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 LP.8.1
Moderna (NASDAQ:MRNA) has received a positive opinion from the European Medicines Agency's CHMP recommending marketing authorization for its updated COVID-19 vaccine Spikevax®. The new formulation targets the SARS-CoV-2 variant LP.8.1 and is intended for the 2025-2026 vaccination season.
The vaccine is designed for individuals six months of age and older. The CHMP's decision is based on manufacturing and preclinical data, along with previous clinical, non-clinical, and real-world evidence. The updated vaccine composition aligns with global health authorities' guidance, which identified LP.8.1 as an appropriate strain for the upcoming vaccination season.
Moderna (NASDAQ:MRNA) ha ricevuto un parere positivo dal CHMP dell'Agenzia Europea per i Medicinali, che raccomanda l'autorizzazione alla commercializzazione del suo aggiornato vaccino COVID-19 Spikevax®. La nuova formulazione è mirata alla variante SARS-CoV-2 LP.8.1 ed è destinata alla stagione vaccinale 2025-2026.
Il vaccino è progettato per persone di età a partire da sei mesi. La decisione del CHMP si basa su dati di produzione e preclinici, insieme a precedenti evidenze cliniche, non cliniche e del mondo reale. La composizione aggiornata del vaccino è in linea con le indicazioni delle autorità sanitarie globali, che hanno identificato la variante LP.8.1 come ceppo appropriato per la prossima stagione vaccinale.
Moderna (NASDAQ:MRNA) ha recibido una opinión positiva del CHMP de la Agencia Europea de Medicamentos que recomienda la autorización de comercialización de su actualizado vacuna contra el COVID-19 Spikevax®. La nueva formulación está dirigida a la variante SARS-CoV-2 LP.8.1 y está destinada a la temporada de vacunación 2025-2026.
La vacuna está diseñada para personas de seis meses de edad en adelante. La decisión del CHMP se basa en datos de fabricación y preclínicos, junto con evidencia clínica previa, no clínica y del mundo real. La composición actualizada de la vacuna está alineada con las directrices de las autoridades sanitarias globales, que identificaron a LP.8.1 como la cepa adecuada para la próxima temporada de vacunación.
모더나(NASDAQ:MRNA)는 유럽의약품청(EMA) CHMP로부터 업데이트된 COVID-19 백신 Spikevax®에 대한 판매 허가 권고 긍정적 의견을 받았습니다. 새 제형은 SARS-CoV-2 변이주 LP.8.1을 대상으로 하며 2025-2026년 접종 시즌을 위해 개발되었습니다.
이 백신은 6개월 이상의 개인을 대상으로 설계되었습니다. CHMP의 결정은 제조 및 비임상 데이터와 이전 임상, 비임상, 실제 사용 증거를 기반으로 합니다. 업데이트된 백신 조성물은 LP.8.1을 다음 접종 시즌에 적합한 균주로 식별한 전 세계 보건 당국의 지침과 일치합니다.
Moderna (NASDAQ:MRNA) a reçu un avis positif du CHMP de l'Agence européenne des médicaments recommandant l'autorisation de mise sur le marché de son vaccin COVID-19 Spikevax® mis à jour. La nouvelle formulation cible la variante SARS-CoV-2 LP.8.1 et est destinée à la saison de vaccination 2025-2026.
Le vaccin est conçu pour les personnes âgées de six mois et plus. La décision du CHMP repose sur des données de fabrication et précliniques, ainsi que sur des preuves cliniques, non cliniques et du monde réel antérieures. La composition mise à jour du vaccin est conforme aux recommandations des autorités sanitaires mondiales, qui ont identifié LP.8.1 comme souche appropriée pour la prochaine saison de vaccination.
Moderna (NASDAQ:MRNA) hat eine positive Stellungnahme des CHMP der Europäischen Arzneimittelagentur erhalten, die die Marktzulassung für seinen aktualisierten COVID-19-Impfstoff Spikevax® empfiehlt. Die neue Formulierung richtet sich gegen die SARS-CoV-2-Variante LP.8.1 und ist für die Impfsaison 2025-2026 vorgesehen.
Der Impfstoff ist für Personen ab sechs Monaten konzipiert. Die Entscheidung des CHMP basiert auf Herstellungs- und präklinischen Daten sowie früheren klinischen, nicht-klinischen und Real-World-Evidenzen. Die aktualisierte Impfstoffzusammensetzung entspricht den Empfehlungen der globalen Gesundheitsbehörden, die LP.8.1 als geeigneten Stamm für die kommende Impfsaison identifiziert haben.
- Positive CHMP opinion recommending marketing authorization in Europe
- Vaccine targets the current dominant LP.8.1 variant
- Broad age range approval (6 months and older)
- Alignment with global health authorities' guidance
- Final European Commission authorization still pending
- Additional regulatory approvals needed in other global markets
Insights
EMA committee's positive recommendation for Moderna's updated COVID vaccine is a significant regulatory milestone toward commercialization.
The European Medicines Agency's CHMP recommendation for Moderna's updated COVID-19 vaccine targeting the LP.8.1 variant represents a critical regulatory milestone in the company's commercialization pathway. This positive opinion is the penultimate step before European Commission authorization, which would enable Moderna to market this updated formulation across the EU for the upcoming 2025-2026 vaccination season.
The recommendation's scope is particularly broad, covering individuals six months of age and older, giving Moderna access to essentially the entire population spectrum. The regulatory basis for this decision combines manufacturing and preclinical data with historical evidence from previous versions, demonstrating the regulatory efficiency of Moderna's platform technology approach to vaccine updates.
This updated vaccine aligns with global health authority guidance that identified LP.8.1 as an appropriate strain target for the upcoming season, suggesting coordinated global regulatory approaches to COVID-19 variant vaccines. While the European market represents a significant opportunity, Moderna notes that similar applications are under review in other jurisdictions, indicating a coordinated global regulatory strategy.
CEO Stéphane Bancel's statement highlighting the ongoing burden of COVID-19 on vulnerable populations suggests Moderna is positioning this updated vaccine as essential for healthcare systems, despite potential public perception that the pandemic emergency has subsided. This regulatory progress represents continued validation of Moderna's mRNA platform's ability to rapidly adapt to emerging variants, a core value proposition of their technology.
Moderna's updated COVID-19 mRNA vaccine will be available for the 2025-2026 vaccination season, pending a European Commission authorization decision
CAMBRIDGE, MA / ACCESS Newswire / July 25, 2025 / 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 vaccine Spikevax®, targeting the SARS-CoV-2 variant LP.8.1, 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 a marketing authorization decision on Moderna's updated COVID-19 vaccine for the 2025-2026 season.
"The CHMP's positive opinion on our updated COVID-19 vaccine targeting the SARS-CoV-2 variant LP.8.1 is an important milestone in our ongoing effort to protect people across the European Union," said Stéphane Bancel, Chief Executive Officer of Moderna. "COVID-19 continues to place a significant burden on vulnerable populations and healthcare systems. Updated vaccines can be an important tool for protecting individuals and societies."
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 vaccines. The updated vaccine composition aligns with guidance from various global health authorities, which have identified the LP.8.1 strain as an appropriate update to the COVID-19 vaccine composition for the 2025-2026 vaccination season.
Additional regulatory applications for Moderna's updated COVID-19 vaccines targeting LP.8.1 are under review around the world.
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 potential authorization by the European Commission of Moderna's COVID-19 vaccine targeting the SARS-CoV-2 variant LP.8.1; and the opportunity for Moderna to sell COVID-19 vaccines to up to 17 participating European Union countries over a four-year period. 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
Media:
Clothilde Caillet
Director, Country and Europe Communications Lead
Clothilde.caillet@modernatx.com
Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com
SOURCE: Moderna, Inc.
View the original press release on ACCESS Newswire
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