BEXSERO

What it is

BEXSERO is a multicomponent Meningococcal group B vaccine presented as a suspension for injection in a pre-filled syringe containing purified recombinant meningococcal protein antigens expressed in E. coli and outer membrane vesicles derived from N. meningitidis group B. Each 0.5 mL dose contains four active components: Neisseria Heparin Binding Antigen fusion protein (50 micrograms), Neisseria Adhesin A protein (50 micrograms), Factor H Binding Protein fusion protein (50 micrograms), and outer membrane vesicles from N. meningitidis group B strain NZ98/254 measured as 25 micrograms of total protein. Bactericidal antibodies directed against components of the bacterium protect against Invasive Meningococcal Disease.

Approved indications —

Active immunisation against invasive disease caused by N. meningitidis group B strains. BEXSERO is indicated for vaccination of individuals from 2 months of age and older.

Dosing overview

Dosing varies by age group. Infants aged 2 to 5 months receive a primary series of two or three doses of 0.5 mL with an interval of 1 to 2 months between doses, followed by a booster dose in the second year of life (12 months or later) with an interval of at least 6 months after the primary series. Infants aged 6 to 11 months receive two doses of 0.5 mL with an interval of at least 2 months, followed by a booster dose in the second year of life with an interval of at least 2 months after the primary series. Toddlers aged 12 to 23 months receive two doses of 0.5 mL with an interval of at least 2 months, followed by a booster dose with an interval of 12 to 23 months after the primary series. Children aged 2 to 10 years receive two doses of 0.5 mL with an interval of at least 1 month; the need for a booster dose has not been established but should be considered in individuals at continued risk based on official recommendations. Adolescents and adults from 11 years of age receive two doses of 0.5 mL with an interval of at least 1 month; the need for a booster dose has not been established but should be considered in individuals at continued risk based on official recommendations.

Key safety warnings

Safety and efficacy in infants less than 8 weeks of age has not yet been established. Safety and efficacy in individuals above 50 years of age have not been established.

PBS listing

BEXSERO is listed on the National Immunisation Program (NIP) for routine immunisation of Aboriginal and Torres Strait Islander children and individuals with medical conditions, with PBAC endorsing an extension of the NIP listing and supporting a change to an ongoing, routine catch-up program in May 2023.

Regulatory history

BEXSERO was first registered on the ARTG on 14 August 2013 in two variant presentations: a 0.5 mL pre-filled syringe without needle (ARTG 190718) and a 0.5 mL pre-filled syringe with needle (ARTG 190719). The AusPAR approval date was 9 August 2013, for active immunisation against invasive disease caused by N. meningitidis group B strains in individuals from 2 months of age and older. In November 2019, PBAC recommended listing on the NIP for Aboriginal and Torres Strait Islander children and individuals with medical conditions, with the vaccine not recommended for the broader infant and adolescent population at that time. In May 2023, PBAC endorsed extending the NIP listing and supported a change to an ongoing, routine catch-up program.