Monoclonal Antibodies in Short Supply
Local Physician Says
Impact Already Being Felt
The federal government has changed the way COVID-19 monoclonal antibody treatments will be distributed in the United States, including Georgia.
Health care providers, like Memorial Health Meadows Hospital in Vidalia, will no longer be able to order the treatments directly from the manufacturer, and this may affect people at high risk for severe COVID illness and drive hospital admissions up, a local healthcare provider warned.
Monoclonal antibodies are synthetic, laboratory-created antibodies. They help people at high risk for severe COVID illness, individuals who have recently tested positive (within 10 days) for the virus, or people who are close contacts of persons who have tested positive for COVID. “They do not teach a patient’s body how to create its own antibodies and they are not a replacement for COVID- 10 vaccination,” the Georgia Department of Public Health stated in a September 15 news release.
On Tuesday, Dr. R. Chris Rustin, Director of the Georgia DPH’s Division of Health Protection, told a virtual Board of Public Health meeting that preliminary data shows monoclonal antibody therapy is effective mostly early in treatment.
“You have to get it early on,” said Rustin, who added the state DPH is collaborating with the Department of Community Health to support the existing 36 sites across Georgia currently administering the treatment. “It is important to stress this is not a substitute for vaccines,” Rustin said.
The decision to alter the way the treatments are distributed was announced September 13 by the U.S. Department of Health and Human Services (HHS). The reason continued from page
given for the change was “supply shortages and extraordinary demand for the treatments across the country, particularly due to the rapid spread of the delta variant,” the state DPH news release said.
HHS assured that it will determine each state’s weekly allocation of monoclonal antibody products based on use and the number of new COVID cases. The Georgia DPH will identify which sites in the state will receive the product and the amount each site receives. Healthcare providers must record their administration of the products in order to be eligible to receive additional shipments.
“DPH will work to provide monoclonal antibody treatments quickly and equitably to as many Georgia providers as possible. The Department will also address the backlog of requests previously made to HHS, which DPH was not made aware of until yesterday (September 14),” the Georgia DPH release stated.
“We have safe and highly effective vaccines to protect against COVID-19. It is much easier to get a vaccine than risk becoming seriously ill with life-threatening complications,” said Kathleen E. Toomey, M.D., M.P. H., Commissioner of the Georgia DPH. “Monoclonal antibodies are in short supply and high demand and hospital beds are full. What Georgia does have is enough vaccine for all Georgians aged 12 and over to be vaccinated.”
The Georgia DPH reported that as of September 15, 53% of Georgians have received at least one dose of COVID vaccine and 46% of Georgians are fully vaccinated. “COVID vaccine is available statewide and is the best tool for ending this pandemic and reducing the overwhelming strain on EMS, the healthcare system and healthcare providers,” the state DPH emphasized.
“We are already seeing an impact,” said Dr. Geoff Conner, a local physician said of the monoclonal antibody treatments. Conner has been sending his COVID-positive patients to Meadows for monoclonal antibody infusions since the drugs became available, but is now concerned these treatments may be delayed or even unavailable in the early stages of COVID when their administration is most effective. Jake Dailey, a nurse practitioner at Conner’s urgent care clinic, said Meadows informed him last week that supplies of Regeneron were nearing depletion. Regeneron is considered the most effective drug in treating COVID patients, but other products, like Bamlanivimab, are also used in the treatment, and Meadows still has Bamlanivimab available, Dailey said. Conner explained that the distribution protocol has been for the state’s primary healthcare facilities to receive the treatments and for physicians to order the treatment for their patients. The infusions were administered at the hospital. “We had an ample supply until this recent wave hit,” Conner said of the delta variant. “The state had even relaxed criteria as to who could receive it and that was a good thing. That allowed us to send more people to get infusions and helped keep the hospital admissions down. When more people caught onto the value of the infusions, coupled with a spike in cases because of the delta variant, demand was driven up.”
As state health authorities saw the infusions were actually helping to decrease the number of patients developing serious COVID illness and having to be hospitalized, efforts were being made to make the treatments accessible to more health care providers like Dr. Conner. “I was in the process of adding an account to have the treatment sent directly to us when we got the notice that monoclonal antibody treatments were in short supply,” he said. “I am not clear on how DPH is going to peg who gets it,” Conner said of the monoclonal antibody treatments. It might be based on how much they have given out or how high the infection rate is for the area.”
Dailey expects to see hospital admissions go up again if the treatments are not available. In the past two weeks, the clinic where he works was beginning to see a “slow decline” in cases. About 60 persons per day are tested at the clinic and in the drive-through operated by Dr. Conner. “My hope is that the federal government will approach this shortage like they did with the ventilator shortage and recruit other companies to manufacture the monoclonal antibody treatments. The federal government should step in do whatever is has to expand production,” Dr. Conner stressed. In the interim, “people will have to go back to what we said in beginning—be extra careful with mitigation like social distancing, washing hands and wearing masks,” Conner said. The state DPH COVID dashboard shows Toombs County is an “orange zone” for COVID infection, an improvement over the past few weeks in the “red zone,” and local cases are still de- continued from page
clining. Dr. Karen McColl, Vice President of Medical Affairs and Chief Medical Officer at Memorial Health Meadows Hospital, said Monday that the hospital was treating 34 COVID patients, down from the week before. “Unfortunately, the number of patients on ventilators is not going down,” she said. This week, 16 of the most critically ill COVID patients were on ventilators, an indication that many people are developing more severe complications because of COVID infections.
Dr. McColl said that overall, the community density for COVID infection has declined over the last two weeks. She said the positive COVID test rate had declined to 12% over a high two weeks ago of 35%. But, the lack of availability for monoclonal antibody infusions might cause somewhat of a backslide. “This may throw a bit of a wrench in our hopes if the lack of availability of infusions affects our ability to prevent the worsening of infection,” Dr. McColl said. She agreed that the community could see an increase in hospitalizations of those who could have benefited from an early-onset infusion.
She said Meadows has a very limited supply of Regeneron, but has a better supply of Bamlanivimab, and efforts will be ongoing to obtain and maintain monoclonal antibody supplies.
Patients should talk to their healthcare provider about monoclonal antibody treatments and must have a prescription or physician’s referral to receive treatments. Those receiving infusions must fit certain criteria. To find a COVID vaccination location, visit dph.georgia.gov/covid-vaccine.