Two for two: GSK fol­lows Pfiz­er, se­cures ad­comm thumbs-up for RSV vac­cine in old­er adults

FDA’s vac­cine ad­vi­so­ry com­mit­tee gave a thumbs-up to GSK’s RSV vac­cine can­di­date on Wednes­day, mark­ing the end of a two-day ad­comm where ex­perts gave their feed­back on two Big Phar­ma can­di­dates.

The Vac­cines and Re­lat­ed Bi­o­log­i­cal Prod­ucts Ad­vi­so­ry Com­mit­tee (VRB­PAC) vot­ed 10-2 Wednes­day af­ter­noon that GSK’s da­ta sup­port the safe­ty of its RSV vac­cine can­di­date, which would be brand­ed as Arexvy, in adults at least 60 years of age. The com­mit­tee lat­er vot­ed unan­i­mous­ly — 12-0 — that GSK’s da­ta show ef­fi­ca­cy.

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