06:35 AM EDT, 09/16/2025 (MT Newswires) -- Moderna ( MRNA ) said Tuesday that preliminary immunogenicity data from an ongoing phase 4 trial of its 2025 to 2026 Spikevax COVID-19 vaccine showed greater than eight-fold increase in neutralizing antibodies against a certain variant among adults aged 65 and up, as well as individuals aged 12 through 64 with at least one high-risk condition.

The safety profile was also found to be consistent with previous studies, with no new safety concerns, Moderna ( MRNA ) said.

The new preliminary clinical findings also support the recent US Food and Drug Administration approval of the 2025 to 2026 Spikevax formula for high-risk individuals aged six months through 64 years with at least one underlying condition and all adults 65 years and older, the company said.