Ricciardi G W, Toumi M, Weil-Olivier C, Ruitenberg E J, Dankó D, Duru G, Picazo J, Zöllner Y, Poland G, Drummond M
European Public Health Association and Department of Public Health, Catholic University of the Sacred Heart, Rome, Italy.
University Aix-Marseille, Faculty of Medicine - Public Health, Marseilles, France.
Vaccine. 2015 Jan 1;33(1):3-11. doi: 10.1016/j.vaccine.2014.09.023. Epub 2014 Sep 23.
Vaccines are specific medicines characterized by two country-specific market access processes: (1) a recommendation by National Immunization Technical Advisory Group (NITAG), and (2) a funding policy decision.
The objective of this study was to compare and analyze NITAGs of 13 developed countries by describing vaccination committees' bodies and working processes.
Information about NITAGs bodies and working processes was searched from official sources from June 2011 to November 2012. Retrieved information was completed from relevant articles identified through a systematic literature review and by information provided by direct contact with NITAGs or parent organizations. An expert panel was also conducted to discuss, validate, and provide additional input on obtained results.
While complete information, defined as 100%, was retrieved only for the UK, at least 80% of data was retrieved for 9 countries out of the 13 selected countries. Terms of references were identified in 7 countries, and the main mission for all NITAGs was to provide advice for National immunization programs. However, these terms of references did not fully encompass all the actual missions of the NITAGs. Decision analysis frameworks were identified for 10 out of the 13, and all NITAGs considered at least four criteria for decision-making: disease burden, efficacy/effectiveness, safety and cost-effectiveness. Advices were published by most NITAGs, but few NITAGs published meeting agendas and minutes. Only the United States had open meetings.
This study supports previous findings about the disparities in NITAGs processes which could potentially explain the disparity in access to vaccinations and immunization programs across Europe. With NITAGs recommendations being used by policy decision makers for implementation and funding of vaccine programs, guidances should be well-informed and transparent to ensure National Immunization Programs' (NIP) credibility among the public and health care professionals.
疫苗是一类特殊的药物，其具有两个因国家而异的市场准入流程：（1）国家免疫技术咨询小组（NITAG）的建议，以及（2）资金政策决策。
本研究的目的是通过描述疫苗接种委员会的机构和工作流程，对13个发达国家的NITAG进行比较和分析。
2011年6月至2012年11月期间，从官方来源搜索有关NITAG机构和工作流程的信息。通过系统文献综述确定的相关文章以及与NITAG或其上级组织直接联系提供的信息，对检索到的信息进行补充。还组建了一个专家小组，对获得的结果进行讨论、验证并提供额外的意见。
虽然仅从英国获取了定义为100%的完整信息，但在所选择的13个国家中，有9个国家至少获取了80%的数据。在7个国家确定了职责范围，所有NITAG的主要任务是为国家免疫规划提供建议。然而，这些职责范围并未完全涵盖NITAG的所有实际任务。在13个国家中的10个国家确定了决策分析框架，所有NITAG在决策时至少考虑四个标准：疾病负担、疗效/有效性、安全性和成本效益。大多数NITAG发布了建议，但很少有NITAG发布会议议程和会议记录。只有美国举行公开会议。
本研究支持了先前关于NITAG流程存在差异的研究结果，这些差异可能解释了欧洲各国在疫苗接种和免疫规划获取方面的差异。由于政策决策者将NITAG的建议用于疫苗计划的实施和资金投入，因此指南应内容详实且透明，以确保国家免疫规划（NIP）在公众和医疗保健专业人员中的可信度。
