Sanofi’s MenQuadfi has received European approval for use in infants from six weeks old, expanding protection against invasive meningococcal disease and marking a significant milestone in early childhood immunisation efforts.
Sanofi has said MenQuadfi has won European approval for use in infants from six weeks of age, broadening the vaccine’s reach beyond its previous EU authorisation for children aged 12 months and above. The expanded indication covers protection against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y, a set of strains that can trigger severe and rapidly progressing illness.
According to the company, the move is backed by data from the MET58 study, which assessed the vaccine’s immune response, safety and tolerability in very young infants. Sanofi has previously highlighted wider clinical evidence supporting MenQuadfi, including earlier regulatory filings based on large international study programmes in older age groups.
The European Medicines Agency said on 25 June 2026 that its Committee for Medicinal Products for Human Use had recommended extending the marketing authorisation to include infants from six weeks of age, with the final European Commission decision still awaited at that point. That sequence suggests the latest change follows the usual EU regulatory path, in which a committee recommendation is followed by formal commission approval.
MenQuadfi is also approved in the United States for active immunisation against invasive meningococcal disease caused by serogroups A, C, W and Y in people aged six weeks and older. As with other quadrivalent meningococcal conjugate vaccines, it does not protect against serogroup B disease.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
