LONDON – In January 2023, the US FDA granted mRNA-1345 Breakthrough Therapy Designation for the prevention of RSV-LRTD in adults aged 60 years or older, and mRNA-1345 was previously granted Fast Track designation by the U.S. FDA in August 2021.“We’ve seen the impact that respiratory viruses like RSV can have on the health and wellbeing of Canadians. As we approach the height of respiratory virus season, we’re pleased to now have a second vaccine candidate from our mRNA platform seeking regulatory approval in Canada,” said Leslie Madden, Head of Regulatory Science, Moderna Canada. “Our mRNA platform is enabling us to tackle this pervasive public health burden with speed and clinical rigor and we look forward to supporting the Health Canada review of this important submission.”
