Why Did the FDA Just Ignore Safety Signals on HPV Vaccine in Women Aged 26 to 45?


Last Friday, the FDA approved of HPV vaccination of older women – at the end of a week in which a blockbuster book came out that highlights serious issues with the HPV vaccine – including troubling safety signals that the FDA knows about.

Previously, the vaccine had been approved for use ages 9-26, although scant data exists on the efficacy and safety in 9-year olds.  The FDA extended the approved use into an age group (27 to 45 years old women), some of whom will now almost certainly feel the effects of FDA’s latest flawed approval by experiencing autoimmunity, paralysis and death.

What the FDA Knows We Now Know, Too

From the information submitted from Merck to the US FDA, it is apparent that the vaccine used in Protocol 018, the only study of the safety of the vaccine market group  (9-15 year-olds) used only one-half the standard AAHS dose in the formulation of the vaccine. Most of the protocols of 16-26 year-olds appear to have used the full dose of AAHS in the vaccine formulation and the 9-15 year-olds in the prior immunobridging study, which compared used 9-15 year olds and 16-26 year-olds, with no controls (merely to study antibody response), which used a full dose of AAHS. In addition, the 9-15 year old cohorts were boys and girls, so, small as they were, only about half the children were female.

They also know that for the new age group there is a likely increase in the incidence of cervical cancer following vaccination.  Through two years of sleuthing, the authors of the book “HPV Vaccines of Trial” found that Merck informed FDA of a group that experienced “negative efficacy” – that is, an increase in the rate of pre-cancerous lesions that could lead to cervical cancer, and that the data show that if a woman is already infected or has evidence of prior infection at vaccination, combined with real world co-factors like smoking, they risk a 44% greater chance of developing CIN 2/3 lesions or worse. (Examiner Article, webarchive)

Which age group is most likely to already have had infection?  Women over 26.

So, combined with the bombshell reveal that the product on the market is not the product that was tested, we now have the sad problem that women over the age of 26 will join the ranks of those already at risk of autoimmune disease, paralysis and death due to the HPV vaccine.

Misinformation Campaign Gets Worse

The press does not have the scientific acumen to know that their latest coverage claiming that Australia may “eliminate HPV” (New York Times, BBC) is based on a flawed modeling effort that assumes HPV vaccination confers lifelong immunity to HPV infection.  First, it does not confer lifelong immunity to the HPV types in the vaccine; second, many other types of HPV virus exist that are not targeted by the vaccine at all – including no cross-protection – that are also high-risk (see High-Risk Type Replacement)

I have just completed recording a lecture on HPV Virus, HPV Infection and the HPV vaccines, which will be available at cancercourse.com   Persistent infection appears to be a risk – and I have a hypothesis that vaccination of the most prevalent types allows the non-vaccine targeted types present in co-infection to flourish. You can preview the lecture slides at the IPAK website.

You can hear from all three authors of this extremely important book from Thursday’s Highwire Episode:


You can read the evidence yourself, see the submitted data, see the pseudo-science used by Merck to convince the FDA that the HPV vaccine is safe.  What is most unbelievable is that there are people who want to mandate this vaccine.  This vaccine’s time is up.

I would like to thank Kim Mack Rosenberg for checking the accuracy of the text in first paragraph.  For the full story, #readthebook.

HPV vaccine on trial


  1. The FDA’s actions make it obvious who they work for. Thanks for the heads up, James.

  2. Thank you for the High Wire link. Powerful episode. Especially damning statement from Dr. Lee, that (in the developed world) cervical cancer is virtually completely preventable or curable, that, in the U.S., a cervical cancer death under medical care is grounds for a malpractice suit.

  3. I’m so grateful for this article and for the book mentioned in this article. I just received my copy of the book in the mail today. Now, I am wondering what can we do about this? Will there be any repurcussions from this book for Merck/Gardasil? MERCK just announced their recommendation that men & women get this vaccine up through the age of 45? They just keep going in the opposite direction of what should be happening.

  4. James, thank you for your articulate and well informed information on this subject.

  5. Thank you for getting as much information out there about this vaccine. My daughter was injured from this vaccine ten years ago and it has devastated her life. She has pain throughout her body, POTS, her skin feels like it is burning many times, and her legs often give out while she is walking. Most of the doctors she has been to try to tell her that this is not from the vaccine and many have used the, “it’s all in her head” excuse. It is horrendous that this poison is still on the market and on top of it she no longer has any faith in doctors as they have been so horrible to her.

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