FDA clos­es the door on EUA re­quests for some fu­ture Covid-19 vac­cines

The FDA late Tues­day said that for the re­main­der of the pan­dem­ic, it may de­cline to re­view and process fur­ther EUA re­quests for Covid-19 vac­cines, un­less a de­vel­op­er has al­ready en­gaged with the agency.

The move os­ten­si­bly will push lat­er Covid-19 vac­cine en­trants to go the long route and sub­mit a full BLA with more man­u­fac­tur­ing and safe­ty da­ta rather than use the short­ened EUA process.

The de­ci­sion al­so comes as Pfiz­er has al­ready sub­mit­ted its full BLA to the FDA (and Mod­er­na will soon fol­low suit), and FDA’s top vac­cine of­fi­cial Pe­ter Marks pre­vi­ous­ly told End­points News that it may on­ly take a few months to re­view those ap­pli­ca­tions.

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