Overview of Rabies Vaccine Supply 2005 C E

Overview of Rabies Vaccine Supply - 2005 C. E. Rupprecht Centers for Disease Control & Prevention USA

Rabies Vaccine Supplies - Objectives - Describe current situation - Propose partial near term solutions - Discuss future strategies

Animal Rabies in the USA is Common (n=7560*) * Current 5 year mean value Usually 1 -3 human cases per year

Human Rabies Via Transplanted Organs/Tissues – May/June 2004 Lung (died during surgery) Liver Donor Kidney Arterial Graft

Rabies is Episodic: Human Exposures To A Suspect Sheep – July, 2004 At a petting zoo more than ~600 persons were exposed to Cybill, a mature ewe (unvaccinated)… Non-specific inclusions

Canine Rabies Translocations, 2004 June May Laredo, March

Rabies Continues to Evolve: Flagstaff, AZ, 2004 -2005 A rabid skunk was reported in August and a gray fox during September with bat virus characteristics… A previous outbreak in skunks (N=19) during 2001 was mediated by bat (Western Eptesicus fuscus) rabies…

Rabies Prophylaxis - Wound care - Immune globulin (20 IU/kg) -Vaccination (days 0, 3, 7, 14, 28) 20, 000 -40, 000 exposures per year Estimated costs: $1200 -$1500/per course

Rabies Biologicals 3 Vaccines: - HDCV - PCEC - RVA 2 Immune globulins: -Bayrab -Imogam

Human Rabies Vaccine Recall - March, 2004 CDC and the FDA were notified that a quality-assurance test of IMOVAX® Rabies Vaccine (Aventis Pasteur, Swiftwater, Pennsylvania) identified the presence of noninactivated Pitman-Moore rabies virus in a single product lot. The vaccine lot containing noninactivated virus was not distributed. As a precautionary measure, Aventis Pasteur initiated a voluntary recall of lots produced during the same period, with an expectation of additional vaccine availability in 2005…

Rabies Vaccine Needs Consideration of RV stockpiles Development of emergency INDs Resolution of indigent concerns Renewed discussions w/FDA Advocacy for research on RV biologicals