White House cited drug companies’ objections in overruling FDA’s vaccine standards

“In a normal procedure, the industry wouldn’t be talking at all to the White House about this,” said John Moore, a professor of microbiology and immunology at Weill Cornell Medical College. “The White House again is blurring and muddying the waters on all of this.”

Trump has repeatedly telegraphed his eagerness to deliver a vaccine before Nov. 3, and one drug maker – Pfizer – has said it could still meet that timeline. During last week’s presidential debate, Trump went as far as to assert he’d been personally assured a coronavirus vaccine could be ready within weeks.

“I’ve spoken to Pfizer, I’ve spoken to all of the people that you have to speak to – Moderna, Johnson & Johnson and others,” he said, dismissing his own health officials’ projections that a vaccine likely won’t be available until the end of the year. “They can go faster than that by a lot.”

Trump’s claims prompted Pfizer CEO Albert Bourla to publish a staff memo decrying the politicization of the vaccine race, though he also criticized those “who argue for delay” and stuck to his pre-November target – writing that “we are approaching our goal and despite not having any political considerations with our pre-announced date, we find ourselves in the crucible of the U.S. Presidential election.”

The appearance of political interference in the vaccine authorization process has long worried FDA Commissioner Stephen Hahn and other agency officials. They felt that setting more stringent standards and releasing them to the public would reassure Americans that science, not politics, was driving the process. Public trust in a vaccine is crucial to ensuring that enough people take the shots to create a broader herd immunity against Covid-19.

But in initial conversations about the new guidelines, current and former administration officials told POLITICO the White House’s Office of Information and Regulatory Affairs – which oversees all federal rulemaking – highlighted industry objections as among the key problems with the new standards.

White House Chief of Staff Mark Meadows later conveyed similar concerns to Hahn, two officials said.

Soon afterward, Trump during a Sept. 23 press briefing dismissed the FDA’s proposed new guidelines as “a political move more than anything else” and threatened to reject them, overriding the FDA’s career scientists in the process.

The agency has since submitted additional justifications to the White House for revising its standards and making them public. But White House officials over the past week continued to raise doubts about the need for more stringent guidelines, a senior administration official said, including questioning why the FDA would alter its criteria so late in the process and why a coronavirus vaccine should face tougher standards than other vaccines.

The FDA has countered that it previously signaled it would hold Covid-19 vaccines to a higher bar given the stakes of the pandemic and the need to rebuild public confidence that any emergency authorization will be grounded in science.

Yet there is little belief those arguments are swaying the White House. Trump’s fixation

Read more

Trump, White House demand FDA justify tough standards for coronavirus vaccine, raising concerns of political interference

The White House’s involvement appears to go beyond the perfunctory review that agency officials had expected, and is likely to reinforce public concerns that a vaccine may be rushed to benefit the president’s reelection campaign. Polls show that the number of people who say they’re willing to take a coronavirus vaccine if it were available today has nosedived from 72 percent in May to 50 percent as of early this month, according to Pew Research Center, largely because of concerns that politics, rather than science, is driving the process.

Trump has repeatedly said a vaccine would be available by Election Day, or possibly sooner, worrying scientists that he might attempt to intervene in the review process. Companies will begin reporting safety and effectiveness data in coming weeks and months. And in conversations with some advisers, the president has directly tied the vaccine to his reelection chances, according to a senior administration official, who spoke on the condition of anonymity to discuss private deliberations.

The White House’s decision to weigh in on the FDA plan was assailed by former FDA commissioners who had served both Republican and Democratic presidents.

“I don’t know of any precedent where the White House asked to adjudicate scientific and clinical guidances, even in past public health emergencies,” said Scott Gottlieb, Trump’s first FDA commissioner. “To build trust among patients and providers, you wanted to leave these matters to the FDA process, which has a lot of rigor and integrity.”

Robert Califf, commissioner under President Barack Obama, said White House officials lack the expertise to assess the FDA’s safety protocols. “For the president to weigh in is not good,” he said, “and it sets a precedent, which is worrisome in many regards, and makes you worry about what he’ll do about the decision itself about individual vaccines.”

The push from the White House comes during a week in which top health administration officials, including FDA Commissioner Stephen Hahn, vowed there would be no political interference in the vaccine approval process and sought to boost public trust in the process.

So far, the White House has not asked the FDA to withdraw or change the guidance for an emergency authorization of the vaccine — a far quicker process than a formal approval that gives the FDA the flexibility to set a lower bar for safety and effectiveness. The agency expects to use the process because of the urgency of the situation. In a Wednesday phone call, White House Chief of Staff Mark Meadows told Hahn the agency had to provide the detailed justification for the guidance, according to two people familiar with the call who spoke on the condition of anonymity to discuss internal deliberations.

The FDA, which had planned to release the guidance this week, instead has been working on detailed scientific justifications for the questions raised by White House officials, according to two people who spoke on the condition of anonymity to discuss internal deliberations. White House officials are especially interested in the agency’s recommendation

Read more