Immunisation against meningococcus B: the case of Spain

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Federico Martinón-Torres commented recently (Nov 9, p 1552)1Martinón-Torres F immunisation against meningococcus B: the case of Spain.Lancet. 2013; 382: 1552-1553Summary Full Text Full Text PDF PubMed Scopus (8) Google Scholar on the proposal drawn up by the Committee on Immunisation Programmes and Registries on the use of the new vaccine against meningococcal B disease (4CMenB vaccine) in Spain.2Limia A Navarro-Alonso JA Vázquez J Cano R Salmerón F Vaccine against invasive meningococcal disease by serogroup B and its use in Public Health, June 2013 (in Spanish).http://www.msssi.gob.es/profesionales/saludPublica/prevPromocion/vacunaciones/docs/MenB.pdfGoogle Scholar As the main contributors to this report,2Limia A Navarro-Alonso JA Vázquez J Cano R Salmerón F Vaccine against invasive meningococcal disease by serogroup B and its use in Public Health, June 2013 (in Spanish).http://www.msssi.gob.es/profesionales/saludPublica/prevPromocion/vacunaciones/docs/MenB.pdfGoogle Scholar we would like to express some concerns. First, from a public health perspective, the 4CMenB vaccine is surrounded by several uncertainties regarding safety, clinical effectiveness, and laboratory surveillance and monitoring, which, together with the decreasing trend in the incidence of invasive meningococcal B disease in Spain, warrant a cautious decision regarding the use of this vaccine in a routine programme at present and reserving it for specific high-risk situations (such as outbreaks) and for immunosuppressed patients. Second, an economic analysis was not done taking into consideration that the main variables (such as vaccine price, effectiveness, vaccination schedule, effect of fever rates after immunisation on parental acceptability, effect on acquisition of carriage, and duration of protection, are currently unknown. The data and the analyses included in the report2Limia A Navarro-Alonso JA Vázquez J Cano R Salmerón F Vaccine against invasive meningococcal disease by serogroup B and its use in Public Health, June 2013 (in Spanish).http://www.msssi.gob.es/profesionales/saludPublica/prevPromocion/vacunaciones/docs/MenB.pdfGoogle Scholar took more than a year to complete and were not done in a hasty way as Martinón-Torres suggests. In addition, the framework for assessment of new vaccines in Spain3Committee on Immunisation Programmes and RegistriesCriteria for the assessment of changes in the immunisation programme in Spain (in Spanish).http://www.msssi.gob.es/ciudadanos/proteccionSalud/vacunaciones/docs/Criterios_ProgramaVacunas.pdfGoogle Scholar advises taking the economic analysis into consideration (step 3 in the mentioned framework) after criteria such as burden of disease, efficacy, and safety of vaccine (in step 1), effect of the introduction of the vaccine in the immunisation programme and ethical aspects (in step 2)—have been assessed.3Committee on Immunisation Programmes and RegistriesCriteria for the assessment of changes in the immunisation programme in Spain (in Spanish).http://www.msssi.gob.es/ciudadanos/proteccionSalud/vacunaciones/docs/Criterios_ProgramaVacunas.pdfGoogle Scholar Third, although the vaccines against meningococcal diseases serogroup B and serogroup C are completely different, Martinón-Torres compares the epidemiological situation of both diseases at the time of authorisation of each vaccine and considers these similar. However, the evaluation done in September, 2000, showed an incidence rate for disease by serogroup C during the 1999–2000 season of 1·01 per 100 000 (404 cases), whereas the incidence rate for disease by serogroup B in the 2011–12 season was about half of that: 0·52 per 100 000 (240 cases).2Limia A Navarro-Alonso JA Vázquez J Cano R Salmerón F Vaccine against invasive meningococcal disease by serogroup B and its use in Public Health, June 2013 (in Spanish).http://www.msssi.gob.es/profesionales/saludPublica/prevPromocion/vacunaciones/docs/MenB.pdfGoogle Scholar, 4Committee on Immunisation Programmes and RegistriesCurrent situation of meningococcal disease in Spain. Modification of immunisation schedule against meningococcus C, October 2005 (in Spanish).http://www.murciasalud.es/recursos/ficheros/82833-Informe_Enf._Meningococica_y_recuerdos._Abril_2006.pdfGoogle Scholar In conclusion, we would like to emphasise that public health decisions regarding the inclusion of a vaccine into the National Immunisation Programme should be made not on emotional and rapid considerations, but only after an in-depth assessment of all epidemiological data and available information concerning the vaccine in the first place; other criteria should be considered afterwards. We declare we have no conflict of interest. Immunisation against meningococcus B: the case of Spain4CMenB vaccine (Bexsero, Novartis Vaccines and Diagnostics, Siena, Italy) was buried before birth in Spain, as it was in the UK.1 Despite the approval by the European Medical Agency, the Spanish Agency on Drugs and Health Products (AEMPS) decided to restrict the use of this vaccine to hospital use only—whatever that means—until they established specific recommendations for its use.2 AEMPS's report was released 2 months later, and restricted the indication to the control of potential local serogroup B outbreaks, and stated that the vaccine will not be included in the national immunisation programme until other regions or countries start to use it and provide effectiveness data. Full-Text PDF