Volume 40, Issue 19 Pages 2647-2818 (26 April 2022)
Japanese Society for Vaccinology paper
Proposal for the revision of the guidelines for Non-clinical studies of vaccines for the prevention of infectious diseases in Japan
Yumiko Nomura, Kiyohito Noda, Yuusuke Oohashi, Shin Okuda, … Nobuhiko Okabe
• We identified the current challenges in the development of vaccines and propose revision of the guidelines for the non-clinical studies of vaccines.
• The results of repeated-dose toxicity studies can be used to decide whether safety pharmacology studies are required.
• The studies to evaluate toxicity due to systemic effects may not be necessary for both intramuscular and subcutaneous administration.
• Women of childbearing potential could be included in clinical trials with appropriate pregnancy avoidance prior to the reproductive toxicity studies.