The European Commission has expanded the indication for MenQuadfi to include infants from 6 weeks of age, offering earlier protection against invasive meningococcal disease—a bacterial infection known to cause permanent hearing loss in survivors.

The European Commission (EC) has approved an expanded indication for Sanofi’s MenQuadfi (Meningococcal Group A, C, W and Y conjugate vaccine), clearing it for use in infants from six weeks of age to protect against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. Previously approved in the EU for individuals 12 months and older, the vaccine can now be integrated into routine infant immunization schedules from the earliest weeks of life.

The decision, announced Aug 4, 2026, follows a positive opinion adopted by the Committee for Medicinal Products for Human Use on June 25, 2026, and is supported by data from the MET58 pivotal clinical study, which evaluated immunogenicity, safety, and tolerability of MenQuadfi in infants starting at six weeks of age.

Significance for Acquired Hearing Loss

For hearing healthcare professionals, the approval carries direct clinical relevance. Invasive meningococcal disease is among the most serious preventable causes of acquired sensorineural hearing loss in young children. Even with appropriate treatment, the disease carries a case fatality rate of approximately 10%–15%, and up to 20% of survivors experience permanent complications — including hearing loss, limb amputation, and neurological damage. Infants represent one of the highest-risk populations, facing elevated rates of both mortality and long-term sequelae.

Bacterial meningitis is a well-established etiology of pediatric hearing loss, and children who survive the disease may require audiological evaluation and, in some cases, cochlear implantation. Expanding vaccine access to the youngest infants has the potential to reduce the incidence of meningococcal-related hearing impairment before irreversible cochlear damage can occur.

Dosing and Co-administration

The approved dosing regimens for infants under the new indication include:

  • 2+1 schedule: Two primary doses (each 0.5 mL) administered at least two months apart, followed by a booster dose in the second year of life (from 12 months of age), at least two months after the last primary dose. This schedule is aligned with standard EU immunization schedules.
  • 3+1 schedule: For infants at increased risk due to serogroup A exposure, a three-dose primary series at two, four, and six months, followed by one booster dose from 12 months of age.
  • Single dose: For individuals 12 months of age and older.

MenQuadfi can be co-administered with several common pediatric vaccines, including combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus-hepatitis B-Haemophilus influenzae type b (DTaP-IPV-HepB-Hib) vaccine, rotavirus vaccine (live attenuated), and 10-valent pneumococcal conjugate vaccine (PCV10).

Clinical Data and Context

MenQuadfi’s clinical profile in infants draws from a dataset of more than 6,000 infants studied across 11 countries and multiple immunization schedules. The vaccine’s safety profile is described as comparable to other MenACWY vaccines currently licensed.

“Meningococcal disease moves fast and strikes the hardest in younger children. Having a product indicated across a broad age range is key to meeting public health needs — giving healthcare providers the flexibility to help protect infants within routine immunization schedules and increase vaccine coverage. The immunogenicity data for MenQuadfi in infants is robust and supports the usage with confidence in the EU,” says Federico Martinon-Torres, pediatrician and clinical researcher, head of pediatrics and vaccine research unit at Hospital Clínico Universitario de Santiago in Spain and principal investigator of MET58, in a release.

Bogdana Coudsy, global head of medical, vaccines, Sanofi, added: “Offering protection for the EU’s youngest children is at the heart of what we do — and this approval is a direct expression of that commitment. It reflects the scientific rigor behind this work, and it means healthcare providers now have an additional option to help protect infants against invasive meningococcal disease from the early weeks of life,” in a release.

The European Medicines Agency has also issued a Paediatric Investigation Plan compliance statement for MenQuadfi, marking the completion of all pediatric post-licensure commitments linked to the vaccine’s initial marketing authorization. MenQuadfi is currently approved in the EU, US, and multiple other countries.

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