That uncertainty poses a challenge for the U.S. Food and Drug Administration, which is considering an AS03-containing vaccine for use in the event of an H5N1 bird flu epidemic. Like Pandemrix, which has not been approved in the United States, it is made by GSK and is almost identical in structure.Yes that's nice, but guess who the "premier Narcolepsy expert" is working for...
A 14-member panel of advisors to the FDA voted unanimously in November to recommend the vaccine to protect against bird flu. The panel considered early studies from Europe showing an increase in the number of narcolepsy cases but concluded that the potential benefit of the vaccine outweighed the risk.
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Since then, however, new data, including the study results from Britain, suggest the scale and strength of the narcolepsy link could be greater than first thought. At least one committee member would like the FDA to reconvene the panel.
Friday, March 8, 2013
Foxes and Henhouses
Narcolepsy link to Glaxo vaccine poses challenge for FDA