Lévy-Bruhl Daniel
Institut de Veille Sanitaire, Département des maladies infectieuses, 12, rue du Val d'Osne, 94415 Saint-Maurice Cedex, France.
Med Sci (Paris). 2007 Apr;23(4):404-8. doi: 10.1051/medsci/2007234404.
Once a new vaccine has been granted its licensing, a public health expertise is needed in order to support the decision regarding its possible inclusion within the national immunisation schedule. This analysis, based on an assessment of the benefits/risks balance and costs/effectiveness ratio, is a multidisciplinary exercise. Largely based on epidemiological and immunological expertises, it also requires bio-mathematical and economical inputs, if the long term consequences of the vaccination are to be taken into account. Indeed, the main drivers of the decision are the burden of the disease, the characteristics of the vaccine in term of effectiveness and safety, the cost of the vaccination, the feasibility of the adjunction of the vaccine in the schedule, the social demand for this vaccination and the positive or negative indirect effects of a large vaccination on the epidemiology of the disease, in addition to the direct protective effect for vaccinated individuals. New vaccines are generally characterised by a more limited epidemiological impact than older vaccines, in a context of growing requirements from our society regarding drugs, and especially vaccines, safety. Both the real and perceived benefits/risks balances for the more recent vaccines appear questionable. The possibility of detrimental epidemiological consequences of either insufficient vaccination coverage or serotype (or serogroup) replacement is another factor that makes the decision regarding vaccination strategies increasingly complex.
一旦一种新疫苗获得许可，就需要公共卫生专业知识来支持关于其是否可能被纳入国家免疫规划的决策。基于对益处/风险平衡和成本/效益比的评估进行的这种分析是一项多学科工作。如果要考虑疫苗接种的长期后果，该分析很大程度上基于流行病学和免疫学专业知识，还需要生物数学和经济学方面的投入。实际上，决策的主要驱动因素包括疾病负担、疫苗在有效性和安全性方面的特性、疫苗接种成本、将疫苗纳入规划的可行性、对该疫苗接种的社会需求以及大规模接种对疾病流行病学的正面或负面间接影响，此外还有对接种疫苗个体的直接保护作用。在我们的社会对药物，尤其是疫苗安全性的要求不断提高的背景下，新疫苗的流行病学影响通常比旧疫苗更有限。较新疫苗的实际和感知的益处/风险平衡似乎都存在问题。疫苗接种覆盖率不足或血清型（或血清群）替换可能产生有害的流行病学后果，这是另一个使疫苗接种策略决策日益复杂的因素。
