FDA releases Gardasil documents

Discussion at Thursday's meeting of FDA's Vaccines and Related Biological Products Advisory Committee is likely to focus on recommendations for the use of Gardasil human papillomavirus vaccine from Merck (MRK), including the appropriate age for immunization. According to briefing documents released Wednesday, the committee also will be asked to discuss a trend toward an increased rate of stage 2/3 cervical intra-epithelial neoplasia (CIN 2/3) in women who were infected with HPV when they received Gardasil. It also will be asked to discuss the degree to which HPV types not contained in the vaccine might offset its clinical effectiveness. Gardasil is a recombinant vaccine against HPV types 6, 11, 16 and 18.

The agency also plans to ask for a discussion of five congenital anomalies among infants born to women who were vaccinated with Gardasil near the time of conception. MRK reported that there is no causal relationship between the vaccine and birth defects. ...