Safety considerations for nucleic acid vaccines.

Whilst it is premature to formulate guidelines for the manufacturing requirements of a nucleic acid vaccine, it can never be too early to discuss and debate the issues surrounding the use of a novel biotherapeutic. The major safety issues posed by nucleic acid vaccination include the possibility of transformation (or tumorigenic) events in recipients of a DNA vaccine, the potential formation of anti-DNA antibodies, and unexpected and untoward effects of long-term expression of a foreign antigen. This paper examines the extent to which these points impinge on the safety of DNA vaccines.