FOOD AND DRUG ADMINISTRATION
CENTER FRO
BIOLOGICS EVALUATION AND RESEARCH
(VRBPAC)
Committee
Questions and Discussions
March 15, 2005
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.
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.