Most vaccines, including the currently available glycoconjugate vaccines, are administered to healthy infants, to prevent future disease. The safety of a prospective vaccine is a key prerequisite for approval. Undesired side effects would not only have the potential to damage the individual infant but also lead to a loss of confidence in the respective vaccine—or vaccines in general—on a population level. Thus, regulatory requirements, particularly with regard to safety, are extremely rigorous. This chapter highlights regulatory aspects on carbohydrate-based vaccines with an emphasis on analytical approaches to ensure the consistent quality of successive manufacturing lots.
CITATION STYLE
Jones, C. (2015). Glycoconjugate vaccines: The regulatory framework. In Methods in Molecular Biology (Vol. 1331, pp. 229–251). Humana Press Inc. https://doi.org/10.1007/978-1-4939-2874-3_14
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