Spikevax authorised to target LP.8.1 variant ahead of 2025-2026 season
Moderna has received marketing authorisation from the European Commission for its updated COVID-19 vaccine, Spikevax, which targets the SARS-CoV-2 variant LP.8.1. The vaccine is approved for use in individuals aged six months and older.
The authorisation follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use. It applies across all 27 EU member states, as well as Iceland, Liechtenstein and Norway.
Doses will be available ahead of the 2025-2026 vaccination season for eligible populations. The decision aligns with guidance from global health authorities recommending vaccines be updated to target LP.8.1.
Moderna’s chief executive officer Stéphane Bancel said: “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.”
He added: “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.”
Moderna’s COVID-19 vaccines have generally been well-tolerated. The most common local adverse event is injection site pain. Systemic adverse events include headache, fatigue, myalgia and chills.
Additional regulatory applications for the updated vaccine are under review in other countries.