FDA poised to announce tougher standards for a COVID-19 vaccine that make it unlikely one will be cleared by Election Day

Washington Post

23 September 2020 - The guidance is part of an effort to boost transparency and public trust as polls show many are skeptical a vaccine will be safe and effective.

The Food and Drug Administration is expected to spell out a tough new standard for an emergency authorisation of a coronavirus vaccine as soon as this week that will make it exceedingly difficult for any vaccine to be cleared before Election Day.

The agency is issuing the guidance to boost transparency and public trust as it approaches the momentous decision of whether a prospective vaccine is safe and effective. Public health experts are increasingly worried that President Trump’s repeated predictions of a coronavirus vaccine by 3 November, coupled with the administration’s interference in federal science agencies, may prompt Americans to reject any vaccine as rushed and potentially tainted.

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Michael Wonder

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Michael Wonder

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US , Regulation , Timelines , Vaccine , COVID-19