FDA Approves Moderna’s mNEXSPIKE: A Targeted Approach in the Changing COVID-19 Vaccine Landscape

By Alejandra Legarda, Health Correspondent

In a significant step in the ongoing fight against COVID-19, the U.S. Food and Drug Administration (FDA) has approved Moderna’s new vaccine, mNEXSPIKE (mRNA-1283). This next-generation, low-dose vaccine is specifically authorized for individuals aged 65 and older, as well as for those aged 12 to 64 with at least one underlying health condition that increases their risk of severe COVID-19.

The FDA’s decision signals a shift in vaccination strategy, focusing on protecting the most vulnerable populations. This approach aligns with recent policy changes under Health Secretary Robert F. Kennedy Jr., who has advocated for stricter vaccine approval processes and a targeted approach toward high-risk groups.

Clinical trials involving approximately 11,400 participants showed that mNEXSPIKE offers comparable—and in some cases superior—efficacy to Moderna’s original vaccine, Spikevax (mRNA-1273). Notably, the new vaccine demonstrated a 9.3% higher relative efficacy in individuals aged 12 and older, and a 13.5% increase among those 65 and over.

Beyond its effectiveness, mNEXSPIKE has significant logistical advantages. Its formulation allows storage under standard refrigeration conditions, making distribution easier and potentially expanding access—especially in areas with limited cold-chain infrastructure.

However, the approval comes amid a complex political and regulatory landscape. The current administration has re-evaluated vaccine policy, pulling significant funding from other Moderna initiatives, including a $590 million contract for an H5N1 bird flu vaccine.

With the 2025–2026 respiratory virus season approaching, Moderna plans to offer mNEXSPIKE alongside its existing vaccines, giving healthcare professionals and patients more tools to combat COVID-19. This development highlights the evolving nature of vaccine science and policy and the continued effort to adapt to the shifting challenges of the pandemic.