The U.S. Food and Drug Administration announced Friday that it approved a Pfizer COVID-19 vaccine for emergency use. One of Pfizer’s U.S. manufacturing sites to produce the vaccine is in Andover, according to a release by Pfizer on Friday.
The other sites are in Saint Louis, Missouri and Kalamazoo, Michigan. Their Pleasant Prairie, Wisconsin, and Puurs, Belgium sites will also be used.
The emergency use of the mRNA vaccine will be available to those 16 years of age or older, Pfizer said. Pfizer and BioNTech will gather additional data and prepare to file a planned Biologics License Application with the FDA for a possible full regulatory approval for 2021, the company said.
“Pfizer’s purpose is breakthroughs that change patients’ lives, and in our 171-year history there has never been a more urgent need for a breakthrough than today with hundreds of thousands of people continuing to suffer from COVID-19,” said Albert Bourla, Chairman and Chief Executive Officer of Pfizer.
The FDA based its decision on the totality of scientific evidence shared by the companies, Pfizer said.
Pfizer said that with BioNTech, they project to have the potential to supply globally 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021.
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Cox Media Group
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