GSK announced in June 2024 that the US FDA has approved its RSV vaccine, Arexvy, for the prevention of RSV lower respiratory tract disease (LRTD) in adults between the ages of 50 and 59 with increased risk. The vaccine is already approved for use in adults aged 60 and older in the US. RSV is estimated to cause 42,000 hospitalisations each year in adults between 50 and 64 years old, and adults with underlying medical conditions are at increased risk for “severe consequences” from an RSV infection.
Arexvy
GSK’s vaccine contains recombinant RSV glycoprotein F stabilised in the prefusion conformation (RSVPreF3). The antigen is combined with the proprietary AS01E adjuvant. The vaccine was approved by the FDA in May 2023 for the prevention of RSV-LRTD in older adults. It has also been approved for the prevention of RSV-LRTD in this population in over 40 countries, with regulatory reviews ongoing in more countries.
The latest approval was supported by positive results in a phase III, placebo-controlled, observer-blind, randomised, multi-country immunogenicity trial in participants aged 50 to 59. GSK has filed regulatory submissions to extend the use of the vaccine to adults aged 50-59 at increased risk in Europe and Japan, among others. It also has trials underway to evaluate the immunogenicity and safety of the vaccine in adults aged 18-49 at increased risk and immunocompromised adults aged 18 and over.
Chief Scientific Officer, GSK, Tony Wood, commented that the approval “reflects the importance of broadening the benefits of RSV immunisation to adults aged 50-59 who are at increased risk”.
“For those with underlying medical conditions, RSV can have serious consequences, so we are proud to be the first to help protect them from RSV-LRTD.”
Professor Ann R. Falsey from the University of Rochester School of Medicine is “thrilled” by the approval.
“When it comes to the risks associated with RSV, age is just a number, an important number, but not the only factor to consider. Many adults in this age group have underlying health conditions that place them at increased risk for serious illness with RSV infection compared with those without these conditions. Now there is a vaccine approved that can help them.”
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