Abstract

Although meningococcal disease has a low incidence in Italy, it is a public health concern owing to its high lethality rate and high frequency of transitory and/or permanent sequelae among survivors. The highest incidence rates are recorded in infants, children and adolescents, and most of the cases are due to Neisseria meningitidis B. In Italy, anti-meningococcal B (anti-MenB) vaccination is free for infants but, despite the considerable disease burden in adolescents, no national recommendation to vaccinate in this age-group is currently available. The aim of this study was to assess the main available scientific evidence to support the Italian health authorities in implementing a program of free anti-MenB vaccination for adolescents. We conducted an overview of the scientific literature on epidemiology, disease burden, immunogenicity and safety of available vaccines, and economic evaluations of vaccination strategies. Each case of invasive meningococcal disease generates a considerable health burden (lethality rate: 9%; up to 60% of patients experience at least one sequela) in terms of impaired quality of life for survivors and high direct and indirect costs (the mean overall cost of acute phase for a single case amounts to about EUR 13,952; the costs for post-acute and the long-term phases may vary widely depending of the type of sequela, reaching an annual cost of about EUR 100,000 in cases of severe neurological damage). Furthermore, vaccination against meningococcus B in adolescence proved cost-effective. The study highlights the need to actively offer the anti-MenB vaccination during adolescence at a national level. This would make it possible to avoid premature deaths and reduce the high costs borne by the National Health Service and by society of supporting survivors who suffer temporary and/or permanent sequelae.

Highlights

  • Neisseria meningitidis (N. meningitidis) is an aerobic, Gram-negative bacterium that exclusively infects the human species and is the leading cause of invasive bacterial disease in the world [1]

  • The notification system has become more sensitive over the years: the causative agent (Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae) of invasive bacterial disease was not identified in about 6% in 2014, 4.4% in 2016, 3.9% in 2017, and 2.4% in 2018 [12,13]

  • The latest available report (2016–2018) reported incidence rates that were between 0.37 and 0.28 cases per 100,000 inhabitants in 2016 and 2018, respectively; these values are lower than the European average of 0.6 cases reported in 2017 [6]

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Summary

Introduction

Neisseria meningitidis (N. meningitidis) is an aerobic, Gram-negative bacterium that exclusively infects the human species and is the leading cause of invasive bacterial disease in the world [1]. Of the 13 serogroups currently known, only six are able to cause invasive disease (A, B, C, W-135, Y and X) [2,3], and the distribution of serogroups varies from one geographical area to another [3]. The incidence of invasive meningococcal disease varies greatly according to the geographical area [3]. The disease is rare in developed countries, it imposes a heavy clinical, social and economic burden, owing to its high lethality (8–15%); in the event of sepsis, the lethality rate can reach 40% [4–6]. With regard to Europe, the latest report by the European Centre for Disease Prevention and Control (ECDC) (2011–2015) showed that the overall rate of lethality was 9%. A large number of survivors (up to 60%) suffer of transient and/or permanent sequelae that impact heavily on their quality of life and that of their family members [7]

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