Moderna has submitted its vaccine for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease (ARD) to regulatory agencies, including Australia's TGA.
mRNA-1345 is an investigational vaccine that consists of 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 said it has submitted the vaccine for authorisation to the European Medicines Agency (EMA), Swissmedic in Switzerland, and the TGA in Australia and has initiated the rolling submission process for a Biologics License Application to the US FDA.
"We are proud to announce these filings for the use of our RSV vaccine candidate, mRNA-1345, in the European Union, Switzerland, Australia, and the U.S. RSV is a major cause of lower respiratory tract infections in older adults and can cause a significant burden to health systems through hospitalizations and emergency care admissions," said Stephane Bancel, CEI of Moderna.
"Our mRNA platform has allowed us to move from initial clinical testing to our first international Phase 3 trial to initiation of regulatory submissions for mRNA-1345 in just two years, enabling us to tackle this pervasive public health burden with speed and clinical rigor. mRNA-1345 represents the second product coming from our mRNA platform to seek global approval, and with recent positive data in rare disease and cancer, we expect more in the future - further demonstrating the tremendous potential of mRNA to combat disease."
The company said the regulatory applications are based on positive data from a prespecified interim analysis of the pivotal ConquerRSV study, a randomised, double-blind, placebo-controlled study of approximately 37,000 adults 60 years or older in 22 countries. The trial met both its primary efficacy endpoints, with a vaccine efficacy 83.7 per cent RSV-LRTD as defined by two or more symptoms.