Moderna files RSV vaccine for older adults in US and Europe

Mod­er­na said Wednes­day that it start­ed a rolling sub­mis­sion to the FDA for its RSV vac­cine in adults 60 years and old­er as it aims to take on Pfiz­er and GSK in what is ex­pect­ed to be a multi­bil­lion-dol­lar mar­ket.

Mod­er­na al­so said it filed for reg­u­la­to­ry re­view of its RSV vac­cine hope­ful in Aus­tralia, Eu­rope, and Switzer­land.

In a news re­lease, the com­pa­ny said it based its sub­mis­sions on an in­ter­im analy­sis from an on­go­ing piv­otal RSV tri­al, known as Con­querRSV. Mod­er­na had ini­tial­ly re­port­ed the win in Jan­u­ary, when the can­di­date, mR­NA-1345, met both of its pri­ma­ry ef­fi­ca­cy end­points — de­fined by ei­ther at least two symp­toms of RSV-as­so­ci­at­ed low­er res­pi­ra­to­ry tract dis­ease or at least three symp­toms of the dis­ease. The biotech said then the vac­cine showed 83.7% ef­fi­ca­cy in the two-symp­toms group and 82.4% in the three-symp­toms group.

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