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A closer look at the approval process for a COVID-19 vaccine

A second COVID-19 vaccine could be approved in a matter of days, but what does that process look like?

NEW ORLEANS — Vaccines can take years to create and test, so when it comes to the COVID-19 vaccine there's worry corners were cut.

Experts argue that's not the case.

Dr. Lucio Miele with the LSU Health Center is one of hundreds of medical professionals who have reviewed the facts and says, in this case, there's no room for error. 

"Keep in mind they don't just review data from the final trial, they review everything," he said. "I remember reading facts, charts of patients before speaking to a sponsor (company) in a meeting. There's an ongoing interaction, it's not like the FDA is waiting for a company to give them their side of the story."

The process, he says is thorough, and looked at by hundreds. It also begins before the company starts the first of three human trials (or phases), because approval must be given by the FDA before any testing can begin on anyone.

"Phase 1 is to establish safety," he outlined. "Phase 2 confirms the best dose and phase 3 looks at efficacy."

Efficacy is another way of saying how effective the vaccine actually is. All these phases usually take time, however, companies like Pfizer, moved faster given what they were after.

"What sponsors (companies) did in this case, is once they had the safety data, meaning Phase 1, they started Phase 2 trials," Miele said. "And once they saw the Phase 2 trials were confirming the safety information from Phase 1, they started Phase 3 trials. So essentially, instead of going 1, pause, 2, pause, and then three, it was 1, 2, 3. Also, they put a lot of resources into enrolling many patients quickly."

If a vaccine passes all three trials, which Pfizer's did, a panel will review separate data from both the company and FDA.

"The data is presented at a Public Advisory Committee meeting," Miele said. "This is made up of experts who do not work at either the company or the FDA and are not a conflict of interest. There's a public presentation of the analysis of the data. The FDA presents its analysis, the company presents its analysis and then the panel can ask any question and then based on the evidence the panel votes for approval or deny approval."

In essence, it gives a recommendation which the FDA considers. The FDA doesn't have to follow the panel's recommendation, but usually does. However, before giving a final say, those with the FDA go back line by line, double checking everything from start to finish. Because with the world watching, Miele says, nobody wants to be the one to make a mistake.

"Quality of review is not something that's compromised because there's no anonymity," said Miele. "Reviewers sign their reviews so everyone knows who approved it and nobody wants to make mistakes. Even a company the size of Pfizer would have a lot to lose by doing a bad job developing a vaccine if it turns out to be unsafe or ineffective. From the FDA standpoint, they have their reputation to lose if they do a sloppy review."

With the vaccine now being distributed to thousands, Miele, like so many others are standing behind it. They say the process moved quicker than normal, but the goal of developing a safe and effective vaccine never changed.

"FDA reviewers see everything, what works and what doesn't work," he said. "And honestly having read their side of the data myself, it's very comforting. Ultimately, we're all doctors and what we're trying to do is save as many lives as we can, rather than developing something for the sake of it."

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