US Food and Drug Administration approves first RSV vaccine
On Wednesday, the U.S. Food and Drug Administration (FDA) approved Arexvy, a respiratory syncytial virus (RSV) vaccine for individuals 60 years of age and older — the first to be approved anywhere in the world.
RSV hit the U.S. hard in late 2022, just as COVID-19 hospitalizations plateaued. Infants and children under 5 years and individuals 60 years or older were most susceptible to acquiring the virus.
According to the CDC's data, approximately 58,000 children under 5 are hospitalized for RSV each year. In adults over 65, the infection causes approximately 177,000 hospitalizations and an estimated 14,000 deaths in the U.S. each year.
According to the GSK, the biopharma company behind the new vaccine, older adults, including those with underlying medical conditions such as diabetes and chronic heart and lung disease, are at increased risk of severe RSV illness and drive the majority of RSV hospitalizations.
In a press release, GSK calls the approval of Arexvy "groundbreaking."
“Today marks a turning point in our effort to reduce the significant burden of RSV," Chief Scientific Officer Tony Wood said in the press release. "Our focus now is to ensure eligible older adults in the U.S. can access the vaccine as quickly as possible and to progress regulatory review in other countries.”
The company plans to launch the vaccine in the U.S. before the 2023/24 RSV season.