Why the Anti-Meningococcal B Vaccination during Adolescence Should Be Implemented in Italy: An Overview of Available Evidence

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.

Meningococcal Disease in Pediatric Age: A Focus on Epidemiology and Prevention

“…Conversely, Trumenba can be co-administered with DTaP, HPV4, and meningococcal serogroups A, C, W, and Y. However, to date, in most vaccination schedules, Bexsero is not routinely co-administered with other vaccinations [ 50 , 51 , 52 ].…”

“…According to the “lifetime immunization schedule”, from 2014, the use of Bexsero in infants between 2 and 5 months of age was initially approved with a 3-dose vaccine immunization schedule at 3, 4, and 6 months, with each dose separated by at least 4 weeks, followed by 1 catch-up dose between 12 and 15 months of age [ 51 , 52 ].…”

Invasive Meningococcal Disease and Meningococcal Serogroup B Vaccination in Adults and Their Offspring: Knowledge, Attitudes, and Practices in Italy (2019)

“…For example, shortly before the inception of the MenB vaccination campaign, Lithuania had experienced very high rates of IMD (2.56 per 100,000 persons in 2013), but it dropped to 1.1 per 100,000 in 2018 [ 15 ]: in this timeframe, the incidence of serogroup B IMD declined from 1.62 per 100,000 in 2012 to 0.46 in 2018. Contrarily to the vaccine against serogroup C (MenC), MenB does not guarantee any effect on meningococcal carriage, only providing direct protection against IMD [ 17 , 18 , 19 , 20 ]. As a consequence, high vaccination rates among high-risk groups (i.e., children and adolescents, as well as adults affected by significant comorbidities) are instrumental in reducing the risk for IMD [ 19 , 21 , 22 , 23 ].…”

“…Contrarily to the vaccine against serogroup C (MenC), MenB does not guarantee any effect on meningococcal carriage, only providing direct protection against IMD [ 17 , 18 , 19 , 20 ]. As a consequence, high vaccination rates among high-risk groups (i.e., children and adolescents, as well as adults affected by significant comorbidities) are instrumental in reducing the risk for IMD [ 19 , 21 , 22 , 23 ].…”

“…More precisely, Italian Medicines Agency (AIFA) has authorized the use of a quadrivalent recombinant vaccine developed through “reverse vaccinology” (i.e., preparation of the vaccine starting from the identification of genes encoding antigenic proteins), or 4CMenB, among infants >2 months since 2014, and a bivalent recombinant vaccine (MenB-FHbp) in children >10 years of age since 2017 [ 23 ]. Despite considerable efforts, vaccination rates for MenB have remained suboptimal due to a series of factors, ranging from the heterogeneity in the vaccination policies in terms of official recommendations and the actual costs of the vaccine [ 19 , 27 , 28 , 29 ], limited effectiveness of the sanctioning system, low-risk perception of infectious diseases, confidence in the availability of antimicrobial therapies, scientific misinformation, and the re-emergence of anti-vaccination movements [ 25 , 30 , 31 ]. More precisely, while all children born after 2015 were offered MenB vaccine totally at no cost to their parents, parents of individuals born before 2015 and not affected by risk factors for IMD may be requested to partially or even totally contribute to the costs of the vaccine [ 19 ].…”