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The WHO vaccines prequalification process consists of three areas of activity:
- biennial vaccines priority setting: WHO, in consultation with UNICEF and the PAHO Revolving Fund, establishes a biennial vaccine priority list. The list categorizes vaccines that are anticipated to be available for supply before the end of the biennium according to four levels of priority: high, medium, low and no priority. Vaccines listed as “no priority” cannot be considered for prequalification. All other vaccines will be accepted according to priority order and resources available within WHO.
- evaluating vaccines for prequalification: Manufacturers of vaccines that comply with the priority list may apply for prequalification by completing a WHO vaccine prequalification dossier Each application will be comprehensively screened and evaluated following the prequalification procedure which includes: a review of the vaccine production process; quality control procedures and available clinical data relevant to the target population; verification of compliance with required WHO standards and other best practices, and an inspection of the product manufacturing site(s). A streamlined procedure may be used in selected cases, where the responsible national regulatory authorities are eligible and willing to share regulatory information with WHO through a “collaboration agreement”.
- regularly re-evaluating prequalified vaccines: A post-prequalification process is also in place to ensure the continued acceptability of vaccines that have been prequalified. Post-prequalification requirements include the submission and evaluation of annual reports, reassessments of product at regular intervals, targeted testing of vaccine lots to monitor compliance with product standards, and follow-up of quality complaints.