Regulatory issues relating to the use of recombinant vectors in production of human vaccines.

Vectored vaccines for human use are biological products and are regulated by The Center for Biologics Evaluation and Research (CBER). In terms of regulation, there is nothing unique to vectored vaccines. Adequate regulations are already in place to enable CBER to evaluate vectored vaccines. Vectored vaccines bring together aspects of many other product classes. These vaccines include purified recombinant proteins, those in which the vector is inactivated or live, and <> DNA. Regulatory issues common to all these vaccine types as well as those issues specific to each type are discussed.