Topline
Drugmaker GSK on Wednesday announced promising preliminary results from a late-state trial of its RSV vaccine in people aged 50 to 59, offering hope of expanding access to the landmark shot and boosting efforts to combat the common and potentially deadly respiratory infection.
Key Facts
GSK said the vaccine, marketed as Arexvy, elicited an immune response in adults aged 50 to 59 who are at risk of RSV disease due to underlying medical conditions after a single dose.
This immune response was not worse than that observed in adults aged 60 and above, a group for whom a single shot conveys strong protection against lower respiratory tract disease and severe disease from RSV, GSK said.
The preliminary results are from a late-stage clinical trial for the vaccine that involves around 1,520 people across eight countries.
The company 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.
GSK added that it is “on track” to become the first company to submit data to regulators covering this age group and expects a decision on a potential “label expansion” in 2024 that would allow it to market the shot to a wider array of people.
Tony Wood, GSK’s chief scientific officer, said the trial “reinforces our confidence in our RSV vaccine’s ability to help protect adults” at an increased risk from RSV and that the company plans to submit data for regulatory “review as quickly as possible.”
Key Background
Respiratory syncytial virus, often known as just RSV, is a ubiquitous infection that will visit almost all people by the time they reach two years of age. For most healthy people, RSV will only cause a mild, cold-like illness but it can cause serious and potentially fatal disease in older adults, infants and people with underlying medical issues like compromised immune systems. It is responsible for thousands of hospitalizations and deaths each year in the U.S. and globally is the biggest killer of young infants after malaria. Among infants, RSV is responsible for around 100 to 300 deaths and around 58,000-80,000 hospitalizations in children younger than 5 years old each year, according to the CDC, and causes an estimated 14,000 deaths and 160,000 hospitalizations in adults 65 and over.
News Peg
Should GSK’s request to expand Arexvy’s label receive a regulatory green light, it will become the first RSV shot on the market for this age group. It marks the next leg of a decades-long race to develop an RSV vaccine that has challenged—and eluded—scientists for decades. Arexvy made history as the first RSV vaccine to reach market in May when it secured approval from the Food and Drug Administration. It was closely followed by Pfizer’s shot, Abrysvo, which has now been authorized for use in both older adults and as a maternal vaccine for pregnant people in order to protect infants from birth. A protective drug—an antibody shot from Sanofi that can help prevent RSV infection—is also on the market, though it is in short supply and health care providers have been advised to prioritize at-risk infants.
CDC updates RSV shot recommendations due to drug shortages (WaPo)
FDA Approves First RSV Vaccine For Kids—Given To Pregnant Moms—Here’s What To Know (Forbes)
FDA Approves Pfizer’s RSV Vaccine For Older Adults—It Could Be Available This Fall (Forbes)
Read the full article here