US COVID-19 Advisors Vexed By Vaccine Post-EUA Placebo Controls, But Agree On Need

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.

No U turn sign (source: Shutterstock) — Sponsors need to push ahead with placebo-controlled COVID-19 vaccine studies post-EUA, agency advisors say. • Source: Shutterstock

Coronavirus vaccine sponsors may be stuck with the US Food and Drug Administration’s call for placebo-controlled follow up of COVID-19 vaccines after they receive emergency use authorization. The agency's Vaccines and Related Biological Products Advisory Committee reaffirmed the need for such data to support a full biologics license application during its 22 October meeting.

Yet neither the FDA nor the advisory committee offered companies much advice on how to achieve this outcome, which they...