What Are Monoclonal Antibodies?

You may have heard that monoclonal antibodies can help you avoid serious complications of Covid-19. What are monoclonal antibodies, and how do they work? Is monoclonal antibody IV treatment right for you?

What are monoclonal antibodies, and how do they work?

Antibodies are proteins produced by the immune system to defend the body against illness and other harmful substances. Monoclonal antibodies (mAb) are specific antibodies produced in a laboratory. They are created from cells harvested from people who have recovered from a particular illness.

Covid-19 monoclonal antibodies defend the body by attaching to Covid-19 viral cells to prevent them from replicating, which helps the body fight infection. They also help protect human cells from being infected by the virus. This is accomplished by targeting the virus’ spike protein, which is used to enter host cells. By neutralizing the protein’s function that helps the viral cells enter host cells and begin replicating, mAb can help limit the damage done by Covid-19.

Monoclonal antibody treatments are typically administered intravenously (more commonly known as an IV). Treatment may also be administered with four shots in strategic areas of the body; however, intravenous infusion is the FDA-recommended delivery method.

The infusion itself takes approximately 20 minutes, after which there is an hour-long observation period to ensure patients don’t experience side effects. The entire process takes about two hours to complete.

There are several monoclonal antibody therapies that have been authorized for emergency use by the U.S. Food and Drug Administration (FDA). Some that emerged early in the pandemic have been discontinued as they are no longer effective against newer variants of Covid-19. Combination therapies that contain two or more antibody therapies appear to be the most effective in combating Covid-19 and its variants. As more variants of Covid-19 emerge, it is likely that mAb treatments will continue to evolve and change as well.

Understanding the different monoclonal antibody treatments

There are currently two Covid-19 antibody treatments that have been authorized for emergency use by the FDA:

• Sotrovimab, produced by GlaxoSmithKline and Vir, is also approved for patients 12 or older. A study analysis showed an 85% reduction in hospitalization or fatality as compared to a placebo group that did not receive treatment.
• Genentech produces Tocilizumab, also known as Actemra, a monoclonal antibody treatment for those 2 years or older who are already hospitalized due to Covid-19. It is an established drug in treating autoimmune diseases like rheumatoid arthritis. The drug works by reducing inflammation that occurs due to Covid-19 infection. It has become a frequent Covid-19 treatment in part due to its high availability.

The monoclonal antibodies below were authorized for use under the FDA’s EUA clearance, but are no longer available as of February 2022:

• REGEN-COV2, created by Regeneron, is a combination drug containing casirivimab and imdevimab. One study showed that it reduced the risk of hospitalization and death in infected patients 12 or older by over 80%.
• Eli Lilly and Company created two different therapies – bamlanivimab monotherapy, and bamlaniviman & etesevimab combination therapy. While these therapies are effective against the early strains of Covid-19, they are not as effective against variants that have since emerged. They are only used sparingly against particular strains of Covid-19 at this time.

What are the benefits of monoclonal antibodies?

Monoclonal antibody therapy first became widely publicized after it was announced the former President of the United States received the treatment in October 2020. With the help of monoclonal antibodies, along with antiviral drugs and steroids, the former president recovered from Covid-19.

Vaccines teach your body how to defend itself against a particular illness over time, with full effects being reached approximately two weeks after your second dose. Once exposed to the virus, it is unlikely that vaccination will work quickly enough to offer protection from the exposure or subsequent infection. Monoclonal antibodies, on the other hand, start offering protection within minutes to hours of being administered.

A high viral load, meaning there is a high volume of viral cells in the body, has been linked to more serious symptoms and hospitalization for those infected with Covid-19. Preventing the replication of viral cells in infected people can help prevent viral loads from becoming too high and help the immune system fight off the Covid-19 virus faster.

Getting mAb treatment within the first few days of infection can have a positive impact on the long-term prognosis of a person at high risk for severe symptoms. Monoclonal antibodies can help regulate the body’s inflammatory response to the virus, which can determine the severity of symptoms you may experience. One study showed that patients who received treatment required hospitalization 60-70% less often.

Monoclonal antibody therapy can also benefit those at high risk of severe illness who have been exposed to Covid-19. Studies are still in progress but indicate that monoclonal antibody therapy can prevent infection if given shortly after exposure.

Monoclonal antibodies can be administered after a known exposure even if a high-risk person has not yet shown symptoms or tested positive. This is beneficial not just for the unvaccinated, but also for those with medical conditions who cannot fully benefit from vaccination the way most people do.

Who is eligible to receive monoclonal antibodies?

The FDA has authorized mAb treatments for mild-to-moderate Covid-19 infections in those at high risk of experiencing severe symptoms, regardless of vaccination status. High-risk people who have been exposed to the virus qualify even if they have not tested positive. People who have tested positive and have been hospitalized or prescribed oxygen due to Covid-19 are not eligible for monoclonal antibody therapy.

People at high risk of severe disease progression from Covid-19 includes people who have at least one of the following:

• Body Mass Index of 30 or greater in adults, or equal or greater than the 85th percentile in children ages 12-17
• Chronic kidney disease, diabetes, or a medication or condition that affects the immune system
• Being 65 years or older – the death rate of those over age 65 from Covid-19 is 80 times higher than that of those aged 18-29
• Being 55 years or older with a chronic respiratory disease, chronic obstructive pulmonary disease, cardiovascular disease, or hypertension
• Pregnancy
• Being aged 12-17 with sickle cell disease, chronic respiratory disease, neurodevelopmental disorder, asthma, or medical-related technological dependence

Monoclonal antibodies make a significant impact on those who are at high risk. Studies show that people with preexisting medical conditions require hospitalization at six times the rate as those without preexisting medical conditions. Studies are underway to determine if mAb could function as a “passive vaccine” to prevent the spread of Covid-19 within households. Current ongoing studies indicate that monoclonal antibodies can provide immediate protection for high-risk individuals from infection from household contacts.

Are there any risks or drawbacks to monoclonal antibodies?

While monoclonal antibodies are effective at helping patients avoid severe symptoms and recover more quickly, there are some side effects and other considerations to keep in mind.

Side effects

Monoclonal antibody therapy may cause hypersensitivity reactions or allergic reactions, usually related to infusion. Common examples of infusion-related reactions include:

• Low or high blood pressure
• Headache, fever, or nausea
• Chills, fatigue, rash, or dizziness
• Chest pain, difficulty breathing, or irregular heartbeat
• Anaphylaxis (severe allergic reaction)

These side effects are rare, and typically not severe. After mAb is administered, there is a mandatory monitoring period to ensure no side effects or reactions occur.

Logistics to consider

Meeting eligibility requirements does not necessarily guarantee easy access to mAb treatments. Shortages of monoclonal antibody treatments are anticipated as Covid-19 cases surge again over the holidays.

Additionally, finding a treatment center can be challenging as hospital space becomes increasingly limited due to Covid-related hospitalizations. This is exacerbated by the full amount of time needed to administer a treatment – 1.5 – 2 hours – which makes getting treatments to everyone who needs them in the hardest-hit areas even more difficult.

Monoclonal antibody therapy should only be administered within the first 10 days of symptoms developing. After that point, the inflammatory response of the body to the virus will already be triggered, meaning mAb are unlikely to impact prognosis. It may be a challenge for some people to get an appointment with their doctor and make arrangements to receive therapy within that window, especially if hospital resources are limited in those areas with the highest rates of infection.

Can I get monoclonal antibodies instead of getting vaccinated?

Although monoclonal antibodies can effectively help reduce the severity of symptoms, experts stress that they are no replacement for vaccination. The positive effects of mAb treatments last for approximately a month, whereas vaccines continue to offer significant protection for 6 months or longer. The best way to stay safe from Covid-19 and its variants is to avoid getting sick in the first place, and the surest way to avoid getting sick is through vaccination.

Practically, the cost of monoclonal therapy is unsustainable as the primary weapon against Covid-19. Each vaccination shot only costs the government $20 – $40 (although it is free for individuals). Monoclonal antibody therapy, on the other hand, can cost up to $2,100 per treatment. While the government is covering the cost of mAb therapy itself for now, patients may find themselves responsible for some of the cost of servicing monoclonal antibody treatments.

Experts have been frustrated by those who are resistant to vaccines and are trying to use monoclonal therapy as a replacement. They agree the only way to end the pandemic is for everyone who is able to get vaccinated. Currently, seven Southern states account for 70% of monoclonal antibody orders – Alabama, Florida, Georgia, Louisiana, Mississippi, Tennessee, and Texas. Vaccination rates in these states are among the lowest, while infection rates rank among the highest.

This trend has been confusing for experts. Many people cite concerns about how quickly Covid-19 vaccines were developed and the lack of FDA approval when asked why they are hesitant to get vaccinated. However, Covid-19 monoclonal antibodies were developed just as quickly, and still have not received full FDA approval.

In August, the Pfizer & BioNTech Covid vaccine was granted full FDA approval for ages 16 years and older and will be marketed as Comirnaty. The Moderna and Janssen vaccines are expected to receive full FDA approval in coming months. However, the trend of people embracing mAb while refusing the Covid-19 vaccine continues despite these new developments.

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