Report: White House Blocking More Stringent FDA Guidelines On Covid-19 Vaccine Approval

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Report: White House Blocking More Stringent FDA Guidelines On Covid-19 Vaccine Approval
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The new guidelines call for tracking volunteers in late-stage clinical trials for around two months after the final dose of the vaccine is administered in order to ensure no severe side-effects and adequate immunity from the virus.

Trump previously cast doubt on whether the White House would approve the guidelines, alleging on September 23 that it"was a political move more than anything else."

The guidelines would make it highly unlikely a vaccine would be approved by the November presidential election, an especially abbreviated timeline that Trump has frequently touted as possible, contradiction public health experts and vaccine developers who generally expect approval by the end of the year and distribution later in 2021 at the earliest.

One of the frontrunners to develop a coronavirus vaccine, Moderna, tempered expectations by stating that it may know its vaccine is safe enough to apply for an emergency use authorization by November 25, adding that it wouldn't expect approval until late first quarter or early second quarter of 2021.

Whether the guidelines are approved by the White House or not, they could be taken into account by an independent expert committee that advises in the approval process, according to the. The politicization of coronavirus vaccine development has fueled worries around the efficacy and safety of candidates, with a YouGov poll published in early September finding that 65% of U.S. adults surveyed would consider an immunization available this year"rushed through.

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