Pediatric Advisory Committee Meeting
December 7, 2010
Michael Nguyen, MD
FDA Center for Biologics Evaluation and Research
Office of Biostatistics and Epidemiology
New Context for Vaccine Safety Surveillance
• Introduction of large-scale US adolescent immunization program
– Between May 2005 and June 2006, 3 new vaccines for adolescents
– Menactra, Boostrix/Adacel (2005); Gardasil (2006)
– Creation of 11–12 year-old routine vaccination platform
• New safety surveillance challenges
– New background of adolescent diseases
– Limited knowledge of baseline incidence
–New concomitant medications (contraceptives), disease modifiers (smoking)
• Unique issues
– HPV sexually transmitted; Gardasil had female-only indication (initially)
– Existing and successful cervical cancer prevention program
– Difficult messaging
• Prophylactic / not therapeutic
• Efficacy against subset of oncogenic HPV types
• Lag between infection and cancer onset
– Rapid inclusion into school-entry mandates
• Stimulated reporting for Gardasil
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