A clinical researcher examines a flask of COVID antibodies used to develop monoclonal antibodies therapies to treat early-stage COVID-19 infections. (Gianluca Panella/Getty Images 2021)
For the last nine months, Augusta Health has been mounting an intensive immunization campaign, administering more than 85,000 doses across its small community in Virginia’s Shenandoah Valley.
“Given that we don’t have unlimited resources, we’ve chosen to focus most recently on the vaccination efforts,” said John Mack, chief operating officer of the hospital system. But faced with surging COVID-19 hospitalizations and a community positivity rate that’s spiked to 31 percent, Augusta made the decision to open its own monoclonal antibody clinic on Monday out of its Waynesboro primary care office, hoping to administer between 16 and 20 infusions a week to eligible patients.
“We are at critical staffing,” Mack said. “At this point, all of our ICUs are full. And so any reduction in unnecessary hospitalizations is something Augusta Health wants to ensure we provide.”
It’s not the only health system grappling with strained capacity and an ongoing wave of severe COVID-19 cases. But combined with Virginia’s stubbornly stagnant immunization rates — with under 60 percent of the population fully vaccinated as of Thursday — it’s one of the latest to turn to monoclonal antibodies, a laboratory-made treatment, for relief.
The drugs have been authorized since late November, but demand has shifted rapidly since the rise of the delta variant. One week in mid-June, a single provider ordered 40 doses through the Virginia Department of Health, said Dr. Brooke Rossheim, a public health physician specialist for the department. By the first week of September, 44 different facilities had ordered a total of 1,700 doses.
“And I will tell you, I know there have been requests that have come in from new providers to give out the treatment,” Rossheim said. “So I have no doubt the number now is even higher.”
The irony of the growing demand isn’t lost on some doctors. Like mRNA vaccines, research on monoclonal antibodies isn’t new, but their use for the treatment of COVID-19 is currently allowed under an emergency use authorization from the U.S Food and Drug Administration (the Pfizer vaccine, on the other hand, is now fully approved). Like vaccines, they target the spike protein of the virus, attaching and neutralizing its ability to attach and spread among host cells.
“They’ve been shown in clinical trial to actually decrease the need for hospital admission and medical utilization for people who are treated and at high risk for disease,” said Dr. Debbie-Ann Shirley, the medical director of UVA Health’s COVID-19 clinic. Their effectiveness has led to global calls to expand access, with many describing them as an often “life-saving” therapy.
Still, hospitals and doctors across Virginia emphasized that monoclonal antibodies are no replacement for vaccines. While they can stop the virus from replicating in 70 to 80 percent of cases when given correctly — keeping disease mild to moderate — the results are temporary. Rossheim said the therapy is often referred to as “passive immunity,”
“You’re giving the person antibodies in a vial,” he said. “Whereas with a vaccine, you’re getting active immunity.” The effects of antibody treatment wane after a few weeks, according to Shirley, while vaccines offer sustained protection against contracting and developing severe COVID-19 infections.
“With a vaccine, your own immune system is going to produce those antibodies,” Rossheim added. “And really, that’s what you want.” But it hasn’t stopped unvaccinated Virginians from gravitating toward monoclonal antibody treatment. Dr. Sheranda Gunn-Nolan, the chief medical officer for Sovah Health, which operates hospitals in Danville and Martinsville, said the hospital system has seen a wave of patients requesting the treatment, even as they’ve passed up vaccines that could have prevented them from requiring hospital care.
“We get that every day,” she said. “Every day. And that’s the frustrating part. A lot of those patients are people who have waited too long and perhaps don’t even qualify for the treatment anymore. And they want to bargain to get an infusion inpatient, which we just can’t do, but have refused the vaccination.”
It’s put hospitals and medical providers in the difficult position of advocating for the treatment, even as they try to maintain messaging on the importance of vaccines. Gunn-Nolan said the politicization of both resources has become a problem. Former President Donald Trump, who was initially reluctant to fully endorse vaccinations, received monoclonal antibodies during his own bout of COVID-19. That led to wider awareness of the therapy, but many patients don’t understand there are strict eligibility requirements.
“There’s a mindset that COVID-19 is just like the common cold, that it’s been hyped by the media, that there are other politics involved to make it look more severe than it really is,” Gunn-Nolan said. But monoclonal antibodies are meant to be administered within the first 10 days of symptom onset to prevent other side effects — like struggling to breathe — that require hospitalization.
When patients wait until their disease progresses to that point, they’re generally not eligible for the treatment anymore. Dr. Carnell Cooper, chief medical officer for LewisGale Medical Center in Salem, said the system has scheduled appointments for infusions and ended up admitting those patients into the hospital.
“That’s one of the reasons why we’ve been working very hard to make sure folks are aware of this treatment — especially our local providers,” he said. But even as unvaccinated patients and rising hospitalizations have spurred demand, new challenges have emerged. The national demand for monoclonal antibodies recently led the federal government to cap deliveries by state. So far, shipments to hospitals haven’t been affected, and Virginia still has a surplus of doses, Rossheim said — another concern since future shipments could be restricted if enough aren’t used.
But if cases continue to rise, Shirley said there’s always a concern that demand could exceed supply. Utilization tends to depend on local vaccination rates — while UVA, in one of the most heavily immunized parts of the state, has treated around 137 patients, Ballad Health in far Southwest Virginia has provided 2,504 infusions, according to spokesperson Ashlea Ramey. Staffing challenges could also restrict supply. Most monoclonal antibody infusions take between two to three hours to deliver, and often require transferring nursing staff to oversee the treatments.
At a time when hospitals across the state are experiencing staffing shortfalls, the intensity of the therapy is another limiting factor.
“Though it’s not comfortable, we realize this is vital to trying to prevent hospitalizations,” Mack said. “Our staff is tired, they’re stretched very thin, but they’re working together to get it done.”
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