Risk Modelling for Vaccination: a Risk Assessment Perspective

摘要

Any risk assessment involves a number of steps. First, the risk manager, in close liaison with the risk assessor, should identify the question of interest. Then, the hazards associated with each risk question should be identified. Only then can the risks themselves be assessed. Several questions may reasonably be asked about the risk associated with avian influenza vaccines and their use. Some apply to any vaccine, while others are specific to avian influenza. Risks may occur during manufacture and during use. Some concern the vaccines themselves, while others address the effect of failure on disease control. The hazards associated with each risk question are then identified. These may be technical errors in design, development or production, such as contamination or failure to inactivate appropriately. They may relate to the biological properties of the pathogens themselves displayed during manufacture or use, for example, reversion to virulence, shedding or not being the right strain for the subsequent challenge. Following a consideration of risks and hazards, the information needed and an outline of the steps necessary to assess the risk is summarized, for an illustrative risk question using, as an example, the risks associated with the use ofvaccines in the field. A brief consideration of the differences between qualitative and quantitative risk assessments is also included, and the potential effects of uncertainty and variability on the results are discussed.