Press release
Moderna Receives European Commission Approval for Updated COVID-19 Vaccine Targeting SARS-CoV-2 Variant LP.8.1
CAMBRIDGE, MA / ACCESS Newswire / July 30, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Commission (EC) has granted marketing
About this update from Moderna, Inc.
[{"type":"text","content":"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 ModernaModerna 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...