Kamis, 25 Agustus 2011

TOWARDS A GLOBAL SOLUTION: a WHO initiative to improve availability of safe antisera

chapter 2 Stakeholders participating at the consultation agreed that WHO should lead a global initiative to improve access to life-saving therapeutic antisera. This effort should promote transfer of technologies and building-up of technical capacity, skills and experience of regulatory authorities and manufacturers, where needed. A pre-qualifi cation programme was considered essential to facilitate the procurement of antisera which quality and safety would be assessed by WHO.


The collaboration of other international organizations, including nongovernmental organizations, and the identifi cation of fi nancial resources are essential for the development of this global strategy aiming to ensure access to effective and safe therapeutic sera, and as such to reduce the mortality and disease burdens of these neglected public health conditions.

The dimension and complexity of this problem requires a multifaceted strategy for its solution, which should involve many partners at national, regional and global levels coordinated by WHO. This strategy should include the following components:

(1) The development of WHO guidelines on the production, control and regulation of antisera.

These guidelines should include all aspects of antiserum manufacture and control, from the starting materials to the large-scale implementation of manufacturing steps and the control of critical parameters to release products of assured quality and safety. The elaboration of such a consensus document should be achieved through a wide consultation process of manufacturers and regulators, at global level, together with a series of technical workshops.

(2) The development of national and regional technical capacity to manufacture safe and effective antisera.

The target groups to benefi t from this initiative are the national regulatory authorities and manufacturers of antisera, especially laboratories in developing countries. This objective will be fulfi lled through the organization of regional and inter-regional workshops focusing on GMP, on good animal husbandry practices, on collection and fractionation of animal plasma, on preparation and storage of antigens (rabies virus and venoms), and on the correct implementation of manufacturing steps aimed at assuring the effi cacy and safety of the products.

(3) The implementation of an international technological cooperation strategy.

Because of the large variation in the capacities and skills of the laboratories involved in antisera production, there is a good opportunity to organize a dynamic process of innovation and transfer of technology between regions and countries. These activities may be based on training courses and exchange of information, technology and expertise among laboratories. An international distribution of tasks can be envisaged. For instance, some laboratories may be in charge of keeping collections of snakes and scorpions of medical importance, as well as preparing high quality antigens which would be used by other laboratories to immunize animals and fractionate the hyperimmune plasma for antiserum production. This type of arrangement should strengthen the parties, while guaranteeing the production of the required volumes of antisera.

(4) The implementation of a prequalifi cation scheme for antisera producers.

On the basis of the experience gained by WHO in the process of prequalifi cation of medicinal products, the implementation of such a scheme for antisera may represent an incentive towards the supply of suffi cient quality products. This process is voluntary and does not involve any direct cost to the laboratories. For laboratories aiming to contribute to the global production of antisera, this process would help them to qualify as international providers of these products through different procurement schemes.

(5) The improvement in the clinical management of rabies and envenomings.

The global initiative should include a component aimed at acquiring in-depth knowledge of the public health impact of these diseases at global, regional and national levels. This includes the promotion and development of community-based epidemiological studies on the incidence of rabid dog bites and envenomings due to snake bites or scorpion stings. In addition, preclinical assessment of antivenoms, together with well designed clinical trials are required in order to gain precise knowledge of the spectrum of effi cacy and safety of antivenoms and of the most relevant clinical manifestation of envenomings. These efforts should be linked to the development of regional guidelines for the clinical management of envenomings and rabies post-exposure prophylaxis, which should be widely distributed to the health workers in rural areas. Strategies of continuing education of health work-ers as well as public campaigns on prevention and management of the diseases should complement the guidelines.

(6) The improvement in the logistics of antiserum distribution.

A concerted effort is needed between epidemiologists at ministries of health, procurement agencies and antiserum producers to assure the design and implementation of distribu-tion strategies for these products. This should include the design and maintenance of an adequate cold chain. The use of distribution channels already developed in the health systems for other products (e.g. vaccines) should be fostered, as well as the collaboration and help of international organizations that support the distribution of other medicines.

The experiences of some countries with well-developed distribution systems should be shared, through collaborative efforts, with less developed regions.

(7) The implementation of a fi nancially-sustainable strategy.

The solution to the lack of effective and safe antivenoms on a global basis demands the fi nancial support of governments, non-governmental organizations and other international agencies. Without adequate fi nancial support it will not be possible to pursue the objectives described in this plan of action. A concerted international effort, led by WHO, will guarantee full international exposure of this problem thereby attracting the attention of agencies devoted to solutions for health problems in the developing world.

Such a concerted international effort, involving producers, regulators, researchers, national and regional health authorities, international agencies and the community organizations, under the coordination of WHO, can be expected to result in:

■ increased availability of safe and effective animal-derived antisera;

■ enhanced technical capacity of regulatory agencies and manufacturers;

■ guaranteed production of safe and effective antisera

■ improved clinical management of rabid bites and envenomings

■ optimal clinical use of antisera

■ improved health programmes in the affected countries.


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