The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on December 15, 2025, recommending that the European Commission grant marketing authorization for Moderna’s mNEXSPIKE (mRNA‑1283) vaccine for individuals aged 12 years and older. The decision marks the third Moderna product to receive a CHMP positive opinion, following Spikevax and the RSV vaccine mRESVIA, and removes a key regulatory hurdle for the company’s next‑generation COVID‑19 vaccine.
mNEXSPIKE is engineered to encode only the N‑terminal domain and receptor‑binding domain of the SARS‑CoV‑2 spike protein, allowing a smaller 10 µg dose compared with the 50 µg dose of Spikevax. The vaccine can be stored at standard refrigerator temperatures (2–5 °C) and comes in prefilled syringes, features that could improve distribution efficiency and reduce the burden on healthcare workers in the EU market.
Moderna’s revenue has fallen sharply in recent quarters, driven largely by a steep decline in COVID‑19 vaccine sales. The company reported a 56 % drop in revenue over the last twelve months and a 45 % decline in Q3 2025 sales compared with Q3 2024. In response, management has accelerated cost‑cutting initiatives and is shifting focus toward its broader mRNA platform, including RSV and influenza‑COVID combination candidates. CEO Stéphane Bancel emphasized that adults 65 years and older remain the most vulnerable to severe COVID outcomes, underscoring the public‑health importance of mNEXSPIKE’s expanded age indication.
The positive CHMP opinion is a significant step toward a commercial launch in the EU, potentially opening a new revenue stream for Moderna as it seeks to diversify beyond the waning demand for its original COVID‑19 vaccine. While the approval is a milestone, investors remain attentive to the company’s ongoing revenue decline and the timeline for achieving cash‑breakeven, which analysts have projected as late as 2030. The approval therefore represents both an opportunity to capture a share of the European COVID‑19 vaccine market and a reminder of the broader headwinds facing Moderna’s core vaccine business.
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