French pharma company Sanofi has won approval from the European Commission (EC) for its meningococcal (MenACWY) vaccine MenQuadfi.
The EC has given MenQuadfi the green light for active immunisation of individuals from the age of 12 months and older against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y.
The approval is based on results from Sanofi’s international clinical programme of MenQuadfi, which included seven phase II and phase III studies.
Sanofi’s vaccine was compared to other licensed combination vaccines across all age groups, with MenQuadfi demonstrating a good safety profile and inducing a high immune response against all four serogroups consistently across the studies.
“Meningococcal meningitis can take one’s life in as little as one day and leave survivors with severe permanent disabilities. 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,” said 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,” he added.
Sanofi is continuing to study MenQuadfi in phase III studies in order to investigate the vaccine’s ability to prevent MenACWY over the life course in infants.