ARTICLE | Regulation

Ethics arising from EUAs could disrupt COVID-19 vaccine trials

Participants in COVID-19 trials could demand unblinding, right to receive authorized vaccine

October 21, 2020 1:52 AM UTC

FDA and its vaccines advisory committee are facing ethical and practical conundrums that, unless they are resolved quickly, threaten to undermine the development of COVID-19 vaccines.

The most pressing challenge centers on whether it is acceptable to continue placebo-controlled, blinded trials after a vaccine has been authorized. If there is a need to unblind trials, FDA will need to outline what steps must be taken to ensure that the studies for the authorized or other vaccines can still support regulatory requirements...