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FL forced to close COVID treatment sites after FDA revoked authorization for ‘lifesaving antibody treatments’

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The Food and Drug Administration (FDA) has made a very controversial decision angering many in the state of Florida. Governor Ron DeSantis tweeted on the matter Tuesday morning writing, “Without a shred of clinical data to support its decision, the Biden Administration has revoked the emergency use authorization for lifesaving monoclonal antibody treatments.”

In a follow-up Tweet, the Governor added, “Floridians have benefited from the state’s treatment sites and their access to treatment shouldn’t be denied based on the whims of a floundering president.”

A press release from the Florida Department of Health stated, “this evening, without any advanced notice, the U.S. Food and Drug Administration (FDA) revised the Emergency Use Authorization (EUA) for bamlanivimab / etesevimab and REGEN-COV. The revised EUAs do not allow providers to administer these treatments within the United States.”

Florida was effectively forced to shut down its sites administering monoclonal antibodies, which have been widely used as supplemental treatment, once the FDA revoked its authorization for distribution.

“Unfortunately, as a result of this abrupt decision made by the federal government, all monoclonal antibody state sites will be closed until further notice” the press release continues. National Review reports on the rocky relationship between Florida and the Biden administration as it relates to monoclonal treatments:

The development comes after Florida surgeon general Joseph Ladapo accused the Biden administration of intentionally restricting the circulation of Covid-19 therapeutics. Governor Ron DeSantis had launched dozens of antibody-treatment sites as part of the state’s strategy to defeat the disease.

The federal government is “actively preventing the effective distribution of monoclonal antibody treatments,” Ladapo wrote in a letter to Secretary of Health and Human Services Xavier Becerra in December.

The Biden administration had reportedly suspended shipments of Covid-19 antibody treatments, which can shorten severity and duration of illness in those who contract the virus, amid mounting evidence that they had been rendered ineffective by the Omicron variant.

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  1. Elena

    January 25, 2022 at 6:54 pm

    Get everyone exposed on mullein .this herbal medicine is greatly helping and grows easily..take generously..this is safe..use of this goes back to Hippocrates and Dioscoredes

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COVID-19

Fauci’s NIH gives another $3.5 million to EcoHealth despite dangerous past of coronavirus research

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Just before he retires, Dr. Anthony Fauci has pushed through a new five-year grant for EcoHealth.  EcoHealth Alliance, is the U.S. nonprofit that Fauci and the National Institute of Health’s funds, “to conduct dangerous coronavirus research in partnership with China’s Wuhan Institute of Virology prior to the global Covid-19 pandemic” reports National Review.

Over the next five years, the troublesome EcoHealth will receive over $3.25 million; their first check comes this year for $653,392. The grant is one of four concurrent NIH grants that EcoHealth has; three of the grants were awarded after the start of the Covid-19 pandemic.

The description of the grant on the NIH RePORTER website is to analyze “the potential for future bat coronavirus emergence in Myanmar, Laos, and Vietnam.”

“This is high-risk research that involves going into remote, often inaccessible areas, and sampling bats and bat excreta, and then returning those samples to laboratories in population centers where they attempt to isolate the virus … and then seek to characterize the threat level posed by the virus,” said Richard Ebright, a biosafety expert and professor of chemistry and chemical biology at Rutgers University. “This is one of the kinds of research that may have been directly responsible for the current pandemic.”

The term gain-of-function research has become very controversial since the global Covid-19 pandemic, and National Review reports on the subject:

This newest EcoHealth project wouldn’t qualify as gain-of-function research, Ebright said. Gain-of-function research involves extracting viruses from animals and engineering them in a lab to make them more transmissible or dangerous to humans. But Ebright said two of EcoHealth’s grants do involve gain-of-function research and enhanced potential pandemic research on coronaviruses. And even if the current description of the new project doesn’t involve gain-of-function research, that doesn’t mean it couldn’t later.

From securing funding to completing the research, it is a six-year process, Ebright said, and the project is bound to change over those six years. “If researchers robotically followed what they proposed six years ago, they would not be taking into account developments in their own labs and in the field at any point along the way,” he said. “You have to have this flexibility. That also means you need oversight to make sure the flexibility isn’t going into forbidden areas.”

Going into forbidden areas is exactly how EcoHealth and its president, Peter Daszak, previously got into trouble. Starting in 2014, the U.S. government temporarily paused funding for gain-of-function research due to concerns over biosafety and biosecurity. When some of EcoHealth’s research – involving infecting genetically-engineered mice with hybrid viruses – seemed to cross that line, NIAID staff and EcoHealth leaders crafted work-around guidelines to allow the nonprofit to continue its work.

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