Antitoxin, Baby BIG (Botulism Immune Globulin)

The California Department of Health Service and the Massachusetts Public Health Biologic Laboratories jointly developed Baby BIG (Botulism Immune Globlulin) antitoxin to treat infants infected with infant botulism. In adults and older children, botulism infection is the result of ingesting food containing botulinum toxin produced by botulism bacteria growing in food. Infant botulism on the other hand, occurs when babies ingest bacterial spores and the bacteria colonize their large intestines. The disease is rare enough to have qualified for “orphan disease” status in 1989, which helped provide funding for the development of Baby BIG.

While botulism antitoxin has been produced commercially in the United States since 1940, using it to treat infants carried risks. Historically, antitoxin was derived from the blood serum of horses who had been injected with the botulinum toxin. Blood serum from these inoculated horses contained protective antibodies, which when injected into infected humans worked as an immune-response boosting antitoxin. (For more on equine botulism antitoxin see object 2001.0131.02 Vial, botulism anti-toxin.) Although generally successful in treating botulism, the horse-derived antitoxin serum sometimes induced allergic responses or serum sickness in patients, a complication that could be particular harmful for already ill infants.

For this reason, doctors preferred to use human-derived rather than horse-derived serum in the treatment of infants. Human-derived serum was first developed by the U.S. Army in the late 1970s and became available for public use in the early 1980s. With the start of the Gulf War, however, the military source of the antitoxin dried up as reserves were diverted to prepare for possible biological warfare attacks. In 1991 the California Department of Health Service and the Massachusetts Public Health Biologic Laboratories began work to develop their own human-derived botulism antitoxin. CDHS collected blood plasma from volunteers on its staff, who had already been inoculated against botulism for workplace safety. Their antibody-rich blood plasma formed the basis of the drug Baby BIG, which the FDA gave final approval for commercial sale for the treatment of infant botulism in 2003.

“Human Botulism Immune Globulin for the Treatment of Infant Botulism.” Stephen S. Arnon et al. New England Journal of Medicine. Vol. 354, No. 5. 2 February 2006. p.462.

“Creation and Development of the Public Service Orphan Drug Human Botulism Immune Globulin.” Stephen S. Arnon. Pediatrics. Vol. 119, No. 4. 4 April 2007.

“Summary Basis of Approval: Botulism Immune Globulin Intravenous (Human) (BIG-IV)” U.S. Food and Drug Administration.

http://www.fda.gov/downloads/biologicsbloodvaccines/bloodbloodproducts/approvedproducts/licensedproductsblas/fractionatedplasmaproducts/ucm117169.pdf

“Frequently Asked Questions (FAQs) about Infant Botulism.” Infant Botulism Treatment and Prevention Program, Division of Communicable Disease Control, California Department of Public Health. http://www.infantbotulism.org/

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