GSK Starts Preparations for Regulatory Filings as RSV Vaccine Clears Phase III Test in Adults
GSK plans to initiate preparation for regulatory submissions for its respiratory syncytial virus (RSV) vaccine after the vaccine performed well in the much-anticipated AReSVi 006 trial in individuals aged 60 and above.
According to the company, the RSVPreF3 OA vaccine demonstrated “statistically substantial and clinically important” efficacy in this scenario, with consistent action across RSV A and B strains and in older age groups, including those aged >70. The findings are comparable with in-house findings from a parallel Phase III trial (AReSVi 004), w...
