Meningococcal disease is caused by the bacterium Neisseria meningitidis. At least 12 groups have been identified, including groups A, B, C, X, Y and W. The pattern of disease caused by each group varies by time and country or geographical areas. In New Zealand over 2014–2017, meningococcal group B caused around two-thirds of meningococcal disease each year, group C almost one-third and groups Y or W the remaining few cases. In 2022, group B was the prominent type causing 80% of group-identified cases, and group Y and group W made up the other cases. Meningococcal group A rarely causes disease in NZ.
Bexsero, a multicomponent recombinant vaccine against meningococcal group B disease only is available in New Zealand. Bexsero was first approved for use in Europe in 2013, since then the vaccine has been approved for use in more than 40 countries including Australia, the United Kingdom and the United States. Conjugated meningococcal vaccines that protect against either groups A, C, W and Y or group C disease only are also available in New Zealand. For best protection against all meningococcal disease in New Zealand, separate vaccinations against group B disease and groups A, C, Y and W disease are recommended.
Bexsero is broadly protective against meningococcal group B disease and is different to the MeNZB™ vaccine used in New Zealand between 2004 and 2011. The MeNZB vaccine was designed to target a specific type of meningococcal group B bacterium that only caused disease here in New Zealand. MeNZB was not meant for long term use. The vaccine was withdrawn once the rate of disease was significantly reduced. However, the active component of the MeNZB vaccine has contributed to the successful development of Bexsero.
Bexsero is funded for individuals with a medical condition that increases their risk of invasive meningococcal disease AND listed on the Pharmaceutical Schedule. Bexsero is also available as a purchased vaccine through your family doctor.
For individuals with a medical condition that increases their risk of invasive meningococcal disease AND is listed on the Pharmaceutical Schedule, the meningococcal vaccines NeisVac-C and/or Menactra are available as funded vaccines. However, these vaccines do not provide protection against meningococcal group B disease.
Meningococcal group B only vaccine:
Meningococcal A, C, Y and W conjugate vaccine:
Meningococcal C only conjugate vaccine:
Bexsero is recommend and funded for:
Bexsero is recommended but not funded for:
Bexsero and MeNZB vaccines are not interchangeable in a course of vaccines to protect against meningococcal group B disease.
The recommended dose schedule for Bexsero does not change for individuals with a history of immunisation with MeNZB vaccines. Bexsero utilises four antigen components to induce broad protection against meningococcal group B disease and is significantly different to MeNZB that utilised only one of these antigen components.
Bexsero is administered by deep intramuscular injection into the vastus lateralis in infants or deltoid in older children, adolescents and adults.
Bexsero can be administered at the same visit as other vaccines in separate syringes and at separate injection sites. When giving two intramuscular (IM) injections in the same limb in infants, the vastus lateralis is preferred because of its greater muscle mass. The injection sites should be on the long axis of the thigh and separated by at least 2 cm so that localised reactions will not overlap.
Bexsero is approved for use from 8 weeks of age, however, infants eligible to funded meningococcal vaccination and high risk of meningococcal disease can receive Bexsero from 6 weeks of age. The recommended number of Bexsero doses is determined by the age of the individual when they receive their first Bexsero vaccination. The recommended Bexsero vaccination schedules are shown in table 1.
The recommended minimum interval between doses in this age group has recently changed to 8 weeks (from 4 weeks). After an 8 week interval between doses 91–100% of children were expected to be protected from meningococcal group B disease compared with 69–100% of children after a 4 week interval. The safety and efficacy in individuals aged 50 years or over has not been established but there are no safety concerns expected.
Bexsero has an excellent safety record. The most common vaccine responses include fever and discomfort or pain around the injection site. Infants and children may also be irritable, have unusual crying or a decreased appetite, whilst adolescents and adults may experience headache, muscle or joint aches, malaise or nausea. Very rarely, a severe allergic reaction (anaphylaxis) to a component in the vaccine occurs.
Fever is part of a robust immune system response to Bexsero, usually peaking around 6 hours after vaccination and settling over 24–48 hours. A fever over 38°C is more likely to occur in infants and children aged under 2 years after vaccination with Bexsero compared with other routinely used infant vaccines. When Bexsero is administered at the same visit as other Immunisation Schedule vaccines, a fever over 38°C or 39°C is almost twice as likely as when the Immunisation Schedule vaccines are given alone.
Similarly, redness, swelling and/or mild–moderate pain around the injection site are also common expected immune responses to Bexsero, peaking on the day of vaccination followed by a significant decrease, and settling from around 24 hours after vaccination.
The advice for the use of prophylactic paracetamol for children aged under 2 years (see below) only applies to immunisation events when Bexsero is administered, either as the only vaccine or with other vaccines. This is because of the evidence of a robust immune response to Bexsero in young children and that the use of prophylactic paracetamol around fever over 39°C, and injection site pain. Some infants will still develop a fever and/or injection site pain even though they have received paracetamol doses.
Ibuprofen may be given as an alternative to paracetamol.
Other strategies that can also be used to help manage fever and injection site discomfort or pain are described below.
Bexsero should not be given to:
Immunisation generates circulating antibodies. Over time, the antibody levels decrease. The number and quality of antibodies and how long they last depend on what type of vaccine is used, the meningococcal group(s) covered by the vaccine, and the age of the person receiving the vaccine.
During clinical trials, as there are generally low numbers of meningococcal disease cases in countries such as Australia, England, Germany, New Zealand and the United States, it is not possible to determine exactly how many cases of disease are prevented by vaccination or how long protection after vaccination lasts. Instead, the immune system response and antibody levels are used as an alternative measure of how well and how long meningococcal vaccines can protect from disease.
The impact on the number of cases can indicate how well a vaccine programme performs. In the UK, the first country to introduce Bexsero to its infant immunisation programme, a 75% decline in group B disease was reported during the first three years of the programme in the vaccine-eligible age groups. Similar reductions in cases were reported Australia and Canada in vaccinated infants and adolescents.
Bexsero is expected to provide protection against disease caused by a broad range of group B meningococcal bacterium types, including the New Zealand specific type of meningococcal group B. On average in New Zealand, meningococcal group B causes more than three-quarters of meningococcal disease each year.
Table 2 shows the expected protection against group B meningococcal disease after completion of an age appropriate course of Bexsero.