Success Stories
BabyBIG®: A Public Health Collaboration
Client:
California Department of Public Health (CDPH)Challenge:
- Infant botulism is a life-threatening illness that hospitalizes approximately 80-110 babies annually in the U.S.
- The one available treatment, BabyBIG®, has for the past 20 years been made from hyperimmune plasma donated by volunteers immunized with pentavalent botulinum toxoid.
- The investigational pentavalent botulinum toxoid is no longer available, and there is no currently FDA-licensed botulism vaccine.
Solution:
- CSC’s DynPort needs to develop supporting data for one of our vaccine programs.
- The California Department of Public Health needs to investigate opportunities that will boost immunity to botulinum toxin in previous plasma donors to provide hyperimmune plasma for ongoing BabyBIG® production.
- DynPort and CDPH are working together to benefit both programs.
Results:
- The CDPH goal is to ensure a steady supply of donor plasma to produce BabyBIG®, meeting an important medical and public health need.
- Babies diagnosed and treated with BabyBIG® for infant botulism are expected to recover completely.
- It is important that CDPH maintain the BabyBIG® supply because CDPH is the only source in the world for this public service orphan drug.
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More infoInfant Botulism Treatment and Prevention Program, CDPH
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BabyBIG® is designated as an orphan drug by the FDA, because it is expected to treat less than 200,000 people in the U.S. each year.FDA: Developing Products for Rare Diseases and Conditions
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ArticleNew England Journal of Medicine - Human Botulism Immune Globulin for the Treatment of Infant Botulism (PDF, 190K)
A Microscopic Threat
Although foodborne botulism receives more media attention, the most common form of human botulism in the United States is infant botulism, with approximately 80 to 110 cases occurring each year in the U.S. (CDC, 2011). Approximately 95% of its victims are less than 6 months old. Most infants are thought to contract botulism by swallowing microscopic dust particles that carry the botulism spores, which then activate in the large intestine. These spores are everywhere, but babies are particularly vulnerable because the flora (“microbiome”) in their large intestines has not fully developed. The only known way to prevent infant botulism is to avoid feeding honey—an avoidable food reservoir of the causative botulism spores—to infants younger than 12 months of age.
A Treatment in Jeopardy
Although it is difficult to prevent, infant botulism can be treated. Botulism Immune Globulin Intravenous (Human) (BIG-IV), better known as BabyBIG®, was approved by the U.S. Food and Drug Administration (FDA) in 2003. BabyBIG® is manufactured from purified human-derived botulism antitoxin antibodies obtained from plasma donated by volunteers immunized with the now out-of-production investigational pentavalent botulinum toxoid. With no currently licensed botulism vaccine, manufacture of BabyBIG® is in jeopardy; plasma donors need booster shots to maintain enough antibodies for BabyBIG® production.
Collaborating for Public Health
Dr. Stephen Arnon of the California Department of Public Health (CDPH) Infant Botulism Treatment and Prevention Program contacted DynPort Vaccine Company LLC, a CSC company, regarding a possible collaboration. Through mutual agreement, the CDPH and DynPort will investigate boosting anti-botulinum antibodies in plasma donors which, if successful, will enable the continued manufacture of BabyBIG®. Through this collaboration, DynPort may be able to help support two divergent—yet vital—public health initiatives.
References
Arnon SS, Schechter R, Maslanka SE, Jewell NP, Hatheway CL. Human Botulism Immune Globulin for the Treatment of Infant Botulism. N Engl J Med. 2006; 354;5;462-471. (PDF, 190K)
Koepke R, Sobel J, Arnon SS. Global Occurrence of Infant Botulism, 1976 2006. Pediatrics. 2008;122;e73-e82. (PDF, 967K)
U.S. Centers for Disease Control and Prevention. National Enteric Disease Surveillance: Botulism Annual Summary 2010. 2011, Dec. (PDF, 522K)
The safety and efficacy of this product in humans has not been established. The product is currently under clinical investigation and has not been licensed by the FDA. This work was funded in part by CBMS-JVAP, DoD Contract DAMD17-98-C-8024 and does not represent official DoD positions, policies or decisions.