Pfizer, Biontech Receive Emergency Use Approval For Covid Vaccine In U.S.

Pfizer (PFE) and BioNTech (BNTX) announced last night that the Food and Drug Administration has authorized the emergency use of the mRNA vaccine, BNT162b2, against COVID-19 in individuals 16 years of age or older.

The vaccine is now authorized under an Emergency Use Authorization while Pfizer and BioNTech gather additional data and prepare to file a planned Biologics License Application with the FDA for a possible full regulatory approval in 2021. Under Operation Warp Speed, the Department of Defense in partnership with agencies within the Department of Health and Human Services, including the U.S. Centers for Disease Control and Prevention, will manage allocation and distribution of the vaccine in the U.S., the companies said in a statement.

Pfizer and BioNTech plan to provide an option for trial participants who received the placebo to receive the vaccine at scheduled timepoints in the study. Pfizer is leveraging three of its U.S. manufacturing sites to produce the COVID-19 vaccine - Saint Louis, Missouri, Andover, Massachusetts, and Kalamazoo, Michigan. Pfizer's Pleasant Prairie, Wisconsin and Puurs, Belgium sites are also being used.

 

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