Background and Objectives: In Italy, the peak of invasive meningococcal B disease (IMBD) occurs mainly between the 4th and 8th month of age but encompassing cases up to 5 years of age and beyond. The 4 components meningococcal B vaccine (Bexsero; 4CMenB) was first commercialized in Italy in 2013. The present work Aims to summarize 9-year experience of 4CMenB use in Italy in the Public Health perspective. Methods: A non-systematic review of scientific literature (2013–2022) on IMBD and 4CMenB in Italy was carried out including web searching for official documents. Results: IMBD vaccination was firstly introduced in Italy among selected Regions in 2014, on a spontaneous basis. In 2017, IMBD vaccination was recommended to all newborns in the National Immunization Plan, and offered for free. The initial schedule was 3+1 doses but it was turned into a 2+1 after posology update in the label (albeit with differences among Regions). Overall, 10 million doses of 4CMenB were distributed in Italy, potentially protecting about 3 million subjects, mainly newborns. In the latest figures (2019 birth cohort), the average national coverage of 4CMenB was 79.7%. 4CmenB effectiveness measured in Italy was higher than 90%, with a greater impact of early immunization schedule. Different Regions released formal recommendations on the co-administration of 4CMenB with other pediatric vaccines (measles-mumps-rubella-varicella, rotavirus, 13-valent conjugate pneumococcal vaccine). In the national post-marketing surveillance of 4CMenB adverse events (AEs), fever and injection-site reactions are the most frequently observed. In 2017, highest rates of severe AEs were hyperpyrexia (6.7/100000 4CMenB doses) and fever (1.5/100000 4CMenB doses). Occurrence of 4CMenB AE was reported similar among healthy children or those with chronic conditions. Conclusions: The continuous efforts of different health professionals (public health vaccinators, pediatricians, etc.) made 4CMenB vaccination a wellknown and accepted practice in Italy, protecting millions of babies from IMBD.
The first 9 years of use of 4 components meningococcal B vaccine administered to nearly 3 million subjects in Italy: an outstanding achievement in public health / Bonanni P.; Marchetti F.; Azzari C.; Castagna S.. - In: POPULATION MEDICINE. - ISSN 2654-1459. - STAMPA. - 5:(2023), pp. A2054.0-A2054.0. [10.18332/popmed/165265]
The first 9 years of use of 4 components meningococcal B vaccine administered to nearly 3 million subjects in Italy: an outstanding achievement in public health
Bonanni P.;Azzari C.;
2023
Abstract
Background and Objectives: In Italy, the peak of invasive meningococcal B disease (IMBD) occurs mainly between the 4th and 8th month of age but encompassing cases up to 5 years of age and beyond. The 4 components meningococcal B vaccine (Bexsero; 4CMenB) was first commercialized in Italy in 2013. The present work Aims to summarize 9-year experience of 4CMenB use in Italy in the Public Health perspective. Methods: A non-systematic review of scientific literature (2013–2022) on IMBD and 4CMenB in Italy was carried out including web searching for official documents. Results: IMBD vaccination was firstly introduced in Italy among selected Regions in 2014, on a spontaneous basis. In 2017, IMBD vaccination was recommended to all newborns in the National Immunization Plan, and offered for free. The initial schedule was 3+1 doses but it was turned into a 2+1 after posology update in the label (albeit with differences among Regions). Overall, 10 million doses of 4CMenB were distributed in Italy, potentially protecting about 3 million subjects, mainly newborns. In the latest figures (2019 birth cohort), the average national coverage of 4CMenB was 79.7%. 4CmenB effectiveness measured in Italy was higher than 90%, with a greater impact of early immunization schedule. Different Regions released formal recommendations on the co-administration of 4CMenB with other pediatric vaccines (measles-mumps-rubella-varicella, rotavirus, 13-valent conjugate pneumococcal vaccine). In the national post-marketing surveillance of 4CMenB adverse events (AEs), fever and injection-site reactions are the most frequently observed. In 2017, highest rates of severe AEs were hyperpyrexia (6.7/100000 4CMenB doses) and fever (1.5/100000 4CMenB doses). Occurrence of 4CMenB AE was reported similar among healthy children or those with chronic conditions. Conclusions: The continuous efforts of different health professionals (public health vaccinators, pediatricians, etc.) made 4CMenB vaccination a wellknown and accepted practice in Italy, protecting millions of babies from IMBD.
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