Peter Marks on Covid-19 vaccine efficacy, EUAs and challenge trials
A week after the FDA issued guidance on vaccines to prevent 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.
Efficacy and approval
In its guidance, FDA said it expected sponsors to demonstrate a vaccine is at least 50% effective in a placebo-controlled trial, with an adjusted lower bound of >30%.
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