
Vaccine maker Moderna announced late last week that the Food and Drug Administration (FDA) has approved its next-generation COVID-19 vaccine.
Marketed under the name mNexspike (mRNA-1283), the updated shot targets a portion of the SARS-CoV-2 spike protein for virus neutralization, allowing for a dose that's one-fifth the size of Moderna's original COVID-19 vaccine, Spikevax (mRNA-1273). Company officials have also characterized the updated shot as potentially refrigerator-stable vaccine that could be more easily distributed and administered in a wider range of settings.
Moderna said the approval was based on the results of a phase 3 randomized controlled trial involving 11,400 participants ages 12 and older, which found that a 10-microgram (μg) dose of mNexspike demonstrated a 9.3% higher relative vaccine efficacy (rVE) compared with a 50-μg dose of Spikevax, with a 13.5% higher rVE in adults ages 65 and older. The safety profiles of the two vaccines were similar, the company added.
"The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19," Stéphane Bancel, CEO of Moderna, said in a company press release. "COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone."
Limited approval
Moderna said it expects to have mNexspike available for the 2025-26 respiratory virus season, alongside Spikevax. But, under the new COVID-19 vaccine framework outlined recently by FDA Commissioner Martin Makary, MD, MPH, and Vinay Prasad, MD, MPH, director of the FDA's Center for Biologics Evaluation and Research, mNexspike is approved for use only in adults 65 and older and people aged 12 to 64 years with at least one condition that puts them at higher risk for severe disease.
Spikevax currently remains available for use in anyone 6 months and older.