To be approved, any vaccine must be at least 50 percent more effective than a placebo and clearly demonstrate its safety in a clinical study. The FDA will not approve a vaccine if it only produces antibodies in patients’ blood, as the level of antibodies needed to ensure protection against COVID-19 is unknown.
The FDA also told The Wall Street Journal it would require the drugmaker of any approved vaccine to monitor patients for a year after they receive it.
Stephen Hahn, MD, the agency’s commissioner, will deliver the guidelines in a hearing before a Senate committee held to regulate the economy’s reopening.
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