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

Rhea-AI Summary

Moderna (NASDAQ:MRNA) has received approval from the Australian Therapeutic Goods Administration (TGA) for mRESVIA®, its mRNA vaccine against respiratory syncytial virus (RSV), for adults aged 60 and older. The vaccine is designed to prevent lower respiratory tract disease caused by RSV infection.

This marks a significant milestone as the first mRNA vaccine approved in Australia for use beyond COVID-19. The approval is supported by data from the Phase 3 ConquerRSV trial, which involved approximately 37,000 adults aged 60+ across 22 countries.

The approval addresses a significant health concern, as RSV laboratory-notified cases in adults aged 65+ during the 2024 Australian winter period reached nearly two-thirds of influenza cases. Notably, 90% of RSV-related deaths were reported in those aged 60 years and older. The vaccine will be supplied from Moderna's Melbourne facility.

Positive

• First mRNA vaccine approved beyond COVID-19 in Australia, expanding market reach
• Local manufacturing capability through Melbourne facility ensures supply chain control
• Addresses significant market need with 90% of RSV deaths occurring in target age group

Negative

• None.

News Market Reaction

-8.90%

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On the day this news was published, MRNA declined 8.90%, reflecting a notable negative market reaction.

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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
Luke.Mirceawillats@modernatx.com

Australia Media:
Jemimah Brennan
Director, Communications & Corporate Affairs, Australia
jemimah.brennan@modernatx.com

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com

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.

View the original press release on ACCESS Newswire

FAQ

What is the significance of Moderna's RSV vaccine approval in Australia?

It's the first mRNA vaccine approved in Australia for use beyond COVID-19, targeting RSV in adults 60+ years old.

How many participants were involved in Moderna's ConquerRSV Phase 3 trial?

The trial included approximately 37,000 adults aged 60+ across 22 countries.

What is the impact of RSV on older Australians?

90% of RSV-related deaths in Australia occur in people aged 60+, with cases reaching nearly two-thirds of influenza cases in the 2024 winter period.

Where will Moderna manufacture mRESVIA for the Australian market?

The vaccine will be supplied from Moderna's Melbourne facility.