A new MenB (meningococcal B) vaccine

The first ever MenB vaccine against meningitis and septicaemia designed to cover different strains of meningococcal B infection around the world, has become a licensed product. This is wonderful news for our member families, and for doctors and scientists alike who have worked tirelessly against this devastating disease.

The vaccine will be licensed for anyone over 2 months of age.

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 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.

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.

Have there been other MenB vaccines?

Vaccines covering just one strain of MenB have been used successfully in New Zealand and Cuba to control epidemics in those countries caused by particular MenB strains. Our research has helped to show that neither of these vaccines would cover the majority of MenB infection in the UK and the rest of Europe. This new MenB vaccine is the first one designed to cover different strains of meningococcal B infection around the world.

What does vaccine licensure mean?

Getting the vaccine licensed by the European Commission is the first big step towards making it available in Europe. It can now be sold as a product and it can be considered by governments in the UK and Ireland for inclusion in immunisation programmes. This takes time, so even once a vaccine is licensed it could be months or even years before it is introduced. For example, pneumococcal vaccine was not introduced in the UK and Ireland until five years after it was licensed in Europe. We hope that a decision will be made in 2013 to introduce the vaccine promptly, and MRF will be campaigning to ensure that introduction happens as quickly as possible.

How do governments decide whether to introduce a new vaccine?

In the UK, advice to government health departments comes from the Joint Committee on Vaccination and Immunisation (JCVI), and in Ireland it comes from the National Immunisation Advisory Committee (NIAC). The JCVI has been officially considering this vaccine since the Meningococcal Sub-committee first met in February 2011. There is a legal obligation on the Secretary of State for Health in England to ensure recommendations from the JCVI on new vaccines for the national programme are implemented if he or she has asked JCVI for advice and the programme is shown to be cost-effective.

Evidence from a range of sources is considered including information on the burden of disease, the likely impact of the vaccine, and the safety of the vaccine, as well as cost-effectiveness. MRF members have been campaigning to ensure that cost-effectiveness is assessed fairly and accurately.

If JCVI and NIAC recommend the vaccine, will it be introduced right away?

After JCVI recommends a vaccine in the UK, the Department of Health negotiates with the vaccine company to establish a price and details of vaccine supply. The Department of Health also has to negotiate with the Treasury to fund the vaccination programme. Once the funding is secure, there are further negotiations to arrange for the vaccine to be administered either in GP surgeries, schools, or other settings depending on which age groups the vaccine is offered to. Similarly, in Ireland, once a new vaccine has been recommended by NIAC, the Department of Health and Children negotiates with the vaccine company, and then secures funding from the Department of Finance. The National Immunisation Office can then work with colleagues in the Primary Care Directorate of the Health Service Executive to implement the recommended programme in the community.

How effective will this vaccine be?

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 73% of MenB circulating in the UK ⁴, and 78% of MenB in Europe over all. 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 equally well in all age groups.

This means that the new MenB vaccine is unlikely to be able to prevent all cases, and there are other causes of meningitis and septicaemia for which no vaccine is available, so even after it is introduced to the routine schedule it will still be important to know the symptoms.

Why isn’t coverage of MenB predicted to be 100%?

It is impossible to be certain about the precise extent of coverage. The MenB vaccine is based on four main protein components found on the bacterial surface across most of the hundreds of different MenB strains. However, the structure of each protein can vary a lot and some bugs have more of a particular protein on their surface than other bugs do. The antibodies we produce after we’ve been vaccinated may not be able to attach very well to a protein carried on the surface of an invading MenB bug 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 an invading bug, our immune system will be unable to destroy it.

However, in addition to these 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.

What are these active ingredients in the vaccines?

The active ingredients of the vaccine that equip our immune system to fight MenB bacteria include four main components (that is why scientific publications refer to it as 4CMenB). The first three 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 of the bacteria are all involved in helping the bacteria to 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).

Will my child be entitled to the vaccine?

If the JCVI and NIAC recommend introducing the vaccine into childhood immunisation programmes in the UK and Ireland, they will also advise on the most effective immunisation strategy (what age groups will be immunised). These decisions will be made by considering scientific evidence on how well the vaccine works in different age groups, and alongside existing vaccines in the routine schedule, whether vaccination prevents the bacteria from being passed on, and the impact that the vaccine will have on overall disease incidence.

Can the vaccine be given alongside other childhood vaccines?

Yes, there is evidence that it produces an immune response whether it is given alone or at the same time as the other childhood vaccines, and whether given at 2,3, and 4 months of age (as in the UK immunisation schedule) or at 2,4, and 6 months of age (as in the Irish schedule)¹. It is likely that for full protection, babies will need three injections plus a booster at or after 12 months of age. However, decisions about who will be offered the vaccine and the timing of injections will be made after licensure and recommendations by the advisory bodies (JCVI and NIAC).

Is the vaccine safe?

As with all drugs, vaccines can cause side effects. Vaccine side effects may include soreness at the injection site, and sometimes fever, lack of appetite, muscle aches, irritability and rashes. Over 7,500 people, including more than 5000 infants and toddlers, have had the new MenB vaccine during clinical trials^1-3,5-7, and the side effects are the usual ones we expect with any of the current childhood vaccines.⁸

Could this be the end of meningitis?

This vaccine is a tremendous step forward and could have a major impact on MenB, but it is unlikely to prevent all cases. This is why Meningitis Research Foundation continues to fund the development of future MenB vaccines, as well as research that will tell us what impact this vaccine is having. We hope this will bring us closer to achieving a world free from meningitis and septicaemia.

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. Boccadifuoco G, e.a., Presented at: Meningitis and Septicaemia in Children and Adults 2011 (Organized by Meningitis Research Foundation); 8–9 November 2011; London, UK. Poster V36.
5. Vesikari T et al., Immunogenicity of an investigational, multicomponent, meningococcal serogroup b vaccine in healthy infants at 2, 4, and 6 months of age, Presented at IPNC, Sept 11-16, 2010; Banff, Canada. Poster #180.
6. 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.
7. 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.
8. 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.