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Challenges of evaluating and modelling vaccination in emerging infectious diseases.
Madewell, Zachary J; Dean, Natalie E; Berlin, Jesse A; Coplan, Paul M; Davis, Kourtney J; Struchiner, Claudio J; Halloran, M Elizabeth.
  • Madewell ZJ; Department of Biostatistics, University of Florida, Gainesville, FL, USA. Electronic address: zmadewe@emory.edu.
  • Dean NE; Department of Biostatistics, University of Florida, Gainesville, FL, USA.
  • Berlin JA; Global Epidemiology, Johnson & Johnson, Titusville, NJ, USA.
  • Coplan PM; 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.
  • Davis KJ; Global Epidemiology, Janssen R&D, LLC, Titusville, NJ, USA.
  • Struchiner CJ; Escola de Matemática Aplicada, Fundação Getúlio Vargas, Rio de Janeiro, Brazil.
  • Halloran ME; Fred Hutchinson Cancer Research Center, Seattle, WA, USA; Department of Biostatistics, University of Washington, Seattle, WA, USA.
Epidemics ; 37: 100506, 2021 12.
Article in English | MEDLINE | ID: covidwho-1514167
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Communicable Diseases, Emerging / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans Language: English Journal: Epidemics Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Communicable Diseases, Emerging / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Humans Language: English Journal: Epidemics Year: 2021 Document Type: Article