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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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.
With goal of distributing vaccines within 24 hours of emergency use authorization, HHS is hoping to convene CDC's ACIP concurrent with the FDA review, Alex Azar says.
Crossover could happen along with the EUAs, Operation Warp Speed's Slaoui says, or when enough high-priority groups are inoculated, or maybe when the vaccines receive full BLA approval. Whatever officials and sponsors decide, it will create challenges for vaccine candidates still in development.