As the COVID-19 pandemic continues, medical providers are discovering new tools to battle the deadly virus.
One of these tools is monoclonal antibodies, also known as mAbs.
The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) of two monoclonal antibody treatments specifically targeted for COVID-19. One is made by pharmaceutical company Regeneron; the other by GlaxoSmithKline.
What are monoclonal antibodies?
Monoclonal antibodies are proteins made in a lab. These antibodies, when administered, can join a person’s natural immune system as a potent ally to fight the COVID-19 virus.
When a person is infected with COVID-19, it takes their 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” that can arrive to the battle early while the body is training the natural immune forces for the fight.
Monoclonal antibodies are administered either as infusions or shots by a medical provider or pharmacist.
Who can receive monoclonal antibodies?
Not everyone who has COVID-19 can receive monoclonal antibodies.
This therapy is for people who are 12 years of age 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 are mildly ill but at high risk of becoming seriously ill from COVID-19, and those who are not currently ill but who have been exposed to an infected person. For example, people living in a nursing home where someone who was recently diagnosed with COVID-19 would be eligible.
If used as a preventive measure, the person receiving the therapy:
- Should be classified as high risk for progression to severe COVID-19, including hospitalization or death, and
- Not fully vaccinated, or someone who would not be expected to build an adequate immune response after completing a 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 the Centers for Disease Control and Prevention (CDC), or
- At high risk of exposure due to a COVID-19 infection in other individuals in the same institutional setting (for example, nursing homes or prisons).
If someone is mild to moderately sick, monoclonal antibody 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 antibody 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 local 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 teach your body to make their own antibodies against the virus. A vaccine can prevent you 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. Vaccines may soon also be available for children as young as 5.
That’s why medical providers still stress to get vaccinated and wear a mask.
To find out more, visit with your healthcare provider and check for the latest information at vaccinatethenaturalstate.com.
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Creshelle Nash, M.D., is the Medical Director for Health Equity and Public Programs at Arkansas Blue Cross and Blue Shield.
