Moderna Receives European Commission Approval for Updated COVID-19 Vaccine Targeting SARS-CoV-2 Variant LP.8.1
Moderna (NASDAQ:MRNA) has received European Commission (EC) approval for its updated COVID-19 vaccine Spikevax® targeting the SARS-CoV-2 variant LP.8.1. The authorization covers individuals six months of age and older across all 27 EU member states, Iceland, Liechtenstein, and Norway.
The approval follows a Positive Opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) and aligns with global health authorities' recommendations for the 2025-2026 vaccination season. The vaccine has shown a favorable safety profile, with injection site pain being the most common local adverse event.
Moderna (NASDAQ:MRNA) ha ottenuto l'approvazione della Commissione Europea (CE) per la sua versione aggiornata del vaccino COVID-19 Spikevax®, specificamente mirata alla variante SARS-CoV-2 LP.8.1. L'autorizzazione riguarda le persone dai sei mesi di età in su in tutti i 27 stati membri dell'UE, nonché in Islanda, Liechtenstein e Norvegia.
L'approvazione segue un parere positivo del Comitato per i Medicinali per Uso Umano (CHMP) dell'EMA e si allinea alle raccomandazioni delle autorità sanitarie mondiali per la stagione vaccinale 2025-2026. Il vaccino ha dimostrato un profilo di sicurezza favorevole, con il dolore nel sito di iniezione come evento avverso locale più comune.
Moderna (NASDAQ:MRNA) ha recibido la aprobación de la Comisión Europea (CE) para su vacuna actualizada contra el COVID-19, Spikevax®, dirigida a la variante SARS-CoV-2 LP.8.1. La autorización abarca a personas de seis meses de edad en adelante en los 27 estados miembros de la UE, así como en Islandia, Liechtenstein y Noruega.
La aprobación sigue a una Opinión Positiva del Comité de Medicamentos de Uso Humano (CHMP) de la EMA y se ajusta a las recomendaciones de las autoridades sanitarias globales para la temporada de vacunación 2025-2026. La vacuna ha mostrado un perfil de seguridad favorable, siendo el dolor en el sitio de inyección el evento adverso local más común.
모더나 (NASDAQ:MRNA)는 SARS-CoV-2 변이주 LP.8.1을 타겟으로 한 업데이트된 COVID-19 백신 스파이크백스®에 대해 유럽연합 집행위원회(EC)의 승인을 받았습니다. 이 승인은 6개월 이상인 모든 개인을 대상으로 하며, 27개 EU 회원국과 아이슬란드, 리히텐슈타인, 노르웨이에 적용됩니다.
이번 승인은 EMA 인체용 의약품 위원회(CHMP)의 긍정적인 의견에 따른 것이며, 2025-2026년 예방 접종 시즌에 대한 전 세계 보건 당국의 권고와 일치합니다. 백신은 주사 부위 통증이 가장 흔한 국소 부작용으로 나타나는 등 안전성 프로필이 우수한 것으로 나타났습니다.
Moderna (NASDAQ:MRNA) a obtenu l'approbation de la Commission européenne (CE) pour son vaccin COVID-19 mis à jour, Spikevax®, ciblant la variante SARS-CoV-2 LP.8.1. Cette autorisation concerne les personnes âgées de six mois et plus dans les 27 États membres de l'UE ainsi qu'en Islande, au Liechtenstein et en Norvège.
Cette approbation fait suite à un avis positif du Comité des médicaments à usage humain (CHMP) de l'EMA et est conforme aux recommandations des autorités sanitaires mondiales pour la saison vaccinale 2025-2026. Le vaccin a démontré un profil de sécurité favorable, la douleur au site d'injection étant l'effet indésirable local le plus fréquent.
Moderna (NASDAQ:MRNA) hat die Zulassung der Europäischen Kommission (EK) für seinen aktualisierten COVID-19-Impfstoff Spikevax® erhalten, der auf die SARS-CoV-2-Variante LP.8.1 abzielt. Die Zulassung gilt für Personen ab sechs Monaten in allen 27 EU-Mitgliedstaaten sowie in Island, Liechtenstein und Norwegen.
Die Zulassung folgt einer positiven Stellungnahme des Ausschusses für Humanarzneimittel (CHMP) der EMA und entspricht den Empfehlungen der globalen Gesundheitsbehörden für die Impfkampagne 2025-2026. Der Impfstoff weist ein günstiges Sicherheitsprofil auf, wobei Schmerzen an der Injektionsstelle das häufigste lokale unerwünschte Ereignis sind.
- EC approval secured for updated COVID-19 vaccine across 30 European countries
- Vaccine will be available ahead of 2025-2026 vaccination season
- Broad age range approval from 6 months and older
- Generally well-tolerated safety profile reported
- Additional regulatory approvals still pending in other global markets
Insights
Moderna secured EC approval for its updated COVID-19 vaccine targeting the LP.8.1 variant, positioning for 2025-2026 vaccination season revenue.
The European Commission's approval of Moderna's updated COVID-19 vaccine represents a significant regulatory milestone that secures the company's position in the European vaccine market for the upcoming 2025-2026 season. This authorization covers all 27 EU member states plus Iceland, Liechtenstein, and Norway – a substantial market encompassing over 450 million people.
The approval specifically targets the LP.8.1 variant, demonstrating Moderna's continued ability to adapt its mRNA platform to address emerging viral strains. This validates the flexibility of their technology platform and their regulatory strategy of maintaining updated formulations.
From a commercial perspective, this approval comes at a strategically optimal time, ahead of the fall/winter vaccination season when demand typically increases. While the press release doesn't specify expected revenue, this approval secures a critical revenue stream as COVID-19 transitions from pandemic emergency to seasonal vaccination model.
The safety profile mentioned – primarily injection site pain, headache, fatigue, myalgia and chills – is consistent with previous COVID-19 vaccines, suggesting no new safety concerns that might limit uptake. The broad age indication (six months and older) maximizes the potential patient population.
The reference to "additional regulatory applications under review around the world" indicates potential for further market expansion, though the timeline and specific regions remain unspecified. Investors should watch for subsequent approvals, particularly from the FDA for the US market, which would represent another significant revenue opportunity.
CAMBRIDGE, MA / ACCESS Newswire / July 30, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Commission (EC) has granted marketing authorization for the 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. This marketing authorization follows the Positive Opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). The authorization is valid in all 27 EU member states, as well as Iceland, Liechtenstein and Norway. Following the EC decision, doses will be available for eligible populations ahead of the 2025-2026 vaccination season.
"We appreciate the EC's timely review and are pleased that our updated COVID-19 vaccine will be available to protect the public against currently circulating strains," said Stéphane Bancel, Chief Executive Officer of Moderna. "COVID-19 continues to impact individuals and healthcare systems globally and we encourage people to speak to their healthcare providers about receiving an updated vaccine."
The marketing authorization follows guidance from various global health authorities, which recommended that COVID-19 vaccines be updated to target the LP.8.1 strain for the 2025-2026 vaccination season.
Moderna's COVID-19 vaccines have been generally well-tolerated. The most common solicited local adverse event for Moderna's COVID-19 vaccines is injection site pain. The most common solicited systemic adverse events include headache, fatigue, myalgia and chills.
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.
Spikevax®is a registered trademark of Moderna.
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 availability of Moderna's COVID-19 vaccines in EU Member State, Iceland, Liechtenstein and Norway; and the tolerability of Moderna's COVID-19 vaccines. 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:
Chris Ridley
Head of Global Media Relations
+1 617-800-3651
Chris.Ridley@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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