Monoclonal antibodies for COVID-19: How they work and who is eligible

C/Net ^ | 08/24/2021 | Jessica Rendall

[SeekAndFind]

Editors' note Aug. 24, 2021: An earlier version of this story implied that Eli Lilly doesn't have emergency use authorization for monoclonal antibody treatments anymore. Distribution of Eli Lilly's bamlanivimab and etesevimab treatment has been paused in the US but is still authorized.

Preventing COVID-19 from making people extremely sick or landing them in the hospital is the public health goal of the pandemic, and the main job of the coronavirus vaccines. While monoclonal antibody therapy has been around for decades, COVID-19 monoclonal antibodies (lab-made antibodies given to a person that help their immune system stop the infection from spreading) have been gaining credibility as a key tool for protecting people most at risk of severe COVID-19. Some preliminary research shows the treatment reduces risk for hospitalization or death by about 70%. At a COVID-19 response briefing Tuesday, Dr. Anthony Fauci, the president's chief medical adviser, said that monoclonal antibodies are "underutilized" and that the drug can reduce the risk of hospitalization or death from COVID-19 by 70% to 85%.

Former President Donald Trump received the Regeneron monoclonal antibody treatment during his presidency, as did Greg Abbott, governor of Texas, when he tested positive for COVID-19 this month. These treatments are authorized for emergency use by the Food and Drug Administration for people who are 65 and older and certain people age 12 and older, including people with obesity, diabetes and heart disease. Importantly, antibody treatment has to begin before COVID-19 progresses into severe disease or hospitalization, usually within the first 10 days of symptoms (or sometimes, as in the case of Abbott, before symptoms appear. On Saturday, he tweeted that he's now testing negative for COVID-19).

Monoclonal antibodies aren't a substitute for the preventive COVID-19 vaccines, but some public health officials have criticized the lack of awareness and access to monoclonal antibody therapy. Dr. Rajesh Gandhi, an infectious disease physician at Massachusetts General Hospital, told The New York Times that more people need to be educated about how effective monoclonal antibodies can be at preventing severe disease.

"Patients need to know to call their physicians," Gandhi said. "In 2020, people with mild COVID were told to stay home. That message needs to pivot to a more proactive message."

More health care providers are beginning to take advantage of the antibody treatments, and the drug itself is free, per a deal struck by the federal government. Regeneron, the main monoclonal antibody drug maker, delivered nine times the number of doses of its treatments to US hospitals one week in August compared with the month before, The Wall Street Journal reported. What's more, Texas and Florida recently opened up state-run monoclonal antibody treatment centers, available to people who are at risk of severe COVID-19 and are in the early stages of their illness.

So what are monoclonal antibodies, exactly? And who needs them? Here's a roundup of what we know right now about antibody treatments for COVID-19 in the US.

A monoclonal antibody treatment center in Pembroke Pines, Florida. Chandan Khanna/Getty

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 the treatment has been used for illnesses including rheumatoid arthritis, cancer and HIV, according to the International AIDS Vaccine Initiative.

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 treatment is only approved for people who are at risk of getting extremely sick -- those who are age 65 or older and those who have "certain medical conditions," per the FDA. The treatment is also approved if an at-risk person is exposed to COVID-19.

Who's eligible? Can I ask my doctor for treatment if I test positive?

If you come down with the coronavirus and are concerned about how the disease will affect you, contacting your doctor to learn your options and the best line of treatment for you is a good idea. But, in general, this specific treatment is reserved for people who are at risk for severe disease. Most people who are infected with COVID-19 will recover at home without medical help.

More people are eligible for monoclonal antibody treatment if they test positive for COVID-19 than those who are eligible right now for an extra COVID-19 vaccine dose. Those who are at least 12 years old and may be eligible for monoclonal antibody treatment because of their individual risk, per the FDA, include:

• All people age 65 and older.
• People with obesity or those who are overweight (adults with a BMI of more than 25, and children age 12-17 who have a BMI at the 85th percentile or greater).
• Pregnant people.
• People with chronic kidney or lung disease (including asthma).
• Individuals with cardiovascular disease or hypertension.
• People with diabetes.
• People with sickle cell disease.
• Those living with neurodevelopmental disorders.
• People who are immunocompromised or taking immunocompromising medication.
• Those who have a "medical-related technological dependence" (such as a tracheostomy or gastrostomy).

Other conditions may also place you at higher risk of COVID-19 complications, and make you a candidate for an antibody treatment. If you think this applies to you, ask your doctor and check out the Centers for Disease Control and Prevention's page for "People with Certain Medical Conditions."

People waiting inside a monoclonal antibody treatment center in Florida. Monoclonal antibody treatments are given through infusion, meaning an IV, or by subcutaneous injection, a series of shots. Chandan Khanna/Getty

I qualify. How do I access the treatment?

Monoclonal antibodies are administered through IV or by injection (a series of four shots, so they're not a prescription you can easily pick up at the pharmacy). 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 to where the treatment is available.

If you live in Texas or Florida where there are state-run monoclonal antibody treatment centers, the same eligibility requirements for patients apply. In Florida, this means everyone age 12 and older who is at "high risk for severe illness" can make an appointment and find a monoclonal treatment center at one of the state's eight locations. In Texas, there are nine antibody infusion centers across the state, but at-risk people need a referral from their doctor.

If you think you qualify for monoclonal antibody treatment but don't have a health care provider, you can call the Combat COVID Monoclonal Antibodies Call Center at 1-877-332-6585. You can also use this link from the US Department of Health and Human Services antibody therapy finder.

Is it free? If so, what brands?

In July 2020, the US government signed a deal with Regeneron, which made doses of the drug free to Americans once the company got emergency use authorization (it did in November). In March, the government invested more money to expand access to monoclonal antibody therapy. You'll still have to pay for the administration of the treatment, though, according to the US Centers for Medicare and Medicaid Services. Medicare, Medicaid and private insurance will cover the administration cost, the Washington Post reported.

Right now, Regeneron appears to be the only brand available and free to US citizens. There are a couple other brands with current emergency use authorization from the FDA, including some from GlaxoSmithKline and Vir Biotechnology and Eli Lilly. However, you'll have to pay for GlaxoSmithKline's treatment, according to the CMS, and Eli Lilly's has been paused in distribution since late June.

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. This recommendation is until more is known about how the antibody response from the treatment affects the immune response from getting vaccinated.

In sum: Monoclonal antibodies for COVID-19 are one type of treatment for the disease, and aren't a substitute for the coronavirus vaccines.

First published on Aug. 24, 2021 at 5:00 a.m. PT.

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.

[GOPJ]

...treatment reduces risk for hospitalization or death by about 70%.

It's a winner...

[TChad]

I hope the ugly vax wars don’t turn people off to monoclonal antibody treatment. It has nothing to do with the vaccines, and it definitely works,

[SeekAndFind]

READ THIS:

Despite going head-to-head throughout the pandemic over coronavirus safety measures, Florida Governor Ron DeSantis and Dr. Anthony Fauci seem to agree when it comes to the use of monoclonal antibody treatment for COVID-19.

[Freedom56v2]

Hmm What’s up with this ;)

[Bobalu]

At this time I think monoclonal antibody infusion is the best course of treatment...it needs to be administered EARLY on so do not dawdle!

I wish there was enough to infuse everyone who is at great risk due to comorbidities.

Myself I am taking zinc and a zinc ionophore called Quercetin to help it easily pass through cell membranes... I also take D3 and C and several others.
https://pubmed.ncbi.nlm.nih.gov/25050823/

It is interesting that obese individuals generally have a lower level of zinc in their system and are also prone to bad covid outcomes.

I keep 1% ivermectin injectable at hand as well as Azithromycin, Doxycycline is also useful if no Azithromycin is available... now antibiotics are not generally useful to treat a viral infection but there is reason to believe they offer some benefit against covid.
https://pubmed.ncbi.nlm.nih.gov/32873175/

[SeekAndFind]

RE: Hmm What’s up with this ;)

They both ARE following the science. If it works, it works.

[Bobalu]

Ditto to what u said.

If u need the infusion then demand it early and do not take no for an answer!

[Freedom56v2]

LOL—makes me nervous that Fauxi agrees with DeSantis ;)

[RummyChick]

What constitutes cardiovascular disease. For example..if you have an aorta that meets a certain size does that qualify?

People need to parse through the requirements and try to sledgehammer their way into qualifying

[garandgal]

There are plenty of these drugs available & they have been since early this year. Most Doctors are not prescribing them & most patients are completely unaware that they exist.

The only reason it is coming out now (& Fauci of all people) is because Florida..and now Texas...took the bull by the horns and bypassed the road blocks being thrown up by the “medical providers.”

It will soon be obvious that this works & they will be made to look like the fools that they are...again. The families of 100,000 DEAD AMERICANS should be very angry.

Sorry to be cynical, but a free drug with a $300 fee to infuse it, or a $200,000 hospital stay. They chose the money; screw the patients.

[catnipman]

“More people are eligible for monoclonal antibody treatment if they test positive for COVID-19 than those who are eligible right now for an extra COVID-19 vaccine dose. Those who are at least 12 years old and may be eligible for monoclonal antibody treatment because of their individual risk, per the FDA, include:

All people age 65 and older.

People with obesity or those who are overweight (adults with a BMI of more than 25, and children age 12-17 who have a BMI at the 85th percentile or greater).

Pregnant people.

People with chronic kidney or lung disease (including asthma).

Individuals with cardiovascular disease or hypertension.

People with diabetes.

People with sickle cell disease.

Those living with neurodevelopmental disorders.

People who are immunocompromised or taking immunocompromising medication.

Those who have a “medical-related technological dependence” (such as a tracheostomy or gastrostomy).

Other conditions may also place you at higher risk of COVID-19 complications, and make you a candidate for an antibody treatment. If you think this applies to you, ask your doctor and check out the Centers for Disease Control and Prevention’s page for “People with Certain Medical Conditions.” gettyimages-1234764390

People waiting inside a monoclonal antibody treatment center in Florida. Monoclonal antibody treatments are given through infusion, meaning an IV, or by subcutaneous injection, a series of shots. Chandan Khanna/Getty
I qualify. How do I access the treatment?

Monoclonal antibodies are administered through IV or by injection (a series of four shots, so they’re not a prescription you can easily pick up at the pharmacy). 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 to where the treatment is available.

If you live in Texas or Florida where there are state-run monoclonal antibody treatment centers, the same eligibility requirements for patients apply. In Florida, this means everyone age 12 and older who is at “high risk for severe illness” can make an appointment and find a monoclonal treatment center at one of the state’s eight locations. In Texas, there are nine antibody infusion centers across the state, but at-risk people need a referral from their doctor.

If you think you qualify for monoclonal antibody treatment but don’t have a health care provider, you can call the Combat COVID Monoclonal Antibodies Call Center at 1-877-332-6585. You can also use this link ( https://protect-public.hhs.gov/pages/therapeutics-distribution ) from the US Department of Health and Human Services antibody therapy finder. “

https://protect-public.hhs.gov/pages/therapeutics-distribution

[Bobalu]

It makes my soul hurt to think that there are actually people that could put profit ahead of patient safety.... but I know that such creatures exist :-/

I do hope that is not happening with covid treatment.

[NoLibZone]

“Myself I am taking zinc and a zinc ionophore called Quercetin to help it easily pass through cell membranes... I also take D3 and C and several others.”

Does zinc, vit d3 and Quercetin prevnt Covid or help recover?

[Covenantor]

Bkmrk

[Bobalu]

Not enough research has been done, or if it has I somehow missed it.

IMO, if someone opts out of taking the vaccine for whatever reason, contraindicated in their case, fear that the vaccines are unsafe, confusion due to bad info coming out of both pro and con camps..etc then prophylactic measures might be useful.

BUT, if you are taking the various prophylactic measures and become ill with covid or flu-like symptoms then immediately locate a monoclonal antibody treatment center and get an infusion quickly... if you come down with symptoms antibody treatment is your best bet IMO... but fast action is critical... possibly the difference between life and death.

DO NOT make the mistake of waiting until you develop symptoms and then start taking a home remedy and sit on your butt and wait and hope to recover. Get your ass to the nearest monoclonal antibody infusion center!

The mess we are in is what happens when politics is crossed with a pandemic... it gives birth to a monster.

This mess does not surprise me given the divided state of the country... I’m not surprised, I’m disgusted.

[Republican Wildcat]

In sum: Monoclonal antibodies for COVID-19 are one type of treatment for the disease, and aren't a substitute for the coronavirus vaccines.

Treatments are not a substitute for preventatives, and preventatives are not a substitute for treatments.

[Republican Wildcat]

BMI over 25 would cover a lot of people.