Evaluation of the decision-making process underlying the initial off-label use of vaccines: a scoping review protocol

Introduction 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. Methods and analysis 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. Ethics and dissemination 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.

Automated summary

This study aims to examine the off-label assessment processes for vaccines to provide a standardized decision-making framework and analytical approach. The research will systematically identify reports and studies on off-label vaccine use in public health, with screening conducted independently by two reviewers and data extracted using a standard form.