Panel reluctantly backed flu vaccine to FDA

[TeeYiYi]

Panel reluctantly backed flu vaccine to FDA

(CNN) -- Members of an advisory panel that backed this year's flu vaccine expressed doubts about its potential effectiveness before recommending it for the Food and Drug Administration's approval.

Some said they were concerned the vaccine would not provide as much protection against the Fujian strain of flu that was thought most likely to dominate this year's flu season, according to a transcript of the group's deliberations.

The Fujian strain, which emerged in the Far East, is now responsible for 75 percent of U.S. flu cases, the Centers for Disease Control and Prevention said.

But drug makers could not culture the Fujian strain in a way to meet FDA standards, forcing the advisory committee to make this year's flu vaccine the same as it was last year.

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Nancy Cox, chief of the influenza branch at the CDC, told the group that manufacturers had been unable to grow the Fujian strain in chicken eggs -- the only FDA-approved method of reproducing the virus for use in vaccines.

More: http://www.cnn.com/2003/HEALTH/12/13/sprj.flu03.vaccine/index.html

TYY

[Occulus]

1. Why can't they use other methods?

Why is the egg method the only one approved? It can be argued that people died as a direct result of this...

[TeeYiYi]

2. They disagreed on whether it would be safe . . .

"But, she added, when lab workers extracted the Fujian strain from dog kidneys and then put it into chicken eggs, it grew well.

The prospect of using a virus extracted from an animal did not sit well with Dr. Karen Midthun, director of the FDA's office of vaccines research and review, who said it could pose a risk to vaccine recipients if it turned out to be contaminated.

"One really needs to know a lot about the cells that were used," she said. "They need to be qualified, characterized, to really address the different safety issues that we feel need to be addressed."

Palese disagreed, according to the transcript.

"One can make a reasonable argument" that there is a theoretical possibility that cells used in the approved vaccine could contain contaminants "and that we are perfectly happy to accept that," he said.

"We are ... not making the best vaccine decision if we don't allow the Fujian type to be part of this new formulation."

Palese downplayed the possibility of contamination, calling it "a potential very, very minimal risk." "

http://www.cnn.com/2003/HEALTH/12/13/sprj.flu03.vaccine/index.html

TYY

[TeeYiYi]

3. kick

:kick: