Why potentially life-saving monoclonal antibodies are going unused

Overburdened hospitals storing hundreds of thousands of doses
Posted at 4:02 PM, Jan 21, 2021
and last updated 2021-01-21 21:42:11-05

SAN DIEGO (KGTV) -- There is only one authorized treatment designed to keep high-risk COVID-19 patients out of the hospital, but hundreds of thousands of doses of the same experimental therapy given to former President Donald Trump are sitting in storage.

Inundated hospitals have been slow to administer monoclonal antibodies because of what one infectious disease expert called a “perfect storm” of complicating factors. Some healthcare providers have refused doses altogether.

Those challenges include limits on staffing and space during the surge in cases, the length of time it takes to administer an infusion, and the short window providers have to reach patients who qualify for the treatment.

Still, federal and state health officials urged providers to expand access to the experimental therapy, which has shown promise in early stage trials. One clinical trial on the monoclonal antibody cocktail made by Regeneron found hospitalizations fell to 3 percent compared to 9 percent in the group that got a placebo.

At Family Health Centers of San Diego, they’ve converted a dentist’s office and some unused medical space into a monoclonal antibody infusion clinic.

“My feeling is that we need to do everything we can to keep our hospitals from being overwhelmed,” said assistant medical director Dr. Christian Ramers.

Dr. Ramers said he and two assistants are infusing about five patients a day with the lab-made antibodies, four days a week. They plan to scale up the operation to serve up to eight patients a day, but already the clinic for low-income patients is doing more infusions than some large hospitals.

“Interestingly the supply is not the problem. This is another case where there are hundreds of doses of this medicine sitting in fridges throughout San Diego County,” he said.

As of late last month, the Department of Health and Human Services said 378,000 doses of monoclonal antibodies had been distributed to hospitals and clinics around the county. Only 20 percent of the supply had been used.

Regeneron and a second company, Eli Lilly, got emergency use authorizations in November to treat people at high risk for severe disease in outpatient settings, before an individual is admitted into a hospital.

The drug itself is free, with thousands of doses paid for by the federal government.

“Everyone thought it'd be snapped up as soon as they went to the centers. But unfortunately, due to a perfect storm of things. It hasn't really picked up as much,” said Dr. Peter Chin-Hong, an infectious disease specialist at UC San Francisco.

Some hospitals have avoided the treatment because there’s limited data. The National Institutes of Health says there is “insufficient data” to recommend for or against the medications. Clinical trials are still underway.

The infusions take two hours for the patient, plus some additional preparation time to thaw and mix the solution. That’s a challenge at a moment when staffing is tight.

“This is the middle of a surge right now and there aren't that many folks to move around,” Dr. Chin-Hong said. He said UCSF is doing about two to four infusions per day.

There is also a narrow window of time to administer the treatment. Under the emergency use authorization from the FDA, qualified patients have to be given the antibodies within 10 days of their symptoms appearing.

Dr. Ramers said the average patient might wait a few days to get a test, then wait a few more to get results. By then, “you're already pushing the end of that window, so there's a lot of work that has to go into very rapidly identifying people.”

Family Health Centers developed an algorithm to scan its positive tests for the best candidates, so they can quickly contact those patients and try to schedule an appointment for the lengthy treatment.

They target people over 65 years old or with risk factors like obesity, diabetes, lung disease and other conditions.

Because of the need to rapidly analyze medical histories and test results, Family Health Centers can only offer monoclonal antibodies to existing patients who test positive at one of its clinics, Dr. Ramers said.

But he said other providers are offering the treatment. Patients just need to know to ask.