Public Health Emergency - Leading a Nation Prepared
On May 3, 2020, the United States government accepted a donation of the investigational drug remdesivir from Gilead Sciences Inc. Gilead Sciences, Inc. initially committed to supplying 606,840 vials of remdesivir—enough to treat an estimated 78,000 hospitalized COVID-19 patients in the United States. Remdesivir received an
emergency use authorization from the FDA on May 1, 2020, and preliminary
clinical trial results indicate the drug accelerates recovery in serious COVID-19 cases.
All states and U.S. territories have received at least one shipment of remdesivir (as of May 22), and HHS continues to work with partners to ensure further distribution of the product as it becomes available.
On May 18, Gilead Sciences, Inc. confirmed that it will donate an additional 333,160 vials of remdesivir with an expected delivery date in early June. This will bring the total donation to 940,000 vials of remdesivir - enough to treat an estimated 120,512 hospitalized COVID-19 patients. Hospitals will be asked to input data into the TeleTracking database in early June so that HHS can make allocations of the additional donated remdesivir to state health departments in a manner that is consistent with current hospital need.
The Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services (HHS/ASPR) has been working with Gilead Sciences, Inc. and our partners in state health departments to get remdesivir into the hands of healthcare providers quickly, focusing on the areas of the country hardest hit by the pandemic. The Trump Administration is committed to equitable and efficient distribution of the donated drug with the goal of reaching as many patients as possible across all states and territories.
As of May 29, 2020, all of the original donated amount of remdesivir has been allocated. Less than ten percent of the first donation is being held in reserve in the event “hotspots” emerge in the coming weeks.
Hospitals will be required to input current COVID-19 patient data no later than 8:00pm EDT June 8 in support of allocations to be distributed the weeks of June 15 and June 29. There will be no shipments the week of June 22.
In addition to allocations to states and territories, remdesivir is being allocated to the Department of Defense, the Veterans Health Administration, and the Indian Health Service for distribution within those healthcare systems.
With urgency to get doses to hospitalized patients, state health departments have provided insight into which hospitals in their states have the greatest number of COVID-19 patients meeting the criteria for use of remdesivir under the Emergency Use Authorization.
State health departments have worked with hospitals on strategies for caring for COVID-19 patients within their states, and will be working with hospitals on distribution of the limited supply of donated remdesivir. This strategy provides states with the opportunity to develop clear, individualized criteria tailored to their communities.
Here’s how the Trump Administration is allocating remdesivir to states and territories:
HHS is working with hospitals to balance the need for accurate, up-to-date data on COVID-19 patient counts to inform the allocation of remdesivir with the need to lower data collection burden on hospitals so they can focus on continuing to provide care during this pandemic. Based on feedback from hospitals, state health officers, and stakeholder associations regarding the burden placed on hospitals to input data into TeleTracking, allotments for the week of June 1 will be made using the same hospital-based algorithm used for the week of May 12. Hospitals will be required to input current COVID-19 patient data no later than midnight, June 8. Two additional allocations of the drug (Week of June 15 and Week of 29) will be based on June 8 Teletracking data.
The product is not being distributed all at once. Cases of remdesivir, which contain 40 vials of product each, are being sent to states and territories over the course of approximately nine (9) weeks.
Commonwealth of the Northern Mariana Islands
District of Columbia
Department of Defense
Federated States of Micronesia
HHS Indian Health Service
On May 1, 2020, The FDA granted an
Emergency Use Authorization allowing remdesivir to be administered by healthcare providers to treat 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 1,063 patients. Preliminary results suggested that remdesivir was associated with faster recovery, although the data was not sufficient to determine if the drug was associated with lower mortality.
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