Hope Re-Armed: FDA Approves Moderna's Advanced mNEXSPIKE COVID-19 Vaccine!

A New Shield Forged: The U.S. FDA has officially approved Moderna's mNEXSPIKE, a next-generation mRNA vaccine to combat COVID-19.
Protecting the Vulnerable: This approval specifically targets adults 65 and older, and individuals aged 12-64 with underlying health conditions that put them at high risk^{2, 4, 5}.
Superior Defense Demonstrated: Rigorous Phase 3 trials show mNEXSPIKE offers enhanced protection, with higher relative vaccine efficacy against COVID-19 compared to Moderna's original Spikevax vaccine^{2, 4, 5}.

In the unyielding battle against COVID-19, a formidable new ally has arrived. Moderna today announced the U.S. Food and Drug Administration (FDA) has granted approval for mNEXSPIKE (mRNA-1283), injecting fresh hope into our ongoing public health efforts. With the virus still claiming tens of thousands of lives annually in the U.S. alone—over 47,000 last year^{1, 2, 4}—this approval marks a critical advancement, particularly for those most susceptible to severe illness.

"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," declared Stéphane Bancel, Moderna's CEO, underscoring the relentless urgency^{2, 5}. Specifically designed to target variants like Omicron JN.1 for those previously vaccinated^{1, 3}, mNEXSPIKE's approval stems from a comprehensive Phase 3 trial involving approximately 11,400 participants. The results were compelling: mNEXSPIKE demonstrated a 9.3% higher relative vaccine efficacy in individuals 12 and older, and a significant 13.5% higher rVE in adults 65 and older, compared to the original Spikevax^{2, 4, 5}.

While offering this boosted protection, mNEXSPIKE maintains a safety profile similar to its predecessor, with common side effects including injection site pain, fatigue, and headache^{1, 3}. Moderna anticipates mNEXSPIKE will be available for the 2025-2026 respiratory virus season, reinforcing our defenses alongside Spikevax and the mRESVIA RSV vaccine^{2, 4}. This milestone further cements Moderna's leadership in mRNA technology, continuing their mission to transform how we prevent and treat disease. Underlying risk factors are defined by the Centers for Disease Control and Prevention (CDC).

Hope Re-Armed: FDA Approves Moderna's Advanced mNEXSPIKE COVID-19 Vaccine!

References

Stay Updated!