FDA Grants Limited Approval to Moderna’s Next-Gen COVID-19 Vaccine
The new vaccine is designed to elicit a stronger immune response at a smaller dose than current vaccines.
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Moderna has announced that the US Food and Drug Administration (FDA) has approved its next-generation COVID-19 vaccine, mNEXSPIKE® (mRNA-1283). The approval is limited to adults 65 and older, as well as individuals aged 12–64 years with at least one underlying health condition that increases their risk for a severe COVID outcome.
Young, healthy adults won’t be eligible to receive the vaccine, despite their inclusion in Moderna’s Phase 3 clinical trial. The FDA imposed similar limitations on Novavax’s COVID-19 vaccine when it was approved last month. Expansion to healthy, younger populations could come through post-marketing studies.
The approval of mNEXSPIKE marks the first FDA vaccine approval since FDA Commissioner Dr. Marty Makary and the Center for Biologics Evaluation and Research Director Dr. Vinay Prasad issued a new framework on how the FDA plans to regulate future COVID vaccines.
The framework, outlined in an editorial published in the New England Journal of Medicine, states that future approvals will focus on adults 65 years and older and persons above the age of 6 months with underlying risk factors as described by the Centers for Disease Control and Prevention.
For healthy individuals, the FDA recommends “the need for randomized, controlled trial data evaluating clinical outcomes before Biologics License Applications can be granted.”
A lower-dose COVID vaccine
mNEXSPIKE is intended to elicit a stronger immune response at a fraction of the dose of Moderna’s first-generation COVID-19 vaccine, Spikevax® (mRNA-1273). Unlike Spikevax, which encodes the entire spike protein, mNEXSPIKE encodes two segments of the SARS-CoV-2 spike protein: the receptor-binding domain and the N-terminal domain.
Approval of mNEXSPIKE followed positive results from a randomized, observer-blind, active-controlled Phase 3 clinical trial. In the trial, approximately 11,400 participants aged 12 years and older received either a 10 μg dose of mNEXSPIKE or a 50 μg dose of Spikevax.
Participants who received the mNEXSPIKE vaccine showed a 9.3% higher relative vaccine efficacy (rVE) compared to Spikevax, in individuals aged 12 years and older. In a descriptive subgroup analysis, mNEXSPIKE showed a 13.5% higher rVE in adults aged 65 and older, according to Moderna.
The vaccine was found to have a similar safety profile to the existing Spikevax vaccine, with fewer local reactions such as swelling at the injection site, and comparable systemic reactions, which may include fever or headache. Moderna cited the most common side effects as injection site pain, fatigue, headache and myalgia.
"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, chief executive officer of 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.”
The approval is likely to be welcome news for Moderna, which hit a roadblock last week when it received notice that the US Department of Health and Human Services was terminating funding for the late-stage development of its investigational pandemic influenza vaccine.
Moderna expects to have mNEXSPIKE available for eligible populations in the US for the 2025–2026 respiratory virus season, alongside Spikevax and its respiratory syncytial virus vaccine, mRESVIA®.
