“In the general process, the industry will not talk to the White House about this at all,” said John Moore, a professor of microbiology and immunology at Will Cornell Medical College. “The White House will again obscure and muddy the water on all of this.”
Trump repeatedly cut off his eagerness to deliver the vaccine before Nov. 3, and one drugmaker – Pfizer – has said he can still reach that timeline. During last week’s presidential debate, Trump went so far as to insist that he was assured that the coronavirus vaccine could be ready in a week.
“I’ve talked to Pfizer, I’ve talked to everyone I have to talk to – Moderna, Johnson and Johnson and others,” he said, refuting allegations by his own health officials that the vaccine may not be available. Will be available until the end of the year. “They can move faster than that.”
Trump’s claims prompted Pfizer CEO Albert Bourla to publish a memo from staff deciding on race politics, although he also criticized “arguing for delays” and sticking to his November target – writing that “we are getting closer to our goal.” And even though there is no political ideology with the date of our pre-announcement, we Going into the crucible of the presidential election. ”
FDA Commissioner Stephen Hahn and other agency officials have long been concerned about the appearance of political interference in the vaccine authorization process. He felt that setting stricter standards and making them public would convince Americans that science, not politics, was running the process. Public confidence in the vaccine is crucial to ensuring that enough people take shots to build widespread mob immunity against Covid-19.
But in an initial conversation about the new guidelines, current and former administration officials told POL Litoco in the White House Office of Information and Regulatory Affairs – which oversees all federal legislation – highlighting industry objections to key issues with the new standards.
White House Chief of Staff Mark Meadows later expressed similar concerns to Hahn, two officials said.
Shortly afterwards, Trump dismissed the FDA’s proposed new guidelines during a Sept. 23 press briefing as a “political move more than anything else” and threatened to reject them, pushing the FDA’s career scientists forward in the process.
The agency has since submitted additional justices to the White House to revise its standards and make them public. Also Over the past week White House officials have continued to question the need for more stringent guidelines, with a senior administration official explaining why the FDA will change its criteria so late in the process and why the coronavirus vaccine should meet stricter standards than others. Vaccines.
The FDA has responded that it has indicated that it will keep the Covid-19 vaccine on a higher bar in view of the epidemic and the need to re-create the belief that the Covid-19 vaccine will be made science-based.
Yet it is hard to believe that such an argument is creeping up on the White House. Rather than Trump’s fixation on vaccine protection in the week, the FDA has low expectations that new standards have ever been officially released, as announcing the benchmark would make it clear that vaccine authorization by election day is almost impossible, said three people familiar with the process. .
“It’s a toast,” a senior administration official said of the FDA’s proposal.
On Monday the White House did not respond to questions about guidance and the impact pharmaceutical companies make on its decision-making. Earlier declined to comment on Trump’s conversation with vaccine developers.
An FDA spokesman said the revised vaccine guideline is under review, but whether it is made public will not affect how the agency evaluates the vaccine for emergency authorization. The spokesman said the FDAA has “already communicated with individual producers about its expectations, the agency that intends to consider the data and what we expect to see,” the spokesman said.
