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The EC’s approval comes after positive results from seven Phase II and III randomized, active-controlled, multi-center studies.
Sanofi announced on Nov. 23, 2020 that the European Commission (EC) approved MenQuadfi (meningococcal [groups A, C, Y, W] conjugate vaccine) for immunization against meningococcal meningitis, the inflammation of the brain and spinal cord caused by a viral infection, in patients from the age of 12 months and older.
The EC’s approval comes after positive results from seven Phase II and III randomized, active-controlled, multi-center studies, a Sanofi press release said. Immunogenicity and safety of the vaccine were assessed in 6300 individuals who received a single dose of MenQuadfi, which showed a good safety profile and induced a high immune response against all four Neisseria meningitidis serogroups.
“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 3000 cases of Invasive Meningococcal Disease in 2018, half of them caused by serogroups C, W, and Y,” said Thomas Triomphe, head of Sanofi Pasteur, in the press release. “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.”