Regulatory considerations in the nonclinical safety assessment of adjuvanted preventive vaccines

Publisher Summary The regulatory considerations for vaccines are, for the most part, also applicable to vaccines formulated with adjuvants. However, for the latter products, additional issues may be considered that are unique to novel adjuvants. Preventive and therapeutic vaccines for infectious disease indications are regulated by the Office of Vaccines Research and Review in the Center for Biologics Evaluation and Research (CBER) within the U.S. Food and Drug Administration (FDA). This is in contrast to vaccines for other indications such as cancer vaccines, which have different risk-benefit considerations and are regulated by a different office within CBER, the Office of Cell, Tissue, and Gene Therapies (OCTGT). Topics covered in this chapter include a brief overview of the Investigational New Drug Application (IND) regulations as they apply to preventive vaccines, an overview of the information to be included in the IND submission, and a discussion of the utility of the pre-IND meeting. Furthermore, this chapter includes recommendations regarding the nonclinical safety program for preventive adjuvanted vaccines, with emphasis on approaches to the design of preclinical toxicity studies to support initiation of phase I clinical trials.