Morning Briefing
Summaries of health policy coverage from major news organizations
White House Stops FDA From Issuing High Vaccine Safety Standards For EUA
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 鈥 perhaps as soon as this week 鈥 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鈥檚 reaction. (LaFraniere and Weiland, 10/5)
At issue was the FDA鈥檚 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 鈥渘o clinical or medical reason鈥 for the additional requirement. (Miller and Perrone, 10/6)
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)
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鈥 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 鈥
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."聽Doctors and scientists have repeatedly refuted that claim.聽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.聽In the video, Trump also said, "The vaccines are coming momentarily."聽 (Culver, Weise and Weintraub, 10/5)
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聽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)