monoclonal antibody therapy

What Is Monoclonal Antibody Therapy? Here's What We Know

Treatments are not authorized for patients who are hospitalized due to COVID-19 or who require oxygen therapy due to the virus

More health systems across the U.S. are offering monoclonal antibody therapy as a way of fighting COVID-19 infection, but how exactly do the treatments work, and how effective are they in reducing the effects of the virus?

The therapy is being touted by politicians like Florida Gov. Ron DeSantis amid a concerning rise in COVID-19 hospitalizations and cases across the state, fueled largely in part by the highly contagious delta variant. States like Texas, Louisiana and Arkansas have also seen an alarming surge in cases and hospitalizations, making the need for vaccinations and other treatments more crucial.

Experts stress that while antibody therapy is an option, vaccination remains the most powerful way to combat COVID-19 infection.

Here’s what we know so far about monoclonal antibody therapy, how it works, and what health care systems are offering the treatment.

What is monoclonal antibody therapy?

Monoclonal antibody treatments, which are ​​delivered intravenously or by injection, mimic the immune system’s ability to fight off harmful antigens such as viruses, according to the U.S. Food & Drug Administration. They are laboratory-made proteins made by Regeneron Pharmaceuticals and can be used to treat mild-to-moderate cases of COVID-19. 

Candidates for monoclonal antibody treatments include elderly patients (those 65 years or older) and those with chronic kidney disease, diabetes, morbid obesity and sickle cell. Treatments are not authorized for patients who are hospitalized due to COVID-19 or who require oxygen therapy due to the virus. 

“This is not for someone with severe symptoms, this is not for someone who is hospitalized, not for someone hospitalized on oxygen,” said Dr. Aldo Calvo, the medical director of ambulatory services at Broward Health Medical Center.

The treatments are primarily used to reduce future hospitalizations and severe illness caused by the virus.

The monoclonal antibody specifically directed against the spike protein of the COVID-19 virus is called Sotrovimab. Treatment is also known simply as Regeneron.

Are monoclonal antibody treatments safe for kids?

Kids 12 years and older are authorized to receive monoclonal antibody treatments. Doctors say the treatment needs to be administered within a few days of a positive COVID-19 diagnosis in order for it to be 70% effective.

Other eligibility requirements include weighing at least 88 pounds, being COVID-19 positive with mild to moderate symptoms and having at least one high-risk factor such as obesity, diabetes or cardiovascular disease.

Is monoclonal antibody infusion FDA approved?

The FDA has issued emergency use authorization for monoclonal antibody treatment, which is not the same as approval.

The federal agency considers the therapy “investigational,” saying: “It is reasonable to believe that sotrovimab may be effective in treating adults and certain pediatric patients with mild-to-moderate COVID-19. And, when used to treat COVID-19 for the authorized population, the known and potential benefits outweigh the known and potential risks for the drug.”  

The agency stresses that vaccination remains the most effective way of protecting oneself against COVID-19.

Where can I get monoclonal antibody therapy?

You can check the U.S. Department of Health and Human Services website to find a treatment center near you. You can also call 1-877-332-6585 (English) or 1-877-366-0310 (Spanish) for more information about locations.

In Florida, Gov. Ron DeSantis announced that he is launching a rapid response unit to expand the use of monoclonal antibodies in the state.

Treatment centers have sprouted in places like Jacksonville, Ormond Beach, Orlando and are scheduled to open in other Florida cities on both coasts of the state.

In South Florida, the antibody therapy is available in Pembroke Pines, West Palm Beach and Miami. You can find a list of state-run treatment centers here.

In Miami-Dade County, the therapy is available at Tropical Park and is open from 9 a.m. to 5 p.m.

Other hospital systems like the Memorial Health Care System and Broward Health Medical Center are also offering the therapy.

In Texas, nine antibody infusion centers have launched, Gov. Greg Abbott announced Friday.

DeSantis has previously said Regeneron helped former President Donald Trump when he was infected last fall.

DeSantis said he believes this monoclonal antibody treatment is not as well known because it received federal emergency use authorization about the same time as the mRNA vaccines were being approved, and that the focus "rightfully" was on vaccines at the time.

He said he felt it was important to increase its use along with vaccines saying they were "the most effective" yet seen for people who are already infected.

“I don't think it's an either or,” he said. “We have people in society that are not vaccinated. We also have people who are vaccinated who are still testing positive. Either way, if you get in that situation, particularly in these high-risk categories, this should be your stop.”

Is Remdesivir a monoclonal antibody treatment?

According to the U.S. Department of Health and Human Services, Remdesivir is an "antiviral drug approved by the FDA for the treatment of COVID-19 in hospitalized adults and hospitalized pediatric patients at least 12 years of age."

The drug works by stopping SARS-CoV-2 from spreading in the body. While monoclonal antibodies are used to prevent future hospitalizations and are administered to high-risk patients, Remdesivir is used in patients who are already hospitalized.

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