On 11 December 2025, the CHMP of the European Medicines Agency (EMA) issued a positive opinion recommending the marketing authorisation of Moderna's mNexspike (COVID-19 mRNA vaccine) for persons aged 12 years and older[3]. mNexspike contains mRNA encoding the linked N-terminal and receptor-binding domains of the SARS-CoV-2 spike protein and stimulates the production of neutralizing antibodies against the virus[3]. The randomized, observer-blind, active-controlled phase 3 trial enrolled approximately 11,400 participants aged ≥12 years; the primary endpoint metric was non-inferiority to Spikevax (mRNA-1273)[1][2][4]. The relative efficacy (rVE) of mNexspike versus Spikevax was 9.3% (99.4% CI -6.6 to 22.8), with an rVE of 13.5% in the subgroup of subjects ≥65 years (CI reported in the study)[1][4]. mNexspike uses a lower mRNA dose of 10 µg compared to Spikevax 50 µg; in the study, the vaccine had a similar safety profile to Spikevax with more frequent local reactions and systemic reactions such as fatigue, headache and myalgias[1][2][3]. Indication proposed by the CHMP: active immunisation for the prevention of COVID-19 in individuals aged 12 years and older; detailed recommendations will be in the Summary of Product Characteristics following Commission approval[3].