May 4, 2023 – After decades of efforts, the FDA has approved the world’s first vaccine for RSV from GSK. Approved for adults 60 years old and over, GSK is the first of multiple companies to deliver an approved RSV vaccine.
“There’s just the broad excitement of finally, after all these years, having good options emerging for RSV,” Phil Dormitzer, GSK SVP and global head of vaccines research and development, told STAT in an interview. “I guess also the triumph of the basic science — the fact that a very basic study … really changed the hunt for a vaccine and led to one or even more than one potential products coming forward to prevent RSV.”
Phase Pfizer’s vaccine is still awaiting approval. The FDA approval is based on GSK’s landmark positive pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial data. In the trial, the vaccine showed statistically significant and clinically meaningful overall efficacy of 82.6% against RSV-LRTD in adults aged 60 years and older, meeting the primary endpoint. In addition, efficacy was 94.6% in older adults with at least one underlying medical condition of interest, such as certain cardiorespiratory and endocrine-metabolic conditions. Efficacy against severe RSV-LRTD, defined as an RSV-associated LRTD episode preventing normal, everyday activities, was 94.1%.