Effective government/industry collaboration bolsters flu vacc...( d says NIH Director Elias A. Zerhouni...),Health

"This effort is a model for the type of effective collaboration that will be needed to produce vaccines in the event of an influenza pandemic," adds NIAID Director Anthony S. Fauci, M.D.

"There was real synergy between academia, which supplied the clinical trial infrastructure; NIH, which supplied the necessary funding and direction; industry, which had the desire to bring Fluarix to the U.S. market; and the FDA, which agreed to review the study results in a speedy fashion," states lead investigator John Treanor, M.D., of the University of Rochester Medical Center, one of the four NIAID-sponsored Vaccine Treatment and Evaluation Units (VTEUs) that conducted the study. "The end result was that we now have 8 million doses of a new flu vaccine available in the U.S. for the 2005-2006 flu season."

In addition to the University of Rochester, the 30-day clinical study was conducted at the following VTEUs: Cincinnati Children's Hospital; University of Maryland School of Medicine, Baltimore; and Baylor College of Medicine. The study participants included 952 healthy adults ages 18 to 64 years old; 760 received a single dose of the 0.5-ml vaccine while 192 received placebo. Those who received the placebo were offered the U.S.-licensed flu vaccine at the conclusion of the study.

Researchers observed the study participants for adverse events immediately following vaccination and provided them with diary cards to record any reactions that occurred during the three subsequent days following immunization. According to the study findings, the vaccine was well-tolerated with redness and mild-to-moderate pain at the injection site as the most common reported adverse events. Importantly, symptoms patients might expect after influenza vaccination, such as headache, fatigue, chills and fever, were no different between those who received the vaccine and those who received the placebo--verification that inactiv
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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