VRBPAC January 25, 2007

Questions and Discussion items for the morning session:

1. Are the available data adequate to support the safety of four doses of Pentacel administered at 2, 4, 6 and 15-18 months of age?

(Voting Item)

If the available data are not adequate, what additional data are needed?

2. Please discuss whether the available data are adequate to support the efficacy of:

a) The diphtheria, tetanus and polio components of Pentacel,

b) The Hib (PRP-T) component of Pentacel, and

c) The pertussis component of Pentacel.

Are the available data adequate to support the efficacy of Pentacel?

(Voting Item)

If the available data are not adequate, what additional data are needed?

3. If Pentacel is licensed, please identify any issues which should be addressed in post-licensure studies.