Sanofi Wins EU Approval To Expand MenQuadfi Vaccine Use To Infants From Six Weeks Of Age

Sanofi has received approval from the European Commission (EC) to expand the use of its MenQuadfi vaccine to include infants from six weeks of age. The vaccine is designed 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 latest approval follows a positive recommendation issued by the Committee for Medicinal Products for Human Use (CHMP) in June 2026.

The expanded indication gives healthcare professionals across the European Union an additional option to vaccinate infants at an earlier age as part of routine childhood immunization programs. Sanofi said the approval is supported by clinical data demonstrating strong immune responses in infants, allowing the vaccine to be integrated into existing vaccination schedules while providing broad protection against four meningococcal serogroups.

Invasive meningococcal disease is a serious and rapidly progressing bacterial infection that can become life-threatening within 24 hours of the first symptoms. Infants are among the groups most vulnerable to the disease and face a higher risk of death or severe long-term complications, including hearing loss, neurological damage, and limb amputation. Even with prompt treatment, the disease has a mortality rate of around 10% to 15%, while up to one in five survivors may experience permanent health complications. Although serogroup A is now uncommon in Europe, serogroups C, W, and Y continue to account for a significant number of cases across the region.

Federico Martinon-Torres, Pediatrician, Clinical Researcher, and Principal Investigator of the MET58 study, said meningococcal disease progresses quickly and poses the greatest risk to young children. He noted that having a vaccine approved across a broader age range gives healthcare providers greater flexibility to protect infants through routine immunization programs and may help improve overall vaccine coverage. He also highlighted the strong immunogenicity data supporting MenQuadfi's use in infants.

Bogdana Coudsy, Global Head of Medical, Vaccines at Sanofi, said the approval reflects the company's commitment to protecting young children from serious infectious diseases. She added that healthcare providers across the European Union now have another option to help safeguard infants against invasive meningococcal disease from the earliest weeks of life.

Sanofi said the expanded approval represents another step in its efforts to improve access to meningococcal vaccination for vulnerable populations across Europe. By extending MenQuadfi's indication to younger infants, the company aims to strengthen early disease prevention and support broader public health initiatives focused on reducing the burden of invasive meningococcal disease.