​World Health Organization Prequalification of Vaccines
​A brief overview and considerations for clinical development
White Paper

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.

Vaccines to prevent at least 25 infectious diseases have been licensed by global regulators. In the past, new vaccines typically became available in low- and middle income countries only years (often decades) after being introduced in high-income countries.

More recent initiatives (e.g., the Expanded Program on Immunization [EPI]) and collaborations among international organizations (e.g., The World Health Organization [WHO]; United Nations International Children’s Fund [UNICEF]; Gavi, The Vaccine Alliance) have narrowed this inequity, however, with welldocumented positive impacts on health and survival in these vulnerable populations.

A key contributor to this success has been the creation and execution of a sustainable program to oversee the quality, safety and suitability of vaccines used in national immunization programs: WHO Prequalification (WHO PQ). The WHO PQ program for vaccines was created in 1987 in order to support UNICEF and the Pan American Health Organization [PAHO] Revolving Fund, the two UN agencies primarily responsible for vaccine procurement, by providing assurance that the vaccines purchased would be consistently safe and effective under deployment conditions. In the years since its inception, the program’s processes and procedures have been revised and modified to meet evolving needs, generally at the behest of expert groups. Each revision has been endorsed or noted by the WHO Expert Committee on Biological Standardization prior to implementation and publication as part of the WHO Technical Report series or as a WHO Vaccines Department document.

 

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