Covid-19 roundup: Pfiz­er and Mod­er­na take their vac­cines to the EMA; Chief of Staff Mark Mead­ows calls Hahn to White House — re­port

With their Covid-19 vac­cines now in the FDA’s hands, part­ners Pfiz­er and BioN­Tech and their close com­peti­tor Mod­er­na have filed for con­di­tion­al mar­ket­ing au­tho­riza­tion in Eu­rope.

The sub­mis­sions mark the com­ple­tion of rolling re­view process­es ini­ti­at­ed on Oct. 6 and Nov. 17, re­spec­tive­ly, to speed up ap­proval. In do­ing so, the EMA’s hu­man med­i­cines com­mit­tee be­gan eval­u­at­ing the first batch of da­ta be­fore the rest was sub­mit­ted. For Pfiz­er and BioN­Tech, that meant sub­mit­ting non­clin­i­cal and par­tial CMC da­ta be­fore send­ing in its clin­i­cal da­ta. Mod­er­na sub­mit­ted some im­muno­genic­i­ty da­ta and safe­ty da­ta from an ear­ly study be­fore com­plet­ing its fil­ing.

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