COVID-19 Vaccine Sponsors Want US FDA To Find Alternatives For Control-Arm Data After First EUA
US FDA must rethink guidance on maintaining placebo-control in COVID-19 trials after any vaccine gets an EUA, companies say, arguing current proposal may not be ethical or feasible. Disease organizations who agree with the hurdles to preserving placebo-control maintain this is a reason why any EUA must meet a very high standard.
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FDA indicates it expects sponsors and other government agencies to come up with ways to fulfill its request for placebo-controlled studies post-emergency use authorization of COVID-19 vaccines, but neither it nor vaccines advisory committee see a clear way to do this.
Agenda for Thursday’s meeting on coronavirus vaccine development and approval includes lots of background, which may help public confidence, but not necessarily FDA assessors as they weigh the tough decisions ahead of them.
There are 18 people on the committee that will issue the first recommendations on COVID-19 vaccine development and licensure. Among the experts are a University of Michigan epidemiologist who will serve as acting chairman and seven temporary voting members, two of whom required conflict-of-interest waivers.