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Trump: FDA Vaccine Rules Are a 'Political Hit Job'

With 2-month observation period, pre-election authorization is unlikely
By Arden Dier,  Newser Staff
Posted Oct 7, 2020 6:36 AM CDT

(Newser) – The Trump administration has signed off on FDA guidelines for a thorough coronavirus vaccine review, which is likely to delay authorization until after Election Day, per the Wall Street Journal. Though officials had initially blocked the guidelines, per the AP, a senior administration official tells the Journal that the White House approved them without changes on Tuesday—two weeks after they were received, per the Guardian. The FDA then issued the guidelines, which require a vaccine to lower the rate of COVID-19 in study participants by 50% or better compared with a placebo, as well as a two-month observation of anyone given the vaccine. President Trump wasn't happy. "New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!" he tweeted, tagging FDA Commissioner Stephen Hahn.

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White House chief of staff Mark Meadows and the Office of Management and Budget had refused to sign off on the guidelines for emergency-use authorization, to last until the end of the pandemic, according to the Journal's reporting, though an OMB rep denies that. Meadows reportedly questioned why the FDA was altering vaccine standards in place for decades. But the FDA—which has authorized emergency use of only one vaccine, an anthrax shot in 2005—said it would push ahead with the guidelines in spite of the opposition and had forwarded the information to vaccine producers. It sought White House approval largely to reassure the public, per the Journal. In a Tuesday statement, Hahn said he hoped the release would help "the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy." (Read more coronavirus vaccine stories.)

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