The U.S. Food and Drug Administration (FDA) has approved a new COVID-19 vaccine developed by Moderna, called mNexspike. Unlike the company’s existing Spikevax vaccine, this new version is intended as an additional option—not a full replacement—and will be available only to specific groups.
The mNexspike vaccine represents a step toward next-generation COVID-19 protection. It uses an updated method that allows for a significantly lower dose—just one-fifth of the dose in the original vaccine—while still effectively targeting the virus.
Moderna CEO Stéphane Bancel described the approval as an important step forward, especially for protecting individuals at higher risk of severe illness from COVID-19.
The FDA authorized mNexspike for adults aged 65 and older, as well as individuals aged 12 to 64 who have at least one underlying health condition that increases their risk. These guidelines mirror those set for Novavax’s recently licensed COVID-19 vaccine.
This limited-use approach marks a shift from how the U.S. has previously distributed COVID-19 vaccines, likely influenced by evolving public attitudes toward vaccination, including skepticism voiced by Health Secretary Robert F. Kennedy Jr. and other figures in the Trump administration.
Moderna’s original Spikevax remains available to anyone 6 months and older without these new restrictions. The company plans to offer both vaccines in the upcoming fall season.
The FDA based its approval of mNexspike on a clinical study involving 11,400 participants aged 12 and up. The study showed that the new low-dose vaccine was safe and, in some respects, even more effective than the original.
This development comes shortly after the federal government decided to withdraw funding from Moderna’s efforts to create a vaccine targeting potential pandemic flu strains like H5N1, despite promising early trial results.