PARIS, Aug. 4, 2026
Sanofi announced that the European Commission (EC) has approved an expanded indication for MenQuadfi® (Meningococcal Group A, C, W and Y conjugate vaccine), extending its use to infants from six weeks of age for the prevention of invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, W, and Y. The approval follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) in June 2026 and expands the vaccine’s previous EU authorization, which covered individuals aged 12 months and older. The decision provides healthcare professionals with an additional vaccination option for protecting infants, one of the populations at greatest risk for severe meningococcal disease.
EU Approval Expands Early Infant Protection Against Meningococcal Disease
The expanded indication enables MenQuadfi to be administered from six weeks of age, aligning with routine pediatric immunization schedules across Europe. Approved dosing includes a 2+1 schedule consisting of two primary doses administered at least two months apart, followed by a booster dose during the second year of life. For infants considered at increased risk of serogroup A exposure, a 3+1 schedule may also be used. Individuals aged 12 months and older continue to receive a single-dose regimen. MenQuadfi may also be co-administered with commonly used childhood vaccines, including DTaP-IPV-HepB-Hib, rotavirus, and 10-valent pneumococcal conjugate vaccine (PCV10).
MET58 Trial Demonstrated Strong Immunogenicity and Safety
The European Commission’s decision is supported by data from the pivotal MET58 clinical study, which evaluated the vaccine’s immunogenicity, safety, and tolerability in infants beginning at six weeks of age. Across its global clinical development program, MenQuadfi has been studied in more than 6,000 infants across 11 countries and demonstrated robust immune responses with a safety profile comparable to currently licensed MenACWY vaccines. The approval also marks completion of all pediatric post-licensure commitments under the European Medicines Agency (EMA) Pediatric Investigation Plan for MenQuadfi.
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Expanded Indication Strengthens Sanofi’s Global Vaccine Portfolio
Invasive meningococcal disease remains a rapidly progressing and potentially fatal bacterial infection, particularly among infants and young children, with mortality rates of approximately 10–15% and permanent complications affecting up to 20% of survivors. By extending MenQuadfi’s indication to infants as young as six weeks, Sanofi broadens early protection against meningococcal serogroups A, C, W, and Y, supporting public health efforts to improve vaccine coverage among vulnerable populations. MenQuadfi is now approved for use in the European Union, United States, and multiple other countries, further strengthening Sanofi’s global vaccine portfolio.
Source: Sanofi,press release
