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