MenQuadfi Approved in the EU for Infants from Six Weeks of Age Against Invasive Meningococcal Disease – Sanofi

Sanofi announced that the European Commission (EC) has approved an extension of the indication for MenQuadfi (Meningococcal Group A, C, W and Y conjugate vaccine) 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. MenQuadfi was previously approved in the EU for use in individuals aged 12 months and older. The expanded indication follows the positive opinion adopted by the Committee for Medicinal Products for Human Use on June 25, 2026.

Invasive meningococcal disease is a life-threatening bacterial infection that can progress rapidly, with patients potentially deteriorating from the onset of symptoms to death within 24 hours. Infants are among the populations at highest risk for invasive meningococcal disease, facing high rates of mortality and severe long-term complications, including limb amputation, hearing loss, and neurological damage. Even with appropriate treatment, invasive meningococcal disease carries a case fatality rate of approximately 10–15%, and up to 20% of survivors experience permanent complications. Although serogroup A is now rarely reported in the EU, serogroups C, W, and Y remain responsible for a significant share of invasive meningococcal disease cases across Europe, reinforcing the importance for broad protection against these four serogroups from an early age.

“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.” – Federico Martinon-Torres, Pediatrician and Clinical Researcher, Head of Pediatrics and Vaccine Research Unit at Hospital Clínico Universitario de Santiago in Spain and Principal Investigator of MET58.

With this approval, MenQuadfi provides healthcare professionals in the EU with an additional option for vaccinating infants against invasive meningococcal disease from as early as six weeks of age. This expanded indication, aligned with routine infant immunization schedules, is supported by MenQuadfi’s demonstrated immunogenicity data.

“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.” – Bogdana Coudsy, Global H

ead of Medical, Vaccines, Sanofi.

This milestone embodies Sanofi’s contribution, fighting against invasive meningococcal disease, a devastating disease, by expanding vaccine access to the most vulnerable populations across the EU.

About the MET58 pivotal study

The EU approval is supported by comprehensive data from the MET58 pivotal clinical study, which evaluated the immunogenicity, safety, and tolerability of MenQuadfi in infants from six weeks of age.