White House Blocks New Coronavirus Vaccine Guidelines - The New York Times - 0 views
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The F.D.A. proposed stricter guidelines for emergency approval of a coronavirus vaccine, but the White House chief of staff objected to provisions that would push approval past Election Day.
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The vaccine guidelines carry special significance: 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.
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A main sticking point has been the recommendation that volunteers who have participated in vaccine clinical trials be followed for a median of two months after the final dose before any authorization is granted, according to a senior administration official and others familiar with the situation, who spoke on the condition of anonymity
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The testing and release of a vaccine is an issue that has gained wide national attention. Mr. Trump has repeatedly misrepresented how quickly a vaccine might be available to most Americans, promising a major breakthrough in vaccine development as early as this month.
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Staff members at the budget office scrutinize the documents for statements that could undercut the president’s public message that the administration either has the pandemic under control or will soon, according to former and current federal officials.
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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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In addition to the two-month follow-up period, the guidelines stated that there should be at least five cases of severe infection in the placebo group as evidence that a vaccine is effective in preventing more than just mild to moderate illness. About 10 percent of Covid-19 cases are considered severe.
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Top White House officials are blocking strict new federal guidelines for the emergency release of a coronavirus vaccine, objecting to a provision that would almost certainly guarantee that no vaccine could be authorized before the election on Nov. 3, according to people familiar with the approval process.
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Facing a White House blockade, the Food and Drug Administration is seeking other avenues to ensure that vaccines meet the guidelines. That includes sharing the standards — perhaps as soon as this week — with an outside advisory committee of experts that is supposed to meet publicly before any vaccine is authorized for emergency use.
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The Food and Drug Administration submitted the guidelines to the Office of Management and Budget for approval more than two weeks ago, but they stalled in the office of Mark Meadows, the White House chief of staff. Their approval is now seen as highly unlikely.
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“The public must have full faith in the scientific process and the rigor of F.D.A.’s regulatory oversight if we are to end the pandemic,”
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Mr. Trump publicly cast doubt on whether the guidance would be approved. “We may or may not approve it,” he said, suggesting that the regulatory action “was a political move more than anything else.”
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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.