Sanofi has received European Commission (EC) approval to extend the indication of its MenQuadfi (Meningococcal Group A, C, W and Y conjugate vaccine) to include infants from six weeks of age. The vaccine is approved to help protect against invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, W and Y. MenQuadfi was previously authorised in the European Union for people aged 12 months and older. The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) issued on 25 June 2026.

Invasive meningococcal disease is a serious bacterial infection that can develop rapidly and become life-threatening within 24 hours of the first symptoms. Infants are among the groups at greatest risk and may face severe complications, including limb loss, hearing impairment and neurological damage. The disease has a mortality rate of around 10–15%, while up to one in five survivors experience permanent health problems. Although serogroup A is now uncommon in the EU, serogroups C, W and Y continue to account for a significant number of cases across Europe.

The expanded approval allows healthcare professionals across the EU to vaccinate infants with MenQuadfi from six weeks of age. The vaccine can be incorporated into routine infant immunisation schedules, providing an additional option to help protect young children against meningococcal disease. The approval is supported by clinical data demonstrating the vaccine’s immunogenicity in infants.

The EC decision is based on findings from the pivotal MET58 clinical study, which assessed the immunogenicity, safety and tolerability of MenQuadfi in infants aged six weeks and older.

The latest approval supports Sanofi’s efforts to improve access to meningococcal vaccination and expand protection for infants, one of the populations most vulnerable to invasive meningococcal disease.

Source: globenewswire.com