Moderna (MRNA) said late Friday it filed an application with the US Food and Drug Administration for review of its Spikevax formula targeting SARS-CoV-2 variant LP.8.1.

The application is based on FDA guidance updating COVID-19 vaccines to a monovalent JN.1 lineage, with a preference for the LP.8.1.

The most common adverse reactions were headache, fatigue, myalgia, chills, arthralgia, axillary swelling, nausea, and fever.