Placebo-Unblinding Should Be Uniform Across COVID Vaccine Trials, Advisory Committee Says
US FDA’s outside advisors say Moderna should offer vaccine to placebo-arm patients when they are eligible, the same plan adopted for the Pfizer/BioNTech COVID-19 vaccine.
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Placebo Unblinding Process For Pfizer’s COVID Vaccine No Detriment To US FDA Safety Analysis
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.
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.
Modeling Is Not a Drug Approval Pathway: Why Merck Flunked Keytruda’s TNBC Advisory Panel
Advisory panel agrees with US FDA that Merck’s pathological complete response data is not strong enough for accelerated approval in high-risk, early-stage triple-negative breast cancer patients and says modeling of expected outcomes data cannot make up for this weakness.