​World Health Organization Prequalification of Vaccines

​A brief overview and considerations for clinical development

White Paper

World Health Organization Prequalification of Vaccines

Global regulatory agencies have licensed vaccines to prevent at least 25 infectious diseases. Historically, however, new vaccines typically became available in low- and middle-income countries years (often decades) after being introduced in high-income countries. More recent initiatives have narrowed this inequity, with well-documented positive impacts on health and survival in these vulnerable populations. This White Paper discusses the World Health Organization’s Prequalification program, which has been a key contributor in overseeing the quality, safety, and suitability of vaccines used in national immunization programs.