On Pfiz­er's heels, GSK boasts 'tru­ly ex­cep­tion­al' PhI­II da­ta for RSV vac­cine — mak­ing a bee­line to FDA

Pfiz­er won’t be the on­ly drug­mak­er to file an RSV vac­cine with the FDA this year.

GSK — an­oth­er fron­trun­ner in the long race to de­vel­op a shot that can pro­tect the el­der­ly from res­pi­ra­to­ry syn­cy­tial virus in­fec­tions — is out with what CSO Tony Wood calls “tru­ly ex­cep­tion­al” Phase III re­sults, open­ing the door to reg­u­la­to­ry sub­mis­sions in 2022.

The up­date marks a key and much-need­ed win for GSK’s RSV am­bi­tions af­ter an ob­ser­va­tion re­lat­ed to safe­ty forced it to stop tri­als in preg­nant women. It had hoped that by vac­ci­nat­ing preg­nant women, it could im­mu­nize ba­bies against the virus.

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