On 11 December 2025, the Committee for Medicinal Products for Human Use (CHMP) issued a positive proposal for the marketing authorization of mNexspike for the prevention of COVID-19 in persons 12 years of age and older.[1] The applicant is Moderna Biotech, Spain, S.L.[1] The mNexspike vaccine is an mRNA vaccine in the form of a dispersion for injection in a prefilled syringe, containing mRNA encoding parts of the SARS-CoV-2 spike protein: the membrane-bound N-terminal domain and the receptor-binding domain.[1] Vaccination induces the formation of neutralizing antibodies against the spike protein, thereby protecting against COVID-19.[1] Efficacy was demonstrated in a large clinical trial where mNexspike resulted in a comparable proportion of symptomatic COVID-19 cases to Spikevax, confirming that its efficacy is non-inferior to Spikevax.[1] The most common side effects include injection site pain, fatigue, headache, muscle and joint pain, chills, armpit swelling or tenderness, and nausea/vomiting.[1] The vaccine should be administered at least 3 months after the last dose of the previous COVID-19 vaccine in previously vaccinated individuals.[1] Detailed recommendations will be in the summary of product characteristics after approval by the European Commission.[1]