MenB (meningococcal B) vaccine


In March 2015 it was announced that all babies in the UK will soon be vaccinated against meningococcal B (MenB) disease as part of the national childhood immunisation programme after a deal was agreed between the Government and GlaxoSmithKline (GSK), the vaccine manufacturers. GSK own the MenB vaccine, Bexsero®. following acquisition of Novartis Vaccines and Diagnostics earlier the same month. 

In September 2015 UK babies born on or after 1 July 2015 will be offered the vaccine alongside their other routine immunisations and babies born on or after 1 May will be offered the vaccine as part of a one off catch-up.  

The Joint Committee on Vaccination and Immunisation (JCVI), which advises the UK government on vaccination, recommended that the MenB vaccine be offered to babies at 2, 4 and 12 months of age back in March 2014 as long as the Department of Health could obtain the vaccine at a cost effective price. Now that a price has been agreed, the Department of Health will work with GSK to secure supplies of the vaccine and arrangements will be made with GPs for implementation which is likely to be from September 2015 at the earliest.

The National Immunisation Advisory Committee (NIAC), which advises the Irish Government, have also recommended that the vaccine be made routinely available to infants as part of the Primary Childhood Immunisation Schedule ( subject to cost effectiveness) but a decision is yet to be made by the Department of Health.

Stocks of the vaccine are also available privately in the UK and Ireland, which means that people who can pay for can get it. The vaccine is also already available free of charge to people in the UK and Ireland with medical conditions that increase their risk of the disease.

Why do we need a 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 kinds of meningitis.

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 Hib, MenC and pneumococcal.

Thanks to meningitis vaccines, thousands of children are alive today who would otherwise have died from these deadly diseases.

Developing a MenB vaccine has been much more difficult – until now, protection against MenB has been a distant possibility.

Meanwhile, meningococcal meningitis and septicaemia remain the leading infectious cause of death for children under five in the UK.


How effective is this vaccine?


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. Results from the vaccine trials are very encouraging, showing that the vaccine triggers a strong immune response in infants, toddlers and adolescents[1-3]. Studies of circulating MenB strains looking at how well they match the vaccine have predicted that it will cover approximately 88% of MenB circulating in the UK[4], and 78% of MenB in Europe over all[5]. The actual proportion of cases prevented will depend on other things too, including how widely the vaccine is offered and taken up, whether it prevents the bacteria from being carried and passed on as well as protecting from disease, how long protection lasts, and whether it works sufficiently well in all age groups.

Who will be entitled to receive this vaccine free of charge in the UK?


The vaccine will be introduced into the UK routine programme for babies at 2, 4 and 12 months of age. Although the vaccine is licensed to be given to 2 month olds as 3 primary doses in infancy with 1 booster dose, the JCVI considered 2 primary doses to be sufficient based on evidence from vaccine trials.

Once the vaccination programme begins, babies who are 3 and 4 months old should also be offered the vaccine. Those aged 3 months will receive 3 doses at 3, 4 and 12 months, and those at 4 months will receive 2 doses at 4 and 12 months of age.

Babies and children who are older than 4 months by the time the vaccine is rolled out will not be offered the vaccine on the NHS. As the vaccine is not likely to be routinely available before September, it is unlikely that babies born during or before May 2015 will be eligible for this vaccine on the NHS.

MenB vaccine should be free of charge to people with medical conditions that put them at high risk of getting meningococcal disease: people with asplenia, splenic dysfunction or complement disorder, including those on Eculizumab therapy (the same groups who are entitled to get MenACWY vaccine under current guidelines, see https://www.gov.uk/government/publications/meningococcal-the-green-book-chapter-22).

The vaccine should also be offered to laboratory workers who are at risk of exposure to MenB bacteria in their job and Public Health England (PHE) has written guidance about when the vaccine should be offered to close contacts of people who get meningococcal B disease, see https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/328835/Invasive_meningococcus_secondary_case_prevention_April_2014.pdf.

Who will be entitled to receive this vaccine free of charge in Ireland?


In Ireland, the detail of NIAC’s recommendation for routine childhood immunisation has not yet been made public and a price for the vaccine is yet to be agreed.

NIAC has recommended that those with at risk medical conditions and
close contacts of confirmed cases of MenB disease in Ireland should receive the vaccine http://www.hse.ie/eng/health/immunisation/hcpinfo/guidelines/chapter13.pdf.

If everyone at risk can get the vaccine within the health service, why is it so important for it to be offered universally in national immunisation programmes?

Although medical conditions such as complement deficiency greatly increase a person’s risk of getting meningococcal disease, the vast majority of people who get MenB infection have no risk factor. Also many people who do have risk factors do not find out that they are at risk until after they get meningococcal disease.

Is the vaccine safe?

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. Almost 8,000 people, including more than 5000 infants and toddlers, have had the new MenB vaccine during clinical trials[1-3, 6-8]. Results from these trials have shown that Bexsero® has a good safety profile[9]. 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 is growing. Nearly 17,000 students in the US were vaccinated in response to an outbreak of MenB disease at Princeton University in late 2013 and the University of California, Santa Barbara in early 2014. Additionally, in the summer of 2014 over 45,000 people between 2 months to 20 years of age, were vaccinated as part of a public immunisation program in the Saguenay-Lac-St-Jean region of Quebec, Canada[10]. No serious adverse events were reported following the program and rates of fever and local reactions were similar to that of other routine immunisations.The vaccine has also been administered to nearly 4,000 students at the University of Bristol with no serious adverse events being reported. From 2013 to the time of writing (June 2015) over 1 million doses of Bexsero have been distributed in 19 countries worldwide.

Is it safe for Bexsero® to be given at the same time as other routine vaccines?


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. This is also true when the vaccine is given at the same time as hepatitis B and varicella vaccines. 

Fever is more common in babies when Bexsero® is given alongside other vaccines although taking paracetamol 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[11].

What are the active ingredients in the vaccine?

The active ingredients that equip our immune system to fight MenB bacteria include four main components of meningococcal bacteria. 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).

All of these components have been processed and inactivated and are not part of any living bacteria, but can still stimulate the immune system.

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

Are there any safety reasons not to have the vaccine? What about allergies? 

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 study[13] 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 true[14].

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.

Will this vaccine be offered to adolescents free of charge within the health service?

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 even lower than usual.

In theory, vaccinating teenagers could have benefits for the whole population, in addition to directly protecting those vaccinated. Teenagers are the main carriers of meningococcal bacteria, so if vaccinating them could prevent them from carrying the bug and passing it on, it could protect everyone, including people who aren’t vaccinated.

However, in the UK the JCVI concluded that there was not enough evidence about the extent to which the MenB vaccine would stop teenagers from carrying and transmitting the bug, nor how long vaccination would directly protect this age group. For these reasons the JCVI recommended that a carriage study should be undertaken in adolescents to show whether the vaccine could stop them acquiring the bacteria in their throats. The results from this study will help them decide whether the vaccine should be offered to all teenagers in future.

How can I get the vaccine for my child if s/he is not eligible for it free of charge within the health service?


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, http://www.bexsero.co.uk/healthcare-professional/ordering-bexsero.htm. 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 a company called Allphar Services based in Dublin. Health professionals can ring to get the vaccine on 014688456.

How much will the vaccine cost if I want to get it privately?


As a guideline, the NHS list price of the vaccine is £75 per dose excluding VAT. It is being supplied to pharmacies in Ireland at a similar price. 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®) (http://ec.europa.eu/health/documents/community-register/2013/20130114125155/anx_125155_en.pdf)


Age Group

Primary dose series 

Interval

Booster?

 2 – 5 months3No less than 1 monthYes, at 12 - 23 months
Unvaccinated infants 6 - 11 months2No less than 2 monthYes, at 12 - 23 months with an interval of at least 2 months after the last primary dose
Unvaccinated children, 12 - 23 months2No less than 2 monthYes, between 12-23 months after the last primary dose
Children, 2 - 10 years2No less than 2 monthNo need yet established
Those over 11 years2No less than 1 monthNo need yet established

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.

Why has it been so difficult to develop a MenB vaccine?

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.

Are there other MenB vaccines?

Yes. A newer MenB vaccine, Trumenba®, has been developed by Pfizer and was licensed for 10 to 25 years olds in the United States in November 2014, but it is not licensed in Europe.

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.

Why aren’t the MenB vaccines Bexsero® and Trumenba® expected to cover all cases?


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.

References

  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. Frosi G, et al., Bactericidal antibody against a representative epidemiological meningococcal serogroup B panel confirms that MATS underestimates 4CMenB vaccine strain coverage. Vaccine, 2013. Epub ahead of print.
  5. Vogel, U., et al., Predicted strain coverage of a meningococcal multicomponent vaccine (4CMenB) in Europe: a qualitative and quantitative assessment. Lancet Infect Dis, 2013. 13(5): p. 416-25.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. Novartis. Novartis vaccine Bexsero® sees high uptake in first large-scale public vaccination program to help protect against devastating meningitis B. 2014 [cited 2014 October]; Available from: http://www.novartis.com/newsroom/media-releases/en/2014/1840453.shtml.
  11. 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).
  12. 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.
  13. Erlewyn-Lajeunesse, M., et al., Anaphylaxis following single component measles and rubella immunisation. Arch Dis Child, 2008. 93(11): p. 974-5.
  14. 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.

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Further information

For more information about MenB our Freefone helpline is available 365 days a year
080 8800 3344 (UK), 1800 41 33 44 (Ireland)
email helpline@meningitis.org