More than three dozen babies have been sickened in an infant botulism outbreak tied to contaminated formula, federal health officials say.

All of the babies were treated with an unusual orphan drug created from the blood plasma of people who were immunized against botulism. The product, called BabyBIG, is the only treatment in the world for this rare and life-threatening condition that affects infants under age 1.

BabyBIG was licensed by the FDA in 2003.

It was championed and produced by the late Dr. Stephen Arnon, after spending more than 45 years at the California Health Department working on infant botulism.

Arnon worked with Nancy Shine and other scientists who were immunized against botulism because they worked in a laboratory with the high-risk pathogen. That small group of scientists were the first of a dedicated group of about 30 donors who developed high levels of antibodies in their blood used to produce the treatment.

"I was lucky enough to be one of those people who was for occupational safety because we work with botulinum toxin. I was vaccinated," Shine said.

They only make BabyBIG every 5 years and Shine donated three times over 15 years before she aged out of being eligible to donate.

"It's probably the highlight of my career that I actually was able to participate in this project and donate plasma," Shine said.

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