Broader indication boosts protection against invasive meningococcal disease across a wider paediatric population in the EU.
The European Commission (EC) has extended the indication for Sanofi’s MenQuadfi (conjugate vaccine) to infants from six weeks old to help protect against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y.
This approval expansion, supported by data from the Phase III MET58 study, widens the eligible pool of patients younger than 12 months old.
While a single dose is indicated for this latter age group, for infants the dosing regimen for MenQuadfi comprises of two doses (each 0.5mL) from six weeks old, then one booster dose from 12 months old and at least two months from the last dose. A 3+1 schedule for infants expected to be at increased risk of invasive meningococcal disease due to serogroup A exposure can be considered.
Federico Martinon-Torres, Principal Investigator of MET58, said: “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 immunisation schedules and increase vaccine coverage. The immunogenicity data for MenQuadfi in infants is robust and supports the usage with confidence in the EU.”
“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”
Federico Martinon-Torres, Principal Investigator of MET58
In infants, MenQuadfi can be co-administered with combined diphtheria - tetanus - acellular pertussis (DTaP) - inactivated poliovirus (IPV) - hepatitis B (HepB) - Haemophilus influenzae type b (Hib) vaccine (DTaP-IPV-HepB-Hib), rotavirus vaccine (live attenuated) and with 10-valent pneumococcal conjugate vaccine (PCV10).
This approval precedes Sanofi’s new incoming Executive Vice President, Global Head of Research & Development Pharma. Dr Paulo Fontoura will replace Dr Houman Ashrafian on 1 September.
In 2023, the FDA authorised the first single vaccine against the five most common meningococcal disease serogroups—specifically for adolescents in the US.
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