Clinical evaluation

The World Health Organization (WHO) has made available guidelines and requirements that are relevant to the evaluation of vaccines: good clinical practice for trials on pharmaceutical products, good manufacturing practice for pharmaceutical preparations, good manufacturing practice for biological products, regulation and licensing of biological products in countries with newly developing regulatory authorities and guidelines for national authorities on quality assurance for biological products. Guidelines and recommendations for the production and control of specific vaccines have been review in detail in a series of WHO technical reports, which should be consulted where applicable. However, there is no existing WHO documents that gives guidance on the planning, performance and assessment of clinical studies on vaccines with a regulatory perspective. Specific WHO guidelines are available for malaria and dengue or are in preparation in the case of certain candidate vaccines, such as for human immunodeficiency virus (HIV). Basic standards of care, including details about the cold chain required for transport and storage of vaccines, proper injection techniques for delivery of vaccines and safety of jections have already been described in the WHO manual "Immunization in practice".

Guidance on various aspects of clinical trials of vaccines is also available from several other bodies such as the International Conference on Harmonization (ICH), the European Agency for the Evaluation of Medicinal Products (EMEA), the United States Food and Drug Administration (FDA), and the United Kingdom Medical Research Council (MRC).

The WHO guidelines on clinical evaluation of vaccines: regulatory expections outline the data that should be obtained during the different stages of vaccine development in order to support a marketing approval. The document was developed in response to requests from national regulatory authorities for assistance in the evaluation of clinical trials, both during the clinical development of a new vaccine and also during the regulatory review of dossiers submitted in support of applications for marketing authorizations. The guidelines provide the basis for protection of individual patient safety and also to safeguard the public health.