GSK’s Arexvy Vaccine Approved for 18–49-Year-Olds at Increased Risk
The FDA expanded AREXVY’s approved indication to cover adults aged 18–49 at increased risk for RSV-caused lower respiratory tract disease, building on its prior approval for adults 50–59 at risk and those 60 and older. This group sees around 17,000 hospitalizations, 277,000 emergency visits and 1.97 million outpatient RSV cases annually in the US.
1. FDA Expands AREXVY Age Indication
The FDA has broadened the approved use of AREXVY to include adults aged 18–49 at increased risk of RSV-induced lower respiratory tract disease, supplementing prior approvals for those aged 50–59 at risk and all adults 60 and above.
2. Significant Adult RSV Burden
In the US, adults aged 18–49 with underlying conditions account for an estimated 17,000 RSV-related hospitalizations, 277,000 emergency department visits and 1.97 million outpatient encounters each year, underscoring a substantial preventive opportunity.
3. Phase IIIb Trial Results
A Phase IIIb immunogenicity trial involving 426 participants aged 18–49 at elevated risk demonstrated a non-inferior antibody response compared with adults aged 60 and older, reinforcing data from earlier efficacy trials.
4. Safety and Reactogenicity
Reported adverse events in the younger cohort mirrored the broader program, with the most common reactions being injection site pain, fatigue, myalgia, headache and arthralgia, most of which were transient and mild to moderate.