Challenges of evaluating and modelling vaccination in emerging infectious diseases

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


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.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • COVID-19*
  • Communicable Diseases, Emerging* / epidemiology
  • Communicable Diseases, Emerging* / prevention & control
  • Humans
  • SARS-CoV-2
  • Vaccination
  • Vaccine Efficacy