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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.
US FDA has the unenviable task of picking the most important adverse events to track once coronavirus vaccinations begin; CDC's list will need to be winnowed to 10-20 to make the surveillance feasible, and which AEs make the cut may be informed by the vaccine trials, as well as clinical experience with COVID infections.
After threats to overrule the agency, the Trump administration has indicated that the stricter guidance will be allowed to stand.
The European Medicines Agency is fast-tracking its review of the vaccine that BioNTech and Pfizer are developing and testing in Phase III trials.
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