Invasive meningococcal disease (IMD) is a rare but serious illness which usually presents as meningitis or septicaemia (or both). The disease can progress very quickly, especially in children and young adults, and may result in mortality. Survivors of IMD may go on to develop long-term issues which include hearing loss, renal failure, psychological disorders, amputation of limbs or digits, and impairment in intellectual development and memory.
There are 13 serogroups of Neisseria meningitidis, with serogroups A, B, C, W135 and Y being responsible for virtually all cases of meningococcal disease. The National Notifiable Disease Surveillance System (NNDSS) reported that the majority of IMD in Australia is caused by meningococcal B (MenB); 88% in 2009. The highest incidence of MenB disease occurs in children under four years of age, followed by a peak in adolescents aged between 15 and 19 years.
In response to meningococcal B epidemics, vaccines that target a single epidemic strain have been developed and used successfully in several countries, including New Zealand. However, they are not suitable for routine use in Australia where there are many different strains of MenB in circulation.
Bexsero® (4CMenB) is a recombinant meningococcal B vaccine containing four antigenic components. It induces the formation of bactericidal antibodies to provide protection against an estimated 76% of MenB strains in Australia.
The following doses are recommended for Bexsero®:
Infants aged two months to five months:
Three doses (0.5ml each), interval of at least one month between doses. The first dose is at two months. A booster dose is recommended at 12 to 23 months of age.
Unvaccinated infants between six months to 11 months:
Two doses (0.5ml each), interval of at least two months between doses. A booster dose is recommended in second year of life.
Unvaccinated children between 12 months to 10 years of age:
Two doses (0.5ml each), interval of at least two months between doses. The need for a booster dose has not been established.
Individual 11 years to 50 years of age:
Two doses (0.5ml each), interval of at least one month between doses. The need for a booster dose has not been established.
Bexsero® can be given with other routine vaccines, however it is not currently funded under the National Immunisations Program.
Bexsero® is recommended for use in the following groups of people due to their higher risk of IMD.
- Infants and young children (particularly those under 24 months of age)
- Adolescents aged 15 to 19 years
- Laboratory personnel who frequently handle Neisseria meningitidis
- People with medical conditions that place them at high risk of IMD e.g. asplenia and complement component disorders.
In clinical trials, fever was the most notable systemic reaction in children aged two to twelve months. The Australian Technical Advisory Group on Immunisation recommend the routine use of paracetamol in all children under two years of age who receive this vaccine. Paracetamol should be administered 30 minutes prior to vaccination or as soon as practicable afterwards, regardless of the presence of fever. This can be followed by two additional doses of paracetamol given six hours apart. In adolescents and adults, the most common adverse reactions were pain at the injection site, malaise and headache.
- Australian Government Department of Health. National Notifiable Diseases Surveillance System. Latest update: 11th March 2014.
- Australian Technical Advisory Group on Immunisation. The Australian immunisation handbook. 10th ed. Canberra: Australian Government Department of Health; 2013.
- Bexsero (meningococcal vaccine: 4CMenB) Australian approved product information. North Rye. Novartis Vaccines & Diagnostics Pty. Ltd. Approved 14th August 2013.
- Carter N. Multicomponent meningococcal serogroup B vaccine (4CMenB; Bexsero): a review of its use in primary and booster vaccination. BioDrugs 2013; 27(3): 263–274.
- Serruto D, Bottomley M, Ram S, et al. The new multicomponent vaccine against meningococcal serogroup B, 4CMenB: Immunological, functional and structural characterisation of the antigens. Vaccine 2012; 30(Suppl 2): B87-97.
- Vesikari T, Esposito S, Prymula R, Ypma E, Kohl I, Toneatto D, et al. Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials. Lancet. 2013; 381: 825-35.