On July 30, 2025, Moderna announced that the European Commission (EC) granted marketing authorization for the updated formulation of Moderna's COVID-19 vaccine Spikevax®. The updated vaccine targets the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19 in individuals 6 months of age and older.
According to the announcement, the granted marketing authorization for Moderna's updated vaccine is based on the positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use and 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." Per Moderna, "[t]he authorization is valid in all 27 EU member states, as well as Iceland, Liechtenstein and Norway" and "doses will be available for eligible populations ahead of the 2025-2026 vaccination season." Moderna's CEO, Stéphane Bancel, noted that "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 further reports that "[a]dditional regulatory applications for Moderna's updated COVID-19 vaccines targeting LP.8.1 are under review around the world."
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