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Commentary

Selection of Filovirus Isolates for Vaccine Development Programs

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U.S. Department of Health and Human Services (DHHS), Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA), Washington, DC 20201, USA
2
Tunnell Government Services, Inc., Supporting Biomedical Advanced Research & Development Authority (BARDA), Assistant Secretary for Preparedness and Response (ASPR), U.S. Department of Health and Human Services (DHHS), Washington, DC 20201, USA
3
U.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Rockville, MD 20852, USA
4
U.S. Department of Defense (DOD), Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical), Fort Detrick, MD 21702, USA
*
Author to whom correspondence should be addressed.
Academic Editor: Steven B. Bradfute
Vaccines 2021, 9(9), 1045; https://doi.org/10.3390/vaccines9091045
Received: 17 August 2021 / Revised: 13 September 2021 / Accepted: 15 September 2021 / Published: 19 September 2021
The continuing outbreaks of ebola virus disease highlight the ongoing threat posed by filoviruses. Fortunately, licensed vaccines and therapeutics are now available for Zaire ebolavirus. However, effective medical countermeasures, such as vaccines for other filoviruses such as Sudan ebolavirus and the Marburg virus, are presently in early stages of development and, in the absence of a large outbreak, would require regulatory approval via the U.S. Food and Drug Administration (FDA) Animal Rule. The selection of an appropriate animal model and virus challenge isolates for nonclinical studies are critical aspects of the development program. Here, we have focused on the recommendation of challenge isolates for Sudan ebolavirus and Marburg virus. Based on analyses led by the Filovirus Animal and Nonclinical Group (FANG) and considerations for strain selection under the FDA Guidance for the Animal Rule, we propose prototype virus isolates for use in nonclinical challenge studies. View Full-Text
Keywords: ebola; Sudan; Marburg; filovirus; animal rule; viral isolate; challenge strain ebola; Sudan; Marburg; filovirus; animal rule; viral isolate; challenge strain
MDPI and ACS Style

Wolfe, D.N.; Sabourin, C.L.; Merchlinsky, M.J.; Florence, W.C.; Wolfraim, L.A.; Taylor, K.L.; Ward, L.A. Selection of Filovirus Isolates for Vaccine Development Programs. Vaccines 2021, 9, 1045. https://doi.org/10.3390/vaccines9091045

AMA Style

Wolfe DN, Sabourin CL, Merchlinsky MJ, Florence WC, Wolfraim LA, Taylor KL, Ward LA. Selection of Filovirus Isolates for Vaccine Development Programs. Vaccines. 2021; 9(9):1045. https://doi.org/10.3390/vaccines9091045

Chicago/Turabian Style

Wolfe, Daniel N., Carol L. Sabourin, Michael J. Merchlinsky, William C. Florence, Larry A. Wolfraim, Kimberly L. Taylor, and Lucy A. Ward. 2021. "Selection of Filovirus Isolates for Vaccine Development Programs" Vaccines 9, no. 9: 1045. https://doi.org/10.3390/vaccines9091045

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