Florida shuts down monoclonal sites after FDA halts use of Regeneron treatment

US health regulators say Regeneron, Eli Lilly treatments don’t work against omicron variant

The Florida Department of Health is shutting down all state-run monoclonal antibody treatment sites. The move comes after the FDA revoked its emergency use authorization for some treatments, saying the treatment does not work on the omicron variant.

JACKSONVILLE, Fla. – The Florida Department of Health is shutting down all state-run monoclonal antibody treatment sites until further notice after the Food and Drug Administration revoked its emergency use authorization for Regeneron.

Gov. Ron DeSantis, who heavily promoted the treatment as a part of his administration’s COVID-19 response, released a statement Monday night saying, in part, “This indefensible edict takes treatment out of the hands of medical professionals and will cost some Americans their lives.”

The shutdown impacts two sites in Jacksonville: the Southside Senior Center and the Joseph Lee Center in Brentwood. If you already had an appointment, the state will let you know if it’s canceled.

A sign on the Southside Senior Center site explaining the closure reads, “The Biden Administration has removed the ability for any state to administer Regen-Cov or BAM-ETE monoclonal antibody treatments. As a result, this site is closed.” It advises visitors to call 911 if they are experiencing severe symptoms, to contact their health care provider for COVID-19 treatment options and to call the FDA for information on why the antibody treatments were halted.

After weeks of back-and-forth with the federal government, Florida secured 15,000 doses of Regeneron monoclonal treatments to support opening new centers around the state, including the one on the Southside. But now the FDA said Regeneron and Eli Lilly’s monoclonal antibody drugs don’t work against omicron. The FDA said there is a chance if the drugs are proven effective, the agency could reauthorize them.

“Florida disagrees with the decision that blocks access to any available treatments in the absence of clinical evidence,” the state health department said.

The FDA said restricting their use will eliminate unnecessary side effects, including allergic reactions.

On Tuesday, Pfizer announced it has begun a study comparing its original COVID-19 vaccine with doses specially tweaked to match the omicron variant.

Dr. Mohammed Reza, Infectious Disease Specialist at CAN Community Health, said there are alternate therapies available to battle early COVID-19 cases.

“They’re available in limited supply. So sotrovimab, which is a monoclonal antibody that does work to decrease your risk of hospitalization and death by 85%. Remdesivir, which is another medication, anti-viral, that they can use in the outpatient setting to decrease your risk of hospitalizations. And there are other oral medications: Paxlovid and another medication by Merck that are also shown to reduce your risk of hospitalization,” Reza said. “But granted, these are in limited supply at this point, but these are other fantastic options that are coming available and are available at this point.”

COVID-19 antibody drugs from Regeneron and Eli Lilly should no longer be used because they don't work against the omicron variant of COVID, the FDA says.

The state is encouraging people to seek out what it called “emerging treatments” on its new website healthieryoufl.com, which was launched as part of the new surgeon general’s wellness initiative.

The state also recommends supplements to guard against COVID-19:

  • Zinc
  • Vitamin D
  • Vitamin C
  • Quercetin

Also, Fluvoxamine, a pill approved to treat obsessive-compulsive disorders, is often prescribed to treat anxiety depression and panic attacks. Studies have shown it is highly effective at preventing hospitalization in COVID-19 patients. Another is Inhaled Budesonide, a steroid found to improve the condition of patients infected with COVID-19.

According to the National Institutes of Health, there’s not enough data to recommend for or against the use of any vitamin to prevent or treat COVID-19.

As with any treatment, it’s important to consult with your doctor.


About the Author:

This native of the Big Apple joined the News4Jax team in July 2021.