VRBPAC Background Document Gardasil™ HPV Quadrivalent Vaccine May 18, 2006 VRBPAC Meeting
- 1. FDA
Vaccine and Related Biological Products Advisory Committee (VRBPAC) discussion on the results submitted for the biologics license application (BLA) from the clinical development program of Gardasil® for prevention of HPV diseases in females. This important background document providing unpublished results was obtained in 2008 by the nonprofit organization Judicial Watch through a Freedom of Information Act (FOIA) request (http://www.judicialwatch.org/documents/2008/JWReportFDAhpvVaccineRecords.pdf).
While the vaccine showed a near 100% efficacy in preventing CIN 2+ associated with HPV 16 and 18, the result for all high-risk HPV-associated CIN 2+ was dramatically below the 70% expected by the vaccine manufacturer. In fact, the result for the “per protocol” analysis was only 16.9%, and did not reach statistical significance. These results had never been published before, despite their importance; although the FOIA filed by Judicial Watch made these very relevant data available to the public and to the medical and scientific community, they never made it to be part of the conversation around HPV vaccines efficacy.