FDA grants limited approval to new Covid vaccine from Moderna

Moderna announced this weekend that the Food and Drug Administration approved its lower-dose Covid-19 vaccine for adults 65 and older, as well as people ages 12 to 64 with at least one medical condition that increases their risk for severe Covid.

Moderna announced this weekend that the Food and Drug Administration approved its lower-dose Covid-19 vaccine for adults 65 and older, as well as people ages 12 to 64 with at least one medical condition that increases their risk for severe Covid.

The approval, which is limited to individuals who have previously received a Covid vaccine, was granted by the FDA on Friday.

Moderna said in a Saturday press release that the new vaccine should be available in the U.S. in time for the 2025-26 respiratory virus season, which starts in the fall. Moderna is also updating its original vaccine to target the LP.8.1 variant this fall. The company submitted an application in May for the FDA to approve the updated formula.

The newly approved vaccine, mNEXSPIKE, contains one-fifth of of Moderna’s original Covid vaccine dose, Spikevax. It is intended as an alternative for individuals who prefer a lower-dose option, not as a replacement for existing Covid vaccines.

But young, healthy adults won’t be eligible to receive it, despite their inclusion in Moderna’s clinical trial.