Posted by Michael Wonder on 22 Sep 2020
CHMP recommends approval of MenQuadfi for active immunisation of individuals from the age of 12 months and older against invasive meningococcal ACWY disease
22 September 2020 - Positive opinion based on a large, international clinical program demonstrating a good safety profile and a high immune response against all four serogroups (A, C, W and Y).
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for MenQuadfi 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 recommendation is supported by seven double-blind, randomised, multicenter Phase 2 and 3 clinical studies that assessed safety and immune responses following vaccination, with nearly 6,300 persons from toddlers 12 month and older to older adults. These studies compared MenQuadfi with other licensed combination vaccines, demonstrating a good safety profile and high immune response against all four serogroups (A, C, W and Y).
