1434214
doi
10.5281/zenodo.1434214
oai:zenodo.org:1434214
VRBPAC Background Document Gardasilâ„¢ HPV Quadrivalent Vaccine May 18, 2006 VRBPAC Meeting
VRBPAC
FDA
info:eu-repo/semantics/openAccess
Creative Commons Attribution 4.0 International
https://creativecommons.org/licenses/by/4.0/legalcode
HPV vaccine
Gardasil
Approval
VRBPAC
FDA
<p><strong>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.</strong> This important background document providing unpublished results was obtained in 2008 by the nonprofit organization Judicial Watch through a Freedom of Information Act (FOIA) request (<a href="http://www.judicialwatch.org/documents/2008/JWReportFDAhpvVaccineRecords.pdf">http://www.judicialwatch.org/documents/2008/JWReportFDAhpvVaccineRecords.pdf</a>).</p>
<p>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. </p>
Zenodo
2006-05-18
info:eu-repo/semantics/other
1434213
1554819463.57353
336111
md5:2b5de26a52e2b3847a126873842d96aa
https://zenodo.org/records/1434214/files/2006-VRBPAC_Background_Document-4222B3.pdf
public
10.5281/zenodo.1434213
isVersionOf
doi