Sanofi has received European Commission approval to extend the indication of MenQuadfi to infants from six weeks of age, broadening access to protection against invasive meningococcal disease caused by serogroups A, C, W and Y.
The vaccine had previously been authorised in the EU for individuals aged 12 months and older.
Invasive meningococcal disease is a rapidly progressing bacterial infection that can lead to death within 24 hours of symptom onset. Infants face some of the highest mortality rates and long-term complications, including limb amputation, hearing loss and neurological damage.
Although serogroup A is now rarely reported in the EU, serogroups C, W and Y continue to account for a significant proportion of cases. This reinforces the need for broad protection from early infancy.
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, said: “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.”
With the EC decision, healthcare professionals gain an additional option for vaccinating infants from six weeks of age. The expanded indication aligns with routine immunisation schedules and is supported by MenQuadfi’s demonstrated immunogenicity data.
Bogdana Coudsy, Global Head of Medical, Vaccines, Sanofi, explained: “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.”
Sanofi said the milestone reflects its ongoing efforts to expand vaccine access for vulnerable populations across the EU.
