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

Thomas P. Monath; Jeroen Kortekaas; Douglas M. Watts; Rebecca C. Christofferson; Angelle Desiree LaBeaud; Brian Gowen; Clarence J. Peters; Darci R. Smith; Robert Swanepoel; John C. Morrill; Thomas G. Ksiazek; Phillip R. Pittman; Brian H. Bird; George Bettinger

doi:10.1016/j.jvacx.2020.100060

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

Thomas P. Monath, Jeroen Kortekaas, Douglas M. Watts, Rebecca C. Christofferson, Angelle Desiree LaBeaud, Brian Gowen, Clarence J. Peters, Darci R. Smith, Robert Swanepoel, John C. Morrill, Thomas G. Ksiazek, Phillip R. Pittman, Brian H. Bird, George Bettinger

Pathology

Research output: Contribution to journal › Review article › peer-review

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.

Original language	English (US)
Article number	100060
Journal	Vaccine: X
Volume	5
DOIs	https://doi.org/10.1016/j.jvacx.2020.100060
State	Published - Aug 7 2020

Keywords

Genetic reassortment
Rift Valley Fever vaccine
Target Product Profile

ASJC Scopus subject areas

Molecular Medicine
General Immunology and Microbiology
General Veterinary
Public Health, Environmental and Occupational Health
Infectious Diseases

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10.1016/j.jvacx.2020.100060

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Monath, T. P., Kortekaas, J., Watts, D. M., Christofferson, R. C., Desiree LaBeaud, A., Gowen, B., Peters, C. J., Smith, D. R., Swanepoel, R., Morrill, J. C., Ksiazek, T. G., Pittman, P. R., Bird, B. H., & Bettinger, G. (2020). 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, Article 100060. https://doi.org/10.1016/j.jvacx.2020.100060

Monath, TP, Kortekaas, J, Watts, DM, Christofferson, RC, Desiree LaBeaud, A, Gowen, B, Peters, CJ, Smith, DR, Swanepoel, R, Morrill, JC, Ksiazek, TG, Pittman, PR, Bird, BH & Bettinger, G 2020, '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, vol. 5, 100060. https://doi.org/10.1016/j.jvacx.2020.100060

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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.",

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AU - Monath, Thomas P.

AU - Kortekaas, Jeroen

AU - Watts, Douglas M.

AU - Christofferson, Rebecca C.

AU - Desiree LaBeaud, Angelle

AU - Gowen, Brian

AU - Peters, Clarence J.

AU - Smith, Darci R.

AU - Swanepoel, Robert

AU - Morrill, John C.

AU - Ksiazek, Thomas G.

AU - Pittman, Phillip R.

AU - Bird, Brian H.

AU - Bettinger, George

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AB - 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.

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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

Abstract

Keywords

ASJC Scopus subject areas

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