Postmarketing surveillance of rabies vaccines for dogs to evaluate safety and efficacy.

V accination of dogs against rabies began with Louis Pasteur and his colleagues in 1884. 1 Mass vaccination of dogs against rabies, however, did not begin until 1919 with a phenol inactivated vaccine developed in Ja-pan. 2 This same product was introduced for use in the United States in 1922. 3 Since then, various types of rabies vaccines for animal use have been licensed by the USDA CVB. These products are an important component of rabies control programs that have resulted in a substantial decline of rabies in dogs throughout the world and the elimination of canine variants of rabies in the United States. The number of laboratory-confirmed cases of rabies in dogs in the United States has decreased from 5 Currently, 14 rabies vaccines are labeled for use in dogs. These vaccines must meet the standard requirements established in the Title 9 Code of Federal Regulations. This requires that the vaccine provide a protected fraction of ≥ 83% when comparing vaccinated animals versus control animals. Also, all rabies vaccines are evaluated for safety prior to licensure, which includes performance of a field safety trial. Additionally , each serial of rabies vaccine is tested for potency by use of the National Institutes of Health potency test or another test approved by the CVB and is tested for safety in host and laboratory animals. Although the CVB licenses veterinary biological products for use in the prevention of rabies, state and local authorities govern and administer their respective rabies animal control programs. Some of these programs allow exemptions to the vaccination requirements if medical concerns exist related to potential adverse events. Postmarketing safety and efficacy information regarding rabies vaccines for dogs from April 1, 2004, through March 31, 2007, is summarized and reported here. The findings represent information collected from spontaneous field reports of adverse events. Data were received from multiple sources by use of nonstandard-ized methods of collection. The findings and conclusions in this report are those of the authors and do not necessarily represent the views of their agencies. Address correspondence to Dr. Frana. provide useful information for veterinarians and program administrators to aid in the implementation of rabies animal control programs. Safety Review Before licensure, a product must be shown to be safe through a combination of safety evaluations. The field safety trial is the most comprehensive evaluation and has the objective of assessing the safety of the product …