Well, Peter,
What do you make of this? I'm gonna be PO'd if they get a half baked approval and the stock just sits there.
>>GAITHERSBURG, Md., July 26 (Reuters) - A nasal spray vaccine has shown the power to prevent influenza in healthy children but studies fell short in adults, a health official told U.S. advisers on Thursday.
The experimental vaccine called FluMist, made by Aviron (NasdaqNM:AVIR - news) , could offer a painless alternative to annual flu shots as early as the upcoming flu season.
A Food and Drug Administration advisory panel is scheduled to decide on Friday whether to recommend approval for FluMist for preventing the illness that brings fever, aches and misery to millions of Americans each year.
Aviron previously had disclosed that a study in adults failed to show FluMist significantly reduced rates of feverish illnesses. Chrisanna Mink, an FDA official who reviewed Aviron's clinical trials involving more than 24,000 people, noted that shortcoming but said other studies showed FluMist worked in children.
``Efficacy against ... influenza illness was demonstrated in healthy children,'' Mink said.
The FDA has not completed its analysis of FluMist's safety, Mink added. Aviron said most side effects were mild, such as a runny nose.
The company also said FluMist reduced severe illness and upper respiratory infections in adults even if its study did not meet the main research objective.
Some industry analysts predict FluMist, which American Home Products Corp. (NYSE:AHP - news) would co-market, could become a billion-dollar seller in a few years. The vaccine is the leading product candidate for Mountain View, California-based Aviron.
Previous manufacturing problems have slowed FluMist's development, and an FDA official said talks with the company about FluMist's production were ongoing.
``There are some manufacturing issues which continue to be discussed,'' the FDA's Peter Patriarca told the panel.
Aviron said FluMist would be especially valuable for children, a group hard-hit by the illness and the main carriers of flu infections.
In one study, FluMist provided 95 percent protection from feverish illnesses and 97 percent protection from ear infections, a common flu complication. Kids who did get sick had shorter episodes of fever with the vaccine. FluMist patients also missed fewer days of school and made fewer doctor visits, said Dr. Robert Belshe, an Aviron consultant from St. Louis University.
``By a number of measures, FluMist improved the health and well-being of children,'' Belshe said.<<
snip
Cheers, Tuck |
