Moderna Inc (NASDAQ:MRNA) provided an update on regulatory submissions for the mRNA-1345 vaccine to prevent RSV-associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease in adults aged 60 years or older.
mRNA-1345 is an investigational RSV vaccine with a single mRNA sequence encoding for a stabilized prefusion F glycoprotein. The vaccine uses the same lipid nanoparticles as in the Moderna COVID-19 vaccines.
The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency, Swissmedic in Switzerland, and the Therapeutic Goods Administration in Australia and has initiated the rolling submission process for a Biologics License Application (BLA) to the FDA.
The regulatory applications are based on positive data from a prespecified interim analysis of the pivotal ConquerRSV study in approximately 37,000 elderly adults.
The primary efficacy endpoints were based on two definitions of RSV-LRTD, defined as either two or more symptoms or three or more symptoms of the disease.
The trial met both its primary efficacy endpoints, with vaccine efficacy (VE) of 83.7% against RSV-LRTD as defined by two or more symptoms and 82.4% defined by three or more symptoms.
The vaccine was well tolerated with a favorable safety profile.
The ConquerRSV study is ongoing, and additional efficacy analyses are planned as cases accrue, including for severe RSV.
In addition to older adults, mRNA-1345 is being investigated in a fully enrolled, ongoing Phase 1 trial in pediatric populations.
In May, the FDA approved GSK Plc's (NYSE: GSK) Arexvy vaccine in individuals 60 and older, making it the first RSV vaccine for older adults to be approved worldwide.
Price Action: MRNA shares are up 0.43% at $122.25 during the premarket session on the last check Wednesday.
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