Republican Florida Gov. Ronald DeSantis slammed the Biden administration Monday for ending its emergency use authorization of two major COVID-10 monoclonal antibody treatments.
The Food and Drug Administration announced earlier that day that it will permit the use of Lilly’s (bamlanivimab and etesevimab) treatment and Regeneron’s REGEN-COV (casirivimab and imdevimab) treatment only when a patient “is likely to have been infected with or exposed to a variant that is susceptible to these treatments.”
Referring to Centers for Disease Control and Prevention statistics indicating that omicron is the dominant COVID-19 strain in the United States, constituting 99 percent of cases nationwide as of Jan. 15, Dr. Patrizia Cavazzoni, director of the FDA Center for Drug Evaluation and Research, said that “data show these treatments are highly unlikely to be active against the omicron variant.”
Therefore, she said, “these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time.”
“In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions,” Cavazonni said.
The FDA decided to restrict the monoclonal antibody treatments to prevent “exposing patients to side effects, such as injection site reactions or allergic reactions, which can be potentially serious, from specific treatment agents that are not expected to provide benefit to patients who have been infected with or exposed to the omicron variant,” Cavazonni said.
The move is a revocation of a Trump-era emergency use authorization the agency implemented in November 2020 to fight the rising number of COVID-19 cases in the country. --->READ MORE HERE
When asked on Tuesday about the FDA's decision to yank the Emergency Use Authorization for monoclonal antibodies, the White House press secretary spat out a word-salad of disinformation.
"Let's just take a step back here just to realize how crazy this is," Psaki began, reading her answer. "We've approached Covid treatments like filling a medicine cabinet. We're not relying on one type, one brand, or treatment. We invested in, and continue to buy a variety across [sic] monoclonal antibodies, pre-exposure prevention therapies, and oral antivirals.
"What the FDA is making clear is that these treatments, the one that they are fighting over - that the governor is fighting over - do not work against Omicron, and they have side effects. That is what the scientists are saying.
Psaki then put monoclonals on par with 'advocating for things that don't work, even though we know things do work; injecting disinfectant, promoting other pseudo-science, sowing doubt on the effectiveness of vaccines and boosters, and now promoting treatments that don't work." --->READ MORE HEREFollow links below to relevant/related stories and resources:
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