Moderna files for approval of RSV vaccine MRNA-1345

https://www.thepharmaletter.com/article/moderna-files-for-approval-of-rsv-vaccine-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.