Sanofi: MenQuadfi vaccine approved in the EU from six weeks of age
The European Commission has approved an extension of indication for Sanofi's meningococcal vaccine MenQuadfi, enabling its use in infants from six weeks of age. This approval expands access to vaccination against invasive meningococcal infections in the most vulnerable populations of the European Union.
Extension of indication granted for infants
The European Commission approved, on August 4, 2026, an extension of indication for MenQuadfi (meningococcal conjugate vaccine of groups A, C, W and Y) to include infants from six weeks of age. The vaccine was previously authorized in the European Union for use in subjects from 12 months of age.
This extension follows the favorable opinion of the Committee for Medicinal Products for Human Use (CHMP) issued on June 25, 2026. It is based on data from the pivotal clinical study MET58, which evaluated the immunogenicity, safety and tolerability of MenQuadfi in infants from six weeks of age.
Dosing schedules aligned with pediatric vaccination calendars
The dosing schedules approved for infants are aligned with the vaccination calendars of the European Union pediatric populations. A "2+1" schedule is proposed: two doses at an interval of at least two months, followed by a booster dose during the second year of life (from 12 months of age). A "3+1" schedule may also be considered for infants at increased risk of invasive meningococcal infections.
MenQuadfi can be co-administered with combined vaccines against diphtheria, tetanus, acellular pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b, as well as rotavirus vaccine and 10-valent pneumococcal conjugate vaccine. The safety and immunogenicity profile has been established across a wide age range, from six weeks to adulthood.
Invasive meningococcal infections: epidemiological burden and sequelae
Invasive meningococcal infections constitute a potentially fatal bacterial infection that can progress rapidly, with the possibility of death within 24 hours. Infants are among the most exposed populations to risk, presenting high mortality rates as well as serious long-term complications, including amputations, hearing loss and neurological impairment.
Even with appropriate treatment, these infections present a fatality rate of approximately 10 to 15%, and up to 20% of survivors retain permanent sequelae. Although serogroup A is now rarely reported in the European Union, serogroupes C, W and Y remain responsible for a significant proportion of invasive meningococcal infection cases in Europe.
