Moderna starts application process for RSV vaccine for older adults

(Reuters) -Moderna Inc said on Wednesday it had started the application process to get an approval for its respiratory syncytial virus (RSV) vaccine in older adults with regulators in the United States, Australia and Europe.

The company said it had started rolling submission of data for the shot with the U.S. Food and Drug Administration. It is aiming to be the third vaccine maker to get an approval in the country after GSK and Pfizer Inc.

Moderna has also submitted applications to the European, Swiss and Australian regulators, the company said.

Its RSV vaccine is one of the key products in Moderna's pipeline that is expected to help revive sales for the company next year as it transitions from a possible net loss this year.

Moderna's shot, which it is aiming to launch in the United States in 2024, was found to be 82.4% effective against RSV lower respiratory tract disease with three or more symptoms in older adults in a late-stage trial.

GSK and Pfizer are expected to launch their vaccines this fall season.

The efficacy of Pfizer's vaccine fell to 78.6% through the middle of a second RSV season from 88.9% at the end of the first season in older adults, while that of GSK's shot fell to 84.6% from about 94% at the end of first.

At a meeting of advisers to the U.S. Centers for Disease Control and Prevention, GSK said it expects to price its shot between $200 and $295 a dose.

Meanwhile, Pfizer provided the CDC with a price range of $180 to $270 per dose, but would not guarantee that its final price would fall within that range, saying it was in the middle of competitive price negotiations on the shots.

(Reporting by Leroy Leo in Bengaluru; Editing by Shinjini Ganguli)