Moderna Initiates Regulatory Application Process Seeking Approval For Its RSV Vaccine In Older Adults

Moderna Inc 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 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.