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Full FDA approval may be key to COVID vaccine acceptance, but the timeline is murky

Though Pfizer and Moderna have both applied for full FDA authorization, experts say the process could take several weeks...or several months. Here's why.

MINNEAPOLIS — Months after COVID-19 vaccines were first granted Emergency Use Authorization by the FDA, and as vaccination rates have slowed, it appears that full FDA authorization may prove more pivotal than any state lottery or incentive program.

According to the latest vaccine monitor report from the Kaiser Family Foundation, nearly a third (32%) of unvaccinated adults are waiting for full FDA approval of a vaccine before getting it.

Though employers already have the ability to mandate the vaccine, which was reinforced by a recent federal court ruling, experts say many employers and institutions are also waiting for the next round of approval.

"I think that, by and large, most will wait for full FDA approval before mandating, just like we do for other (vaccines)," said Dr. William Morice, President of Mayo Clinic Labs.

Dr. Morice says it's important to note that Pfizer, which applied for full FDA authorization on May 7, and Moderna, which followed suit on June 1, had to wait until they had six months of data before pursuing full authorization, and he says that's just the beginning.

"The amount of time that (the FDA) spends pouring over that data will be longer, and it's not a check the box type of a process," Dr. Morice said. "It really is an interaction between the FDA scientists and the pharmaceutical companies, so they might ask for more information on the safety data. They'll also look in real detail on the manufacturing for a biological product like a vaccine. They'll want proof of purity, that what they say is in the vaccines is in them."

In comparison, Dr. Morice says the Emergency Use Authorization process also prioritized safety and manufacturing data, but within a shorter window of time.

So how long will full authorization take? Dr. Morice says nobody knows for sure.

"Going off of prior experiences, this can take months or even years, but this is not analogous to prior experiences because now we've had literally millions of patients and individuals who have been vaccinated, so we have a lot more real world evidence regarding the vaccines," Dr. Morice said. "Six months is the estimate that I've heard but I think, again, it's a little difficult for people to prognosticate because the situation is so different than anything we've ever seen before."

Still, others with knowledge of the process believe those same factors mean the FDA could actually move much faster.

"I would suspect that, if things go as I guess they will - and that's all I have for information - is that we will hear something in the next two to four weeks," said Jason Varin, Assistant Professor for Pharmaceutical Care and Health Systems at the University of Minnesota College of Pharmacy. 

Kent Erdahl: "You think (FDA authorization) could come before fall?"

Varin: "Absolutely, I think it could be. Yes."

Varin says several real world studies give him confidence, including a study by the CDC showing the mRNA vaccines reduce the risk of infection by 91%. He says extended safety monitoring has been even more encouraging.

"These mRNA vaccines, the Pfizer and the Moderna, are very simple vaccines. There's less ingredients, shall we say, in it than other vaccines, so, it's a very high safety profile on them," Varin said. "We also have a lot of data on the number of people who have been immunized at this point, and it's a very, very miniscule small number of people that have been negatively impacted beyond the first day or two that they have symptoms."

Dr. Morice says no matter when full approval comes, he would advise people not to wait.

"Personally, I've heard more unfortunate stories of people who have gotten sick with COVID, who have struggled to recover, than those who have been vaccinated," Dr. Morice said. "It is an effective tool. It's the most effective tool that we have right now, and if you're comfortable getting vaccinated you should really strongly consider it."

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