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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

The US Food and Drug Administration’s insistence that COVID-19 vaccine sponsors find a way to continue randomized, placebo-controlled Phase III trials after an emergency use authorization is granted has some experts questioning whether an expanded access program would be preferable to an EUA.

The prospect of an expanded access program as an alternative to an EUA arose at the 22 October meeting of the Vaccines and Related Biological Products Advisory Committee. The...

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