Posted by Michael Wonder on 30 Jan 2023
Moderna granted FDA breakthrough therapy designation for mRNA-1345, an investigational respiratory syncytial virus vaccine candidate
30 January 2023 - Designation based on positive topline data from the ConquerRSV Phase 3 pivotal efficacy trial, which demonstrated vaccine efficacy of 83.7% against RSV lower respiratory tract disease, defined by 2 or more symptoms in older adults
Moderna today announced mRNA-1345, an investigational mRNA vaccine candidate for respiratory syncytial virus (RSV), has been granted breakthrough therapy designation by the US FDA for the prevention of RSV associated lower respiratory tract disease in adults aged 60 years or older.
