Sanofi’s MenQuadfi now approved for infants as young as 6 weeks in the EU, offering earlier protection against invasive meningococcal disease and its serious complications, including hearing loss.
The European Commission has cleared Sanofi’s MenQuadfi vaccine for use in infants from 6 weeks of age, widening protection against invasive meningococcal disease in one of the most vulnerable patient groups. The decision means the shot can now be used earlier in routine immunisation schedules across the European Union, after previously being authorised only for people aged 12 months and older.
The move follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use on June 25, based on data from the MET58 study. According to the EMA, the trial supported the expanded label by assessing immune response, safety and tolerability in infants beginning at 6 weeks of age. MenQuadfi protects against meningococcal serogroups A, C, W and Y, caused by Neisseria meningitidis.
The decision matters beyond infection prevention because invasive meningococcal disease is a recognised cause of permanent acquired hearing loss in children who survive it. Public health experts note that the illness can move quickly and leave lasting complications even with treatment, including neurological injury, limb loss and hearing damage. In its infant programme, Sanofi said the vaccine can be given alongside several standard childhood immunisations, including combination diphtheria, tetanus, pertussis, polio, hepatitis B and Hib vaccines, as well as rotavirus and PCV10.
Clinical data supporting the expanded indication came from more than 6,000 infants studied across 11 countries, according to the company. Federico Martinon-Torres, who led the MET58 study, said in a Sanofi release that having a product spanning a wide age range is important for public health because it gives clinicians more flexibility to protect infants within routine schedules. Bogdana Coudsy, Sanofi’s global head of medical for vaccines, said the approval reflects the company’s focus on protecting the EU’s youngest children. The EMA also issued a paediatric compliance statement, marking completion of the vaccine’s post-authorisation child-study commitments.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
