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U.S. Department of Health and Human Services

Remdesivir

ASPR’s Portfolio of COVID-19 Medical Countermeasures under Investigation

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.


Remdesivir Allocation Process

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:

  • To help states and territories make informed decisions regarding the distribution of remdesivir to hospitals within their jurisdiction, hospitals provide data on the number of patients with confirmed or suspected cases of COVID-19 whether in the ICU or not in the ICU using the TeleTracking platform. CDC’s National Healthcare Safety Network and data submitted by State Health Departments are used to understand the number of confirmed or suspected cases of COVID-19 within each state to ensure we have the full picture.

  • This data is then used to determine the state-by-state percentage of suspected and confirmed COVID-19 patients in U.S. hospitals. That percentage is applied to the total amount of remdesivir available for distribution that week, and determines the amount to be shipped to each state, jurisdiction, or territory.

  • Gilead is using its distributor to deliver the donated remdesivir to state health departments.

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.


Allocation of Remdesivir by Jurisdiction

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.

State Week 1
(May 4-10)
 
Week  2 
(May 11-17)
 
Week  3
(May 18-24)
 
Week 4
(May 25-31)
Week 5
(June 1-7) 
Jurisdiction Total

Alabama

10

55

60

035

160

Alaska

5

0

1

01

7

American Samoa

2

0

0

00

2

Arizona

10

85

93

050

238

Arkansas

10

11

12

010

43

California

30

395

432

0225

1082

Colorado

20

43

47

024

134

Commonwealth of the Northern Mariana Islands

2

0

0

00

2

Connecticut

30

99

108

054

291

Delaware

10

21

23

011

65

District of Columbia

10

34

37

019

100

Department of Defense

0

300

250

00

550

Federated States of Micronesia

2

0

0

00

2

Florida

37

158

172

087

454

Georgia

30

206

225

0113

574

Guam

3

0

0

00

3

Hawaii

5

4

4

02

15

Idaho

10

4

4

02

20

HHS Indian Health Service

20

80

50

050

200

Illinois

140

324

353

0179

996

Indiana

48

95

103

052

298

Iowa

10

34

37

018

99

Kansas

10

26

28

014

78

Kentucky

10

32

35

018

95

Louisiana

30

93

101

055

279

Maine

10

7

8

04

29

Marshall Islands

2

0

0

00

2

Maryland

30

139

152

076

397

Massachusetts

137

243

265

0133

778

Michigan

40

117

128

064

349

Minnesota

40

40

44

022

146

Mississippi

10

48

53

027

138

Missouri

10

47

51

026

134

Montana

5

3

3

01

12

Nebraska

10

18

20

010

58

Nevada

10

18

20

010

58

New Hampshire

10

12

13

06

41

New Jersey

214

289

315

0158

976

New Mexico

10

18

20

013

61

New York

623

560

610

0300

2093

North Carolina

10

81

89

050

230

North Dakota

10

5

6

03

24

Ohio

20

125

136

068

349

Oklahoma

10

24

27

013

74

Oregon

10

12

13

07

42

Palau

1

0

0

00

1

Pennsylvania

30

201

220

0110

561

Puerto Rico

10

18

20

010

58

Rhode Island

30

23

26

013

92

South Carolina

10

110

120

020

260

South Dakota

10

6

7

03

26

Tennessee

17

40

43

022

122

Texas

30

217

237

0125

609

Utah

10

11

12

06

39

Vermont

5

2

2

01

10

Veterans' Administration

82

460

250

00

792

Virgin Islands

2

0

1

01

4

Virginia

43

96

104

055

298

Washington

20

41

45

022

128

West Virginia

10

9

10

05

34

Wisconsin

10

24

26

020

80

Wyoming

5

4

4

02

15

Total

2,040

5,167

5,275

0 2,425

14,907



Emergency Use Authorization

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.


Preliminary Results of Randomized Clinical Trial

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.


  • This page last reviewed: June 01, 2020