COVID: St. Lucie monoclonal antibody clinic closed after FDA unauthorizes drugs
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The state-run monoclonal antibody clinic in St. Lucie County has closed indefinitely after the Food and Drug Administration revoked emergency use authorization of two COVID-19 treatments.
Regeneron Pharmaceuticals’ REGEN-COV (casirivimab and imdevimab) and an antibody cocktail manufactured by Eli Lilly (bamlanivimab and etesevimab) were pulled from the market Monday.
“Data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States,” Dr. Patrizia Cavazzoni, director of the FDA Center for Drug Evaluation and Research, said in a statement.
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Omicron accounted for 99.9% of COVID-19 infections nationwide the week ending Jan. 22, compared to 38% five weeks earlier, according to the Centers for Disease Control and Prevention.
In the four-week period ending New Year’s Day, 89% of Florida infections were attributable to omicron and 10% to delta.
DeSantis condemns ‘medical authoritarianism’
All monoclonal antibody treatment sites throughout the state are closed until further notice, the Florida Department of Health announced Monday night.
Gov. Ron DeSantis, who with Surgeon General Dr. Joseph Ladapo has long lauded the treatment, blamed the FDA’s latest move on the Biden administration.
“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,” he said in a statement Monday. “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.”
The National Institutes of Health’s independent COVID-19 Treatment Guidelines Panel, however, asserts omicron is “predicted to have markedly reduced susceptibility” to the Regeneron and Eli Lilly treatments.
Regeneron itself announced last month that REGEN-COV antibodies “have diminished potency against omicron, [but] are active against delta.”
The health department canceled some 2,000 clinic appointments scheduled for Tuesday alone, the governor’s office said. A spokesperson for DOH-St. Lucie has not responded to TCPalm’s inquiry about the impact on the Fort Pierce clinic.
The treatment site, which opened at the Havert L. Fenn Center in August, was the only state-run antibody clinic on the Treasure Coast. It moved to the St. Lucie County Fairgrounds in November, where it since had been open weekdays, from 9 a.m. to 5 p.m. Emergency management firm CDR Maguire oversaw daily operations.
Are other COVID treatments available?
The FDA may reauthorize Regeneron’s and Eli Lilly’s drugs for emergency use, “if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments,” the agency said.
In the meantime, these therapies remain authorized:
Molnupiravir (Merck tablet)
Paxlovid (Pfizer tablet)
Sotrovimab (GlaxoSmithKline antibody treatment)
Veklury (remdesivir) (Gilead Sciences antiviral medication).
Health care providers that administer such treatments are listed at floridahealthcovid19.gov. If you test positive for COVID-19, consult your doctor about which treatment may work best for you.
No therapy should be a substitute for vaccination, the FDA stressed. Vaccines have been authorized for children as young as 5, and are available for free at over 120 pharmacies, clinics and other providers throughout the Treasure Coast.
“One of the first things you learn in public health and epidemiology is about the types of prevention,” University of Florida epidemiologist Cindy Prins told TCPalm in September. “Getting people vaccinated so they don’t get infected in the first place. That’s the important part.”
Lindsey Leake is TCPalm’s health, welfare and social justice reporter. She has a master’s in journalism and digital storytelling from American University, a bachelor’s from Princeton and is a science writing graduate student at Johns Hopkins. Follow her on Twitter @NewsyLindsey, Facebook @LindseyMLeake and Instagram @newsylindsey. Call her at 772-529-5378 or email her at lindsey.leake@tcpalm.com.
This article originally appeared on Treasure Coast Newspapers: Omicron: COVID monoclonal antibody treatment clinics close in Florida
