Public Health Emergency - Leading a Nation Prepared
May 3, 2020 - The United States Government (USG) 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 97,000 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.
May 18, 2020 - Gilead Sciences, Inc. confirmed a second donation to the USG of 333,160 vials of remdesivir. This additional donation increased the total donated amount to 940,000 vials - enough to treat an estimated 150,000 hospitalized COVID-19 patients.
June 28, 2020 - The U.S. Department of Health and Human Services (HHS) signed a Memorandum of Agreement with Gilead Sciences, Inc. (the manufacturer of remdesivir) and AmerisourceBergen (the distributor of remdesivir) to secure approximately 500,000 treatment courses of remdesivir for use in American hospitals. This represents 100 percent of Gilead’s projected production for July (94,200 treatment courses), 90 percent of production for August (174,900 treatment courses), and 90 percent of production in September (232,800 treatment courses), in addition to an allocation for clinical trials.
In alignment with the
current terms of the Emergency Use Authorization (EUA) for remdesivir, the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services (HHS/ASPR) continues to work with Gilead Sciences, Inc., AmerisourceBergen, and our partners in state and territorial health departments to get commercially available 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 drug with the goal of reaching as many patients as possible across all states and U.S. territories.
The allocation process for commercially available remdesivir has been updated to ensure we utilize the most current COVID-19 patient data, and that the process accounts for COVID-19 hotspots that may develop in the country. The current process is based on recent cases of COVID-19 in states/territories and helps identify where the outbreak has been most active by highlighting changes in COVID-19 patient data over given periods. It is important to note that hospitals no longer have the requirement of inputting data into the TeleTracking system specifically for remdesivir allocation calculations. As of July 15, 2020, HHS will use information that hospitals already input into the TeleTracking portal on a daily basis along with other data from HHS Protect to determine allocations for each distribution period. It should be noted that the TeleTracking portal is part of the HHS Protect system. HHS no longer requires hospitals to also use CDC’s National Healthcare Safety Network (NHSN) for COVID-19 hospital reporting. This does not impact reporting for other conditions through NHSN. (For example, COVID-19 nursing home data will continue to be reported through NHSN.) Access to HHS Protect is available to all state/territorial health departments.
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