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Veklury (remdesivir)

ASPR's Portfolio of COVID-19 Medical Countermeasures Made Available as a Licensed Product

On October 22, 2020, the U.S. Food and Drug Administration (FDA) approved the antiviral drug Veklury (remdesivir) for the treatment of patients with COVID-19 requiring hospitalization. As an antiviral drug, Veklury works to stop replication of SARS-CoV-2, the virus that causes COVID-19. Previously authorized by the FDA for emergency use to treat COVID-19, Veklury was the first approved COVID-19 treatment in the United States. The drug is now widely available in hospitals across the country.

The U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response (HHS/ASPR) led the fair and equitable allocation of Veklury (remdesivir) from May 4 – September 30, 2020. During this time, approximately 150,000 treatment courses of donated Veklury (remdesivir) and more than 500,000 treatment courses of the commercial drug were made available to states, U.S. territories, the Department of Defense, the Department of State, the Veterans Health Administration, National Institutes of Health, and the Indian Health Service.

  • May 3, 2020: USG accepted donation of Veklury (remdesivir) from Gilead Sciences Inc. (the manufacturer). Gilead Sciences, Inc. initially committed to supplying 606,840 vials of Veklury (remdesivir)- enough for approximately 97,000 treatment courses.
  • May 18, 2020: Gilead Sciences, Inc. confirmed a second donation to the USG of 333,160 vials of Veklury (remdesivir). This additional donation increased the total donated amount to 940,000 vials - enough for approximately 150,000 donated treatment courses.
  • June 28, 2020: HHS entered into a memorandum of agreement with Gilead Sciences, Inc. and AmerisourceBergen (the distributor of Veklury (remdesivir)) to secure approximately 500,000 commercially available treatment courses of Veklury (remdesivir) for use in U.S. hospitals. This represented 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. The term of the agreement was June 28 - September 30, 2020.
  • September 30, 2020: The memorandum of agreement between HHS, Gilead Sciences, Inc., and AmerisourceBergen signed on June 28, 2020, concluded.
  • October 1, 2020: Updated EUA released; USG oversight of the allocation and distribution of Veklury (remdesivir) is no longer required as supply is greater than demand by U.S. hospitals. Hospitals now work directly with the distributor to purchase Veklury (remdesivir) (just as they do with other COVID-19 associated drugs).
  • October 22, 2020: FDA approved use of Veklury (remdesivir) for treatment of patients with COVID-19 requiring hospitalization.
  • HHS/ASPR led the allocation and distribution of Veklury (remdesivir) through frequent and consistent coordination with Gilead Sciences, Inc., AmerisourceBergen, state/territorial health departments, and national healthcare and medical associations/organizations. A total of 650,000 treatment courses of Veklury (remdesivir) was made available to state and territorial health departments by HHS/ASPR from May 4 – September 30, 2020, for use in in U.S. hospitals to treat COVID-19 patients.

How was Veklury (remdesivir) Allocated under U.S. Government Oversight?

In alignment with the terms of the original Emergency Use Authorization (EUA) for Veklury (remdesivir), the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services (HHS/ASPR) coordinated with Gilead Sciences, Inc., AmerisourceBergen, state and territorial health departments, and national healthcare and medical organizations and associations to get Veklury (remdesivir) into the hands of healthcare providers quickly, with a focus on areas of the country hardest hit by the pandemic.

The allocation process for Veklury (remdesivir) evolved over the 5-month period to ensure utilization of the most current COVID-19 data, and to ensure the process accounted for COVID-19 hotspots that developed across the country. The final process used for allocation of the commercially available drug was based on recent cases of COVID-19 in states/territories and helped identify where outbreaks were most active by highlighting changes in COVID-19 patient data over given periods.

HHS/ASPR used information input by hospitals into the HHS Protect data collection platform to determine allocations for each distribution period. In general, a state/territory's percentage of the country's total number of confirmed or suspected COVID-19 hospitalized patents during a 7-day reporting period equaled that state/territory's percentage of available Veklury (remdesivir) for a given distribution week. Once allocation amounts were determined, HHS/ASPR notified state/territorial health departments of their Veklury (remdesivir) allocations. State/territorial health departments, not the USG, then determined how much Veklury (remdesivir) hospitals within their respective jurisdictions could purchase based on the state/territory's allocation. Hospitals identified by their respective state/territorial health department to receive an allocation of Veklury (remdesivir) coordinated shipping and payment directly with the distributor, AmerisourceBergen.

Throughout the process, the USG remained committed to the equitable and efficient distribution of Veklury (remdesivir) with the goal of reaching as many patients as possible across all states and U.S. territories. Allocation and distribution of Veklury (remdesivir) under USG oversight occurred May 4 - September 30, 2020, and served as a great example of successful public-private partnerships in the fight against COVID-19.

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