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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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Approximately 9% of subjects have withdrawn from the 32,000-person trial because they were eligible to receive one of the mRNA vaccines in the US; AstraZeneca expects limited impact on efficacy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.
Timeline for getting data on COVID-19 vaccines ability to prevent transmission is likely pushed due to the decision not to proceed with a NIH study on the topic. CDC warns that it will take more time than people expect to get other key data points filled in and vaccine regimen plans shouldn’t change without such data.