The FDA has expanded its approval of a GSK vaccine that prevents respiratory syncytial virus (RSV) to affect younger adults, in a move the company hopes will prevent thousands of hospitalisations each year.
The vaccine, Arexvy, is produced by British pharmaceutical company GSK and is currently only available for adults aged 60 years of older in the US.
According to the firm’s research, there are about 13 million people between the ages of 50 and 59 in the US with underlying conditions that place them at higher risk of RSV disease, including congestive heart disease, asthma, diabetes and chronic kidney disease.
Around 42,000 people between the age of 50 and 65 are hospitalised by the contagious virus every year.
Tony Wood, GSK’s chief scientific officer, said: “Today’s 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.”
“The regulatory application was supported by positive results from a phase III trial evaluating the immune response and safety of GSK’s RSV vaccine in adults aged 50-59, including those at increased risk for RSV-LRTD due to certain underlying medical conditions.”
Professor Ann R. Falsey from University of Rochester School of Medicine, added: “I am thrilled that GSK’s RSV vaccine is now approved for adults aged 50-59 at increased risk of RSV-LRTD.
“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 protect them.”
GSK has also filed submissions to extend the use of its RSV vaccine in Europe and Japan, with regulatory decisions undergoing review.
Trials of the vaccine in adults aged 18-49 at increased risk, and immunocompromised adults aged 18 and over, are expected to conclude later in the year.