Pfiz­er heads to the FDA with an ear­ly lead over ri­vals in the $10B RSV vac­cine mar­ket

The 50-year race to de­vel­op an RSV vac­cine turned a cor­ner on Thurs­day with Pfiz­er un­veil­ing promis­ing piv­otal da­ta for its bi­va­lent RSV vac­cine can­di­date, promis­ing to take the da­ta to the FDA ahead of sev­er­al ri­vals in a mar­ket that could stretch to $10 bil­lion by 2030.

In as­sess­ing pro­tec­tion against RSV-as­so­ci­at­ed low­er res­pi­ra­to­ry tract ill­ness (LR­TI-RSV), de­fined by two or more symp­toms, Pfiz­er said the can­di­date demon­strat­ed vac­cine ef­fi­ca­cy of 66.7% (96.66% CI: 28.8%, 85.8%) in a place­bo-con­trolled Phase III tri­al with about 37,000 par­tic­i­pants.

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