Briefs

Treating COVID

Monoclonal antibody therapy treatment site opens in Ormond Beach

JARLEENE ALMENAS

ASSOCIATE EDITOR

Gov. Ron DeSantis is continuing to increase access to monoclonal antibody therapy treatment, and on Thursday, Aug. 19, he announced the opening of a treatment site at the Ormond Beach Senior Center.

The governor expressed his confidence that the state will see a reduction in hospital admissions with the introduction of these treatment sites, particularly naming the treatment by biotechnology company Regeneron. At the time of the press conference, DeSantis had announced the opening of monoclonal antibody therapy treatment sites in Jacksonville, Orlando, Merritt Island, Pembroke Pines and West Palm Beach. As of Tuesday, Aug. 24, he’d opened 18 sites across the state.

“It’s our belief that if this is something that everybody understands is available, and it’s utilized, that you will be able to reduce the admissions into hospitals, and I think hopefully in a pretty significant way,” DeSantis said.

The new sites come as Florida COVID-19 hospitalizations continue to rise, with the Florida Hospital Association reporting hospitalizations are now 165% higher than they were during the state’s previous peak in July 2020. Hospitalizations, as of Tuesday, Aug. 24, totaled 16,820 since the start of the pandemic, according to FHA, up 100 from the time of the governor’s press conference in Ormond Beach. The association reports that 53.7% of adult ICU beds in Florida are currently occupied by COVID-19 patients.

The announcement came a day after the Associated Press reported that Regeneron is one of DeSantis’ top political donors.

NOT A SUBSTITUTE FOR VACCINES

As of Aug. 16, Halifax Health reported it was caring for 162 COVID-19 patients, with 47 in the ICU. Of those in the ICU, only 7 were vaccinated. By Monday, Aug. 23, the number of hospitalizations dropped to 148. In AdventHealth’s Central Florida division, which includes Orange, Osceola, Seminole, Lake, Polk, Volusia and Flagler counties, there are about 1,680 people hospitalized with COVID-19 as of Tuesday, Aug. 24.

The monoclonal antibody therapy treatment isn’t meant to replace COVID-19 vaccinations. Vaccines have been the “centerpiece” of the state’s efforts to fight the spread of COVID-19 since December, the governor said, but they aren’t meant to treat the virus; only prevent an individual from contracting it in the first place.

“Obviously we worked very hard in Volusia County and throughout the state to be able to provide easy access to vaccines, focusing on seniors first,” DeSantis said. “We brought it to communities here in Volusia, retail pharmacies, of course the hospitals, the whole nine yards, and we’re happy to have done that. The data in Florida for hospitalizations still is that the people who are admitted to hospitals in Florida for covid and are being treated, particularly people who end up in the ICU, tend to be people who were not vaccinated.”

IMMEDIATE TREATMENT POSSIBLE

Dr. Kenneth Scheppke, Florida Department of Emergency Management chief medical officer, said Regeneron monoclonal antibody therapy treatment is the best tool the state has to combat COVID-19. He stated the treatment works for all COVID-19 variants, and could be used as a post-exposure prophylaxis for COVID-19.

“So if you’re sick, or if you’re unvaccinated and you’re exposed, and you’re a high-risk individual, this is something that will treat you right now, which is very important,” Scheppke said.

On Aug. 10, the U.S. Food and Drug Administration revised its emergency use authorization for Regeneron’s monoclonal antibody therapy treatment to allow it to be used as a post-exposure prophylaxis for COVID-19 in adults and children 12 and older “who are at high risk for progression to severe COVID-19, including hospitalization or death,” according to the FDA.

It is not authorized as a prevention measure before an individual is exposed to COVID-19, and the FDA further explains it is not a substitute for a vaccine.

INCREASING AWARENESS

DeSantis said his goal is to have between 15 and 20 monoclonal antibody therapy treatment sites in the state by the end of the week. Each site, including the one in Ormond Beach, is able to perform over 300 treatments daily. The move by the state to add these sites is meant to boost what health systems already have in place.

“I think this is expanding access, but also increasing awareness, which will be good,” DeSantis said.

Treatment is free for patients, as the federal government is bearing the cost, the governor explained.

How did the treatment site end up in Ormond Beach? Jenn Elston, spokesperson for the city, said in an email that the Volusia County Emergency Operations Center, on behalf of FDEM, requested use of a facility in Ormond Beach to host a state-run monoclonal antibody treatment site.

The Ormond Beach Senior Center is located at 351 Andrews St., and the treatment site will operate daily from 9 a.m. to 5 p.m. Walk-ins are welcome, according to a city press release, but appointments are encouraged and can be made at patientportalfl.com

WHAT ARE MONOCLONAL ANTIBODIES?

Photo by Jarleene Almenas Gov. Ron DeSantis announces the opening of a new monoclonal antibody therapy treatment site in Ormond Beach.

According to the FDA, monoclonal antibodies “are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses.”

The antibody treatment is administered using an IV and though unapproved by the FDA, it does have an emergeny use authorization. It is meant to treat mild to moderate COVID-19 cases in adults and pediatric patients 12 years or older.

It is not authorized to be used in COVID-19 patients who are hospitalized, require oxygen therapy, or an increase in basely oxygen flow rate. It “may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requriing high flow oxygen or mechanical ventilation, the FDA states in its fact sheet for health care providers for the emergency authorization of the treatment. “It’s our belief that if this is something that everybody understands is available, and it’s utilized, that you will be able to reduce the admissions into hospitals, and I think hopefully in a pretty significant way,”

MASKS

State begins to make its case against mandates

Attorneys for Gov. Ron DeSantis on Tuesday began calling witnesses to back the state’s case against allowing school districts to impose student mask mandates, as a hearing continued in a lawsuit challenging a DeSantis executive order.

As the legal battle plays out, eight school districts as of Tuesday afternoon had voted to require masks for students, with exceptions only for students whose parents submit doctors’ notes. The mask mandates in the eight counties cover an estimated 1.23 million students, based on state enrollment data from the 2020-2021 school year.

DeSantis issued the order July 30 in an effort to block county school boards from requiring students to wear masks as the delta variant of the coronavirus has caused a surge in COVID-19 cases. The governor contends that parents should be able to decide whether their children wear masks.

But a group of parents filed the lawsuit, alleging that the executive order violates a section of the state Constitution that requires providing a “uniform, efficient, safe, secure and high quality system” of public schools. Leon County Circuit Judge John Cooper began hearing testimony Monday and is scheduled to finish Wednesday.

The hearing Tuesday kicked off with plaintiffs’ attorneys calling medical doctors as witnesses, with arguments centered mostly on the efficacy of wearing masks to help the spread of COVID-19.

“It keeps me from sharing my germs with you, and it keeps you from sharing your germs with me. So, regardless of whether I’m vaccinated or not or you’re vaccinated or not, it is protecting both of us,” said Mona Mangat, an allergist and immunologist.

The state’s lawyers later called their first witness, Stanford University professor of medicine Jay Bhattacharya, who testified about “harms” of requiring children to wear masks.

“If you look at the pre-COVID literature, it emphasizes that children need to be able to see faces,” he said.