COVID-19 Vaccines: FDA’s Broad Authority To Craft Narrow EUAs May Push Agency Out Of Its Comfort Zone

US FDA may not be comfortable using some of the powers the emergency use authorization statute provides to limit a product’s use; regulatory distinctions for EUAs go beyond the lower ‘may be effective‘ standard needed for an authorization versus an approval. EUAs come with a lot of other tools to micromanage use that aren’t available for most approvals.