FDA Removes Emergency Use Authorization for Monoclonal Antibodies 'Without Any Advanced Notice'

Nick Kangadis | January 25, 2022
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The Florida Department of Health tweeted out a memo late Monday evening announcing that they will be closing “all monoclonal antibody state sites” in the state after the U.S. Food and Drug Administration (FDA), “without any advanced notice,” removed “Emergency Use Authorizations” (EUA) for the COVID alternative treatment.

“Florida disagrees with the decision that blocks access to any available treatments in the absence of clinical evidence,” the memo stated. “To date, such clinical evidence has not been provided by the United States Food and Drug Administration (FDA).”

According to the Cleveland Clinic, “Monoclonal antibodies are proteins made in a laboratory meant to stimulate your immune system.”

The reasoning for the FDA removing the EUA for monoclonal antibody treatment for COVID-19, according to CBS News, is that “infusion drugs [like monoclonal antibodies] are less able to target Omicron due to its mutations.”

The problem with that your average COVID test doesn’t indicate which strain of the virus people may have contracted.

Dr. Emily Landon, infectious disease specialist and chief hospital epidemiologist at the University of Chicago Medicine, told NBC 5 - Chicago that unless you a test is examined by “specialized labs,” your COVID test will only tell you whether or not you have the virus, not the specific strain.

“When you get a COVID test they're just looking for whether or not you have COVID," said Landon. "They're not on which kind of in order to figure out the exact strain of COVID. You have to do this thing called sequencing, which takes a lot longer. It's much more intensive. You certainly can't get that back in 24 hours, and it's only done by specialized labs.”

Also, there’s another drug that apparently doesn’t do much against Omicron, which remains approved by the FDA, the fourth vaccine shot.

The New York Post reported on a study by researchers at Sheba Hospital in Israel — “the first country on Earth to fully vaccinate a majority of its citizens against COVID-19, as reported by NPR — that indicated a fourth shot is “still not enough to prevent Omicron.”

Even if a majority of people who contract COVID are getting the Omicron strain — which, as indicated above, the test goes to a specialized lab, they don’t really know whether that’s the strain a person came down with — why would you limit the alternative treatments a person could get if they happen to get a previous strain?

H/T: Timcast

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