TOPLINE
Drugmaker GSK said Wednesday its RSV vaccine gave long-term protection in older adults after a single shot, according to results from its late stage clinical trial, promising news for efforts to combat the common and potentially lethal infection.
KEY FACTS
GSK said the shot, which is designed to protect adults ages 60 and older and is marketed as Arexvy, conveyed strong protection against lower respiratory tract disease and severe disease from RSV over two full seasons.
The findings, which have yet to be fully published, come from the company’s late stage trial of around 25,000 people testing the safety and efficacy of a single dose of Arexvy against RSV, a very common respiratory infection that normally only causes mild, cold-like illness in healthy adults but can trigger severe, possibly fatal, disease in older adults, young infants and those with underlying health conditions.
Lasting protection was also observed in people with underlying health conditions or of advanced age, GSK said, a particularly important finding given the vulnerability of these groups following infection.
Tony Wood, GSK’s chief scientific officer, said the result “reinforces our confidence in [the vaccine’s] potential to make a significant public health impact.”
Other data, notably the shot’s safety and ability to provoke an immune response, were consistent with earlier observations from the trial, which showed the shot to be safe and have side effects in line with other vaccines.
WHAT WE DON’T KNOW
It’s not clear how often people will need to be vaccinated against RSV and the seasonal nature of the virus—similar to what happens with flu—suggests vaccines could be yearly. This is still an open question and one that will be guided over time by public health policy, real-world data and other concerns in addition to clinical trial data. GSK evaluated an annual revaccination schedule in around half of its trial participants. The findings were similar to those who had only received the one shot and suggested “revaccination after 12 months does not appear to confer additional benefit for the overall population,” GSK said. The company said it will continue to “evaluate longer term follow up” and assess the “optimal timing for potential revaccination.”
WHAT TO WATCH FOR
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is set to meet Wednesday. The group, comprised of vaccine and public health experts, meets regularly to discuss the science surrounding vaccines and infectious diseases and develop guidelines for how vaccines should be administered to the civilian population. These guidelines form the basis of official immunization schedules. RSV vaccines for older adults are on the agenda and talks will determine how they are rolled out for the very first time. There are now two authorized shots intended to protect older adults from RSV, both of which were only approved this year after years of setbacks. GSK’s shot was the first to gain clearance, followed closely by Pfizer’s shot, Abrysvo. FDA advisors have recommended the agency clear Pfizer’s shot for use in pregnant people to protect infants in their first months of life.
FURTHER READING
FDA Approves Pfizer’s RSV Vaccine For Older Adults—It Could Be Available This Fall (Forbes)