Monoclonal antibody therapy is a COVID-19 treatment for people who are at risk for severe disease or death. In early December, the US Food and Drug Administration authorized a monoclonal antibody treatment for at-risk children age 11 and younger, including newborns, after they test positive for COVID-19 or have a confirmed exposure to someone with COVID-19.
The therapy, made by Eli Lilly, is the same one that's been authorized for at-risk people age 12 and up after they test positive for COVID-19. The antibodies are also authorized for that same group if they have a confirmed exposure to COVID-19 and are either unvaccinated or can't mount an immune response to the coronavirus vaccines (people who are immunocompromised). Other antibody therapies produced by GlaxoSmithKline and Regeneron also have emergency use authorization as of early December, according to the US Centers for Disease Control and Prevention. Regeneron's treatment, called REGEN-COV, was when he contracted COVID-19 in October 2020.
As the coronavirus pandemic closes in on its second year as a global threat that has killed more than 5.3 million people globally, and 800,000 in the US, scientists are working to find effective treatments for those most at risk for hospitalization and death from COVID-19. They also need to find out which ones are effective against variants of the ever-mutating coronavirus -- most recently, . Regeneron has said that its widely-used treatment might be less effective against the omicron variant. Scientists have also questioned how well antibody treatment will hold up, as evidence continues to show that omicron can get around antibodies induced by prior infection with COVID-19 or the vaccines. COVID-19 boosters , according to Dr. Anthony Fauci. He also noted at a press briefing Wednesday that "considerable protection" against severe disease is still given by two doses of a vaccine.
So far, no antiviral pill has been authorized by the FDA. Merck's pill barely passed a vote by an FDA panel and is yet to be authorized, and could bring a more enthusiastic endorsement from experts but hasn't been authorized by the FDA yet, either. Monoclonal antibodies are an important tool against COVID-19 because they are used in the first stage of COVID-19 disease, within 10 days of the first symptoms, before a person needs to be hospitalized. Monoclonal antibodies are also paid for by the federal government, though some people's insurance may require them to pay for the administration or infusion of the therapy.
As the science continues to evolve, here's what we know about monoclonal antibody treatment right now.
Are monoclonal antibodies effective against omicron?
Experts don't know exactly how effective the authorized monoclonal antibodies will be against COVID-19 cases caused by the omicron variant. But Regeneron, one of the antibody producers, released a statement on Nov. 30 that said omicron might reduce the effectiveness of its treatment. Preliminary research suggests that most monoclonal antibody treatments aren't as effective, or might be outright ineffective, against omicron. The same study highlighted the effectiveness of a vaccine booster dose.
However, more research is needed, and the vast majority of COVID-19 cases in the US continue to be caused by the.
If omicron becomes resistant to one of the monoclonal antibody therapies with authorization from the FDA, the agency may remove its emergency-use authorization for that therapy. With previous variants, monoclonal antibody therapy reduced the risk of hospitalization in high-risk patients by 70% to 85%.
Monoclonal antibodies aren't a substitute for COVID-19 vaccines (though there is one antibody therapy CDC data, unvaccinated people were 14 times more likely to die from COVID-19 in September compared with fully vaccinated people. Everyone age 5 and up is eligible for a COVID-19 vaccine.who don't respond to the vaccine). According to
What are monoclonal antibodies, and how do they work?
Monoclonal antibodies are lab-made antibodies that work by binding to bacteria, cancer cells or viruses the way natural antibodies do, stopping them from infecting more cells. The first monoclonal antibody therapy was approved more than 30 years ago and has been used for other diseases, including cancer.
Monoclonal antibody treatments for COVID-19 are used before a person gets really sick, usually within 10 days of their first symptom, to prevent hospitalization. The antibodies can't be used in someone who is already hospitalized and being treated with supplemental oxygen, for example.
The treatment is also only authorized for people who are at risk of getting extremely sick -- including newborn babies and children who have diabetes, asthma, obesity or one of the many health conditions that makes a person more susceptible to severe COVID-19 disease. Older adults age 65 and older are eligible, as well as many other adults with underlying health conditions.
Monoclonal antibody therapy is also authorized for people age 12 and up if an at-risk person is exposed to COVID-19, but the definition of "at-risk" in this instance, per the FDA, is a little narrower and reserved for people who are at risk because of a medical condition and unvaccinated or not fully protected by the COVID-19 vaccines because of an immunocompromising condition.
Many adults and children who test positive for COVID-19 would be eligible for monoclonal antibodies. In its fact sheet for Eli Lilly's treatment, the FDA lists certain groups at high risk for severe COVID-19, including babies less than one year old, older adults age 65 and up, pregnant people, and adults and children with many health conditions including diabetes, obesity, lung disease, kidney disease and more. The FDA also refers to the CDC's list of "people with certain medical conditions" for providers and patients to consider, which is an even more extensive list.
In short: if you are sick or have been exposed to COVID-19 and think you may qualify for monoclonal antibodies because of your underlying health condition, it's likely you do. If you're uncertain, call your health care provider.
Why are kids and babies eligible?
In general, children are much less likely to experience severe COVID-19 disease than adults are, and most children will fully recover at home. The FDA's authorization of monoclonal antibodies for at-risk children opens the door for treatment for kids who might have an underlying condition that makes them more susceptible to severe illness, including common conditions like diabetes, obesity or moderate to severe asthma.
"Now all patients at high risk of severe COVID-19, including children and newborn babies, have an option for treatment and post-exposure prevention," Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, said in an FDA news release. "Children under one year of age who are exposed to the virus that causes COVID-19 may be at particularly high risk for severe COVID-19 and this authorization addresses the medical needs of this vulnerable population."
All kids ages 5 and older are, which is a smaller dose than the company's vaccine for people age 12 and up. Pregnant people and their newborns are at a .
How do I access treatment? Is it free?
Monoclonal antibodies are most commonly given through infusion or IV, so it's not a prescription you can pick up at the pharmacy. To find treatment near you, you can call the Combat COVID Monoclonal Antibodies Call Center at 1-877-332-6585 or your primary care doctor. The most widely used antibody therapies are free, but you may need to pay for the administration fee if it isn't covered through your insurance. Medicare covers the cost of infusion right now. Medicaid may also cover the cost, depending on the state you live in. For more information, you can call the Combat COVID hotline or your insurance provider.
According to CNN, the infusion process takes about an hour and patients need to wait a while to be observed for side effects. If you're at risk for severe COVID-19 and you've tested positive or think you have it, ask your doctor where the treatment is available.
Do monoclonal antibodies interfere with the coronavirus vaccines?
If you were treated with monoclonal antibodies and you haven't been vaccinated yet, you should wait 90 days after your treatment to make an appointment, according to the CDC. If you were given antibodies as a precaution because you were exposed to COVID-19, you should wait at least 30 days to be vaccinated. This recommendation is until more is known about how the antibody response from the treatment affects the immune response from getting vaccinated.
Monoclonal antibodies are not a substitute for the preventative COVID-19 vaccines which everyone age 5 and up is eligible for in the US. According to the CDC, unvaccinated people were 14 times more likely to die from COVID-19 in September compared with fully vaccinated people.
The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.