Genital Warts Vaccine Tested on Infants

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February 28, 2017 | 43,528 views

Story at-a-glance

  • In a trial sponsored by the National Institute of Child Health in Hungary, in collaboration with Merck, researchers are testing the 4-valent Gardasil vaccine in children to treat recurrent respiratory paillomatosis (RRP), a rare childhood disease caused by HPV
  • Initially the study was to enroll children as young as 1 year old with RRP and administer three doses of HPV vaccine to “assess response to vaccination,” but recent study details indicate the tests are ongoing in children as young as 28 days old
  • The study’s status remains unknown, as it has not yet been reported as completed

By Dr. Mercola

Human papillomavirus (HPV) vaccines, marketed under the brand names Gardasil and Cervarix, are among the most controversial vaccinations offered in the U.S. — and the controversy, it appears, is only slated to get worse.

Gardasil vaccine, manufactured by Merck, was fast-tracked to the U.S. market in 2006, without adequate evidence for safety and effectiveness in children. It was only studied in fewer than 1200 girls under 16 years old, who were followed up for about two years, before it was licensed by the Food and Drug Administration (FDA).1

The vaccine was originally touted as an anti-cervical cancer vaccine that should be given to all girls and women aged 9 to 26 years old, despite the fact it was rushed to licensure without first proving that it actually prevented cervical cancer, especially when given to pre-adolescent girls.2

Within five years, U.S. public health officials broadened HPV vaccine recommendations to include all pre-adolescent boys as well, in order to target cancers of the penis, anus and back of throat.3

Originally the U.S. Centers for Disease Control and Prevention (CDC) recommended a three-dose HPV vaccine regimen, but in October, 2016, the CDC changed its recommendation to two doses for girls and boys aged 9 to 14 years old to be given six months apart.

The CDC still recommends that three doses be given to females and males who get the vaccine between the ages of 15 and 26 years old.4

Since sexual contact with an infected person is a high-risk factor for both hepatitis B and HPV, public health officials maintain that hepatitis B and HPV vaccines need to be given to children before they become sexually active.

It is thought that sometimes pregnant women with active HPV infection that has not been cleared can transmit HPV to their newborns during the birth process.5

This may be why there has been speculation that HPV vaccines may one day be recommended for much younger children, even infants, similar to the hepatitis B vaccine, which is given to newborns in hospital nurseries before hospital discharge.6

Authors of a 2012 article published in the medical journal, Vaccine, called for a "reframing" of global cervical cancer prevention policies and stated:

"On a global scale, vaccination of newborns and infants is well established and has developed a successful working infrastructure.

The hepatitis B virus (HBV) vaccination programs offer a model for HPV introduction in which newborn and infant immunization achieves a rapid reduction in the prevalence of the HBV carrier rates in immunized cohorts of children, and of liver cirrhosis and liver cancer decades later."7

Was the HPV Vaccine Tested on Newborns?

In a clinical trial sponsored by the National Institute of Child Health in Hungary in collaboration with Merck, researchers indicated in 2014 they were going to test the original 4-valent Gardasil vaccine to treat recurrent respiratory papillomatosis (RRP), a rare disease in children caused by HPV types 6 and 11, which also cause genital warts.

The study was designed to enroll children as young as 1 year old with RRP and administer three doses of the HPV vaccine to "assess response to vaccination."8 The trial was first registered with the U.S. government's clinical trial database in November, 2013, with an estimated completion date of February, 2017.

Its status has not been updated in the U.S. since it was first registered; however, a check with the European Union Clinical Trials Register shows that the trial, conducted with Silgard — the European version of Gardasil — is now underway with 20 children ages 28 days to 17 years old.9

It is unknown whether Merck's original plan was to eventually get Gardasil licensed for infants and added to the CDC's infant vaccination schedule, even before the vaccine was licensed in 2006 for children as young as 9 years old.

But it is interesting to note that the first Gardasil vaccine contained four HPV types — two associated with cervical and other genital cancers (types 16 and 18) and two associated with genital warts and respiratory infections, including RRP10 (types 6 and 11).

There are over 100 types of HPV and 40 types are sexually transmitted, but only about a dozen of these types are associated with cancer11 — and HPV types 6 and 11 that cause genital warts and RRP do not cause cancer.12

In 2014, the FDA approved Merck's new Gardasil vaccine that contains 9 HPV types, stating that, "Gardasil 9 has the potential to prevent approximately 90 percent of cervical, vulvar, vaginal and anal cancers."13

Gardasil vaccine was originally marketed as a vaccine that should be given to young girls to prevent HPV infection that could lead to cervical cancer later in life.

So why would Merck include two HPV strains not linked to cancer, unless, as a writer for Vaccine Impact News, Marcella Piper-Terry, put it, "this was planned from the beginning?"14

Why Vaccinate Newborns Against a Sexually Transmitted Disease?

Even if you overlook the potential for adverse effects from HPV vaccination,15 which have been widely reported since Gardasil vaccine was first licensed,16 as explained below, the practice of vaccinating infants for diseases for which the vast majority of infants are at low risk for contracting, deserves careful scrutiny.

Such is the case with the hepatitis B vaccine, which is recommended to be given starting at birth. Three hepatitis B shots are part of the standard government-recommended childhood vaccination schedule, with the third dose to be given before 18 months of age.

But hepatitis B is a primarily blood-transmitted adult disease associated with risky lifestyle choices such as unprotected sex with multiple partners and intravenous drug use involving sharing needles — it is not primarily a "children's disease" or one that is a common threat to newborn babies (unless the infant is born to a hepatitis B-infected mother who has not been screened for infection prior to giving birth, which rarely happens in U.S. hospitals).

The practice of giving hepatitis B vaccine to infants and young children becomes even more questionable in light of research that shows that, by the time a child reaches his or her teenage years — the time when acquiring a hepatitis B infection may be more likely — the protection from hepatitis B shots given in early childhood may have long since waned.17

For the HPV vaccine, at this point studies have only followed individuals vaccinated as adolescents for 10 years,18 so it's unknown whether HPV vaccine given in infancy would remain effective by the time a child reaches adolescence and beyond — again, the time when the most common means of transmission of the virus is sexual.

Dr. Diane Harper, an HPV vaccine researcher who was involved in the early studies of both Gardasil and Cervarix, has since spoken out that the vaccines are being oversold.19 In 2008 she told The New York Times:20

"Merck lobbied every opinion leader, women's group, medical society, politicians, and went directly to the people — it created a sense of panic that says you have to have this vaccine now.

Because Merck was so aggressive, it went too fast. I would have liked to see it go much slower."

Despite admitted concerns that vaccinating newborns against HPV may offer them little or no protection as teenagers, the study published in the journal Vaccine in 2012 still touts "vaccination of newborns and infants" as a way to expand the use of HPV vaccines for "global HPV immunization."21

Not surprisingly, as Gaia Health pointed out in a commentary on the Vaccine study, it was funded by European government health agencies, and a number of the study's authors were employed by universities and organizations or companies financially associated with vaccine manufacturers.22

Gardasil's Effectiveness Questioned

It's also important to understand that both Cervarix's and Gardasil's effectiveness has been seriously questioned since nearly the beginning.

To start, the endpoints for proof of HPV vaccine effectiveness in prelicensure clinical trials, Gardasil and Cervarix, were CIN2/3 — cervical dysplasia and precursors for cancer — not cancer.23 The truth is this vaccine is being sold on an assumption that it'll prevent cancer.

What's more, because cervical cancer rates are already so low in the U.S., according to Harper, it will take vaccinating at least 70 percent of the entire eligible population for 60 years before we see any circumstantial evidence of a decrease in cervical cancer rates due to the vaccine.24

Considering that recent studies show that only 28 percent of U.S. boys and 42 percent of girls ages 13 to 17 years old had been fully vaccinated in 2015,25 it's going to be a long, long time before anyone knows if this vaccine actually prevents cancer — and that's presuming that the girls will continue to get lifelong Pap smears.

Further, in 2012, a systematic review of HPV vaccine pre- and post-licensure trials concluded "optimism regarding HPV vaccines' long-term benefits appears to rest on a number of unproven assumptions (or such which are at odds with factual evidence) and significant misinterpretation of available data."26

Also in 2012, research revealed that the HPV vaccine reduced HPV type-16 infections by only 0.6 percent in vaccinated women compared to unvaccinated women — and data showed other high-risk HPV infections were diagnosed in vaccinated women 2.6 percent to 6.2 percent more frequently than in unvaccinated women.27

There are also suspicions that Gardasil HPV vaccine might paradoxically increase your risk of cervical cancer if you are actively infected at the time of vaccination. Further, 60 percent of women who received the Gardasil vaccine in one study had a higher risk of being infected with another type of HPV.28

If You Get Regular Pap Smears, Gardasil Is of Little or No Benefit for Cervical Cancer Prevention

Perhaps the most compelling fact of all, however, is that more than 90 percent of HPV infections are asymptomatic and clear up on their own, usually within six months to two years of infection.29

For example, only 5 percent of HPV infections persist and become chronic, usually in individuals with high risk factors. Women at high risk for cervical cancer include those who do not get regular pap screening, who have an HIV infection, who smoke, who have multiple sex partners, who have a long-term use of oral contraceptives and who are immunosuppressed.30

The point is without regular Pap testing to detect pre-cancerous cervical lesions that can be identified and treated, these lesions can progress to cervical cancer in about half of women within 30 years — if they're left untreated.31

In developed countries, pap screening programs have reduced the incidence of cervical cancer significantly. Among women who get regular pap smears, Harper stated, the benefit of HPV vaccines focuses on individual abnormal pap test reduction, not cancer prevention.32 In a review of Gardasil published in the Journal of Vaccines & Vaccination, Harper and colleagues wrote:33

"Gardasil can only offer women participating in [pap] screening programs a 10 percent reduction in abnormal Pap tests with a resultant 20 percent decrease in colposcopies and a 42 percent decrease in treatments."

Gardasil Vaccine Linked to Neuroinflammation and Autoimmune Reactions

Health problems associated with the Gardasil vaccine include immune-mediated inflammatory neurodegenerative disorders, suggesting that something is causing the immune system to overreact in a detrimental way — sometimes fatally. In fact, at the 4th International Vaccine Conference presented by the National Vaccine Information Center in 2009, Harper reported that researchers by then already knew of at least 32 deaths connected to Gardasil, 20 of which were verified.34

A growing body of medical literature also demonstrates that the HPV vaccine is linked to nervous and immune system disorders in some young women and girls. Its safety is so questionable that Japan no longer recommends Gardasil.35 In July 2016, a study published in Immunologic Research showed that the aluminum adjuvant and HPV antigens in Gardasil caused behavioral changes in mice, as well as triggered neuroinflammation and autoimmune reactions.36

Pre-licensure clinical trials of Gardasil, which contains an aluminum adjuvant, used an aluminum containing "placebo" as a control, rather than using a true placebo. The 2016 study compared the reactivity of Gardasil against a true placebo. The study was first published in the journal Vaccine in January, 2016, but was withdrawn due to supposed concerns about the paper's "scientific soundness."37

However, when the paper was republished five months later in Immunologic Research, the findings remained the same. Study co-author Lucija Tomljenovic blamed pharmaceutical lobbying for why the study may have received such intense criticism that it was withdrawn by Vaccine. According to the National Post:38

"The reason for 'temporarily' removing our paper may be this: [I]f it was to be wildly circulated it would deprive the world of these allegedly 'life saving' cervical cancer vaccines, and as a result 'millions of women' would surely die … "

Another primary issue here is that no properly performed safety studies were done on Gardasil pre- or post-licensure and, by that, I'm referring to well-designed safety studies that are not corrupted by using toxic placebos, such as another vaccine or aluminum adjuvant, rather than a truly inert placebo. And, knowing that, how can such vaccines be promoted to or even tested on a child population, especially infants at their most vulnerable point in life: at birth?

In the end, basic good nutrition and safe-sex practices and hygiene principles are excellent HPV preventive measures. Optimizing vitamin D and avoiding sugar, along with using condoms, have a far more dramatic effect in maximizing robust immune function and preventing illness, including sexually transmitted HPV infections from which most people naturally recover, without needing medical intervention.

[+]Sources and References [-]Sources and References

  • 1 New York Times. July 18, 2006
  • 2 NVIC. June 27, 2006.
  • 3 Pediatrics. November 2015.
  • 4 Centers for Disease Control. Oct. 19, 2016.
  • 5 Clinical Infectious Diseases. Human Papillomavirus Vertical Transmission: Review of Current Data. February 7, 2013
  • 6 Centers for Disease Control. February 2016.
  • 7 Vaccine. 2012.
  • 8 ClinicalTirals.gov
  • 9 A Phase III, Single-center Clinical Trial to Evaluate the 4-valent HPV Vaccine for the Treatment and Prevention of Recurrent Respiratory
  • 10 National Institute on Deafness and Other Communication Disorders, Recurrent Respiratory Papillomatosis
  • 11 Reviews in Obstetrics & Gynecology 2008.
  • 12 National Cancer Institute. Feb. 19, 2015.
  • 13 FDA. Dec. 10, 2014.
  • 14 Vaccine Impact
  • 15 JAMA Aug. 19, 2009.
  • 16 NVIC. Aug. 15, 2007.
  • 17 Hepatology January 2013; 57(1):37-45
  • 18 U.S. CDC, HPV Vaccine
  • 19 NPR September 19, 2011
  • 20 The New York Times. Drug Makers’ Push Leads to Cancer Vaccines’ Rise. August 19, 2008
  • 21 Vaccine. 2012 Nov 20;30 Suppl 5:F1-11.
  • 22 Gaia Health
  • 23 Journal of Vaccines & Vaccination. Review of Gardasil. November 2010.
  • 24 Cervical Cancer Prevention — Gardasil Vaccination: Informed Consent? Slide No. 77. 2009
  • 25 Science Daily. American Cancer Society Endorses Two-Dose Regimen for HPV Vaccination. February 7, 2017
  • 26 Current Pharmaceutical Design 2012 Sep 24. [Epub ahead of print]
  • 27 Am J Obstet Gynecol 2012;206:46
  • 28 American Association for Cancer Research Annual Meeting April 19, 2015
  • 29 CDC. Apr. 1, 2014.
  • 30 CDC. Aug. 27, 2015.
  • 31 Cervical Cancer Prevention — Gardasil Vaccination: Informed Consent? Slide No. 78. 2009
  • 32, 33 J Vaccines Vaccin. 2010 Nov 23; 1(107): 1000107.
  • 34 Cervical Cancer Prevention — Gardasil Vaccination: Informed Consent? Slide No. 74. 2009
  • 35 Yakugai Medwatcher Japan March 1, 2014
  • 36  Immunologic Research July 16, 2016
  • 37 Collective Evolution February 10, 2017
  • 38 National Post February 26, 2016