FOOD AND DRUG ADMINISTRATION

CENTER FRO BIOLOGICS EVALUATION AND RESEARCH

VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE

(VRBPAC)

Committee Questions and Discussions

March 15, 2005

Session 1 – Open Committee Discussion

1. Are the available data adequate to support the efficacy of Boostrix™ in individuals 10-18 years of age?

VOTE

2. Are the available data adequate to support the safety of Boostrix™ when administered to individuals 10-18 years of age?

VOTE

Discussion item:

Please identify any issues which should be addressed, including post-licensure studies.

Session II – Open Committee Discussion

1. Are the available data adequate to support the efficacy of ADACEL™ in individuals 11-64 years of age?

VOTE

2. Are the available data adequate to support the safety of ADACEL™ when administered to individuals 11-64 years of age?

VOTE

Discussion item:

Please identify any issues which should be addressed, including post-licensure studies.