Meningococcal serogroup B vaccine in Italy: state-of-art, organizational aspects and perspectives.

Neisseria meningitidis causes severe invasive meningococcal diseases (IMDs) in humans including meningitis and septicemia, responsible for serious clinical conditions and leading to life-long disabilities and death. Serogroup B dominates IMDs burden in Italy, accounting for over 60% of total cases. On January 2013 the European Medicine Agency (EMA) licensed the first serogroup B meningococcal (MenB) vaccine in Europe. A number of European countries and Regions have introduced the new MenB vaccine in their immunization schedule, including Italy. In this paper we present the state of art, related critical issues and future perspectives of MenB vaccine introduction in Italy, in the context of the most recent available epidemiological data. In particular, we systematically assess the ongoing processes in the 8 Italian regions and one autonomous province that have already introduced MenB vaccine. With the new 2014-2018 National Vaccine Prevention Plan including active MenB vaccine offer about to be adopted, it is of fundamental importance to gather further evidence on MenB vaccine clinical effectiveness, duration of protection and cost-effectiveness. Italian regions are called to organize and manage MenB immunization programs. Careful consideration will need to be devoted on timing, doses, and co-administration with other vaccines but also to economic assessments and strengthened communication to the general public. Our data will help to plan, implement and evaluate MenB immunization programmes in other Italian and international settings.