The Maryland Department of Health has advised health care providers statewide to conserve the lifesaving monoclonal antibody treatments for certain individuals based on need after the federal government found much of the current supply to be ineffective against COVID-19′s fast-moving omicron variant.
The federal government has authorized three types of monoclonal antibody medications to states, two of which do not work against the new strain and have been paused for distribution in Maryland, according to a letter the state health department sent to clinicians Thursday and shared with The Baltimore Sun. The third, effective medication is now in limited supply nationwide and being reserved for patients who are 65 and older or who are immunocompromised.
“It is possible that some monoclonal sites will run out of [them] prior to the next shipment expected in early January 2022,” wrote Dr. Howard Haft, the health department’s senior medical adviser, and Dr. Jinlene Chan, deputy secretary for public health, in their letter to providers. “The state is making every effort to ensure that our supply of [monoclonal antibody] therapies are available to patients who need them most.”
It’s a dramatic shift from just last week, when Maryland Gov. Larry Hogan and the health department made monoclonal antibodies a cornerstone of the state’s response to the latest surge of coronavirus cases and hospitalizations, especially as it pertained to residents in congregate care settings such as nursing homes.
The treatments, once widely available in Maryland and elsewhere, are said to reduce the risk of serious COVID-19 illness by as much as 70% to 80% in some patients.
Andy Owen, a Maryland Department of Health spokesman, said in an email that additional therapies approved by the federal government will be incorporated in the state’s planning process and response.
People were slow to use monoclonal antibodies during the pandemic, largely because many didn’t know about them and no one recommended them. Use grew after states’ health officials began promoting their stocks and doctors learned of their effectiveness. Former President Donald Trump received them when he contracted the virus in October 2020. They are said to work best at the earliest point of infection, before the onset of major symptoms and ahead of being hospitalized.
The Biden administration bought and shipped about 100,000 doses of the antibodies a week to states during the summer and upped the doses by 50% in September. Nearly 20,400 doses had been used in Maryland by mid-November, according to the state health department, which has marketed the therapy to older adults and those with underlying health conditions.
“We estimate that we have avoided 956 hospitalizations and 391 deaths thanks to these lifesaving treatments,” Owen said last month.
The cutback in the outpatient therapy comes amid a dramatic surge of cases and hospitalizations both in Maryland and elsewhere, and as other inpatient medications used to treat COVID-19 patients are harder to come by, said Dr. Theodore Bailey, chief of the division of infectious diseases at Greater Baltimore Medical Center.
The increased patient volume means fewer resources are available to care for the sick, said Bailey, adding that the Towson hospital expects to turn some patients away over the next several weeks as the surge continues.
“Typically, removing tools from the toolbox is never an appropriate solution to that problem,” Bailey said. “There still is certainly delta, and delta may be disproportionately represented in severe cases. Omicron may tend toward milder cases.
“If monoclonal antibodies are active against what appears to be more serious, severe variants, taking them out of the market seems inappropriate.”
Omicron has spread rapidly over the last month, now accounting for a majority of all cases in Maryland and the U.S., according to the state health department’s letter and the latest sampling data published by the U.S. Centers for Disease Control and Prevention.
In early December, omicron made up less than 1% of all U.S. cases analyzed for genomic sequencing. By Dec. 18, it constituted more than 70% of all the sequenced cases, reflecting how much more contagious it is and how quickly it’s spreading.
In Maryland, hospitalizations have risen, in tandem with a jump in cases, to more than 1,500 Thursday — though it is unknown whether the hospitalized are infected with delta variant or the omicron variant, said Eili Klein, associate professor of emergency medicine at Johns Hopkins, who studies how individuals influence infectious disease spread.
In other places where omicron has spread, such as the United Kingdom and South Africa, the case-hospitalization ratio has stayed relatively small compared with prior coronavirus waves, Klein said, which suggests that omicron may not completely overwhelm the medical system. At the same time, hospitals should not expect to have light loads, he said.
“There’s still delta, and still lots of unvaccinated people out there, so there are still risk levels,” Klein said. “It’s not projecting 5,000 [COVID-19] hospitalizations, but it’s projecting into the range where we were in the peak last January.”
There’s evidence that vaccinations, particularly boosters, can help people stay out of hospitals, Klein said. And the third doses tend to work immediately or within days, based on research conducted in Israel and elsewhere.
Consumers will soon see additional medications and therapeutics available, including two newly authorized antiviral pills that can help keep COVID-19 cases from becoming severe. But the pills will not be widely available for some time, GBMC’s Bailey said, and should not be considered as a replacement for a full vaccination regimen.
“If I get in a car with an air bag, and I go faster, or I start texting, or I disregard street signs, I offset the air bag,” he said. “Be sure to be vaccinated. It gives you a prolonged period of protection, and you don’t have to test positive to get it. The use of pills and monoclonal antibodies is going to depend on having a positive case.”
There also may eventually be outpatient convalescent plasma therapies available, such as the one submitted for federal review based on research at the Johns Hopkins University and partially funded by the state of Maryland.
The research results, publicized earlier this week by Hopkins, show that the infusion of blood plasma from patients who have recovered from COVID-19 in patients who have it reduced the need for hospitalization by more than 50%, said Dr. Barry Meisenberg, director of research at Luminis Health Anne Arundel Medical Center and one of the study’s co-authors.
Meisenberg said the transfusions of antibody-rich blood plasma had similar benefits as monoclonal antibody therapies and were shown to be even more effective when they were used quickly. They also could become more cost-effective than other outpatient therapies on the market, especially in low- and middle-income countries, he said.
The U.S. Food and Drug Administration will review the group’s data and decide whether the benefits of the treatment outweigh the risks, said Meisenberg, adding that the therapy also might help fend off new variants since it will source antibodies from infected patients whose infections will vary as different strains come and go.
It’s promising, but there’s no telling when the FDA will give the therapy the green light, he said, meaning other measures and non-pharmaceutical interventions will have to be prioritized for now.
“We should never have relied on the monoclonal antibodies to treat the virus when we have something to prevent it,” Meisenberg said. “If you are vaccinated, you likely won’t need the hospital. For now, we all have to pretend we’ve been exposed and be careful.”
Baltimore Sun reporters Meredith Cohn and Justin Fenton contributed to this article.