An RSV vaccine approved for use in older adults could help protect people as young as 50 who have certain underlying medical conditions and are at increased risk from the respiratory virus, according to preliminary data released by vaccine maker GSK.
The company said it would submit the information to the US Food and Drug Administration for potential expansion of the vaccine’s availability. Earlier this year, the FDA approved Arexvy for adults age 60 and older. Respiratory syncytial virus, known as RSV, is a highly contagious virus that causes flu-like illness in people of all ages.
GSK said Wednesday that a Phase 3 trial found Arexvy elicited an immune response in adults ages 50 to 59 who were at an increased risk for RSV due to underlying medical conditions.
Study participants were diagnosed with at least one underlying medical condition, such as chronic pulmonary disease, chronic cardiovascular disease or diabetes. Researchers also met the primary endpoint for a group of adults aged 50 and above enrolled in the study who did not have any pre-defined chronic diseases.
“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,” Tony Wood, GSK’s chief scientific officer, said in a statement. “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.”
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Data from the trial has not yet been peer-reviewed or published. The results were to be presented Wednesday at the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices meeting.
The data will also be submitted to the FDA and other regulators to support potential label expansions, according to GSK. Any decisions on the potential label expansion of Arexvy are expected in 2024.
Another RSV vaccine, Pfizer’s Abrysvo, was also approved this year for use in people age 60 and older.