FDA Willing to Authorize Coronavirus Vaccine Before Phase 3 Trials Are Complete, Agency Head Says
Food and Drug Administration (FDA) Commissioner Stephen Hahn told the Financial Times in an interview published Sunday that the agency is willing to issue an emergency use authorization (EUA) for vaccines that protect against the novel coronavirus before phase 3 clinical trials for the vaccines are complete. He noted, however, that a final decision will ultimately be based on the data that's submitted by drugmakers.
One of the main differences between an EUA and a full approval is that the former only lasts as long as an emergency continues. Because it's temporary for a specific emergency, an EUA has a lower threshold for the calculation of benefit versus risk. One way the FDA might mitigate the unknown risk is by authorizing the use of the vaccine in only high-risk populations -- healthcare workers, for example -- until the full phase 3 data are available.
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Source Fool.com
