VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE

 

May 16-17, 2001

Holiday Inn, 2 Montgomery Village Avenue, Gaithersburg, Maryland

 

QUESTIONS FOR THE COMMITTEE

 

 

Wednesday, May 16

 

Session 2 Open Session

1. Please discuss OVRR/CBERs approach in considering potential risks for the use of 293, PER.C6 and other similar "designer cell substrates" for the production of viral vaccines, including:

  1. Tumorigenicity
  2. Residual cell substrate DNA
  3. Possible contamination with adventitious (including oncogenic) agent testing

 

2. Please discuss any other safety concerns that should be addressed prior to initiating larger-scale human studies.