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ARS Home » Southeast Area » Athens, Georgia » U.S. National Poultry Research Center » Exotic & Emerging Avian Viral Diseases Research » Research » Publications at this Location » Publication #363927
Research Project: Intervention Strategies to Prevent and Control Disease Outbreaks Caused by Emerging Strains of Avian Influenza Viruses

Location: Exotic & Emerging Avian Viral Diseases Research

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

Author
item CHEN, LI-MEI - Centers For Disease Control And Prevention (CDC) - United States
item DONIS, RUBEN - Centers For Disease Control And Prevention (CDC) - United States
item Suarez, David
item WENTWORTH, DAVID - Centers For Disease Control And Prevention (CDC) - United States
item WEBBY, RICHARD - St Jude Children’s Research Hospital
item ENGELHARDT, OTHMAR - The National Institute For Biologial Standards And Control
item Swayne, David

Submitted to: Influenza and Other Respiratory Viruses
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 10/8/2019
Publication Date: 2/5/2020
Publication URL: https://handle.nal.usda.gov/10113/6964474
Citation: Chen, L., Donis, R.O., Suarez, D.L., Wentworth, D.E., Webby, R., Engelhardt, O.G., Swayne, D.E. 2019. Biosafety risk assessment for production of candidate vaccine viruses to protect humans from zoonotic highly pathogenic avian influenza viruses. Influenza and Other Respiratory Viruses. 14:215-225. https://doi.org/10.1111/irv.12698.
DOI: https://doi.org/10.1111/irv.12698

Interpretive Summary: A shortened time period is needed for delivery of vaccines to prepare for an influenza pandemic. One critical need was an accelerated process to approve candidate vaccine viruses (CVV) for use in vaccine manufacture. In this study, we provided 15 years of biosafety evidence in support of eliminating mandatory chicken safety testing requirements, thus expediting the transfer of vaccine candidates to manufacturing by nearly three weeks.

Technical Abstract: 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.