Academic journal article Bulletin of the World Health Organization

Regulatory Pathways for Vaccines for Developing Countries

Academic journal article Bulletin of the World Health Organization

Regulatory Pathways for Vaccines for Developing Countries

Article excerpt

Voir page 132 le resume en francais. En la pagina 133 figura un resumen en espanol.


Vaccine regulation is a complex process, and improvement of national infrastructure in this area has progressed slowly. In 1999, WHO defined six regulatory functions that could be used to assess a NRA, monitor its improvement, and design interventions to impact it (Box 1) (1). This definition is useful in that it provides a transparent basis for assessing regulatory functions, while noting potential differences in data analysis because of differing risk--benefit scenarios (2). In fact, the differing risk-benefit assessment has led to product divergence (3, 4): for example, whole cell versus acellular pertussis vaccine and oral versus inactivated polio vaccine.

Box 1. Six regulatory functions defined by WHO to assess,
monitor, and improve national regulatory authorities

* Published set of requirements for licensing (of products and

* Surveillance of Vaccine field performance (safety and efficacy)

* System for batch or lot release

* Use of the laboratory when needed

* Regular inspections of manufacturers for good manufacturing
practice compliance

* Evaluation of clinical performance through authorized clinical

Currently, vaccines are developed and used first in the industrialized world in which the regulatory decisions for these products are taken. New vaccines for the developing world targeted at diseases in developing countries may never be used in the industrialized world. These vaccines need to be under appropriate regulatory control from development to use to ensure they are sale, effective, and of high quality.

NRAs differ with respect to the export and import of vaccines. The US Food and Drug Administration was established by its national government with a mandate to function only for the domestic market. The European Medicines Evaluation Agency operates similarly on behalf of the countries of the European Community but has expressed interest in providing additional regulatory functions for vaccines made in Europe but targeted at developing markets. Many competent NRAs in the developing and industrialized worlds could make decisions on new product licensing, but they would need a new regulatory framework to do so on behalf of other countries in the developing world. Finally, some countries import vaccines only from assured sources, counting on the decisions of other regulatory authorities or the recommendations of WHO, or bath, because they lock the basic infrastructure to make regulatory decisions on their own. As many manufacturers distribute vaccines beyond their borders, the existing regulatory gaps must be addressed, or vaccine supply will be jeopardized.

This paper addresses three types of situations for which regulatory pathways must be assured, given the different national regulatory activities defined above:

1. To ensure that vaccines developed, produced, and licensed in an industrialized country for intended global use are evaluated for their safety and efficacy, not only for the target population in the country of manufacture but also in the target populations of the developing world. This would be the case for an 11-valent pneumococcal conjugate vaccine that could be used in many countries with different disease burdens.

2. To maintain a licence for a product developed, produced, and licensed in an industrialized country when there is no longer a product market in that country. This is the expected situation for combination vaccines based on diphtheria-tetanus-whole cell pertussis (vaccines manufactured and licensed in Europe).

3. To find a pathway to licensure for a product when the market is only in the developing world, regardless of where the product is developed. This could be the case for vaccines against many tropical diseases, such as malaria and leishmaniasis. Lack of a pathway represents "regulatory risk" for potential product developers. …

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