Generation and characterization of candidate vaccine viruses for prepandemic influenza vaccines.

Vaccination will be a critical public health intervention to mitigate the next influenza pandemic. Its effectiveness will depend on preparedness at multiple levels, from the laboratory bench to the population. Here we describe a global approach to ensure that appropriate candidate vaccine viruses are produced, evaluated, and made available to vaccine manufacturers in a timely fashion. This is an integrated activity involving global virologic and epidemiologic surveillance, genetic and antigenic characterization of influenza viruses, pandemic risk assessments, selection of appropriate virus strains for vaccines, production of reassortant viruses by reverse genetics, and finally, analysis of their safety and growth characteristics prior to distribution. These procedures must comply with national and international regulations governing vaccine and environmental safety.