FDA Briefing Document - Vaccines and Related Biological Products Advisory Committee Meeting

[link to www.fda.gov]

This meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) is being held to discuss the use of cell lines derived from human tumors as substrates for the production of preventive viral vaccines.
Over the last decade, it has become clear that the current repertoire of cell substrates is inadequate to manufacture the next generation of viral vaccines (i.e., certain viruses cannot be propagated or grow poorly in the available cell lines). Therefore, manufacturers have submitted additional cell lines to the FDA for consideration for use in the production of viral vaccines. All of the new mammalian cell lines being considered are immortal, having been transformed by various oncogenes or are spontaneously immortalized, and some are derived from human tumors. Over the last 15 years, when new types of cell substrates have been proposed, starting in 1998, CBER has presented its review approach to the Advisory Committee to address the issues raised first by the use of immortalized mammalian cell lines and then tumorigenic cell lines. The purpose of those discussions with the Advisory Committee was to obtain their input and to make public a discussion of the issues. This current VRBPAC meeting is a continuation of this process.
To date, only a limited number of preventive vaccines made in tumorigenic cell lines have entered clinical trials. Some live-vector vaccines made in laboratory-immortalized human cells have entered clinical trials (VRBPAC 2001), as have some inactivated vaccines manufactured in non-human tumorigenic cell lines (VRBPAC 2005). However, tumor-derived cell lines have not been used for production of prophylactic vaccines (see Section 2 for definitions). The purpose of the present VRBPAC meeting is to discuss the scientific issues associated with the use of cell lines derived from human tumors for the production of both live and inactivated prophylactic viral vaccines and to identify safety concerns and determine how they can be addressed.

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