On the US FDA's accelerated approval and animal rules of vaccines

CHEN Qing-hua; LUO Jian-hui; WANG You-chun

Abstract：To facilitate and expedite the development and review of new drugs for unmet medical need in serious or life-threatening condition,US FDA established accelerated approval in 1992 and animal rule in 2002,respectively.Compared with traditional approval,accelerated approval is based on adequate and well-controlled clinical trials using a surrogate endpoint that is reasonably likely to predict clinical benefit or an intermediate clinical endpoint,and animal rule is based on adequate and well-controlled animal efficacy studies when the results of those animal studies establish that the product is reasonably likely to produce clinical benefit for humans.Learning from experience of US FDA,it is worth trying to make some meaningful explorations in technique review and market approval for vaccines which has great public health significance,when it is challenged to conduct definitive human efficacy and the potential benefits justify the potential risks.