Sanofi wins EU approval for MenQuadfi in infants from six weeks old

Sanofi said on August 4, 2026 that the European Commission approved an extension of MenQuadfi's indication to include infants from six weeks of age to help protect against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y, expanding on the prior approval for individuals aged 12 months and older.¹ The company noted that the expanded indication follows a positive opinion from the Committee for Medicinal Products for Human Use adopted on June 25, 2026.¹

Sanofi described invasive meningococcal disease as a fast-moving infection, noting that it can progress from symptom onset to death within 24 hours,¹ and that even with treatment the case fatality rate is roughly 10 to 15%, with up to 20% of survivors facing permanent complications.¹

The approval rests on findings from what the company calls the "MET58 pivotal study," which Sanofi says looked at how well the vaccine triggers immune response along with its safety and tolerability in infants starting at six weeks old.

For dosing, Sanofi outlined a 2+1 schedule for infants from six weeks of age in line with standard EU immunization timing, consisting of two 0.5 mL doses spaced at least two months apart, followed by a booster dose in the second year of life, at least two months after the last dose.¹ A 3+1 schedule may be used instead for infants considered at higher risk from serogroup A exposure, with three primary doses at two, four and six months and a booster from 12 months of age.¹

Sanofi also confirmed it has fulfilled its EU pediatric study requirements, saying the Paediatric Investigation Plan compliance statement was received from the European Medicines Agency, completing all pediatric post-licensure commitments tied to MenQuadfi's original marketing authorization.¹ MenQuadfi already holds approval in the United States and multiple other markets in addition to the EU, according to the release.