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What does full FDA approval mean for the COVID-19 vaccine?

Pfizer could be given an indefinite green light soon.
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TAMPA, Fla. — The Pfizer-BioNTech COVID-19 vaccine may soon be the first to become fully-approved by the U.S. Food and Drug Administration.

According to the New York Times, the FDA would like to fully approve the vaccine by Labor Day. The Pfizer, Moderna and Johnson & Johnson vaccines currently only have emergency use authorization in the U.S.

Full approval, or biologics licensing, would be the next step. That full approval, which means the vaccines would have an indefinite green-light, could lead to more businesses requiring vaccinations nationwide. Some organizations have appeared to be waiting for clearance beyond the "emergency" authorization given previously.

“It's a full licensure that means they can market it. I think there have been conflicting legal theories about whether you can mandate a vaccine that's under emergency use authorization, but full licensure kind of will take away that question. We have mandated vaccines for our school aged children for decades, right. So now we get to a point where it's like, well, it's a fully approved, biological licensing," explained Dr. Michael Teng with USF Public Health.

So far in the state of Florida, more than 12.6 million people have received at least one dose of a coronavirus vaccine. A little less than 10.6 million people are classified as fully-vaccinated, according to the latest CDC data. That's roughly 51.4 percent of Florida's population.

If the Pfizer vaccine does get fully-approved, it will be available for those over the age of 16. Twelve to 15-year-olds will still be under emergency use authorization.

Pfizer submitted its request for full approval back in May, with Moderna following in June. Johnson & Johnson is planning to do so later this year.

Normally, it would take the FDA months to decide to grant full approval for a vaccine, but the agency is working to fast-track the applications for the coronavirus vaccines by pausing some other work.

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