Moderna’s Next-Gen mRNA COVID-19 Vaccine, mNexspike, Receives Targeted FDA Approval

CHICAGO – May 31, 2025 – Moderna today announced the Food and Drug Administration (FDA) has granted approval for its next-generation mRNA COVID-19 vaccine, mNexspike. This marks the first approval under the agency’s new guidelines for COVID-19 shots. It’s specifically cleared for healthy adults 65 years and older and individuals aged 12 to 64 years with one or more underlying health risk factors.

Moderna CEO Stéphane Bancel called mNexspike an “important new tool” to protect people from COVID-19, highlighting the more than 47,000 U.S. deaths from the disease last year.

The FDA’s decision was based on a Phase 3 study showing mNexspike was “non-inferior” to Moderna’s original mRNA vaccine, Spikevax, and slightly more effective on a relative basis in those over 12. Moderna expects mNexspike, currently targeting the JN.1 coronavirus variant, to be available this fall.

This approval comes amidst recent shifts in federal vaccine policy. This includes new FDA requirements for placebo-controlled trials for healthy individuals and mixed messaging from HHS Secretary regarding COVID-19 shots for healthy children and pregnant women.

Similar to Novavax’s recently approved protein-based Nuvaxovid, mNexspike’s approval reflects a more targeted approach to COVID-19 vaccination. HHS recently canceled a significant contract with Moderna to develop mRNA vaccines for pandemic-prone influenza. mRNA shots like Moderna’s and Pfizer’s Cominarty have faced increased scrutiny.

Despite these challenges, Jefferies analyst Michael Yee views the on-time approval as an “incremental positive” for Moderna, suggesting the FDA remains rational when presented with good, well-conducted data.