White House Stops FDA From Issuing High Vaccine Safety Standards For EUA
The bar set by the proposed guidelines would have been hard for any vaccine maker to clear by the Nov. 3 election. President Donald Trump has pinned much of his re-election campaign message on a vision that a COVID-19 vaccine would secure FDA emergency use authorization by that date.
The New York Times:
White House Blocks New Coronavirus Vaccine Guidelines
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. 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. The hope is that the committee will enforce the guidelines, regardless of the White House’s reaction. (LaFraniere and Weiland, 10/5)
White House Nixes Updated FDA Guidelines On Vaccine Approval
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. (Miller and Perrone, 10/6)
White House Blocks New FDA Coronavirus Guidelines That May Have Delayed Vaccine: Report
The FDA first submitted the proposal for new guidelines in late September, but they were immediately rebuffed by President Trump and top officials who worried it would delay the release of a vaccine as Trump's "Operation Warp Speed" has sought to quickly move one through the approval process. (Seipel, 10/5)
White House Cited Drug Companies’ Objections In Overruling FDA’s Vaccine Standards
A White House decision to halt release of new standards for emergency authorization of a Covid-19 vaccine came after officials close to President Donald Trump told the FDA that the pharmaceutical industry had objected to the tougher requirements, according to three people with knowledge of the situation. The White House cited the private-sector opposition as a chief reason for blocking the guidelines, which aim to hold companies’ vaccines to a higher bar for safety and effectiveness and would likely push any authorization beyond Election Day, they said. (Cancryn, 10/5)
In other vaccine news —
Donald Trump Says COVID-19 Vaccines Coming 'Momentarily.' They're Not.
President Donald Trump, back at the White House days after being diagnosed with COVID-19, said vaccines in the fight against the coronavirus pandemic are coming "momentarily." Doctors and scientists have repeatedly refuted that claim. Trump, speaking in a video posted to Twitter after leaving the Walter Reed National Military Medical Center on Monday, said he felt "better than 20 years ago" after praising the medicines and equipment involved in his treatment. Earlier in the day, he said people shouldn't be afraid of COVID-19, and said, "Maybe I'm immune, I don't know," during Monday night's video. In the video, Trump also said, "The vaccines are coming momentarily." (Culver, Weise and Weintraub, 10/5)
Just Over Half Say They Would Get Low-Cost Vaccine If Available: Poll
Slightly more than half of respondents said they would get a low-cost coronavirus vaccine if it were available, according to a poll released on Monday. The CNN survey conducted by SPSS found that 51 percent of American adults said they would try to get inoculated if a low-cost vaccine was made available. Forty-five percent of respondents said they would not, and 4 percent were undecided or refused to answer the question. (Coleman, 10/5)