Trial Dropouts Illustrate Worries For J&J, Other Later Entrants To COVID Vaccine Space
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.
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Switzerland's medicines agency says it wants to see more data on AZD1222 before it can approve the vaccine. Also, a rolling review of Novavax's NVX-CoV2373, yet another COVID‑19 vaccine, is under way at the European Medicines Agency.
Approximately 9% of subjects have withdrawn from the 32,000-person trial because they were eligible to receive one of the mRNA vaccines in the US; AstraZeneca expects limited impact on efficacy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.
Pfizer relies on investigators to determine when prioritization recommendations apply, Moderna offers unblinding to everyone.