Manufacturing, safety and quality control of vaccines part 1

How a vaccine is approved for production

Once a vaccine has reached pre-approval stage following clinical trials, it is assessed by the relevant regulatory body for compliance with quality, safety and efficacy criteria. Following regulatory approval, manufacturers can submit a vaccine to WHO for prequalification, an assessment process that ensures quality, safety and efficacy and helps the UN and other International procurement organizations determine the programmatic suitability of a vaccine.

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