How the FDA will decide if a coronavirus vaccine is safe and effective

(Image credit: SIPHIWE SIBEKO/POOL/AFP via Getty Images))

published 30 June 2020

The Food and Drug Administration has received some criticism amid the coronavirus pandemic for rushing approval on some medications, but the agency is expected to assure everyone Tuesday that it "will not reduce its standards or cut corners in its review to approve a vaccine" despite moving at unprecedented speed to do so, The Wall Street Journal reports.

FDA Commissioner Stephen Hahn is expected to discuss the agency's guidance for vaccine approval in Congressional testimony Tuesday. Per the Journal, the FDA won't give a candidate the green light unless the manufacturer "clearly" demonstrates its safety and effectiveness through a clinical study, and the production of antibodies in patients' bloodstream alone won't lead to approval since it's still unknown what levels of antibodies provide protection.

The Journal's report doesn't contain much more detail beyond about what warrants approval, but it does reveal the FDA's watch won't end after a vaccine hits the market. Instead, vaccine makers will reportedly be required to monitor recipients for a year after treatment since "post-market studies" may be necessary to "further assess known or potential serious risks." Read more at The Wall Street Journal.

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Tim is a staff writer at The Week and has contributed to Bedford and Bowery and The New York Transatlantic. He is a graduate of Occidental College and NYU's journalism school. Tim enjoys writing about baseball, Europe, and extinct megafauna. He lives in New York City.