Sanofi's MenQuadfi wins EU approval for infants from six weeks
Sanofi has secured European Commission approval to extend the indication for MenQuadfi, its quadrivalent meningococcal conjugate vaccine, to infants from six weeks of age. The decision, published on 4 August 2026, broadens coverage from the previous lower age limit of 12 months and follows a positive opinion from the Committee for Medicinal Products for Human Use issued on 25 June 2026.
MenQuadfi targets Neisseria meningitidis serogroups A, C, W, and Y. The approval is supported by the MET58 pivotal clinical study, which evaluated immunogenicity, safety, and tolerability in infants from six weeks. Sanofi says more than 6,000 infants across 11 countries were enrolled in the vaccine's clinical programme across multiple immunisation schedules.
Dosing and schedule
The new EU label includes two approved regimens for infants starting vaccination before 12 months. A 2+1 schedule, comprising two primary doses at least two months apart followed by a booster from 12 months, is aligned with standard EU national immunisation programmes. For infants considered at elevated risk of serogroup A exposure, a 3+1 schedule using doses at two, four, and six months is available. Infants aged 12 months and older continue to receive a single dose.
The label also permits co-administration with a range of routine infant vaccines, including DTaP-IPV-HepB-Hib combination vaccines, rotavirus vaccine, and 10-valent pneumococcal conjugate vaccine. Sanofi also confirmed that the European Medicines Agency has issued a Paediatric Investigation Plan compliance statement, completing all paediatric post-licensure commitments attached to the original marketing authorisation.
Federico Martinon-Torres, Head of Paediatrics and Vaccine Research at Hospital Clínico Universitario de Santiago and principal investigator of MET58, said the immunogenicity data in infants was "robust and supports the usage with confidence in the EU," adding that a product indicated across a broad age range gives healthcare providers the flexibility to integrate protection into routine immunisation schedules from an early age.
Market context
Invasive meningococcal disease carries a case fatality rate of approximately 10 to 15 percent even with treatment, and up to one in five survivors experiences permanent complications including limb amputation, hearing loss, or neurological damage. Infants represent one of the highest-risk groups, making early-life immunisation coverage a priority for EU public health authorities.
The quadrivalent meningococcal conjugate vaccine market is contested. GSK's Menveo and Pfizer's Nimenrix have both held infant indications in some markets, and national immunisation programme tenders remain the primary commercial lever in Europe. Sanofi's extension of MenQuadfi's indication to six weeks places it in direct competition for these tender slots, particularly in countries where programmes start vaccination before 12 months. The practical advantage of schedule alignment with existing hexavalent combination vaccines could influence formulary decisions at a national level.
For Sanofi, which has invested heavily in its vaccines franchise alongside its immunology and oncology pipelines, the approval reinforces the commercial position of MenQuadfi in a geography where meningococcal vaccination policy is driven by individual EU member states rather than a single centralised payer. Uptake will depend on national immunisation advisory committees updating their recommendations to incorporate the new age indication.