Benjamin Franklin famously said, “An ounce of prevention is worth a pound of cure.” And although it’s been more than two centuries since the colonial inventor and statesman proffered this sagacious suggestion, some people seem to find little value in its inherent wisdom. As the delta variant surges through the United States, filling ICUs to capacity and straining already-overwhelmed hospital nursing staff, people are opting for the pound via monoclonal antibodies (mAb) over the ounce, the vaccine.
The demand has come primarily from states where vaccination rates are below the national averages, mostly in the south. According to CBS News, “Seven states — Alabama, Florida, Texas, Mississippi, Tennessee, Georgia, and Louisiana — made up 70% of orders for monoclonal antibodies in recent weeks.”
Acknowledging this increasing demand, a spokeswoman from the U.S. Department of Health and Human Services (HHS) stated, “Given this reality, we must work to ensure our supply of these life-saving therapies remains available for all states and territories, not just some.”
Essentially, monoclonal antibodies mimic how our natural immune system creates antibodies in an effort to target and destroy infectious sources, such as the SARS-CoV-2 virus. Much like the current vaccines by Pfizer, Moderna, and Johnson & Johnson, “Monoclonal antibodies are antibodies made in a laboratory to fight a specific infection and are similar to the ones naturally produced in the body” and are “used to treat COVID-19 target the spike protein of SARS-CoV-2 virus—the virus which causes COVID-19—blocking it from attaching to and entering the body’s cells” according to allscripts.com.
The use of monoclonal antibodies have shown promise in preventing hospitalizations due to COVID-19 infections. As Dr. Morgan Hakki, Interim Head of the Division of Infectious Diseases at OHSU and the Vice-Chair for Clinical programs for OHSU’s Department of Medicine explains, “It does appear that this treatment does what it’s supposed to do, which is keep people from getting so sick that they need to go to the emergency room or the hospital.
Moreover, The FDA has issued a statement that “when used under the conditions described in this authorization, the known and potential benefits of bamlanivimab and etesevimab [the ingredients in the monoclonal antibody infusion] administered together outweigh the known and potential risks of such products.”
In some cases, monoclonal antibodies have proven nothing short of miraculous. As one patient testified, “I got my positive COVID test on Palm Sunday and I began to feel the respiratory issue the following Thursday. … It turned out I was eligible [for monoclonal antibodies] and I went for the infusion on Good Friday. For me, the infusion seemed to have a rapid and positive effect in helping to arrest the progress of the virus and speeding the path to recovery.” Another patient offered the following endorsement: “If I can go get an infusion and feel as good as I do right now, man, I’d rather not take a vaccine that has just been developed. That makes me nervous, still.”
Source: KHANNA / AFP) (Photo by CHANDAN KHANNA/AFP via Getty Images)
The fact that these monoclonal antibodies cocktails were just as recently created as the vaccines seems unable to prick the bubble of fear of those who are vaccine-hesitant, which hints at a subtle yet potent form of a psychological denial mechanism.
As Steven L. Taylor writes in Outside the Beltway, “There may be some psychological aspects of all of this wherein people are more predisposed to being willing to take treatment over preventative actions. For example, getting the shots and not getting sick is different from getting sick and then getting cured (or even just being made better). Prevention that leads to no infection looks a lot like no vaccine and avoiding infection while getting sick and then getting a treatment that make one feel better is more concrete.”
Regardless of the reasons, demand remains robust for mAb. However, meeting this demand poses its own set of challenges. To begin with, there are potential health risks associated with receiving mAb. The FDA points out that bamlanivimab and etesevimab “are both investigational drugs and are not currently approved for any indication, but have been authorized for emergency use.” (Ironically, it was this provisional nature of the approval of the COVID-19 vaccines that stirred the ire of the leading voices against the vaccination.)
There are also side effects associated with using mAb, including fever, difficulty breathing, rapid/slow heart rate, tiredness, weakness, and confusion for bamlanivimab and etesevimab and nausea, vomiting, hyperglycemia, and pneumonia for casirivimab and imdevimab, the other mAb cocktail manufactured by Regeneron Pharmaceuticals.
And in the past, research shows that other mAb have carried the “risk of immune reactions such as acute anaphylaxis, serum sickness and the generation of antibodies” as well as “organ-specific adverse events such as cardiotoxicity.” Again, these side effects to be transient and uncommon, much like the current COVID-19 vaccines.
As effective as mAb are at keeping people out of hospitals, they come at a cost. As Newsweek reports,” Regeneron is selling its monoclonal antibody cocktail to the U.S. government at $2,100 per dose, the same price as Eli Lilly’s treatment. That’s about 52 times more than the cost of two doses of the Pfizer vaccine.”
And according to the New York Times, “Vaccine-resistant Americans are turning to the treatment with a zeal that has, at times, mystified their doctors, chasing down lengthy infusions after rejecting vaccines that cost one-hundredth as much. Orders have exploded so quickly this summer — to 168,000 doses per week in late August, up from 27,000 in July — that the Biden administration warned states this week of a dwindling national supply.”
Furthermore, the elevated demand has caused a shortage in supply, at least temporarily. This means the availability of mAb may not always be reliable. As Kentucky Gov. Andy Beshear warns, “What this shortage ought to tell you is that if you’re unvaccinated and you get really sick, not only might there not be a bed in the hospital for you because they are so full, but that monoclonal antibody treatment might not be there for you, either.”
Although Kentucky has been gaining ground in vaccinations, 50% of its population remains unvaccinated. In fact, things have gotten so bad in Kentucky hospitals, “Galen College of Nursing students are working in hospitals across the commonwealth to address staff shortages” and have “given a total of 4,600 hours” of service, as reported by WLKY, a local news source.
This reliance upon mAb over the vaccine is straining medical systems throughout the United States, forcing policymakers and hospitals to realign priorities and resources amid the clamor for the treatment. As Dr. Christian Ramers, an infectious disease specialist and the chief of population health at Family Health Centers of San Diego, a community-based provider, argues,
“It’s clogging up resources, it’s hard to give, and a vaccine is $20 and could prevent almost all of that.” Ramers stated that opting for monoclonal antibodies over a vaccine is “like investing in car insurance without investing in brakes.”
Beyond the shortage of the mAb treatment and its exorbitant cost remains the issue of reinfection. That’s because even though mAb is proving a valuable weapon against severe illness and morbidity in the fight against COVID-19, it does not offer any long-term prevention against contracting the virus again. The University of Alabama at Birmingham Professor Turner Overton, M.D warns, “The monoclonal antibodies are not as durable as the vaccine. The vaccine trains a healthy immune system to protect from a future infection, and the protection can last much longer.”
Additionally, states have criteria in place that restrict the use of monoclonal antibodies. For example, based on the FDA’s guidance, Minnesota prioritizes people with the following conditions:
- Obesity or being overweight
- Pregnancy.
- Chronic kidney disease
- Diabetes.
- Immunosuppressive disease or immunosuppressive treatment
- Cardiovascular disease or hypertension.
- Chronic lung diseases
- Sickle cell disease
- Neurodevelopmental disorders
- Other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital abnormalities).
- Having a medical-related technological dependence
But treatment is still a local decision as these are merely guidelines. This means, ultimately, that people who would not typically qualify but have decided to choose treatment with mAb over vaccinations are competing with those that meet the criteria, thus likely increasing overall demand that exacerbates shortages. As Newsweek reports, “While some of those doses are likely being used on vaccinated people who are breakthrough cases, many people seeking the treatment are unvaccinated.”
Meanwhile, the Biden Administration has used this crisis of demand for mAb to assert federal control over its distribution. This means that the U.S. Department of Health and Human Services will decide where the supplies are sent and in what quantity. “This system will help maintain equitable distribution, both geographically and temporally, across the country, providing states and territories with consistent, fairly distributed supply over the coming weeks,” an HHS spokesman stated recently.
As a result of this power move, states that are relying upon mAb to combat COVID-19 illnesses are likely going to find themselves on the proverbial short end of the stick with regard to access to the supply of the treatment.
“We are very, very concerned with the Biden administration and the HHS’s recent, abrupt, sudden announcement that they are going to dramatically cut the number of monoclonal antibodies that are going to be sent to the state of Florida,” Gov. Ron DeSantis said during a recent press conference, adding “There’s going to be a huge disruption and patients are going to suffer as a result of this.”
And some leaders ascribe a darker motive, one based on employing punitive measures against those that are vaccine-hesitant. Florida Sen. Marco Rubio said in a recent video, “This reeks of politics. This is the Biden administration punishing Florida. They’re saying to states like Florida, ‘Oh yeah, you’re not gonna have mandates? You’re not gonna do what we want you to do? Well then guess what, we’re gonna cut off your antibody treatments and your access to them.'”
This is a very dangerous and unprecedented move by our federal government. Let me be clear: I wholeheartedly endorse vaccinations and believe the resistance to vaccinations has been largely unfounded and costly. Still, such a power move does not bode well for our collective future. In addition to giving the federal government more and more control over our lives, the federal government is remarkably inept at coordinating large-scale responses.
As a recent Cato article points out, “the U.S. response to the COVID-19 pandemic is a master class in government failure. Some of the failures involved inadequate or ineffective preparation for a pandemic, while others involved ineffective or irrational responses to COVID-19 once it appeared on our shores,” adding, “The primary lesson to be drawn from America’s experience with COVID-19 is that putting the federal government in charge of the health care system would saddle it with administrative responsibilities that it could not possibly handle.”
At the end of the day we are all in this together, and effectively denying people treatment is not the way to bring our country together nor combat COVID-19. If the Biden administration asked states that prefer to use monoclonal antibodies over vaccines to share more of the economic burdens of the cost, this would have been a rational move in line with free-market principles. But by using the issue as a political weapon to punish those who they see as enemies, Biden has once again taken what is being seen as an adversarial and divisive approach.
Such an approach is unlikely to win hearts and minds. It may, in fact, make people even more hardened in their stances against the vaccine and amplify a core sense of distrust regarding our federal government. In our highly fractured society, with nearly 2,000 COVID-19-related deaths daily, we cannot afford either of these dynamics.
As founding father Benjamin Franklin himself captured so astutely, “We must, indeed, all hang together or, most assuredly, we shall all hang separately.”
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