The U.S. Department of Health and Human Services is enacting a policy of portioning the distribution of COVID-19 antibody treatments to some states experiencing a surge in infections.
Politico reported Tuesday that the limits come as the treatments are in greater demand in Republican-run states in the South such as Florida, Texas, Georgia, Louisiana, Alabama, Tennessee and Mississippi, which have seen large case increases with the delta variant.
President Joe Biden has called out these states, although not by name, for contradicting his mandates regarding masks and vaccines.
According to an HHS video conference call Sept. 8 dealing with distributing antibody treatments to states, Dr. John Redd said that the recent surge in the delta variant of COVID has led to a surge in the use of monoclonal antibody drugs, causing the agency to limit ordering and shipments to ”administration sites with HHSProtect accounts and current use reporting.”
”To make sure the drugs will continue to be available, and to make sure things remain fair and equitable in terms of our national supply, we’re limiting ordering to sites that have HHSProtect set up,” he said. ”That has been standard, but we are enforcing reporting requirements.”
He said that the amount ordered each week is used at a rate of around 70%, and the agency wants to make sure a supply is still available.
According to the agency, the changes will allow it to move rapidly toward distribution levels that will ”help ensure equitable distribution of a limited resource.”
According to the Food and Drug Administration, ”monoclonal antibodies are laboratory-made proteins that mimic the immune systems ability to fight off harmful antigens such as viruses. Sotrovimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2 and is designed to block the virus attachment and entry into human cells.”
In May, the FDA issued emergency use authorization for one such treatment therapy, sotrovimab, to treat mild or moderate infections in patients 12 and older.
”With the authorization of this monoclonal antibody treatment, we are providing another option to help keep high-risk patients with COVID-19 out of the hospital,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.
”It is important to expand the arsenal of monoclonal antibody therapies that are expected to retain activity against the circulating variants of COVID-19 in the United States.”
According to HHS, the agency has distributed 2.17 million treatments so far to 8,003 sites, and 43% (938,000 treatments) of the supply have already been used.
The agency can ship about 150,000 treatments a week, according to the Politico article.
”HHS will determine the amount of product each state and territory receive on a weekly basis,” an HHS spokesperson said in the Politico story. ”State and territorial health departments will subsequently identify sites that will receive product and how much.”