Moderna Wins FDA Approval, With Limits, for COVID Vaccine

Moderna's next COVID-19 vaccine has received Food and Drug Administration approval, albeit with restrictions not placed on the company's current shot. The new vaccine, called mNEXSPIKE, can be given to adults 65 and older and those 12 to 64 years old who have an underlying condition putting them at risk of severe infection, Axios reports. Moderna said the vaccine, which the FDA cleared late Friday, should be available for the 2025-26 respiratory virus season. For now, the company said, mNEXSPIKE and Spikevax, its original COVID vaccine, will be on the market.

The FDA put similar restrictions on Novavax's COVID vaccine earlier this month, per the AP. The underlying conditions listed include diabetes, chronic obstructive pulmonary disorder, and obesity, per STAT. Moderna's mNEXSPIKE showed 9.3% higher relative efficacy compared to Spikevax in recipients 12 and older, per Axios. The Phase 3 trial of roughly 11,400 people demonstrated a 13.5% higher efficacy in those 65 and older. The vaccine uses a refined target to generate antibodies against the SARS-CoV-2 virus, allowing for a dose one-fifth of that in Spikevax.

Such restrictions are new in the government's approval process, per the AP, under the Trump administration and Health Secretary Robert F. Kennedy Jr., who have been critical of vaccines. Considering that and the canceling this week of Moderna's contract to develop an mRNA-based vaccine for pandemic flu, including the H5N1 bird flu, STAT casts mNEXSPIKE's approval as a success for Moderna. Billions of doses of mRNA-based vaccines have been administered around the world since late 2020. Moderna's original vaccine has been used for anyone 6 months or older. (More Moderna stories.)