Late Friday, U.S. health authorities granted approval for a new COVID-19 vaccine developed by Moderna. This newly authorized vaccine, known as mNexspike, does not replace the company’s existing Spikevax shot but offers an additional option for certain individuals. Moderna’s new vaccine represents a step forward in the development of next-generation coronavirus vaccines, utilizing a refined immune target to allow for a lower dosage—just a fifth of the dose used in Spikevax.
Moderna’s CEO, Stephane Bancel, emphasized the significance of this development, stating, “The approval provides an important new tool to help protect individuals at high risk of severe COVID-19 infection.” The Food and Drug Administration (FDA) has approved the use of this vaccine for adults 65 and older, as well as individuals aged 12 to 64 who possess at least one health condition heightening their risk from the virus.
This move aligns with the FDA’s decision regarding a similar COVID-19 vaccine from Moderna’s competitor, Novavax, which shares the same usage limitations. The addition of such restrictions marks a shift in the U.S. strategy towards COVID-19 vaccinations, influenced by rising skepticism from Health Secretary Robert F. Kennedy Jr. and other officials.
Unlike the mNexspike vaccine, Moderna’s original Spikevax does not face these usage restrictions and continues to be available for people aged 6 months and older. The company anticipates offering both vaccines as options during the fall season.
The FDA’s approval for the new vaccine was based on a comprehensive study involving 11,400 participants aged 12 and up. This research compared the safety and effectiveness of the low-dose mNexspike vaccine against Moderna’s existing vaccine. Findings indicated that the new vaccine provides at least equal protection, and possibly more under certain measures, than the original shot.
This news coincides with the recent cancellation by the Trump administration of funding for Moderna’s pursuit of a vaccine targeting potential pandemic influenza viruses, such as the H5N1 avian flu, despite promising preliminary study results.