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Why aren't COVID-19 vaccines FDA approved yet?

Right now, only the government can distribute the three COVID-19 vaccines in the United States because they are under Emergency Use Authorization.

FLORIDA, USA — While the Department of Veteran Affairs and other health care entities are starting to mandate COVID-19 vaccines, some are saying that they won’t require the shot until it's FDA approved, including Flager Hospital in St. Augustine.

Right now, only the government can distribute the three COVID-19 vaccines in the United States because they are under Emergency Use Authorization.

“A fully approved product can be sold directly from a manufacturer to health care entities," said Dr. Michael Koren, Jacksonville Center for Clinical Research Medical Director. “So, the main difference between the two is all these details that come into play in terms of the distribution system. But from the patient's perspective, there's actually relatively little difference. Right now, you can get the messenger RNA and other vaccines at public pharmacies, and that's because the government has allowed that to occur."

What does FDA approval require?

Koren, who leads local vaccine trials, said manufacturers are constantly collecting vaccine data and submitted longer-term data in their applications for FDA approval.

He said the three currently approved COVID-19 vaccines meet the FDA's rigorous standards for safety, effectiveness and manufacturing quality, and they’re still going through all the small and big findings in-depth.

However, there’s more to consider.

“There's really no issue with safety. I've heard some again, chatter like, 'Maybe I'll wait till the FDA fully approves it.' Well, there’s not going to be any more safety or efficacy data," Koren said. "The approval is really based on some of these logistical issues of getting the vaccine to other vendors, to doctors' offices. But these are gonna be the same vaccines you can get right now in a public pharmacy.“

In fact, he said when COVID-19 vaccines are FDA approved, the government will no longer be covering the costs of the supplies.

"During typical approval, either a patient or their insurer would be paying for the product," Koren explained. "So there's actually some advantages in the current situation in terms of the cost of the product." 

What do we know about the timeline?

Koren said full FDA approval for a vaccine usually happens within six to nine months of submitting an application.

Pfizer submitted for full approval on May 7, almost three months ago, and Moderna on June 1, almost two months ago.

However, the FDA has said the COVID-19 vaccines are under priority review and it intends to complete the process much more quickly than that.

Koren said Pfizer’s full approval could happen as early as next month.