Pfizer Doesn’t Like Crossover Design For Placebo Patients In COVID-19 Vaccine Trial
Only vaccinating the placebo group would be much easier once the US FDA grants an EUA for its coronavirus vaccine, Pfizer says.
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Departures of Marion Gruber and Philip Krause may stem from White House and CDC actions related to the COVID-19 vaccines.
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Approximately 9% of subjects have withdrawn from the 32,000-person trial because they were eligible to receive one of the mRNA vaccines in the US; AstraZeneca expects limited impact on efficacy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.