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Federal
health advisers on Tuesday recommended that the Food and
Drug Administration approve an avian-influenza vaccine despite
evidence that the drug would not shield most people from
infection.
The advisory committee voted that the vaccine was safe and
effective, the two conditions that must be met for FDA to
approve a drug. FDA officials have said that the Sanofi
Aventis SA vaccine could play a role in protecting public
health despite its limited effectiveness. Panel member Dr.
Robert Couch of the Baylor College of Medicine in Houston
echoed the claim. "I am of the view that anything is better
than nothing," he said just before the vote.
In a clinical trial, the two-shot series showed a protective
immune response in only 45 percent of adults receiving the
highest dose, and FDA has said it would like to see effectiveness
in at least 70 percent of those vaccinated.
Though FDA is not required to follow the recommendations
of its advisory boards, it historically does.
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