Covid-19 roundup: Ear­ly fall ap­proval date of Pfiz­er-BioN­Tech jab still an­tic­i­pat­ed; EU buys 200M dos­es of No­vavax vac­cine

The FDA has set an un­of­fi­cial dead­line to ful­ly ap­prove the Pfiz­er-BioN­Tech by La­bor Day, the New York Times re­port­ed Wednes­day.

The timetable is in line with what Pe­ter Marks, the FDA’s di­rec­tor of the Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search, has said in pre­vi­ous in­ter­views.

In an April in­ter­view with End­points News, Marks said that the ex­act time­line will vary de­pend­ing on the qual­i­ty of the da­ta for each man­u­fac­tur­er, not­ing that for the 2014 meningo­coc­cal B out­break, it took 3-4 months to ap­prove BLAs.

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