Moderna files for approval of RSV vaccine MRNA-1345

Shares of US biotech Moderna (Nasdaq: MRNA), which is pioneering messenger RNA (mRNA) therapeutics and vaccines, edged up 1.5% to $123.54 yesterday, as it updated on regulatory submissions for mRNA-1345.

The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia and has initiated the rolling submission process for a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for the licensure of the mRNA-based RSV vaccine, for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease (ARD) in adults aged 60 years or older.

Two vaccines for the prevention of RSV-LRTD have recently been approved by the FDA. The first was UK pharma major GSK’s (LSE: GSK) Arexvy (respiratory syncytial virus vaccine, adjuvanted), followed swiftly by Pfizer’s (NYSE: PFE) Abrysvo brand.