Thursday, November 19, 2009

FDA panel votes against new bug-based flu vaccine

Some panel members were concerned about some side-effects seen in people who volunteered to test it, such as a woman who had Bell's palsy, a temporary paralysis of the face, that flared up an hour after she was vaccinated.

"I don't feel the safety database is large enough," said Pamela McInnes of the National Institutes of Health. She said the vaccine is a new formulation and so the burden of proof is higher than simply changing the influenza strain from one season to another.

"I feel the safety data do not raise significant red flags," disagreed Dr. Jack Stapleton of the University of Iowa.

"What we are dealing with, rock bottom, is a pretty mediocre vaccine,' said Dr. Theodore Eickhoff, a professor emeritus at the University of Colorado School of Medicine and a panel member.

The vaccine is made using cells from a caterpillar and would be the first influenza vaccine made using cell cultures approved in the United States.

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