Good Question: When will the COVID-19 vaccines get full FDA approval?
CHARLOTTE, N.C. (WBTV) - “There doesn’t seem to be a lot of conversation about the fact that the FDA has only provided emergency authorization for current vaccines. What will it take for the FDA to award them full approval and when can we expect that to occur?” - viewer Stephen asks.
An Emergency Use Authorization is meant to make things like vaccines available during public emergencies. It’s an option for when there are no other approved and available alternatives.
In order for a vaccine to get emergency use, the manufacturer has to bring in tens of thousands of study participants. They have to go through at least three phases of clinical trials.
Once there’s enough information to give a scope of how the vaccine works during that third trial, they can apply for either that emergency use authorization.
That application is then reviewed by a board of experts.
“When the data are looked at by an independent data and safety monitoring board of trusted individuals who have no allegiance to anyone, not to the administration and not to the company, they looked at the data and they found that the vaccine was safe and effective,” Dr. Anthony Faucis has told CBS News. “That data then goes to the company, which then brings it to the FDA, who, together with their own advisory committee, determines whether an emergency use authorization and ultimately a license should be given.”
The Pfizer and Moderna vaccines have emergency authorizations right now.
The next step would be a Biologics License Application, or a BLA. But, the FDA says there’s no “clock” for that.
The manufacturers have to keep collecting data and continuing trials until they have enough information to submit for a BLA.
According to Reuters, Pfizer has said it plans to submit for a full approval in April.
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