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FDA Suddenly Pulls Monoclonal Antibody Treatment EUAs: ‘They are Not a Substitute for Vaccination’

The Food and Drug Administration suddenly rescinded the Emergency Use Authorization (EUAs) for a number of monoclonal antibody treatments that have been used for early treatment of Covid-19.

The Florida Department of Health made the announcement about the FDA’s “abrupt decision” to pull the EUAs for bamlanivimab/etesevimab as well as Regeneron. The decision has led to the Florida health department closing its monoclonal antibody sites statewide.

 

“This evening, without any advanced notice, the US Food and Drug Administration (FDA) revised the Emergency Use Authorization (EUA) for bamlanivimad/etesevimab and REGEN-COV,” Florida Health announced. “The revised EUAs do not allow providers to administer these treatments within the United States.”

The Florida Health Department informed patients that their appointments for the Covid-19 treatment have been canceled. DeSantis has set up infusion sites in five counties: Palm Beach, Broward, Miami-Dade, Duval, and Seminole.

“Florida disagrees with the decision that blocks access to any available treatments in the absence of clinical evidence,” the announcement continued. “To date, such clinical evidence has not been provided by the FDA,” it added.

Gov. Ron DeSantis demanded the Biden administration reverse “its sudden and reckless decision” in a statement.

“Without a shred of clinical data to support this action, Biden has forced trained medical professionals to choose between treating their patients or breaking the law,” DeSantis said. “This indefensible edict takes treatment out of the hands of medical professionals and will cost some Americans their lives. There are real-world implications to Biden’s medical authoritarianism – Americans’ access to treatments is now subject to the whims of a failing president.”

Governor DeSantis also blasted the FDA policy during a press conference on Tuesday. Watch:

Florida’s surgeon general Joseph A. Ladapo also responded to the FDA decision.

 

“After [Health & Human Services] avoided communication with [the Florida Health Department]regarding statewide allocations, without any warning, [the FDA] suspended the use of multiple MABs treatments,” Dr. Ladapo stated. “Such decisions should be made based on clinical data – which the FDA has not provided.”

The National Institute of Health on January 19 revised its guidelines for Covid-19 drugs, including monoclonal antibodies. A January 25 release provided an overview of these changes.

“The Panel has updated this statement to address the fact that the B.1.1.529 (Omicron) variant of concern (VOC) is now the dominant SARS-CoV-2 variant in the United States,” NIH said. “Because the anti-SARS CoV-2 monoclonal antibodies (mAbs) bamlanivimab plus etesevimab and casirivimab plus imdevimab are predicted to have markedly reduced activities against this VOC, and because real-time testing to identify rare, non-Omicron variants is not routinely available, the Panel recommends against the use of these anti-SARS-CoV-2 mAbs (AIII).”

In mid-December, German researchers found in a pre-print study that the monoclonal antibody treatments “lose most of their effectiveness” against the Omicron variant.

“German researchers have found that COVID-19 therapies developed by Eli Lilly and Regeneron lose most of their effectiveness when exposed in laboratory tests to the Omicron variant of coronavirus, likely reducing treatment options if the new variant prevails,” Reuters earlier reported.

The FDA said it could reauthorize the EUAs if the two drugs prove to be effective against future variants or if they are updated to target Omicron.

“Just like vaccines will have to adapt, we’re probably going to have to constantly adapt our monoclonals,” Regeneron CEO Len Schleifer said in December.

The CDC and FDA have argued that monoclonal antibody treatments are not a substitute for vaccination and are generally reserved for vulnerable people, including seniors, transplant recipients and those with serious pre-existing health conditions, such as diabetes and heart disease.

During the Delta variant wave in late summer and early fall, demand soared for monoclonal antibodies. In late December, HHS announced it was pausing the distribution of Regen-CoV treatment and Eli Lilly’s bamlanivimab and etesevimab treatments, citing Omicron as the rationale. The Biden administration initially resumed distribution after Republican governors, including Florida Govt. DeSantis, argued that the treatments were helping some omicron patients.

The FDA is now touting alternate therapies for early Covid treatment, including  two recently approved antiviral pills from Pfizer and Merck, which it has begun shipping to states.

Former President Donald Trump had received Regeneron’s antibody combination after he tested positive for Covid-19 in July 2020. Donald Trump attributed much of his recovery to Regeneron, which he said helped him feel better “immediately.”

“But I spent four days there, and I went in,” Trump said about Walter Reed hospital. “I wasn’t feeling so hot. And within a very short period of time, they gave me Regeneron. It’s called Regeneron. And other things too, but I think this was the key. But they gave me Regeneron, and it was, like, unbelievable. I felt good immediately. I felt as good three days ago as I do now. So I just want to say, we have Regeneron.”

“We have a very similar drug from Eli Lilly, and they’re coming out, and we’re trying to get them on an emergency basis,” he said. “We’ve authorized it. I’ve authorized it. And if you’re in the hospital and you’re feeling really bad, I think we’re going to work it so that you get them and you’re going to get them free. And especially if you’re a senior, we’re going to get you in there quick. We have hundreds of thousands of doses that are just about ready. I have emergency use authorization all set, and we got to get it signed now.”

The FDA’s recent decision to pull the emergency use authorization for the treatments drew additional rebuke from DeSantis.

“Without a shred of clinical data to support this action, Biden has forced trained medical professionals to choose between treating their patients or breaking the law,” DeSantis said. “There are real-world implications to Biden’s medical authoritarianism – Americans’ access to treatments is now subject to the whims of a failing president.”

Florida’s surgeon general Joseph Ladapo argued that the Biden administration’s abrupt decision was being made for political reasons.

“In our field of medicine, when someone comes to you seeking a treatment that could save their life, it is essential to have treatment options to ensure health care providers can make the best decisions for their patients,” Ladapo said. “The Federal Government has failed to adequately provide the United States with adequate outpatient treatment options for COVID-19. Now, they are scrambling to cover up a failure to deliver on a promise to ‘shut down the virus.’”

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