New database for WHO prequalified vaccines now online
A new database to enable immunization programme managers, procurement agencies, regulatory authorities, and other partners to search for vaccines prequalified by WHO by type of vaccine, manufacturer and country of manufacture is now available on WHO's web site. Users can consult summary pages for each prequalified vaccine which include information such as date of prequalification, vaccine presentation, route of administration, shelf life, packaging, and cold chain requirements.
The ultimate goal of WHO's prequalification programme for vaccines is to ensure that all countries have access to vaccines that meet international standards of quality, safety and efficacy and are appropriate for the target population. The rigourous evaluation process includes review of comprehensive documentation on production methods, vaccine composition, quality control and clincial experience; independent testing for consistency by WHO-accredited laboratories; and site audits of the manufacturer to ensure that vaccine and production methods conform to international standards. Complaints about vaccine quality and reports of adverse events following immunization are investigated by WHO. United Nations procurement agencies only purchase vaccines that have been prequalified by WHO.
The system is widely credited with contributing to the growing number and proportion of quality vaccines being supplied by companies in developing countries, such as Brazil, Cuba, India, Indonesia and Senegal.
The prequalification pages on WHO's web site contain sections on overall goals, principles, process and priority-setting for WHO vaccine prequalification, together with guidance documents for vaccine manufacturers.