Florida Gov. Ron DeSantis, a major supporter of monoclonal antibody treatments for COVID-19, is going to war with the Biden administration over the Food and Drug Administration’s revocation of authorization for two antibody cocktails found to be ineffective against the omicron variant.
DeSantis, a Republican who has gained support from conservatives for his opposition to pandemic restrictions and mandates, is arguing that COVID-19 patients should be able to decide for themselves whether to take the two brands of antibodies in question and that the FDA’s decision was based on lab results rather than clinical data.
“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,” DeSantis said Tuesday. “It’s really a reckless decision to be able to take this option away from patients when we’ve had the sites set up — we’ve had this distributed to different medical groups or hospitals.”
DeSantis said he was weighing suing the administration over its decision.
Federal regulators made the decision to pull the emergency use authorizations for monoclonal antibody cocktails made by Eli Lilly and Regeneron, drawing on a growing body of evidence showing that they are not effective against the omicron variant, which now accounts for over 99% of cases in the United States.
FDA LIMITS MONOCLONAL ANTIBODY TREATMENTS SHOWN TO BE INEFFECTIVE AGAINST OMICRON
For example, a December study conducted by a cadre of doctors from around the world concluded that only two antibody treatments held up against omicron — the ones from GlaxoSmithKline and AstraZeneca. All other monoclonal antibodies lost their ability to fight the omicron strain.
In another study, researchers in France and Belgium reported that five types of monoclonal antibodies made by Eli Lilly and Regeneron “lost antiviral activity against Omicron,” while sotrovimab “was the only antibody displaying a rather similar activity against both strains [delta and omicron].”
The makers of the two therapies in question have acknowledged their shortcomings against the omicron variant. Regeneron said its antibodies had “diminished potency” against omicron, though they remained protective against delta. Eli Lilly said it agreed with the FDA’s decision.
Still, other antibody treatments would be available, including to Florida residents, if not for supply shortfalls. The AstraZeneca-made monoclonal antibody treatment marketed under the name Evusheld is still authorized for use.
Furthermore, two antiviral treatments, Paxlovid and molnupiravir, have also been authorized for people in the early stages of illness. However, Evusheld and the antivirals are difficult to come by.
Monoclonal antibodies, administered intravenously by a healthcare professional, are manufactured in a lab to mimic or enhance the body’s natural ability to fight infection. The antibody evolves over the course of a few days to make a very specific binding to a small patch on the surface of the virus’s spike protein. The monoclonal antibody’s target on the spike protein is known as the epitope. Omicron, which has about 32 new mutations on its spike protein, is configured differently than the delta variant and the strains that preceded it. Because the epitope on the spike protein has changed with this highly mutated variant, the antibody cannot create a secure binding, ruining the effectiveness of the Eli Lilly and Regeneron treatments.
“The antibody doesn’t do what it’s supposed to do anymore,” said Dr. Robert Garry, an immunologist at Tulane University School of Medicine. “The unfortunate thing is this virus is spreading around to literally millions of people, and that gives it the opportunity to come up with these mutations — and it’s going to render drugs like these monoclonal antibodies useless in some cases.”
The move to pull the emergency use authorizations, which are less permanent than full approvals, follows the release of updated treatment guidelines from the National Institutes of Health last week that discouraged the use of most monoclonal antibody treatments.
“The FDA is not going to come in — and shouldn’t in my opinion … leave drugs on the market that don’t work. And it was an emergency use authorization too. They specifically do that for reasons like this,” Garry said.
DeSantis and his allies have accused the Biden administration of targeting Florida over differences in politics. DeSantis, a staunch opponent of mask and vaccine mandates, has been a thorn in Biden’s side throughout his first year in office.
“[The Biden administration] had months and months and months to stockpile [treatments], and they chose not to do it,” DeSantis said. “I think there’s politics at play. But I think part of it is I just don’t think they have enough treatments to go around. And I think they realize that and I think it would look very bad to be able to admit that so instead they’re saying this is revoked.”
The White House, however, slammed DeSantis for fighting for a treatment that will not do any good for the vast majority of Floridians who get COVID-19.
“Let’s just take a step back here just to realize how crazy this is,” White House press secretary Jen Psaki said Tuesday. “What the FDA is making clear is that these treatments — the ones that they are fighting over, that [DeSantis] is fighting over — do not work against omicron, and they have side effects. That is what the scientists are saying.”
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Many other states, including blue states, promoted and benefited from monoclonal antibody treatments. In Michigan, for example, demand for the treatments in hospitals outpaced supply even before the omicron variant supplanted delta last month. Meanwhile, six other Southern states accounted for 70% of orders nationwide ahead of the White House’s decision in September to take over the distribution of treatment shipments amid a national shortage.
Texas has also been a major beneficiary of monoclonal antibodies. But Gov. Greg Abbott, who has called on the Biden administration to increase allocations of the treatments to the state, has stayed mum on the FDA’s decision.
