Risk-benefit assessment of snakebite antivenoms

WHO has established a risk-benefit assessment process for snake antivenoms, and has piloted this procedure to evaluate antivenoms used in sub-Saharan Africa. This project will extend the process to manufacturers producing products for use in countries with medically important snakes in WHO’s South-East Asian Region. WHO will evaluate products for the classic “Big Four” (Common cobra Naja naja; Common krait Bungarus caeruleus; Russell’s viper Daboia russelii; and saw-scaled viper Echis carinatus). A future phase will assess products for other South-East Asian and Western Pacific species. The aim is to determine whether available data demonstrates a reasonable likelihood that a product’s quality, safety and efficacy are acceptable, and that, when used to treat snakebite the benefits outweigh any foreseeable risks and uncertainties. The goal is to publish a list of WHO-recommended antivenom products for countries or regions that supports decision-making by procurement agencies, public health officials and other users. Moreover, the risk-benefit assessment provides important guidance to future prequalification processes; gives manufacturers detailed information about compliance with Good Manufacturing Practice (GMP), and product quality and preclinical efficacy; and stimulates manufacturers to remedy deficiencies and improve products. The process helps WHO understand the antivenom landscape, identify priority areas and focus future activities.