During Health Department Director Kathy McGaha’s Tuesday night’s COVID19 update during the meeting of the Macon County Board of Commissioners, Commissioners Paul Higdon and Josh Young asked why Clay County is able to provide monoclonal antibody treatment for residents and Macon County is not. However, the experimental treatment has been approved and utilized in Macon County for several weeks, while Clay County has not yet been able to begin offering the treatment.
The U.S. Food and Drug Administration originally issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy sotrovimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death at the end of May. Since then, the treatment has been utilized more frequently, especially as the Delta Variant of COVID19 rapidly increased across the country. The FDA also has revised the original EUA to also allow the treatment to be used as post-exposure prophylaxis (prevention) for COVID-19 in adults and pediatric individuals.
While the treatment is not used for all patients who are hospitalized and already receiving oxygen, with monoclonal antibody therapy, physicians now have a way to help prevent severe symptoms from developing in those who are high risk.
The primary data supporting the EUA reissuance for post-exposure prophylaxis of COVID-19 are from a Phase 3 trial. The trial was a randomized, double-blind, placebo-controlled clinical trial studying a single dose of REGEN-COV for prevention of COVID-19 in household contacts of individuals infected with SARS-CoV-2. Cases were confirmed using real-time reverse transcription–polymerase chain reaction (RT-PCR), one of the most accurate laboratory methods for detecting, tracking, and studying COVID-19. An 81% reduction in confirmed symptomatic COVID-19 cases was observed with REGEN-COV compared to placebo at day 29 in cases who were RT-PCR negative and seronegative at baseline (the primary analysis population). In the overall trial population, there was a 62% reduction in RT-PCR confirmed symptomatic COVID-19 cases in the REGEN-COV group compared to placebo at day 29.
REGEN-COV consists of the monoclonal antibodies casirivimab and imdevimab, administered together. Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens, such as viruses like SARS-CoV-2.
The authorized dose for REGEN-COV for both treatment and as post-exposure prophylaxis is 600 mg of casirivimab and 600 mg of imdevimab administered together.
For treatment, intravenous infusion is strongly recommended; subcutaneous (under the skin) injection is authorized as an alternative route of administration when intravenous infusion is not feasible and would lead to delay in treatment.
For post-exposure prophylaxis, either intravenous infusion or subcutaneous injection is appropriate. For individuals who remain at high risk of exposure to another individual with SARS-CoV-2 for longer than 4 weeks, and who are not expected to mount an adequate immune response to full SARS-CoV-2 vaccination, following an initial dose of 600 mg of casirivimab and 600 mg of imdevimab, repeat doses of 300 mg of casirivimab and 300 mg of imdevimab once every 4 weeks are appropriate for the duration of ongoing exposure.
Commissioners Young and Higdon asked McGaha about the testing site established in Clay County — specifically for the antibody treatment.
At the beginning of September, Clay County Leadership announced that a Regeneron COVID-19 Monoclonal Antibody Treatment facility will open soon and that county staff had been working for several weeks to make the facility a reality, utilizing existing space and resources, while partnering with State officials and departments to ensure adequate supplies and materials. The site is expected to serve as a pilot program for the state, however according to Clay County Commissioner Rob Peck, the facility has not been approved for operations.
“Clay County staff stands ready to begin administering the Regeneron Covid-19 Monoclonal Antibody Infusions,” Peck said on Tuesday night. “Our facility is prepared and our staff eager to begin therapies to help ease the stress on our EMS, local providers and hospitals, by reducing hospitalizations and severe illnesses. However, we continue to await approval by the Department of Health and Human Services. Currently, our order request “is still under review with HHS and has not yet been approved to ship. In light of the states support for our pilot program, and the actions taken by county staff, it is our hope that the order will soon be authorized. Upon receipt, treatments will begin.”
While Clay County has not yet begun the antibody treatment, Angel Medical Center has been providing the treatment for COVID19 positive patients for several weeks. In Jackson County, Harris Regional Hospital has also been providing the treatment for patients in the region.
McGaha noted that the health department, which currently has 15 vaccancies for a staff of 63, do not have the staffing or capacity to operate an individual antibody treatment program at this time.
While the antibody treatment is intended to reduce the severity of COVID19 once positive, hospitals working to treat hospitalized patients remain the priority and prevent additional staffing be available for new operations.
As of 2:30 a.m. on Sept. 15, there were 160 COVID positive inpatients in Mission Health system; 124 at Mission Hospital; 6 at Angel Medical Center; 11 at Blue Ridge Regional Hospital; 1 at Highlands-Cashiers Hospital; 10 at Mission Hospital McDowell; 8 at Transylvania Regional Hospital.
McGaha stated that the antibody treatment is a welcome option to treat patients after they become positive, however vaccines remain the best option at not only preventing exposure, but with controlling the spread of COVID19 to begin with, especially since the antibody treatment is limited as to who it is available for.
With the majority of individuals hospitalized due to COVID19 being unvaccinated, the Kaiser Family Foundation reported that treating those patients have cost the United States nearly $6 billion in just the last three months.
From June to August, approximately 287,000 unvaccinated adults were hospitalized for COVID-19. The Kaiser Family Foundation estimated the cost of a preventable COVID-19 hospitalization was about $20,000.
The analysis estimates that the preventable costs of treating unvaccinated patients in the hospitals total $3.7 billion in August, almost twice the estimates for June and July combined. The total preventable costs for those three months now stand at an estimated $5.7 billion.