The FDA plans to require that any Covid-19 vaccine be at least 50% more effective than a placebo to gain approval
WASHINGTON—The Food and Drug Administration released guidance Tuesday outlining its conditions for approving a Covid-19 vaccine, including a requirement that any vaccine be at least 50% more effective than a placebo in preventing the disease.
The FDA said that no vaccine would be approved unless a vaccine company had “clearly demonstrated” proof of a vaccine’s safety and effectiveness through a clinical study, according to the guidance.
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