Centre de Recherche, Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada.
Microbiology, Infectious Diseases, and Immunology, University of Montreal Faculty of Medicine, Montreal, Quebec, Canada.
BMJ Open. 2021 Mar 4;11(3):e042748. doi: 10.1136/bmjopen-2020-042748.
Vaccination has become a central part of public health prevention. Vaccines are introduced after licensure by national regulatory authorities, whereas recommendations for use of licensed vaccines are made by national or international advisory committees and may include off-label use. The methodological and decision-making processes that are used to assess novel initial off-label vaccine use are unclear. This review aims to examine the off-label assessment processes to map evidence and concepts used in the decision-making process and present a common approach between all recommendations and specifics of each decision.
The methodological framework described at the Joanna Briggs Institute will be applied to this scoping review. A search strategy was developed, in collaboration with an experienced senior health research librarian, by combining Mesgarpour's highly sensitive search strategies. Peer-reviewed and grey literature will be systematically identified using PubMed, Medline and EMBASE; governmental agency and pharmaceutical websites; and search engines, such as Google Scholar. Reports and studies on off-label vaccine use in public health will be included. Screening will be independently undertaken by two reviewers. Data will be extracted using a standard form. Results will be narratively summarised to highlight relevant findings and guide the development of an analytical framework for off-label vaccination recommendations.
This research does not require ethical approval. This scoping review will provide decision-making elements and a synthesis of knowledge on vaccines off-label use. Findings will be relevant to decision-makers/advisory committees and public health. These will be disseminated through peer-reviewed articles and conferences.
疫苗接种已成为公共卫生预防的核心部分。疫苗在获得国家监管机构许可后推出，而国家或国际咨询委员会则针对已许可疫苗的使用提出建议，其中可能包括标签外使用。用于评估新型初始标签外疫苗使用的方法学和决策过程尚不清楚。本综述旨在检查标签外评估流程，以绘制用于决策过程的证据和概念，并展示所有建议之间的共同方法和每个决策的具体内容。
将应用乔安娜·布里格斯研究所（Joanna Briggs Institute）描述的方法学框架进行本次范围综述。通过结合经验丰富的高级健康研究图书管理员，共同制定了搜索策略，使用 PubMed、Medline 和 EMBASE 系统地搜索同行评审和灰色文献；政府机构和制药公司网站；以及搜索引擎，如谷歌学术。将纳入关于公共卫生中标签外疫苗使用的报告和研究。筛选工作将由两名评审员独立进行。使用标准表格提取数据。结果将以叙述方式进行总结，以突出相关发现并指导标签外疫苗接种建议的分析框架的制定。
本研究不需要伦理批准。本次范围综述将提供有关疫苗标签外使用的决策要素和知识综合。研究结果将与决策者/咨询委员会和公共卫生相关。将通过同行评审文章和会议进行传播。
