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

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Trump claims White House can overrule FDA’s attempt to toughen guidelines for coronavirus vaccine

President Donald Trump claimed Wednesday that the White House could override the US Food and Drug Administration if the agency released tougher standards for the authorization of a Covid-19 vaccine, casting such a move as “political.”



Donald Trump wearing a suit and tie


© MANDEL NGAN/AFP via Getty Images


His comments come as the FDA considers new Covid-19 vaccine guidelines that would likely push an authorization beyond Election Day, according to three sources familiar with the situation. That timeline would dash Trump’s hopes of a pre-election authorization, having repeatedly said the vaccine could be ready by November 3.

“We’re looking at that and that has to be approved by the White House. We may or may not approve it,” the President said of the new FDA guidelines at a White House news conference. “That sounds like a political move.”

The FDA “respectfully” declined to comment on Trump’s claims. But generally speaking, agency guidelines do go through the White House Office of Management and Budget review process, an FDA official told CNN Wednesday.

In the meantime, the President’s comments are sure to fuel new unease in a vaccine process that was already being greeted with skepticism by many Americans in polls. A lack of trust in the program is a nightmare scenario, public health experts say, since a vaccine is the best hope of eventually ending the pandemic and restoring normal life.

Earlier Wednesday, the commissioner of the FDA, Dr. Stephen Hahn, made a commitment to America that the “FDA will not authorize or approve a vaccine that we would not feel comfortable giving to our families.”

“FDA will not authorize or approve any Covid-19 vaccine before it has met the agency’s rigorous expectations for safety and effectiveness. Decisions to authorize or approve any such vaccine or therapeutic will be made by the dedicated career staff at FDA, through our thorough review processes, and science will guide our decisions,” Hahn specifically promised the Senate Health Committee.

“FDA will not permit any pressure from anyone to change that,” he added.

National Institutes of Health Director Dr. Francis Collins told CNN’s Wolf Blitzer on “The Situation Room” that he trusts the FDA to apply the highest safety and efficacy standards to all the coronavirus vaccines, though he conceded that he wasn’t sure if the FDA or White House had the final say on vaccine approval.

“I am not a lawyer or a constitutional scholar,” he said. “I actually don’t know the answer to that.”

Two former FDA commissioners previously told CNN that while they think it’s very unlikely that Trump could pressure scientists into authorizing or approving a Covid-19 vaccine, it’s possible. The Department of Health and Human Services has in the past overruled the FDA’s recommendations on medications.

Despite reassurances from federal officials, there are fears that the typical pathway for review and approval of the Covid-19 vaccine will be eschewed, or at least bent, because of political pressure.

“What I’m concerned about is there could be a gray zone where a vaccine looks partially protective and it

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Trump Says White House Could Veto FDA’s Vaccine Rules

(Bloomberg) — President Donald Trump signaled that he could overrule any tightening of U.S. rules for the emergency clearance of a coronavirus vaccine, a move that could increase concerns that the race to find a Covid-19 shot is being politicized ahead of the presidential election.



Donald Trump wearing a suit and tie: U.S. President Donald Trump speaks during a news conference in the James S. Brady Press Briefing Room at the White House in Washington, D.C., U.S., on Wednesday, Sept. 23, 2020.


© Bloomberg
U.S. President Donald Trump speaks during a news conference in the James S. Brady Press Briefing Room at the White House in Washington, D.C., U.S., on Wednesday, Sept. 23, 2020.

The Food and Drug Administration is expected to soon issue final guidelines for an emergency-use authorization. Regulators and drugmakers have in recent weeks vowed to adhere to science, not politics, in deciding when a vaccine is ready to reach the market.

At a news conference on Wednesday, Trump said it “sounds like a political move” when asked whether the FDA was considering stricter standards for an authorization, suggesting that the White House could intercede if it thought the agency was too rigorous.

“That has to be approved by the White House,” Trump said. “We may or may not approve it.”

A representative for the FDA declined to comment.

If a vaccine shows promising early signs of being safe and effective, it could be allowed to reach the market on an emergency basis before full results from a clinical trial are available. Companies including Pfizer Inc., Moderna Inc., AstraZeneca Plc and Johnson & Johnson have vaccine candidates in late-stage clinical trials. Some of those studies could produce efficacy data as soon as October.

Trump is trailing Democrat Joe Biden in polls ahead of the November election, with surveys showing that a majority of Americans disapprove of the president’s handling of the virus. Trump has sought to focus on other topics while claiming that his administration is doing a good job handling the virus.

The president has been promising that a coronavirus vaccine will be approved within weeks — a gambit to turn a pandemic inoculation into an October surprise for his struggling re-election campaign.

Trump and his supporters have also questioned whether government employees are trying to sabotage his efforts to combat the virus. In August, the president attacked the FDA for harboring “deep state” staff slowing vaccine and drug work to hurt him politically. There’s no evidence that’s the case.

Read more: Covid Vaccine to Be Widely Available by April, CDC Chief Says

FDA officials have indicated they would hold a vaccine to a higher standard than other medications that typically receive emergency waivers from the agency.

Peter Marks, head of the agency’s biologics office, earlier this month described what he called an EUA-plus program that would accelerate the review of a vaccine but require data standards similar to those that are used when the FDA is considering a full approval.

Marks also said at the time that the FDA would like companies to have a median of two months of follow-up on trial participants after they receive the vaccine.

“That’s what we’re hoping for,” Marks said. “Most adverse events will happen

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