U.S. health advisers recommended Tuesday that the government approve
the first bird flu vaccine as a stopgap measure, despite evidence it
would not protect most people.In
separate votes, the outside panel said the vaccine was both safe and
effective. A vaccine must meet both standards to win approval from the
Food and Drug Administration. The votes came after FDA officials said
the Sanofi Aventis SA vaccine still could play an important role in
protecting against the increased likelihood of a pandemic, despite its
limited effectiveness.
The FDA is not required to follow the
advice of its advisory committees, but usually does. The vaccine
produced by the Paris-based company is the first against the H5N1
influenza strain to seek U.S. government approval.
The vaccine
already is being stockpiled, even without FDA approval, for eventual
interim use to protect emergency workers and others in a pandemic. It
would be used until better vaccines could be developed. Though not
required, FDA approval would state the agency's opinion on the
vaccine's safety and effectiveness, said Dr. Jesse Goodman, FDA's chief
of biologic products.
In a clinical trial, the two-shot series
appears to provide protection to just 45 percent of adults who received
the highest dose. An earlier, interim analysis of the same study had
suggested it prompted a protective immune response in 54 percent of
patients, when measured 28 days after getting the second of two shots.
The FDA said it would like to see a response in at least 70 percent of
those vaccinated against bird flu.
"The more antibodies, the
better. But even at lower levels, there is a possibility of
protection," Goodman told reporters on the sidelines of the meeting.
The
government plans to buy and stockpile enough bird flu vaccine for 20
million people, including emergency and health care workers. The Sanofi
vaccine wouldn't be sold commercially.
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