Boostrix, Adacel Seek Approval Based On Studies Comparing Infants And Adolescents
This article was originally published in The Pink Sheet Daily
FDA vaccine advisory committee will meet March 15 to review the Tdap boosters from GlaxoSmithKline and Sanofi Pasteur. The products are intended to address the rising incidence of pertussis. Applications rely on trial design recommended by the committee in 1997.
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Advisory panel members urge postmarket monitoring for GSK and Sanofi Pasteur boosters in patients who received full series of acellular pertussis vaccines as children, given that the studies were conducted in patients who received whole-cell vaccines. Committee endorses “effectiveness,” but offers no opinion on “efficacy.”
FDA is clarifying that it expects sponsors to provide analysis of efficacy data rather than simply a summary of clinical data as part of the integrated summary of effectiveness in new drug applications