White House backs new FDA guidelines for vetting COVID-19 vaccines
The White House has endorsed new safety standards for coronavirus vaccines after initially opposing the guidelines — which make it unlikely that a shot will be cleared before Election Day, according to several reports.
The Food and Drug Administration on Tuesday published the standards, which require drug makers to follow trial participants for at least two months to rule out safety issues, including negative side-effects, before requesting emergency approval.
The guidelines were proposed by the agency two weeks ago, but White House officials opposed the plan based on the two-month data requirement, arguing there was “no clinical or medical reason,” according to The Associated Press.
President Trump has previously said he would like a vaccine to be ready before the presidential election on Nov. 3, and argued last month that the FDA proposal might have been “a political move more than anything else.”
White House officials declined to sign off on the guidelines during talks with FDA officials, sources told The Wall Street Journal.
But the administration officials eventually cast aside objections and backed the plan, officials told the Journal and USA Today.
FDA Commissioner Stephen Hahn said in a statement that he hoped the guidelines would help “the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy.”
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