Moderna Receives Health Canada Approval For Updated COVID-19 Vaccine Targeting KP.2 Variant Of SARS-COV-2 For Ages Six Months And Older
Moderna has received Health Canada approval for its updated COVID-19 vaccine, SPIKEVAX® KP.2 variant, for individuals aged six months and older. This marks the first authorized updated COVID-19 vaccine in Canada for 2024-2025. The vaccine targets the KP.2 sub-lineage of SARS-CoV-2 and is expected to provide better protection against circulating strains compared to earlier versions.
Moderna will promptly begin delivering the updated vaccines to the Public Health Agency of Canada, ensuring ample supply for provincial and territorial vaccination campaigns. The approval is based on manufacturing and pre-clinical data, along with previous clinical, non-clinical, and real-world evidence supporting the efficacy and safety of Moderna's mRNA vaccines.
Moderna ha ricevuto l'approvazione da parte di Health Canada per il suo vaccino aggiornato contro il COVID-19, SPIKEVAX® KP.2 variante, per individui di età pari o superiore ai sei mesi. Questo segna il primo vaccino COVID-19 autorizzato e aggiornato in Canada per il 2024-2025. Il vaccino mira alla sottolofia KP.2 di SARS-CoV-2 ed è previsto che fornisca una protezione migliore contro le varianti circolanti rispetto alle versioni precedenti.
Moderna inizierà rapidamente a consegnare i vaccini aggiornati all'Agenzia di sanità pubblica del Canada, garantendo un'ampia fornitura per le campagne di vaccinazione provinciali e territoriali. L'approvazione si basa su dati di produzione e pre-clinici, insieme a evidenze cliniche, non cliniche e del mondo reale che supportano l'efficacia e la sicurezza dei vaccini mRNA di Moderna.
Moderna ha recibido la aprobación de Health Canada para su vacuna actualizada contra el COVID-19, SPIKEVAX® KP.2 variante, para individuos a partir de seis meses de edad. Esto marca la primera vacuna COVID-19 actualizada autorizada en Canadá para 2024-2025. La vacuna se dirige a la sub-línea KP.2 de SARS-CoV-2 y se espera que proporcione una mejor protección contra las cepas circulantes en comparación con versiones anteriores.
Moderna comenzará a entregar de inmediato las vacunas actualizadas a la Agencia de Salud Pública de Canadá, asegurando un suministro suficiente para las campañas de vacunación provinciales y territoriales. La aprobación se basa en datos de fabricación y preclínicos, junto con evidencia clínica, no clínica y del mundo real que respalda la eficacia y seguridad de las vacunas de ARNm de Moderna.
모더나가 6개월 이상 개인을 위한 업데이트된 COVID-19 백신, SPIKEVAX® KP.2 변종에 대해 캐나다 보건부의 승인을 받았습니다. 이는 2024-2025년 캐나다에서 승인된 최초의 업데이트된 COVID-19 백신입니다. 이 백신은 SARS-CoV-2의 KP.2 하위 계통을 표적으로 하며, 이전 버전보다 현재 유행하는 변종에 대해 더 나은 보호를 제공할 것으로 예상됩니다.
모더나는 신속하게 업데이트된 백신을 캐나다 공공 보건 기구에 배달하여, 주 및 준주 예방접종 캠페인을 위한 충분한 공급을 보장할 것입니다. 승인은 제조 및 전임상 데이터와 함께 모더나의 mRNA 백신의 효능 및 안전성을 뒷받침하는 이전의 임상, 비임상 및 실제 증거를 바탕으로 하고 있습니다.
Moderna a reçu l'approbation de Santé Canada pour son vaccin COVID-19 mis à jour, SPIKEVAX® variante KP.2, pour les individus âgés de six mois et plus. Cela marque le premier vaccin COVID-19 mis à jour autorisé au Canada pour 2024-2025. Le vaccin cible la sous-lignée KP.2 de SARS-CoV-2 et devrait offrir une meilleure protection contre les souches circulantes par rapport aux versions antérieures.
Moderna commencera rapidement à livrer les vaccins mis à jour à l'Agence de santé publique du Canada, garantissant un approvisionnement suffisant pour les campagnes de vaccination provinciales et territoriales. L'approbation est fondée sur des données de fabrication et précliniques, ainsi que sur des preuves cliniques, non cliniques et du monde réel soutenant l'efficacité et la sécurité des vaccins à ARNm de Moderna.
Moderna hat die Genehmigung von Health Canada für seinen aktualisierten COVID-19-Impfstoff, SPIKEVAX® KP.2 Variante, für Personen ab sechs Monaten erhalten. Dies markiert den ersten genehmigten aktualisierten COVID-19-Impfstoff in Kanada für 2024-2025. Der Impfstoff zielt auf die KP.2-Unterlinie von SARS-CoV-2 ab und wird voraussichtlich besseren Schutz gegen zirkulierende Stämme im Vergleich zu früheren Versionen bieten.
Moderna wird umgehend mit der Lieferung der aktualisierten Impfstoffe an die Öffentliche Gesundheitsbehörde Kanadas beginnen, um eine ausreichende Versorgung für die Impfkampagnen der Provinzen und Territorien sicherzustellen. Die Genehmigung basiert auf Herstellungs- und präklinischen Daten sowie auf früheren klinischen, nicht klinischen und realen Evidenzen, die die Wirksamkeit und Sicherheit der mRNA-Impfstoffe von Moderna unterstützen.
- First updated COVID-19 vaccine authorized in Canada for 2024-2025 season
- Targets the KP.2 sub-lineage of SARS-CoV-2, potentially providing better protection against current strains
- Approved for a wide age range, from six months and older
- Prompt delivery to ensure robust supply for vaccination campaigns
- None.
Insights
Health Canada's approval of Moderna's updated SPIKEVAX® vaccine targeting the KP.2 variant is a significant development in the ongoing battle against COVID-19. This authorization marks the first updated COVID-19 vaccine for 2024-2025 in Canada, demonstrating Moderna's agility in adapting to emerging variants.
The vaccine's approval for individuals six months and older is particularly noteworthy, as it provides broad population coverage. The monovalent formulation targeting the KP.2 sub-lineage suggests a more focused immune response against currently circulating strains, potentially offering improved protection compared to earlier versions.
However, it's important to note that while updated vaccines are generally expected to provide better protection against circulating strains, real-world effectiveness data will be necessary to confirm this. The timely delivery of doses to coincide with provincial and territorial vaccination campaigns is a positive aspect, potentially leading to higher uptake rates.
The approval of Moderna's updated COVID-19 vaccine by Health Canada is a proactive step in public health management. The timing of this authorization, ahead of the fall and winter seasons when respiratory infections typically surge, is strategically important.
The National Advisory Committee on Immunization's recommendation for updated doses, especially for vulnerable populations, aligns with best practices in pandemic response. The flexibility of drawing both adult and pediatric doses from the same multidose vial could streamline vaccination efforts and reduce potential waste.
However, public health officials should be prepared to address potential vaccine fatigue among the population. Clear communication about the benefits of updated vaccines and their role in preventing severe illness will be crucial. Additionally, the co-administration with flu shots could enhance overall protection against respiratory illnesses but may require careful logistical planning.
Moderna's swift approval for its updated COVID-19 vaccine in Canada is a positive signal for the company's market position. As the first authorized updated vaccine for 2024-2025, Moderna gains a competitive advantage in the Canadian market, potentially leading to increased revenue and market share.
The immediate commencement of vaccine delivery to the Public Health Agency of Canada suggests a smooth supply chain and could result in early revenue recognition. However, investors should note that the financial impact may be moderated compared to earlier pandemic phases due to potentially lower demand and pricing pressures.
Looking ahead, Moderna's demonstrated ability to rapidly adapt its vaccine technology to new variants could be a key differentiator in the evolving vaccine market. This agility may support long-term growth prospects beyond COVID-19, potentially applying to other mRNA-based treatments. Investors should monitor uptake rates and any potential government contracts for further indications of financial performance.
SPIKEVAX® is the first updated COVID-19 vaccine authorized in Canada for 2024-2025, offering a timely solution to help protect Canadians this fall and winter season.
Moderna will promptly begin delivery of updated COVID-19 vaccines to the Public Health Agency of Canada, so there is robust supply available in time for provincial and territorial vaccination campaigns.
CAMBRIDGE, MA / ACCESSWIRE / September 17, 2024 / Moderna Inc (Nasdaq:MRNA) today announced that Health Canada has authorized its updated COVID-19 vaccine, SPIKEVAX® KP.2 variant, to help prevent COVID-19 in individuals six months of age and older. Moderna's updated COVID-19 vaccine targets the KP.2 sub-lineage of SARS-CoV-2. With vaccines ready, Moderna will begin delivery of updated doses to the Public Health Agency of Canada, ensuring supply is available in time for provincial and territorial vaccination campaigns.
"As we face another critical season in the fight against COVID-19, we remain steadfast in our dedication to delivering innovative solutions that help protect communities," said Stéphane Bancel, CEO of Moderna. "The authorization of our updated COVID-19 vaccine by Health Canada ensures that Canadians have timely access to the latest vaccines, helping them to stay protected during the upcoming fall and winter months."
Receiving the most recently updated COVID-19 vaccine is expected to provide a better immune response against circulating COVID-19 strains compared to earlier vaccines. It is especially important for those at increased risk for COVID-19 infection or severe COVID-19 illness.1
"With the recent increase in COVID-19-infections,2 staying up to date with your COVID-19 vaccination remains one of the best ways to help protect yourself from severe illness," said Dr. Shehzad Iqbal, Country Medical Director, Moderna Canada. "Canadians are encouraged to speak to their healthcare providers about receiving an updated 2024-2025 COVID-19 vaccine alongside a flu shot this fall."
Health Canada's approval is based on a combination of manufacturing and pre-clinical data, as well as previous clinical, non-clinical, and real-world evidence supporting the efficacy and safety of Moderna's COVID-19 mRNA vaccines.
Highlights for Fall 2024-2025 KP.2 Variant Updated Vaccine:
The updated vaccine is based on consultations with the Public Health Agency of Canada that the preferred composition for the 2024-2025 updated COVID-19 vaccine is a monovalent KP.2.
SPIKEVAX®will be available in one presentation, allowing adult and pediatric doses to be drawn from the same multidose vial.
The National Advisory Committee on Immunization (NACI) recommends that anyone not vaccinated or without a known COVID-19 infection in the past three months may receive an updated dose, with a focus on safeguarding vulnerable individuals.1
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 approval of Moderna's updated KP.2-targeting COVID-19 vaccine by Health Canada; the ability of Moderna's updated COVID-19 vaccine to induce an immune response and provide protection against circulating SARS-CoV-2 variants; and Moderna's ability to supply its COVID-19 vaccine to the Public Health Agency of Canada. 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
1 Summary of NACI statement of May 3, 2024: Guidance on the use of COVID-19 vaccines during the fall of 2024. Available at: https://www.canada.ca/en/public-health/services/publications/vaccines-immunization/national-advisory-committee-immunization-summary-guidance-covid-19-vaccines-fall-2024.html Accessed August 27, 2024.
2 COVID-19 epidemiology update: Summary: https://health-infobase.canada.ca/covid-19/ Accessed September 3, 2024.
SOURCE: Moderna, Inc.
View the original press release on accesswire.com
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