Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults

This international phase 3 trial evaluated the efficacy and safety of a single dose of an adjuvanted RSV prefusion F protein–based candidate vaccine (RSVPreF3 OA) in adults ≥60 years. Among 24,966 participants randomized to receive RSVPreF3 OA or placebo, vaccine efficacy against RT-PCR–confirmed RSV-related lower respiratory tract disease was 82.6% (CI: 57.9–94.1). Efficacy was 94.1% against severe cases and 71.7% against RSV-related acute respiratory infection. Protection was robust across RSV subtypes (A and B), age groups (60–79), and participants with coexisting conditions or prefrail status. Immunogenicity assessments confirmed strong antibody responses. Adverse events, though more frequent with the vaccine, were mostly transient and mild to moderate. No concerning safety signals emerged, and the vaccine demonstrated an acceptable safety profile. Authors conclude that RSVPreF3 OA offers effective protection during one RSV season, regardless of subtype or comorbidity.

This international phase 3 trial evaluated the efficacy and safety of a single dose of an adjuvanted RSV prefusion F protein–based candidate vaccine (RSVPreF3 OA) in adults ≥60 years. Among 24,966 participants randomized to receive RSVPreF3 OA or placebo, vaccine efficacy against RT-PCR–confirmed RSV-related lower respiratory tract disease was 82.6% (CI: 57.9–94.1). Efficacy was 94.1% against severe cases and 71.7% against RSV-related acute respiratory infection. Protection was robust across RSV subtypes (A and B), age groups (60–79), and participants with coexisting conditions or prefrail status. Immunogenicity assessments confirmed strong antibody responses. Adverse events, though more frequent with the vaccine, were mostly transient and mild to moderate. No concerning safety signals emerged, and the vaccine demonstrated an acceptable safety profile. Authors conclude that RSVPreF3 OA offers effective protection during one RSV season, regardless of subtype or comorbidity.