European Commission approves MenQuadfi, the latest innovation in meningococcal (MenACWY) vaccination for individuals 12 months of age and older

European Commission approves MenQuadfi, the latest innovation in meningococcal (MenACWY) vaccination for individuals 12 months of age and older

• EC approval based on robust data from seven pivotal Phase 2 and 3 trials^{1,2,3,4,5,6,7} involving more than 6,300 individuals aged 12 months and older
• First quadrivalent meningococcal conjugate vaccine available in Europe in a fully liquid presentation, avoiding the need for vaccine reconstitution
• Meningococcal disease is a rare but highly unpredictable deadly bacterial infection, with more than 3,000 cases per year in Europe⁸

  

PARIS – November 23 – The European Commission (EC) has approved MenQuadfi for active immunization of individuals from the age of 12 months and older against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y.⁹

“Meningococcal meningitis can take one’s life in as little as one day and leave survivors with severe permanent disabilities.^10,11 In Europe, there were more than 3,000 cases of Invasive Meningococcal Disease in 2018, half of them caused by serogroups C, W and Y,”⁸ says Thomas Triomphe, Head of Sanofi Pasteur. “One case is one too many. It is our ambition to make this vaccine available worldwide to further expand protection to as many people as possible. The European Commission’s approval of MenQuadfi takes us one step closer to achieving this goal.”

Efficacy and safety profiles for MenQuadfi confirmed in robust clinical program

The European Commission’s decision is based upon results from a robust and comprehensive international clinical program, including seven pivotal Phase 2 and 3 randomized, active-controlled, multi-center studies. The immunogenicity and safety of MenQuadfi were evaluated in over 6,300 healthy individuals aged 12 months and older, who received a single dose of MenQuadfi.^{1,2,3,4,5,6,7}

MenQuadfi was compared with other licensed combination vaccines across all age groups. It demonstrated a good safety profile and induced a high immune response against all four serogroups (A, C, W and Y) consistently across all studies.^{1,2,3,4,5,6,7}

“The introduction of a new vaccine against four of the major serogroups of meningococcal disease is very welcome news. The disease is unpredictable and remains the biggest cause of sepsis and septic shock in children across Europe today,¹²” says Professor Federico Martinón-Torres, Pediatrician and Clinical Researcher, Head of Pediatrics and Vaccine Research Unit at Hospital Clínico Universitario de Santiago in Spain. “Meningococcal disease is vaccine-preventable but, in spite of its threat, there is currently no common immunization schedule for it in Europe. The approval of MenQuadfi in Europe will contribute to our efforts to protect against, and help defeat, this truly devastating disease.”