French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) announced on Tuesday that it has received European Commission approval to expand the EU indication for MenQuadfi (Meningococcal Group A, C, W and Y conjugate vaccine) to include infants from six weeks of age, providing protection against invasive meningococcal disease caused by serogroups A, C, W and Y.

The vaccine was previously approved in the EU for individuals aged 12 months and older.

This expanded indication follows a positive opinion from the Committee for Medicinal Products for Human Use issued in June 2026, and is supported by data from the MET58 pivotal clinical study evaluating immunogenicity, safety and tolerability in infants.

Invasive meningococcal disease can progress rapidly and carries an estimated case fatality rate of 10% to 15%, while up to 20% of survivors experience permanent complications. Infants are among the populations at highest risk, and serogroups C, W and Y continue to account for a significant share of cases across Europe.

The approval provides EU healthcare professionals with an additional vaccination option aligned with routine infant immunisation schedules. MenQuadfi is also approved in the United States and multiple other countries.