Washington, DC—The investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients was granted emergency use authorization by the FDA, but limited supply means the treatment isn’t available for everyone.

That’s why federal officials have had to come up with an allocation and distribution process.

The FDA explains that bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are aged 12 years and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. Included in that group are patients who are aged 65 years or older, or who have certain chronic medical conditions.

“While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo,” according to the approval group.

Bamlanivimab is not authorized, however, for patients who are hospitalized due to COVID-19 or who require oxygen therapy due to the virus, according to the FDA. Not only has bamlanivimab treatment not been shown to be beneficial in patients hospitalized due to COVID-19, but monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation, the announcement explains.

Bamlanivimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells.

“The FDA’s emergency authorization of bamlanivimab provides healthcare professionals on the frontline of this pandemic with another potential tool in treating COVID-19 patients,” said Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation and Research. “We will continue to evaluate new data on the safety and efficacy of bamlanivimab as they become available.”

The Office of the Assistant Secretary for Preparedness and Response of the U.S. Department of Health and Human Services (HHS/ASPR) said its distribution goal is to reach “as many patients as possible, no matter where in the country they live and regardless of their income.” HHS is coordinating with Eli Lilly and Company, AmerisourceBergen (the distributor of the drug), state and territorial health departments, and national healthcare and medical organizations and associations to get bamlanivimab to speed delivery of the drug. The focus is also on areas of the country that have been hardest hit by the pandemic.

“In general, a state/territory’s percentage of the country’s total number of confirmed COVID-19 patients and the total number of confirmed hospitalized patients during a 7-day reporting period will equal that state/territory’s percentage of available bamlanivimab for a given distribution week,” according to the agency. “Once allocation amounts are determined, HHS-ASPR will notify state/territorial health departments of their bamlanivimab allocations.”

How much bamlanivimab each healthcare facility within their respective jurisdictions can receive will then be determined by state/territorial health departments, not the federal government. At the same time, healthcare facilities chosen to receive an allocation of bamlanivimab will coordinate shipping directly with the distributor, AmerisourceBergen, according to HHS.

Allocations will occur on a weekly basis, with each case containing 10–100 vials of the product, depending on the amount distributed to receiving facilities. One vial equals one treatment course.

The plan states that allocations will be made in two phases.
• In Phase 1, states/territories will allocate Bamlanivimab to hospitals and hospital-affiliated locations. Upon further assessment of drug administration requirements.
• In Phase 2, allocations will include expanded distribution to additional outpatient facilities.
In the first week, November 9–17, 79,350 vials were to be distributed.

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