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Vaccines and
antitoxins, collectively known as "biologics," were made in animals, hence
the possibility of contamination was large. In 1901, 13 children in St.
Louis, Missouri, died from diphtheria antitoxin that had been contaminated
with tetanus spores. This tragedy led Congress in 1902 to pass a Biologics
Control Act that required commercial manufacturers to demonstrate the purity
(and later potency) of their products. The Hygienic Laboratory was assigned
regulatory responsibility. This useful activity helped to protect its more
politically vulnerable research activities. |