Moderna Gains Fast-Track Designation for mRNA-Based RSV Vaccine

The FDA has granted Moderna Fast-Track designation for mRNA-1345, its investigational single-dose mRNA vaccine against respiratory syncytial virus (RSV) in adults older than age 60.

Moderna’s RSV vaccine candidate uses the same lipid nanoparticle as the company’s authorized COVID-19 vaccine and contains optimized protein and nucleotide sequences.

There is currently no approved vaccine for RSV, a common respiratory virus that generally causes cold-like symptoms but can be fatal for elderly adults and young children.