The Regulatory Framework for Glycoconjugate Vaccines

摘要

Vaccines, including glycoconjugate vaccines, are frequently administered to healthy infants in government-sponsored immunisation schemes to prevent diseases which are now rare, due largely to the effectiveness of these vaccines. High levels of confidence in the efficacy and safety of vaccines are demanded by the public, so that vaccine development, production, licensing and sale are strictly regulated processes. Glycoconjugate vaccines against three pathogens have been licensed. These have shaped detailed requirements within the existing regulatory framework, and similar principles are likely to be applied when assessing novel glycoconjugate vaccines. As glycoconjugate vaccines modify bacterial carriage and alter natural exposure to the organisms, surveillance after vaccine introduction may modify immunisation schedules. This article discusses the framework within which glycoconjugate vaccines are regulated and those factors which have been shown to be important in ensuring their efficacy.