Sanofi has received approval from the European Commission (EC) to expand the indication of its MenQuadfi (Meningococcal Group A, C, W and Y conjugate vaccine) to include infants from six weeks of age, providing earlier protection against Invasive Meningococcal Disease (IMD) caused by Neisseria meningitidis serogroups A, C, W and Y.

The approval extends MenQuadfi's previous European Union indication, which covered individuals aged 12 months and older, and follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) in June 2026.

The expanded indication is expected to strengthen routine infant immunisation programmes across Europe, offering healthcare providers an additional vaccination option for one of the populations most vulnerable to invasive meningococcal disease.

IMD is a rapidly progressing bacterial infection that can become fatal within 24 hours of symptom onset. Infants face the highest risk of severe disease, with complications including limb amputation, hearing loss and permanent neurological damage. Despite appropriate medical treatment, the disease carries a mortality rate of approximately 10–15 percent, while up to one in five survivors experiences long-term health complications.

Although meningococcal serogroup A is now uncommon across the European Union, serogroups C, W and Y continue to account for a significant proportion of reported cases, highlighting the importance of broad protection during early infancy.

Federico Martinon-Torres, paediatrician, clinical researcher and Principal Investigator of the MET58 study, said broad age indications are essential for meeting public health needs. He noted that MenQuadfi's robust immunogenicity data in infants supports its integration into routine vaccination schedules while helping improve vaccine coverage across the region.

The EC approval is supported by data from the pivotal MET58 clinical trial, which evaluated the vaccine's immunogenicity, safety and tolerability in infants beginning at six weeks of age. The evidence demonstrated strong immune responses and a safety profile comparable to other licensed quadrivalent meningococcal conjugate vaccines.

Bogdana Coudsy, Global Head of Medical, Vaccines at Sanofi, said the approval reinforces the company's commitment to protecting the youngest and most vulnerable populations by providing healthcare professionals with an additional option to help prevent invasive meningococcal disease from the earliest weeks of life.

Under the updated label, infants starting vaccination from six weeks of age will receive a 2 plus 1 dosing schedule, consisting of two primary doses administered at least two months apart, followed by a booster dose in the second year of life. For infants at increased risk of exposure to serogroup A, a 3+1 schedule may also be used. Individuals aged 12 months and older will continue to receive a single-dose regimen.

MenQuadfi can also be administered alongside routine childhood vaccines, including diphtheria, tetanus, acellular pertussis, inactivated poliovirus, hepatitis B, Haemophilus influenzae type b, rotavirus and pneumococcal conjugate vaccines, facilitating its incorporation into existing immunisation programmes.

Sanofi noted that more than 6,000 infants across 11 countries have participated in MenQuadfi clinical studies, generating extensive evidence supporting the vaccine's safety and effectiveness. The vaccine is currently approved in the European Union, the United States and several other countries, and the latest approval completes all paediatric post-authorisation commitments outlined under the European Medicines Agency's Paediatric Investigation Plan.