COVID-19 Vaccines: Lost Placebo Control Could Mean Lost Approval, US FDA Officials Say
Getting an EUA is not a reason to vaccinate all placebo patients, US FDA officials write in NEJM article.
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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.
EUA request for COVID-19 vaccine is unlikely before late November; the CEO’s frequent comments that the timetable isn’t politically motivated are unusual to say the least.
CDC officials designing distribution plans worry some eligible for vaccination may wait for a better product to emerge.