Clinical trials for accelerating pandemic vaccines

Abstract

AbstractWe provide a short overview of clinical trials of vaccines, with particular focus on (i) adaptive and platform trials, (ii) human challenge trials, and (iii) vaccine use optimization, especially fractional dosing. We describe their relationship with regulatory approval and review main developments during Covid-19. We review the literature on risk–benefit analyses of alternative testing approaches but find few results, suggesting need for further quantitative research. We conclude by discussing some lessons for the next pandemic, such as the need for pre-pandemic R&D and clear guidelines; improving capability to use new trial approaches; arguments for diversifying research methods; research incentives and disincentives; and the need to use risk–benefit in approving new vaccines and targeting.