To Expand or Not Expand–That's the Question....Will FDA Approve Merck’s 4th Request to Expand Gardasil?

Research submitted to the Center for Biologics Evaluation & Research (CBER) on Monday October 25, 2010 related to the adverse effects of the HPV Vaccines. Will the FDA respond?

Dec 06, 2010 – Leslie Carol Botha and Cynthia Ann Janak prepared an extensive power point for the FDA on HPV Vaccines Mechanisms of Action in Women – Endocrine Influence, HPV – Pre Testing and Immune System Involvement. The document was submitted to the Center for Biologics Evaluation & Research (CBER) on Monday October 25, 2010.

The information included in the presentation has implications not only for female adolescent health – but for women ages 26 to 45 and older who may be the next age group for HPV vaccination approval.

December 3, 2010 – HPV Vaccine VAERS reports (women ages 9 to 26)

20,575 adverse reactions
352 reports of abnormal pap smears post vaccination.
89 reported deaths – plus 5 reports submitted to the FDA, missing from VAERS, uncovered via the Freedom of Information Act (FOIA) by Judicial Watch

Botha and Janak’s intent is to provide research and data to support the hypothesis that the HPV vaccines may even be more dangerous in an older age group with hope of preventing FDA approval of Merck’s 4th request to expand Gardasil use to older women.

The FDA declined to make a comment about the research presented - nor did they choose to listen to a verbal presentation – nor did they attempt to answer any questions raised by the research presented. Instead Botha and Janak were told via email: The CBER team thanks you for the additional information since the last listening session. At this point, they do not want to have any additional listening sessions, and instead will answer in writing any questions you may have.

Botha and Janak did respond with one additional question:

With the additional information that was presented will the CBER review team be looking at the possibility of suspending the license of the HPV vaccines pending further safety review?

Although acknowledgment was received that the question would be forwarded to CBER, a response has yet to be received.

HPV Vaccine Mechanisms of Action in Women has been converted to a 63 page PDF file (may take some time to download) filled with research and documentation on issues not considered during HPV vaccine clinical trials – nor in any other vaccine or medical trial for that matter.

With all of the studies coming out about the relevance the endocrine system has to women’s health – it is time that the menstrual cycle be given its due as the regulating system in a woman’s body.

Botha and Janak raised the following issues/questions in the HPV Mechanisms of Action Presentation: (Research, data, documentation and corresponding links are documented in the PDF file.)

To read the full story, go to http://sanevax.org/blog/?p=1286.

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