TAMPA, Fla. — Governor Ron DeSantis criticized the decision by the FDA to revise authorizations for two monoclonal antibody treatments, which led the state to close all monoclonal sites "until further notice."
The Florida Department of Health announced the closure of the sites on Twitter on Monday night. DOH said it was the result of the "abrupt" decision by the FDA.
DeSantis, who has been an avid proponent of the treatments, took to Twitter on Tuesday morning to condemn the decision.
"Without a shred of clinical data to support its decision, the Biden Administration has revoked the emergency use authorization for lifesaving monoclonal antibody treatments," DeSantis said in a Tweet. "Floridians have benefited from the state’s treatment sites and their access to treatment shouldn’t be denied based on the whims of a floundering president."
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The FDA said the use of the treatments is limited to when a patient is likely to have been infected with a variant susceptible to the treatment.
The treatments have been proven to prevent hospitalizations. In August, Hal Escowitz, Chief Quality Officer and Chief Medical Informatics Officer at Lakeland Regional Health said they were "the most effective treatment against delta."
However, recent studies have shown the treatments are ineffective against the omicron variant.
"None of the three monoclonals that are in the Regeneron cocktail show any activity whatsoever against the omicron variant," Dr. Thomas Unnasch, a distinguished health professor at The University of South Florida, told ABC Action News earlier this month. "Zero activity.”
Unnasch cited four studies published in December that show Regeneron has no effect in preventing an omicron infection. Eli Lilly, the company that created the treatment, admitted the same after its own tests of Regeneron.
DeSantis further criticized the decision during a press conference on Tuesday morning where he announced that more than 81,000 students are receiving free books through the “New Worlds Reading Initiative.”
"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.
DeSantis claimed the FDA's decision is based on a single, non-peer-reviewed and non-clinical study that was done by a consultant for a rival company to the two treatments.
"This is not based on a clinical trial. This is not even peer-reviewed," DeSantis said. "This is something that they claim shouldn't be used because we have omicron and what we would say in Florida is we have had people use it and we've had good results."
A COVID-19 Communications spokesperson fired back at DeSantis on Twitter saying the "drugmakers themselves say (the drugs don't work)."
1. The 2 monoclonal drugs he's talking about *don't work* against Omicron (99% of FL cases). The drugmakers themselves say so.
— Ian Sams (@IanSams) January 25, 2022
2. New CDC clinical data show booster shots reduce risk of hospitalization by 90%
Will the Gov follow clinical data & encourage boosters to save lives? https://t.co/ziydO3t6r1
Both Regeneron and Eli Lilly addressed the monoclonal antibody treatments and the FDA decision in statements. Those statements can be read at the end of the story.
"It's not 100%, we understand that," DeSantis added. "But you also don't even know when someone gets it whether it's omicron or still the delta."
The governor added that Florida is seeing mostly omicron cases right now.
"Even if, with omicron, it's half as effective or even 25% as effective, that's better than nothing for people," DeSantis said.
"This is wrong what they're doing," DeSantis said.
Monoclonal antibody treatments have proven to be effective against the delta variant, but Unnasch says delta accounts for less than 1% of coronavirus cases in Florida. The remaining 99% is occupied by omicron.
Eli Lilly is developing a new antibody treatment to fight omicron, but it may be another month or two before one is approved for clinical use.
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Regeneron
"The U.S. Food and Drug Administration (FDA) today amended the Emergency Use Authorization (EUA) for Regeneron’s REGEN-COV® (casirivimab and imdevimab) to exclude its use in geographic regions where, based on available information including variant susceptibility and regional variant frequency, infection or exposure is likely due to a variant such as Omicron (B.1.1.529) that is not susceptible to the treatment. With this EUA revision, REGEN-COV is not currently authorized for use in any U.S. states, territories or jurisdictions, since Omicron is currently the dominant variant across the United States. REGEN-COV remains an investigational drug and is not approved for any indication. The FDA stated that if, in the future, patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to REGEN-COV, then the limitation on use may be revised in these areas. Regeneron continues to progress next generation antibodies that are active against Omicron, Delta (B.1.617.2) and other variants of concern. The company is working urgently and collaboratively with the FDA to determine how to bring additional safe and effective monoclonal antibody treatments to patients as quickly as possible. Pending regulatory discussions, new therapeutic candidates could enter the clinic in coming months."
Eli Lilly
Lilly continually monitors the COVID-19 environment and is committed to ensuring our antibodies are available, as appropriate, to patients as variants continue to evolve and their patterns of transmission and prevalence shift.The FDA has updated the Fact Sheet for bamlanivimab and etesevimab to include a new Limitation for Authorized Use: due to the high frequency of the Omicron variant, these therapies are not currently authorized in any U.S. region.Lilly and the FDA agree that it is not medically appropriate, at this time, to treat patients with mild to moderate COVID-19 with bamlanivimab and etesevimab together in the U.S. Evaluation of both pseudovirus and authentic virus confirm that they are not effective at treating the currently predominant Omicron variant. Authorization status will change as needed, depending on prevalence and trends of variants of concern.Authentic virus analysis of Lilly’s third investigational antibody therapy, bebtelovimab, confirm our earlier pseudovirus findings, which demonstrate our investigational antibody potently inactivates all known variants of concern, including Omicron. We are working urgently with the FDA to potentially bring bebtelovimab to patients through emergency use authorization. FDA review of the bebtelovimab submission is ongoing."
