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

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

10 Citations (Scopus)

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
Article number	100060
Journal	Vaccine: X
Volume	5
DOIs	https://doi.org/10.1016/j.jvacx.2020.100060
Publication status	Published - 7 Aug 2020

Keywords

Genetic reassortment
Rift Valley Fever vaccine
Target Product Profile

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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https://edepot.wur.nl/521156Licence: CC BY-NC-ND

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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

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title = "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 = "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.",

keywords = "Genetic reassortment, Rift Valley Fever vaccine, Target Product Profile",

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

year = "2020",

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doi = "10.1016/j.jvacx.2020.100060",

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journal = "Vaccine: X",

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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

TY - JOUR

T1 - 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

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

PY - 2020/8/7

Y1 - 2020/8/7

N2 - 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.

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.

KW - Genetic reassortment

KW - Rift Valley Fever vaccine

KW - Target Product Profile

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DO - 10.1016/j.jvacx.2020.100060

M3 - Article

AN - SCOPUS:85083359427

SN - 2590-1362

VL - 5

JO - Vaccine: X

JF - Vaccine: X

M1 - 100060

ER -

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

UN SDGs

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