Moderna announced on Friday, May 31, 2025, that the U.S. Food and Drug Administration (FDA) has approved its new, lower-dose COVID-19 vaccine, mNEXSPIKE (mRNA-1283), reports NBC News.
Approval Granted
The FDA has approved Moderna’s new COVID-19 vaccine, mNEXSPIKE, on Friday, May 30, 2025. This approval is specifically limited to individuals who have previously received a COVID-19 vaccine.
Moderna announced on Saturday, May 31, 2025, that mNEXSPIKE is expected to be available in the U.S. for the upcoming 2025-26 respiratory virus season, which commences in the fall. The company is also working on an updated version of its original vaccine, Spikevax, to target the LP.8.1 variant, with an application for FDA approval submitted in May.
mNEXSPIKE contains one-fifth of the dose of Moderna’s original Spikevax vaccine. It is positioned as a lower-dose alternative for those who prefer it, rather than a replacement for existing COVID-19 vaccines.
Notably, young, healthy adults will not be eligible to receive mNEXSPIKE, despite their inclusion in Moderna’s clinical trial. This aligns with similar limitations imposed by the FDA on Novavax’s COVID-19 vaccine when it was approved in May 2025. This approval marks the first time the FDA has greenlit a vaccine since the Trump administration’s call for tighter restrictions on vaccine eligibility and approvals, reflecting a broader shift in regulatory approach.
Stricter Approach
The Trump administration has advocated for a stricter approach to new COVID-19 vaccine clinical trials, asserting that they must include an inert placebo. This means some participants would receive the new vaccine while others would receive an inactive substance, such as saline, to allow for a direct comparison of results.
This stance contrasts with the common practice for many new vaccines, which are tested against older, already approved versions. This “active comparator” method is often considered more ethical, as it avoids withholding the known benefit of a vaccine from study participants.
Moderna’s newly approved vaccine, mNEXSPIKE, was tested using this “active comparator” method. In a trial involving approximately 11,400 participants aged 12 and older, Moderna reported that the new vaccine generated higher antibody levels compared to the company’s original COVID-19 shot, Spikevax.
Furthermore, Moderna indicated that mNEXSPIKE resulted in fewer local reactions (such as redness or swelling at the injection site). Systemic reactions, which can include fever, headaches, or chills, were found to be comparable between the new vaccine and the original shot.
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Source: NBC News
