COVID Vaccines: Is Expanded Access A Better Option Than Emergency Use Authorization?

 
• By Sue Sutter

Given concerns about completing Phase III trials, advisory committee member asks whether US FDA has considered ‘the possibility of an expanded access protocol,’ but agency official points to added complexity that comes with the pathway; bioethics experts talk to the Pink Sheet about pros and cons of expanded access vs. EUA pathways.

Two arrows pointing in different directions
Concern about completing clinical trials has led to questions about whether expanded access might be a better path than emergency authorization for COVID-19 vaccines. • Source: Shutterstock

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