Gessner Bradford D, Feikin Daniel R
Agence de Médecine Preventive, 164 Rue de Vaugirard, 75015 Paris, France.
International Vaccine Access Center, Department of International Health, Johns Hopkins School of Public Health, Baltimore, MD, USA; Division of Preparedness and Emerging Infections, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.
Vaccine. 2014 May 30;32(26):3133-8. doi: 10.1016/j.vaccine.2014.04.019. Epub 2014 Apr 13.
Traditionally, vaccines have been evaluated in clinical trials that establish vaccine efficacy (VE) against etiology-confirmed disease outcomes, a measure important for licensure. Yet, VE does not reflect a vaccine's public health impact because it does not account for relative disease incidence. An additional measure that more directly establishes a vaccine's public health value is the vaccine preventable disease incidence (VPDI), which is the incidence of disease preventable by vaccine in a given context. We describe how VE and VPDI can vary, sometimes in inverse directions, across disease outcomes and vaccinated populations. We provide examples of how VPDI can be used to reveal the relative public health impact of vaccines in developing countries, which can be masked by focus on VE alone. We recommend that VPDI be incorporated along with VE into the analytic plans of vaccine trials, as well as decisions by funders, ministries of health, and regulatory authorities.
传统上，疫苗是在临床试验中进行评估的，这些试验确定疫苗针对病因确诊的疾病结局的效力（VE），这是疫苗获批的一项重要指标。然而，效力并不能反映疫苗对公共卫生的影响，因为它没有考虑相对疾病发病率。另一个更直接确定疫苗公共卫生价值的指标是疫苗可预防疾病发病率（VPDI），即在特定情况下可通过疫苗预防的疾病发病率。我们描述了效力和疫苗可预防疾病发病率如何因疾病结局和接种人群的不同而有所变化，有时甚至呈相反方向。我们提供了一些例子，说明疫苗可预防疾病发病率如何用于揭示疫苗在发展中国家的相对公共卫生影响，而这种影响可能会因仅关注效力而被掩盖。我们建议在疫苗试验的分析计划以及资助者、卫生部和监管机构的决策中，将疫苗可预防疾病发病率与效力结合起来考虑。
