Moderna Receives European Commission Approval for Updated COVID-19 Vaccine Targeting SARS-CoV-2 Variant LP.8.1
Rhea-AI Summary
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.
Positive
- 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
Negative
- Additional regulatory approvals still pending in other global markets
News Market Reaction
On the day this news was published, MRNA declined 8.06%, reflecting a notable negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
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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