Reason for request
Substantial in subjects aged 12 months and older, and only in those populations recommended by the Haut Conseil de santé publique ( HCSP, or the French High Council for Public Health), i.e., people with risk factors for invasive meningococcal infections and people visiting an endemic area.
Improvement in actual benefit
In light of the available information and given the lack of alternative treatments with a Marketing Authorisation for serogroups A, W135 and Y in the 12-to-23-month age range, the Committee considers that NIMENRIX offers a substantial improvement in actual benefit (IAB I) in the prevention of invasive meningococcal infection caused by serogroups A, W135 and Y in children 12 to 23 months of age
in the populations recommended by the HCSP.
NIMENRIX does not offer an improvement in actual benefit (non-existent IAB) in the prevention of invasive meningococcal infection caused by serogroups A, C, W135 and Y in children aged 2 years and older, adolescents and adults.