Moderna’s new COVID-19 vaccine mNexspike approved by FDA, but there’s a limit on who can use it

The U.S. approved a new COVID-19 vaccine made by Moderna late Friday but with limits on who can use it — not a replacement for the company’s existing shot, but a second option.

The new vaccine, mNexspike, is a step toward next-generation coronavirus vaccines. It’s made in a way that allows for a lower dose – a fifth of the dose of its current COVID-19 vaccine, Spikevax – by refining its immune target.

The approval “adds an important new tool to help protect people at high risk of severe disease from COVID-19,” Stephane Bancel, Moderna’s CEO, said in a statement Saturday.

The Food and Drug Administration approved the new vaccine for use in all adults 65 and older, and for people age 12 to 64 who have a least one health condition that puts them at increased risk from the coronavirus.

That’s the same limit that the FDA set in licensing another COVID-19 vaccine option from competitor Novavax.

Those restrictions are a departure from how the U.S. has handled COVID-19 vaccines until now, reflecting skepticism about vaccines from Health Secretary Robert F. Kennedy Jr. and other Trump officials. 

Moderna’s existing vaccine doesn’t face those limits and has long been used for anyone ages 6 months and older. The company said it expected to offer both options this fall.

The FDA’s approval was based on a study of 11,400 people age 12 and older that compared the new low-dose vaccine with Moderna’s existing vaccine. It found the new vaccine was safe and was at least as effective – and more by some measures – than the original shot, the company said.

The news came just days after the Trump administration canceled funding for Moderna to develop a vaccine against potential pandemic flu viruses, including the H5N1 bird flu, despite promising early study results.

It also comes as the Centers for Disease Control and Prevention changes its recommendation to children for COVID-19 vaccine under Kennedy’s directive.

The agency on Thursday dropped its recommendation for all children to get the vaccinated but still broadly recommends COVID-19 vaccines for moderately or severely immunocompromised children, in addition to most adults for now.

Kennedy’s directive cited “a review of the recommendations” of the Food and Drug Administration and National Institutes of Health, saying that the risks of the COVID-19 vaccine for healthy children “do not outweigh the purported benefits of the vaccine.” The directive also cited “the lack of high-quality data demonstrating safety of the mRNA vaccines during pregnancy combined with the uncertainty of the benefits” for pregnant moms and their baby.

“Truly the death of expertise. This would be like the secretary of transportation directing that all planes must fly 5,000 feet higher than current. It’s vibe-based decision making,” one federal health official said of the directive.