tetano
Editor, Senior Moderator
Influenza Other Respir Viruses. 2019 Oct 28. doi: 10.1111/irv.12698. [Epub ahead of print] [h=1]Biosafety risk assessment for production of candidate vaccine viruses to protect humans from zoonotic highly pathogenic avian influenza viruses.[/h]
Chen LM[SUP]1[/SUP], Donis RO[SUP]1[/SUP], Suarez DL[SUP]2[/SUP], Wentworth DE[SUP]1[/SUP], Webby R[SUP]3[/SUP], Engelhardt OG[SUP]4[/SUP], Swayne DE[SUP]2[/SUP].
[h=3]Author information[/h] 1 Virology, Surveillance, and Diagnosis Branch, Influenza Division, National Center for Immunization and Respiratory Disease, Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA. 2 Exotic and Emerging Avian Viral Diseases Research Unit, Agricultural Research Service, U.S. National Poultry Research Center, U.S. Department of Agriculture, Athens, GA, USA. 3 Department of Infectious Diseases, St Jude Children's Research Hospital, Memphis, TN, USA. 4 Division of Virology, National Institute for Biological Standards and Control, Potters Bar, UK.
[h=3]Abstract[/h] 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.
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.
[h=4]KEYWORDS:[/h] avian influenza; biosafety; candidate vaccine viruses; influenza vaccine; pandemics; pre-pandemic
PMID: 31659871 DOI: 10.1111/irv.12698
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Chen LM[SUP]1[/SUP], Donis RO[SUP]1[/SUP], Suarez DL[SUP]2[/SUP], Wentworth DE[SUP]1[/SUP], Webby R[SUP]3[/SUP], Engelhardt OG[SUP]4[/SUP], Swayne DE[SUP]2[/SUP].
[h=3]Author information[/h] 1 Virology, Surveillance, and Diagnosis Branch, Influenza Division, National Center for Immunization and Respiratory Disease, Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA. 2 Exotic and Emerging Avian Viral Diseases Research Unit, Agricultural Research Service, U.S. National Poultry Research Center, U.S. Department of Agriculture, Athens, GA, USA. 3 Department of Infectious Diseases, St Jude Children's Research Hospital, Memphis, TN, USA. 4 Division of Virology, National Institute for Biological Standards and Control, Potters Bar, UK.
[h=3]Abstract[/h] 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.
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.
[h=4]KEYWORDS:[/h] avian influenza; biosafety; candidate vaccine viruses; influenza vaccine; pandemics; pre-pandemic
PMID: 31659871 DOI: 10.1111/irv.12698
Free full text