COVID-19 Vaccine Sponsors Want US FDA To Find Alternatives For Control-Arm Data After First EUA

 
• By Sarah Karlin-Smith

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.

Vial with placebo medicine and syringe for injection
Sponsors are worried they may not be able to maintain placebo arms once any COVID-19 vaccine gets an EUA • Source: Shutterstock

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