First WHO guidance on snakebite treatments published.
The World Health Organization (WHO) has published the first
in a series of WHO public-benefit target product profiles (TPPs) for snakebite
treatments, in order to improve the quality of antivenoms available in the
market. This is the first-ever guidance to improve the quality of such
products. The TPP is a document that provides regulators, manufacturers,
researchers and procurement agencies with essential information about the
minimum and optimum characteristics of specific products for specific use cases,
in this case, antivenoms used for the treatment of snakebites caused by various
types of sub-Saharan African snakes. TPPs help to ensure that products are
designed and manufactured to meet the match the clinical needs of populations
at risk, and are “fit-for-use” – e.g., are safe, effective and adapted to the
use environment,
A high-quality antivenom provides the best available
treatment for approximately 5.4 million people who are bitten by snakes each
year. Safe, effective antivenoms could prevent many of the 83 000-138 000
deaths caused by snakebites and reduce the severity of serious disabilities
that impact many thousands more victims.
“Access to high quality, safe and effective antivenom is an
issue of equity and this critical work brings us one step forward in being able
to make this a reality” Dr Socé Fall, Director of the WHO Global NTD Programme.
Antivenoms have been made for some 130 years and yet,
remarkably, there has been until now, no guidance on how to design and
manufacture a product of high quality that meets the correct requirements for
safety, effectiveness, and functional use.
Four TPPs for different types of conventional
animal plasma-derived antivenoms
The first of these is for products that are intended for
widespread use throughout sub-Saharan Africa, for treatment of snakebites
irrespective of the species of snake causing the bite. The second is for
treatment of bites from a single species (or group) of snake(s). Products in
both these categories are currently on the market.
The other two
categories are for products that do not yet exist in sub-Saharan Africa, but
evidence from other parts of the world suggests that if developed they may have
a useful role to play. One of these new product types is for antivenoms where
the snakebite mainly causes a syndrome dominated by neurotoxic effects, while
the other is intended for non-neurotoxic snakebite syndromes that involve
effects on blood clotting or tissue necrosis without paralytic effects.
These TPPs, are
intended to provide guidance to manufacturers, regulators, procurement
agencies, clinicians and researchers and will contribute to improvements in the
quality, safety and effectiveness of antivenoms and thus better treatment of
snakebites.
