FDA approves first RSV vaccine for adults
The U.S. Food and Drug Administration (FDA) has approved the first-ever RSV vaccine for adults, specifically those aged 18 to 59.
The vaccine was developed by Pfizer in response to a rise in adult RSV cases and hospitalizations in the wake of COVID-19. The company’s vaccine, Abrysvo, was already approved by the FDA in May 2023 for use in adults over 60—as well as pregnant women at 32 through 36 weeks of gestation, in an effort to protect newborns and infants from the worst effects of the virus.
Abrysvo is the only RSV vaccine available that’s been FDA approved for adults and pregnant maternity patients. It’s intended to be mainly prescribed to individuals at high-risk for severe complications from the virus, such as those who are obese, have diabetes, chronic obstructive pulmonary disease (COPD), heart failure, chronic kidney disease or asthma.
Of adults 18 to 49 years of age, 9.5% have one of these underlying chronic conditions, according to data from the Centers for Disease Control and Prevention (CDC). That number rises to 24.3% among people 50 to 64 years old, many of whom end up hospitalized from RSV.
“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 U.S. commercial officer and executive vice president at 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,” Malik added.
The approval stems from Pfizer's successful Phase 3 MONeT trial, which evaluated the vaccine's safety and efficacy. Abrysvo was found to be reasonably safe and to produce a significant immune response in high-risk adults, the company said.
The vaccine can be administered to protect against RSV-A and RSV-B strains of the virus.
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