Bexsero is recommend and funded for:

• Children between 3months-12months; catch up for 13 month to 59 month olds available until 31 August 2025 - including tamariki who were aged under 5 years on 1 March 2023 who have since turned 5 years old
• Young adults 13 to 25 year olds entering within the next three months, or currently in their first year of specified close living situations
• Catch up programme for young adults 13 to 25 year olds living in specified, close living situation (until 28 Feb 2024)
• 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:

• Travellers to high-risk countries and Hajj pilgrims
• Laboratory workers regularly exposed to meningococcal cultures

If MeNZB has been used previously

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 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 is 8 weeks (however, a 4 week interval can be accepted if clinically indicated). 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 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 (using 120mg/5ml solution) 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:

• 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.

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.

Table 2:  Expected protection against meningococcal disease after vaccination with Bexsero

• Das RR, Panigrahi I, Naik SS. The effect of prophylactic antipyretic administration on post-vaccination adverse reactions and antibody response in children: A systematic review. PLoS One. 2014;9(9):e106629.
• Fact sheet: Meningococcal vaccines for Australians [Internet]. Sydney: National Centre for Immunisation Research and Surveillance (NCIRS) [updated 2020 June; cited 2020 September 28]. Available from: http://www.ncirs.org.au/ncirs-fact-sheets-faqs/meningococcal-vaccines-australians
• Flacco ME, Manzoli L, Rosso A, Marzuillo C, Bergamini M, Stefanati A, et al. Immunogenicity and safety of the multicomponent meningococcal B vaccine (4CMenB) in children and adolescents: A systematic review and meta-analysis. Lancet Infect Dis. 2018;18(4):461-72.
• Gossger N, Snape MD, Yu LM, 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: A randomized controlled trial. JAMA. 2012;307(6):573-82.
• Hong E, Terrade A, Taha M-K. Immunogenicity and safety among laboratory workers vaccinated with Bexsero vaccine. Hum Vaccin Immunother. 2017;13(3):645-8.
• Institute of Environmental Science and Research Ltd. Notifiable diseases in New Zealand: Annual report 2016. Porirua: Institute of Environmental Science and Research Ltd (ESR); 2017. Report No.: FW17028.
• Institute of Environmental Science and Research Ltd. New Zealand public health Surveillance report March 2018. Wellington: Institute of Environmental Science and Research Ltd (ESR); 2018.
• Institute of Environmental Science and Research Ltd. Invasive meningococcal disease report 3 April 2019. Porirua: Institute of Environmental Science and Research Ltd (ESR); 2019.
• Iro MA, Snape MD, Voysey M, Jawad S, Finn A, Heath PT, et al. Persistence of bactericidal antibodies following booster vaccination with 4CMenB at 12, 18 or 24 months and immunogenicity of a fifth dose administered at 4 years of age - A phase 3 extension to a randomised controlled trial. Vaccine. 2017;35(2):395-402.
• Jackson C, Yarwood J, Saliba V, Bedford H. UK parents’ attitudes towards meningococcal group B (MenB) vaccination: A qualitative analysis. BMJ open. 2017;7(4):e012851.
• Kimura A, Toneatto D, Kleinschmidt A, Wang H, Dull P. Immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine and a quadrivalent meningococcal CRM197 conjugate vaccine against serogroups A, C, W-135, and Y in adults who are at increased risk for occupational exposure to meningococcal isolates. Clin Vaccine Immunol. 2011;18(3):483-6.
• Lopez L, Sherwood J. The epidemiology of meningococcal disease in New Zealand 2013. Wellington: Institute of Environmental Science and Research Ltd (ESR), (2014) FW14023.
• Martinon-Torres F, Safadi MAP, Martinez AC, Marquez PI, Torres JCT, Weckx LY, et al. Reduced schedules of 4CMenB vaccine in infants and catch-up series in children: Immunogenicity and safety results from a randomised open-label phase 3b trial. Vaccine. 2017;35(28):3548-57.
• Martinon-Torres F, Carmona Martinez A, Simko R, Marquez PI, Arimany J-L, Gimenez-Sanchez F, et al. Antibody persistence and booster responses 24-36 months after different 4CMenB vaccination schedules in infants and children: A randomised trial. J Infect. 2018;76(3):258-69.
• Medsafe. New Zealand data sheet: Bexsero [Internet]. Wellington: New Zealand Medicines and Medical Devices Safety Authority; 2018 [updated 2020 March 31; cited 2021 August 13]. Available from: https://medsafe.govt.nz/profs/Datasheet/b/bexseroinj.pdf
• Ministry of Health. Immunisation handbook [Internet]. Wellington: Ministry of Health; 2020 [updated 2021 June 23; cited 2021 August 13]. Available from: https://www.health.govt.nz/publication/immunisation-handbook-2020
• Parikh SR, Andrews NJ, Beebeejaun K, Campbell H, Ribeiro S, Ward C, et al. Effectiveness and impact of a reduced infant schedule of 4CMenB vaccine against group B meningococcal disease in England: A national observational cohort study. Lancet. 2016;388(10061):2775-82.
• PHARMAC. Community Pharmaceutical Schedule [Internet]. Wellington:PHARMAC. 2021 [cited 13 August 2021]. Available from: https://pharmac.govt.nz/pharmaceutical-schedule/community-section-b/
• Prymula R, Siegrist CA, Chlibek R, Zemlickova H, Vackova M, Smetana J, et al. Effect of prophylactic paracetamol administration at time of vaccination on febrile reactions and antibody responses in children: Two open-label, randomised controlled trials. Lancet. 2009;374:1339-50.
• Prymula R, Habib A, François N, Borys D, Schuerman L. Immunological memory and nasopharyngeal carriage in 4-year-old children previously primed and boosted with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) with or without concomitant prophylactic paracetamol. Vaccine. 2013;31(16):2080-8.
• Prymula R, Esposito S, Zuccotti GV, Xie F, Toneatto D, Kohl I, et al. A phase 2 randomized controlled trial of a multicomponent meningococcal serogroup B vaccine (I): Effects of prophylactic paracetamol on immunogenicity and reactogenicity of routine infant vaccines and 4CMenB. Hum Vaccin Immunother. 2014;10(7):1993-2004.
• The UK immunisation schedule [Internet]. Oxford: Oxford Vaccine Group. [updated 2020 August 12; cited 2020 September 28]. Available from: http://vk.ovg.ox.ac.uk/uk-schedule
• 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(9869):825-35.
• Watson PS, Turner DPJ. Clinical experience with the meningococcal B vaccine, Bexsero: Prospects for reducing the burden of meningococcal serogroup B disease. Vaccine. 2016;34(7):875-80.
• Wysocki J, Center KJ, Brzostek J, Majda-Stanislawska E, Szymanski H, Szenborn L, et al. A randomized study of fever prophylaxis and the immunogenicity of routine pediatric vaccinations. Vaccine. 2017;35(15):1926-35.
• Deceuninck G, Lefebvre B, Tsang R, Betala-Belinga JF, De Serres G, De Wals P. Impact of a mass vaccination campaign against Serogroup B meningococcal disease in the Saguenay-Lac-Saint-Jean region of Quebec four years after its launch. Vaccine. 2019;37(31):4243-5
• Lucidarme J, Bai X, Lekshmi A, Clark SA, Willerton L, Ribeiro S, et al. Invasive serogroup B meningococci in England following three years of 4CMenB vaccination – First real-world data. Journal of Infection. 2022;84(2):136-44.10
• McMillan M, Wang B, Koehler AP, Sullivan TR, Marshall HS. Impact of meningococcal B vaccine on invasive meningococcal disease in adolescents. Clinical Infectious Diseases. 2021;73(1):e233-e7