Influenza Gain-of-Function Experiments: Their Role in Vaccine Virus Recommendation and Pandemic Preparedness

Influenza Gain-of-Function Experiments: Their Role in Vaccine Virus Recommendation and Pandemic Preparedness

1. S. Schultz-Cherry^a, 
2. R. J. Webby^a, 
3. R. G. Webster^a, 
4. A. Kelso^b, 
5. I. G. Barr^b,
6. J. W. McCauley^c, 
7. R. S. Daniels^c, 
8. D. Wang^d, 
9. Y. Shu^d, 
10. E. Nobusawa^e, 
11. S. Itamura^e,
12. M. Tashiro^e, 
13. Y. Harada^e, 
14. S. Watanabe^e, 
15. T. Odagiri^e, 
16. Z. Ye^f, 
17. G. Grohmann^g,
18. R. Harvey^h, 
19. O. Engelhardt^h, 
20. D. Smithⁱ, 
21. K. Hamilton^j, 
22. F. Claes^k, 
23. G. Dauphin^k

+Author Affiliations

1. aWHO Collaborating Center for Studies on the Ecology of Influenza in Animals, Department of Infectious Diseases, St. Jude Children’s Research Hospital, Memphis, Tennessee, USA
2. bWHO Collaborating Centre for Reference and Research on Influenza, Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia
3. cWHO Collaborating Centre for Reference and Research on Influenza, Division of Virology, MRC National Institute for Medical Research, Mill Hill, London, United Kingdom
4. dWHO Collaborating Center for Reference and Research on Influenza, Chinese National Influenza Center, National Institute for Viral Disease Control and Prevention China CDC, Beijing, People’s Republic of China
5. eWHO Collaborating Centre for Reference and Research on Influenza, National Institute of Infectious Diseases, Laboratory of Influenza Virus Surveillance, Influenza Virus Research Center, Tokyo, Japan
6. fDivision of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland, USA
7. gImmunology and Vaccines, Therapeutic Goods Administration Laboratories, Woden, ACT, Australia
8. hNational Institute for Biological Standards and Control, Medicines and Healthcare Products Regulatory Agency, Potters Bar, United Kingdom
9. iCenter for Pathogen Evolution, Department of Zoology, WHO CC for Modeling Evolution and Control of Emerging Infectious Diseases, University of Cambridge, Cambridge, United Kingdom
10. jOIE Scientific and Technical Department, OIE, Paris, France
11. kOFFLU/EMPRES Laboratory Unit, Animal Health Service, FAO, Rome, Italy

1. Address correspondence to S. Schultz-Cherry, Stacey.schultz-cherry@stjude.org.

ABSTRACT

In recent years, controversy has arisen regarding the risks and benefits of certain types of gain-of-function (GOF) studies involving avian influenza viruses. In this article, we provide specific examples of how different types of data, including information garnered from GOF studies, have helped to shape the influenza vaccine production process—from selection of candidate vaccine viruses (CVVs) to the manufacture and stockpiling of safe, high-yield prepandemic vaccines for the global community. The article is not written to support a specific pro- or anti-GOF stance but rather to inform the scientific community about factors involved in vaccine virus selection and the preparation of prepandemic influenza vaccines and the impact that some GOF information has had on this process.

FOOTNOTES

• Citation Schultz-Cherry S, Webby RJ, Webster RG Kelso A, Barr IG, McCauley JW, Daniels RS, Wang D, Shu Y, Nobusawa E, Itamura S, Tashiro M, Harada Y, Watanabe S, Odagiri T, Ye Z, Grohmann G, Harvey R, Engelhardt O, Smith D, Hamilton K, Claes F, Dauphin G. 2014. Influenza gain-of-function experiments: their role in vaccine virus recommendation and pandemic preparedness. mBio 5(6):e02430-14. doi:10.1128/mBio.02430-14.

• Published 12 December 2014

• Copyright © 2014 Schultz-Cherry et al.

This is an open-access article distributed under the terms of the Creative Commons Attribution 3.0 Unported license.