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New drugs are needed, researchers say, because there are now only four approved flu drugs that work by only two different mechanisms.
The nation does not have an approved flu vaccine for people or enough antiviral drugs or respirators for all who would need them.
Peramivir is given intravenously, making it usable by hospitalized patients who are too ill to take two approved flu drugs that work against the virus in similar ways — Tamiflu by Roche, which is typically given as a pill, or Relenza from GlaxoSmithKline, which is inhaled.
Q: There's obviously the question of adjuvants, the immune system boosters that currently are not used in FDA approved flu vaccines.
The group noted that this would require using "the most dose-sparing formulations," which means adding vaccine boosters called adjuvants; approved flu vaccines in some countries, including the United States, do not use adjuvants.
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[C5.] As health officials worked to avoid another flu vaccine shortage like that in the 2004-5 season, regulators approved a flu shot from GlaxoSmithKline, and a Chiron vaccine plant in Liverpool that was shut last year because of contamination moved closer to being opened.
CAIV-T is a new version of the company's nasal spray vaccine FluMist, which is approved to prevent flu in healthy children and adolescents, 5 to 17 years of age, and healthy adults, 18 to 49 years of age.
Although zanamivir is not yet approved for preventing flu, a study at the University of Virginia and the University of Michigan, published last week in The New England Journal of Medicine, showed that when flu victims' family members were given zanamivir once a day for 10 days, their flu risk dropped by 79percentt.
IDBE hopes to have its flu vaccine approved and ready for distribution in the U.S. by the 2006-2007 flu season.
Mr. Bush spoke as the flu vaccine shortage moved to center stage in the campaign and as his secretary of health and human services, Tommy G. Thompson, said that Aventis Pasteur, the only company approved this year to sell flu vaccines, would be able to make the extra doses of flu vaccines available so the total would be about 58 million doses in all.
So the drug will not be approved for use this flu season.
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