Safety assessment of adjuvanted vaccines: Methodological considerations.

摘要: Adjuvants mainly interact with the innate immune response and are used to enhance quantity quality of downstream adaptive vaccine antigens. Establishing safety a new adjuvant-antigen combination is achieved through rigorous evaluation that begins in laboratory, continues throughout life-cycle. The strategy for pre-licensure guided by disease profile, indication, target population, it also influenced available regulatory guidelines. In order allow meaningful interpretation clinical data, program methodology should be optimized standardized, making best use all data sources. Post-licensure activities directed field experience accumulated pre- post-licensure trial spontaneous adverse event reports. Continued evolution processes keep pace advances technology updated communication benefit-risk profile necessary maintain public confidence vaccines.