Moderna: breakthrough designation in RSV

(CercleFinance.com) - Moderna has announced that its investigational mRNA-1345 mRNA vaccine candidate has received FDA breakthrough designation for the prevention of respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRD) in people aged 60+.


This designation is based on initial positive data from the pivotal Phase 3 efficacy trial ConquerRSV, which demonstrated 83.7% vaccine efficacy against disease defined as two or more symptoms in older adults.

The biotech company says that its mRNA-1345 previously received Fast Track designation from the FDA in August 2021. Moderna intends to submit a license application for regulatory approval in the first half of 2023.



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