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FDA Commissioner acknowledges adjuvant risk: "There wasn't experience with that vaccine in other populations, including pregnan

Posted Nov 13 2009 10:03pm

U.S. Food and Drug Administration Commissioner Hamburg speaks at the Reuters Health Summit in New Yo U.S. Food and Drug Administration Commissioner Dr. Margaret Hamburg spoke at the Reuters Health Summit in New York, November 12, 2009. An excerpt from the Reuters article on her talk follows:

Some experts have suggested the government could have increased supplies by embracing adjuvant vaccine technology that is widely used in Europe.

Adjuvanted vaccines contain an additive to boost the immune system response and need less of the active ingredient than the unadjuvanted types approved by the FDA.

But Hamburg said they have not been widely tested and that the agency did not want to risk using them when standard vaccines worked well with a single dose.

"Had the shape of epidemic or the characteristics of the virus and the disease required it, we would have moved toward an adjuvanted approach," she said.

"Europe took a little bit more of a risk. Yes, there was experience with an adjuvanted vaccine but it was really only used in the elderly and there wasn't experience with that vaccine in other populations, including pregnant women and children."

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