A bit more color on the Advisory Committee's concerns:
>>GAITHERSBURG, Md., Jul 28, 2001 (AP Online via COMTEX) -- A panel of health experts says FluMist, a painless flu vaccine, can protect against the illness and will probably one day prove safe enough for use.
However advisers to the Food and Drug Administration said Friday that too many safety questions remain for the long-awaited nasal vaccine developed by Aviron Inc. to be sold yet.
Unlike today's flu shots, FluMist is made with live influenza virus, so more proof is needed that squirting live virus into people's noses - especially the toddlers who would be prime targets - is safe, panelists concluded after two days of debate.
The FDA is not bound by its advisers' recommendations but typically follows them.
Concerns include how well FluMist combines with other vaccines that toddlers receive, and whether there might be a rare risk of pneumonia or asthma among certain children.
Aviron had hoped to begin selling limited supplies of FluMist in time for this year's flu season, offering the first needle-free vaccine alternative to healthy people ages 1 to 64.
Aviron chief executive C. Boyd Clarke said the company now hopes to answer the panel's safety questions in time for FluMist to be used in the 2002-2003 flu season.<<
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Can the participants in prior trials be easily recruited into a follow up study to address the pneumonia and asthma concerns? Anybody know how long it would take for those pathologies to become apparent? In other words, how long would that study take? Would the adverse effects of mixing vaccines manifest quickly or could some take a while to show up?
TIA. Guess I'll try to get up early and listen. Good night &
Cheers, Tuck |
