Ethics arising from EUAs could disrupt COVID-19 vaccine trials
Participants in COVID-19 trials could demand unblinding, right to receive authorized vaccine
Participants in COVID-19 trials could demand unblinding and the right to receive an authorized vaccine.
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.
The stakes are high. In the worst case, failure to resolve the unblinding problem could mean that the first COVID-19 vaccine would be the only vaccine.
The emergency use authorization (EUA) of a COVID-19 vaccine will create two sets of problems related to placebo-controlled trials. Patients enrolled in the ongoing Phase III trial of the authorized vaccine will want to know whether they