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FDA calls for new flu vaccine guidelines

Published September 29, 2006

WASHINGTON - For a half-century, flu vaccine has been brewed in chicken eggs. The government issued new guidelines Thursday that promise to spur a more modern recipe: using vats of cells instead.

Revamping the nation's flu-shot production still is years away. But the Bush administration has awarded manufacturers tens of millions of research dollars to try - because if the Asian bird flu or some other influenza super-strain sparks a worldwide epidemic, today's factories couldn't brew vaccine fast enough to help.

"Once you run out of eggs, you can't make more vaccine. But if you have cells banked, you can always make more vaccine," said Philip Krause, the Food and Drug Administration's deputy director of viral vaccines.

FDA's guidelines come just two days after the nation's leading flu-shot maker, Sanofi Pasteur, opened its first safety study of a cell-based influenza vaccine.

Banks of cells taken either from animals or people already are used to make numerous medical products, including a host of vaccines.

But cell-based manufacturing is becoming more sophisticated, even as flu vaccine makers explore switching to so-called cell cultures, too. So FDA's guidelines, the first update since 1993, are aimed at manufacturers.

"The advice will assist manufacturers ... both to develop new and better vaccines and to boost production capacity, making us better prepared for the threat of a future influenza pandemic and other infectious diseases," said Dr. Jesse Goodman, FDA's chief of biologic products.

[Last modified September 29, 2006, 01:20:46]

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