The European Union’s drug regulator has recommended approval of Moderna’s (MRNA.O), opens new tab updated formulation of COVID-19 shot Spikevax, the vaccine maker said on Friday.
The updated shot targets the LP.8.1 variant, part of the JN.1 lineage, to prevent COVID-19 in individuals six months of age and older, Moderna said.
It expects to make the mRNA-based shot available for the 2025-26 vaccination season, pending a European Commission approval.
Any recommendation by the European Medicines Agency’s human medicines committee has to be formally approved by the EC, which usually follows the regulator’s decision.
Moderna had filed a marketing application for the review of its updated vaccine with the U.S. Food and Drug Administration in May.
