When faced with an urgent public health need, the federal government, vaccine manufacturers and university-based researchers can work together quickly and effectively to come up with solutions, as demonstrated in the successful clinical trial of the influenza vaccine Fluarix. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), working closely with the Food and Drug Administration (FDA), sponsored the clinical trial that demonstrated the vaccine's safety and ability to generate an immune response and ultimately led to its expedited approval by FDA in August 2005. Fluarix is the first vaccine to receive FDA approval under the agency's accelerated approval regulations.

Details of the Fluarix clinical study are discussed in the November/December 2005 issue of Human Vaccines, available online December 22.

Clinical testing of the seasonal influenza vaccine Fluarix began in December 2004 as an effort to augment the future U.S. flu vaccine supply, which was experiencing an unexpected, significant shortage. Fluarix, which is manufactured by GlaxoSmithKline Biologicals of Rixensart, Belgium, had been approved in 1998 for use in other countries but had never been tested or licensed for use in the United States.

The vaccine was evaluated in a clinical trial involving nearly 1,000 healthy adults at four sites nationwide. Clinical evaluation of the candidate vaccine was performed under an FDA-reviewed "investigational new drug" application, in which potential study volunteers are fully informed about potential risks and benefits and must provide their informed consent before receiving the investigational product. The clinical trial was rapidly initiated and reached capacity enrollment within five days of its launch in December 2004.

"The Fluarix study is an excellent example of what government and industry can accomplish in a short timeframe when faced with a serious public health nee
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Contact: Kathy Stover
kstover@niaid.nih.gov
301-402-1663
NIH/National Institute of Allergy and Infectious Diseases
22-Dec-2005

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