Great read on the latest COVID-related regulatory developments, namely the FDA’s announcement on treatment efficacy thresholds for upcoming vaccines.
A week after the US Food and Drug Administration (FDA) issued guidance on vaccines to prevent coronavirus disease (COVID-19), Peter Marks, director of the Center for Biologics Evaluation and Research, shed light on the reasoning behind the agency’s 50% efficacy threshold and where the agency stands on challenge trials and emergency use authorizations (EUAs).
Source: Marks on COVID-19 vaccine efficacy, EUAs and challenge trials | RAPS
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