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.
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Advisory Committee on Immunization Practices work group also says previous infection with SARS-CoV-2 should not exclude someone from receiving vaccine if they are in one of the early groups recommended for prioritization; ACIP group unveils updated ethical principles intended to guide vaccine allocation decisions.
FDA's recommendation that COVID-19 vaccine sponsors conduct two months of median follow-up to support an emergency use authorization may not be long enough, some experts say in what can be viewed as validation for agency's position in battle with White House.
FDA indicates it expects sponsors and other government agencies to come up with ways to fulfill its request for placebo-controlled studies post-emergency use authorization of COVID-19 vaccines, but neither it nor vaccines advisory committee see a clear way to do this.