Ashley Lee. 01/08/2021
With the vaccination process beginning a few weeks ago, the approval and use of monoclonal antibodies for treating COVID-19 is still new to many. Many people were not fully aware of the development of these drugs until President Donald Trump received an experimental antibody cocktail earlier in October.
An antibody is a protein that is used by the immune system to recognize and neutralize antigens, any substances the body identifies as foreign. And monoclonal antibodies are created in labs by cloning a white blood cell.
On Nov. 9, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for monoclonal antibody therapy using a drug called bamlanivimab. The FDA issued another EUA for Regeneron’s monoclonal antibody cocktail (REGN-COV2) combining casirivimab and imdevimab on Nov. 21. Both treatments were intended for patients with moderate symptoms and who are at high risk for COVID-19; therefore, patients who were already hospitalized or required oxygen treatment could not receive this therapy. There were additional requirements as well. For example, patients had to be of at least 12 years of age and weigh at least 40 kilograms. Patients at a higher risk for COVID-19, such as those with chronic medical conditions, were also eligible.
The FDA stated that after clinical trials, both treatments were shown to “reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo.”
According to CNBC, the United States purchased 300,000 doses of bamlanivimab in October. They later purchased another 650,000 doses. And according to BioSpace, the United States plans on providing 300,000 doses of REGN-COV2 to patients at no cost by January 2021. Due to Trump’s appraisal regarding his treatment, many health officials were concerned about the potential of a high demand for these drugs.
Surprisingly, administering these drugs has been a challenge in many hospitals nationwide, despite the number of drugs available.
The Wall Street Journal explains that only 20% of the doses are being administered. There is a prominent divide regarding the use of these treatments. Some disease specialists such as the National Institute of Health do not recommend the antibody treatments because of the insufficient amount of data from trials. In contrast, officials from Operation Warp Speed encourage health professionals to use the doses. In fact, chief scientific adviser of the operation Moncef Slauoi said that he found the use of monoclonal antibodies “disappointing,” as his data revealed that only 5 to 20% of the doses had been used.
Additionally, the treatments should be given within 10 days after the patients’ first symptoms. Health officials must isolate the patients and observe them for about an hour after the infusion, so the lack of staff or space in a hospital can be another contributing factor to the lack of treatment administered.
“Antibody therapies always work best the earliest they’re given,” immunologist at Johns Hopkins Bloomberg School of Public Health Arturo Casadevall said to Business Insider. “This has been known for 130 years.”
The only patients eligible for the treatments are those who exhibit mild COVID-19 symptoms, so ensuring that those patients come to the hospital for the infusion can be a difficult task in itself.
“As they are infectious, they can’t just hail a ride-sharing app and show up at the infusion center,” member of the Medstar Health system in Washington, D.C., Dr. Princy Kumar said to NPR. “And many of them are reluctant to put a family member, who has to ride with them in the car, at risk. So that’s what we’ve identified to be our main challenge.”
On the other hand, some scientists are concerned about how virus mutations may negatively impact the efficacy of the treatments. Research from COVID-19 cases in France suggests that certain mutations may cause the virus to escape the antibodies from REGN-COV2, according to Nature.
The monoclonal antibodies are modeled based on naturally occurring antibodies. However, mutations of the virus affect the receptor-binding domain, the protein segment the virus uses to enter cells. A mutation of this type is known to be prevalent in Europe.
However, many scientists remain optimistic about the use of monoclonal antibodies for treatment, despite the mutations. Casadevall explains how the antibody cocktails can be effective against multiple strains. Many also see this treatment as a back-up plan, as not everyone will have access to the COVID-19 vaccines in the near future.
“These antibodies will find a niche in the arsenal as long as we have COVID around,” Casadevall said. “My hope is that the companies continue to produce them and to make even better cocktails.”
Cover Photo: (Getty Images)