Other brands:
Meningococcal group B only vaccine
Meningococcal A, C, Y and W conjugate vaccine:
Meningococcal C only conjugate vaccine:
Vaccine type: Subunit protein vaccine
Schedule and administration
Bexsero® is not funded in New Zealand but is available for purchase.
Bexsero is recommended but not funded for individuals at increased risk of infection with or exposure to group B meningococcal bacteria including:
- Individuals pre/post-splenectomy or with functional asplenia
- HIV positive individuals
- Individuals with inherited or acquired complement deficiency
- Pre/post-solid organ transplantation
- Following stem cell/bone marrow transplantation
- Prior to immunosuppression for longer than 28 days
- 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
Special groups
Bexsero is not funded for any special groups.
Catch-up doses
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. 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.
Table 1: Bexsero vaccination schedules
|
|---|
| Age when Bexsero first dose given |
Number and timing of doses |
Infants ≥8 weeks
to ≤11 months |
– 2 doses separated by 8 weeks plus
– Booster dose aged ≥12 months or a minimum of 6 months after second dose, whichever is later. |
| Children 12–23 months |
– 2 doses separated by 8 weeks
– The need for a booster dose has not yet been established |
Children ≥2 years
to ≤10 years |
– 2 doses separated by a minimum of 4 weeks¥
– The need for a booster dose has not yet been established |
Adolescents and adults ≥11 years
to ≤50 years |
– 2 doses separated by 4 weeks
– The need for a booster dose has not yet been established |
¥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 from 8 weeks to 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.
Parents may choose for their child to have an interval of more than 4 weeks between their two Bexsero doses.
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.
Box 1: Use of prophylactic paracetamol in children aged under 2 years to help manage post-Bexsero fever
|
|---|
|
Note: This advice only applies to immunisation events when Bexsero is administered, either as the only vaccine or with other vaccines.
Prophylactic paracetamol use is recommended with every dose of Bexsero in children aged under 2 years:
- Three doses of paracetamol (15mg/kg) are recommended with 6 hours between each dose, whether the child has a fever or not:
- The first dose administered 30 minutes prior to Bexsero
- If the first paracetamol dose has not been given before the child is vaccinated, administer the dose at the time of vaccination
- The second paracetamol dose is given 6 hours after the first dose, the third dose is given a further 6 hours later.
- If the infant or child is sleeping when the second or third paracetamol dose is due:
- It is not necessary to wake the child
- The dose can be given when the child wakes up as long as it is at least 6 hours since the previous dose was given
- Ensure parents:
- Have the 120mg/5mL paracetamol strength formulation
- The doctor can provide a prescription for them to fill at the pharmacy
- Measure the paracetamol dose using a measuring spoon or syringe
- If the child is miserable or distressed because of a fever or injection site pain 6 hours after the third dose of paracetamol and is otherwise well:
- The parent can continue to administer the paracetamol doses with a minimum of 6 hours between doses until the discomfort resolves or 48 hours after vaccination, whichever occurs first
- No more than four doses of paracetamol can be given in a 24-hour period
- A child who is miserable or distressed because of a fever or injection site pain 48 hours or more after vaccination is advised to be seen by their doctor
|
Box 2: Other strategies to help manage fever or injection site discomfort or pain
|
|---|
|
If the child has a fever
- Give lots of breastfeeds or fluids
- Undress them to a single layer
- Make sure the room is not too hot or too cold
- Give lots of cuddles
If the child has injection site discomfort or pain
- Do not rub the injection site
- Hold a cool damp cloth or an ice pack well wrapped in a dry cloth on the injection site
- Give lots of cuddles
|
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.
Table 2: Expected protection against meningococcal disease after vaccination with Bexsero
|
|---|
| Age group |
Expected protection |
| Under 2 years |
63–100% |
| 2–3 years |
97–100% |
| 4–10 years |
72–100% |
| Adolescents |
99–100% |
| Adults |
91–100% |
| Duration of protection |
|
| Under 5 years |
1–3 years |
| Older children, adolescents and adults |
Not yet established |
