Thread by @highbrow_nobrow

BREAKING

1. The White House is blocking new coronavirus vaccine guidelines from the FDA over concerns they will push emergency authorization past the November election.

President Trump has said repeatedly that a vaccine would be ready by Nov. 3.
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2. At issue is the recommendation that authorization not be granted until volunteers who participated in the vaccine clinical trials have been followed for a median of two months after receiving their final dose.
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3. The FDA submitted the guidelines to the Office of Management and Budget over two weeks ago, but they are hung up in the office of White House chief of staff Mark Meadows over political concerns.
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4. FDA officials later explained further to the White House “that the two-month follow-up was necessary to identify possible side effects and ensure that a vaccine’s protection against Covid-19…was not short-lived.” (NYT)
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5. The White House blockade has not yet budged, so the FDA is seeking other avenues to make sure the vaccines meet new guidelines. This includes sharing the standards with an outside advisory committee of experts.
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6. FDA officials hope the committee, which is supposed to meet publicly prior to the emergency authorization of any vaccine, will enforce the guidelines no matter the White House’s reaction.
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7. “By refusing to allow the Food and Drug Administration to release them, the White House is undercutting the government’s effort to reassure the public that any vaccine will be safe and effective, health experts fear.” (NYT)
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8. “A survey published last month by the Pew Research Center found that 51 percent of Americans would either probably or definitely take one, down from 72 percent in May.” (NYT)
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9. Per the NYT, “Some vaccine makers, including Johnson & Johnson, have publicly indicated that they will follow the agency’s recommendations, regardless of the White House’s actions.”
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10. The most likely candidates for receiving any vaccine that achieves emergency authorization are high-risk populations like health care workers.
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