European Commission Approves CSL and Arcturus Therapeutics’ KOSTAIVE®, the First Self-amplifying mRNA COVID-19 Vaccine
CSL and Arcturus Therapeutics (ARCT) have received European Commission marketing authorization for KOSTAIVE®, the first self-amplifying mRNA (sa-mRNA) COVID-19 vaccine for individuals 18 and older. The approval follows a positive CHMP opinion from the European Medicines Agency on December 12, 2024.
KOSTAIVE demonstrated superior immunogenicity and antibody persistence for up to 12 months post-vaccination compared to conventional mRNA COVID-19 vaccines in clinical trials. The approval is based on data from multiple studies, including an integrated phase 1/2/3 study showing efficacy and tolerability, and Phase 3 booster trials.
The vaccine is already marketed in Japan and will be valid across all EU member states and EEA countries. CSL is working to optimize KOSTAIVE's formulation to better serve healthcare professionals and patients in Europe.
CSL e Arcturus Therapeutics (ARCT) hanno ricevuto l'autorizzazione al commercio dalla Commissione Europea per KOSTAIVE®, il primo vaccino COVID-19 a mRNA auto-amplificante (sa-mRNA) per individui di età pari o superiore a 18 anni. L'approvazione segue un parere positivo del CHMP dell'Agenzia Europea dei Medicinali del 12 dicembre 2024.
KOSTAIVE ha dimostrato superiore immunogenicità e persistenza degli anticorpi per un periodo fino a 12 mesi dopo la vaccinazione, rispetto ai vaccini COVID-19 a mRNA convenzionali, nei trial clinici. L'approvazione si basa su dati provenienti da diversi studi, incluso uno studio integrato di fase 1/2/3 che ha mostrato efficacia e tollerabilità, e trial di richiamo di fase 3.
Il vaccino è già commercializzato in Giappone e sarà valido in tutti gli Stati membri dell'UE e nei paesi SEE. CSL sta lavorando per ottimizzare la formulazione di KOSTAIVE per servire meglio i professionisti sanitari e i pazienti in Europa.
CSL y Arcturus Therapeutics (ARCT) han recibido la autorización de comercialización de la Comisión Europea para KOSTAIVE®, la primera vacuna COVID-19 de ARNm auto-amplificante (sa-ARNm) para personas de 18 años o más. La aprobación sigue a un dictamen positivo del CHMP de la Agencia Europea de Medicamentos del 12 de diciembre de 2024.
KOSTAIVE demostró superior inmunogenicidad y persistencia de anticuerpos durante hasta 12 meses después de la vacunación en comparación con las vacunas COVID-19 de ARNm convencionales en ensayos clínicos. La aprobación se basa en datos de múltiples estudios, incluido un estudio integrado de fase 1/2/3 que mostró eficacia y tolerabilidad, y ensayos de refuerzo de fase 3.
La vacuna ya se comercializa en Japón y será válida en todos los Estados miembros de la UE y países del EEE. CSL está trabajando para optimizar la formulación de KOSTAIVE para servir mejor a los profesionales de la salud y a los pacientes en Europa.
CSL과 Arcturus Therapeutics (ARCT)는 KOSTAIVE®에 대한 유럽연합 집행위원회의 마케팅 승인을 받았습니다. 이는 18세 이상의 개인을 위한 첫 번째 자기 증폭 mRNA (sa-mRNA) COVID-19 백신입니다. 이 승인은 2024년 12월 12일 유럽 의약품청의 CHMP 긍정적 의견을 따른 것입니다.
KOSTAIVE는 임상 시험에서 기존 mRNA COVID-19 백신에 비해 백신 접종 후 최대 12개월 동안 우수한 면역원성과 항체 지속성을 입증했습니다. 승인은 효능과 내약성을 보여주는 통합 1/2/3상 연구를 포함한 여러 연구의 데이터를 기반으로 합니다.
이 백신은 이미 일본에서 판매되고 있으며, 모든 EU 회원국 및 EEA 국가에서 유효합니다. CSL은 유럽의 의료 전문가와 환자들에게 더 나은 서비스를 제공하기 위해 KOSTAIVE의 제형 최적화 작업을 진행하고 있습니다.
CSL et Arcturus Therapeutics (ARCT) ont reçu l'autorisation de mise sur le marché de la Commission Européenne pour KOSTAIVE®, le premier vaccin COVID-19 à ARN messager auto-amplifiant (sa-ARNm) pour les personnes de 18 ans et plus. L'approbation fait suite à un avis positif du CHMP de l'Agence Européenne des Médicaments du 12 décembre 2024.
KOSTAIVE a démontré une immunogénicité supérieure et une persistance des anticorps pouvant aller jusqu'à 12 mois après la vaccination par rapport aux vaccins COVID-19 à ARN messager conventionnels lors des essais cliniques. L'approbation est basée sur des données provenant de plusieurs études, y compris une étude intégrée de phase 1/2/3 montrant l'efficacité et la tolérance, ainsi que des essais de rappel de phase 3.
Le vaccin est déjà commercialisé au Japon et sera valable dans tous les États membres de l'UE et les pays de l'EEE. CSL travaille à optimiser la formulation de KOSTAIVE pour mieux servir les professionnels de la santé et les patients en Europe.
CSL und Arcturus Therapeutics (ARCT) haben die Genehmigung der Europäischen Kommission für KOSTAIVE® erhalten, den ersten selbstverstärkenden mRNA (sa-mRNA) COVID-19-Impfstoff für Personen ab 18 Jahren. Die Genehmigung folgt auf eine positive Stellungnahme des CHMP der Europäischen Arzneimittel-Agentur vom 12. Dezember 2024.
KOSTAIVE hat in klinischen Studien überlegene Immunogenität und Antikörperpersistenz von bis zu 12 Monaten nach der Impfung im Vergleich zu herkömmlichen mRNA COVID-19-Impfstoffen gezeigt. Die Genehmigung basiert auf Daten aus mehreren Studien, darunter eine integrierte Phase 1/2/3-Studie, die Wirksamkeit und Verträglichkeit zeigt, sowie Phase 3 Auffrischungsstudien.
Der Impfstoff ist bereits in Japan auf dem Markt und wird in allen EU-Mitgliedstaaten und EWR-Ländern gültig sein. CSL arbeitet daran, die Formulierung von KOSTAIVE zu optimieren, um den Gesundheitsfachkräften und Patienten in Europa besser zu dienen.
- First sa-mRNA COVID-19 vaccine approved by European Commission
- Superior immunogenicity and 12-month antibody persistence compared to conventional mRNA vaccines
- Marketing authorization valid across all EU member states and EEA countries
- Already commercially available in Japan
- Product not immediately available in Europe pending technical enhancements
Insights
The European Commission's approval of KOSTAIVE marks a transformative moment for Arcturus Therapeutics, establishing the company as the pioneer in self-amplifying mRNA vaccine technology. This regulatory milestone carries substantial commercial implications, as it opens access to the entire EU and EEA markets, significantly expanding beyond KOSTAIVE's existing Japanese presence.
The vaccine's demonstrated 12-month antibody persistence represents a important competitive advantage in the crowded COVID-19 vaccine market. This extended protection period could translate into reduced vaccination frequency, potentially lowering healthcare costs and improving compliance rates. The superior immunogenicity data against multiple SARS-CoV-2 strains also positions KOSTAIVE favorably against existing mRNA vaccines.
From a technology perspective, this approval validates Arcturus's sa-mRNA platform, potentially catalyzing its application across other therapeutic areas. The successful development and commercialization of KOSTAIVE, in partnership with global biotechnology leader CSL, establishes a blueprint for future collaborations and pipeline expansion.
The market opportunity is substantial, considering the EU's population of approximately 450 million. While COVID-19 vaccination rates have stabilized, the demonstrated superior efficacy and duration of protection could drive market share gains, particularly in the booster segment. The partnership with CSL provides robust manufacturing and distribution capabilities, essential for capitalizing on this opportunity.
- KOSTAIVE represents a significant advancement in vaccine technology, demonstrating superior immunogenicity and antibody persistence for up to 12 months post-vaccination compared to conventional mRNA COVID-19 vaccines in clinical trials
The European Commission approval follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on December 12, 2024. The centralised marketing authorization of KOSTAIVE is valid in all EU member states and in the EEA countries.
“The European Commission's approval marks a significant milestone in our ongoing development program for KOSTAIVE,” said Jonathan Edelman, MD, Senior Vice President of the Vaccines Innovation Unit, CSL. “We are actively working to optimize KOSTAIVE's formulation to better meet the needs of healthcare professionals and their patients. As COVID-19 remains an unpredictable global threat, CSL is dedicated to completing these technical enhancements and making this innovative vaccine available in
The approval is based on positive clinical data from several studies, including an integrated phase 1/2/3 study demonstrating KOSTAIVE’s efficacy and tolerability, and Phase 3 COVID-19 booster trials, which achieved higher immunogenicity results compared to a conventional mRNA COVID-19 vaccine comparator. A follow-up analysis evaluating a booster dose of KOSTAIVE also showed that the vaccine elicited superior immunogenicity and antibody persistence for up to 12 months postvaccination against multiple SARS-CoV-2 strains in both younger and older adult age groups versus the same mRNA comparator.
“KOSTAIVE and sa-mRNA technology signify a major advancement in vaccine innovation, providing the potential for broader and more enduring protection,” said Joseph Payne, CEO of Arcturus. “This approval highlights the clinical promise of KOSTAIVE and its ability to protect against the ever-changing COVID-19 virus.”
About sa-mRNA
mRNA vaccines help protect against infectious diseases by providing a blueprint for cells in the body to make a protein to help our immune systems recognize and fight the disease. Unlike standard mRNA vaccines, self-amplifying mRNA vaccines instruct the body to make more mRNA and protein to boost the immune response.
About CSL
CSL (ASX: CSL; USOTC: CSLLY) is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses: CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For inspiring stories about the promise of biotechnology, visit CSLBehring.com/Vita and follow us on Twitter.com/CSL.
For more information about CSL, visit www.CSL.com.
About Arcturus
Founded in 2013 and based in
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact included in this press release, are forward-looking statements, including those regarding strategy, future operations, the likelihood of success (including safety, efficacy and commercialization) of KOSTAIVE, the likelihood that clinical results received to date will be predictive of future clinical results and of protection against changing virus variants, the likelihood of optimizing KOSTAIVE’s formulation and completing technical enhancements, and the impact of general business and economic conditions. Arcturus may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in any forward-looking statements such as the foregoing and you should not place undue reliance on such forward-looking statements. These statements are only current predictions or expectations, and are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements, including those discussed under the heading "Risk Factors" in Arcturus’ most recent Annual Report on Form 10-K, and in subsequent filings with, or submissions to, the SEC, which are available on the SEC’s website at www.sec.gov. Except as otherwise required by law, Arcturus disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.
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FAQ
What makes KOSTAIVE (ARCT-154) different from other COVID-19 vaccines?
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