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The U.S. Food and Drug Administration has approved GSK’s RSV vaccine, the British drugmaker said on Wednesday, making it the first shot to be cleared for protection against a common respiratory disease that can be fatal for older people.
The vaccine, Arexvy, was approved for people aged 60 and older, the company said.
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.
The approval marks a huge development in the fight against RSV, as scientists have been trying for decades to produce a vaccine for the respiratory virus.
“There’s just the broad excitement of finally, after all these years, having good options emerging for RSV,” Phil Dormitzer, GSK’s senior vice president and global head of vaccines research and development, told STAT News in an interview. “I guess also the triumph of the basic science — the fact that a very basic study … really changed the hunt for a vaccine and led to one or even more than one potential products coming forward to prevent RSV.”
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 on Wednesday, 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 U.S. Centers for Disease Control and Prevention (CDC) said.
The question of how often the vaccine should be given is to be placed before the CDC’s panel of advisors on immunization. The RSV vaccination is a topic that is expected to be discussed when the panel is set to meet in late June, a CDC spokesperson told Reuters.
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% and was about 94% effective against severe lower respiratory tract disease associated with an RSV infection among participants aged 60 and older in its late-stage trial.
Later this year, the FDA is expected to give approval to a Pfizer RSV vaccine that targets infants under six months. This is the demographic most likely to be hospitalized by the virus.
Copyright 2023 Thomson/Reuters. Additions and edits for FISM News by Michael Cardinal.