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

BMJ Open
March 2021 – Volume 11 – 3
https://bmjopen.bmj.com/content/11/3

 

Protocol: Evaluation of the decision-making process underlying the initial off-label use of vaccines: a scoping review protocol (4 March, 2021)
Dieynaba Diallo, Caroline Quach
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.
Strengths and limitations of this study
:: Strengths of this review comprise the substantial significance of mapping the decision-making processes and methods used for off-label vaccine recommendations.
:: The use of recognised scoping review methodology.
:: A search strategy developed in collaboration with an experienced senior health research librarian.
:: Systematic screening and extraction of data independently conducted in duplicate.
:: Off-label vaccine use established practices, not published in an official form by national authorities, potentially represent a limitation for this review.