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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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.
US FDA’s Top Two Vaccine Officials Announce Surprise Retirements
Departures of Marion Gruber and Philip Krause may stem from White House and CDC actions related to the COVID-19 vaccines.
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.