GlaxoSmithKline PLC (LSE:GSK) said it engaged regulators to submit a new respiratory virus vaccine for approval before the end of the year.
The pharma group announced interim results of the third phase of the AReSVi 006 trial of its respiratory syncytial virus vaccine today, a virus which can exacerbate pulmonary disease, asthma and heart failure. There is no existing vaccine.
The group is trialling the use of the vaccine in patients aged 60 years or over and is investigating the efficacy of annual revaccination and longer-term multi-season protection following a primary dose.
GSK said the vaccine showed “statistically significant and clinically meaningful efficacy” and that no “unexpected safety concerns” were observed.
The vaccine contains a recombinant subunit prefusion RSV F glycoprotein antigen combined with its proprietary AS01 adjuvant, which together tackle an age-related decline in immunity.
The ongoing randomised and placebo-controlled trial consists of 25,000 participants across 17 countries.
Parallel trials in older adults suggest a single dose of the vaccine could induce “strong humoral and cellular immune responses” for at least six months, GSK said.
Dr Hal Barron, chief scientific officer and president of research and development at GSK, said: "These data suggest our RSV vaccine candidate offers exceptional protection for older adults from the serious consequences of RSV infection.
“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."