FDA Expands Approval of GSK’s Arexvy RSV Vaccine to Adults Aged 50–59

Gelonghui June 11 | The U.S. Food and Drug Administration (FDA) approved on Friday the expanded use of GlaxoSmithKline's respiratory syncytial virus (RSV) vaccine to adults aged 50 to 59, making it the first vaccine authorized for this age group. The vaccine, named Arexvy, along with competing vaccines from Pfizer and Moderna, has already been approved for use in individuals aged 60 and above for viral infections. RSV typically causes cold-like symptoms and is a leading cause of pneumonia in young children and the elderly, resulting in 177,000 hospitalizations and 14,000 deaths annually in the United States. Since its launch last year, Arexvy has dominated the U.S. RSV vaccine market, with its sales in the first quarter surpassing those of Pfizer's Abrysvo, capturing two-thirds of the market share. The U.S. Centers for Disease Control and Prevention (CDC) has yet to endorse the use of GSK's vaccine for the expanded patient population. The CDC’s independent panel of experts is scheduled to meet from June 26 to 28. GSK anticipates that over time, the annual peak sales of Arexvy will reach £3 billion (approximately $3.82 billion).