Will COVID-19 vaccine be deemed safer after full approval by FDA?
BIRMINGHAM, Ala. (WBRC) - Pfizer may soon become the first COVID-19 vaccine fully authorized by the U. S. Food and Drug Administration, according to a state health officer but will that deem the vaccine safer?
Dr. Landers said she expected Pfizer’s COVID-19 vaccine to be fully approved by FDA fall 2021 because they were the first to submit their product in 2020.
Landers said the process between evaluating a vaccine for emergency use and full authorization is similar.
“An emergency use authorization, really the same information is looked at like safety, data, and overall manufacturing,” Landers explained.
The manufacture must submit data about the vaccine to the FDA. Landers said the amount of data submitted to the FDA differs by months.
“With full authorization, you’re talking about 6 months of data overall. For expedited (emergency use authorization ) it’s a couple of months.”
Then the FDA begins their evaluation of the vaccine.
Landers said the evaluation process could take 10 months or more for full approval with emergency use au
Authorization taking about six months.
As for if a vaccine is safer after full approval, Landers said there’s always risks but there’s an upside with emergency use of the COVID vaccines.
“We have certainly had a lot more experience giving this vaccine and a lot more data that really supports the safety and the efficacy of the vaccine,” Landers said.
Once a vaccine is fully approved by the FDA, according to Landers consent will change meaning you likely won’t be required to sign a waiver before getting a shot.
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