The US Food and Drug Administration (FDA) has given its approval to AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) for preventing lower respiratory tract disease (LRTD) caused by RSV in high-risk adults between the ages of 50 and 59. RSV is a prevalent respiratory virus that can cause severe illness, particularly in adults with chronic underlying health conditions such as COPD, asthma, heart failure, and diabetes.

Data indicates that RSV accounts for approximately 42,000 hospitalizations annually in US adults aged 50-64, underscoring the need for expanded immunization. GSK’s RSV vaccine is currently approved and recommended for adults 60 and older, but the new approval extends its reach to younger adults at increased risk.

Phase III trial results demonstrated the vaccine’s safety and effectiveness in adults aged 50-59, including those with underlying medical conditions. Experts emphasize that age alone is not a reliable indicator of RSV risk, as underlying health conditions significantly elevate susceptibility to severe outcomes.

GSK has submitted regulatory applications to extend the vaccine’s use to high-risk adults aged 50-59 in Europe, Japan, and other countries. Clinical trials are also underway to assess the vaccine’s immunogenicity and safety in immunocompromised adults and adults aged 18-49 at increased risk. The vaccine contains recombinant RSV glycoprotein F, stabilized in the prefusion conformation, and is combined with GSK’s AS01E adjuvant.

Source link: http://www.businesswire.com/news/home/20240606055012/en/US-FDA-Approves-Expanded-Age-Indication-for-GSK%E2%80%99s-AREXVY-the-First-Respiratory-Syncytial-Virus-RSV-Vaccine-for-Adults-Aged-50-59-at-Increased-Risk

Jon Napitupulu
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Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.