Unblinding Plans For COVID-19 Vaccine Trials Take Roads Less Travelled
Pfizer relies on investigators to determine when prioritization recommendations apply, Moderna offers unblinding to everyone.
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Despite initial concerns among FDA staff and its advisory committee about unblinding the Comirnaty pivotal trial after emergency authorization, agency’s review of the first COVID vaccine to receive full licensure suggests its safety conclusions were not adversely affected.
More than 5% of participants in J&J’s vaccine trial chose to be unblinded because they were eligible to receive a vaccine that had already gained a US FDA emergency use authorization.
Approximately 9% of subjects have withdrawn from the 32,000-person trial because they were eligible to receive one of the mRNA vaccines in the US; AstraZeneca expects limited impact on efficacy assessment but is working on a potential plan for crossover of all participants to try to keep as many in the study as possible for safety follow-up.