Sanofi’s MenQuadfi gains EU approval for use in infants from six weeks of age against invasive meningococcal disease

Sanofi has announced that the European Commission has approved an extension of the indication for MenQuadfi to cover infants from six weeks of age, broadening protection against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. Previously authorised in the EU for individuals aged 12 months and above, the expanded indication follows a positive opinion issued by the Committee for Medicinal Products for Human Use on 25 June 2026.

Invasive meningococcal disease is a potentially fatal bacterial infection capable of advancing with frightening speed, with patients at risk of deteriorating from the first appearance of symptoms to death within a single day. Among all age groups, infants face some of the most severe consequences, with high rates of mortality and lasting complications including limb amputation, hearing impairment, and neurological injury. Even when patients receive appropriate care, the condition carries a case fatality rate of around 10 to 15%, and up to one in five survivors are left with permanent health effects. While serogroup A has become rare across the EU, serogroups C, W, and Y continue to drive a meaningful proportion of invasive meningococcal disease cases throughout Europe, highlighting the value of broad early protection against all four serogroups.

“Meningococcal disease moves fast and strikes the hardest in younger children. Having a product indicated across a broad age range is key to meeting public health needs, giving healthcare providers the flexibility to help protect infants within routine immunization schedules and increase vaccine coverage. The immunogenicity data for MenQuadfi in infants is robust and supports the usage with confidence in the EU,” said Federico Martinon-Torres, Pediatrician and Clinical Researcher, Head of Pediatrics and Vaccine Research Unit at Hospital Clínico Universitario de Santiago, Spain, and Principal Investigator of MET58.

With this decision in place, healthcare professionals across the EU gain an additional tool for vaccinating infants against invasive meningococcal disease from as early as six weeks of life. The expanded indication aligns with existing routine infant immunisation schedules and is grounded in a strong body of immunogenicity data for MenQuadfi in this age group.

“Offering protection for the EU’s youngest children is at the heart of what we do, and this approval is a direct expression of that commitment. It reflects the scientific rigor behind this work, and it means healthcare providers now have an additional option to help protect infants against invasive meningococcal disease from the early weeks of life,” said Bogdana Coudsy, Global Head of Medical, Vaccines, Sanofi.

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Meningococcal Disease, Sanofi's MenQuadfi