The Food and Drug Administration (FDA) has approved Moderna’s next-generation COVID-19 vaccine, mNEXSPIKE, for specific high-risk populations, the company announced Saturday. This marks a significant development as it’s the first such approval since the FDA implemented more stringent standards for COVID-19 vaccine authorization.
The newly approved vaccine is cleared for adults aged 65 and older, as well as individuals between 12 and 64 years old who have at least one underlying medical condition that could increase their risk of severe COVID-19 infection. Moderna anticipates mNEXSPIKE will be available for the upcoming 2025-2026 respiratory virus season.
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This approval comes amidst a broader shift in regulatory oversight under HHS Secretary Robert F. Kennedy Jr., with new restrictions being placed on COVID-19 vaccine recommendations.
Notably, regulators are no longer recommending these vaccines for healthy children and healthy pregnant women, signaling a more targeted approach to vaccine deployment.
Moderna CEO Stéphane Bancel emphasized the continued threat posed by the virus, stating in a news release, “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. COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone. We appreciate the FDA’s timely review and thank the entire Moderna team for their hard work and continued commitment to public health.”
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Clinical trials for mNEXSPIKE demonstrated promising results. A Phase 3 trial involving approximately 11,400 participants showed a 9.3% higher relative efficacy compared to Moderna’s original vaccine, Spikevax, in individuals aged 12 and older. For those 65 and older, the new vaccine exhibited an even greater advantage, with a 13.5% higher efficacy.
The FDA’s decision to approve mNEXSPIKE under these new, more rigorous guidelines underscores a pivotal moment in the ongoing fight against COVID-19, prioritizing protection for the most vulnerable populations while adapting to evolving public health needs and research.
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