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Politics FDA chief: 'Science will guide' vaccine decisions

19:06  23 september  2020
19:06  23 september  2020 Source:   politico.com

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Food and Drug Administration Commissioner Stephen Hahn sought to reassure the public Wednesday that any Covid-19 vaccine approved by the agency would be safe and effective, but offered few details on the bar for emergency use.

a man wearing a suit and tie: © Alex Edelman-Pool/Getty Images "Science will guide our decisions," Hahn added. "FDA will not permit any pressure from anyone to change that."

"FDA will not authorize or approve a vaccine we won’t be confident in giving to our families," he said at a Senate hearing on the government's coronavirus response, adding later that he would "absolutely" encourage his own family to take an FDA-authorized shot.

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"Science will guide our decisions," Hahn added. "FDA will not permit any pressure from anyone to change that."

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.

And several major vaccine developers have pledged to only submit their experimental coronavirus vaccines for approval or emergency use authorization after demonstrating safety and efficacy in a final stage, or Phase III, trial that meets Food and Drug Administration requirements.

Fauci says he will take responsibility if a coronavirus vaccine rolled out in the US is faulty

  Fauci says he will take responsibility if a coronavirus vaccine rolled out in the US is faulty In comments to media outlets Thursday Fauci sought to reassure the public amid a dispute between Trump and the CDC over vaccines."Do you assure all of us that if the corners have been cut, if there is something sideways or wrong with the process, that you will tell us and take the heat for that?" MSNBC's Chris Hayes asked Fauci.

"It is incredibly alarming that the administration has undermined public trust in the work of your agency," Sen. Patty Murray (D-Wash.) told Hahn, listing pressure the White House exerted on FDA to authorize hydroxychloroquine and convalescent plasma despite thin evidence, plus the president's repeated allegations that career scientists are working against him.

"Any of these examples of political pressure would be alarming on their own. But together they paint a clear pattern of interference that is downright terrifying," the committee's ranking Democratic member said.

The FDA is expected to soon release updated guidance on its standards for issuing an emergency use authorization for any coronavirus vaccines; Hahn tweeted earlier this month that the beefed-up guidance would be published last week.

Hahn said Wednesday that the agency would expect "data from at least one well designed Phase III clinical trial that demonstrates its safety and efficacy in a clear and compelling manner."

Trump says U.S. will manufacture enough coronavirus vaccine doses for every American by April

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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 .
"FDA relies on public trust and the FDA staff I have worked with and befriended in over a decade of practice understand this keenly," Marc Sanchez said.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.

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This is interesting!