Rabies Immune Globulin (Human) Treatment Demonstrated As Safe and Effective for Use in Children in First Pediatric Trial Study; Results Have Been Submitted to US FDA for Review

A treatment, known as KEDRAB (Rabies Immune Globulin [Human]), currently used in the prevention of rabies has been demonstrated to be safe and effective for patients age 17 and under. Results published online on February 10, 2021 in Human Vaccines & Immunotherapeutics report the first and only pediatric trial of any human rabies immunoglobulin (HRIG) currently available in the US. The open-access article is titled “Safety and Efficacy of Rabies Immunoglobulin in Pediatric Patients with Suspected Exposure.” Findings have been submitted to the US Food and Drug Administration (FDA) for review. In the United States, someone is treated for possible exposure to rabies every 10 minutes. Globally, the World Health Organization (WHO) estimates that rabies causes 59,000 human deaths annually in over 150 countries, with 95% of cases occurring in Africa and Asia—however, they concede it is likely a gross underestimate of the true burden of disease. The WHO also estimates that 40% of the global rabies disease burden occurs in children under 15 years of age, and that most encounters of the disease follow a dog bite. Once clinical symptoms appear; rabies is virtually 100% fatal. The current treatment for previously unvaccinated people potentially exposed to rabies is called rabies post-exposure prophylaxis (PEP), which includes thorough wound washing, passive neutralization of the virus with infiltration of human rabies immune globulin (HRIG) into and around the wound site, and a series of 4 doses of rabies vaccine given over a 2-week timeframe. And in this latest study carried out by a team of international experts from the US and Israel, KEDRAB® (HRIG150) has become the first HRIG shown to be safe and effective in children when administered promptly and properly as part of the rabies PEP process.
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