COVID-19 monoclonal antibody treatment operation in Rockledge shuts down for now

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The monoclonal antibody site in Rockledge has stopped offering the COVID-19 treatment, after the U.S. Food and Drug Administration removed its authorization.

The FDA said it took its action because the monoclonal treatments are not effective against the now-dominant omicron variant of the virus.

The monoclonal antibody treatment had been available by appointment only at Rockledge City Center at 920 Barton Blvd. for those who tested positive for COVID-19.

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The treatment offered there involved getting four injections — two in the abdomen and one in each arm.

Previously, the treatment had been available at a site at Kiwanis Island Park on Merritt Island, with no appointment required and no positive COVID-19 test result required.

A statement from Brevard County said the treatment in Rockledge "has been halted until further notice, based on changes to approved treatment availability."

The monoclonal antibody treatment had involved getting four injections, two in the abdomen and one in each arm.
The monoclonal antibody treatment had involved getting four injections, two in the abdomen and one in each arm.

People with appointments are being notified that their appointments have been canceled.

In all, a total of 10,429 monoclonal treatments have been provided at the Merritt Island and Rockledge sites, according to Brevard County Communications Director Don Walker. The facilitity opened on Merritt Island in August and moved to Rockledge in December.

The county coordinated the treatment sites, and they were run by a private contractor, CDR.

The Florida Department of Health said it was closing monoclonal antibody treatment sites statewide because the FDA's revised emergency use authorizations "do not allow providers to administer these treatments within the United States."

As a result, appointments made by more than 2,000 Floridians for the treatment scheduled for Tuesday were canceled.

The Rockledge site will continue to offer drive-thru COVID-19 testing from 9 a.m. to 5 p.m. seven days a week. Pre-registration is recommended, but walk-in clients are welcome.

Treatments affected in the federal government's decision to pause allocations of COVID-19 therapeutics include bamlanivimab plus etesevimab, as well as casirivimab plus imdevimab, which also is known as Regen-Cov or Regeneron.

Dispute with DeSantis escalates

American Medical Association President Gerald Harmon said he supported the FDA's decision.

"Given the latest data showing the omicron variant of SARS-CoV-2 is responsible for 99% of current COVID-19 infections, 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," Harmon said in a statement. "Limiting the use of these treatments will help ensure patients receive the best available therapy."

But Florida Gov. Ron DeSantis and Florida Surgeon General Joseph Ladapo attacked the Biden administration's decision. DeSantis and Lapado in recent months have pushed the monoclonal treatments, while downplaying the importance of COVID-19 vaccinations.

The Rockledge City Center site at 920 Barton Blvd. will continue to offer drive-thru COVID-19 testing from 9 a.m. to 5 p.m. daily.
The Rockledge City Center site at 920 Barton Blvd. will continue to offer drive-thru COVID-19 testing from 9 a.m. to 5 p.m. daily.

“In our field of medicine, when someone comes to you seeking a treatment that could save their life, it is essential to have treatment options to ensure health care providers can make the best decisions for their patients,” Ladapo said in a statement. “The federal government has failed to adequately provide the United States with adequate outpatient treatment options for COVID-19. Now, they are scrambling to cover up a failure to deliver on a promise to ‘shut down the virus.' ”

DeSantis called the federal government's decision an "indefensible edict" that "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.”

In his statement, DeSantis said he was "demanding the Biden administration reverse its sudden and reckless decision to revoke emergency use authorization for Regeneron and Eli Lilly monoclonal antibody treatments. This abrupt and unilateral action by the Biden administration will prevent access to lifesaving treatments for Floridians and Americans."

DeSantis indicated during a news conference on Tuesday that Florida was considering legal action to reverse the Biden administration's decision.

During a media briefing on Tuesday, White House press secretary Jen Psaki defended the FDA's decision.

"We've approached COVID treatments like filling a medicine cabinet," Psaki said. "We're not relying on one type, one brand or treatment. We invested in and continue to buy a variety across monoclonal antibodies, pre-exposure prevention therapies and oral antivirals."

Psaki said "the FDA is making clear is that" the treatments that DeSantis "is fighting over do not work against omicron, and they have side effects. That is what the scientists are saying."

"We've seen, unfortunately, from the beginning in our pandemic response, a range of steps or pushes that have been made, through social media platforms, unfortunately, from the mouths of elected officials advocating for things that don't work, even when we know things do work — injecting disinfectant, promoting other pseudoscience, sowing doubt on the effectiveness of vaccines and boosters, and now promoting treatments that don't work."

Pushing vaccines and boosters

Psaki added that "we know what works: vaccines and boosters."

In a statement, the U.S. Department of Health and Human Services said it will continue "to make available more treatments that do work against omicron than ever before, including two antiviral pills from Pfizer and Merck; one monoclonal antibody treatment from GSK; and one pre-exposure therapy for the immune compromised from AstraZeneca. And FDA recently authorized commercially available Remdesivir for outpatient COVID-19 treatment."

"We encourage states and providers to continue offering effective treatments to Americans who get sick with COVID-19, and HHS remains committed to providing these to states at no cost," the agency said in its statement.

Harmon said the AMA continues "to strongly urge every eligible individual to make sure they are up to date on their COVID-19 vaccinations, including booster doses. The omicron variant is highly contagious, and the unvaccinated remain most at risk of severe illness, hospitalization and death if infected. Data further suggests that a booster dose provides greater protection against the omicron variant.”

In Florida, 15,141,101 people have received at least one dose of a COVID-19 vaccine, which is 73% of the population ages 5 and up who are eligible for a vaccine. That includes 402,421 people in Brevard County, or 69% of the county's eligible population.

There have been 5,280,903 COVID-19 reported cases in Florida, including 116,349 in Brevard.

There have been 63,763 COVID-19-related deaths in Florida, including 1,749 in Brevard.

Dave Berman is business editor at FLORIDA TODAY. Contact Berman at dberman@floridatoday.com. Twitter: @bydaveberman.

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This article originally appeared on Florida Today: COVID-19 monoclonal antibody treatment site in Rockledge shuts down

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