Sanofi receives EU approval for infant meningococcal vaccine
Sanofi's MenQuadfi vaccine has received European Commission approval for use in infants from six weeks of age to protect against invasive meningococcal disease.
The European Commission has approved an expanded indication for Sanofi's MenQuadfi vaccine, allowing its use in infants from six weeks of age to protect against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. The vaccine was previously approved for individuals aged 12 months and older.
The expanded approval follows a positive opinion from the Committee for Medicinal Products for Human Use in June 2026. This change enables vaccination to begin earlier, aligning with routine infant immunization schedules in the EU.
Invasive meningococcal disease is a rapid and potentially fatal bacterial infection. Infants are particularly vulnerable due to their developing immune systems. While serogroup A is now rarely reported in the EU, serogroups C, W, and Y continue to cause a significant proportion of cases across Europe.
This expanded indication provides healthcare professionals in the EU with an additional option to protect the youngest populations against this serious illness. Sanofi states that the vaccine has demonstrated robust immunogenicity and safety data in infants through clinical studies.