Moderna received marketing authorization from the European Commission for its next‑generation COVID‑19 vaccine, mNEXSPIKE (mRNA‑1283), on February 17, 2026. The approval, following a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use, allows the company to commercialize the vaccine in all 27 EU member states for individuals aged 12 and older.
mNEXSPIKE distinguishes itself from Moderna’s existing Spikevax by using a lower 10‑µg dose, which clinical trials showed delivers 9.3% higher relative efficacy overall and 13.5% higher in adults 65 and older. The vaccine can be stored at standard refrigeration temperatures for up to 90 days, improving distribution logistics and reducing cold‑chain costs compared with earlier mRNA products.
The authorization makes mNEXSPIKE Moderna’s third EU‑approved product, joining Spikevax and the RSV vaccine mRESVIA. Together, the trio positions the company as a leading provider of respiratory vaccines in Europe, a market that is expected to rebound as COVID‑19 restrictions ease. The new product also strengthens Moderna’s portfolio against competitors that rely on single‑product strategies.
Moderna’s Q4 2025 earnings, released on February 13, 2026, beat expectations with revenue of $678 million versus the consensus of $662.84 million, and a GAAP earnings‑per‑share loss of $2.11 versus the expected $2.62. The beat was driven by disciplined cost control that offset a 30% decline in overall COVID‑19 vaccine sales, and by strong demand for the company’s RSV and COVID‑19 products in international markets. The company guided for up to 10% revenue growth in 2026, reflecting confidence in the expanded product mix and the anticipated rebound in the EU respiratory vaccine market.
CEO Stéphane Bancel said the approval “reflects the strength of the scientific data supporting mNEXSPIKE and our continued commitment to advancing innovative vaccines for populations most at risk.” He added that Europe “represents a key region for respiratory vaccines, and we are pleased to have a new vaccine available to help protect Europeans when the EU COVID market reopens starting this year in some markets.”
The approval adds to the positive narrative that followed Moderna’s earnings beat, reinforcing investor confidence in the company’s cost‑control strategy and its expanding product portfolio. While the FDA’s refusal‑to‑file letter for the mRNA‑1010 flu vaccine earlier in February introduced a short‑term regulatory headwind, the EU authorization signals a broader regulatory success that supports the company’s long‑term growth strategy.
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