Sanofi gains European Commission approval to extend its MenQuadfi meningococcal vaccine for infants from six weeks old, marking a significant shift in the EU’s meningococcal prevention landscape and heightening competition with Pfizer’s Nimenrix.
Sanofi has won European Commission approval to broaden the use of its MenQuadfi meningococcal vaccine so it can be given to infants from six weeks of age, extending the product’s reach beyond the previous EU authorisation for people aged 12 months and above. The decision follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use on 25 June 2026, according to the agency.
The move gives clinicians in the bloc another option for protecting very young children against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y. Sanofi said the revised label is intended to fit routine infant immunisation schedules, with a two-plus-one course for babies starting at six weeks and a booster in the second year of life. In higher-risk situations involving serogroup A exposure, the company said a three-plus-one schedule may be considered.
Invasive meningococcal disease is a fast-moving infection that can become fatal within hours. Sanofi said infants are among the groups at greatest risk, with the illness capable of leaving survivors with severe long-term harm, including hearing loss, neurological damage and amputations. The company said the vaccine’s expanded use is backed by data from the MET58 study, which assessed immunogenicity, safety and tolerability in infants, and by a broader clinical record covering more than 6,000 infants across 11 countries.
The new authorisation also sharpens competition in the European infant meningococcal market. Pfizer said last year that its rival vaccine Nimenrix had been approved in the EU for use from six weeks of age, calling it the first and only MenACWY conjugate vaccine in the bloc with no upper age limit at the time. Sanofi, meanwhile, said the European approval reflects its push to widen access to prevention for the most vulnerable age groups, while the European Medicines Agency said updated prescribing details will follow in the product information published after the commission’s decision.
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