06:05 AM EDT, 06/02/2025 (MT Newswires) -- Moderna ( MRNA ) said Saturday it received approval from the US Food and Drug Administration for the mNEXSPIKE COVID-19 vaccine for use in all adults aged 65 years and above.

The approval also covers individuals aged between 12 and 64 years with at least one or more underlying condition that puts them at high risk for severe outcomes from COVID-19, the company said.

The drugmaker said it expects to have mNEXSPIKE available in the US for the 2025-2026 respiratory virus season.

Moderna ( MRNA ) shares were up 4.6% in recent premarket activity Monday.