The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use has recommended granting marketing authorization for Moderna’s new RNA-based vaccine, mNexspike, for preventing COVID-19 in people aged 12 years or older.
The vaccine was approved in May 2025 by the US FDA for individuals aged 65 years or older or aged 12-64 years with at least one underlying condition putting them at a high risk for severe COVID-19.
mNexspike contains an mRNA that encodes the SARS-CoV-2 spike protein’s membrane-bound, linked N-terminal domain and receptor-binding domain. Vaccination activates the production of neutralizing antibodies that target the spike protein and boost immunity to COVID-19.
The decision comes after results from a randomized phase 3 trial that compared mNexspike with Moderna’s first-generation mRNA vaccine, Spikevax. Close to 11,500 participants with a median age of 56 years were recruited and were randomly allocated one 10-μg dose of mNexspike or a 50-μg dose of Spikevax. Both vaccines encoded the same variants.
Rates of symptomatic COVID-19 were similar among those administered mNexspike and Spikevax, indicating that mNexspike is not inferior to Spikevax. mNexspike also produced higher antibody response, especially in adults aged 50 years or older, and was generally well-tolerated.
Both vaccines resulted in a similar number of adverse events in the 28 days following injection. The most common events included injection-site pain, fatigue, headache, and myalgia. Most were mild to moderate, beginning within a day or two of vaccination and resolving within an average of 3 days.
mNexspike was associated with fewer injection-site pain reactions than Spikevax. Participants aged 65 years or older also had fewer adverse reactions than younger adults and adolescents.
mNexspike will be available as a dispersion for injection in a prefilled syringe. The vaccine should be used in accordance with official recommendations.
Detailed recommendations for use of mNexspike will be available in the Summary of Product Characteristics, which will be published on the EMA website after the European Commission grants it marketing authorization.
Annie Lennon is a medical journalist. Her writing appears on Medscape, WebMD, and Medical News Today, among other outlets.
