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COVID-19 Monoclonal Antibody Therapy: What You Need to Know

This information was accurate at the time of publication. Due to the changing nature of the COVID-19 pandemic, some information may have changed since the original publication date.

COVID-19 vaccination is the best line of defense against the novel coronavirus. But if you've recently tested positive for COVID-19, you might be wondering how you can reduce your risk of becoming sicker. Depending on your age, health history, COVID-19 vaccination status, and how long you've had symptoms of COVID-19, you may qualify for a form of treatment called monoclonal antibody therapy.

The Food and Drug Administration (FDA) recently issued an emergency use authorization (EUA) for the first oral antiviral treatment of COVID-19. Pfizer's Paxlovid pill is available by prescription to people ages 12 years and older. Paxlovid is not a substitute for COVID-19 vaccines, which are the best available protection against the virus. Currently, supply of the pill is extremely limited.

There are currently three monoclonal antibody therapies available in the U.S., although some have shown to be less effective against the Omicron variant. Sotrovimab is currently the only mAb treatment active against Omicron, but it is in short supply.

Margaret, age 85, became infected with the virus before she had a chance to get vaccinated. Because of her age and health conditions, including diabetes and heart disease, she was at risk for severe COVID-19. Her doctors recommended monoclonal antibody therapy within seven days after testing positive. After infusion, she still felt fatigued and suffered mild chills for a day or two, but within four days of treatment, her symptoms cleared up completely.

"The treatment was relatively new at that time, so I'm grateful my doctors recommended it," Margaret says. "Though it's hard to know for sure, I do think it's likely that it kept me out of the hospital."

Emily Spivak, MD, associate professor of medicine in the Division of Infectious Diseases at University of Utah Health, answers common questions about monoclonal antibody therapy for COVID-19.

What are monoclonal antibodies?

Our bodies naturally make antibodies to fight infections. However, if you haven't received the COVID-19 vaccine or had a previous COVID-19 infection, your body will not have antibodies designed to recognize a new virus like SARS-CoV-2. "Monoclonal antibodies are laboratory-made proteins that mimic the body's immune system to fight off COVID-19 infection," Spivak says. These antibodies are given to people directly through an intravenous (IV) infusion.

How does monoclonal antibody therapy help?

Monoclonal antibody therapy is a way of treating COVID-19 for people who have tested positive, have had mild symptoms for seven days or less, and are at high risk for developing more serious symptoms.

The goal of this therapy is to help prevent hospitalizations, reduce viral loads, and lessen symptom severity. The FDA has authorized the emergency use of monoclonal antibody therapy for the treatment of COVID-19 under an Emergency Use Authorization (EUA) for people 12 years of age or older.

"In multiple randomized controlled trials, high-risk outpatients with confirmed COVID-19 were 2-7% less likely to be hospitalized with severe COVID-19," Spivak says. "This translates to these treated patients having a 70-80% reduced risk of hospitalization. The therapy does look to be highly effective if you give it to people at high risk of severe COVID-19 early in disease to prevent them from going to the hospital."

Who is eligible for monoclonal antibody therapy?

Given that COVID-19 vaccination provides strong protection against severe disease and need for hospitalization, monoclonal antibody therapy is an option for certain high-risk patients with COVID-19.

THE FDA expanded EUA of two monoclonal antibody treatments to include patients as young as newborns. Criteria for younger pediatric patients includes a positive COVID-19 test and being at high risk for severe illness, hospitalization, or death.

Individuals qualify for monoclonal antibody treatment if:

  • they have tested positive for COVID-19, and
  • it has been 10 days or less since symptoms first started, and
  • they have other health conditions that put them at higher risk.

Monoclonal antibody treatment is most effective when given early—and the sooner it is given, the better. Treatment is not effective for people who are already hospitalized or severely ill with COVID-19. Monoclonal antibodies should not be considered a replacement for vaccination.

"While we have this treatment and it does help keep high-risk people out of the hospital, it doesn't bring hospitalization rates down to zero," Spivak says. "Some people will still be hospitalized for COVID-19. The most effective thing you can do is get vaccinated and to wear a mask."

If you think you may qualify for monoclonal antibody therapy and want to ask about getting treatment, contact your health care provider. If you live in Utah, you may fill out this questionnaire to see if you qualify.

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This information was accurate at the time of publication. Due to the changing nature of the COVID-19 pandemic, some information may have changed since the original publication date.