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US experts vow ‘no cutting corners’ as vaccine tests expand

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Wed, 2020-09-23 19:00 — mike kraft
US experts vow ‘no cutting corners’ as vaccine tests expand WASHINGTON (AP) — A huge international study of a COVID-19 vaccine that aims to work with just one dose is getting underway as top U.S. health officials sought Wednesday to assure a skeptical... AP NEWS

WASHINGTON (AP) — A huge international study of a COVID-19 vaccine that aims to work with just one dose is getting underway as top U.S. health officials sought Wednesday to assure a skeptical Congress and public that they can trust any shots the government ultimately approves.

Hopes are high that answers about at least one of several candidates being tested in the U.S. could come by year’s end, maybe sooner.

“We feel cautiously optimistic that we will be able to have a safe and effective vaccine, although there is never a guarantee of that,” Dr. Anthony Fauci, infectious disease chief at the National Institutes of Health, told a Senate committee.

President Donald Trump is pushing for a faster timeline, which many experts say is risky and may not allow for adequate testing. On Wednesday he tweeted a link to news about the new Johnson & Johnson vaccine study and said the Food and Drug Administration “must move quickly!” ...

FDA Commissioner Stephen Hahn pledged that career scientists, not politicians, will decide whether any coronavirus vaccine meets clearly stated standards that it works and is safe. Vaccine development usually takes years but scientists have been racing to shorten that time, in part by manufacturing doses that will have to be thrown away if studies find they don’t work.

“Science will guide our decisions. FDA will not permit any pressure from anyone to change that,” Hahn said. “I will put the interest of the American people above anything else.”

FDA has faced criticism for allowing emergency use of some COVID-19 treatments backed by little evidence, but Hahn said if vaccine makers want that faster path to market, additional standards will be coming soon.

As for the testing of vaccine candidates, Fauci added: “There is no cutting corners.”  ...

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Wed, 2020-09-23 19:39 — mike kraft

Trump says he might reject stricter FDA vaccine guidelines The FDA has reportedly proposed stricter emergency authorization standards, which are now under review by the White House Office of Management and Budget. Lauren Morello POLITICO

President Donald Trump said Wednesday that the White House may not approve tougher FDA guidelines for authorizing the emergency use of any coronavirus vaccines.

The FDA has reportedly proposed stricter emergency authorization standards, which are now under review by the White House Office of Management and Budget. ...

"That has to be approved by the White House," Trump said of the FDA guidance. "We may or may not approve it." Trump also suggested that the FDA's decision to pursue stricter standards "was a political move more than anything else."  ...

Thu, 2020-09-24 11:15 — mike kraft

Trump attacks FDA plan for tougher standards on emergency vaccine approval as a ‘political move’ The president warned he may reject the proposal, hours after the Food and Drug Administration chief told senators that a vaccine decision will be free of political interference. Amy Goldstein, Laurie McGinley Washington Post

 

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