GSK has announced positive phase 3 trial results for its respiratory syncytial virus (RSV) vaccine candidate for adults aged 60 years and above in what has become a closely-watch race for approval.
Back in June, the drugmaker had shared positive headline results from a pre-specified efficacy interim analysis of the trial, AReSVi-006, but now has released details about the performance of the vaccine. Data unveiled today showed vaccine candidate was highly efficacious, demonstrating overall vaccine efficacy of 82.6% against RSV lower respiratory tract disease, meeting the trial’s primary endpoint. In participants with pre-existing comorbidities, such as underlying cardiorespiratory and endocrinometabolic conditions, vaccine efficacy was 94.6%.
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. This past August, Pfizer announced positive phase 3 topline data. Sanofi and AstraZeneca's jointly developed vaccine, nirsevimab, which is designed to protect infants from RSV, is already in the hands of regulators.
According to GSK, regulatory submissions based on the phase 3 data are anticipated in the second half of 2022.
