COVID-19 Vaccines: Placebo Crossover May Depend Upon Number Of Doses, Allocation Strategy
Although US FDA wants sponsors to maintain blinded Phase III follow-up as long as possible after emergency use authorization or licensure, vaccine researcher Larry Corey says it will become ‘untenable’ to keep individuals in placebo arm once they qualify for vaccine access under the allocation framework.
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US FDA’s Peter Marks says transmission prevention is one of three key missing data points he’d like from Pfizer and BioNTech’s newly authorized vaccine. Another concern is how the vaccine will work is the virus “drifts.”
Pfizer intends to notify placebo patients that an EUA has been issued and offer the vaccine to keep them in the study, but FDA appears to want to maintain placebo control for as long as possible.
CBER Will Need About A Week To Complete COVID Vaccine Assessment Following Advisory Cmte., Marks Says
Timeline is the most pessimistic public projection to date, but still incredibly fast. Clinical trial patients on placebo could be contacted and offered the vaccine after an EUA is granted.