Moderna Receives Australian Therapeutic Goods Administration Approval for RSV Vaccine for Older Adults

Moderna Inc.  announced that the Australian 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. 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.

"We are pleased to receive regulatory approval for mRESVIA in Australia following the TGA's decision," said Stéphane Bancel, Chief Executive Officer 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."

RSV is a highly contagious respiratory virus that causes a substantial burden of disease, particularly in older adults. In the 2024 Australian winter period, RSV laboratory-notified cases in adults aged 65 and older were nearly two-thirds the number of influenza cases in the same age group. Of the RSV-related deaths reported nationally: 90% occurred in those aged 60 years and older, underscoring its potential for severe impact on older Australians.

The approval is based on positive data from the Phase III clinical trial ConquerRSV, a randomized, placebo-controlled, observer-blind, case-driven clinical study conducted in approximately 37,000 adults aged 60 years or older in 22 countries.