US-based biotechnology company Moderna has received the US Food and Drug Administration (FDA) approval for its new Covid-19 vaccine, mNEXSPIKE (mRNA-1283).
The mNEXSPIKE vaccine becomes Moderna’s third FDA-approved product.
It is indicated for adults aged 65 and older, along with individuals aged 12 to 64 with at least one underlying risk factor, as defined by the Centers for Disease Control and Prevention (CDC).
The FDA’s approval follows a Phase 3 clinical trial of the new Covid-19 vaccine in around 11,400 participants, aged 12 and above.
The trial was designed to determine that mNEXSPIKE’s efficacy against Covid-19 is non-inferior to Moderna’s original vaccine, mRNA-1273 (Spikevax).
Participants received either a 10μg dose of mRNA-1283 or a 50μg dose of mRNA-1273.
Results showed that mRNA-1283 had a 9.3% higher relative vaccine efficacy compared to mRNA-1273 in individuals aged 12 and older.
In a sub-group analysis, the efficacy was 13.5% higher in adults aged 65 and older.
The safety profile of mRNA-1283 was similar to that of mRNA-1273, with fewer local reactions and comparable systemic reactions.
Common side effects included injection site pain, fatigue, headache, and myalgia.
Moderna plans to make mNEXSPIKE available in the US for the 2025-2026 respiratory virus season, alongside Spikevax and mRESVIA, which target respiratory syncytial virus (RSV).
The mRNA-1283 vaccine is currently under review by regulators in various global markets.
Moderna CEO Stéphane Bancel said: “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.”
Last year, Moderna received the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) authorisation for its updated Covid-19 vaccine targeting the JN.1 variant of SARS-CoV-2.
