As Covid cases continue to increase throughout the U.S., demand for monoclonal antibody treatments is spiking, especially in areas of the country with low vaccination rates. The use of this treatment gained national and international attention last October after then-President Trump received an antibody cocktail made by Regeneron after he was diagnosed with the illness. Shortly after that, two monoclonal compounds received emergency use authorization by the U.S. FDA.
According to FDA, this therapy uses “laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses.” It is helpful for people with weak immune systems, and these people don’t generate adequate antibodies after vaccination, and for others at high risk of severe illness. This treatment starts to clear Covid within hours of being infused intravenously into the body, but this treatment may not work for everyone. That is the reason complete vaccination is essential.
According to Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, “with the authorization of this monoclonal antibody treatment, we are providing another option to help keep high-risk patients with COVID-19 out of the hospital. It is important to expand the arsenal of monoclonal antibody therapies that are expected to retain activity against the circulating variants of COVID-19 in the United States.”
This antibody is a lab-made protein that functions like the antibodies made by the immune system when the body is affected by the infection. A monoclonal antibody can restore or increase the immune response against these pathogens by binding to a specific molecule called an antigen on a virus or bacteria. This antibody treatment has been used and tested for respiratory syncytial, Ebola, inflammatory bowel, multiple sclerosis, and rheumatoid arthritis.
In a lab, scientists use isolated B cells to recreate monoclonal antibodies. This can be mass-produced and infused intravenously in people. Most of the antibodies created by this method for Covid treatment target the spike protein, which the Covid uses to enter the host cells. By binding to the spike protein, this antibody can help prevent the virus from infecting human cells. Research suggests that specific monoclonal antibodies can reduce the risk of death and hospitalization in people with mild or asymptomatic Covid. Now scientists are also looking at whether this treatment can reduce the risk of someone with Covid transmitting the virus to others in their household.
One of the advantages of this treatment is that less usage of steroids and other immune-suppressive drugs. These are the main reasons for secondary infections, uncontrolled blood sugar levels, and other post-Covid complications. But there has also been concern that the use of these antibodies may cause antibody-dependent enhancement. This occurs when the antibody helps the virus to enter the cell rather than preventing it. There is no evidence till now that this therapy can cause such concerns.
The limitation of this therapy is that many new variants of Covid are coming, and the antibodies used in this therapy may not be effective. When virus proteins are changed by mutation, particularly the spike protein, it causes a significant change in the viral antigen, making it harder for the antibody to bind. The FDA is continuing to update its fact sheets to highlight the impact of this therapy. The high cost of mass-producing and the implementation complexities make the treatment available to low and middle-income countries. The treatment has to be given in a specialized medical facility. The increasing Covid cases have already limited access to specialized medical facilities, making it more challenging to distribute this treatment.
Types of monoclonal antibodies –
Bamlanivimab and etesevimab – Developed by Eli Lilly and Company. The company developed two different antibody therapies, including Bamlanivimab monotherapy and a combination of Bamlanivimab and etesevimab. On February 9, 2021, the combination of both was approved for treating mild to moderate Covid. On November 10, 2020, bamlanivimab therapy was authorized.
REGN-COV2 – Developed by Regeneron, which contains the antibodies casirivimab and imdevimab. On November 21, 2020, authorization was given for mild-moderate Covid treatment.
Levilimab – Developed by the Russian biotechnology company BIOCAD to prevent cytokine storm-related complications caused by Covid. On June 5, 2020, it was approved for use.
Eligibility for monoclonal antibody treatment –
Available to individuals who:
- Are at high risk of getting infected with Covid.
- Have a positive Covid test and have not yet been admitted to the hospital.
- Are 12 years of age or older.
Post-exposure prevention is available to those who have been exposed and who are:
- Are at high risk of getting infected with severe Covid.
- Not fully vaccinated or vaccinated but immunocompromised.
- Are 12 years of age or older.
It is essential to understand that post-exposure preventive monoclonal antibodies are not a replacement for vaccination. High risk includes – 65 years of age or older, medical-related technological dependence, overweight, neurodevelopmental disorders, pregnancy, sickle cell disease, chronic kidney disease, chronic lung disease, weakened immune system, cardiovascular disease/hypertension, currently receiving immunosuppressive treatment. To obtain the treatment, both vaccinated and unvaccinated who fit these criteria are eligible.
Monoclonal antibody administration –
This therapy is given through intravenous infusion. In the outpatient infusion centers, these infusions are given and require about an hour to administer, followed by an hour of observation and monitoring. One possible side effect of this therapy is an allergic reaction and occurs during infusion or soon after. The care team closely monitors for any signs of an allergic reaction. Sometimes infusion reactions can be delayed, so if any of the responses like Fever or chills, Hives, or itchiness, Nausea, Muscle aches, Headache, Swelling of lips, face, or throat, Shortness of breath, Wheezing, Low blood pressure is there, then the doctor has to be contacted immediately. A monoclonal antibody, when used for preventive use, can be given as a subcutaneous injection.
Cost of monoclonal antibody treatment –
Regeneron’s two-drug cocktail cost is $1,250 per infusion, and the federal government currently covers this. The cost of GSK’s and Vir’s monoclonal antibody costs about $2,100 per infusion. This is covered by a combination of GSK’s copay program, reimbursements, and government payments. Some infusion centers charge treatment fees. These are covered by Medicaid, Medicare, and most private health insurances. If a person is not insured, they can check with the treatment center if they will be charged or not.
Places where monoclonal antibody treatment is given –
- Outpatient locations.
- Urgent Care Centers.
- Some physician’s offices throughout the country.
The details are mentioned on the U.S. Department of Health and Human Services website.
Effectiveness of monoclonal antibody treatment –
This treatment is now seen as a relatively effective and safer alternative in treating Covid patients. But doctors suggest timing is essential for the administration of the therapy. If given within 72 hours of the appearance of symptoms, then it is effective. This therapy is now said to help avoid hospitalization in high-risk groups, progression to severe disease, and reduce steroids’ usage. It is to be given only to mild Covid patients who are not requiring oxygen, and there is a high risk of progression or hospitalization.
Alternative treatments for Covid –
There is my alternative treatment for Covid available other than monoclonal antibodies. These treatments include Remdesivir, Dexamethasone, Convalescent plasma, and as per data, these treatments have also been effective for people.