FDA to release guidance on vaccine approval

Katie Adams –
Tuesday, June 30th, 2020
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The FDA will discuss its guidance on vaccine approval during a June 30 appearance before a Senate committee, according to The Wall Street Journal.

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Stephen Hahn, MD, the firms commissioner, will provide the standards in a hearing before a Senate committee held to regulate the economys resuming.

To be approved, any vaccine must be at least 50 percent more reliable than a placebo and clearly demonstrate its safety in a scientific research study. The FDA will not authorize a vaccine if it only produces antibodies in clients blood, as the level of antibodies needed to guarantee protection versus COVID-19 is unidentified.

The FDA also told The Wall Street Journal it would need the drugmaker of any approved vaccine to monitor patients for a year after they get it.

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