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. 2021 Dec:37:100506.
doi: 10.1016/j.epidem.2021.100506. Epub 2021 Oct 5.

Challenges of evaluating and modelling vaccination in emerging infectious diseases

Zachary J Madewell  1 , Natalie E Dean  2 , Jesse A Berlin  3 , Paul M Coplan  4 , Kourtney J Davis  5 , Claudio J Struchiner  6 , M Elizabeth Halloran  7
Affiliations

Challenges of evaluating and modelling vaccination in emerging infectious diseases

Zachary J Madewell et al. Epidemics. 2021 Dec.

Abstract

Outbreaks of emerging pathogens pose unique methodological and practical challenges for the design, implementation, and evaluation of vaccine efficacy trials. Lessons learned from COVID-19 highlight the need for innovative and flexible study design and application to quickly identify promising candidate vaccines. Trial design strategies should be tailored to the dynamics of the specific pathogen, location of the outbreak, and vaccine prototypes, within the regional socioeconomic constraints. Mathematical and statistical models can assist investigators in designing infectious disease clinical trials. We introduce key challenges for planning, evaluating, and modelling vaccine efficacy trials for emerging pathogens.

Keywords: Efficacy trial; Emerging infectious diseases; Mathematical modelling; Preventive vaccines.

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Conflict of interest statement

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: The work was funded by National Institutes of Health grants R01 AI139761 (Natalie E. Dean, M. Elizabeth Halloran, Zachary J. Madewell) and R37 AI032042 (M. Elizabeth Halloran). The content is solely the responsibility of the authors and does not necessarily represent the views of NIH. Claudio J. Struchiner was partially funded by CNPq and FAPERJ. Jesse A. Berlin and Paul M. Coplan are full-time employees of and shareholders in Johnson & Johnson. Kourtney J. Davis is a full-time employee of and shareholder in Janssen.

Figures

Fig. 1
Fig. 1
Evaluation of vaccine efficacy.
See this image and copyright information in PMC

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