Moderna wins FDA’s breakthrough status for RSV vaccine
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Moderna (NASDAQ:MRNA) announced Monday that the FDA issued Breakthrough Therapy Designation for mRNA-1345, a messenger-RNA-based vaccine candidate targeted at the seasonal pathogen respiratory syncytial virus (RSV).
According to the company, the FDA has issued the Breakthrough Therapy Designation for mRNA-1345 to prevent RSV-linked lower respiratory tract disease (RSV-LRTD) in adults aged 60 years or older.

The decision was based on initial data from Modernaâs (MRNA) ConquerRSV Phase 3 pivotal trial, which the company shared this month.

FDAâs Breakthrough Therapy designation aims to speed up the development and review of treatments targeted at serious or life-threatening conditions.
With full features of the designation, a breakthrough therapy developer can receive intensive regulatory guidance with potential eligibility for FDAâs priority review.
The company expects to submit a marketing application for mRNA-1345 in H1 2023. In August 2021, the FDA issued Fast Track designation for mRNA-1345, which has a similar mechanism to the companyâs blockbuster COVID-19 vaccine.