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US Company Could Make Flu Vaccine Abroad After Snub

by Sreeraman on November 22, 2009 at 12:15 PM Drug News

A US company said it would consider making its innovative flu vaccine abroad after a panel of experts advising the US drug regulator voted not to recommend it for approval.

US Company Could Make Flu Vaccine Abroad After Snub

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A panel of 11 experts who sit on the Vaccines and Related Biological Products Advisory Committee failed the seasonal flu vaccine that Protein Sciences produces using caterpillar cells, saying they wanted more evidence that the vaccine was safe and expressing concerns about its efficacy in the over-50 age group.

The panel said it was not slamming the door on the new vaccine for seasonal flu, which would be the first cell-based flu vaccine in the United States and could come to market much more quickly than vaccine made using the traditional egg-based method, but wanted to see more evidence it was safe.

But Protein Sciences' chief operating officer Manon Cox said the company might take its innovative technology for producing vaccine elsewhere.

"Other countries - Australia, for example, and Europe - have already said they feel that our vaccine meets the criteria (for safety), but we have always focused on the US," Cox told AFP.

"Now I'm wondering if that's the right strategy," she said.

The panel's comments will be passed on to the US Food and Drug Administration, which is not bound by the experts' opinions but usually follows them, an FDA official told AFP.

All the flu vaccines currently available in the United States, whether for swine flu or seasonal flu, are developed using chicken eggs.

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US Company Could Make Flu Vaccine Abroad After Snub

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