RSV disease burden in infants and older adults, the development of RSV vaccines approved in 2023-2024, clinical trial data, and current ACIP recommendations.
Respiratory Syncytial Virus (RSV) is a common respiratory virus that typically causes mild, cold-like symptoms but can be severe in infants and older adults. RSV is the leading cause of bronchiolitis and pneumonia in infants worldwide.
In older adults (65+), RSV can cause severe lower respiratory tract disease, leading to hospitalization and death. Prior to 2023, there was no approved vaccine for RSV in the U.S., though monoclonal antibodies (palivizumab) were available for high-risk infants.
In a major milestone, the first RSV vaccines were approved by the FDA in 2023. These vaccines represent decades of research following the initial identification of RSV in 1956.
First RSV vaccine approved. Recombinant subunit vaccine containing RSV fusion (F) protein stabilized in prefusion conformation. Indicated for adults 60+.
Bivalent subunit vaccine containing stabilized prefusion F proteins from RSV-A and RSV-B subtypes. First RSV vaccine with indication for both adults 60+ AND maternal immunization to protect infants.
mRNA vaccine encoding stabilized prefusion F protein. Same platform as Moderna's COVID-19 vaccine.
In addition to vaccines, a new monoclonal antibody (nirsevimab/Beyfortus) was approved in July 2023 for use in infants. Unlike vaccines which stimulate the immune system, nirsevimab provides passive immunity through administered antibodies. It is recommended for all infants born during RSV season, or those entering their first RSV season, regardless of maternal vaccination status.