Confirming the safety characteristics of recombinant vectors used in veterinary medicine: a regulatory perspective.

Regulatory guidelines for experimental vaccines should encourage scientists in the biological industry to consider safety at the onset of product development. They should aid scientists to develop the necessary information to confirm conclusively the safety characteristics of the vaccine micro-organism. Moreover, these guidelines should be incorporated into a standardized regulatory process. Veterinary Biologics (VB) provides these guidelines in Summary Information Formats. These Summary Information Formats specify the relevant information to submit with a product licence application for conventional and recombinant vector vaccines. This paper compares two Summary Information Formats to demonstrate that, apart from the construction process, the information required to confirm the safety characteristics of conventional and recombinant vaccines is equivalent. A short discussion on the availability of established safety studies for experimental veterinary vaccines is included.