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Biosafety risk assessment for production of candidate vaccine viruses to protect humans from zoonotic highly pathogenic avian influenza viruses

A major lesson learned from the public health response to the 2009 H1N1 pandemic was the need to shorten the vaccine delivery timeline to achieve the best pandemic mitigation results. A gap analysis of previous pre‐pandemic vaccine development activities identified possible changes in the Select Age...

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Autores principales: Chen, Li‐Mei, Donis, Ruben O., Suarez, David L., Wentworth, David E., Webby, Richard, Engelhardt, Othmar G., Swayne, David E.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7040978/
https://www.ncbi.nlm.nih.gov/pubmed/31659871
http://dx.doi.org/10.1111/irv.12698
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author Chen, Li‐Mei
Donis, Ruben O.
Suarez, David L.
Wentworth, David E.
Webby, Richard
Engelhardt, Othmar G.
Swayne, David E.
author_facet Chen, Li‐Mei
Donis, Ruben O.
Suarez, David L.
Wentworth, David E.
Webby, Richard
Engelhardt, Othmar G.
Swayne, David E.
author_sort Chen, Li‐Mei
collection PubMed
description A major lesson learned from the public health response to the 2009 H1N1 pandemic was the need to shorten the vaccine delivery timeline to achieve the best pandemic mitigation results. A gap analysis of previous pre‐pandemic vaccine development activities identified possible changes in the Select Agent exclusion process that would maintain safety and shorten the timeline to develop candidate vaccine viruses (CVVs) for use in pandemic vaccine manufacture. Here, we review the biosafety characteristics of CVVs developed in the past 15 years to support a shortened preparedness timeline for A(H5) and A(H7) subtype highly pathogenic avian influenza (HPAI) CVVs. Extensive biosafety experimental evidence supported recent changes in the implementation of Select Agent regulations that eliminated the mandatory chicken pathotype testing requirements and expedited distribution of CVVs to shorten pre‐pandemic and pandemic vaccine manufacturing by up to 3 weeks.
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spelling pubmed-70409782020-03-01 Biosafety risk assessment for production of candidate vaccine viruses to protect humans from zoonotic highly pathogenic avian influenza viruses Chen, Li‐Mei Donis, Ruben O. Suarez, David L. Wentworth, David E. Webby, Richard Engelhardt, Othmar G. Swayne, David E. Influenza Other Respir Viruses Formal Systematic Review (Commissioned or Non‐commissioned) A major lesson learned from the public health response to the 2009 H1N1 pandemic was the need to shorten the vaccine delivery timeline to achieve the best pandemic mitigation results. A gap analysis of previous pre‐pandemic vaccine development activities identified possible changes in the Select Agent exclusion process that would maintain safety and shorten the timeline to develop candidate vaccine viruses (CVVs) for use in pandemic vaccine manufacture. Here, we review the biosafety characteristics of CVVs developed in the past 15 years to support a shortened preparedness timeline for A(H5) and A(H7) subtype highly pathogenic avian influenza (HPAI) CVVs. Extensive biosafety experimental evidence supported recent changes in the implementation of Select Agent regulations that eliminated the mandatory chicken pathotype testing requirements and expedited distribution of CVVs to shorten pre‐pandemic and pandemic vaccine manufacturing by up to 3 weeks. John Wiley and Sons Inc. 2019-10-28 2020-03 /pmc/articles/PMC7040978/ /pubmed/31659871 http://dx.doi.org/10.1111/irv.12698 Text en Published 2019. This article is a U.S. Government work and is in the public domain in the USA. Influenza and Other Respiratory Viruses published by John Wiley & Sons Ltd. This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Formal Systematic Review (Commissioned or Non‐commissioned)
Chen, Li‐Mei
Donis, Ruben O.
Suarez, David L.
Wentworth, David E.
Webby, Richard
Engelhardt, Othmar G.
Swayne, David E.
Biosafety risk assessment for production of candidate vaccine viruses to protect humans from zoonotic highly pathogenic avian influenza viruses
title Biosafety risk assessment for production of candidate vaccine viruses to protect humans from zoonotic highly pathogenic avian influenza viruses
title_full Biosafety risk assessment for production of candidate vaccine viruses to protect humans from zoonotic highly pathogenic avian influenza viruses
title_fullStr Biosafety risk assessment for production of candidate vaccine viruses to protect humans from zoonotic highly pathogenic avian influenza viruses
title_full_unstemmed Biosafety risk assessment for production of candidate vaccine viruses to protect humans from zoonotic highly pathogenic avian influenza viruses
title_short Biosafety risk assessment for production of candidate vaccine viruses to protect humans from zoonotic highly pathogenic avian influenza viruses
title_sort biosafety risk assessment for production of candidate vaccine viruses to protect humans from zoonotic highly pathogenic avian influenza viruses
topic Formal Systematic Review (Commissioned or Non‐commissioned)
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7040978/
https://www.ncbi.nlm.nih.gov/pubmed/31659871
http://dx.doi.org/10.1111/irv.12698
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