Alternatives provided by recent system modelling in animal health for the upscaling of vaccine efficacy to the population level Hans-Hermann Thulke
Field trials On purpose
Vaccine efficacy (VE) • Specific ability of the biological product to produce the result for which it is offered when used under the conditions recommended by the manufacturer
Knight-Jones et al 2014. Veterinary and human vaccine evaluation methods. Proc. R. Soc. B 281: 20132839
VE = 1 – R vaccinated / R unvaccinated (measure of condition or disease) Knight-Jones et al 2014. Veterinary and human vaccine evaluation methods. Proc. R. Soc. B 281: 20132839
Field trials On alternative
System modelling as pseudo field trials Details of transmission and immune response
Brosig et al.(2012).Transboundary & Emerging Diseases, 2006.
Restriction compliance 80%
Field trials On arguments
Endpoints of claimed efficacy Endpoints for vaccine application correlated with prevention or reduction of – Infection/Susceptibility – Disease/adverse effect
Individual animal characteristic, challenge experiments, min max of titre
– Transmission – Infectiousness
Multiple animal characteristic, contact experiments, range of titre
– spread – persistence
Population characteristic, Field trials under programme conditions / sufficient transmission data + model-based upscaling
Quantified efficacy supports
Design, Planning, Budgeting and Monitoring of intervention programmes
Who is responsible for inadequate efficacy revealed in the field post authorisation?
Summary • One fits all answer = field trial based quantification of efficacy needed • Conditional request = consideration of – Claim – Quality of laboratory data – Needs and benefits of possible programmes
Alternatives provided by recent system modelling in animal health for ...
system modelling in animal health for the upscaling of vaccine efficacy to the population level. Hans-Hermann Thulke. Page 2. Field trials. On purpose. Page 3 ...
system modelling in animal health for the upscaling of ... System modelling as pseudo field trials. Epidemiologic model ... Quantified efficacy supports. Design,.
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