Following positive topline data from its ConquerRSV phase 3 pivotal efficacy trial, Moderna announced this week that the FDA had given its RSV jab candidate Breakthrough Therapy designation.
The vaccines, mRNA-1345, which aims to prevent of RSV-associated lower respiratory tract disease in adults aged 60 years or older, was previously granted Fast Track designation back in August of 2021.
Earlier in January, Moderna shared that the vaccine had met all its primary efficacy endpoints in its phase 3 trial, demonstrating an 83.7% vaccine efficacy rate against RSV lower respiratory tract disease.
The race for an RSV vaccine has been neck and neck between pharma giants like GSK and Pfizer as well, both of whom snagged Priority Review for their shots in November and December respectively. Pfizer’s shot, RSVpreF, received Breakthrough Therapy designation in March 2022.
GSK and Pfizer have already submitted their RSV vaccines to regulators; Moderna intends to submit an application for regulatory approval in the first half of 2023.
