Moderna's new COVID-19 vaccine mNexspike approved by FDA

Published: Saturday, May 31, 2025 at 8:41 pm

Moderna's New COVID-19 Vaccine Approved with Limited Use: A New Option for High-Risk Individuals

The U.S. Food and Drug Administration (FDA) has approved Moderna's new COVID-19 vaccine, mNexspike, marking a step towards next-generation coronavirus vaccines. However, the approval comes with specific limitations, targeting its use to a narrower population than Moderna's existing vaccine, Spikevax.

mNexspike, designed with a refined immune target, allows for a significantly lower dose – just one-fifth of the original vaccine. The FDA has approved the new vaccine for 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 mirrors the restrictions placed on Novavax's COVID-19 vaccine.

This limited rollout represents a shift in the U.S.'s approach to COVID-19 vaccines. The FDA's decision was based on a study involving 11,400 participants aged 12 and older, which demonstrated that mNexspike is safe and at least as effective as the original Moderna vaccine.

The approval arrives amidst other significant developments. The Trump administration recently canceled funding for Moderna's pandemic flu vaccine development, despite promising early results. Additionally, the Centers for Disease Control and Prevention (CDC) has altered its COVID-19 vaccine recommendations for children, dropping the general recommendation for all children to be vaccinated. This change, influenced by Health Secretary Robert F. Kennedy Jr., cites concerns about the risks of the vaccine for healthy children and the lack of data on its safety during pregnancy.

BNN's Perspective: While the approval of mNexspike offers a promising new tool for protecting vulnerable populations, the restricted rollout and the CDC's revised recommendations highlight the ongoing complexities and evolving landscape of COVID-19 vaccine policy. It's crucial to balance the potential benefits of vaccination with a thorough understanding of individual risk factors and the latest scientific data.

Keywords: Moderna, mNexspike, COVID-19 vaccine, FDA approval, Spikevax, next-generation vaccine, low-dose vaccine, high-risk individuals, CDC recommendations, Robert F. Kennedy Jr., vaccine safety, pandemic flu, Novavax, vaccine rollout, vaccine effectiveness.

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