Genetically engineered vaccines for control of Aujeszky's disease (pseudorabies).

A gene-deleted pseudorabies (PR) (Aujeszky's disease) vaccine, named OMNIVAC-PRV, was licensed by the United States Department of Agriculture-Animal and Plant Health Inspection Service (USDA-APHIS) on January 16, 1986, the first recombinant DNA-derived modified-live virus vaccine to be licensed for manufacture and sale anywhere in the world. Two months later, a second generation gene-deleted 'marker' vaccine, OMNIMARK-PRV, was described. Surprisingly, these landmark applications of genetic engineering to vaccine development triggered a brouhaha and a lawsuit (ultimately dismissed by Federal District Court Judge Thomas Hogan) as well as a Congressional Hearing on the adequacy of USDA regulatory procedures for the licensing of supposedly 'dangerous' recombinant DNA-derived products. Thus, its is rather gratifying that only 4 years later, a consensus of government, industry, veterinarians and the scientific community has developed, affirming that the recombinant DNA-derived vaccines were in fact a major breakthrough for pseudorabies (PR) control and eradication, and that without the advantages of gene-deleted vaccines, plans for PR eradication would not be practical.