Moderna Receives Health Canada Approval for RSV Vaccine for Adults Aged 60 Years and Older
Moderna (NASDAQ:MRNA) has received Health Canada approval for mRESVIA, an RSV vaccine for adults aged 60 and older. This marks Moderna's second approved product in Canada and the first mRNA vaccine against RSV. The vaccine, available in a unique pre-filled syringe format, is approved for preventing lower respiratory tract disease caused by RSV. The approval is based on Phase 3 ConquerRSV trial data involving 37,000 adults. Supply is expected in Canada in early 2025. The National Advisory Committee on Immunization recommends the vaccine for people aged 75+ and those 60+ in nursing homes, while community-dwelling adults 60+ can decide individually with their healthcare provider.
Moderna (NASDAQ:MRNA) ha ricevuto l'approvazione di Salute Canada per mRESVIA, un vaccino RSV per adulti di età pari o superiore a 60 anni. Questo segna il secondo prodotto approvato da Moderna in Canada e il primo vaccino mRNA contro l'RSV. Il vaccino, disponibile in un formato unico di siringa pre-riempita, è approvato per la prevenzione delle malattie delle vie respiratorie inferiori causate dall'RSV. L'approvazione si basa sui dati del trial di Fase 3 ConquerRSV che coinvolge 37.000 adulti. La fornitura è attesa in Canada all'inizio del 2025. Il Comitato Nazionale Consultivo per l'Immunizzazione raccomanda il vaccino per le persone di età pari o superiore a 75 anni e per quelle di età superiore a 60 anni nelle case di cura, mentre gli adulti della comunità di età superiore ai 60 anni possono decidere individualmente con il proprio fornitore di assistenza sanitaria.
Moderna (NASDAQ:MRNA) ha recibido la aprobación de Salud Canadá para mRESVIA, una vacuna contra el VRS para adultos de 60 años o más. Este es el segundo producto aprobado por Moderna en Canadá y la primera vacuna de ARNm contra el VRS. La vacuna, disponible en un formato único de jeringa precargada, está aprobada para prevenir enfermedades del tracto respiratorio inferior causadas por el VRS. La aprobación se basa en los datos del ensayo de Fase 3 ConquerRSV que involucró a 37,000 adultos. Se espera suministro en Canadá a principios de 2025. El Comité Asesor Nacional de Inmunización recomienda la vacuna para las personas de 75 años o más y aquellos de 60 años o más en hogares de ancianos, mientras que los adultos comunitarios de 60 años o más pueden decidir individualmente con su proveedor de atención médica.
모더나 (NASDAQ:MRNA)가 60세 이상의 성인을 위한 RSV 백신 mRESVIA에 대해 캐나다 보건부의 승인을 받았습니다. 이는 모더나가 캐나다에서 승인받은 두 번째 제품이자 RSV에 대한 첫 번째 mRNA 백신입니다. 이 백신은 고유한 프리필드 시린지 포맷으로 제공되며, RSV로 인한 하부 호흡기 질환 예방을 위해 승인되었습니다. 이 승인은 37,000명의 성인을 포함한 3상 ConquerRSV 시험 데이터를 기반으로 합니다. 2025년 초 캐나다에서 공급이 예상됩니다. 국가 면역 자문 위원회는 75세 이상의 사람들과 요양원에 거주하는 60세 이상의 사람들에게 이 백신을 권장하며, 지역 사회에 거주하는 60세 이상의 성인은 개인적으로 의료 제공자와 상의할 수 있습니다.
Moderna (NASDAQ:MRNA) a reçu l'approbation de Santé Canada pour mRESVIA, un vaccin contre le VRS destiné aux adultes de 60 ans et plus. Cela marque le deuxième produit approuvé par Moderna au Canada et le premier vaccin à ARNm contre le VRS. Le vaccin, disponible dans un format unique de seringue préremplie, est approuvé pour la prévention des maladies des voies respiratoires inférieures causées par le VRS. L'approbation est basée sur les données de l'essai de Phase 3 ConquerRSV impliquant 37 000 adultes. La fourniture est attendue au Canada au début de 2025. Le Comité consultatif national de l'immunisation recommande le vaccin pour les personnes âgées de 75 ans et plus ainsi que pour celles de 60 ans et plus vivant dans des maisons de retraite, tandis que les adultes vivant en communauté de 60 ans et plus peuvent prendre une décision individuelle avec leur fournisseur de soins de santé.
Moderna (NASDAQ:MRNA) hat die Genehmigung von Health Canada für mRESVIA, einen RSV-Impfstoff für Erwachsene ab 60 Jahren, erhalten. Dies ist das zweite genehmigte Produkt von Moderna in Kanada und der erste mRNA-Impfstoff gegen RSV. Der Impfstoff, der in einer einzigartigen, vorgefüllten Spritze erhältlich ist, ist zur Prävention von Atemwegserkrankungen der unteren Atemwege durch RSV zugelassen. Die Genehmigung basiert auf den Daten der Phase-3-Studie ConquerRSV, an der 37.000 Erwachsene beteiligt waren. Der Lieferbeginn in Kanada wird Anfang 2025 erwartet. Das Nationale Beratungskomitee für Immunisierung empfiehlt den Impfstoff für Personen ab 75 Jahren sowie für 60-Jährige in Pflegeheimen, während Erwachsene über 60 Jahren in der Gemeinde individuell mit ihrem Gesundheitsdienstleister entscheiden können.
- First mRNA RSV vaccine approved in Canada
- Unique pre-filled syringe format offering convenience and reduced administrative errors
- Fourth major market approval following U.S., Europe, and Qatar
- Large Phase 3 trial with no serious safety concerns identified
- Product supply delayed until early 2025
- recommendation for community-dwelling adults 60-74 years old (individual decision basis only)
Insights
The Canadian approval of mRESVIA represents a significant market expansion for Moderna's RSV vaccine portfolio. The key competitive advantage lies in the unique pre-filled syringe format, which could drive market share gains against existing competitors. The anticipated 2025 launch timing aligns with the RSV vaccination season, potentially maximizing initial uptake.
The addressable market is substantial, with
This regulatory milestone strengthens Moderna's global commercial presence, marking their fourth major market approval for mRESVIA. The Canadian healthcare market, valued at over
The early 2025 launch timing allows for proper market preparation and healthcare provider education. Success in Canada could accelerate approvals in other markets, potentially driving additional revenue streams. This approval reinforces Moderna's transition from a single-product company to a diverse vaccine manufacturer.
mRESVIA is Moderna's second approved product in Canada, the first mRNA vaccine against RSV, and the only one in single-dose pre-filled syringes
Canada is the fourth jurisdiction to approve mRESVIA following approvals in the U.S., Europe, and Qatar
CAMBRIDGE, MA / ACCESSWIRE / November 8, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced Health Canada has approved mRESVIA™ (Respiratory Syncytial Virus mRNA vaccine) for active immunization for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults 60 years of age and older.1
"Today's approval is an example of how our mRNA platform can help address significant public health challenges like RSV," said Stéphane Bancel, Chief Executive Officer of Moderna. "As our second product approved by Health Canada, mRESVIA underscores our commitment to leveraging mRNA technology to protect vulnerable populations and contribute to a healthier future for Canadians."
mRESVIA is the only RSV vaccine available in a pre-filled syringe. This format offers a convenient, ready-to-use formulation that simplifies the process of administering the vaccine, saving healthcare professionals time and reducing the risk of administrative errors. Supply of mRESVIA is anticipated in Canada in early 2025.
The National Advisory Committee on Immunization (NACI) recommends vaccination against RSV for people in Canada aged 75 years and older, as well as those aged 60 years and older who are residents of nursing homes and other chronic care facilities. Community-dwelling adults aged 60 years and older are recommended for RSV vaccination as an individual decision following consultation with their healthcare provider.2
"With Health Canada's approval of mRESVIA for Canadians aged 60 and older, we are proud to bring the first-ever mRNA vaccine against RSV to Canadians in a convenient and efficient pre-filled syringe format," said Stefan Raos, General Manager at Moderna in Canada. "This milestone highlights the importance of vaccination for older adults, who face heightened risks from RSV, and reinforces our dedication to advancing mRNA innovation for meaningful public health impact."
Health Canada's approval is based on data from the Phase 3 clinical trial ConquerRSV, a global study conducted in approximately 37,000 adults aged 60 years and older in 22 countries. No serious safety concerns were identified in the Phase 3 trial. Moderna continues to file for mRESVIA marketing authorizations worldwide.
About mRESVIA™
mRESVIA is an RSV vaccine that consists of an mRNA sequence encoding RSV glycoprotein F stabilized in the prefusion conformation. 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. The vaccine uses the same lipid nanoparticles (LNPs) as the Moderna COVID-19 vaccine.
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 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.
Moderna 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 potential for mRESVIA to reduce disease burden from RSV, and the safety of mRNA-1345; Moderna's expectation to supply mRESVIA in Canada in early 2025; and Moderna's mRESVIA marketing authorizations worldwide. 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, 2023 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
Media:
International media
Luke Mircea-Willats
Senior Director, International Communications
Luke.mirceawillats@modernatx.com
Moderna Canada
Sacha Kennedy
Director, Communications and Media
sacha.kennedy@modernatx.com
Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com
References
1 mRESVIA™ Product Monograph.
2 Respiratory syncytial virus (RSV) vaccines: Canadian Immunization Guide. Available at: https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/respiratory-syncytial-virus.html Accessed September 23, 2024.
SOURCE: Moderna, Inc.
View the original press release on accesswire.com
FAQ
When will Moderna's mRESVIA RSV vaccine be available in Canada?
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