Key Takeaways
- FDA Approves Moderna’s mNEXSPIKE for High-Risk Populations: Moderna’s next-generation COVID-19 vaccine, mNEXSPIKE (mRNA-1283), has received FDA approval for adults aged 65 years and older and individuals aged 12–64 years with CDC-defined risk factors for severe illness.
- Phase III Trial Shows Higher Efficacy Than Spikevax: In the Phase III NextCOVE trial, mNEXSPIKE demonstrated non-inferiority to Spikevax and delivered up to 13.5% higher relative vaccine efficacy in adults aged 65 years and older.
- Streamlined Formulation Eases Provider Burden: mNEXSPIKE offers improved storage, extended shelf life, and comes in a pre-filled syringe format to enhance convenience for healthcare providers and expand vaccine accessibility.
The FDA has approved mNEXSPIKE (mRNA-1283), Moderna’s next-generation COVID-19 vaccine, for use in adults aged 65 years and older, as well as in individuals aged 12 to 64 years who have at least one risk factor for severe disease as defined by the Centers for Disease Control and Prevention (CDC). This marks the third approved product from Moderna and represents a key advancement in the company’s respiratory vaccine portfolio.
What Makes Moderna’s mNEXSPIKE Different from Previous COVID-19 Vaccines?
According to the company, approval was supported by data from the Phase III NextCOVE trial, which demonstrated that mNEXSPIKE demonstrated non-inferiority to Spikevax (mRNA-1273) in preventing COVID-19. Additionally, the new vaccine showed higher relative vaccine efficacy compared to its predecessor.1
"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," said Stéphane Bancel, CEO, Moderna, in a press release. "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."
Phase III Data Highlight Higher Efficacy in Older Adults
The randomized, observer-blind, active-controlled NextCOVE trial enrolled approximately 11,400 participants aged 12 years and older across the United States, United Kingdom, and Canada. Participants received either a 10 μg dose of mNEXSPIKE or a 50 μg dose of Spikevax. The study’s primary objective was to assess vaccine efficacy beginning 14 days after administration of the mNEXSPIKE dose, compared with the established mRNA-1273 formulation.1,2
Study findings revealed that mNEXSPIKE delivered a 9.3% higher rVE in individuals aged 12 years and older, and a 13.5% higher rVE in adults aged 65 years and older.
Safety Profile and Administration Advantages
In addition to its efficacy, mNEXSPIKE demonstrated a favorable safety profile, with fewer reported adverse events (AEs) than Spikevax. Commonly reported AEs included injection site pain, fatigue, headache, and myalgia.1 Moderna also highlighted operational advantages, noting that improvements in storage, shelf life, and the use of a pre-filled syringe could help reduce the burden on healthcare providers during vaccination efforts.
