1. Snakebites and antivenoms
WHO response

2. The public health challenge
About 5 million people bitten by snakes every year
to deaths annually, and snakebite-related amputations
In sub-Saharan Africa, about 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)

3. 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 This was one of the most effective anti-venoms to counter sub-Saharan African snake toxins

4. 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

5. Other WHO efforts since 2008
Development and publication of a global database on snake species and available antivenoms (
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

6. 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.

7. 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

8. 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

9. 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

10. THANK YOU