Covid-19 roundup: FDA for­mal­ly hands Pfiz­er/BioN­Tech's vac­cine a pri­or­i­ty re­view; Eu­ro­pean reg­u­la­tors look to Kineret to treat at-risk pa­tients

The FDA said last Fri­day that it would give an ex­pe­dit­ed look at the Pfiz­er-BioN­Tech vac­cine for full ap­proval in pa­tients ages 16 and old­er, with a PDU­FA date set in Jan­u­ary. But if past re­ports hold true, the jab could get the go-ahead long be­fore the start of 2022.

Pe­ter Marks, the di­rec­tor of the FDA’s Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search, told End­points News in an April in­ter­view that it typ­i­cal­ly takes eight months to gain full ap­proval, with two months to re­view the fil­ing and six months to re­view the ac­tu­al ap­pli­ca­tion. Due to the pub­lic health emer­gency at hand, Marks said that the agency was look­ing to make a de­ci­sion on a “no­tably ear­li­er ba­sis” than nor­mal.

Endpoints News

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Life Sciences Senior Associate

General Catalyst

San Francisco, CA, USA