Snakebites and antivenoms WHO response

The public health challenge About 5 million people bitten by snakes every year 100 000 to 200 000 deaths annually, and 400 000 snakebite-related amputations In sub-Saharan Africa, about 30 000 people die from snake bite each year Children suffer higher incidence and more severe effects than adults Data taken from the 2008 World Report on Child Injury Prevention (World Health Organization 2008, p.128) http://apps.who.int/iris/bitstream/10665/43851/1/9789241563574_eng.pdf

The access/quality challenge Antivenoms exist but worldwide shortage An effective treatment for snake bite to run out in 2016 Few manufacturers interested in entering the market Generally, limited regulatory oversight of the quality of existing products Bullet 2: French manufacturer Sanofi Pasteur stopped producing Fav-Afrique in 2015. This was one of the most effective anti-venoms to counter sub-Saharan African snake toxins

WHO response Call for manufacturers to submit applications for pilot WHO assessment in late 2015 Joint review in March 2016 confirms need for stringent assessment Corrective actions required of manufacturers before further assessments Once finalized, products that meet assessment criteria to be listed on WHO website Development and publication of WHO assessment and listing of snake antivenoms: In order to support decision-making by procurement agencies, public health officials and users of antivenoms WHO has decided to offer an independent assessment of antivenoms. The WHO assessment process will involve a risk-benefit ratio evaluation based on a minimum set of available quality, safety, and efficacy data. Procedure was posted in the webpage indicating call for expression of interest and timelines

Other WHO efforts since 2008 Development and publication of a global database on snake species and available antivenoms (www.who.int/bloodproducts/snakeantivenoms/database/) Establishment of guidelines for production, control and regulation of antivenoms Regional guidelines on the management of snakebites Bullet 1: This global database is accessible to anyone, and provides information on the identification of snake species and their distribution (including snake images and geographical maps), and potential treatment by specific antivenoms (including product names and manufacturers). Bullet 2: These manufacturing and regulation guidelines were developed in 2008 and are currently under revision Bullet 3: Two regional guidelines were developed in 2010: one by the African regional office, and one by the Southeast Asian regional office, focusing on snakebite management in those regions

Global database on venomous snakes Global database for visual identification of dangerous (two categories) snake species in geographic maps. Further information is provided for potential treatment by specific antivenoms available from manufacturers. Needs continous updating with epidemiological information and product availability.

Guidelines on production, control and regulation Overview of antivenom manufacturing process: Collection of venoms (“milking” of snakes), immunization of horses with one or few venoms, collection of horse plasma by plasmapheresis, plasma fractionation to manufacture equine immunoglobulins, usually pepsin digestion to be provided as F(ab)2 fragments, often lyophilized final products

Guidelines for the management of snake bites Africa and South-East Asia Prevention and epidemiology of snake bites Symptoms, management and diagnosis Treatment Regional treatment guidelines for medical doctors, nurses and community health workers Regional epidemiology of snakes. Prevention, diagnosis, management and treatment of snake bites

The future WHO ready to continue technical leadership but: Additional efforts needed to improve quality of antivenoms and increase sustainable production Political and financial investment necessary to make a difference

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