The FDA has just revoked approval of two of the monoclonal antibody cocktails, including Regeneron™: bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab). Monoclonal antibodies are by far the most effective treatment for Covid-19, and have saved countless iives.
Without warning, the FDA announced that “these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time.” This shuts down this treatment option for patients exposed to COVID-19. One monoclonal antibody cocktail, Sotrovimab, is still available.
The FDA gave no advanced notice of their arbitrary decision; they just issued a press release Monday evening and immediately revoked the Emergency Use Authorization. No states were given any time to prepare for the shutdown or cancel the scheduled appointments of their patients.
The FDA justifies the decision on the basis that the antibody cocktail is, “unlikely to be active against the omicron variant.”
“Based on Centers for Disease Control and Prevention data, the omicron variant of SARS-CoV-2 is estimated to account for more than 99% of cases in the United States as of Jan. 15. Therefore, it’s highly unlikely that COVID-19 patients seeking care in the U.S. at this time are infected with a variant other than omicron, and these treatments are not authorized to be used at this time.”
Ironically, however, the evidence is pretty clear that the vaccines are also ineffective against the Omicron variant, but you’ll never see the FDA withdrawing the EUA for the vaccines. Why not? Because the mandatory vaccines and digital vaccine passports were always one of the main goals of this plandemic. So ineffectiveness against the Omicron variant is grounds for shutting down the monoclonal antibodies, but not grounds for shutting down the vaccines.
Moreover, the FDA has no peer-reviewed studies showing that these two varieties of monoclonal antibody cocktails are ineffective against Omicron. The FDA is revoking the EUAs based upon one study done by a competitor of the companies who make the products who EUAs were revoked!
Moreover, it looks like the FDA is doing this mainly to promote the Pfizer and Merck pills (Paxlovid™ and Molnupirivir™) as the authorized therapeutics. The problem with the pills is they are hard to find and in short supply. A few hours before the FDA shut down monoclonal antibodies to push the pills, CBS wrote an article about how difficult it is to find therapeutic pills.
If public health were driving this decision, the FDA and other alphabet agencies like the CDC and NIH, would make every effort to have all treatments available, and then let your doctor decide which is right for you.
The political subtext of this sudden, arbitrary and ill-considered decision is the Biden Administration’s war on Florida, and particularly on Florida governor Ron de Santis, a political superstar who is almost certain to be president one day. De Santis was incensed by the decision.
Early this morning, thousands of Floridians woke up to news that their appointments to get treatment for Covid-19 infection were canceled by the Biden Administration, which revoked—outright revoked—authorization for two very popular monoclonal anti-body treatments that the state of Florida really pioneered by the state of Florida.
The State of Florida Health Department is not happy about being forced to close all monoclonal antibody treatment sites. They issued the following statement:
Mind you the people who seek this treatment are overwhelmingly people who have been vaccinated. They are relying