GlaxoSmithKline has shared positive phase 3 data for its respiratory syncytial virus (RSV) vaccine candidate, putting the drugmaker one step closer in what has become a closely-watch race for approval.
The drugmaker announced positive headline results from a pre-specified efficacy interim analysis of the AReSVi 006 trial investigating its RSV vaccine candidate for adults aged 60 years and above. According to GSK, the vaccine showed "statistically significant and clinically meaningful efficacy" in the 25,000 person trial. GSK’s vaccine candidate contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK’s proprietary AS01 adjuvant.
The drugmaker aims to submit the vaccine candidate to regulators in the second half of this year.
RSV remains one of the few major infectious diseases without a vaccine — but several drugmakers are vying to be the first.
In late Feb. of this year, Moderna announced that its RSV vax, which uses the same mRNA technology as its COVID-19 vaccine, was heading to phase 3 trials in adults 60 and older. Then, in March, Pfizer announced that the FDA had granted its vaccine, also for use in older adults, breakthrough therapy designation after positive data from phase 2a clinical trials. Sanofi and AstraZeneca's jointly developed vaccine, nirsevimab, which is designed to protect infants from RSV, is already in the hands of regulators.