EMA Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Authorization of Moderna's COVID-19 mRNA Vaccine Targeting the SARS-COV-2 Variant JN.1
Moderna (NASDAQ:MRNA) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for an updated formulation of its COVID-19 mRNA vaccine Spikevax. The vaccine targets the SARS-CoV-2 variant JN.1 and is intended for active immunization to prevent COVID-19 in individuals six months of age and older.
Pending European Commission authorization, the updated vaccine will be available for the 2024-2025 vaccination season. The decision is based on manufacturing and preclinical data, along with previous clinical, non-clinical, and real-world evidence. Moderna has already received approval for this vaccine in Japan, Taiwan, and the UK, while a version targeting the KP.2 variant has been approved in the U.S.
Moderna (NASDAQ:MRNA) ha annunciato che il Comitato per i Medicinali Ad Uso Umano (CHMP) dell'Agenzia Europea dei Medicinali (EMA) ha adottato un parere positivo che raccomanda l'autorizzazione alla commercializzazione per una formulazione aggiornata del suo vaccino mRNA contro il COVID-19 Spikevax. Il vaccino mira al variante JN.1 di SARS-CoV-2 ed è destinato all'immunizzazione attiva per prevenire il COVID-19 in individui di sei mesi e oltre.
In attesa dell'autorizzazione della Commissione Europea, il vaccino aggiornato sarà disponibile per la stagione vaccinale 2024-2025. La decisione si basa su dati di produzione e preclinici, insieme a precedenti prove cliniche, non cliniche e evidenze del mondo reale. Moderna ha già ricevuto l'approvazione per questo vaccino in Giappone, Taiwan e Regno Unito, mentre una versione diretta alla variante KP.2 è stata approvata negli Stati Uniti.
Moderna (NASDAQ:MRNA) anunció que el Comité de Medicamentos Humanos (CHMP) de la Agencia Europea de Medicamentos (EMA) ha adoptado una opinión positiva recomendando la autorización de comercialización para una formulación actualizada de su vacuna de ARNm contra el COVID-19 Spikevax. La vacuna está dirigida a la variante JN.1 de SARS-CoV-2 y se destina a la inmunización activa para prevenir el COVID-19 en individuos de seis meses en adelante.
A la espera de la autorización de la Comisión Europea, la vacuna actualizada estará disponible para la temporada de vacunación 2024-2025. La decisión se basa en datos de fabricación y preclínicos, junto con pruebas clínicas, no clínicas y evidencia del mundo real previas. Moderna ya ha recibido la aprobación para esta vacuna en Japón, Taiwán y el Reino Unido, mientras que una versión dirigida a la variante KP.2 ha sido aprobada en los EE. UU.
모더나(NASDAQ:MRNA)는 유럽 의약품청(EMA) 의약품 인허가 위원회(CHMP)가 마케팅 허가를 추천하는 긍정적인 의견을 채택했다고 발표했습니다. 이번 업데이트된 COVID-19 mRNA 백신 스파이크박스는 SARS-CoV-2 변종 JN.1을 겨냥하며, 6개월 이상의 개인을 대상으로 COVID-19 예방을 위한 능동적 면역을 목표로 하고 있습니다.
유럽연합 집행위원회의 승인을 기다리는 동안, 업데이트된 백신은 2024-2025접종 시즌을 위해 제공될 예정입니다. 이번 결정은 제조 및 전임상 자료와 이전의 임상, 비임상 증거 및 실제 사례를 바탕으로 하고 있습니다. 모더나는 이미 일본, 대만 및 영국에서 이 백신의 승인을 받았으며, KP.2 변종을 겨냥한 버전은 미국에서 승인되었습니다.
Moderna (NASDAQ:MRNA) a annoncé que le Comité des médicaments à usage humain (CHMP) de l'Agence européenne des médicaments (EMA) a adopté un avis positif recommandant l'autorisation de mise sur le marché pour une formulation mise à jour de son vaccin COVID-19 à ARN messager Spikevax. Le vaccin cible la variante JN.1 de SARS-CoV-2 et est destiné à l'immunisation active pour prévenir le COVID-19 chez les personnes de six mois et plus.
En attendant l'autorisation de la Commission européenne, le vaccin mis à jour sera disponible pour la saison de vaccination 2024-2025. La décision est fondée sur des données de fabrication et précliniques, ainsi que sur des constatations cliniques, non cliniques et des preuves du monde réel préexistantes. Moderna a déjà reçu l'approbation de ce vaccin au Japon, à Taïwan et au Royaume-Uni, tandis qu'une version ciblant la variante KP.2 a été approuvée aux États-Unis.
Moderna (NASDAQ:MRNA) gab bekannt, dass das Ausschuss für Arzneimittel für den Humanbereich (CHMP) der Europäischen Arzneimittel-Agentur (EMA) eine positive Stellungnahme zur Empfehlung der Marktzulassung angenommen hat für eine aktualisierte Formulierung seines COVID-19-mRNA-Impfstoffs Spikevax. Der Impfstoff zielt auf die SARS-CoV-2-Variante JN.1 ab und ist zur aktiven Immunisierung zur Vorbeugung von COVID-19 bei Personen ab einem Alter von sechs Monaten gedacht.
In Erwartung der Zustimmung der Europäischen Kommission wird der aktualisierte Impfstoff für die Impfzeit 2024-2025 verfügbar sein. Die Entscheidung basiert auf Produktions- und präklinischen Daten sowie auf früheren klinischen, nicht-klinischen und realen Beweisen. Moderna hat bereits die Genehmigung für diesen Impfstoff in Japan, Taiwan und Großbritannien erhalten, während eine Version, die auf die KP.2-Variante abzielt, in den USA genehmigt wurde.
- Positive CHMP recommendation for marketing authorization of updated COVID-19 vaccine
- Vaccine targets the current dominant SARS-CoV-2 variant JN.1
- Potential availability for 2024-2025 vaccination season in Europe
- Approved for use in individuals 6 months and older
- Already approved in Japan, Taiwan, and the UK
- Pending final European Commission authorization decision
- Competing with other vaccine manufacturers in EC tendering procedure
Insights
The CHMP's positive opinion for Moderna's updated COVID-19 vaccine targeting the JN.1 variant is a significant development for the company's product pipeline. This recommendation paves the way for potential European Commission authorization, which could lead to increased vaccine sales in the EU market for the 2024-2025 season. The vaccine's ability to provide enhanced neutralizing antibody responses against JN.1 and its descendants could give Moderna a competitive edge in the evolving COVID-19 vaccine landscape.
However, investors should note that Moderna faces regional variations in vaccine approvals, with different variants targeted in different markets (JN.1 in EU, Japan, Taiwan, UK; KP.2 in the US). This could impact manufacturing complexity and global distribution strategies. The ongoing HERA tendering procedure in the EU adds another layer of uncertainty to Moderna's potential market share and revenue projections in this region.
Moderna's potential authorization for its updated COVID-19 vaccine in the EU market could have a positive impact on the company's financials. The timing aligns with the autumn/winter season, typically a period of higher demand for respiratory vaccines. This could translate to increased revenue for Moderna in Q4 2024 and Q1 2025.
However, investors should consider the evolving nature of the COVID-19 vaccine market. As the pandemic transitions to an endemic phase, demand patterns and pricing structures may change. The company's participation in the HERA tendering procedure suggests potential bulk purchasing agreements, which could affect profit margins. Additionally, Moderna's need to produce different variants for different markets may impact production costs and operational efficiency. These factors should be weighed against the potential revenue boost from the new vaccine approval.
The CHMP's positive opinion for Moderna's updated vaccine demonstrates the company's ability to adapt to evolving viral strains, which is important in maintaining market relevance. This flexibility could strengthen Moderna's competitive position against other vaccine manufacturers. However, the fragmented global approval landscape, with different variants approved in different regions, may present logistical challenges and potentially impact market penetration.
The EU market represents a significant opportunity, but Moderna's success will depend on factors such as vaccination rates, public health policies and competition from other approved vaccines. The HERA tendering process adds an element of uncertainty to Moderna's potential market share. Investors should monitor how effectively Moderna can leverage this approval to secure contracts and distribution channels across EU member states, as this will be critical in translating regulatory success into commercial performance.
Moderna's updated COVID-19 mRNA vaccine will be available for the 2024-2025 vaccination season, pending a European Commission authorization decision
CAMBRIDGE, MA / ACCESSWIRE / September 5, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization for an updated formulation of the COVID-19 mRNA vaccine Spikevax, targeting the SARS-CoV-2 variant JN.1, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals six months of age and older. Following the CHMP's positive opinion, the European Commission will make an authorization decision on the use of Moderna's updated COVID-19 vaccine for the autumn/winter season 2024-2025.
"The CHMP's positive recommendation for our updated COVID-19 mRNA vaccine targeting the SARS-CoV-2 variant JN.1 is a key milestone, demonstrating our commitment to protecting citizens across the European Union," said Stéphane Bancel, Chief Executive Officer of Moderna. "As respiratory diseases increase during the winter months, it is crucial for people to protect themselves by getting vaccinated with an updated COVID-19 vaccine that provides enhanced neutralizing antibody responses to JN.1 and its descendant lineages."
The CHMP decision is based on a combination of manufacturing and preclinical data, as well as previous clinical, non-clinical, and real-world evidence supporting the efficacy and safety of Moderna's COVID-19 mRNA vaccines. The updated vaccine composition is based on guidance from the EMA's Emergency Task Force (ETF) in April 2024, which recommended that COVID-19 vaccines be updated to target the JN.1 family of Omicron subvariants for the 2024-2025 vaccination campaign. The EMA confirmed this recommendation in July 2024.
Moderna has received approval for its COVID-19 mRNA vaccine targeting the SARS-CoV-2 variant JN.1 in Japan, Taiwan, and the UK. In the U.S., Moderna has received approval for its COVID-19 vaccine targeting the KP.2 variant of SARS-CoV-2. Additional regulatory applications for Moderna's updated COVID-19 vaccines targeting KP.2 or JN.1 are under review by other regulatory agencies.
In the European Union, Moderna is participating in a tendering procedure for mRNA COVID-19 vaccines by the Health Emergency Preparedness and Response Authority (HERA) of the European Commission (EC).
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.
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 authorization by the European Commission of Moderna's updated JN.1-targeting COVID-19 vaccine for autumn/winter 2024; the availability of Moderna's JN.1-targeting COVID-19 vaccine; and the ability of Moderna's updated COVID-19 vaccine to induce an immune response against circulating variants and provide protection for autumn/winter 2024. 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:
Luke Mircea-Willats
Senior Director, International Communications
Luke.mirceawillats@modernatx.com
Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.com
SOURCE: Moderna, Inc.
View the original press release on accesswire.com
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