The European Commission (EC) has approved an extension of the indication for Sanofi’s MenQuadfi (Meningococcal Group A, C, W and Y conjugate vaccine) to include infants from six weeks of age. The vaccine is indicated to help protect against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y.
MenQuadfi was previously approved in the European Union for individuals aged 12 months and older. The expanded indication follows the positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) on June 25, 2026.
Invasive meningococcal disease is a life-threatening bacterial infection that can progress rapidly, with patients potentially deteriorating from the onset of symptoms to death within 24 hours. Infants are among those at highest risk and can experience severe outcomes, including death and long-term complications such as limb amputation, hearing loss and neurological damage.
The expanded indication is aligned with routine paediatric immunisation schedules and is supported by MenQuadfi’s immunogenicity data.
“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 rigour 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,” said Bogdana Coudsy, global head of medical, vaccines, Sanofi.
The new dose regimen approved for those starting vaccination from six weeks of age is aligned with routine pediatric vaccination schedules.
Approved dosing regimens:
Infants from six weeks of age: A 2+1 schedule, with two 0.5 mL doses administered at least two months apart, followed by a booster dose in the second year of life, from 12 months of age and at least two months after the previous dose.
Infants at increased risk due to serogroup A exposure: A 3+1 schedule may be considered, consisting of three primary doses at two, four and six months, followed by a booster from 12 months of age.
Individuals aged 12 months and older: A single dose.
Sanofi said that, in infants, MenQuadfi can be co-administered with the combined diphtheria-tetanus-acellular pertussis, inactivated poliovirus, hepatitis B and Haemophilus influenzae type b vaccine (DTaP-IPV-HepB-Hib), live attenuated rotavirus vaccine and 10-valent pneumococcal conjugate vaccine (PCV10).
The European Medicines Agency has also issued a Paediatric Investigation Plan compliance statement, marking the completion of all paediatric post-authorisation commitments associated with MenQuadfi’s initial marketing authorisation.
MenQuadfi is approved in the EU, US and several other countries.
