Doctor breaks down rigorous FDA approval process

INDIANAPOLIS (WISH) — A U.S. Food and Drug Administration committee met virtually for the first time this week to discuss whether it’s safe to move forward and grant full approval of Pfizer’s booster COVID-19 shots. 

So, what does it take for a vaccine to be granted FDA approval?

The undertaking, to put it mildly, is rigorous. The independent review committee recruits the best scientists in each of their fields of expertise to evaluate different sectors. The goal is to make an evidence-based, informed decision as to whether to move forward.

Full approval is much different than emergency use authorization, according to Dr. Aaron Lottes, a professor of engineering at Purdue University. The standards are higher and the process is much longer. If granted, the public, he says, should have full confidence in the agency’s determination whether it’s yes or no.

“It’s really a different bar. Approval has a higher bar. It is a full standard review process that any vaccine would go through,” Lottes said. “And once the FDA has reviewed all the data, which is really extensive data. There is long-term follow-up data now available …. They determine the vaccine is safe and effective against COVID-19.”

Full approval is contingent on a number of factors. There are different sectors and scientists who specialize in each category who are assigned to evaluate the data presented under a microscope. Some of which include:

• Evidence: There are tens of thousands of studies from across the world researchers will evaluate to determine whether the evidence is strong enough to support the vaccine.
• Manufacturing: Is the facility responsible for making the vaccination sterile and up to code? Labeling–are the labels clear and systematic across all packaging and vaccine vials?
• Dosage: Are some diluted? Are some more potent? Each dose must be consistent in terms of concentration across the board to avoid complications.

The risks versus benefits are then weighed, meaning what are the potential side effects and is there more to gain by getting the vaccine than not.

After this lengthy process, the committee decides if the vaccine is safe and effective enough to warrant full FDA approval.

While Pfizer’s initial two-dose series is FDA-approved, the Moderna shot is not. However, Lottes says, we can expect a final decision in the coming weeks.

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Below is the full interview with Lottes. App users can go online to find it with this story.