Journal Article

Clinical experience with the meningococcal B vaccine, Bexsero®: Prospects for reducing the burden of meningococcal serogroup B disease

Watson, Philip S., Turner, David P.J.

2016

Overview

•MenB is the most common disease-causing meningococcal serogroup in many countries.•Based on in vitro data (Meningococcal Antigen Typing System assay), Bexsero is predicted to elicit a bactericidal response against most circulating MenB strains.•Bexsero has also demonstrated an acceptable safety profile.•Clinical recommendations on Bexsero use have been published in many countries.•Here we summarise the use of the vaccine since licensure. Although rare, invasive meningococcal disease remains an important cause of mortality and morbidity in children and young adults. Vaccines have been successfully introduced to help protect against meningococcal disease caused by serogroups A, C, W and Y, but until recently, a vaccine for serogroup B (MenB) was not available. In many industrialised countries, MenB causes the majority of meningococcal disease. Moreover, MenB outbreaks occur unpredictably, particularly in high-risk populations, such as university students. In 2013, Bexsero® became the first broad-coverage vaccine to be licensed for active immunisation against MenB disease. Bexsero is now licensed in more than 35 countries worldwide for varying age groups, including the EU, Australia, Brazil, Canada, Chile, Uruguay and the USA. Clinical recommendations for the use of Bexsero have been published in several countries. Recommendations include use in high-risk groups, outbreak control and routine infant immunisation. Since initial licensure, considerable clinical experience has been gained. In Canada, 43,740 individuals received Bexsero during a vaccination programme in the Saguenay–Lac-Saint-Jean region of Quebec, where local disease incidence was high. In the USA, Bexsero was administered to >15,000 individuals during two college outbreaks prior to licensure, under an Investigational New Drug protocol. In the UK, the Joint Committee on Vaccination and Immunisation has recommended the inclusion of Bexsero in the routine immunisation schedule for infants. Publically funded vaccination programmes have been initiated in Italy, and there has been widespread use of the vaccine outside of publically reimbursed programmes. Overall, >1,000,000 doses of Bexsero have been distributed in 19 countries worldwide since 2013. The emerging clinical experience with Bexsero is consistent with findings from pre-licensure clinical studies, and no new safety concerns have been identified. Additional data on length of protection, potential impact on meningococcal carriage and transmission and strain coverage have also been published and will be reviewed.

• Publisher: Elsevier Ltd,Elsevier Limited
• Subject: Allergy and Immunology / Australia / Bexsero / Brazil / children / Chile / clinical trials / college students / disease incidence / Disease Outbreaks - prevention & control / Epidemics / European Union / Humans / Immunization / Immunization Programs / industrialization / Infants / Italy / Licensure / MenB / Meningitis / Meningococcal disease / Meningococcal Infections - prevention & control / Meningococcal Vaccines - therapeutic use / morbidity / mortality / Neisseria meningitidis, Serogroup B / Outbreaks / Quebec / Serogroup / serotypes / Teenagers / United Kingdom / United States / Uruguay / vaccination / Vaccine / Vaccines / Young adults