Sanofi's MenQuadfi Wins EU Approval for Infants from Six Weeks of Age Against Invasive Meningococcal Disease
核心洞察
The European Commission has approved MenQuadfi for infants from six weeks of age, expanding the previous indication which covered individuals aged 12 months and older.
Invasive meningococcal disease (搜索) carries a case fatality rate of approximately 10–15%, and up to 20% of survivors experience permanent complications such as limb amputation and neurological damage.
The approval is supported by the MET58 pivotal study, with more than 6,000 infants studied across 11 countries and multiple immunization schedules.
Sanofi today announced that the European Commission has approved an extension of the 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 (搜索) caused by Neisseria meningitidis (搜索) serogroups A, C, W, and Y. The decision, announced on August 4, 2026, follows the positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) on June 25, 2026. MenQuadfi was previously approved in the EU only for individuals aged 12 months and older.
A life-threatening disease with rapid progression
Invasive meningococcal disease (搜索) is a severe bacterial infection that can progress from initial symptoms to death within 24 hours. Infants represent one of the populations at highest risk, facing elevated rates of mortality and severe long-term complications, including limb amputation, hearing loss, and neurological damage. Even with appropriate treatment, the disease carries a case fatality rate of approximately 10–15%, and up to 20% of survivors experience permanent complications. Although serogroup A is now rarely reported in the EU, serogroups C, W, and Y continue to account for a significant share of invasive meningococcal disease cases across Europe, underscoring the importance of broad protection against all four serogroups from an early age.
Clinical evidence and dosing flexibility
The EU approval is supported by comprehensive data from the MET58 pivotal clinical study, which evaluated the immunogenicity, safety, and tolerability of MenQuadfi in infants from six weeks of age. MenQuadfi benefits from a robust clinical dataset, with more than 6,000 infants studied across 11 countries and multiple immunization schedules.
The approved dosing regimen for infants starting vaccination from six weeks of age follows a 2+1 schedule aligned with standard EU immunization practices: two doses (each 0.5mL) administered with an interval of at least two months, followed by one booster dose given in the second year of life, from 12 months of age, and at least two months after the last primary dose. For infants at increased risk of invasive meningococcal disease (搜索) 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 one booster dose from 12 months of age. Individuals aged 12 months and older continue to receive a single dose.
In infants, MenQuadfi can be co-administered with the combined DTaP-IPV-HepB-Hib vaccine, rotavirus vaccine (live attenuated), and the 10-valent pneumococcal conjugate vaccine (PCV10). The safety and immunogenicity profile of MenQuadfi has been established across a broad age range, from six weeks through adulthood, and the vaccine is well tolerated with a safety profile comparable to other currently licensed MenACWY vaccines.
Expert perspectives
"Meningococcal disease moves fast and strikes the hardest in younger children. Having a product indicated across a broad age range is key to meeting public health needs — giving healthcare providers the flexibility to help protect infants within routine immunization schedules and increase vaccine coverage. The immunogenicity data for MenQuadfi in infants is robust and supports the usage with confidence in the EU," said Federico Martinon-Torres, Pediatrician and Clinical Researcher, Head of Pediatrics and Vaccine Research Unit at Hospital Clínico Universitario de Santiago in Spain and Principal Investigator of MET58.
Bogdana Coudsy, Global Head of Medical, Vaccines at Sanofi, added: "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 rigor behind this work, and it means healthcare providers now have an additional option to help protect infants against invasive meningococcal disease (搜索) from the early weeks of life."
Regulatory milestones
The Paediatric Investigation Plan compliance statement has been received from the European Medicines Agency, marking the completion of all pediatric post-licensure commitments linked to MenQuadfi's initial marketing authorization. MenQuadfi is now approved in the EU, the United States, and multiple other countries.