U.S. FDA announces approval of Pfizer’s RSV Vaccine ABRYSVO for Adults Aged 18 to 59

Pfizer announces that the U.S. FDA has approved ABRYSVO, the company’s bivalent RSV prefusion F vaccine, for the prevention of lower respiratory tract disease caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. ABRYSVO now offers the broadest RSV vaccine indication for adults, which previously included those 60 years and older. Additionally, it remains the only RSV immunization approved for pregnant individuals at 32 through 36 weeks of gestation to protect infants from birth up to 6 months of age.

“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,” said Aamir Malik, Chief U.S. Commercial Officer and Executive Vice President, Pfizer. “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.”

 



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