Analysis: Why Is It So Difficult To Obtain COVID-19 Monoclonal Antibody Treatments?

The demand for monoclonal antibody treatments to help in the recovery of COVID-19 patients has outpaced the supply, and this situation runs the risk of becoming more acute as federal regulators consider whether to limit the authorization of certain treatments that have yet to show their efficacy in mitigating the fast-spreading omicron variant. 

What Happened: Monoclonal antibodies are treatments made from the cells of “people who’ve had COVID and whose immune cells are responding to COVID. We’re basically growing them in a test tube and having them build antibody — then you use that antibody to infuse into patients rather than rely solely on their own natural antibody,” said Dr. Kevin Dieckhaus, professor of medicine and chief of the division of infectious diseases at UConn Health, a branch of the University of Connecticut. 

Dieckhaus acknowledged the challenge of testing new treatments and gaining regulatory approval after studying the test results is slow, although special accommodations can be made in the face of a public health crisis, such as with the emergency authorizations of the COVID-19 vaccines.

In the case of the monoclonal antibodies, he added, there are other factors creating distribution hiccups.

“The problem that people are facing right now is not so much that regulatory issue — it's the fact there are limited amounts of products that are available to distribute,” he said. “And the number of people who would qualify or who can benefit from this far exceeds the number of units that are available.”

Dieckhaus predicts the supply and demand imbalance will be alleviated within the next six months because “the manufacturers are trying to do this as fast as they possibly can.” Yet he also cautioned that his expectation is predicated on COVID infections declining.

“Frankly, the number of people who are needing it hopefully will go down,” he said. “Because right now, we're just experiencing a very large upswing in the number of cases and the number of cases far exceeds the amount of product that's available.”

Another factor that weighs on monoclonal antibody treatment availability, Dieckhaus said, is the distribution of the treatments to hospitals.

Within his state, he observed that the Department of Public Heath distributed the treatments “amongst the various hospitals according to what their perceived need is, and the hospitals are kind to their own devices in terms of trying to figure out how to best administer this among their own population.”

Complicating matters is the lengthy nature of the treatment.

“The monoclonal antibodies are a fairly intensive intervention and it requires having someone come in for an IV infusion, which takes several hours,” he said. “You’ve got to place an IV line, you need a place to do that and you need to have nursing to be able to administer you're at. And I'm sure you've heard that the staffing crisis has been pretty substantial — we're having difficulty finding the nursing staff. Typically, a treatment course takes about four hours, so it's not easy in terms of trying to build that into a system.”

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What Else Happened: Also impacting the situation is the potential for a government-mandated clamp on these treatments.

According to a CNN report based on input by an unnamed “source familiar with the decision-making,” the U.S. Food and Drug Administration could potentially announce as soon as this week whether to restrict the use of antibody treatments produced by Eli Lilly and Company LLY and Regeneron Pharmaceuticals Inc. REGN.

This decision is based on evidence that does not support their ability to stop the spread of the omicron variant.

If the FDA went this route, it would follow the decision made by the National Institutes of Health, which advised clinics not to use these treatments on patients with mild to moderate COVID-19 based on their minimal effectiveness against the omicron variant. Regeneron affirmed that its monoclonal antibody treatment is ineffective against the omicron variant.

Since most COVID cases are not sequenced to determine which variant has infected the patient, doctors risk making treatment decisions without knowing whether they are dealing with the delta or omicron variant.

With the delta variant in decline and the evidence failing to show the monoclonal antibodies have the same effect on the omicron variant as it had on the delta variant, CNN’s unnamed source said the Biden administration hopes states will wind down these treatments and aim for other treatments including antiviral pills from Merck & Co. Inc. MRK and Pfizer Inc. PFE antiviral pills and the pre-exposure prophylaxis from AstraZeneca plc AZN.

Also Happening: Complicating matters is the question of whether monoclonal antibodies are being distributed evenly among racial demographics.

BuzzFeed News reported that a Centers for Disease Control and Prevention report found Hispanic COVID patients received monoclonal antibodies 58% less often than their non-Hispanic counterparts, while Asian Americans received it 48% less and Black patients received it 22% less often. The data was culled from electronic records for COVID treatments in more than 805,000 adult patients across 41 health care systems between November 2020 and August 2021.

The CDC data noted that roughly 11% were treated in a hospital, where the differences in use among the demographics were less pronounced.

A FDA spokesperson told BuzzFeed News the use of these therapies was based on doctors’ responsibility to “consider the benefit-risk for an individual patient.”

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