On Tuesday, the US Food and Drug Administration (FDA) approved Pfizer’s respiratory syncytial virus (RSV) vaccine, Abrysvo, for people 18 to 59 who are more vulnerable to the virus.
Pfizer’s vaccine is currently approved for people aged 60 and older as well as for women during weeks 32 through 36 of pregnancy to protect infants from birth up to six months old.
In June, the Centers for Disease Control and Prevention said vaccines should be used only by people aged 60 and up. Before Tuesday’s approval, a CDC panel recommended the shot in people who are 75 years or older, and those aged 60-74 who are at increased risk for severe RSV disease. The CDC still needs to green-light the FDA’s approval before the shots are available to the younger age groups. The CDC is expected to discuss the data later this week, but not to vote on it, Reuters reportsed
In a late-stage trial, researchers tested two doses of the vaccine in immunocompromised adults aged 18 and older. It was well tolerated and had similar safety with previous findings, according to Pfizer.
“RSV represents a significant threat to younger adults with certain chronic conditions. After decades of vaccine research by the scientific community and Pfizer, we now have the opportunity to help alleviate the burden of RSV in this high-risk adult population,” Aamir Malik, chief US commercial officer and executive vice president of Pfizer, said in a statement. “With this approval, we are proud that Abrysvo is now the only RSV vaccine indicated for adults aged 18 to 49 at increased risk for the disease, expanding on its existing indications for older adults and pregnant women.”
A report out earlier this month stated that both RSV shots on the market (GSK makes another one) were about 80% effective in older adults during the 2023-24 respiratory disease season, which was the first season after the shot was first approved in the US.
