Sanofi’s MenQuadfi cleared in the EU for infants from six weeks old against invasive meningococcal disease

The European Commission has approved an expanded indication for Sanofi’s MenQuadfi (Meningococcal Group A, C, W and Y conjugate vaccine), extending its use to infants as young as six weeks to help guard against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y. The vaccine had only been cleared in the EU for people aged 12 months and older until now. The expanded approval follows a positive opinion from the Committee for Medicinal Products for Human Use issued on June 25, 2026.

Invasive meningococcal disease is a fast-moving bacterial infection capable of killing within 24 hours of the first symptoms appearing. Infants are among those at greatest risk, facing elevated odds of death as well as severe lasting effects such as limb amputation, hearing loss and neurological damage. Even when treated promptly, the disease kills roughly 10 to 15 percent of those infected, and as many as one in five survivors is left with permanent complications. Serogroup A has become rare in Europe, but serogroups C, W and Y still account for a substantial share of cases, which is why officials point to the value of protecting against all four strains starting in early infancy.

Federico Martinon Torres, who heads the pediatrics and vaccine research unit at Hospital Clínico Universitario de Santiago in Spain and served as principal investigator on the MET58 study, said the speed and severity of meningococcal disease in young children make it valuable to have a vaccine authorized across such a wide age span. He said this flexibility allows providers to fold infant protection into existing immunization schedules and lift overall vaccine coverage, adding that the immunogenicity results supporting use in infants are strong enough to give the EU confidence in the expanded approval.

The new indication gives EU healthcare providers an added tool for immunizing infants from six weeks of age, fitting within routine pediatric vaccination schedules and backed by data on how well the vaccine triggers an immune response in that age group.

Bogdana Coudsy, Sanofi’s global head of medical for vaccines, said protecting the EU’s youngest children sits at the center of the company’s mission and framed the approval as a reflection of that focus. She said it demonstrates the scientific work behind the vaccine and gives clinicians another way to shield infants from meningococcal disease from their earliest weeks of life.

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Related Topics and Keywords

invasive meningococcal disease, Meningococcal Disease, MenQuadfi, Sanofi, Sanofi's MenQuadfi