FDA approves Modernas new lower-dose COVID-19 vaccine - AP News
3 minute readPublished: Saturday, May 31, 2025 at 5:05 pm
Moderna's New, Lower-Dose COVID-19 Vaccine Approved by FDA
The U.S. Food and Drug Administration (FDA) has approved a new COVID-19 vaccine from Moderna, marking a significant development in the ongoing fight against the virus. This new vaccine, dubbed mNexspike, is a next-generation shot designed to offer protection with a lower dose than Moderna's existing vaccine, Spikevax.
The FDA approval, announced late Friday, comes with specific limitations. The new vaccine is authorized for use in adults aged 65 and older, and for individuals aged 12 to 64 with at least one health condition that increases their risk from the coronavirus. This targeted approach mirrors the restrictions placed on another COVID-19 vaccine from Novavax.
Moderna's CEO, Stephane Bancel, hailed the approval as a crucial step in protecting those most vulnerable to severe COVID-19. The company plans to offer both the new, lower-dose vaccine and its existing vaccine this fall.
The FDA's decision was based on a study involving over 11,400 participants aged 12 and older. The study compared the new vaccine to Moderna's original shot, finding the new vaccine to be safe and at least as effective, and in some measures, more effective.
This approval arrives amidst a backdrop of shifting priorities. Notably, the Trump administration recently 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 new vaccine is a welcome addition to the arsenal against COVID-19, particularly for those most at risk. While the targeted approach may raise questions, it reflects a cautious approach to vaccine deployment. The availability of both the new and existing vaccines provides flexibility for individuals and healthcare providers. The decision to limit the new vaccine's use is likely influenced by evolving public health considerations and the ongoing debate surrounding vaccine mandates and recommendations.
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