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February 8 , 2001

Vaccines Replace Cow Ingredients


WASHINGTON (AP)--Cow-derived ingredients from mad cow-infected countries are being replaced in certain vaccines as an extra precaution, even though the government's top mad cow experts call any risk theoretical.

The Food and Drug Administration discovered last February that a few makers of common childhood vaccines, from diphtheria to polio, had continued using the ingredients for seven years after the FDA told them to stop.

In July, the FDA's scientific advisers publicly debated the issue and ``we agreed any risk was very small,'' said panelist Dr. Peter Lurie, a physician and consumer advocate. ``It's not like they used cow cells in the final vaccines. ... It's complicated.''

As The Associated Press reported this week, the vaccines are being reformulated as a precaution.

To ensure consumers understood the issue, FDA last year created an Internet page stressing the vaccines are safe to use. The Centers for Disease Control and Prevention reiterated that in a December report recounting what happened.

One of the first steps in making vaccines involves growing bacterial or viral cultures. Certain animal-derived ingredients are added to help the cultures grow; some, for instance, are briefly bathed in blood from calves or sugars from cow's milk. The vaccine mix then undergoes repeated purification.

The FDA warned manufacturers starting in 1993 that as a precaution, they should not use cattle-derived ingredients from any country infected with mad cow disease, or bovine spongiform encephalopathy.

Companies caught in violation said they had used the same ingredients for decades and didn't realize FDA was concerned about culturing.

The FDA's scientific advisers determined the risk theoretical, noting many ingredients aren't made of BSE-infectious tissue, such as milk sugars. Last month, the same advisory panel warned that some dietary supplements--products containing raw cows' brains, the most infectious tissue, and other animal organs--are of far more concern but are not being properly checked by the FDA.

 

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