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Monoclonal antibodies are lab-created antibodies that can help your body fight off specific infections.

Scientists have been working hard since the start of the COVID-19 pandemic to find treatments. Monoclonal antibodies are one of the most promising COVID-19 treatments.

To learn more about Monoclonal Antibody Treatment for COVID-19, and to see if you qualify, please call 866-804-5251.

The U.S. Food and Drug Administration (FDA) has authorized multiple monoclonal antibody treatments for COVID-19. Here’s what you need to know.

What Are Monoclonal Antibodies?

When a pathogen such as a virus or bacteria enters the body, your immune system recognizes it as foreign.

Your immune system then produces Y-shaped proteins called antibodies that attach to the pathogen and stop it from entering cells. Antibodies also help destroy the pathogen.

Monoclonal antibodies are antibodies that scientists created in the lab. They act like “substitute” antibodies in someone with a disease.

Researchers design monoclonal antibodies to attach to a single specific substance in the body. These antibodies help the immune system attack the disease by mimicking the body’s antibodies or supporting the immune system’s work.

“We’ve designed the monoclonal antibodies to block the ability of the virus to attach and enter into your cells,” says Graham Snyder, MD, medical director, Infection Prevention and Hospital Epidemiology, UPMC. “Essentially, it’s now floating around helpless and weak, so your body can clear it out.”

Several different monoclonal antibodies are already important in fighting certain cancers or slowing the progression of diseases such as rheumatoid arthritis.

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How Do Monoclonal Antibodies Fight COVID-19?

The FDA has issued emergency use authorization (EUA) for the monoclonal antibody bebtelovimab to treat COVID-19. It is available as COVID-19 treatment for people who:

  • Have tested positive for SARS-CoV-2, the virus that causes COVID-19.
  • Are at high risk for severe COVID-19.
  • Are not candidates for other COVID-19 treatments authorized by the FDA.

COVID-19 monoclonal antibody treatments specifically look for and attach to the spike protein of SARS-CoV-2. When they attach to the spike protein, they can block the virus’s ability to enter cells. This slows down infection and allows your body to fight off the disease.

In December 2021, the FDA authorized another monoclonal antibody — a combination of the drugs tixagevimab and cilgavimab, known as Evusheld™ — as a preventive COVID-19 treatment. Unlike other authorized monoclonal antibody treatments, Evusheld is geared toward COVID-19 prevention. It must be administered before exposure or infection with SARS-CoV-2.

More potential monoclonal antibody treatments could become available in the future.

Who Is Eligible for Monoclonal Antibodies for COVID-19?

Currently, the FDA has authorized monoclonal antibodies for people who have mild or moderate COVID-19 with a high risk of progressing to severe disease. People at high risk include those with pre-existing medical conditions, among other factors.

Mild to moderate COVID-19 can become a severe case, so the goal is to treat it before that happens.

To be eligible for monoclonal antibodies, you must have tested positive for COVID-19 and must begin treatment within seven days of symptom onset. You cannot have a new or increased oxygen requirement. You must also have one or more of the following medical conditions:

  • Age 65 years or older.
  • CD4 count of less than 200 or less than 15%.
  • Chimeric antigen receptor (CAR-T) therapy within the past two years.
  • Graft-versus-host disease.
  • Hematological malignancy.
  • Hematopoietic cell transplant.
  • Pregnancy.
  • Receiving alemtuzumab, fludarabine, cladribine, ibritumomab, rituximab, ocrelizumab, ofatumumab, ibrutinib, acalabrutinib, fingolimod, Siponimod, ozanimod, or ponesimod therapy.
  • Solid organ transplant recipient.
  • Severe primary immunodeficiency, as defined here.
  • You are ineligible for Paxlovid™, an oral treatment for COVID-19.

“The most important thing is if you are diagnosed with COVID-19, even if your symptoms are mild, even if you’ve been vaccinated, ask about monoclonal antibodies,” says Tami Minnier, MSN, RN, chief quality officer, UPMC. “There’s a good chance you’re eligible, and they work best the sooner we can get them to you.”

The FDA has not yet authorized monoclonal antibodies for people who already have severe COVID-19, including people who are hospitalized or receiving oxygen treatment. Dr. Snyder says more data is needed before the FDA can authorize monoclonal antibodies for severe COVID-19.

Monoclonal antibodies as preventive treatment

In December 2021, the FDA authorized Evusheld for COVID-19 prevention. Evusheld differs from other monoclonal antibodies because it is authorized only for prevention. It is not currently authorized for people who have been exposed to or tested positive for COVID-19.

To be eligible for Evusheld, you must be at least 12 years old, weigh at least 40 kilograms (88 pounds), and meet one of the following criteria:

  • Have a moderate to severely compromised immune system because of a medical condition or from receiving an immunosuppressive medication or treatment.
  • Have a history of severe adverse reactions to COVID-19 vaccines and/or ingredients of COVID-19 vaccines.

Supplies of Evusheld are currently very limited and are not available to the general public.

How Do Monoclonal Antibody Treatments Work?

Patients can receive monoclonal antibody treatments as intravenous (IV) infusions or through subcutaneous injection. An infusion involves placing a needle in a vein and gradually sending the medicine through the IV.

Patients must receive this treatment at an office or clinic that’s able to provide infusions. A medical professional administers the treatment and monitors the patient for any serious reactions.

Infusion treatments involve a one-time IV infusion that takes about one hour. Patients also must wait at least one hour after the infusion ends so clinicians can watch for any negative reactions.

Subcutaneous injections require less time to administer, resulting in shorter appointment times.

How Effective Are Monoclonal Antibodies?

Scientists tested the monoclonal antibody treatments in clinical trials. The treatments reduced hospitalizations and emergency room visits for people with COVID-19 during the 28 days after receiving the monoclonal antibodies.

A May 2021 study from UPMC and the University of Pittsburgh School of Medicine reported monoclonal antibodies cut the risk of hospitalization and death in our patients by 60% when given shortly after COVID-19 infection.

“It’s incredibly effective in bending the disease outcome,” says Donald Yealy, MD, senior vice president and chief medical officer, UPMC.

“In other words, you’re much less likely to need hospital care or to have a serious or bad outcome after getting monoclonal antibody therapy, if you get it early. So if you get sick, or if you come to know of a positive test, ask early about it. Don’t wait. It works better before the disease is entrenched.”

The FDA and researchers are continuing to study monoclonal antibodies to see how well they treat and prevent COVID-19 and its variants. Some monoclonal antibody treatments are more effective than others against COVID-19 variants like Omicron (B.1.1.529). As a result, doctors will work to administer the most effective treatments possible.

Are Monoclonal Antibodies Safe?

According to reported data, monoclonal antibodies are safe. The most common side effects are infusion site reactions and allergic reactions. Those could include pain, bleeding, skin bruising, soreness, swelling, and infection at the infusion site.

Other potential side effects could include:

  • Difficulty breathing.
  • Fever.
  • Nausea/vomiting.
  • Rapid/slow heart rate.
  • Tiredness.
  • Weakness.
  • Confusion.
  • Hyperglycemia.
  • Pneumonia.

Serious side effects are rare. Talk to your doctor if you experience any side effect that doesn’t go away within a few days.

Does UPMC Offer Monoclonal Antibodies?

UPMC is currently providing monoclonal antibodies to patients with mild or moderate COVID-19 who are at risk of severe illness.

Monoclonal antibodies can help to stop your symptoms from getting worse and may prevent hospitalization due to worsening symptoms of COVID-19. They are NOT a replacement for the COVID-19 vaccine; they are an option to treat your current COVID-19 infection.

Paxlovid, an oral antiviral medication, also is available for the treatment of mild to moderate COVID-19. It is available at retail pharmacies with a prescription. Patients should receive either Paxlovid or monoclonal antibodies, not both.

Patients must have a doctor referral and a high-risk medical condition to receive monoclonal antibodies at this time. Ask your doctor if you qualify for Paxlovid.

UPMC is committed to providing equal access to monoclonal antibodies to communities of color and other communities severely affected by COVID-19.

“This disease has disproportionately affected communities of color,” says Steven Evans, MD, surgical oncologist, UPMC Hillman Cancer Center. “We at UPMC have taken every precaution to mitigate any racial disparity in our administration of this lifesaving treatment. Black, Brown, and white all are receiving this treatment at equal rates.”

To learn more about monoclonal antibodies:

Editor's Note: This video was originally published on , and was last reviewed on .

Sources

National Cancer Institute. Monoclonal antibody. Link

US Food and Drug Administration. Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibody for Treatment of COVID-19. November 9, 2020. Link

US Food and Drug Administration. Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19. November 21, 2020. Link

US Food and Drug Administration. COVID-19 Frequently Asked Questions. Link

US Food and Drug Administration. Fact sheet for healthcare providers emergency use authorization (EUA) of bamlanivimab. Link

US Food and Drug Administration. Fact sheet for healthcare providers emergency use authorization (EUA) of casirivimab and imdevimab.

About UPMC

Headquartered in Pittsburgh, UPMC is a world-renowned health care provider and insurer. We operate 40 hospitals and 700 doctors’ offices and outpatient centers, with locations throughout Pennsylvania, Maryland, New York, West Virginia, and internationally. We employ 4,900 physicians, and we are leaders in clinical care, groundbreaking research, and treatment breakthroughs. U.S. News & World Report consistently ranks UPMC Presbyterian Shadyside as one of the nation’s best hospitals in many specialties and ranks UPMC Children’s Hospital of Pittsburgh on its Honor Roll of America’s Best Children’s Hospitals. We are dedicated to providing Life Changing Medicine to our communities.