GSK RSV shot ap­proved by FDA, start­ing next block­buster vac­cine race

GSK se­cured the first-ever FDA ap­proval for an RSV vac­cine on Wednes­day, end­ing half a cen­tu­ry of failed ef­forts against the elu­sive, shape-shift­ing virus and of­fi­cial­ly start­ing what an­a­lysts ex­pect will be a high­ly com­pet­i­tive and lu­cra­tive new vac­cine mar­ket.

The FDA cleared GSK’s shot, which will be sold as Arexvy, for adults 60 and old­er. In a tri­al, it showed strong ef­fi­ca­cy in stop­ping low­er-res­pi­ra­to­ry tract in­fec­tions as well as more se­vere dis­ease. It’s giv­en as a sin­gle dose.

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