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.
The fact that the president was siding with drug makers over his own regulators in shelving the guidance – which has not been previously reported – adds a new dimension to concerns about White House interference in the FDA, which has continued to insist that any decision on whether to approve a coronavirus vaccine will be based on scientific benchmarks alone.
“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 on securing a vaccine within weeks has instead left the FDA with little expectation the new standards will ever be officially released, because publicizing the benchmarks would make it clear a vaccine authorization by Election Day is nearly impossible, three people familiar with the process said.
“It’s toast. It’s done,” the senior administration official said of the FDA proposal.
The White House on Monday did not respond to questions about the guidance and the influence that pharmaceutical companies have had on its decision-making. It previously declined to comment on Trump’s conversations with vaccine developers.
An FDA spokesperson said the revised vaccine guidance remains under review, but whether it’s made public or not won’t affect how the agency evaluates vaccines for emergency authorization. The FDA has “already communicated with individual manufacturers about its expectations, the data the agency intends to consider and what we expect to see,” the spokesperson said.
Of the four companies with vaccines in final-stage trials, only Pfizer believes it may know whether its candidate is safe and effective before the election – a finding that could put the company well ahead in the lucrative race to be first to market, and match up with Trump’s preferred timeline.
But if it were held to the tougher guidelines sought by the FDA, Pfizer would need to track its vaccine trial participants for a median of two months after receiving their final dose to qualify for an emergency authorization, in addition to passing a series of other more thorough safety and efficacy tests.
The company began its trial in July and took roughly a month to enroll half the necessary participants. Those people would not get their final shot until three to four weeks later, putting them well into September. Tacking on another two months from there makes it appear unlikely Pfizer would have enough data to evaluate its vaccine until after the election.
“The chance of this happening before Nov. 3 is getting lower,” Eric Topol, director of the Scripps Research Translational Institute, said of an emergency authorization under that standard. “And it was already slim.”
Pfizer spokesperson Sharon Castillo told POLITICO that the company speaks regularly with Trump and other White House officials about health policy issues including its work on a Covid-19 vaccine.
She declined to provide specifics of Pfizer’s conversations with Trump, but said the company has not voiced objections to the FDA’s plan for more stringent guidelines, and has pledged publicly to abide by the standards the agency sets out.
“When it comes to developing and testing our vaccine candidate, there are only two considerations guiding our work, and that is safety and efficacy,” Castillo said, characterizing Pfizer’s communications with the White House as standard check-ins “that were happening before Covid, are happening during Covid and will continue to happen after Covid.”
Moderna and Johnson & Johnson, the two other companies Trump said last week he had spoken with, did not respond to requests for comment.
AstraZeneca – which is also in final-stage trials – did not address questions about whether it had spoken with Trump, saying only that it “is committed to working with governments and key partners to ensure we develop and gain regulatory approval for an effective vaccine as quickly as possible.”
The White House’s references to private-sector pushback have in the meantime puzzled FDA officials, who say the agency itself never came under similar pressure from vaccine developers.
In fact, a memo on the revised guidelines that the FDA presented to health secretary Alex Azar just prior to sending them to the White House included a prediction that new standards would be “widely welcomed” by the industry, two people with knowledge of the document said.
White House officials have not specified to the FDA which companies or groups raised concerns. And in the past week, executives from Johnson & Johnson and Merck, as well as the trade group BIO expressed support for publishing the updated requirements.
“The release of the FDA guidance would provide scientists and researchers greater regulatory clarity and strengthen public confidence in any future vaccine that may be authorized or approved,” BIO CEO Michelle McMurry-Heath wrote Azar in an Oct. 1 letter on behalf of the group’s members, which include every company involved in the vaccine race except AstraZeneca.
Those developments have spurred competing theories within the FDA, with some officials now suspecting the White House is exaggerating the level of industry opposition to justify vetoing release of guidelines that might undercut Trump’s campaign message that the pandemic is close to being over.
Others wondered whether the pharmaceutical industry did indeed lobby the White House, and is only now expressing support to distance itself from the politicization of standards that the FDA insists it will enforce anyway.
“The companies know what we’re expecting,” Peter Marks, who heads the FDA office overseeing vaccine approvals, said Sept. 30 of the agency’s revised guidelines. “The guidance was trying to explain that, explain what we expected and to reassure the public.”
The industry’s public backing has nevertheless bolstered the FDA’s resolve to disseminate the guidelines viewed by some in the agency as crucial to its credibility, even if it means inviting yet another showdown with Trump and his top aides.
In recent days, FDA officials went as far as to discuss how they could effectively publicize the standards without official approval from the White House, a senior administration official said, through a combination of direct conversations with vaccine developers and information posted strategically to the FDA’s website.
“The goal is to get all the information out in its totality,” the official said. “So what remains to be seen is whether that’s going to infuriate the White House.”