Drugmaker GSK said its RSV, or respiratory syncytial virus, vaccine Arexvy is safe and effective for adults ages 50-59 who have a higher risk of complications from RSV. GSK submitted findings from its Phase 3 trial to the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices on Wednesday.
The committee could soon decide to recommend making the vaccine available for these adults.
Arexvy is currently approved for adults ages 60. It became the first RSV vaccine approved by the Food and Drug Administration for adults earlier this year.
“Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said earlier this year.
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The CDC estimates that RSV causes 6,000-10,000 deaths among adults 65 years of age and older annually.
As part of its Phase 3 trials, GSK enrolled adults ages 50-59 with with chronic pulmonary disease, chronic cardiovascular disease, diabetes, chronic kidney disease or chronic liver disease. The vaccine provided an improved immune response compared to those given a placebo, the company says.
“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. 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," Tony Wood, GSK chief scientific officer, said.
RSV tends to disproportionately affect infants and the elderly. Adults and older children who are healthy tend to have mild cases if infected. Doctors say preventing the spread of RSV is similar to stopping the spread of other diseases, including COVID-19 and the flu.
The CDC said that adults over age 60 should talk to their doctor on whether to get an RSV vaccine.
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