Pfizer Asks FDA To Approve Its COVID-19 Vaccine For Emergency Use
Pfizer is formally asking federal authorities to authorize its COVID-19 vaccine for emergency use. The pharmaceutical giant and its partner BioNTech announced that they are submitting their request to the Food and Drug Administration on Friday.
"Filing for Emergency Use Authorization in the U.S. is a critical step in making our vaccine candidate available to the global population as quickly as possible," BioNTech CEO Ugur Sahin said in a joint statement released by the companies. "We intend to continue to work with regulatory agencies worldwide to enable the rapid distribution of our vaccine globally."
The request comes as little surprise, as NPR's Joe Palca reported Thursday that the companies intended to move quickly after the release of promising clinical trial data about the vaccine earlier this week. The final analysis of the vaccine, released Wednesday, found the vaccine to be 95% effective — a significant improvement over the 90% effectiveness shown in an interim analysis earlier this month.
On Thursday, Pfizer CEO Albert Bourla told NPR's All Things Considered that once the vaccine receives federal authorization for emergency use, "we will be ready to start distributing our vaccine within hours."
The vaccine developed by Pfizer and BioNTech is not alone. The American biotech company Moderna announced Monday that its own COVID-19 vaccine is 94.5% effective in preventing illness following exposure to the coronavirus.
Moderna is also expected to file a request with the FDA to begin emergency use.
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