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What You Need To Know About Monoclonal Antibodies And COVID-19

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As the COVID-19 pandemic continues to rage, medical providers are discovering new tools to battle the deadly virus. One of these is monoclonal antibodies, also known as mAbs. The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) of two monoclonal antibodies treatments specifically targeted for COVID-19. One is made by Regeneron, the other by GlaxoSmithKline.

What are monoclonal antibodies?

Monoclonal antibodies are proteins made in a lab. These proteins, when administered, can join a person’s natural immune system as a potent ally to fight the COVID virus. When a person is infected with COVID-19, it takes a person’s immune system some time to produce antibodies that can fight off the virus. That’s true even if a person has been vaccinated. Monoclonal antibodies are the “first responders” which can arrive to the battle early while the body is training the natural immune forces for the fight. Monoclonal antibodies are administered as infusions or shots either by a medical provider or a pharmacist.

Who can receive monoclonal antibodies?

Not everyone who has COVID-19 can receive monoclonal antibodies. This therapy is for people who are 12 and older and are not hospitalized or severely ill. If someone is critically ill with the virus, the FDA recommends they not receive this therapy. Monoclonal antibodies are meant to be used at the onset of COVID-19 to prevent the virus from progressing. So, it is very important that both providers and patients be aware of their existence. The FDA authorized Regeneron’s therapy for people who has been exposed to an infectious person or who is at high risk of exposure. An example is people in a nursing home with a recent case.
  • If used as a preventive measure, the person receiving the therapy should be at high risk for progression to severe COVID-19, including hospitalization or death, and
  • not fully vaccinated or are someone who would not be expected to mount an adequate immune response to complete COVID-19 vaccination (for example, people with immunocompromising conditions, including those taking immunosuppressive medications), and
    • have been exposed to an individual infected with COVID-19 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC), or
    • who are at high risk of exposure to an individual infected with COVID-19 because of occurrence of COVID-19 infection in other individuals in the same institutional setting (for example, nursing homes or prisons)
If someone is mild to moderately sick, this treatment should begin as soon as possible after a positive test and within 10 days of symptoms.

How do you receive this therapy?

There are two ways to receive monoclonal antibodies therapy – either through an IV transfusion or injected under the skin with a very small needle. A qualified health professional must prescribe the treatment. The Arkansas Department of Health has authorized appropriately trained pharmacists to administer it. An infusion or injection treatment takes about an hour. Patients must wait afterwards to be monitored for side effects, which are unlikely but possible as with any medical treatment. Some symptoms may worsen after treatment, according to the FDA.

Is the therapy effective?

Studies show this therapy is highly effective at preventing high-risk patients from developing severe Covid-19 symptoms that would lead to hospitalization, and possibly, death.

How much do the treatments cost?

The United States has spent more than $2 billion on monoclonal antibody treatment doses. Why? This treatment has proven effective in preventing hospitalizations in some people who test positive for COVID-19. “With COVID-19 cases continuing to rise, treating people with mild or moderate infections can help prevent hospitalizations, which will reduce the burden on healthcare systems,” said Health and Human Services Assistant Secretary for Preparedness and Response Robert Kadlec, M.D. “To ensure equitable and efficient distribution, we will continue coordinating with state and territorial health departments to get these additional therapeutics into the hands of healthcare providers quickly, with a focus on areas of the country currently hardest hit by the pandemic.”
Are antibody treatments a replacement for vaccines?
People should still get vaccinated. Vaccines protect people longer and differently. A vaccine can prevent people from initially getting sick. If a breakthrough case occurs, which is possible, a vaccinated person may have milder symptoms. A vaccine takes about two weeks to start providing some protection, and 21 to 28 days for more protection. But research currently shows COVID-19 vaccines offer protection for at least eight months if not longer. Antibody treatments work faster, but the protection from the treatments may only last for a month. In that way, they are not a cure for COVID-19. Not every COVID-19 patient can receive monoclonal antibody treatments, but almost everyone 12 years and older can receive a COVID-19 vaccination. That’s why medical providers still stress to get vaccinated and wear a mask.
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