GSK has reported new clinical data pointing to a benefit with its respiratory syncytial virus (RSV) vaccine Arexvy when used to treat a younger age group than the over-60s for whom it is approved.
Preliminary results from a phase 3 trial of the shot have shown that it can generate the same level of immune response adults aged 50 to 59 as in older patients, including those who have underlying health conditions that could make them more vulnerable to RSV disease.
GSK said it is already preparing regulatory filings for Arexvy in this population and is hoping for approvals to expand the label for the vaccine next year, which could give it a segment of the market in which it does not have to compete with Pfizer’s Abrysvo, currently the only other FDA-approved RSV vaccine.
Both Arexvy and Abrysvo were cleared earlier this year to prevent RSV-related lower respiratory tract disease (RSV-LRTD) in people aged 60 and over and have also been recommended for use in the upcoming RSV season by the Centres for Disease Control and Prevention (CDC) Advisory Committee on Immunisation Practices (ACIP) for people who feel it is appropriate.
The ACIP’s recommendation was not a ringing endorsement, stopping short of backing widespread use of the shots, which has led to speculation that they may be used mainly for older adults with underlying health conditions. Abrysvo meanwhile can also be used as a maternal vaccine to prevent RSV disease in newborns and infants.
The placebo-controlled study in 1,576 subjects was designed to show non-inferiority in the younger age group compared to the over-60s, including a cohort of healthy adults in the 50 to 59 bracket as well as a cohort with a range of conditions including chronic pulmonary, cardiovascular, kidney or liver disease and diabetes.
GSK said it would present the data to the ACIP today, and also submit it for publication and presentation at an upcoming medical conference.
“This trial reinforces our confidence in our RSV vaccine’s ability to help protect adults aged 50 to 59 at increased risk for RSV-LRTD,” commented Tony Wood, GSK’s chief scientific officer.
“We will submit these data for regulatory review as quickly as possible with the goal of offering adults in this age group the option of a vaccine for the first time,” he added.
Pfizer is also running a phase 3 trial of Abrysvo in adults at elevated risk of RSV disease due to chronic medical conditions involving 675 subjects, aged between 18 and 59, with results due next year.
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