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U.S. Department of Health and Human Services

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MBio 2014 Dec 12;5(6):e02430-14

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

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


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.

Category: Journal Article
PubMed ID: #25505124 DOI: 10.1128/mBio.02430-14
PubMed Central ID: #PMC4278542
Includes FDA Authors from Scientific Area(s): Biologics
Entry Created: 2014-12-05 Entry Last Modified: 2015-01-31