TGA approval for Moderna RSV vaccine for older adults

Australian medicines regulator, the Therapeutic Goods Administration (TGA), has granted approval for mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to prevent lower respiratory tract disease caused by RSV infection in adults aged 60 years and older.

Developed by US mRNA specialist Moderna (Nasdaq: MRNA), mRESVIA's approval marks a significant milestone as it is the first mRNA vaccine in Australia approved for use against a disease beyond COVID-19, according to the company.

mRESVIA generated sales of $25 million in 2024 for Moderna. However, competitors Arexvy, from GSK (LSE: GSK), and Pfizer’s (NYSE: PFE) Abrysvo, have a headstart on mRESVIA.

"We are pleased to receive regulatory approval for mRESVIA in Australia following the TGA's decision," said Stéphane Bancel, chief executive of Moderna. "This approval underscores our commitment to protecting older adults from RSV-related respiratory diseases. We look forward to supplying mRESVIA from our Melbourne facility to older Australians vulnerable to RSV in the future," he added.