Challenges of evaluating and modelling vaccination in emerging infectious diseases
Zachary J. Madewell,
Natalie E. Dean,
Jesse A. Berlin,
Paul M. Coplan,
Kourtney J. Davis,
Claudio J. Struchiner,
M. Elizabeth Halloran
Affiliations
Zachary J. Madewell
Department of Biostatistics, University of Florida, Gainesville, FL, USA; Correspondence to: Department of Biostatistics, University of Florida, PO Box 117450, Gainesville, FL 32611, USA.
Natalie E. Dean
Department of Biostatistics, University of Florida, Gainesville, FL, USA
Jesse A. Berlin
Global Epidemiology, Johnson & Johnson, Titusville, NJ, USA
Paul M. Coplan
Medical Device Epidemiology and Real World Data Sciences, Johnson & Johnson, New Brunswick, NJ, USA; Department of Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, PA, USA
Kourtney J. Davis
Global Epidemiology, Janssen R&D, LLC, Titusville, NJ, USA
Claudio J. Struchiner
Escola de Matemática Aplicada, Fundação Getúlio Vargas, Rio de Janeiro, Brazil
M. Elizabeth Halloran
Fred Hutchinson Cancer Research Center, Seattle, WA, USA; Department of Biostatistics, University of Washington, Seattle, WA, USA
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.
