GSK RSV vax grabs expanded approval for at-risk adults

June 10, 2024

The U.S. FDA has approved a label expansion for GSK's RSV vaccine, Arexvy, for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50 through 59 years of age who are at increased risk. 

In May 2023, Arexvy became the first RSV vaccine to win approval in the U.S. when it got the nod for use in individuals aged 60 and older. But according to GSK, RSV is estimated to cause 42,000 hospitalizations each year in adults aged 50-64 years old and adults with underlying conditions such as COPD, asthma, heart failure and diabetes face increased risk of severe consequences.

GSK has filed regulatory submissions to extend the use of its RSV vaccine — which contains recombinant RSV glycoprotein F stabilized in the prefusion conformation combined with the company's proprietary AS01E adjuvant — to adults aged 50-59 at increased risk in Europe, Japan and other geographies. Trials are also underway testing the vaccine in adults aged 18-49 at increased risk, with results expected in the second half of this year.  

There are currently three FDA approved vaccines for the highly contagious and commonly found RSV virus. Pfizer’s bivalent RSV vaccine, Abrysvo, was approved for adults 60 and older in June 2023. A few months later, Abrysvo was approved  for use in pregnant individuals, marking the first and only U.S. approval of a maternal vaccine to help protect infants from LRTD and severe LRTD due to RSV.
Last month, the FDA approved Moderna's mRNA vaccine, mRESVIA, for adults aged 60 and older.