Alternative title: Bexsero

A joint statement between The Royal Children’s Hospital and Monash Children’s Hospital Immunisation Services June 2014

A Meningococcal B vaccine is now available on the private market (BexseroTM, Novartis). It is the first ever vaccine registered for the prevention of serogroup B meningococcal disease. This 4-valent vaccine [4CMenB] was licensed for use by the Therapeutic Goods Administration (TGA) in November 2013. The Australian Technical Advisory Group on Immunisation (ATAGI) provided advice regarding use of the vaccine in March 2014.(1)

What is the evidence for using the vaccine?

The vaccine has been administered to thousands of children and adolescents in clinical trials, with a robust immune response produced to the primary course and ‘booster’ doses.(2-5) Similar immune responses for previous meningococcal vaccines (against different serogroups), have been shown to be protective, and it is hoped the 4CMenB vaccine immune responses will provide protection against Meningococcal serogroup B (Men B) disease. The vaccine has not yet been introduced onto any National Immunisation Program (NIP), so the impact on invasive meningococcal disease cases is still not known. Men B disease, currently accounts for approximately 85% of invasive meningococcal disease in Australia. This is partly due to the very successful Meningococcal serogroup C conjugate vaccine program, which has led to a dramatic reduction in Meningococcal serogroup C disease over the past 10 years. The Men C vaccine is still given to all infants at 1-year of age on the Australian NIP.

Who is the 4cMenB vaccine recommended for?

The ATAGI position statement(1) includes recommending the use of 4CMenB vaccine in groups that have the highest risk of disease:

  • Infants < 2-years
  • Adolescents 15-19 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

Recommended vaccine schedule (number primary doses + booster by age)

  • Dosage 4cMenB: 0.5ml intramuscular (IM)
  • Infants < 6 month: 3 doses (2-months apart) + 1 booster*
  • 6 to 11 months: 2 doses + 1 booster*
  • > 12 months: 2 doses (2-months apart)

*Booster dose to be administered > 12 months of age, minimum of 2-months since the last 4CMenB dose

Vaccine safety

One of side effects noted in the clinical trials was high fever rates in children < 2-years of age. This effect was increased when the 4CMenB vaccine was co-administered with other vaccines. The BexseroTM product information and the ATAGI advice recommend include the use of paracetamol in children @ the time of vaccination.(1) The RCH & Monash Immunisation services position is that paracetamol should be administered to all children < 4 years of age as per the specifications below.

Paracetamol advice

The RCH and Monash Immunisation services recommend the use of paracetamol with every dose of 4CMenB given to children < 4-years of age, to reduce the likelihood and severity of fever that may occur after immunisation with 4CMenB. The first dose of paracetamol (15 mg/kg per dose) should be given in the 30 minutes before vaccination, or as soon as possible after immunisation, even if children do not have a fever. This should be followed by 2 more doses of paracetamol given 4 to 6 hours apart.

Co administration with other vaccines:

Consider giving the 4CMenB vaccine at a separate time to other vaccines (minimum of 3 days) to reduce the risk of fever in children < 4-years of age, however, avoid delaying routine funded vaccines in infants < 12-months of age.

Is the vaccine funded? How much does it cost?

The vaccine is currently available only on the private market, at a cost of approximately $150.00 per dose. The vaccine requires a script to be written out by a medical practitioner.

An application has been made to the Australian Pharmaceutical Benefits Advisory Committee (PBAC), to consider including the 4CMenB vaccine in the funded National Immunisation Program.

Children who attend RCH or Monash Children’s Hospital (MCH) who have a high-risk medical condition (asplenia or complement deficiency) may be eligible for funded* 4CMenB vaccination. Please discuss this with your doctor if you have one of these conditions. For more information, see the RCH/MCH Asplenia guideline or contact us.

Meningococcal B vaccine position statement summary

  • The RCH & MCH Immunisation Services support the use of the Meningococcal B vaccine (4CMenB) as detailed in the March 2014 ATAGI recommendations(1)
  • The vaccine is recommended for:
    • Infants < 2-years of age
    • Adolescents 15-19 years
    • Infants, children and adolescents with asplenia or complement deficiency
  • We recommend paracetamol be given at the time of the 4CMenB vaccine for all children < 4-years of age
    • The 1st dose of paracetamol (15 mg/kg per dose) should be given in the 30 minutes before vaccination or as soon as possible afterwards, even if children do not have a fever
    • This should be followed by 2 more doses of paracetamol, given 4 to 6 hours apart

*Please note: There will be vaccine handling/administration fee payable at the pharmacy (discounts available for concession or healthcare card holders)

References

  1. (ATAGI) ATAGoI. Advice for immunisation providers regarding the use of Bexsero®. 2014 [cited 2014 1st June]; Available from: http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/atagi-advice-bexsero – full
  2. Gossger N, Snape MD, Yu L-M, Finn A, Bona G, Esposito S, et al. Immunogenicity and Tolerability of Recombinant Serogroup B Meningococcal Vaccine Administered With or Without Routine Infant Vaccinations According to Different Immunization Schedules. JAMA: The Journal of the American Medical Association. 2012 February 8, 2012;307(6):573-82.
  3. 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. The Lancet. 2013;381(9869):825-35.
  4. Snape MD, Saroey P, John TM, Robinson H, Kelly S, Gossger N, et al. Persistence of bactericidal antibodies following early infant vaccination with a serogroup B meningococcal vaccine and immunogenicity of a preschool booster dose. Can Med Assoc J. 2013 October 15, 2013;185(15):E715-E24.
  5. Santolaya ME, O’Ryan ML, Valenzuela MT, Prado V, Vergara R, MuÒoz A, et al. Immunogenicity and tolerability of a multicomponent meningococcal serogroup B (4CMenB) vaccine in healthy adolescents in Chile: a phase 2b/3 randomised, observer-blind, placebo-controlled study. The Lancet. 2012;379(9816):617-24.
Reviewed by: Nigel Crawford (Paediatrician, The Royal Children’s Hospital, Melbourne)
Date: July 2014
Materials in this section are updated as new information and vaccines become available. The Melbourne Vaccine Education Centre (MVEC) staff regularly reviews materials for accuracy.
You should not consider the information in this site to be specific, professional medical advice for your personal health or for your family’s personal health. For medical concerns, including decisions about vaccinations, medications and other treatments, you should always consult a healthcare professional.

 



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