NEWS | Dec. 2, 2019

Recombinant Botulinum Vaccine Generates Antibodies That Save Infants' Lives

By Press Release

The JPM CBRN Medical approved an agreement on 14 January 2013 between Dynport Vaccine Company (DVC) and the California Department of Public Health (CDPH), authorizing DVC to provide the CDPH with the JPM CBRN Medical's recombinant Botulinum A/B (rBV A/B) vaccine, to generate hyperimmune plasma for the production of Human Botulism Immune Globulin Intravenous (BIG-IV, BabyBIG®).BabyBIG® is an FDA-approved orphan drug (a drug developed to treat rare medical conditions) consisting of human-derived anti-botulism toxin antibodies for the treatment of infant botulism types A and B, a disease with high mortality even when treated with the current standard of care (ventilator support, complemented with other conventional life-supporting measures).The administration of rBV A/B antibodies neutralizes the toxin, demonstrating the vaccine’s effectiveness in humans, confirms its mechanism of action, and supports licensure. The BabyBIG® produced using the rBV A/B vaccine is performing well and has been utilized in 381 laboratory-confirmed cases of infant botulism in 40 states, the District of Columbia, and seven additional countries.

Photo caption: Mia (pictured) contracted severe infant botulism at the age of only five weeks old. After initial misdiagnosis, which led to paralysis and respiratory distress, she was placed on a ventilator. Mia’s parents were losing hope their baby girl would survive; however, thanks to an infectious disease specialist who reached out to the California Department of Public Health, Mia received BabyBIG® antibodies produced with the rBV A/B vaccine. Within 24 hours, her eyelids, which had been closed for 3 straight days, opened, and her parents saw hope in those tiny eyes. Today, Mia is an active and energetic toddler!

OUTCOME: Success of the BabyBIG® booster immunization confirms the mechanism of action and effectiveness of the recombinant Botulinum A/B vaccine. Botulinum toxin is the most poisonous biological substance known. Just as BabyBIG® has saved the lives of infants, rBV A/B will save the lives of our warfighters.