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Politics If Trump bypassed the FDA on a COVID-19 vaccine it could 'upend' the traditional approval structure and erode the public's trust in the executive agency, expert says

11:06  25 september  2020
11:06  25 september  2020 Source:   businessinsider.com

Russia vaccine data questioned by experts worried about global distribution

  Russia vaccine data questioned by experts worried about global distribution A growing chorus of experts is calling on Russian scientists to explain potential discrepancies in the data supporting the country's COVID-19 vaccine, dubbed Sputnik V. © Alexander Zemlianichenko Jr./AP A Russian medical worker administers a shot of Russia's Sputnik V coronavirus vaccine in Moscow on Sept. 15, 2020. Russian health authorities have launched trials of the vaccine among 40,000 volunteers, a randomized, placebo-controlled study. Russia was the first country to authorize a COVID-19 vaccine, but it did so before completing proper scientific studies to show it is safe and effective.

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 A lack of trust in the program is a nightmare scenario, public health experts say , since a

Public health experts are increasingly worried that President Trump ’ s repeated predictions of a Still, several FDA experts criticized the timing in the fraught run-up to a vaccine - approval decision. Public confidence also has been eroded by efforts by a top HHS political appointee, now on leave

a hand holding a knife: A photo illustration show a syringe. Argentina was selected to test a vaccine against COVID-19, it is estimated that the clinical phases will begin in August. Carol Smiljan/NurPhoto via Getty Images © Carol Smiljan/NurPhoto via Getty Images A photo illustration show a syringe. Argentina was selected to test a vaccine against COVID-19, it is estimated that the clinical phases will begin in August. Carol Smiljan/NurPhoto via Getty Images
  • President Donald Trump suggested that the White House could bypass the US Food and Drug Administration on approving a coronavirus vaccine.
  • Marc Sanchez, an FDA attorney, and consultant, said the remark was an "unfortunate attempt to increase the pressure on the FDA."
  • Sanchez said doing that would erode public trust in the agency and in a vaccine.
  • Visit Business Insider's homepage for more stories.

President Donald Trump suggested on Wednesday that the White House could bypass the US Food and Drug Administration on approving a coronavirus vaccine.

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( FDA ) can be trusted on a Covid - 19 vaccine , claiming it has been politicized under President Having invested millions in the search for a Covid vaccine , Gates has become a go-to authority for the He is now using that position to criticize both the FDA and the Centers for Disease Control and

A new Pew Research Center survey shows the public trust in vaccines has plummeted since May. Here I focus specifically on the impact this is having on Covid - 19 vaccines . A new Pew Research Center President Donald Trump announced that the Food and Drug Administration is issuing an

Marc Sanchez, an FDA attorney and consultant, said doing so would not only "upend" the FDA's structure but erode the public's trust in the agency to roll out a safe and vaccine on its own.

Sanchez said the comment was an "unfortunate attempt to increase the pressure on the FDA."

"FDA has historically been slower than its counterparts around the world in approving novel medical devices and drugs, taking seriously the role of protecting public health and safety over speedy approvals," Sanchez said.

The FDA announced stricter protocols when it came to approving an emergency coronavirus vaccine, and FDA commissioner Dr. Stephen Hahn made a promise that the "FDA will not authorize or approve a vaccine that we would not feel comfortable giving to our families."

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Scientists, public health officials and lawmakers are worried that the Trump administration will pressure the FDA to authorize a COVID - 19 vaccine in The FDA declined to comment on the meeting. President Donald Trump ' s approval ratings have fallen sharply in the wake of a pandemic that has

US President Donald Trump has signed a series of executive orders giving extended economic relief to Americans struggling economically during the Covid - 19 pandemic after Schumer and Pelosi addressed the potential of executive orders on Friday and warned they could be legally dubious, as

"FDA will not authorize or approve any Covid-19 vaccine before it has met the agency's rigorous expectations for safety and effectiveness," Hahn told the Senate Health Committee. "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."

He added: "FDA will not permit any pressure from anyone to change that."

However, during the news conference at the White House on Wednesday, Trump erroneously cast any delay in releasing a COVID-19 vaccine to the public as "a political move."

"That has to be approved by the White House. We may or may not approve it," Trump said. "Why would they be adding great length to the process?"

Sanchez told Business Insider that he is not aware of whether the president is able to make such a move. But said that considering that the FDA is an executive agency, he supposed "there could be a situation where President Trump revoked this delegation and makes a decision directly," which "would totally upend not only the FDA structure but how we think of executive agencies generally."

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US President Donald Trump has said he wants a vaccine available in the US before 3 November' s election, but his comments have raised fears that politics may be prioritised over safety in the rush for a vaccine . On Tuesday, a group of nine Covid - 19 vaccine developers sought to reassure the public

Dr. Salmon and other experts said that Russia is taking a dangerous step by jumping ahead of so-called Phase 3 trials, which can determine that the vaccine works better than a placebo and doesn’t cause harm to Now, in the midst of the Covid - 19 pandemic, they’re putting those ideas into practice.

"FDA relies on public trust, and the FDA staff I have worked with and befriended in over a decade of practice understand this keenly," Sanchez said. "It is terrible to think of FDA losing that trust."

He added that the independence of the agency is critical so that people can remain confident in the vaccine and the overall quality of the agency.

The coronavirus disease (COVID-19) vaccine test in Thailand Reuters © Reuters The coronavirus disease (COVID-19) vaccine test in Thailand Reuters

Sanchez drew on the contentious reputation of the Centers for Disease Control and Prevention, which has recently been embroiled in public disputes with the Trump administration over health guidelines and recommendations amid the coronavirus pandemic.

"There's this core public trust, and we have that in the FDA. Part of that core trust is that its independent, and that independence is rooted in science and public health, protecting public health through good science," he said, adding that he thinks the CDC has failed to establish such independence and reliance on "pure science."

Sanchez highlighted that the FDA work with hydroxychloroquine, and how despite political pressure they still based their rulings on scientific information.

FDA chief: 'Science will guide' vaccine decisions

  FDA chief: 'Science will guide' vaccine decisions Hahn's remarks come amid plummeting public confidence in vaccines and the Trump administration’s coronavirus response. Six out of 10 adults are worried the FDA will rush to approve a vaccine due to political pressure, according to a recent Kaiser Family Foundation poll.President Donald Trump has repeatedly suggested a shot could be ready before the election despite multiple senior health officials — including infectious disease expert Anthony Fauci and Moncef Slaoui, the former pharmaceutical executive tasked with speeding up vaccine development — saying that timeline is incredibly unlikely.

Dr. Gupta breaks down AstraZeneca Covid - 19 trial pause. "We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID - 19 vaccines are Regulators and companies alike have been working to ensure people trust in the vaccine

President Vladimir Putin said Russia cleared the world’ s first Covid - 19 vaccine for use and hopes to begin mass inoculation soon, even before “This is a political decision by Putin so he can claim that Russia was the first in the race to develop a Covid - 19 vaccine ,” said Svetlana Zavidova, executive

He explained that FDA approval for vaccines in many cases gets more scrutiny than other drugs because they affect essentially the entire population. He said the organization goes through multiple steps from clinical work in several different phases to do a risk-benefit analysis and evaluate the safety and efficacy of a vaccine.

"Normally that process would take years and we're talking about it in a non-pandemic, a non-priority drug. It's a very long process to go through," Sanchez said. "Obviously, we're trying to truncate that process in the interest of public health, but not trying to take shortcuts in a way that introduce new risk or upset that balance of risk and benefit."

He added, however, that the political commentary and focus on a vaccine, including claims by Trump to have one ready before the election, has added some degree of pressure to researchers, who would normally do their work without any rush.

"Now we have the management themselves receiving political pressure that then kind of continues to push down. So I think that's principally what we've seen or can see happen is ordinary reviewers being told to hurry their work or to produce a result more quickly," he said. "And so I think that's part of that public trust element that we've got to make sure that they continue to do the work aware of the pandemic and the public health need for this, but not making a decision or rushing their work to make mistakes."

Read the original article on Business Insider

Fact check: Claim that Trump's positive COVID-19 test result is a 'con' has no basis in fact .
A claim suggesting President Trump will politically leverage his positive test result includes speculations that aren't proven. We rate the claim false.President Donald Trump took to Twitter on Friday morning to confirm a positive COVID-19 test result.

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