccines are approved by the Food and Drug Administration under emergency use authorization (EUA.) Full FDA approval is taking much longer than some experts predicted. 

Dr. Monica Gandhi, an infectious disease expert and professor of medicine at University of California San Francisco, fears the stalled approval could be fueling vaccine hesitancy.

“The reason a lot of us are asking for that approval to happen quickly is it is holding some people back from getting the vaccine to still have them under emergency use authorization,” Gandhi said, adding that the agency has the necessary data from clinical trials and studies. “That’s why a lot of us are wondering why it’s taking so long. What would it take to approve it? Not much. They already have the full clinical trial data; they have all been published in peer-reviewed journals.”

Moderna and Pfizer have both applied for full FDA approval, with Pfizer being granted priority review which could shorten the process. 

“Actually, it’s really frustrating to a lot of us. Number one, we don’t actually have an FDA director named by President Biden,” Gandhi said. “We’re not sure why, but a lot of us are calling for it because I think some people don’t want to sign a piece of paper to get a vaccine and that’s fair. They want it to be approved before they get it.”

During a town hall Wednesday, President Joe Biden alluded to the FDA approval coming sooner than experts predicted.

“The expectation, they’re not promising me any specific date but my expectation talking to the group of scientists, we put together over 20 of them plus others in the field is that sometime maybe in the beginning of school year, at the end of August, September, October, you’ll get a final approval saying the FDA said this is it. It’s good,” Biden said.

The difference between EUA and full authorization is a more in-depth review of data over a longer period. 

Locally, some doctors don’t feel the full FDA approval will have a significant difference on San Diegans who may be hesitant and said there’s more the public can do to ensure vaccines are trusted.

“I think it may make a difference for a small percentage of people,” said Dr. Georgine Nanos with Kind Health Group. “I think what’s going to impact those people the most are when family and trusted community members encourage them to get vaccinated.”

Dr. Nanos said this could however have more of an impact on the vaccine being mandated by certain institutions.

“I don’t necessarily support government overreach into mandating a lot of these things in people’s lives but I do think we have lots of vaccine mandates across the United States and have for decades and decades so this will probably not be that different,” Dr. Nanos said. 

KUSI’s Hunter Sowards joined viewers live from San Diego County’s Health and Human Services Agency with more details.

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