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White House nixes updated FDA guidelines on vaccine approval

WASHINGTON (AP) — The White House has blocked new Food and Drug Administration guidelines on bringing potential vaccines for COVID-19 to market that would almost certainly have prevented their introduction before the Nov. 3 election.

At issue was the FDA’s planned instruction that vaccine developers follow patients enrolled in their trials for at least two months to rule out safety issues before seeking emergency approval from the agency. A senior administration confirmed the move Monday evening, saying the White House believed there was “no clinical or medical reason” for the additional requirement.

WATCH: Trump says he has final vaccine approval, not FDA

The White House action was first reported by The New York Times.

The intervention by Trump officials is the latest example of the administration undercutting its own medical experts working to combat the pandemic that has killed more than 210,000 Americans.

FDA Commissioner Stephen Hahn has been attempting to shore up public confidence in the FDA’s vaccine review for weeks, vowing that career scientists, not politicians, will decide if the shots are safe and effective for mass vaccination.

But President Donald Trump has repeatedly insisted that a vaccine could be authorized before Election Day, even though top government scientists working on the administration’s vaccine effort have stated that that timeline is very unlikely.

Last week seven former FDA commissioners blasted the administration for “undermining the credibility” of the FDA in a Washington Post op-ed and called for the release of the pending vaccine guidelines. The former FDA chiefs warned that public fears that a vaccine was rushed out for political reasons could derail efforts to vaccinate millions of Americans.

The senior administration official, who spoke on the condition of anonymity to discuss the action, said the White House was intent on getting a safe vaccine to market and wanted to make sure “additional loopholes” weren’t added that would slow down the process.

Beyond the damaging optics of overruling its own FDA, the practical impact of the White House move against the guidelines could be relatively limited.

Only one drugmaker, Pfizer, has suggested it could have data on the safety and effectiveness of its vaccine before Election Day. And a number of variables would still have to align for the company to submit, and the FDA to review and greenlight, a vaccine application before Nov. 3. Pfizer’s competitors Moderna, AstraZeneca and Johnson & Johnson are working on longer research timelines.

Additionally, FDA scientists have been discussing the contents of the guidelines publicly for weeks and have made clear that the recommendations have already been shared with each of the vaccine developers.

“There’s no there there to get all excited about this guidance,” said Dr. Peter Marks, the head of FDA’s vaccine division, in an online interview last week with the nonprofit Friends of Cancer Research. “The companies know what we’re expecting.”

Instead, Marks said, releasing the guidelines was

RockFit Reviews – Legit RockFit Smart Fitness Tracker Watch? [Updated]

10/01/2020, Homewood // KISSPR //

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There are