The European Commission (EC) has expanded the approved use of Sanofi’s MenQuadfi vaccine to include babies as young as 6 weeks old. This vaccine helps protect children from invasive meningococcal disease caused by four types of bacteria (serogroups A, C, W, and Y), which can lead to severe meningitis or bloodstream infections. Previously, MenQuadfi was only approved for older children and adults. The approval was based on data from a large clinical study called MET58.
For babies aged 6 weeks to 12 months, the recommended vaccination schedule includes two doses, each 0.5 mL, given a few weeks apart, followed by a booster dose at 12 months or later. If a baby is at higher risk of infection from serogroup A (a specific type of the bacteria), an additional dose may be recommended. The vaccine can be safely given at the same time as other routine childhood vaccines, such as those for diphtheria, tetanus, whooping cough, polio, hepatitis B, Haemophilus influenzae type b (Hib), rotavirus, and pneumonia.
Dr. Federico Martinon-Torres, the lead researcher for the MET58 study, emphasized the importance of this approval: ‘Meningococcal disease can spread quickly and is especially dangerous for young children. Having a vaccine that works for a wide range of ages helps healthcare providers protect more infants as part of regular vaccination programs.’ The data from the study showed that MenQuadfi is effective in generating a strong immune response in babies.
This change comes as Sanofi prepares for a leadership transition in their research and development team. Dr. Paulo Fontoura will take over as the new Executive Vice President and Global Head of Research & Development Pharma starting September 1, replacing Dr. Houman Ashrafian. In 2023, the U.S. Food and Drug Administration (FDA) also approved a vaccine in the U.S. for adolescents that protects against five types of meningococcal bacteria.