Moderna Receives Australian Therapeutic Goods Administration Approval for RSV Vaccine for Older Adults
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.
Moderna (NASDAQ:MRNA) ha ricevuto l'approvazione dall'Australian Therapeutic Goods Administration (TGA) per mRESVIA®, il suo vaccino mRNA contro il virus respiratorio sinciziale (RSV), per adulti di età pari o superiore a 60 anni. Il vaccino è progettato per prevenire le malattie delle vie respiratorie inferiori causate dall'infezione da RSV.
Questo rappresenta un traguardo significativo, essendo il primo vaccino mRNA approvato in Australia per un utilizzo al di là del COVID-19. L'approvazione è supportata dai dati del trial di Fase 3 ConquerRSV, che ha coinvolto circa 37.000 adulti di età superiore ai 60 anni in 22 paesi.
L'approvazione affronta una preoccupazione sanitaria significativa, poiché i casi di RSV notificati in laboratorio negli adulti di età pari o superiore a 65 anni durante l'inverno australiano del 2024 hanno raggiunto quasi i due terzi dei casi di influenza. È importante notare che il 90% delle morti correlate all'RSV sono state segnalate in persone di età pari o superiore a 60 anni. Il vaccino sarà fornito dallo stabilimento di Moderna a Melbourne.
Moderna (NASDAQ:MRNA) ha recibido la aprobación de la Administración de Bienes Terapéuticos de Australia (TGA) para mRESVIA®, su vacuna de ARNm contra el virus sincitial respiratorio (RSV), para adultos de 60 años o más. La vacuna está diseñada para prevenir enfermedades del tracto respiratorio inferior causadas por la infección por RSV.
Esto marca un hito significativo como la primera vacuna de ARNm aprobada en Australia para su uso más allá del COVID-19. La aprobación está respaldada por datos del ensayo de Fase 3 ConquerRSV, que involucró a aproximadamente 37,000 adultos de 60 años o más en 22 países.
La aprobación aborda una preocupación importante de salud, ya que los casos de RSV notificados en laboratorio en adultos de 65 años o más durante el invierno australiano de 2024 alcanzaron casi dos tercios de los casos de influenza. Notablemente, el 90% de las muertes relacionadas con RSV se reportaron en personas de 60 años o más. La vacuna será suministrada desde la instalación de Moderna en Melbourne.
모더나 (NASDAQ:MRNA)는 호주 치료재화청(TGA)으로부터 mRESVIA®, 즉 60세 이상 성인을 위한 호흡기 세포융합 바이러스(RSV) mRNA 백신의 승인을 받았습니다. 이 백신은 RSV 감염으로 인한 하부 호흡기 질환을 예방하기 위해 설계되었습니다.
이는 COVID-19를 넘어 호주에서 승인된 첫 번째 mRNA 백신으로서 중요한 이정표가 됩니다. 이 승인은 22개국에서 60세 이상의 약 37,000명을 대상으로 한 3상 ConquerRSV 시험의 데이터를 기반으로 하고 있습니다.
이번 승인은 2024년 호주 겨울철 동안 65세 이상의 성인에서 실험실에서 신고된 RSV 사례가 인플루엔자 사례의 거의 3분의 2에 달하는 중요한 건강 문제를 다루고 있습니다. 특히, RSV와 관련된 사망자의 90%가 60세 이상의 사람에게서 보고되었습니다. 백신은 모더나의 멜버른 시설에서 공급될 예정입니다.
Moderna (NASDAQ:MRNA) a reçu l'approbation de l'Administration australienne des biens thérapeutiques (TGA) pour mRESVIA®, son vaccin à ARNm contre le virus respiratoire syncytial (RSV), destiné aux adultes de 60 ans et plus. Le vaccin est conçu pour prévenir les maladies des voies respiratoires inférieures causées par l'infection par le RSV.
Ceci marque une étape importante en tant que premier vaccin à ARNm approuvé en Australie pour une utilisation au-delà du COVID-19. L'approbation est soutenue par des données de l'essai de Phase 3 ConquerRSV, qui a impliqué environ 37 000 adultes de 60 ans et plus dans 22 pays.
L'approbation répond à une préoccupation de santé significative, les cas de RSV notifiés en laboratoire chez les adultes de 65 ans et plus durant l'hiver australien de 2024 atteignant près des deux tiers des cas de grippe. Notamment, 90 % des décès liés au RSV ont été rapportés chez des personnes âgées de 60 ans et plus. Le vaccin sera fourni par l'usine de Moderna à Melbourne.
Moderna (NASDAQ:MRNA) hat die Genehmigung der Australian Therapeutic Goods Administration (TGA) für mRESVIA®, seinen mRNA-Impfstoff gegen das respiratorische Synzytialvirus (RSV), für Erwachsene ab 60 Jahren erhalten. Der Impfstoff soll Erkrankungen der unteren Atemwege verhindern, die durch RSV-Infektionen verursacht werden.
Dies stellt einen bedeutenden Meilenstein dar, da es sich um den ersten mRNA-Impfstoff handelt, der in Australien für den Einsatz über COVID-19 hinaus genehmigt wurde. Die Genehmigung stützt sich auf Daten aus der Phase-3-Studie ConquerRSV, an der etwa 37.000 Erwachsene ab 60 Jahren aus 22 Ländern teilnahmen.
Die Genehmigung befasst sich mit einem bedeutenden Gesundheitsproblem, da die im Labor gemeldeten RSV-Fälle bei Erwachsenen ab 65 Jahren während des australischen Winters 2024 fast zwei Drittel der Influenza-Fälle ausmachten. Bemerkenswerterweise wurden 90% der RSV-bedingten Todesfälle bei Personen ab 60 Jahren gemeldet. Der Impfstoff wird aus der Produktionsstätte von Moderna in Melbourne geliefert.
- 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
- None.
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
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
Australian Register of Therapeutic Goods (ARTG) Information - https://www.tga.gov.au/resources/artg/411450
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
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