The vaccine was previously approved in May 2023 for use in adults aged 60 and older, and in August 2023, for pregnant individuals to protect babies from birth up to six months. Other companies also have FDA-approved RSV vaccines, including Moderna’s mResvia and GSK’s Arexvy. However, Pfizer’s Abrysvo is the first and only RSV vaccine that is approved for adults younger than 50 years 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 US Commercial Officer and Executive Vice President of Pfizer, in a press statement.
RSV is a respiratory virus that commonly peaks during the winter months, infecting the throat, nose, and lungs. It usually causes only mild, cold-like symptoms, but can result in severe illness in infants and older adults, causing bronchiolitis, an inflammation of the small airways in the lungs, or pneumonia, an infection of the lungs. Some people may even require hospitalization.
Each year, the US sees between 58,000 and 80,000 RSV-related hospitalizations in children younger than five, while there are 100,000 to 160,000 hospitalizations among adults who are 60 years or older. However, even young adults are at risk of developing severe RSV-related conditions.
In the US, 9.5% of adults aged 18 to 49 suffer from an underlying condition, such as asthma, obesity, diabetes, heart failure, chronic kidney disease, and chronic obstructive pulmonary disease (COPD) that puts them at risk of developing RSV-LRTD and being hospitalized for it. Here, Pfizer’s Abrysvo can lower the risk of severe forms of RSV.
The FDA’s decision to extend the approval of Abrysvo to younger adults is based on data from a pivotal phase 3 clinical trial. The trial called MONeT, studied the safety, tolerability, and immunogenicity of the vaccine in adults with certain chronic medical conditions, who have an increased risk of RSV-associated disease.
