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U.S. FDA to tighten coronavirus vaccine trial standards -paper

by Reuters
Tuesday, 22 September 2020 20:06 GMT

Sept 22 (Reuters) - The U.S. Food and Drug Administration is expected to soon announce new, higher standards for an emergency authorization of a coronavirus vaccine, lowering the chances that a vaccine might be cleared before the Nov. 3 election, the Washington Post reported on Tuesday.

The agency is issuing the guidance to boost transparency and public trust as health experts have become increasingly concerned that the Trump administration might be interfering in the approval process, the paper said.

According to the report, the FDA is expected to ask vaccine manufacturers seeking an emergency authorization to follow trial participants for a median of at least two months after they receive a second vaccine shot. It also said the agency is asking that trials identify a specific number of cases of severe COVID-19, the disease caused by the coronavirus, in patients treated with a placebo.

(Reporting By Deena Beasley Editing by Marguerita Choy)

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