RSV vaccine Abrysvo gets expanded FDA approval

Young African American woman wearing a protective mask receives vaccination.

The U.S. Food and Drug Administration (FDA) has issued a new approval for Pfizer’s Abrysvo. The action allows adults aged 18 to 59 years who are at increased risk to receive the vaccine for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (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,” said Aamir Malik, chief U.S. commercial officer and executive vice president, Pfizer. 

According to the Centers for Disease Control and Prevention (CDC), nearly 10% of U.S. adults aged 18 to 49 years have an underlying chronic condition, such as obesity, diabetes, asthma, COPD, heart failure or chronic kidney disease, that puts them at higher risk of developing and/or being hospitalized for RSV-associated LRTD. The percentage increases to approximately 25% in adults aged 50 to 64 years.

The FDA based its decision for Abrysvo’s new indication on results from the phase 3 clinical trial MONeT, which investigated the safety, tolerability and immunogenicity of the vaccine in adults at risk of RSV-associated disease due to chronic medical conditions. Pfizer announced that it plans to submit these findings for publication in a peer-reviewed scientific journal. 

This latest approval makes Abrysvo the RSV vaccine with the broadest indication. Previously, the FDA approved it for individuals 60 years of age and older as well as pregnant individuals who are 32 to 36 weeks of gestation to protect infants from birth up to six months of age.

Arexvy, an RSV vaccine developed by GSK, is FDA-approved for use in adults 60 years of age and older as well as adults aged 50 to 59 years with certain chronic medical conditions. Arexvy is not approved for pregnant women or adults younger than 50 years old. Neither Abrysvo nor Arexvy are approved for use in children; however, Beyfortus is approved by the FDA for infants born during or entering their first RSV season.

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