The European Commission has approved Sanofi’s MenQuadfi for infants from six weeks of age, expanding protection against invasive meningococcal disease across the EU.
Written By: Kalyani Boharapi,
M.Pharm (Reg. Affairs)
Reviewed By: Pharmacally Editorial Team
The European Commission has approved an expanded indication for MenQuadfi (Meningococcal Group A, C, W and Y conjugate vaccine), allowing its use in infants from six weeks of age to prevent invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, W, and Y. The approval extends the vaccine’s previous authorization, which covered individuals aged 12 months and older, and provides healthcare professionals with an additional option to incorporate MenQuadfi into routine infant immunization schedules across the European Union.
Earlier Protection against a Rapidly Progressive Disease
The expanded indication follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted on June 25, 2026.
Invasive meningococcal disease is a severe bacterial infection that can progress from the first symptoms to death within 24 hours. Infants remain among the populations at greatest risk, with infection associated with high mortality and serious long-term complications, including limb amputation, hearing loss, neurological impairment, and other permanent disabilities.
Despite appropriate medical treatment, IMD carries a case fatality rate of approximately 10% to 15%, while up to 20% of survivors experience lasting complications. Although serogroup A infections are now uncommon in Europe, serogroups C, W, and Y continue to account for a substantial proportion of cases, supporting the need for broad quadrivalent protection during early infancy.
MenQuadfi and the Clinical Evidence Supporting the Approval
MenQuadfi is a quadrivalent meningococcal conjugate vaccine that induces protective immune responses against Neisseria meningitidis serogroups A, C, W, and Y through T-cell-dependent immunity generated by conjugating bacterial polysaccharides to a carrier protein.
The EC decision is supported by data from the MET58 pivotal clinical study (NCT03547271), which evaluated the vaccine’s immunogenicity, safety, and tolerability in infants beginning at six weeks of age. The study demonstrated robust immune responses that supported approval for use within routine pediatric vaccination schedules.
Across its clinical development program, MenQuadfi has been evaluated in more than 6,000 infants enrolled across 11 countries using multiple vaccination schedules. The vaccine demonstrated a safety profile comparable to other licensed MenACWY vaccines and was generally well tolerated across age groups ranging from six weeks through adulthood.
Updated Vaccination Schedule
The newly approved dosing schedule aligns with standard pediatric immunization programs in the EU.
For infants starting vaccination at six weeks of age, MenQuadfi is approved as a 2+1 schedule, consisting of two primary 0.5 mL doses administered at least two months apart, followed by a booster dose during the second year of life (from 12 months of age) at least two months after the last primary dose.
Infants considered at increased risk of serogroup A exposure may receive a 3+1 schedule, with primary doses administered at two, four, and six months, followed by a booster dose from 12 months of age.
Individuals aged 12 months and older continue to receive a single-dose regimen.
MenQuadfi may also be administered alongside routine pediatric vaccines, including combined DTaP-IPV-HepB-Hib, rotavirus vaccine, and 10-valent pneumococcal conjugate vaccine (PCV10).
Expert Perspective
Federico Martinon-Torres, Pediatrician and Head of the Pediatrics and Vaccine Research Unit at Hospital Clínico Universitario de Santiago in Spain and principal investigator of the MET58 study, said broad age coverage is essential for addressing public health needs because meningococcal disease disproportionately affects very young children. He noted that the strong immunogenicity data generated in infants support the vaccine’s use with confidence within European immunization programs.
Bogdana Coudsy, Global Head of Medical, Vaccines at Sanofi, said the approval strengthens options for protecting the EU’s youngest children by allowing vaccination from the first weeks of life while reflecting the scientific evidence supporting the expanded indication.
Clinical Significance
The approval marks another milestone for MenQuadfi’s global lifecycle, expanding protection to one of the most vulnerable age groups while increasing flexibility for national immunization programs across Europe. The vaccine is now approved for use from six weeks of age in the EU and is already authorized in the United States and several other countries.
Sanofi has also completed all pediatric post-licensure commitments associated with MenQuadfi’s original marketing authorization, receiving a Paediatric Investigation Plan (PIP) compliance statement from the European Medicines Agency.
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About the Writer
Kalyani Boharapi (LinkedIn) is a pharmacy professional and healthcare writer currently pursuing an M.Pharm in Regulatory Affairs at Dr. D. Y. Patil College of Pharmacy, with interests in pharmaceutical regulations, drug development, and healthcare innovation. She has academic exposure to dossier preparation, scientific writing, and regulatory documentation. Kalyani has also completed certification courses in Generative AI, AI in Pharma, and Bioinformatics, and actively participates in pharmaceutical conferences to stay updated with emerging trends and advancements in the healthcare and pharmaceutical industry.