GSK RSV vaccine shows potential to guard adults 50 to 59

A vaccine from GlaxoSmithKline showed the potential to guard adults ages 50 to 59 from respiratory syncytial virus in a late-stage clinical trial, the corporate said Wednesday.

The initial trial results suggest that GSK’s shot, referred to as Arexvy, could help protect a wider population from RSV, a disease that causes hundreds of hospitalizations and deaths amongst older Americans every year. Currently, Arexvy is approved within the U.S., Europe, Japan and other countries for adults ages 60 and older. 

A single dose of the British drugmaker’s shot elicited an immune response in adults ages 50 to 59 who’re at an increased risk of catching RSV resulting from certain underlying medical conditions. 

The immune response wasn’t worse than that observed in adults 60 and above, GSK said in a release. A previous late-stage trial on that older age group found that the shot was nearly 83% effective at stopping lower respiratory tract disease brought on by RSV.

Safety data in adults ages 50 to 59 was also consistent with data in adults 60 and above, in line with GSK.

GSK said it plans to present final results from the trial at an upcoming medical conference and submit them for publication in a peer-reviewed journal. The corporate added that it’s “on the right track” to develop into the primary company to submit data on this age group to the Food and Drug Administration and other regulators and expects a choice on a possible label expansion in 2024. 

“We are going to submit these data for regulatory review as quickly as possible with the goal of offering adults on this age group the choice of a vaccine for the primary time,” Tony Wood, GSK’s chief scientific officer, said in a release. 

Pfizer is the one other company with an approved RSV vaccine in the marketplace. The corporate’s shot is approved for adults 60 and older and expectant moms who can pass on protection to their fetuses.

Pfizer didn’t immediately reply to a request for comment on whether it’s going to present its own data on adults ages 50 to 59.

U.S. health officials are banking on the shots from Pfizer and GSK shots to assist the country combat this yr’s RSV season. RSV and other respiratory viruses reminiscent of the flu are already beginning to flow into, but to this point at lower rates than this time last yr, the CDC said last week. 

The U.S. suffered an unusually severe RSV season last yr. Cases of the virus in children and older adults overwhelmed hospitals across the country, largely because the general public stopped practicing Covid pandemic health measures that had helped keep the spread of RSV low. 

RSV often causes mild, cold-like symptoms. But every year the virus kills 6,000 to 10,000 seniors and a couple of hundred children younger than 5, in line with the CDC.