As White House approves vaccine guidelines, Trump sees conspiracy

It was two weeks ago today when Donald Trump first raised the prospect of rejecting strict FDA guidelines on possible coronavirus vaccines. “That has to be approved by the White House,” the president said. “We may or may not approve it.”

Around the same time, the Republican suggested FDA officials were conspiring against him, “delaying” the vaccine as part of a pre-election “political hit” against him.

It was against this backdrop that the public learned this week that White House officials were, in fact, blocking the tougher federal vaccine guidelines. That is, until yesterday, when the White House relented and released the stricter standards.

The Food and Drug Administration said Tuesday that manufacturers of Covid-19 vaccines will need to follow tens of thousands of study participants for at least two months to look for any possible safety issues before the agency would consider authorization…. The FDA will require two months of follow-up for at least half of the study participants after they receive their last doses of vaccine. The vaccine candidates furthest ahead in phase 3 clinical trials, from Moderna and Pfizer, each require two doses, given about one month apart.

This will, among other things, make it impossible for a vaccine to be available before Election Day, which had been a presidential priority.

With this in mind, Trump returned to Twitter last night, writing, “New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!”

Just so we’re all clear, Trump believes FDA officials are only pretending to care about vaccine safety, and the agency has actually issued strict guidelines as part of a political scheme. The president also apparently believes that his own White House is part of the “hit job,” since it was White House officials who yesterday cleared the new standards for public release.

I can’t say whether Trump’s medications are affecting his judgment or not, but I can say it’s weird to see a sitting president denounce a public-health decision made by his own team.

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Trump claimed, without justification, that new tighter FDA vaccine guidelines were a ‘political hit job,’ hours after the White House approved them



a man wearing a suit and tie: President Donald Trump removes his mask upon return to the White House from Walter Reed National Military Medical Center on October 5, 2020 in Washington, DC. Win McNamee/Getty Images


© Win McNamee/Getty Images
President Donald Trump removes his mask upon return to the White House from Walter Reed National Military Medical Center on October 5, 2020 in Washington, DC. Win McNamee/Getty Images

  • Trump claimed the Food and Drug Administration’s (FDA’s) tougher guidelines for COVID-19 vaccine developers are a “political hit job” on him.
  • The White House approved the new regulations on Tuesday.
  • The FDA says that before vaccine makers submit an emergency-approval application they should follow trial participants for at least two months after a final dose.
  • These stricter guidelines will most likely prevent any vaccine being approved before the presidential election on November 3 — a deadline Trump had hoped vaccine makers could hit.
  • Visit Business Insider’s homepage for more stories.

President Donald Trump has accused the Food and Drug Administration (FDA) of launching a “political hit job” on him, hours after the White House accepted the regulator’s stricter guidelines for coronavirus vaccine developers.

Trump has consistently said he hopes to have a vaccine ready before election day, but the new FDA guidelines will make it difficult for any COVID-19 vaccine to be approved before the November 3 vote. 

He lashed out at the FDA in a tweet on Tuesday evening, tagging commissioner Stephen Hahn.

He did not offer any evidence for his claim the new guidelines were motivated by politics.

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The tougher guidelines were cleared by the Office of Management and Budget on Tuesday after a two-week hold-up, during which they were reportedly blocked by senior White House officials, including Mark Meadows, chief of staff.

In the guidelines, the FDA said that before vaccine makers submit an emergency-approval application they should monitor trial participants for a minimum of two months after their final dose in phase-three clinical trials. The agency also expects vaccine developers to document five cases of severe infection in volunteers who took the placebo instead of the vaccine.

Four vaccines have entered the final stage of testing in the US, including one from Pfizer and one from Moderna. The two companies kicked off their trials in July.

Volunteers usually receive their second dose less than a month after their first, but two months of monitoring make it unlikely that either company will have have enough data before November.

Moderna’s CEO said on September 30 that the firm wouldn’t be able to submit an application for emergency approval until late November at the earliest, as it wouldn’t have enough safety data, per the Financial Times.

Coronavirus has claimed more than 210,000 lives in the US so far, and infected more than 7.5 million people.

Among those that have been infected is Trump himself: He tweeted on October 2 that he and Melania Trump had tested positive for the virus. After being flown to Walter Reed Medical Center, he received two experimental treatments to fight the infection. He has since returned to the White House, where staff are reportedly anxious about catching COVID-19 from him, per multiple

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White House OKs FDA asking for 2 months monitoring, likely delaying vaccine authorization past Election Day

The White House denied reports it had tried to block the new FDA guidance.

A spokesperson for the White House budget office denied those reports and said the approved guidance was never blocked and went through the normal review process.

Trump lashed out at the news on Twitter Tuesday night, writing, “New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!” He also tagged FDA Commissioner Stephen Hahn in the tweet.

In September, Trump had said that the White House might not approve the new guidance, given what it could mean in terms of timing. “We may or may not approve it,” he told reporters, suggesting the FDA was reacting to questions about White House pressure to act faster, saying it “was a political move more than anything else.”

The guidance was posted on the agency’s website on Tuesday and as part of a packet of background material posted ahead of the vaccine advisory board’s scheduled meeting on COVID vaccine candidates on Oct. 22.

The FDA is laying out criteria for an emergency authorization of a vaccine candidate, not a full approval, and has repeatedly sought to encourage the public it will make decisions based only on the science and data from clinical trials regardless of political pressure.

FDA officials have said they expect an emergency authorization to target specific populations at higher risk for the virus — including health care workers or older populations living in group settings — and that a vaccine would not be widely available outside those groups until into next year.

Experts including Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, have said it takes about a month and a half for some side effects or problems to present themselves.

“Most of the adverse events that you’re talking

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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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Ex-FDA leaders warn against Trump manipulation of COVID-19 vaccine

  • Seven former FDA commissioners penned an op-ed on Tuesday warning against political manipulation of the administration.
  • The commissioners, including President Trump’s first appointee and former advisor, say the White House is undermining faith in science and contributing to skepticism of a coronavirus vaccine.
  • For decades, “the public knew we were speaking on behalf of experts whose judgments were grounded in science,” the commissioners wrote. “That is changing in deeply troubling ways.”
  • “If the White House takes the unprecedented step of trying to tip the scales on how safety and benefits will be judged, the impact on public trust will render an effective vaccine much less so.”
  • Visit Business Insider’s homepage for more stories.

President Donald Trump’s first head of the Food and Drug Administration has joined six other former commissioners in warning that the White House is undermining faith in science in an apparent effort to rush out a vaccine for the coronavirus.

For decades, “the public knew we were speaking on behalf of experts whose judgments were grounded in science,” the ex-FDA leaders said in an op-ed published Tuesday by The Washington Post. “That is changing in deeply troubling ways.”

The commissioners, including former Trump campaign advisor Scott Gottlieb, cited the president’s own rejection of FDA standards for a vaccine. On Sept. 23, he declared that such standards — ensuring any vaccine meets the approval of career scientists, not just White House flacks — “sounds like a political move.” They also pointed to “acknowledged acts of political influence on the FDA’s coronavirus communications,” including the scientifically dubious emergency authorization for convalescent plasma treatment.

That, they argue, is undermining faith in the FDA and causing widespread skepticism of any Trump-approved coronavirus vaccine. Recent polls have indicated that a third of Americans would refuse to take any such inoculation.

“If the FDA makes available a safe and effective vaccine that people trust, we could expect to meaningfully reduce covid-19 risk as soon as next spring or summer,” they wrote. “Without that trust, our health and economy could lag for years.”

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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

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NIH Head Says FDA Best Judge of Vaccine Safety, After Trump Says White House Must Approve Rules

Dr. Francis Collins, director of the National Institutes of Health (NIH), has said the Food and Drug Administration (FDA) is best placed to judge whether a potential coronavirus vaccine is safe and effective. He made the remarks after President Donald Trump claimed the White House can overrule potential safety guidelines set out by the FDA.



a close up of Francis Collins wearing glasses and looking at the camera: Dr. Francis Collins, director of the National Institutes of Health, gives an opening statement during a Senate Health, Education, Labor, and Pensions Committee hearing to discuss vaccines and protecting public health during the coronavirus pandemic. September 9, 2020 in Washington DC.


© Getty
Dr. Francis Collins, director of the National Institutes of Health, gives an opening statement during a Senate Health, Education, Labor, and Pensions Committee hearing to discuss vaccines and protecting public health during the coronavirus pandemic. September 9, 2020 in Washington DC.

On Wednesday’s The Situation Room, CNN presenter Wolf Blitzer asked Collins whether the White House or the FDA has the final say on whether a coronavirus vaccine is approved.

Collins said that he did not know as he is not a lawyer, but that the FDA is in the “best” position to judge whether a vaccine is safe and effective as the agency that has the experience and scientific expertise.

“You already have a problem in this country where a lot of people are worried about whether this vaccine is going to be something that they want to take. The last thing we need to do is create another cloud of uncertainty on whether this is being done appropriately, so that we can reassure people it’s something they’d want to take advantage of,” he said.

The physician-geneticist made the comments after Trump said the White House could override FDA guidelines on the approval of a vaccine. Trump was responding to reports the FDA was considering stricter rules for an emergency use authorization (EUA) of a coronavirus

vaccine. A EUA has a lower threshold than an approval. Reports suggested this would push authorization past the November 3 presidential election. The president has repeatedly forecast a vaccine could be ready by election day. An FDA spokesperson declined to comment when contacted by Newsweek.

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

An Axios/Ipsos poll published Tuesday, the day that the 200,000th U.S. death in the pandemic was recorded, found most Americans would not get a first-generation COVID-19 vaccine as soon as it is available. A separate ABC/Ipsos poll published over the weekend found most Americans do not have confidence in either Trump or Democratic presidential nominee Joe Biden to confirm a vaccine is effective and safe. Earlier in the month, a KFF Health Tracking Poll found respondents were very or somewhat worried the FDA will rush to approve a coronavirus vaccine without making sure that it is safe and effective due to political pressure from the Trump Administration.

On Wednesday, FDA Commissioner Stephen Hahn told a Senate hearing on

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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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The White House Begs Governors to Help Sell a COVID-19 Vaccine

Over the last several weeks, President Donald Trump has approached the White House press podium with one resounding message: The coronavirus vaccine is just around the corner and it will soon make its way to Americans across the country.

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But behind closed doors Trump’s closest advisers, including those officials working on the White House coronavirus task force, are increasingly concerned about public confidence in the vaccine process. Now, White House officials are leaning on the nation’s governors to help promote the vaccine’s safety and efficacy.

On a private call with governors Monday, Vice President Mike Pence and other top coronavirus task force officials—including Dr. Anthony Fauci and Director of the Centers for Disease Control and Prevention Robert Redfield—aired their fears about the declining public support for taking a COVID-19 vaccine once it becomes available. And they explicitly asked governors to ignore the politics of the impending election when discussing COVID-19 vaccines, even as Trump himself does not.

“Look, I know we’re in an election season. But what I want to do is challenge you governors,” Pence said. “We are working around the clock to get a safe and effective vaccine available but we need… you to do your part to build public confidence that it will be a safe and effective vaccine. What we don’t want is people undermining confidence in the process.”

Redfield noted that while he is confident the American people will be able to access a vaccine by next spring, he is worried about the government’s ability to convince the public that that vaccine will be safe.

“We have vaccine hesitancy in this country that allows some schools to have only 30 or 40 percent of their children vaccinated against measles because they are so convinced the vaccine is harmful,” Redfield said. “So, our biggest challenge… is to build that culture of confidence. Once fear sets in, once doubt sets in, it is going to be very hard for us to reverse that.”

The worries stated on the call echo a deeper fear among scientists and other top officials working with the task force that the American public has lost trust in the nation’s top health agencies.

Part of that lack of confidence seems to stem from the president himself, who has in recent weeks promised the quick delivery of a vaccine. Trump more recently conceded that the American public can expect to access a vaccine by April next year, but he has also stated that the clinical trial data indicates that the U.S. will soon have a viable vaccine.

“He has all of his eggs in the vaccine basket,” said Elizabeth Neumann, a former top Department of Homeland Security official who worked on the office’s coronavirus response before she left the administration earlier this year. “He’s not interested in masks, or social distancing. He likes the quick easy fix. And anybody that looks at what it takes to deploy a vaccine and deliver a vaccine… it is not quick and easy by any stretch

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