GlaxoSmithKline said its vaccine for respiratory virus had shown “statistically significant” and clinically meaningful efficacy in adults aged 60 years and above in a phase 3 trial.
The company said the primary endpoint of the trial was “exceeded with no unexpected safety concerns observed” and would now start talks with regulators to start immediately with anticipated regulatory submissions in the second half of the year.
Respiratory syncytial virus is contagious and affects the lungs and breathing passages. It is one of the major remaining infectious diseases for which there is currently no vaccine or specific treatment, GSK said on Friday.
“These data suggest our RSV vaccine candidate offers exceptional protection for older adults from the serious consequences of RSV infection,” said Dr Hal Barron, GSK’s Chief Scientific Officer.
“RSV remains one of the few major infectious diseases without a vaccine, and these data have the potential to meaningfully impact the treatment of RSV and may reduce the 360,000 hospitalisations and more than 24,000 deaths worldwide each year.”
