Moderna, Inc. has announced that the US Food and Drug Administration (FDA) has approved mNEXSPIKE (mRNA-1283), its latest Covid-19 vaccine. The vaccine is approved for adults aged 65 years and older, as well as for individuals aged 12 to 64 who have at least one underlying risk factor as defined by the Centers for Disease Control and Prevention (CDC).
“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.”
- Stéphane Bancel, chief executive officer of Moderna.
Efficacy Supported by Phase 3 Clinical Trial
The FDA’s approval is based on data from a randomized, observer-blind, active-controlled phase 3 trial (NCT05815498), involving approximately 11,400 participants aged 12 and older. The primary goal was to show non-inferior vaccine efficacy compared to Moderna’s original Spikevax (mRNA-1273).
Participants received either a 10 µg dose of mRNA-1283 or a 50 µg dose of mRNA-1273. mRNA-1283 demonstrated a 9.3 percent higher relative vaccine efficacy in participants aged 12 and older and a 13.5 percent higher efficacy in adults aged 65 and older in a descriptive subgroup analysis.
Comparable Safety Profile
The safety profile of mRNA-1283 was similar to that of Spikevax, with fewer local reactions and similar systemic side effects. Commonly reported side effects included injection site pain, fatigue, headache, and myalgia.
Launch Planned for 2025–2026 Season
Moderna plans to make mNEXSPIKE available in the United States for the 2025–2026 respiratory virus season, alongside Spikevax and mRESVIA, its approved RSV vaccine. Regulatory reviews of mRNA-1283 are also ongoing in other countries.
Indication and Use
mNEXSPIKE is intended for individuals who have previously received a Covid-19 vaccine and are either:
- 65 years of age and older, or
- Between 12 and 64 years of age with risk factors for severe Covid-19.
While the vaccine offers protection, it may not prevent Covid-19 in all vaccinated individuals.
About Moderna
Moderna is a pioneer in the field of mRNA medicine, working to transform how diseases are treated and prevented through the advancement of mRNA technology.
