Nathaniel Weixel, The Hill
The federal government will begin distributing doses of Regeneron’s antibody drug treatment for COVID-19 on Tuesday, top health officials said.
During a call with reporters, Health and Human Services (HHS) Secretary Alex Azar said the administration will distribute 30,000 doses of the drug, with more coming in the weeks ahead.
The company expects to produce 300,000 doses by early January.
In July, the Trump administration’s Operation Warp Speed gave Regeneron $450 million to support manufacturing of the drug.
The limited allocations to state and territorial health departments will be proportionally based on confirmed COVID-19 cases over the previous seven-day period. The information is based on data that hospitals and state health departments submit to the HHS COVID-19 response data hub.
Officials said the drug will be distributed in two phases because of the challenges in administering the drug, which needs to be delivered intravenously over the course of an hour.
Patients then have to be monitored for an hour following the infusion, which could be problematic for health systems that are already strained under a COVID-19 surge.
Outpatient infusion centers might be the best locations for delivering the drug, but facilities may not have the proper equipment, staff training or infection control practices to handle COVID-19 patients when they are at their most infectious. The phased approach will give facilities time to prepare, officials said.
Initially, states and territories will allocate the product only to hospitals and hospital-associated facilities. The second phase will include expanded distribution to additional outpatient facilities.
While the federal government will allocate the medication to state and territorial health departments, those health departments will be responsible for distributing the treatment to the facilities in their respective states and territories.
The Food and Drug Administration (FDA) on Saturday granted emergency authorization for the treatment. The drug combines two monoclonal antibodies, which are lab-generated versions of one of the human body’s main defenses against pathogens.
The drug is authorized for treating mild to moderate COVID-19 in adults and children who are at high risk of progressing to severe COVID-19.
Azar said Americans won’t be charged for the drug itself, and HHS is working with payers to cover the cost of administering the treatment.
The authorization of Regeneron’s product comes shortly after the FDA authorized another antibody treatment for COVID-19 from Eli Lilly.
Azar on Monday said HHS has already distributed more than 85,000 courses of Eli Lilly’s antibody treatment to patients around the country.