Pfizer and BioNTech Apply for Regulatory Clearance of Their COVID Vaccine
There will likely be enough vaccine for 25 million to 30 million people a month
Pfizer and its German partner BioNTech applied Friday for emergency authorization of their coronavirus vaccine, a landmark moment and a signal that a powerful tool to help control the pandemic could begin to be available by late December.
The U.S. race to develop a vaccine has set scientific speed records since it launched in January, and the submission of a first application to regulators cements that. Now, that effort will move to its next, deliberative phase — a weeks-long process in which career scientists at the FDA to scrutinize the data and determine whether the vaccine is safe and effective to be used in a broad population.
"It is with great pride and joy, and even a little relief that I can say our request for emergency use authorization for a COVID-19 vaccine is now in the FDA'hands," Pfizer chief executive Albert Bourla said in a video message shared by the company. "This is a historic day — a historic day for science and for all of us."
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