Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2020 Mar;14(2):215-225.
doi: 10.1111/irv.12698. Epub 2019 Oct 28.

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

Li-Mei Chen  1 , Ruben O Donis  1 , David L Suarez  2 , David E Wentworth  1 , Richard Webby  3 , Othmar G Engelhardt  4 , David E Swayne  2
Affiliations
Review

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

Li-Mei Chen et al. Influenza Other Respir Viruses. 2020 Mar.

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.

Keywords: avian influenza; biosafety; candidate vaccine viruses; influenza vaccine; pandemics; pre-pandemic.

PubMed Disclaimer

Conflict of interest statement

The authors declare no conflict of interest in this review.

Figures

Figure 1
Figure 1
Development of CVVs against HPAI for pandemic preparedness. Schematic of major process steps and corresponding timeline under 2005 biosafety regulatory requirements in compliance with the Select Agent Program (A) and under the revised regulatory policy implemented in 2018 based on cumulative CVV safety data (B)
See this image and copyright information in PMC

References

    1. Cruz‐Aponte M, McKiernan EC, Herrera‐Valdez MA. Mitigating effects of vaccination on influenza outbreaks given constraints in stockpile size and daily administration capacity. BMC Infect Dis. 2011;11:207. - PMC - PubMed
    1. US‐HSC . National Strategy for pandemic influenza Implementation Plan. 2006. https://www.cdc.gov/flu/pandemic-resources/pdf/pandemic-influenza-implem.... Accessed March 19, 2018.
    1. US‐DHHS . 2017 Update IV of the HHS pandemic influenza plan. 2017. https://www.cdc.gov/flu/pandemic-resources/pdf/pan-flu-report-2017v2.pdf. Accessed March 19, 2018.
    1. O'Neill E, Donis RO. Generation and characterization of candidate vaccine viruses for prepandemic influenza vaccines. Curr Top Microbiol Immunol. 2009;333:83‐108. - PubMed
    1. Subbarao K, Chen H, Swayne D, et al. Evaluation of a genetically modified reassortant H5N1 influenza A virus vaccine candidate generated by plasmid‐based reverse genetics. Virology. 2003;305(1):192‐200. - PubMed

Publication types

MeSH terms

LinkOut - more resources