How Monoclonal Antibodies Help Treat COVID

Updated: 03/15/22 Monoclonal antibody therapy is another tool in our fight against COVID-19. If you’ve recently been exposed to the virus, or tested positive and have mild to moderate symptoms, monoclonal antibody therapy may help you prevent severe disease. This therapy can also be used for at-risk individuals, like those who are immunocompromised, to prevent getting COVID-19.

We asked Ihor Sawczuk, M.D., chief research officer at Hackensack Meridian Health to help answer the most commonly asked questions about monoclonal antibody therapy:

Q: How does monoclonal antibody therapy work?

A:  When you’re infected with a virus or get vaccinated, your body produces antibodies that help fight off the virus and/or prevent you from getting severely ill. Monoclonal antibodies are developed in a laboratory and administered into the body to replicate the same response. Ultimately, the monoclonal antibodies mimic the body’s natural immune system and attack infected cells to help you recover and prevent severe disease.

The U.S. Food and Drug Administration (FDA) provided emergency use authorization (EUA) for use of monoclonal antibodies in two settings related to COVID-19:

• For treatment- People who test positive for COVID-19 and are at high risk for progressing to severe illness are eligible. 
• For prevention
  • People who were exposed to COVID-19  and are at high risk for severe illness, including hospitalization or death are eligible.
  • People who were not exposed to COVID-19, but are at-risk due to compromised immune systems or have a history of severe adverse reactions to a COVID-19 vaccine.

Q: Who is eligible for monoclonal antibody therapy for COVID?

A: Under the EUA, the following people may be able to receive monoclonal antibody therapy for COVID:

For treatment:

• Adults and pediatric patients (12 years of age or older weighing at least 88 lbs)
• Who tested positive for COVID-19
• Who are at high risk for progressing to severe COVID-19.* 

Prevention for those exposed to COVID-19

• Adults and pediatric patients (12 years of age or older weighing at least 88 lbs)
• Who were exposed to COVID-19
• Who are at high risk for progressing to severe COVID-19.*

Prevention for those who were not exposed to COVID-19:

• Adults and pediatric patients (12 years of age or older weighing at least 88 lbs)
• Who were not exposed to COVID-19
• Who are high-risk due to a compromised immune system or have a history of severe adverse reactions to a COVID-19 vaccine.

*The CDC defines high risk as:

• People over age 65
• People with the following underlying conditions:
  • Cancer
  • Chronic Kidney Disease
  • Chronic Liver Disease
  • Chronic Lung Disease
  • Cystic Fibrosis
  • Dementia or other neurological conditions
  • Diabetes (type 1 or type 2)
  • Disabilities including attention-deficit/hyperactivity disorder, cerebral palsy, birth defects, learning disabilities and spinal cord injuries
  • Down syndrome
  • Heart conditions
  • HIV infection
  • Immunocompromised state (weakened immune system)
  • Mental health conditions
  • Overweight and obesity
  • Physical inactivity
  • Pregnancy
  • Sickle cell disease or thalassemia
  • Smoking, current or former
  • Solid organ or blood stem cell transplant
  • Stroke or cerebrovascular disease, which affects blood flow to the brain
  • Substance use disorders
  • Tuberculosis

Q: Is monoclonal antibody therapy safe?

A: Yes, the FDA authorized the emergency use of monoclonal antibody therapy for COVID-19 because it has been shown to be safe and effective in clinical trials. Monoclonal antibody treatments have also been FDA approved to treat other diseases for more than three decades.

Q: Do you still need the vaccine if you get monoclonal antibody therapy?

A: Yes, however, you should wait 90 days after your monoclonal antibody therapy to get vaccinated. After the 90-day period, getting vaccinated will give you stronger and longer lasting protection against COVID-19.

Q: How is monoclonal antibody therapy administered?

A: After COVID-19 exposure or testing positive for the virus, monoclonal antibody therapy is administered by intravenous (IV) infusion. It is generally given in an outpatient infusion center or emergency room and usually takes about 2 hours to complete. The infusion itself takes about 30 minutes, then you will be observed for 1 hour to monitor for any allergic reactions or side effects. These side effects are rare, but monitoring is still required for your safety. For COVID-19 prevention for those who qualify, the therapy is administered through two intramuscular injections, given one right after the other.

Q: When is monoclonal antibody therapy most effective?

A: Monoclonal antibody therapy is most effective if you get it soon after COVID-19 symptom onset and diagnosis, or exposure. For those not exposed to COVID-19, and who fit the criteria to seek therapy for prevention, the injections may be effective at prevention for six months.

Q: What are the side effects of monoclonal antibody therapy?

A: You may experience typical side effects of IV infusion therapy, including brief pain, bleeding, bruising of the skin, soreness, swelling and possible infection at the infusion site.

Rare allergic reactions:

Contact your doctor right away if you experience any of the following signs and symptoms of allergic reactions:

• fever
• chills
• nausea
• headache
• shortness of breath
• low or high blood pressure
• rapid or slow heart rate
• chest discomfort or pain
• weakness
• confusion
• feeling tired
• wheezing
• swelling of your lips, face, or throat
• rash including hives
• itching
• muscle aches
• feeling faint
• dizziness
• sweating 

These are not all the possible side effects of monoclonal antibody therapy. Serious and unexpected side effects may happen. These treatments are still being studied so it is possible that all of the risks are not known at this time. Talk to your prescribing doctor if you have any questions. 

Q: Is Monoclonal Antibody Therapy effective against the new Omicron variant?

A: With the emerging Omicron variant, several drugmakers began reviewing whether or not their monoclonal antibody therapies are effective against the mutation. GlaxoSmithKline announced that its Sotrovimab therapy is effective against Omicron, while Regeneron’s REGEN-COV has shown to potentially lose effectiveness against the new variant. Tests are underway for Eli Lilly’s bamlanivimab and etesevimab.

Next Steps & Resources:

• Meet our source: Ihor Sawczuk, M.D., chief research officer at Hackensack Meridian Health.
• To make an appointment with a doctor near you, call 800-822-8905 or visit our website.

The material provided through HealthU is intended to be used as general information only and should not replace the advice of your physician. Always consult your physician for individual care.