FDA approves Moderna’s updated COVID‑19 vaccines targeting LP.8.1 variant

Moderna has received U.S. Food and Drug Administration approval for its 2025‑2026 COVID‑19 vaccine formulations—namely Spikevax and the new vaccine mNEXSPIKE. These updated vaccines are designed to target the emerging LP.8.1 variant of SARS‑CoV‑2. Spikevax is authorised for individuals aged six months through 64 years with at least one underlying high‑risk condition, as well as all adults aged 65 years and older. mNEXSPIKE, a new lower‑dose vaccine, is approved for those aged 12 through 64 with high‑risk conditions and all adults aged 65 and above .

mNEXSPIKE offers a significant dosage reduction—about one‑fifth of Spikevax—achieved by refining the vaccine’s immune target. This design supports enhanced efficacy with potentially fewer side effects. Clinical data show that mNEXSPIKE demonstrated improved protection relative to Spikevax: about 9.3% higher vaccine efficacy in individuals aged 12 and older, and 13.5% higher in those aged 65 and above .

These approvals mark a shift toward more tailored vaccine recommendations, focusing on high‑risk groups rather than universal vaccination across age groups. Moderna plans to offer both Spikevax and mNEXSPIKE during the fall respiratory virus season, giving clinicians and patients added flexibility in immunisation strategies.