ModernaTX, Inc: Moderna Receives Australian Therapeutic Goods Administration Approval for RSV Vaccine for Older Adults

CAMBRIDGE, MA / ACCESS Newswire / March 31, 2025 / Moderna, Inc. (NASDAQ:MRNA) today 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.¹ 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.² 90% of RSV-related deaths reported nationally occurred in those aged 60 years and older, underscoring its potential for severe impact on older Australians.²

The approval is based on positive data from the Phase 3 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.

About mRESVIA (Respiratory Syncytial Virus Vaccine)

mRNA-1345 is an RSV vaccine that consists of an mRNA sequence encoding a stabilized prefusion F glycoprotein. The F glycoprotein is expressed on the surface of the virus and is required for infection by helping the virus to enter host cells. The prefusion conformation of the F protein is a significant target of potent neutralizing antibodies and is highly conserved across both RSV-A and RSV-B subtypes.

To date, Moderna has received marketing authorizations for its RSV vaccine in the United States, the European Union, Canada, Qatar, the United Arab Emirates, Taiwan, and the United Kingdom and has submitted regulatory applications in other markets worldwide.

About Moderna

Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines.

Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the Australian Therapeutic Goods Administration (TGA) granting approval for mRESVIA® (mRNA-1345); the potential for mRESVIA to reduce disease burden from RSV; and Moderna's pending marketing authorization applications for mRNA-1345. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.

Moderna Contacts

International Media:
Luke Mircea-Willats
Senior Director, International Communications
[e-mail]

Australia Media:
Jemimah Brennan
Director, Communications & Corporate Affairs, Australia
[e-mail]

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
[phone]
[e-mail]

References

1. Australian Register of Therapeutic Goods (ARTG) Information - https://www.tga.gov.au/resources/artg/411450

2. Australian Respiratory Surveillance Report 11 - 29 July to 11 August 2024, https://www.health.gov.au/resources/publications/australian-respiratory-surveillance-report-11-12-august-to-25-august-2024 accessed 7 March 2025.

SOURCE: Moderna, Inc.