FDA approves Modernas new lower-dose COVID-19 vaccine
3 minute readPublished: Sunday, June 1, 2025 at 4:46 am
Moderna's New, Lower-Dose COVID-19 Vaccine Approved by FDA
The U.S. Food and Drug Administration (FDA) has given the green light to Moderna's new COVID-19 vaccine, mNexspike, offering a second option for vulnerable populations. This new vaccine, designed as a "next-generation" shot, utilizes a refined immune target, allowing for a significantly lower dose – just one-fifth of the original Moderna vaccine, Spikevax.
The FDA approval, announced late Friday, comes with specific limitations. mNexspike is authorized for adults aged 65 and older, and for individuals aged 12 to 64 with at least one health condition that elevates their risk from the coronavirus. This mirrors the restrictions placed on Novavax's COVID-19 vaccine, marking a shift in how the U.S. is approaching vaccine distribution.
Moderna's CEO, Stephane Bancel, hailed the approval as a crucial step in protecting those most susceptible to severe COVID-19. The company plans to offer both mNexspike and its existing vaccine this fall.
The FDA's decision was based on a study involving 11,400 participants aged 12 and older. The study compared the new low-dose vaccine to Moderna's original shot, concluding that mNexspike is safe and at least as effective, and in some instances, more effective.
This announcement arrives shortly after the Trump administration canceled funding for Moderna's development of a vaccine against potential pandemic flu viruses, including the H5N1 bird flu, despite promising early study results.
BNN's Perspective: This approval is a positive development, offering a potentially more targeted and efficient vaccine option for those most at risk. While the limitations on who can receive mNexspike are understandable given the current landscape, it's crucial to ensure clear communication and accessibility to both vaccine options to maximize public health benefits. The decision to limit the new vaccine's use raises questions about the future of vaccine distribution strategies and the role of public health officials in shaping these policies.
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