US approves 1st vaccine for RSV after decades of attempts

WASHINGTON – The US approved the first vaccine for RSV, shots to protect older adults against a respiratory virus that´s most notorious for attacking babies but endangers their grandparents, too.

The Food and Drug Administration decision makes GSK´s shot, called Arexvy, the first of several potential vaccines in the pipeline for RSV to be licensed anywhere.

The vaccine, Arexvy, was approved for people aged 60 and older, the company said.

The move sets the stage for adults 60 and older to get vaccinated this fall – but first, the Centers for Disease Control and Prevention must decide if every senior really needs RSV protection or only those considered at high risk from the respiratory syncytial virus. CDC´s advisers will debate that question in June.

The approval makes GSK, which has been neck-and-neck with Pfizer in RSV vaccine development, the first company to tap into a multi-billion-dollar market and also puts it ahead of rivals such as Moderna Inc and Bavarian Nordic.

Analysts have estimated the market for RSV vaccines to surpass $10 billion by 2030. Credit Suisse analysts expect $2.5 billion in peak sales for GSK’s RSV vaccine for older adults.

GSK expects the vaccine to be available before the next RSV season in the United States, Chief Commercial Officer Luke Miels told Reuters, ahead of the approval.

He said the vaccine would be priced above $120 per shot provided the data from a study, which is expected soon, shows that it offers protection for two RSV seasons.

RSV cases in the most recent season started last year in June and peaked in November, the US Centers for Disease Control and Prevention (CDC) said.

The question on how often the vaccine should be given is to be placed before CDC’s panel of advisors on immunisation. The panel is scheduled to meet in June and the agenda was not immediately clear.

The CDC did not immediately respond to a Reuters request for comment.

RSV is responsible for 14,000 deaths in adults aged 65 and older annually in the United States, according to government estimates.

GSK’s vaccine showed overall efficacy of 82.6 per cent and was about 94 per cent effective against severe lower respiratory tract disease associated with an RSV infection among participants aged 60 and older in its late-stage trial.