Meningococcal Group B (MenB) vaccine

For decades, MenB has been the most common cause of bacterial meningitis in the UK and Ireland.

Vaccines are the only way to prevent meningitis and have almost eliminated some other causes of this deadly disease. Since the first meningitis vaccine was introduced against Hib meningitis in 1992, many kinds of meningitis have been reduced or have dwindled to a mere handful of cases, including meningitis caused by Hib and MenC.

Thanks to meningitis vaccines, thousands of children are alive today who would otherwise have died or been left seriously disabled from these deadly diseases. The addition of the MenB vaccine is saving even more, which is why Meningitis Research Foundation and our members have tirelessly campaigned for a MenB vaccine to be made freely available in the UK and Ireland.

MenB vaccination is available free of charge to people in the UK and Ireland with medical conditions that increase the risk of contracting MenB disease, in some circumstances when people have been in close contact with someone who was ill with MenB meningitis and/or septicaemia, and in occupations which put people at increased risk of disease.

Medical conditions

In the UK it is recommended that people with asplenia, splenic dysfunction or complement disorder, including those on Eculizumab therapy are entitled to receive the vaccine because they are at a higher risk of contracting meningococcal disease https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/554011/Green_Book_Chapter_22.pdf.

In Ireland, in addition to the conditions listed above, it is also recommended that those who are HIV positive and haematopoietic stem cell transplant and solid organ transplant candidates and recipients receive the vaccine http://www.hse.ie/eng/health/immunisation/hcpinfo/guidelines/chapter13.pdf.

Close contacts of a case of MenB disease

In Ireland, MenB vaccine is offered to close contacts when there has been a case of MenB disease. In the UK there is guidance about when the vaccine should be offered to close contacts of people who get meningococcal B disease, see https://www.gov.uk/government/publications/meningococcal-disease-guidance-on-public-health-management

Occupational risk

The vaccine should be offered to laboratory workers who are at risk of exposure to MenB bacteria in their job.

The effectiveness of a vaccine is determined by many things, including how strong an immune response it produces (its ‘immunogenicity’), and how widely it covers disease-causing strains circulating in the country. Other meningococcal vaccines against MenC and

MenACWY cover all strains of those infections. However, MenB vaccine is formulated differently and there are some non-matching MenB strains it cannot cover.

Results from the vaccine trials were very encouraging, showing that the vaccine triggers a strong immune response in infants, toddlers and adolescents[1-3]. The type of circulating strains can vary over time, however a recent study has found that the vaccine was predicted to cover 73% of strains circulating in England from 2014 to 2018[4].

The actual proportion of cases prevented will depend on other things too, including how widely the vaccine is offered and taken up, and how long protection lasts.

Uptake of the MenB vaccine in the UK is high. In 2020 around 92% of eligible UK infants completed their primary MenB vaccination course by their first birthday and 89% received their booster dose by their second birthday.

Real-world evidence following the introduction of the MenB vaccine across various settings shows it is working well. Three years after the programme was introduced to the UK, cases had declined by 75% in age groups eligible for the vaccine and the effectiveness of two doses plus a booster has been estimated to be around 71% against strains predicted to be covered by the vaccine[5]. A review of data from 7 countries with experience of widespread MenB vaccination found vaccine effectiveness ranged from 59% to 100% against circulating MenB strains [6].

The safety of routine vaccinations is rigorously monitored in the UK and no safety concerns have been raised since the vaccine was routinely introduced in September 2015

As with all drugs, vaccines can cause side effects. Vaccine side effects may include soreness/redness/swelling or hardness of skin at the injection site, fever, lack of appetite, muscle aches, irritability, sleepiness and rashes.

There was already strong safety data from clinical trials involving almost 8,000 people, including more than 5000 infants and toddlers to support the introduction of routine vaccination [1-3, 7-9]. The trials demonstrated that Bexsero® has a good safety profile[10] and a review of the data by the European Commission resulted in vaccine licensure in January 2013 on the basis of the benefits of the vaccine outweighing the risks.

Real-world experience of using Bexsero across the world also continues to grow. Since the vaccine was licensed in 2015, almost 5 million doses have been given to children in the UK [11] with no safety concerns raised [6]. Safety surveillance form other countries that have used the vaccine widely have also been consistent with the safety profile reported in clinical trials [6].

Yes. The side effects seen when Bexsero® is given with other vaccines in the routine childhood schedule are the same as those commonly seen with vaccines in general. 

Fever is more common in babies when Bexsero® is given alongside other vaccines. Taking paracetamol as soon as possible after getting vaccinated (or at the same time) reduces the likelihood and severity of fever without affecting the immune response to any of the vaccines¹². It will also reduce any pain, redness and swelling that vaccination may cause.

Liquid paracetamol should be given to babies who are being vaccinated with Bexsero® alongside other routine immunisations at 2 and 4 months of age. You should make sure that you have a supply of liquid paracetamol at home in readiness for your baby’s immunisations. 

A total of three 2.5ml doses of infant paracetamol suspension 120mg/5ml should be given. The first dose should be administered at the time of vaccination or as soon as possible afterwards. The second and third doses should be administered at 6-8 hourly intervals after the previous dose. Please note that junior paracetamol (six plus) is stronger than infant paracetamol (250/5ml) and should not be used in babies.

There is no need to give your baby paracetamol with their vaccinations at 12 months. This is because at that age the risk of fever from administering MenB vaccine with the routine immunisations is the same as when the routine immunisations are given alone. It is fine to give your 12 month old paracetamol after their vaccinations if they develop a fever or appear to be in discomfort however.

More information about giving paracetamol after immunisation with MenB alongside other routine immunisations is available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/450890/9413-paracetamol-menB-2page-A4-05-web.pdf 

The active ingredients that equip our immune system to fight MenB bacteria include four main components of meningococcal bacteria[13]. All of these components have been processed and inactivated and are not part of any living bacteria, but can still stimulate the immune system.

Three of them are proteins found on the surface of the bacteria:

• Factor H Binding Protein (fHbp)
• Neisseria Heparin Binding Antigen (NHBA)
• Neisserial Adhesin A (NadA)

These three components help meningococcal bacteria invade and survive within the human body. In vaccinated people, the immune system can recognise and ‘neutralise’ these components, so the bacteria cannot make them ill.

The final ingredient is the New Zealand MenB Vaccine (MenZB) derived from the New Zealand outbreak strain of MenB (strain NZ 98/254).

Other ingredients in the vaccine include:

• Aluminium hydroxide (the active ingredients of the vaccine are adsorbed to this to improve immunogenicity)
• Histidine (used to regulate the PH of the vaccine)
• Sodium chloride*
• Sucrose*
• Water for injections

* Used to make an isotonic solution (a solution with a similar salt concentration as cells and blood in the body)

People who have previously had an anaphylactic reaction to any of the vaccine components listed above should not get the vaccine. 

Anaphylaxis to current vaccines is very rare and is estimated to occur in one in a million doses given, although a recent study¹⁴ found no reports of anaphylaxis following more than 5 million preschool and infant immunisations over an entire year in the UK and Ireland. 

People with severe immune system problems cannot have live vaccines, but the new MenB vaccine is not live. Food allergies are not a reason to avoid vaccination, except people with egg allergies who may need to avoid some flu vaccines. People often worry that eczema, asthma, epilepsy and a family history of reactions to vaccinations are a reason to avoid vaccinations, but this is not true¹⁵.

The tip cap of the syringe may contain natural rubber latex. The risk of developing an allergic reaction is very small, but you should speak to your doctor or nurse before being vaccinated.

There is no current UK or Irish recommendation for adolescents to be vaccinated.

Typically, meningococcal disease is most common in babies and children under five, with a second peak in adolescence. However, at present the peak age for meningococcal disease is at 5 months of age, and the number of cases in adolescents is relatively low (see figure 1). Studies on cost effectiveness have concluded that incidence in this age group is too low to justify immunising adolescents on the NHS.

Figure 1: Incidence of invasive meningococcal disease in England:2010 to 2011 to 2019 to 2020. Source Health Protection Report Volume 15 Number 1

Adolescents are the main carriers of meningococcal bacteria. If the vaccine prevented carriage, then immunising this age group could reduce transmission and protect the wider community (as has been the case with the MenACWY vaccine). However, there is no evidence of any impact of the MenB vaccine on carriage of disease causing MenB bacteria.[16, 17]

Interestingly there is some evidence that the MenB vaccine provides some protection against gonorrhoea[18] If this is shown to be significant then there is a chance that the MenB vaccine could be deemed a cost effective spend of NHS funds because it prevents gonococcal disease as well as MenB disease.

If your child was born before 1 May 2015 they are not eligible to receive any vaccine doses on the NHS.

Babies are at the highest risk of contracting meningococcal disease with peak incidence occurring at around 5 months of age. This is why the vaccine is offered early at 2 and 4 months followed by a booster at 12 months.

Children older than 5 months of age are still at risk of disease, but their risk is substantially lower than that of younger babies which is why routine vaccination on the NHS is focussing on the youngest age groups (see Figure 1).

Over the past ten years, the incidence of MenB disease has been steadily declining and at the moment is lower than it has been for decades. Disease incidence prior to the COVID epidemic in the under 1s was around 9 per 100,000, reducing to 3 per 100,000 in the 1-4 age groups.[19] The incidence of disease amongst older age groups is substantially less. Measures introduced to control the spread of COVID, such as social distancing and the wearing of face-coverings has seen rates of meningococcal disease decline even further, although we are already seeing a rise in cases and we may see numbers revert back to pre-COVID as measures are lifted. MenB is a deadly and disabling disease with such a rapid onset that some parents may wish to have their child protected however small the risk of them contracting disease. MenB vaccination is available privately for parents who wish purchase it.

GPs and travel clinics throughout the UK and Ireland have been informed that the vaccine is available. Start by asking your own GP for the vaccine, as if they can provide it, this is likely to be the least costly option. GPs may not be able to offer the vaccine to their own patients, but they may be able to arrange it via another surgery on private prescription. You can also get the vaccine from a travel vaccination clinic in your area, or a private GP practice. It is worth asking more than one clinic as prices can vary considerably. 

The manufacturer has a customer service line in the UK for healthcare professionals only. GPs or other health professionals can ring to get the vaccine: 08457 451500, Mon-Thu 8am-4.45pm and Fri 8am-1pm.  The manufacturer is prohibited by law from speaking to members of the public on this line and any patients who call will be referred back to their healthcare practitioner. 

In Ireland, Bexsero® is available to order through United Drug.  Health professionals can ring to get the vaccine on 01 463 2417.  They can also email GSKvaccines@united-drug.com

As a guideline, the NHS list price of the vaccine is £75 per dose excluding VAT. GPs or clinics can set their own charges for administration – prices in excess of £125/dose are not unusual. More than one dose of the vaccine is needed for sufficient protection – the total number depends on the age of the person being vaccinated.

The table below shows the number of doses and the time intervals between doses, as recommended in the Summary of Product Characteristics (part of the licence for Bexsero®) 

The vaccine is not licensed for children under 8 weeks old because there is not enough information about how well the vaccine works in this age group.

Trumenba®, another MenB vaccine is also available privately for adults and children aged 10 and above (see ‘Are there other MenB vaccines?’ section below).

Meningitis vaccines developed up to now have been made from a fragment of the bacterial sugar coat. When we are vaccinated our immune system learns to recognise and attack this sugar as a ‘foreign invader’ by producing antibodies which help us destroy bacteria if we come into contact with one with the same sugar coat. However, the sugar coat of MenB bacteria does not trigger an immune response, because it looks like developing human cells. This means that the immune system does not recognise it as a foreign invader, and this protects it from attack. So using the sugar coat just does not work for MenB vaccine development. 

The search for a MenB vaccine has focused on other elements of the surface of MenB bacteria but it has been very difficult to find elements which are both ‘visible’ to the immune system and present in every MenB strain. Even elements that are usually present are extremely variable, so the immune response against a vaccine made from one kind of MenB may not be capable of killing all the different MenB strains. 

Yes. Another MenB vaccine, Trumenba®, has been developed by Pfizer and was licensed for 10 to 25 years olds in the United States in November 2014. Trumenba was also licensed in Europe in May 2017 for adults and children aged 10 and above.

The active ingredients in Trumenba® include two variants of Factor H Binding Protein (fHbp) which is found on the surface of meningococcal bacteria. fHbp helps the bacteria survive and go undetected in the human body. Vaccination with Trumenba® helps the immune system to recognise fHbp on the surface of invading bacteria and neutralise them before they can cause serious illness.

Trumenba® is licensed to be given in three doses with a 2 month interval between the first two doses and a 4 month interval between doses two and three. Results from seven clinical trials, which vaccinated a total of 4,282 people aged 11 to 25, have shown that the vaccine has a good safety profile. 

Real-world experience of using Trumenba® is also growing. In early 2015 there was an outbreak of MenB disease at the University of Oregon, USA. Six cases were confirmed amongst students in January to February, including one death. In response to this, a campus wide vaccination programme aiming to immunise around 24,000 students began in February 2015. 

In addition to the universal vaccines Bexsero® and Trumenba®, vaccines covering just one strain of MenB have been used successfully in New Zealand and Cuba in the past to control epidemics caused by a single strain. Our research has helped to show that neither the New Zealand or Cuban vaccines would cover the majority of MenB infection in the UK and the rest of Europe. 

It is impossible to be certain about the precise extent of coverage. Bexsero® is based on four main protein components found on the bacterial surface across most of the hundreds of different MenB strains. Trumenba® is based on 2 versions of one the same surface proteins included in Bexsero®. However, the structure of each protein can vary a lot and some bacteria have more of a particular protein on their surface than others do. The antibodies we produce after we’ve been vaccinated may not be able to recognise a protein carried on the surface of invading MenB bacteria if its structure is a bit different to the protein in the vaccine, or if there is not very much protein to latch onto. If our antibodies cannot attach to invading bacteria, our immune system will be unable to destroy them.

In the case of Bexsero® in addition to the main four protein components, other ingredients that are part of the vaccine formulation may also produce immunity. This may add to the coverage predicted for the four main vaccine components. 

Once Bexsero® is introduced in the UK, it will be very important to monitor how well it is working and how much of the disease it covers .Meningitis Research Foundation’s Meningococcal Genome Library will help this to happen.

1. Gossger, N., 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): p. 573-82.

2. Santolaya, M.E., 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. Lancet, 2012. 379(9816): p. 617-24.

3. Findlow, J., et al., Multicenter, open-label, randomized phase II controlled trial of an investigational recombinant Meningococcal serogroup B vaccine with and without outer membrane vesicles, administered in infancy. Clin Infect Dis, 2010. 51(10): p. 1127-37.

4. Lucidarme, J., et al., Invasive serogroup B meningococci in England following three years of 4CMenB vaccination - first real-world data: Meningococcal B following 4CMenB. J Infect, 2021.

5. Ladhani, S.N., et al., Vaccination of Infants with Meningococcal Group B Vaccine (4CMenB) in England. N Engl J Med, 2020. 382(4): p. 309-317.

6. Martinon-Torres, F., et al., Recent advances in meningococcal B disease prevention: real-world evidence from 4CMenB vaccination. J Infect, 2021. 83(1): p. 17-26.

7. Vesikari T et al., Immunogenicity of an investigational, multicomponent, meningococcal serogroup b vaccine in healthy infants at 2, 4, and 6 months of age., in Presented at IPNC, Sept 11-16, 2010; Banff, Canada. Poster #180.

8. Snape, M.D., et al., Immunogenicity of two investigational serogroup B meningococcal vaccines in the first year of life: a randomized comparative trial. Pediatr Infect Dis J, 2010. 29(11): p. e71-9.

9. Prymula R et al., Catch-up vaccination of healthy toddlers with an investigational multicomponent meningococcal serogroup B vaccine (4CMenB) - exploration of a two-dose schedule., in Presented at 29th ESPID Meeting, 7-11 June 2011; The Hague, The Netherlands.

10. Bai, X., J. Findlow, and R. Borrow, Recombinant protein meningococcal serogroup B vaccine combined with outer membrane vesicles. Expert Opin Biol Ther, 2011. 11(7): p. 969-85.

11. NHS. MenB vaccine overview. December 2021]; Available from: https://www.nhs.uk/conditions/vaccinations/meningitis-b-vaccine/.

12. Prymula, R., et al., A phase 2 randomized controlled trial of a multicomponent meningococcal serogroup B vaccine (I): Efects of prophylactic paracetamol on immunogenicity and reactogenicity of routine infant vaccines and 4CMenB. Hum Vaccin Immunother, 2014. 10(7).

13. Novartis. Bexsero. Summary of Product Characteristics. [cited 2014 October]; Available from: http://ec.europa.eu/health/documents/community-register/2013/20130114125155/anx_125155_en.pdf.

14. Erlewyn-Lajeunesse, M., et al., Anaphylaxis following single component measles and rubella immunisation. Arch Dis Child, 2008. 93(11): p. 974-5.

15. Department of Health. Contraindications and special considerations:the green book, chapter 6. 2013 [cited 2013 November ]; Available from: https://www.gov.uk/government/publications/contraindications-and-special-considerations-the-green-book-chapter-6.

16. McMillan, M., H.S. Marshall, and P. Richmond, 4CMenB vaccine and its role in preventing transmission and inducing herd immunity. Expert Rev Vaccines, 2021: p. 1-12.

17. Marshall, H.S., et al., Meningococcal B Vaccine and Meningococcal Carriage in Adolescents in Australia. N Engl J Med, 2020. 382(4): p. 318-327.

18. Petousis-Harris, H. and F.J. Radcliff, Exploitation of Neisseria meningitidis Group B OMV Vaccines Against N. gonorrhoeae to Inform the Development and Deployment of Effective Gonorrhea Vaccines. Front Immunol, 2019. 10: p. 683.

19. Public Health England, Heath Protection Report, Volume 13, Number 38, 29 October 2019. Invasive meningococcal disease in England: annual laboratory confirmed reports for epidemiological year 2018 to 2019