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Selected Works of Brian B. Gowen
Article
Theoretical Risk of Genetic Reassortment Should Not Impede Development of Live, Attenuated Rift Valley Fever (RVF) Vaccines Commentary on the Draft WHO RVF Target Product Profile
Vaccine: X
  • Thomas P. Monath, Crozet BioPharma LLC
  • Jeroen Kortekaas, Wageningen Bioveterinary Research
  • Douglas M. Watts, University of Texas at El Paso
  • Rebecca C. Christofferson, Louisiana State University
  • Angelle Desiree LaBeaud, Stanford University School of Medicine
  • Brian B. Gowen, Utah State University
  • Clarence J. Peters, University of Texas Medical Branch
  • Darci R. Smith, Naval Medical Research Center
  • Robert Swanepoel, University of Pretoria
  • John C. Morrill, University of Texas Medical Branch
  • Thomas G. Ksiazek, University of Texas Medical Branch
  • Phillip R. Pittman, U.S. Army Medical Research Institute of Infectious Diseases
  • Brian H. Bird, University of California, Davis
  • George Bettinger, University of Texas at El Paso
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Document Type
Article
Publisher
Elsevier Ltd
Publication Date
4-9-2020
Creative Commons License
Creative Commons Attribution-Noncommercial-No Derivative Works 4.0
Disciplines
Abstract

In November 2019, The World Health Organization (WHO) issued a draft set of Target Product Profiles (TPPs) describing optimal and minimally acceptable targets for vaccines against Rift Valley fever (RVF), a Phlebovirus with a three segmented genome, in both humans and ruminants. The TPPs contained rigid requirements to protect against genomic reassortment of live, attenuated vaccines (LAVs) with wild-type RVF virus (RVFV), which place undue constraints on development and regulatory approval of LAVs. We review the current LAVs in use and in development, and conclude that there is no evidence that reassortment between LAVs and wild-type RVFV has occurred during field use, that such a reassortment event if it occurred would have no untoward consequence, and that the TPPs should be revised to provide a more balanced assessment of the benefits versus the theoretical risks of reassortment.

Citation Information
Monath, T. P., et al. Theoretical risk of genetic reassortment should not impede development of live, attenuated Rift Valley fever (RVF) vaccines commentary on the draft WHO RVF Target Product Profile. Vaccine: X, 5(2020) 1-9. https://doi.org/10.1016/j.jvacx.2020.100060