Progress in the research and development of the methods for vaccine stability / 中华实验和临床病毒学杂志

ABSTRACT

The stability of vaccines has a major impact on the success of immunization programmes worldwide. Stability evaluation is a vital part of the assessment of the vaccine quality and safety. It should be regarded as a continuous process from the development of the vaccine through licensing to post-licensure monitoring. To ensure the quality of the vaccine, related guidelines were issued by both World Health Organization and Chinese regulatory authority. This paper reviews the progress of relevant guidelines and studies for providing the stability considerations of vaccine.