Sanofi has received approval from the European Commission to expand the use of its MenQuadfi meningococcal vaccine to infants from six weeks of age. The decision gives healthcare professionals across the European Union an additional option to help protect some of the youngest children against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y.
The approval, announced on August 4, 2026, expands MenQuadfi’s previous EU indication, which covered individuals aged 12 months and older. The European Commission’s decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) adopted on June 25, 2026.
The move is particularly important because invasive meningococcal disease can progress extremely quickly. In some cases, a patient can deteriorate from the first symptoms to life-threatening illness or death within just 24 hours. Infants are considered one of the groups at higher risk of severe disease and its complications.
Even with appropriate treatment, invasive meningococcal disease has a case fatality rate of around 10% to 15%. Among survivors, as many as 20% may experience permanent complications, including hearing loss, neurological damage and limb amputation.
While serogroup A is now rarely reported in the European Union, serogroups C, W and Y continue to contribute significantly to invasive meningococcal disease cases across Europe. This makes broad protection against multiple meningococcal serogroups an important part of prevention efforts, particularly among young children.
Sanofi’s expanded approval is supported by data from the MET58 pivotal clinical study, which evaluated the immunogenicity, safety and tolerability of MenQuadfi in infants starting from six weeks of age. According to Sanofi, a pharma company; more than 6,000 infants across 11 countries have been included in clinical studies evaluating the vaccine across different immunization schedules.
The newly approved infant regimen is designed to fit into routine European pediatric vaccination schedules. For infants beginning vaccination from six weeks of age, the standard 2+1 schedule includes two doses given at least two months apart, followed by a booster during the second year of life.
For infants considered at increased risk because of potential exposure to serogroup A, a 3+1 schedule may also be considered. This includes three primary doses at two, four and six months, followed by a booster from 12 months of age.
For individuals aged 12 months and older, MenQuadfi continues to be available as a single-dose vaccination option. The vaccine can also be co-administered in infants with several routine childhood vaccines, including DTaP-IPV-HepB-Hib, rotavirus and PCV10 vaccines.
Sanofi said MenQuadfi has demonstrated a safety and immunogenicity profile across a broad age range, from six weeks through adulthood. The company also noted that its safety profile is comparable with other licensed MenACWY vaccines.
The approval also represents an important regulatory milestone for Sanofi, as the European Medicines Agency has issued a Paediatric Investigation Plan compliance statement. This marks the completion of pediatric post-licensure commitments associated with MenQuadfi’s initial marketing authorization.
For Sanofi, expanding MenQuadfi’s indication to infants strengthens its position in meningococcal disease prevention while giving European healthcare providers another vaccination option during the early months of life. More importantly, the decision brings protection against four important meningococcal serogroups closer to the routine immunization window for infants.
About Sanofi
Sanofi is a global healthcare and pharmaceutical company focused on developing medicines and vaccines for diseases that affect people around the world. Its portfolio spans vaccines, specialty medicines and innovative healthcare solutions, with a strong focus on immunology, rare diseases, neurology and other areas of significant medical need.
References:
https://www.sanofi.com/en/media-room/press-releases/2026/2026-08-04-05-00-00-3338016
https://www.towardshealthcare.com/