Safety profile of the meningococcal conjugate vaccine (Menafrivac™) in clinical trials and vaccination campaigns: a review of published studies

The study aimed to assess the capacity of AEFI surveillance during vaccination campaigns with the new conjugate meningitis vaccine (MenAfrivac). A systematic review of studies on MenAfrivac (TM) published in English during 2001-2016 was done.AEFIs incidence (I) was estimated and compared between MenAfrivac (TM) clinical trials and immunization campaigns using incidence difference (Id). Nine studies were included with an overall local AEFI I of 11,496/100,000 doses administered per week in clinical trials and 0.72/100,000 doses in immunization campaigns. An Id of 11,497.92 [11,497.91-11,497.93] and 17,243.20 [17,241.80-17,245.90] per 100,000 doses administered per week for overall local and systemic AEFI, respectively, were observed with highest from clinical trials. The incidence of AEFIs after MenAfrivac (TM) vaccination was far lower in campaigns than in clinical trial studies. Current capacity of AEFI surveillance during vaccination campaigns requires extensive re-assessment of its structure and capacity.