Albert Bourla, Pfizer CEO (Steven Ferdman/Getty Images)

It's of­fi­cial: Pfiz­er and BioN­Tech have sub­mit­ted their Covid-19 vac­cine to the FDA — and the agency cir­cled a date for the ad­comm

Pfiz­er and BioN­Tech’s re­quest for emer­gency au­tho­riza­tion of its Covid-19 vac­cine is now in the FDA’s hands. Reg­u­la­tors caught the ap­pli­ca­tion Fri­day af­ter­noon in an open field dash to the goal line.

The agency im­me­di­ate­ly marked Dec 10 on the cal­en­dar for an ad­vi­so­ry com­mit­tee meet­ing to dis­cuss the re­quest. Pfiz­er and BioN­Tech first an­nounced the sub­mis­sion was com­ing on Fri­day morn­ing, and Pfiz­er CEO Al­bert Bourla con­firmed the fil­ing in a video state­ment lat­er that af­ter­noon. The “his­toric day,” as Bourla called it, came just 248 days af­ter the phar­ma first an­nounced plans to de­vel­op the can­di­date with BioN­Tech — a process which typ­i­cal­ly takes years.

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