England and Scotland are first to implement a national vaccination programme: but who will follow?
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On June 21st 2015, an announcement was made by the Department of Health and the UK Public Health Minister that the Meningococcal B (MenB) vaccine, will be offered to babies at 2, 4 and 12 months of age in England and Scotland, from September 1st, 2015 (1). All 17- and 18-year-olds will be offered a combined vaccine against meningococcal strains A, C, W and Y (1).
Meningococcal meningitis and septicaemia occur as a result of a systemic bacterial infection by Neisseria meningitidis. Although the MenB vaccine has been available for several years, this national childhood immunisation programme for meningococcal B infection is the first of its kind in the world.
There has been active campaigning for this vaccination programme by patient groups and by the Meningitis Research Foundation (2). As yet, no other country has implemented a national immunisation programme for Meningococcal B infection.
Babies born in England and Scotland on or after 1st July 2015 will be offered the MenB vaccine, Bexsero® along with their other routine immunisations, as described in the NHS Vaccination Schedule (3).
Meningococcal classification is done according to the characteristics of the bacterial polysaccharide capsule, or by the sequence type (ST). Of the 12 identified capsular groups, groups B, C, W and Y are the most common in the UK (3,4). Since the introduction of a routine Meningococcal C conjugate vaccination programme, cases of group C Meningococcal infections have reduced. Group B Meningococcal infections now account for more than 80% of cases in the UK (3,4).
Meningococci are Gram-negative bacteria (diplococci) and are common commensals of the human nasopharynx. Between 5% and 11% of adults and up to 25 % of adolescents carry the bacteria without any signs or symptoms. Transmission is by droplet or aerosol spread, or by direct contact (3,4).
Meningococcal meningitis and septicaemia are most common in babies and children under five, with a second peak in adolescence. The peak age for meningococcal disease is 5 months of age. In the year 2011 to 2012, there were 613 laboratory-confirmed cases of meningitis B infection and 33 deaths (4). One in ten patients who survive meningococcal meningitis will have major physical and/or neurological disability.
Teenagers are common carriers of these bacteria, so vaccinating teenagers is believed to have benefits for the whole population, as well as protecting those vaccinated (5). So, from 1st September 2015, all 17- and 18-year-olds will be offered a combined vaccine that protects them from the four strains of Meningococcus A, C, W and Y (MenACWY). The MenACWY vaccine will be offered to students starting university this year.
MenB vaccine, Bexsero®, was licensed for use in Europe in January 2013, despite the absence of data to support an assessment of its clinical effectiveness and cost-effectiveness (6). There have been extensive reviews of the health and cost benefits of MenB vaccine over several years, but these have not been convincing either in terms of clinical effectiveness or cost-effectiveness.
In the UK, the Joint Committee on Vaccination and Immunisation (JCVI) have a key role in advising the government regarding vaccination (7). Following the approval of Bexsero®, during 2013 and 2014 the JCVI continued to state that there was insufficient evidence that the protection offered by the vaccine would protect children enough to justify a routine vaccination programme (8,9,10). This decision by JCVI was made despite data from a randomised controlled clinical trial of MenB vaccine, published in the Lancet in 2013 (11). In support of this decision, it was also noted that the numbers of children infected with Meningococcus B and C were falling (4).
The MenB vaccine, Bexsero®, has previously been available privately in the UK and Ireland and is used worldwide during small outbreaks of meningitis B in schools and colleges, for example. The vaccine is already freely available to those with medical conditions that may increase the risk of Meningococcal infection, including asplenia, splenic dysfunction, complement deficiencies and those patients treated with the monoclonal antibody Eculizumab (Soliris®) (4). The MenB vaccine, Bexsero®, is offered to laboratory workers who may be at risk of exposure to Meningococcus B. Public Health England provides guidance regarding the use of the vaccine in those who have been in contact with Meningococcal B infection (5).
In March 2015, GlaxoSmithKline (GSK) acquired Novartis Vaccines and Diagnostics, and now market the MenB vaccine, Bexsero® (12). From March 2015, the Department of Health agreed a price with GSK for the vaccine; this was a key turning point in the decision to implement the immunisation programme this year and was widely reported by the general media (13). This decision was made and announced in advance of the UK General Election held in May 2015 (13).
It is still unclear how much this vaccination programme will cost the NHS, not just in terms of the cost of the vaccine, but also the cost of staffing and administration. Although England and Scotland will be implementing a Meningococcal B vaccination programme from September 1st, and Ireland and Wales may follow, it seems unlikely that Europe and the rest of the world will follow.
If you would like to comment on any of the issues raised by this article, particularly from your own experience or insight, Healthcare-Arena would welcome your views.
(1) Department of Health news. New programmes to protect against meningitis and septicaemia. Published June 21, 2015. https://www.gov.uk/government/news/new-programmes-to-protect-against-meningitis-and-septicaemia Accessed June 26, 2015
(2) Meningitis Research Foundation website. http://www.meningitis.org Accessed June 26, 2015
(3) NHS vaccination schedule website. http://www.nhs.uk/conditions/vaccinations/pages/vaccination-schedule-age-checklist.aspx Accessed June 26, 2015
(3) NHS Choices. Meningitis website. http://www.nhs.uk/conditions/Meningitis/Pages/Introduction.aspx Accessed June 26, 2015
(4) The Green Book. Chapter 22. Meningococcal Meningitis and Septicaemia. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/302904/Green_Book_Chapter_22_v2_5.pdf Accessed June 26, 2015
(5) Ladhani SN, Corderry R, Mandal S et al. Preventing secondary cases of invasive meningococcal capsular group B (MenB) disease: benefits of offering vaccination in addition to antibiotic chemoprophylaxis to close contacts of cases in the household, educational setting, clusters and the wider community. (Version 1.1, Dated 01 April 2014). https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/328835/Invasive_meningococcus_secondary_case_prevention_April_2014.pdf Accessed June 26, 2015
(6) European Medicine Agency (EMA). Medicinal Product Information. Bexsero suspension for injection in pre-filled syringe Meningococcal group B Vaccine (rDNA, component, adsorbed). http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002333/WC500137881.pdf Accessed June 26, 2015
(7) Joint Committee on Vaccination and Immunisation (JCVI) website. https://www.gov.uk/government/groups/joint-committee-on-vaccination-and-immunisation Accessed June 26, 2015
(8) JCVI interim position statement on use of Bexsero meningococcal B vaccine in the UK. July 2013. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/224896/JCVI_interim_statement_on_meningococcal_B_vaccination_for_web.pdf Accessed June 26, 2015
(9) Editorial. Meningitis Vaccine: Moral Maize. The Guardian. July 24, 2013, http://www.theguardian.com/commentisfree/2013/jul/24/meningitis-vaccine-moral-maze-editorial Accessed June 26, 2015
(10) Boseley S. Meningitris B Vaccine Rejected by UK. July 24, 2014. http://www.theguardian.com/society/2013/jul/24/meningitis-b-vaccine-rejected-uk Accessed June 26, 2015
(11) Vesikari T, Esposito S, Prymula R, 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): 825-835. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)61961-8/fulltext Accessed June 26, 2015
(12) GlaxoSmithKline (GSK) Pre-Quarterly Results Communication Q1 2015. On 2 March 2015 GSK completed the major three-part transaction with Novartis. March 2015. https://www.gsk.com/media/628161/q1-2015-pre-announcement-aide-memoire.pdf Accessed June 26, 2015
(13) Little A. Every baby to be vaccinated against meningitis B in world first protection programme. The Express. March 29, 2015. http://www.express.co.uk/news/uk/567144/British-babies-vaccinated-against-meningitis-B Accessed June 26, 2015