Current availability of vaccines including vaccine banks.

Avian influenza can be considered one of the greatest global challenges the animal health sector has ever had to face. It is primarily a disease of animals and must be effectively managed by the veterinary community. Infection of humans in contact with the H5N1 virus continues to occur, however, with the possibility of mutations or re-assortment and the ever-present threat of the emergence of a pandemic. Therefore, whatever measures can be taken when outbreaks of avian influenza occur to reduce the amount of virus in circulation and potential human exposure must be reviewed constantly. Conventional methods for controlling diseases of epizootic proportions, such as avian influenza, have tended to rely on bio-security and culling (stamping out) of enormous numbers of animals. Such approaches might not be adequate in areas of intensive animal husbandry, and society is questioning more and more the ethics of slaughtering millions of animals. The costs and economic impact of this strategy also has a considerable effect on the economy of the country or region in which the disease outbreak occurs.

Regulatory requirements for vaccine authorisation.

Vaccines are one of the most important tools available in the prevention and control of diseases in animals. It is therefore of the utmost importance that when vaccines are used, such use should meet with the requirements of the World Organisation for Animal Health Terrestrial Animal Health Code and must be authorised by the recognised licensing body in the country/region where the vaccines are to be used, in accordance with the three key criteria of quality, safety and efficacy. This article provides a comprehensive and comparative description of the regulatory requirements in place for veterinary vaccines in major regions of the world, highlighting the similarities and pointing out also where there are differences. Recent advances in harmonisation of such testing requirements achieved through the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) are also described. The contents will provide a valuable guide to those engaged in the research and development of vaccines globally, and reassure those involved in the prevention and control of animal diseases that veterinary vaccines, when fully authorised and used according to the label instructions, are safe and efficacious.