Moderna's RSV Vaccine for Older Adults Approved by Australian TGA

Moderna, Inc. has announced a landmark achievement with the approval of its mRNA-based RSV vaccine, mRESVIA® (mRNA-1345), by the Australian Therapeutic Goods Administration (TGA). This vaccine is designed to prevent lower respiratory tract disease caused by respiratory syncytial virus (RSV) in individuals aged 60 and older. The approval represents a significant advancement as mRESVIA® becomes the first mRNA vaccine in Australia to be authorized for a disease other than COVID-19.

Stéphane Bancel, CEO of Moderna, expressed satisfaction with the regulatory approval, highlighting the company’s dedication to protecting the elderly from RSV-related respiratory issues. With this approval, Moderna plans to supply mRESVIA® from its Melbourne facility to safeguard older Australians who are at risk of RSV complications.

RSV is known for its high contagion rate and significant impact on respiratory health, especially among older adults. During the 2024 winter season in Australia, RSV cases in individuals aged 65 and older were almost two-thirds of the influenza cases in the same demographic. Alarmingly, 90% of RSV-related deaths nationwide were reported in individuals aged 60 and above, emphasizing the serious threat RSV poses to older Australians.

The approval of mRESVIA® is grounded in promising results from the Phase 3 clinical trial, ConquerRSV. This trial was a comprehensive, randomized, placebo-controlled, observer-blind study involving approximately 37,000 adults aged 60 and older across 22 countries.

mRESVIA® (mRNA-1345) is an innovative RSV vaccine that utilizes an mRNA sequence to encode a stable prefusion F glycoprotein, which is essential for viral infection as it facilitates the virus's entry into host cells. The prefusion version of the F protein is a crucial target for potent neutralizing antibodies, remaining highly conserved across both RSV-A and RSV-B subtypes.

Globally, Moderna has successfully obtained marketing authorizations for its RSV vaccine in various regions, including the United States, the European Union, Canada, Qatar, the United Arab Emirates, Taiwan, and the United Kingdom. The company has also submitted applications for regulatory approval in additional markets worldwide.

Moderna stands as a pioneer in mRNA medicine development. Through advancing mRNA technology, the company is transforming traditional approaches to medicine production and redefining disease treatment and prevention. Moderna’s rapid and efficient development process has seen the creation of therapeutics and vaccines for diverse conditions such as infectious diseases, immuno-oncology, rare diseases, and autoimmune disorders.

Moderna's mRNA platform has enabled significant progress in medical treatments by combining science, technology, and health. The company's unique culture and global team, driven by core values and a commitment to responsibly altering the future of human health, strive to maximize the impact of mRNA therapies.

Overall, the approval of mRESVIA® in Australia marks a pivotal advancement in public health, offering hope and protection for older adults vulnerable to RSV-related diseases. As Moderna continues to expand its reach and capabilities, the company's innovative approach to mRNA medicine holds promise for addressing a broad spectrum of health challenges in the future.