{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T13:00:03Z","timestamp":1777899603205,"version":"3.51.4"},"reference-count":54,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2019,10,28]],"date-time":"2019-10-28T00:00:00Z","timestamp":1572220800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Influenza Resp Viruses"],"published-print":{"date-parts":[[2020,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>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\u2010pandemic 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\u00a0years 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\u2010pandemic and pandemic vaccine manufacturing by up to 3\u00a0weeks.<\/jats:p>","DOI":"10.1111\/irv.12698","type":"journal-article","created":{"date-parts":[[2019,10,29]],"date-time":"2019-10-29T04:52:09Z","timestamp":1572324729000},"page":"215-225","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Biosafety risk assessment for production of candidate vaccine viruses to protect humans from zoonotic highly pathogenic avian influenza viruses"],"prefix":"10.1111","volume":"14","author":[{"given":"Li\u2010Mei","family":"Chen","sequence":"first","affiliation":[{"name":"Virology, Surveillance, and Diagnosis Branch Influenza Division National Center for Immunization and Respiratory Disease Centers for Disease Control and Prevention (CDC) Atlanta GA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ruben O.","family":"Donis","sequence":"additional","affiliation":[{"name":"Virology, Surveillance, and Diagnosis Branch Influenza Division National Center for Immunization and Respiratory Disease Centers for Disease Control and Prevention (CDC) Atlanta GA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David L.","family":"Suarez","sequence":"additional","affiliation":[{"name":"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"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David E.","family":"Wentworth","sequence":"additional","affiliation":[{"name":"Virology, Surveillance, and Diagnosis Branch Influenza Division National Center for Immunization and Respiratory Disease Centers for Disease Control and Prevention (CDC) Atlanta GA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4397-7132","authenticated-orcid":false,"given":"Richard","family":"Webby","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases St Jude Children's Research Hospital Memphis TN USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0465-9908","authenticated-orcid":false,"given":"Othmar G.","family":"Engelhardt","sequence":"additional","affiliation":[{"name":"Division of Virology National Institute for Biological Standards and Control Potters Bar UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7472-1992","authenticated-orcid":false,"given":"David E.","family":"Swayne","sequence":"additional","affiliation":[{"name":"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"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2019,10,28]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2334-11-207"},{"key":"e_1_2_10_3_1","unstructured":"US\u2010HSC.National Strategy for pandemic influenza Implementation Plan.2006.https:\/\/www.cdc.gov\/flu\/pandemic-resources\/pdf\/pandemic-influenza-implementation.pdf. 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