Advice for immunisation providers regarding the use of Bexsero® – a recombinant multicomponent meningococcal B vaccine (4CMenB)

Summary clinical advice

• In Australia, the Therapeutic Goods Administration (TGA) included 4CMenB on the Australian Register of Therapeutic Goods on 14 August 2013. The vaccine is registered for use in persons ≥2 months of age for the prevention of invasive disease caused by serogroup B meningococci. It is available through purchase on the private market. This vaccine is not funded under the National Immunisation Program (NIP).
• Children aged <5 years, particularly infants aged <1 year, have the highest incidence of invasive meningococcal disease (IMD) caused by serogroup B meningococci (MenB). A lower, secondary peak in incidence is evident in late adolescence and early adulthood.
• Bexsero® (4CMenB) is a recombinant multicomponent meningococcal B vaccine that induces specific bactericidal antibodies against a range of MenB strains. In Australia, based on laboratory tests, about 76% of MenB strains are predicted to be covered by this vaccine, but clinical effectiveness has not yet been shown.
• MenB IMD cannot be prevented by the other meningococcal vaccines currently available in Australia, such as the meningococcal C conjugate and quadrivalent (A, C, W135, Y) vaccines, because they target other meningococcal serogroups.
• Based on their higher disease risk, 4CMenB is recommended for these groups:
• Infants and young children, particularly those aged <24 months
• Adolescents aged 15 to 19 years
• Children and adults with medical conditions that place them at a high risk of IMD, such as functional or anatomical asplenia or complement component disorders
• Laboratory personnel who frequently handle Neisseria meningitidis.
• For infants aged <6 months, 3 primary doses of 4CMenB plus a booster at age 12 months are recommended. Fewer doses are required for older age groups.
• 4CMenB may be given to infants at the same time as other infant vaccines that are given under the NIP, but must be given at a separate injection site. The 1st dose of 4CMenB may be administered as early as 6 weeks of age to align with the NIP infant schedule.
• In clinical trials, injection site and systemic reactions were very common in children after receiving 4CMenB. Fever was the most notable systemic reaction in children aged 2 to 12 months. Among infants, systemic reactions, including fever and high fever, were more common following 4CMenB when it was given concurrently with other vaccines commonly given to infants, compared to when 4CMenB and other routine vaccines were given separately.
• ATAGI recommends the prophylactic use of paracetamol with every dose of 4CMenB administered to children <2 years of age, to reduce the probability and severity of fever that may develop following immunisation with 4CMenB. The 1st dose of paracetamol (15 mg/kg per dose) is recommended within the 30 minute period prior to vaccination or as soon as practicable afterwards, regardless of the presence of fever. This can be followed by 2 more doses of paracetamol given 6 hours apart.