Meningococcal Group B (MenB) vaccine

MenB is one of the most common causes of life-threatening bacterial meningitis in the UKand Ireland.

Vaccines are the only way to prevent meningitis and have almost eliminated some othercauses of this deadly disease. Since the first meningitis vaccine was introduced against Hibmeningitis in 1992, many kinds of meningitis have been reduced or have dwindled to a merehandful 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 has saved even more.

MenB vaccination is available free of charge to people in the UK and Ireland with medicalconditions that increase the risk of contracting MenB disease, in some circumstances whenpeople have been in close contact with someone who was ill with MenB meningitis and/orsepticaemia, 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 complementdisorder, including those on Eculizumab therapy are entitled to receive the vaccine because they are at a higher risk of contracting meningococcal diseasehttps://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 whoare HIV positive and haematopoietic stem cell transplant and solid organ transplantcandidates 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 MenBdisease. In the UK there is guidance about when the vaccine should be offered to closecontacts 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 MenBbacteria in their job.

The effectiveness of a vaccine is determined by many things, including how strong animmune 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 astrong immune response in infants, toddlers and adolescents[1-3]. The type of circulatingstrains can vary over time, however research 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.

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 becovered by the vaccine[5]. A review of data from 7 countries with experience of widespreadMenB vaccination found vaccine effectiveness ranged from 59% to 100% against circulatingMenB 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. Safety surveillance from countries that have used the vaccine widely have been consistent with the safety profile reported in clinical trials [6].

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 vaccines[12]. It will also reduce any pain, redness and swelling that vaccination may cause.

More information about giving paracetamol after immunisation with MenB alongside otherroutine 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 humanbody. 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 NewZealand 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 toimprove immunogenicity)
• Histidine (used to regulate the PH of the vaccine)
• Sodium chloride
• Sucrose
• Water for injections

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 asecond peak in adolescence. Studies on cost effectiveness have concluded that incidencein the adolescent age group is too low to justify immunising adolescents on the NHS

Figure 1: Incidence of invasive meningococcal disease in England:2012/13 to 2021/22. Source UKHSA

If your child was born before 1 May 2015 and they are not considered to be at increased risk of disease for medical reasons they are not eligible to receive any vaccine doses on the NHS.

At the time the MenB vaccine was introduced, the peak incidence of disease was 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.

Over the past ten years, the incidence of MenB disease has been steadily declining. Cases reached an all-time low between July 2020 and June 2021 when measures introduced to stop the spread of COVID, such as social distancing and the wearing of face-coverings, led to even fewer cases of meningococcal disease. After the measures were lifted however, cases started to increase. The increase was rapid in adolescents particularly amongst university students. Despite this, incidence in the adolescent age group is not currently considered to be high enough to justify providing a vaccine for this age group free of charge on the NHS.

MenB is a deadly and disabling disease with such a rapid onset that some parents may wish to have their child protected even if the risk of them contracting disease is low. MenB vaccination is available privately for parents who wish purchase it.

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 wecome 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 onestrain 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.

Now that Bexsero® has been introduced in the UK, it is very important to monitor how well it is working and how much of the disease it covers. Meningitis Research Foundation’s Meningococcal Genome Library is supporting this happening. https://www.meningitis.org/our-work/action-and-support/mrf-meningococcus-genome-library

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