Post-Marketing Safety Monitoring of a New Group B Meningococcal Vaccine in New Zealand, 2004-2006

Abstract

New Zealand introduced a new outer membrane vesicle vaccine in 2004 to combat an epidemic of group B meningococcal disease. An Independent Safety Monitoring Board oversaw intensive safety monitoring, which included hospital surveillance, health professional reporting (passive and active) and mortality monitoring. With over three million doses administered to individuals aged under 20 years, the monitoring results provide consistent evidence supporting the vaccine's safety.

A multicomponent serogroup B meningococcal vaccine is licensed for use in Europe: what do we know, and what are we yet to learn?

“…There was one report of a hypotensive hyporesponsive episode with onset of symptoms 30 min post vaccine [35,52,56]. Eighteen cases of Kawasaki disease were reported in children under 5 years of age, of which only eight had received MenZB prior to the disease onset [52]. Seventeen seizures in children under 5 years were noted in surveillance areas within 4 days of vaccination, of which 11 were simple febrile seizures, and two of these had no other attributable cause.…”

“…There was one report of a hypotensive hyporesponsive episode with onset of symptoms 30 min post vaccine [35,52,56]. Eighteen cases of Kawasaki disease were reported in children under 5 years of age, of which only eight had received MenZB prior to the disease onset [52].…”

“…Seventeen seizures in children under 5 years were noted in surveillance areas within 4 days of vaccination, of which 11 were simple febrile seizures, and two of these had no other attributable cause. The rate of seizures for children under five was one per 18,600 doses, and for simple febrile seizures one per 28,800 doses [52]; again, these were below the thresholds of concern. Additional studies confirmed no increased risk of simple febrile seizures or Henoch Schonlein Purpura associated with MeNZB vaccine [57][58][59].…”

“…Over 3 million doses of MeNZB vaccine, using the same OMV as that in 4CMenB, were administered to children and adults as part of a mass immunization campaign conducted between July 2004 and June 2008 [35,52]. During pre-licensure trials, fever (≥38°) was reported in approximately 16-37% of doses in the early infant study, 15% of doses given during late infant and toddler studies, and 0-3% of 8-12-year old children and adults [36,45,46,53,54].…”

Cost-effectiveness of vaccination against meningococcal B among Dutch infants

“…18 This resulted for our base case in the prediction of 479 adverse event related GP visits and 1 hospitalisation.…”