Florida monoclonal antibody sites shut down after FDA decision. What happens now?

Florida’s health department closed the state’s monoclonal antibody treatment sites Tuesday following the U.S. Food and Drug Administration’s announcement that the two most common therapies available should not be used because they don’t work against the omicron variant, the predominant version of the virus that causes COVID-19.

The Department of Health and Human Services, which controls the supply of monoclonal antibodies, stopped distributing the medications made by Regeneron Pharmaceuticals and Eli Lilly this week after the FDA restricted their use to only when a patient is likely to have been infected with or exposed to a variant that is susceptible to those therapies.

The Centers for Disease Control and Prevention reported that as of the week ending Jan. 22, the omicron variant made up 99.9% of the viral samples sequenced in the Southeastern United States as part of the national genomic surveillance system.

Still, the federal government’s removal of the two medications from the list of COVID-19 therapies reignited an ongoing feud between Florida and the White House over the supply of monoclonal antibodies and their role in the pandemic response.

Gov. Ron DeSantis and other state officials, including Surgeon General Dr. Joseph Ladapo, denounced the decision, saying the federal government hasn’t proven the treatments are ineffective in a clinical setting.

“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 in a statement. “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.”

White House responds

Responding to the governor’s demand that the federal government resume distribution of the medications, the Biden administration accused DeSantis of advocating for treatments that don’t work against the omicron variant and ignoring the advice of the nation’s medical research agency, the National Institutes of Health, and many doctors.

“What the FDA is making clear is that these treatments, the ones that they are fighting over, that the governor is fighting over, do not work against omicron, and they have side effects,” White House press secretary Jen Psaki said on Tuesday. “That is what the scientists are saying.”

A panel of NIH experts that develop COVID-19 treatment guidelines said last week that the omicron variant is predicted to have “markedly reduced susceptibility” to the two drugs, but that alternative therapies distributed to Florida and other states — including the antiviral drugs Paxlovid, Molnupiravir and Remdesivir — are expected to work against omicron.

The American Medical Association, the largest group of physicians in the United States, said it hoped the FDA’s restriction on the two treatments will help ensure that COVID-19 patients are given the proper therapy.

“We are pleased that the FDA is following the scientific evidence and limiting the use of monoclonal antibody treatments to those that are effective against the omicron variant,” Dr. Gerald E. Harmon, AMA president, said in a statement.

DeSantis promoted monoclonal treatment

Florida has promoted monoclonal antibodies as a key part of the state’s pandemic response, with nearly a dozen treatment sites statewide. Last week, the state opened additional treatment sites, including in Miami-Dade, Broward and Palm Beach counties.

DeSantis has traveled the state promoting the treatment sites, which provide the medications for free, and he credited the approach with helping to reduce hospitalizations during Florida’s delta wave in summer 2021.

But as of Tuesday afternoon all state-run monoclonal antibody sites, including the ones in Tropical Park in West Miami-Dade, C.B. Smith Park in Pembroke Pines, Miami Dade College North campus near Opa-locka, Markham Park in Sunrise and the West Boynton Recreation Center had been shut down, according to Florida’s Department of Health.

More than 2,000 patients with appointments for treatment were notified, according to the state. The health department recommends patients contact their doctor to discuss other treatment options. Florida is set to get more monoclonal antibodies and other COVID-19 therapies from the federal government this week, but not the medications made by Regeneron or Eli Lilly.

Psaki said the federal government has provided 71,000 doses of antivirals to Florida over the past month, including 34,000 in the last week, that are effective against omicron.

Florida disagrees with FDA decision

COVID-19 monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight pathogens that cause disease, enough to help keep people out of the hospital. The treatments are not an alternative to COVID-19 vaccinations.

The federal government had temporarily stopped distributing the Regeneron and Eli Lilly drugs in late December as omicron was fueling new cases in Florida and elsewhere. Federal agencies then resumed distributing the therapies after complaints from Republican governors, including DeSantis, who said that the medications were helping patients.

DeSantis has been a vocal advocate of monoclonal antibodies and he has called on the federal government to send more to Florida, where a standing order from the surgeon general had allowed people to get the Regeneron treatment without a doctor’s prescription.

But the FDA said although the Regeneron and Eli Lilly treatments were effective against prior COVID-19 variants and had been used throughout the pandemic, data show the treatments are not likely to work against the highly mutated omicron variant, which remains the dominant strain in the United States.

“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,” the FDA said in its announcement.

Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said the federal agency could reauthorize the medications if they prove to be effective against future variants. But that for now, the treatments are not authorized to be used.

“This avoids exposing patients to side effects,” she said in a statement, “such as injection site reactions or allergic reactions, which can be potentially serious, from specific treatment agents that are not expected to provide benefit to patients who have been infected with or exposed to the omicron variant.”

Both Regeneron and Eli Lilly had previously announced that they were working to develop new antibodies to target omicron.

What other options exist?

Harmon, the AMA president, said vaccination against COVID-19 remains the most effective method to reduce severity of illness and the risk of hospitalization and death from the disease — even if the omicron variant can evade the vaccine’s immunity.

“The omicron variant is highly contagious and the unvaccinated remain most at risk of severe illness, hospitalization and death if infected,” Harmon said. “Data further suggests that a booster dose provides greater protection against the omicron variant.”

In addition, new therapies approved by the FDA for emergency use are reaching Florida and other states but their supplies remain limited. Retail pharmacies, including Publix, CVS, Walgreens and Walmart can fill prescriptions for some antivirals.

Only one monoclonal antibody is known to reduce the severity of disease in those who are infected with SARS-CoV-2: Sotrovimab, which is manufactured by GlaxoSmithKline and received FDA emergency use authorization in May 2021.

Because Sotrovimab is the only available monoclonal antibody that is active against the omicron variant, the NIH COVID-19 treatment guidelines panel recently added a three-day course of intravenous Remdesivir as another treatment option for patients with the disease who are at high risk of severe illness but receiving treatment outside the hospital.

The NIH panel said that the antiviral pill Molnupiravir should only be used when the other three options are not available or cannot be used, because Molnupiravir has a lower effectiveness than the other options.

Herald/Times Tallahassee Bureau reporter Kirby Wilson contributed from Tallahassee, and McClatchy Washington Bureau reporter Alex Roarty contributed from Washington, D.C.