Oct. 4, 2021 -- Houston architect Lanson Jones is one of the nearly 80 million Americans who refuse to get a COVID-19 vaccine, arguing the shots are experimental, were rushed to market, may cause side effects, and aren’t all fully approved by federal officials.
But when he contracted COVID in September, he didn’t hesitate to seek treatment with monoclonal antibodies -- a year-old, laboratory-created therapy no less experimental than the vaccines that is not fully approved by the FDA and can also cause rare side effects.
“I haven’t done the shot because I hear a lot -- a lot -- of information about what are some of the effects of these vaccines and how it’s really not being reported, and I just felt I didn’t want to put something in me that has some question,” says Jones, 65.
“But with this monoclonal antibody treatment, I didn’t hesitate. I had no doubt in my mind -- not even one ounce of doubt about it. Not one person said, ‘Oh, well some people have had a reaction to it.’"
Jones, who was treated at Houston Methodist Hospital, is one of more than a million Americans who have received antibody IVs after getting the virus.
Those numbers are growing, with the federal government recently taking over distribution of the supplies of the drugs, which are limited in many states.
The treatment has been effective against COVID, in helping patients recover, stay out of the hospital, or die from the illness.
But what doctors and public health experts say is most surprising is that so many of those embracing it are unvaccinated Americans who have refused the shot for reasons that could very well apply to the newly developed and experimental monoclonal antibody therapy, as well.
“I think it’s irrational, quite frankly, if you have to boil it down to one word,” says Howard Huang, MD, who heads up Houston Methodist’s infusion program, which is providing up to 900 doses a week. “It really doesn’t make any sense on multiple levels.”
For one thing, he says, the FDA has just granted full approval for the COVID vaccine produced by Pfizer and BioNTech, upgrading its status from its emergency use authorization (EUA). Many experts expect the FDA to grant similar full approvals to the Moderna vaccine and possibly the Johnson and Johnson shot, which currently have EUA designations.
Many vaccine holdouts have cited the EUA status of the COVID vaccines -- one step shy of full approval -- as a reason they don’t trust the shot. But the antibody treatments have also been granted only EUA approval, which hasn’t stopped vaccine-resistant Americans from seeking them.
“So, they’re refusing an FDA-approved and tested [vaccine], and then they’re seeking something that’s still under an FDA EUA,” says Huang. “I just don’t get it. I really don’t.”
Amesh Adalja, MD, an emerging infectious diseases specialist with the Johns Hopkins University Center for Health Security, calls it “paradoxical” thinking for vaccine holdouts to refuse a shot that boosts your natural antibodies to prevent COVID, but take an antibody drug to treat it after infection.
“I don’t understand it, I can’t,” he says. “But the pandemic has been politicized and … I think consistency is not something to expect from people who are thinking about this irrationally [and] for people engaging in these conspiracies about the vaccine.
“I do think the fact that people like Joe Rogan and Gov. Abbot and Donald Trump received the monoclonal antibodies does probably play a role in some of the thinking in some of these individuals.”
Terry Scoggin, CEO of Titus Regional Medical Center in Mount Pleasant, TX, says even the hospital’s doctors have been shocked by the demand for the new therapy among unvaccinated Texans.
“It’s mind-blowing that there’s been such resistance to the vaccine, but that demand for the monoclonal antibodies is so high,” he says, noting only 47% of adults in the region have received at least one dose of the shot. That’s far below CDC estimates that say 75.2% of American adults have received one shot, while 64.7% are fully vaccinated.
“But our doctors believe in the monoclonal antibodies, so it’s a trust factor -- they trust our community physicians,” Scoggin says. “I’ve never put the two and two together about the fear of the vaccine vs. [lack of fear] of the treatment. But it’s really interesting.”
Treatments Effective, Costly
Like the COVID vaccines given to nearly 214 million Americans, the antibody treatments taken by more than 1 million in the U.S. are highly effective and cause only rare (and usually minor) side effects.
Federal health officials say the infusions have helped keep the U.S. death toll -- now about 2,000 per day-- from soaring even higher, even as vaccine hesitancy persists, particularly in Southern states.
The FDA first authorized monoclonal antibody drugs in November 2020 -- just weeks before the vaccines were approved. But their popularity has soared as the Delta variant of the virus that causes COVID-19 has surged in recent months.
Clinical trials show that the drugs can cut COVID-related hospitalization or death in high-risk patients by as much as 70%-80%. They also can prevent infection in healthy people who have been exposed to an infected person, according to research published this month in The New England Journal of Medicine.
Monoclonal antibodies have been used for decades to treat cancer, autoimmune disorders, and other diseases, with the FDA approving nearly 100 such treatments since 1994.
The FDA has granted EUA approvals to four antibody treatments for COVID-19.
A two-antibody drug combination from Regeneron -- containing casirivimab and imdevimab -- has been shown to reduce the risk of hospitalization and death by 70% in people infected with COVID. Sotrovimab, made by GlaxoSmithKline and Vir, has had similar results.
The FDA approved a third treatment -- Eli Lilly’s combination of bamlanivimab and etesevimab -- in 2020, but the agency recommended against its use earlier this year after it proved ineffective against the Delta variant. The combination came back on the market in late August, but only in states where fewer than 5% of COVID infections are from strains, such as Delta, that are resistant to the treatment.
In June, the FDA authorized a fourth drug combination, Genentech’s tocilizumab, for people already hospitalized with COVID. But it is only moderately effective against the disease.
Lab-made monoclonal antibodies mimic the antibodies your body makes to fight viruses and illnesses. They work by targeting the spike protein on the surface of the virus. COVID vaccines work by priming the body’s immune system to recognize this very same spike protein and block it from entering your body’s cells, preventing infection.
Antibody treatments are given as an IV to treat an infection but can also be given as shots into the belly for people who have been exposed to the virus but have not yet been sickened by it, Huang says.
Timing is critical, he says, noting antibodies are most effective when given in the first few days after symptoms emerge.
If you test positive for COVID-19 or have been exposed to an infected person, experts advise asking your doctor for a referral to a hospital that offers antibody IVs. Priority is given to high-risk patients, including pregnant people and those with chronic conditions like high blood pressure, heart disease, obesity, or an autoimmune disorder.
Demands, Concerns on the Rise
Orders for monoclonal antibodies have skyrocketed in recent weeks -- to 168,000 doses per week in late August, up from 27,000 in July. The Biden administration, which has been covering the cost of the treatment for most patients, took over its distribution as well this week.
But experts foresee potential problems as patient demand increases.
Federal officials have already warned states of potential shortages ahead. Only about 2.4 million monoclonal antibody doses have been shipped nationally so far, less than half of which have been administered.
More supplies are on the way, with the federal government recently buying another 1.8 million doses for delivery in the months ahead. But for now, some hospitals are uncertain of supplies and are already struggling to meet the demand for the treatments.
Seven Southern states account for 70% of orders: Texas, Alabama, Florida, Mississippi, Tennessee, Georgia and Louisiana. Those states have among the nation’s lowest vaccine rates and highest infection numbers.
Florida officials said the state’s latest weekly allotment left clinics 41,000 doses short of what they need. Tennessee has begun limiting treatments for unvaccinated patients to give priority to those most at risk of dying from COVID. And in Texas, elective surgeries have been postponed to make room for COVID-19 patients at some hospitals, as operating room nurses have been enlisted to give IVs.
Some strong proponents of monoclonal antibody treatments have been frustrated by Republican governors who are scrambling to push and deliver them, while opposing vaccine and mask mandates.
Raising vaccination rates, scientists say, would make the antibody treatments unnecessary in many cases.
Experts also note the drugs are far more costly than the vaccines -- with a price tag of about $2,100 for each IV, compared to $20-$40 for the shot.
“When you’re talking about just the cost to society as a whole -- turning down a [vaccine] that costs a couple dozen dollars for therapies that cost thousands of dollars -- it just doesn’t make any sense,” says Huang.
“And the tragedy is that a lot of these infections right now are preventable. It’s not like the pre-vaccine days, when we didn’t have anything better. And for these people, it’s just hard to justify that line of thinking. And so, the challenge is changing people’s minds. And that’s really been the difficult thing.”
In addition, the treatments take 90 minutes to administer, taxing health care workers in hard-hit states that have been slammed by the influx of patients.
Beyond these issues, Huang cites other public health costs of people choosing treatment over vaccination. The vaccine protects others because it limits transmission of the virus. By contrast, a single antibody IV helps only that patient and does not keep people from infecting others or becoming reinfected, requiring another IV.
“Getting the vaccine helps people beyond yourself; it helps the community, too,” he notes. “There’s just a strong argument for getting the vaccine. I obviously have a very biased opinion, but I would hope I have more of a scientific or expert opinion, but that doesn’t seem to matter these days.”
Vaccine Resistance Still Remains for Some
Seth Thurman, an IT technician from Mount Pleasant, TX, acknowledges he was hesitant to get the vaccine at first because he felt it was fast-tracked, “experimental,” might cause unknown side effects, was developed quickly, and was being pushed by government officials.
“I shared the same sentiments as a lot of other people [as] some of the reasons why I might have been hesitant in the beginning to get the vaccine, says Thurman, 47. “A lot of people don’t trust what’s out there, maybe what the government is pushing, so I was taking a wait-and-see approach.”
In August, he relented and received the first of the two-shot Moderna vaccine. But several weeks later, he developed COVID and took his doctor’s advice to receive antibody therapy at Titus Regional Medical Center.
The results were almost immediate.
“I noticed within just a few hours of getting that infusion I was feeling better,” he says. “And by the next day, I was feeling great. No more temperature and no cough and no loss of taste and smell. And today, I’m 100%.”
Having had COVID convinced him of the importance of getting the vaccine, and he plans to get the second dose of the shot after the prescribed 90-day waiting period.
But Jones, the Houston architect, remains unconvinced, even after suffering what he describes as a “horrible” experience with COVID.
“It’s something I’m still thinking about,” he says of the vaccine. “But I can’t imagine that there wouldn’t be some sort of side effects from something that was developed so fast and had not gone through 4 or 5 years of vetting or trials. So that kind of just leaves doubt in my mind.
“And it’s just so weird that something so personal has become so public -- like people’s medical decisions now are on the front page of The New York Times. When did we think something like that would ever happen?”
The quick results of his treatment were so “remarkable” that he’d recommend it to anyone without hesitation, he says.
“If my story can help people be willing to seek out this infusion and take it early on in their COVID experience, I think it would not only save lives and keep people out of our hospitals and not overwhelm our hospital systems,” he says.
Huang agrees that the IV therapy is a great “fallback option” for people who’ve been infected, who have weakened immune systems, or can’t receive the vaccine for other health reasons. But for most people, he argues, the vaccine is the best way to go. That’s why Houston Methodist advises the shot for every patient like Jones, who’s been treated for COVID.
“Getting the vaccine is the way to go for the vast number of people,” he says.
Frederick Thurmond, MD, who oversees COVID-related care at Titus Regional Medical Center, believes it will take more than just doctors’ recommendations to move some patients to get the vaccine. The only thing that will motivate some will be contracting COVID, or knowing someone who does, he says.
“It’s clear that least here in Texas, I swear man, you tell people they need to do something, and they just say, ‘Well, then I’m NOT going to do it,’” he says. “But once you’ve got COVID, the game becomes a whole lot more serious. And I think most people in the U.S. know someone who’s died from COVID at this point.”
Thurmond says that for some patients, stubborn resistance to legitimate medical advice persists -- on the vaccine and even treatment -- even after infection.
“We have seen more than one person avoid any medical care whatsoever after they knew they had COVID,” he says. “They languish in private and eventually come to the emergency room extremely sick and doing things with little to no medical value -- such as taking a friend's hydroxychloroquine, random antibiotics, a horse de-worming dose of ivermectin, and gargling with Betadine and even bleach.”
But most of his patients who have the IV therapy take his advice to get the vaccine afterward.
“The only way to end the pandemic is to vaccinate everybody,” he says.
“The monoclonal antibodies work, they are great drugs, so I think it is appropriate to praise them,” says Adalja, who’s given them to his own patients. “But it’s not appropriate to use them as an alternative to vaccination or to think, you know, don’t worry about the getting the vaccine because if you get infected and get the monoclonal antibodies to get through this -- that’s not the way to approach it.
He also worries about what he calls “dark-age mentalities” that have fueled the anti-vaccine movement, which has sought to heighten fears of modern medicine and doctors.
“The anti-vaccine movement has really capitalized on COVID-19, and it’s really a much more virulent form of the anti-vaccine movement than what we’ve seen with measles and other diseases in the past,” he notes. “And I think it’s going to be very difficult to contend with in the future, because no one thought we’d be battling the anti-vaccine movement this late in the pandemic.”
The biggest takeaway?
“When it comes to an infectious disease, prevention is always much better than treatment,” Adalja says. “If you don’t even need to get to the treatment stage because you prevent people from getting infected, that’s the goal.”