Pharmaceutical giant GlaxoSmithKline aims to get its respiratory syncytial virus (RSV) vaccine to regulators for review later this year, after interim data showed the vaccine was effective in a keenly-watched late-stage study involving older adults.
RSV is a leading cause of pneumonia in toddlers and the elderly, but the complex molecular structure of the virus and safety concerns have stymied efforts to develop a vaccine since the virus was first discovered in 1956.
Companies including Pfizer, J&J, Sanofi, Moderna and AstraZeneca are also racing to get an RSV therapy or vaccine approved.
The latest GSK trial is the first to show statistically significant efficacy for RSV in adults aged 60 years and older, the British drugmaker said of the ongoing study on Friday (June 10).
If approved, the RSV vaccine is expected to generate billions for GSK, which is already the world’s biggest vaccine maker by sales but has faced pressure from activist investors such as Elliott Management who have urged the London-based company to shore up its drug pipeline.
The RSV data is a critical boost to GSK’s drug development success rate as it prepares to spin off its consumer health venture next month into an independent listed company called Haleon.
After the split, GSK will focus solely on vaccines and prescription drugs.