Pfiz­er de­clares 'first-ever' PhI­II win for RSV vac­cine in in­fants — and it's steer­ing straight to FDA

In a first, Pfiz­er says it’s demon­strat­ed that it can pro­tect in­fants from res­pi­ra­to­ry syn­cy­tial virus by vac­ci­nat­ing their moth­ers dur­ing preg­nan­cy.

Pfiz­er is stop­ping en­roll­ment in its Phase III MA­TISSE tri­al af­ter it met one of two pri­ma­ry end­points at an in­ter­im analy­sis by the ex­ter­nal da­ta mon­i­tor­ing com­mit­tee. As mea­sured by se­vere med­ical­ly at­tend­ed low­er res­pi­ra­to­ry tract (MA-LR­TI) ill­ness through the first 90 days of life, the com­mit­tee found an ef­fi­ca­cy of 81.8% (CI: 40.6%, 96.3%). The num­ber fell to 69.4% over the six-month fol­low-up pe­ri­od.

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