Bexsero

Other brands:

Meningococcal group B only vaccine

• None

Meningococcal A, C, Y and W conjugate vaccine:

• Menactra^®
• Nimenrix^®

Meningococcal C only conjugate vaccine:

• NeisVac-C^®

Vaccine type: Subunit protein vaccine

Schedule and administration

Bexsero is recommend and funded for:

• Individuals who have previously had meningococcal disease of any group
• Close contacts of a meningococcal disease case of any group
• Individuals pre/post-splenectomy or with functional asplenia
• HIV positive individuals
• Individuals with a complement deficiency
• Pre/post-solid organ transplantation
• Following stem cell/bone marrow transplantation
• Pre- and post-immunosuppression that will be/is for longer than 28 days

Bexsero is recommended but not funded for:

• Other infants and young children aged under 5 years, adolescents and young adults.
  • Particularly adolescents and young adults living in close proximity to each other, e.g. boarding school, university halls of residence or in long-term institutional care
• Travellers to high-risk countries and Hajj pilgrims
• Laboratory workers regularly exposed to meningococcal cultures

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.

Storage and preparation

• Bexsero is provided as a 0.5mL suspension in a pre-filled syringe in a single-dose pack.
• During storage, a fine off-white deposit may form in the syringe. Shake the vaccine well before use to ensure the ingredients are evenly distributed within the vaccine.
• Store the vaccine as per the cold chain between 2°C to 8°C. Protect from light. 

Administration

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 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.

^¥Interval between Bexsero doses for children aged ≥2 years to ≤10 years

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.

Vaccine safety

Bexsero was first licensed in Europe in 2013 and is now licensed in over 40 countries including England and Australia. 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 and local vaccine responses

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.

Recommendation for use of prophylactic paracetamol

The advice for the use of prophylactic paracetamol for children aged under 2 years (refer to box 1) 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. 

Non-pharmaceutical management of fever or injection site pain

Other strategies that can also be used to help manage fever and injection site discomfort or pain are described in box 2.

Bexsero should not be given to:

• Anyone with severe allergy (anaphylaxis) to a previous dose of the vaccine or any component of the vaccine
• Administration of Bexsero should be postponed in individuals suffering from a fever over 38°C.
  • The presence of a minor infection is not a reason to delay immunisation.

Specialist advice should be sought for the following groups:

• Those with bleeding disorders, such as haemophilia. The vaccine should be administered in accordance with the haematologist’s instructions

Vaccine effectiveness

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. 

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. 

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 around  two-thirds 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.