Context
WHO aims to facilitate a 50% reduction in deaths and disabilities caused by snakebite envenoming by 2030. To reach this goal it is imperative that access to safe, effective, and affordable antivenom products for treatment of snakebite envenoming be substantially improved in all countries where snake bites are endemic, particularly in sub-Saharan Africa.
WHO is exploring a pathway for the prequalification of antivenoms, a step that will ensure the availability of well-designed and manufactured products that are quality-assured. As part of this process WHO identified a need to develop Target Product Profiles (TPPs) to support optimization of current and emerging products. A Technical and Scientific Advisory Group (TSAG; see here) was established by WHO to define optimal and minimally acceptable characteristics for antivenoms and other snakebite treatments for specific use cases. The TSAG is supported by a secretariat comprised of personnel from WHO and the Drugs for Neglected Diseases Initiative. The public-benefit TPPs that are produced will assist key stakeholders such as manufacturers and regulators with product standardization, optimized design and set parameters that can lead to improved safety, effectiveness, affordability and accessibility. They can also stimulate targeted research and development of antivenoms across the world.
The first series of draft public-interest antivenom TPPs are focused on conventional (i.e., animal plasma-derived immunoglobulins) antivenoms for sub-Saharan Africa. These drafts are now being made available for broad public consultation so that the development of the final drafts can consider the wide perspectives of diverse stakeholders, including antivenom manufacturers, drug regulators, clinicians and health workers. The document is comprised of a preamble followed by a set of shared characteristics which are common to all the TPPs. The characteristics that are specific to the four individual use cases are in subsequent sections, and there are supplementary reading links in the appendix.
How to participate to this public consultation?
- Download the draft Target Product Profile from here and read them carefully.
- Provide the feedback form. This form must be used to provide technical feedback, indicate areas of ambiguity, or a need for clarification. You may provide your feedback using the pre-defined “Comments” section for specific lines of the TPPs. You can also provide more general feedback using the section “General comments” at the bottom of the form.
- Submit the completed online form with your feedback to Mrs. Dimitra Kavalierou (kavalieroud@who.int) by 23 December 2021.
If you have any questions, please do not hesitate to contact Mrs. Dimitra Kavalierou (kavalieroud@who.int), who will then re-direct your message to the most appropriate person in our snakebite team at WHO.
Final versions of these TPPs will be made publicly available via WHO’s website in 2022.
Thank you very much in advance for your contribution.