Biden Responds to Increased Demand for Monoclonal Antibody Treatments

Many states are turning to monoclonal antibody treatments to curb the rise in hospitalizations and emergency room visits as COVID-19 cases rise. The demand on orders for the drugs has increased twenty-fold since mid-July, according to a spokesperson from the Department of Health and Human Services.

Seven states, Texas, Alabama, Florida, Mississippi, Tennessee, Georgia, and Louisiana, made up about 70% of orders for monoclonal antibody treatments in recent weeks, according to information from the department.

A few of those seven states also saw the highest rates of daily COVID-19 hospitalizations in recent weeks.

To address the demand in treatments, the Biden Administration has announced it will increase the average weekly pace of shipments of free monoclonal antibody treatment to states by 50% this month. 

Monoclonal antibodies are synthetic versions of the body’s antibodies produced in a laboratory and are designed to restore, mimic, inhibit or enhance immune system functions. 

In November 2020, the U.S. The Food and Drug Administration authorized monoclonal antibody treatments for emergency use after conducting a clinical trial of patients with COVID-19. 

The treatment in many cases can help those who are at the highest risk of COVID-19 symptoms to recover faster and can reduce the risk of hospitalization by upwards of 70%, according to data from PhRMA, a trade group representing the pharmaceutical industry. 

“Monoclonal antibody treatments have been successful for many COVID-19 patients and have allowed us to lessen the strain on Missouri’s health care systems,” Gov. Mike Parson said in a written statement. “However, this treatment is not a replacement for the vaccine.”

Parson recently announced that six state-contracted monoclonal antibody treatment sites will remain operational for an additional 30 days, lessening the strain on Missouri’s health care systems as his state battles the virus.

“We mostly see unvaccinated individuals access this treatment, and southeast Missouri has had some lower vaccination rates,” said Lisa Cox, communications director, Missouri Department of Health and Senior Services.

“Hospitalizations are on the decline in Missouri, and we are hopeful that the treatments prevented more than 2,000 Missourians from severe illness or death. While other states may have varying degrees of effectiveness, I believe that any state using monoclonal antibody treatment sites is likely lessening the strain on their health care systems overall. These treatments have been very effective and have helped even unvaccinated individuals recover rather quickly,” said Cox.

One of the manufacturers of monoclonal treatments, Regeneron, announced that the U.S. government has contracted with the company for 1.4 million additional doses, making a total of 3 million doses ordered. 

Regeneron said it will supply the additional treatment for $2,100 per dose to the government by Jan. 31, 2022. 

A second manufacturer, Eli Lilly and Company, said in a statement that the United States bought 388,000 doses of its monoclonal antibody treatment etesevimab, after a previous purchase of Bamlanivimab.

The Department of Health and Human Services awarded two contract modifications totaling $3.2 billion to Regeneron and Eli Lilly and Company to purchase additional doses, the US Department of Defense said in a statement.

The Food and Drug Administration also recently amended its emergency use authorization for Eli Lilly’s drug, to try to prevent the chance of illness in adults and children at high risk of severe COVID-19. In August, Regeneron’s monoclonal antibody drug was also authorized for the same emergency use. 

The Biden administration said earlier this month that it would be “reviewing all orders for alignment with utilization.”

That means that all states may soon have to go through the Department of Health and Human Services to receive monoclonal antibody treatments, as HHS released a statement that it would impose limits on how many treatments each state can receive based on “case burdens.” 

Under the previous guidelines, medical facilities could order the treatments directly from the suppliers.

However, yesterday, U.S. Sens. Marco Rubio, R-Fla., Rick Scott, R-Fla., Roger Marshall, R-Kan., Kevin Cramer, R-N.D., Marsha Blackburn, R-Tenn., Mike Braun, R-Ind., and Tommy Tuberville, R-Ala., introduced the Treatment Restoration for Emergency Antibody Therapeutics Act.

The legislation would prohibit the HHS from implementing policies that restrict hospitals and other appropriate health care facilities from ordering and receiving COVID-19 monoclonal antibody treatments.