Gilead Sciences has donated the experimental antiviral drug remdesivir to the United States to be distributed to hospitals hardest hit by the pandemic.
The donated treatment received Emergency Use Authorization from the U.S. Food and Drug Administration. The limited supply will go to COVID-19 patients who are on ventilators.
The deal was finalized on May 3, and on Saturday, May 9, the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, announced the allocation plan.
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Beginning Thursday, May 7, cases of the drug were delivered to the following states: Connecticut (30 cases), Illinois (140 cases), Iowa (10 cases), Maryland (30 cases), Michigan (40 cases) and New Jersey (110 cases). Each case contains 40 vials of the donated drug.
Earlier this week, an initial allocation was sent to the following seven states: Indiana (38 cases), Massachusetts (117 cases), New Jersey (94 cases), New York (565 cases), Rhode Island (30 cases), Tennessee (7 cases) and Virginia (33 cases).
State health departments will distribute the doses to appropriate hospitals in their states because they and local health departments have the greatest insight into community-level needs in the COVID-19 response, HHS said.
Cases are expected to be delivered to all 50 states, as well as territories, the Veterans Health Administration and the Indian Health Service.
Healthcare providers interested in administering the donated experimental drug should contact their state health department. Candidates for the donated doses must be patients on ventilators or on extracorporeal membrane oxygenation or who require supplemental oxygen due to room-air blood oxygen levels at or below 94%.
Public health experts from the federal government have been in contact with state health departments regarding these allocations.
In addition to the donated doses for hospitalized patients in the United States and other countries, remdesivir is available in the U.S. through clinical trials.
WHY THIS MATTERS
THE LARGER TREND
On May 1, the U.S. Food and Drug Administration issued an emergency use authorization for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.
Severe disease is defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support – such as a mechanical ventilator.
The National Institutes of Health and Gilead Sciences worked together to conduct a randomized, controlled clinical trial of the investigational drug in hospitalized patients.
Gilead Sciences committed to supplying approximately 607,000 vials of the experimental drug over the next six weeks to treat an estimated 78,000 hospitalized COVID-19 patients under the emergency use authorization granted by the FDA.
The donation to the United States is part of 1.5 million vials of remdesivir the company is donating worldwide.
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