FDA sig­nals sup­port for Pfiz­er’s RSV shot in ad­comm docs be­fore cru­cial vote

The FDA re­leased brief­ing doc­u­ments on Tues­day de­scrib­ing Pfiz­er’s RSV vac­cine as ef­fec­tive at pre­vent­ing se­vere dis­ease with a “gen­er­al­ly fa­vor­able” safe­ty pro­file, tee­ing up a crit­i­cal ad­vi­so­ry com­mit­tee vote sched­uled for Thurs­day.

Pfiz­er’s one-shot vac­cine against res­pi­ra­to­ry syn­cy­tial virus, or RSV, could be­come the first such in­oc­u­la­tion ap­proved to pro­tect in­fants by vac­ci­nat­ing preg­nant women 24 to 36 weeks in­to preg­nan­cy. The FDA is set to make an ap­proval de­ci­sion by Aug. 21.

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