Editorial article
Meningococcal disease: Can we predict the unpredictable?
Enfermedad meningocócica: ¿podemos predecir lo impredecible?
a Servicio de Pediatría, Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain
b Grupo de Genética, Vacunas, Infecciones y Pediatría, Instituto de Investigación Sanitaria de Santiago, Universidad de Santiago de Compostela, Santiago de Compostela, Spain
c Servicio de Medicina Preventiva y Epidemiología, Hospital Clinic - Universidad de Barcelona - ISGlobal
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"tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "20" "paginaFinal" => "22" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "Federico Martinón-Torres, Antoni Trilla" "autores" => array:2 [ 0 => array:4 [ "nombre" => "Federico" "apellidos" => "Martinón-Torres" "email" => array:1 [ 0 => "federico.martinon.torres@sergas.es" ] "referencia" => array:3 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] 2 => array:2 [ "etiqueta" => "*" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "Antoni" "apellidos" => "Trilla" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] ] ] ] "afiliaciones" => array:3 [ 0 => array:3 [ "entidad" => "Servicio de Pediatría, Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Grupo de Genética, Vacunas, Infecciones y Pediatría, Instituto de Investigación Sanitaria de Santiago, Universidad de Santiago de Compostela, Santiago de Compostela, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Servicio de Medicina Preventiva y Epidemiología, Hospital Clinic - Universidad de Barcelona - ISGlobal" "etiqueta" => "c" "identificador" => "aff0015" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Enfermedad meningocócica: ¿podemos predecir lo impredecible?" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">By using vaccinations, we can prevent all forms of invasive meningococcal disease, an epidemiologically unpredictable infection, which sometimes occurs as epidemic outbreaks, whose fatality rates in recent decades have not changed, killing one in ten affected patients (mortality rate in Spain: 12.7 %, 2017–2018) and which can have serious and disabling consequences for survivors (amputations, deafness, neurological deficits) in a percentage that is never lower than 10 %, and which can reach up to 30 %.<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1–3</span></a> Meningococcal disease carries a significant and often underestimated burden of disease, which includes psychological sequela for the patient and their families; the financial costs of required assistance and rehabilitation; the expenses of managing a public health crisis that each case may involve, and the costs arising from possible complaints by those affected, among others.<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> We also do not take into account the cost of ‘fear of disease’: How many consultations to the health system are made “in case its meningitis”? How many complementary tests, empirical treatments, or observation admissions do healthcare professionals prescribe in case the patient could have a meningococcal disease?<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> A careful assessment of these aspects may find a balance in the decision-making process of whether to include a vaccine in the schedule, as occurred in the United Kingdom, a country that initially decided not to include the serogroup B meningococcal vaccine and that subsequently reversed that decision, becoming the first country to systematically vaccinate all infants against meningococcus.<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> This is in significant contrast with a recent report by the Spanish Ministry of Health, which once again relied on the efficiency criterion to reject the inclusion of the meningococcal B vaccine in the Spanish universal schedule, using cost-effectiveness calculations that were criticised in 2013 because they were thought of as insufficient<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> and which remain obsolete today, considering the new data available on this vaccine.<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1,6,7</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Spain has significant problems with meningococcal disease: 1) serogroup B, which is the cause of the majority of cases occurring today and throughout the last decade, and that is still the main strain, despite being partially controlled by individual and optional private vaccination, and 2) the increase in serogroups W and Y, in particular the 2013 UK variant of serogroup W, a hypervirulent strain with a lethality close to 30 %, which is wreaking havoc in the EU and already circulating in Spain with a rapid increase in the number of cases.<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">To a large extent, we are conditioned by what the British dictate in regards to the prevention of meningococcal disease, as the United Kingdom is pioneer in the introduction of new meningococcal vaccines in the schedule. Despite the data that this country provides on the effectiveness of vaccinations against meningococcus B, the interpretation that the Spanish health authorities have made so far is different: they have not only not included the vaccine against meningococcus B in the vaccination schedule, a decision that could be understood if only the criterion of ‘classical’ efficiency is considered, but, surprisingly, they question the vaccine itself. Preliminary data from the United Kingdom showed - within 10 months of starting the vaccination campaign – a 50 % impact on the vaccinated cohort but not on the other age groups, with an estimated vaccine effectiveness of close to 90 %, although with wide confidence intervals.<a class="elsevierStyleCrossRefs" href="#bib0040"><span class="elsevierStyleSup">8,9</span></a> In the programme's third year, the decrease in cases was 60 %, with an effectiveness of 70 % against any meningococcus B and 88 % against type B meningococci that express antigens contained in the vaccine. Because meningococcal disease has a low incidence rate and it has a vaccine coverage that is greater than 90 %, estimating vaccination effectiveness and whether that value is statistically significant is difficult, especially since the unvaccinated population numbers are so low. In this context, measuring the vaccine impact (the actual reduction in cases of the disease, which is what really matters in terms of public health) is much more indicative. Thus, the United Kingdom estimates that it has prevented no less than 250 cases since it included the meningococcal B vaccine on the schedule three years ago.<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> In Spain, the National Network for Epidemiological Surveillance registered a greater reduction than expected in cases of meningococcus B since the vaccine was made available, attributable to the vaccine coverage achieved despite not being financed by National Health System.<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> Spain could estimate the effectiveness of the vaccine against meningococcus B, since approximately half the infants that receive the vaccine do so through private health insurance and the other half have not been vaccinated. This is an important figure, but to calculate it, all the autonomous regions would have to be coordinated simultaneously.</p><p id="par0020" class="elsevierStylePara elsevierViewall">The British experience leaves no room for any speculation about the safety of the meningococcal B vaccine, analysing more than three million children vaccinated.<a class="elsevierStyleCrossRefs" href="#bib0050"><span class="elsevierStyleSup">10–12</span></a> The greater reactogenicity of the vaccine when co-administered with routine vaccines in infants has not had a significant impact on the health system, where it is the general practitioner who sees children, nor on the acceptance of the vaccine by the population. Spanish paediatricians use it, and a lot, without any significant problems. Even so, there are still aspects related to the meningococcal B vaccine that we do not fully understand, such as its effect on carriers or what the real duration of clinical protection is,<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a> both issues of added value but not necessary conditions of usefulness.</p><p id="par0025" class="elsevierStylePara elsevierViewall">With regard to serogroups W and Y, Spain's Interterritorial Council recently decided (March 2019) to start vaccination with the quadrivalent meningococcal ACWY-CRM conjugate vaccine, replacing the adolescent dose of the meningococcal C and accompanying that measure with a vaccination rescue plan which must include six cohorts (up to 18 years) in 2–3 years.<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> This is a significant measure similar to the one initiated by the United Kingdom in 2015, and which seems to be working well, according to the impact observed three years later (50 cases prevented), and this despite the difficulties of reaching high coverage in a population that is difficult to access, as is the adolescent group.<a class="elsevierStyleCrossRefs" href="#bib0050"><span class="elsevierStyleSup">10,14</span></a> However, certain nuances must be mentioned: Will we be able to develop this measure in Spain simultaneously in all autonomous communities and reach a high level of coverage to control the disease through the extensive and maintained vaccination of adolescents, the main reservoir of the disease? Do all autonomous communities really have the resources to carry out rescue vaccination in a coordinated manner, essential for that measure to be successful in the short-medium term? Can we prevent cases in infants produced by a strain that has special attraction to this age?</p><p id="par0030" class="elsevierStylePara elsevierViewall">The time between the first autonomous community to vaccinate against ACWY (Castilla y León, January 2019) and the others (Asturias, Valencia and Madrid, June 2019) will be six months, with the deadline to start vaccinating being the entire 2020. We still do not know when and how the rescue plan will begin. Meanwhile, cases of meningococcal W disease have doubled over the past year, and that upward trend remains and has increased during 2019.</p><p id="par0035" class="elsevierStylePara elsevierViewall">And what about infants? Stating that in Spain there are few cases of meningococcal serogroup W disease in infants, a group where the incidence rate is maximum, is true but misleading: the British speculate that the decrease observed in cases of serogroup W disease in young children (aged 1–4) is most likely due to the cross-protection that the meningococcal B vaccine provides and not so much the indirect effect of the ACWY reservoir vaccination, which has only begun to be observed at all ages after four years of vaccination and the once the rescue plan was completed. This statement is based on the presence of the meningococcal B vaccine antigens that are common to the circulating British strain W, and that the impact observed in young children and adolescents is not initially recorded in other ages. With Spain's current real coverage, the meningococcal B vaccine could also have this effect and thus explain why the number of cases in infants has not increased so significantly. In any case, the data from the meningococcal B vaccine leave no room for scepticism, we can no longer put off or argue against its inclusion on the vaccination schedule by claiming insufficient data on the one hand, and on the other accept the expected benefits ‘of class’, in terms of the effect that the ACWY vaccine can have on carriers of serogroups W and Y, even though direct evidence in this regard is still limited.<a class="elsevierStyleCrossRefs" href="#bib0075"><span class="elsevierStyleSup">15–17</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">If we were forced to choose, the Dutch option of vaccination against ACWY would be the most preferable and perhaps the most realistic in a country with autonomous regions such as Spain, with a public health system whose decision-making authority and administration is slow. Following this option, adolescents would be vaccinated for a medium-term control of the disease, but direct immediate protection of infants would also be carried out, where the incidence of serogroup W is higher and in which indirect protection will take years to be noticed.<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">18</span></a> Moreover, we could speculate that by acting on the meningococcal reservoir in infants – less than in the adolescent group, but not negligible – we could also reduce the number of cases in the elderly: Spain's social reality means that many of these infants and children’s caregivers’ are their grandparents, so it seems very likely that children are the elderly's main source of contagion.</p><p id="par0045" class="elsevierStylePara elsevierViewall">Meningococcal disease is unpredictable, both epidemiologically and clinically. We know that not everyone is equally vulnerable to the disease<a class="elsevierStyleCrossRefs" href="#bib0095"><span class="elsevierStyleSup">19,20</span></a> but we are not yet able to use this information to guide a individualised preventive or therapeutic strategy. The only way to control and reduce meningococcal disease is through the systematic vaccination of the population, i.e. including vaccines in the schedule. In this context, the pressure exerted by epidemiological, social, expert, scientific societies and pharmaceutical laboratories opinion, and now also by the active election campaign itself, act as catalysts in the decision-making process. Regardless of any other connotation, Castilla y León has made the most complete, determined and administrative commitment to end the meningococcal disease in its autonomous community, by adopting a vaccination schedule that is even better than the British one, and that includes the protection of infants against meningococcus B and ACWY, in addition to vaccination against ACWY in adolescents.</p><p id="par0050" class="elsevierStylePara elsevierViewall">The fact is that in Spain, and in Europe – where the income levels and the quality of the health systems are high – the majority of children (fortunately few in absolute terms) who have been admitted or died as a result of a serious infection have done so due to causes that could have been prevented by vaccination, and that deserves reflection.<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">21</span></a> The investment in vaccines in the Spanish health budget as a whole is proportionally very low (0.4 % of total public health expenditure), a fact that suggests a lack of perspective in assessing the role of vaccines as a medium- and long-term health instrument by those who manage health resources.<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> This might be an excellent opportunity to rethink the current decision-making process in reference to vaccines in Spain, acknowledging the work done until now, but working towards the future without presumptions or acrimony, strengthening a unique, modern, agile and accepted vaccination schedule in solidarity with everyone. The British model (<span class="elsevierStyleItalic">Joint Committee on Vaccination and Immunisation</span>) is a good reference.<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">22</span></a> The <span class="elsevierStyleItalic">Joint Committee on Vaccination and Immunisation</span> is an independent Committee that advises the British Government, endowed with an excellent Code of Good Practice, a degree of transparency and an inclusiveness of all the different actors involved in all its processes that is remarkable. In the specific case of the meningococcal B vaccine, the <span class="elsevierStyleItalic">Joint Committee on Vaccination and Immunisation</span> was able to go beyond counting deaths and disabilities in a timely manner and considered all other costs and evidence in a balanced manner. The British Government accepted its recommendation and was able to arrive at an excellent economic agreement on the price of the vaccine with the producing laboratory.</p><p id="par0055" class="elsevierStylePara elsevierViewall">Analysing the Spanish reality in its context, we believe that there are lessons to be learned from the past, and that we now have the opportunity to better, more effectively and equitably protect our entire population, not only against what is already inevitable, but also against what might emerge from a disease that is as unpredictable and potentially serious as meningococcal disease.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflict of interest</span><p id="par0060" class="elsevierStylePara elsevierViewall">FMT has received fees as a consultant/advisor and/or speaker from Pfizer, GlaxoSmithKline, Sanofi Pasteur MSD, Merck, Sanofi Pasteur, Novartis, Novavax, and Seqirus, and has participated as a researcher in research studies and/or clinical trials with vaccines for Pfizer, GlaxoSmithKline, Sanofi Pasteur MSD, Merck, Sanofi Pasteur, Novartis, Novavax, Regeneron, Seqirus and MedImmune Inc., the funds from which were paid to his institution.</p><p id="par0065" class="elsevierStylePara elsevierViewall">AT has received fees as a consultant/advisor and/or speaker from GlaxoSmithKline, MSD, Sanofi Pasteur and Seqirus, and has participated as a researcher in clinical trials with vaccines for Pfizer, GlaxoSmithKline, Sanofi Pasteur and MSD, the funds from which were paid to his institution.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Conflict of interest" ] 1 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Martinón-Torres F, Trilla A. 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