Vaxxed and holdouts embrace therapy; experts debate use of therapy by vaccinated

Vaxxed and holdouts embrace therapy; experts debate use of therapy by vaccinated

It isn’t just people who are unvaccinated using Florida’s 25 monoclonal antibody treatment clinics, according to Florida officials.

About 45% of the more than 135,000 people who have received the COVID-19 treatment were fully vaccinated, state officials estimate. In parts of the state with higher vaccination rates, such as MiamiDade County, the percentage has been as much as 60%.

But do vaccinated people with breakthrough cases and mild symptoms need to get monoclonal antibody treatment? The question of who should be prioritized is drawing debate in the medical community. The pricey drug cocktail is free to patients but costs taxpayers about $2,100 a dose.

Patients should talk with their doctor, but people who are fully vaccinated and otherwise healthy don’t benefit much from getting the treatment if they develop a breakthrough case of COVID-19, said Michael Teng a virologist at the University of South Florida.

Although people can still get sick, the COVID-19 vaccines have been highly effective in protecting against serious disease and hospitalization, he said.

“The monoclonal antibodies are not going to add too much to that protection,” Teng said. “If you are in a really high-risk group and it’s been a while since you have had your second dose of vaccine, that may be something to talk with your physician about, but generally speaking, it is not really going to do that much for normal, healthy people.”

The treatment is lifesaving for at-risk people who aren’t vaccinated, reducing the chance of hospitalization by as much as 70%, Teng said. People who are vaccinated but have conditions affecting their immune system, such as being in cancer treatment, also benefit immensely, he said.

Dr. Michael Cacciatore, chief medical officer of AdventHealth Medical Group, said he recommends everyone who is eligible get the treatment, regardless of their vaccination status. Thousands of patients have received the treatment through the hospital system without a single major allergic reaction, he said.

“If you have COVID and you’ve got symptoms, even if mild and you have significant other comorbidities, I would really think hard about getting that antibody infusion,” Cacciatore said.

Under the drug’s emergency authorization, people 12 and older who are at high risk of severe disease are eligible to receive the treatment if they have been infected with or exposed to COVID-19. Risk factors include being 65 years or older, cancer, chronic kidney disease, chronic obstructive pulmonary disease, diabetes, high blood pressure, heart conditions and pregnancy. People who are overweight also qualify.

Patients who want the treatment shouldn’t wait to see if their symptoms worsen. The cocktail is most effective when given early in an infection. It also isn’t as simple as taking a pill. It requires either an IV infusion or four shots given in rapid succession.

Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off viruses.

The state’s clinics have primarily been giving Regeneron’s antibody cocktail, which the federal government purchased in bulk and is providing at no cost to patients. The first state clinic opened on Aug. 12 in Jacksonville.

Gov. Ron DeSantis voiced concerns about supply caps put in place by President Joe Biden’s administration as the delta variant sent demand skyrocketing. With cases now falling, the supply reduction did not lead to a shortage in Florida, state officials said.

Clinics have enough doses to meet demand, and state officials are keeping the clinics open to everyone who is eligible, Christina Pushaw, a DeSantis spokesperson, said in an email.

“Of the many vaccinated patients who have come to Florida’s mAb sites for treatment, all have attested to having one or more comorbidities that put them at higher risk of complications from COVID-19. Many are seniors, immunocompromised, and/or overweight,” she said.

The Florida Department of Health has not released detailed data on the monoclonal antibody treatment program.

Because of a standing order from the state surgeon general, Floridians don’t need a doctor’s prescription to get the treatment. The clinics operate mostly on the honor system because state officials “did not want to create barriers to access that might deter any patients in need from getting this lifesaving treatment,” Pushaw said.

State officials stress the numbers don’t mean the vaccines aren’t working. For instance, unvaccinated people make up about 10% of Miami-Dade’s population but 40% of the patients at the Miami treatment site.

During the peak of the delta surge, hospital officials stressed more than 90% of their COVID-19 patients were unvaccinated. It’s rare that someone who is fully vaccinated dies of COVID19. The Centers for Disease Control and Prevention has recorded 6,617 breakthrough COVID-19 deaths.

If antibody treatment is in short supply, the National Institutes of Health recommends it be given first to unvaccinated and partially vaccinated people along with people who have been fully vaccinated but are not expected to mount an adequate immune response, including people who are 65 years and older.

Because of supply concerns, Tennessee limited the drug to people most at risk of dying, prioritizing unvaccinated people over some vaccinated people who are not immunocompromised.

The antibody cocktail is safe, but like any medication or medical procedure, it isn’t risk-free, Teng said. It’s extremely rare, but the infusion can cause a life-threatening allergic reaction. Other reported side effects include fever, chills, nausea, diarrhea, muscle aches and headache.

“This is an injection,” Teng said. “This is not something that is comfortable. You are either getting a large dose of liquid under the skin or sitting for an IV to get infused. It’s not like taking an Aspirin, and things go away. It’s a procedure.”

Patients could soon have another option that won’t require an injection of IV infusion. The Food and Drug Administration is reviewing an anti-COVID pill manufactured by the drug maker Merck.

Published by the Orlando Sentinel by Skyler Swisher | Saturday; October 16, 2021