FACT FINDERS: How did Pfizer get FDA approval so fast?
TUCSON, Ariz. (KOLD News 13) - Full approval from the U.S. Food and Drug Administration of the COVID-19 vaccine is news many have been waiting for in order to feel safe to get the vaccine. But some remain skeptical, saying FDA approval was rushed.
FDA officials say they did not cut corners. Officials say it meets their standards for safety, effectiveness, and manufacturing quality.
“The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.,” said Peter Marks, who heads the FDA’s Center for Biologics Evaluation and Research.
University of Arizona immunobiologist Dr. Deepta Bhattacharya says not only does he believe this drug is safe but it’s been tested at an unprecedented level.
”Right now, more than any other vaccine, in our lifetimes it’s been given to more people,” he said. “I mean it’s billions of people that have received vaccines and it’s been ongoing since like a year ago if you factor in when these phase three trials were started. So, it’s hard to imagine how one could get any more data on these vaccines than what we have right now.”
So, just how did Pfizer’s COVID-19 vaccine for those 16 and older get approval so quickly? The FDA granted it Priority Review, meaning FDA officials planned to take action within six months of its release..
This does not affect the length of the clinical trial period. In this case, they said they pulled in extra help and worked around the clock to get it done even faster. For comparison, Standard Review can take around 10 months.
More information about the FDA’s Priority Review can be found HERE.
FDA approval is important for a number of reasons. When the health emergency is over, any Emergency Use Authorizations issued based on that declaration go away.
But with full approval, the vaccine can stay on the market unaffected. To learn more about FDA Emergency Use Authorization, click HERE.
Moderna is in the process of applying for full approval for those 18 and older. Johnson and Johnson has not yet filed. To read more about Pfizer’s FDA approval, click HERE.
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