Aviron Message Board - Msg: 5489735

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Biotech / Medical : Aviron

AVIR 3.260

+0.3%

Nov 7 3:59 PM EST

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To: Dennis who wrote (304)	8/13/1998 3:27:00 PM
From: Gerald Walls	Read Replies (2) of 645

If this is true then why doesn't the FDA give them the go ahead?? The news release specifically says it is to establish the safety when used in a large population. Please reread the release. The FDA never moves quickly. If you mean this release: biz.yahoo.com the word "safety" appears only once, and in this context: "The non-randomized, open-label study will evaluate the impact of vaccinating preschool and school-age children with FluMist(TM) intranasal influenza vaccine based on the incidence of doctor visits for flu and flu-related illnesses. The large number of trial participants will also provide additional information on vaccine safety." This is far from your "[t]he news release specifically says it is to establish the safety when used in a large population." This is the true intent of the study: ''This study represents an important step in understanding the impact on an entire community when a key segment of the population is vaccinated against influenza,'' stated J. Leighton Read, M.D., chairman and chief executive officer of Aviron. ''Since children play a key role in the spread of influenza, we hope that high levels of vaccine coverage in children will have benefits for kids as well as others in the population.'' This does not mean, of course, that the FDA is not asking for additional safety information. But if it was then this would be a material fact that the company would be obligated to disclose.

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