Gardasil (HPV vaccine) coverage and safety in the United States

Gardasil-vaccine-virusGenital human papillomavirus (HPV) is the most common sexually transmitted infection (STI) in the USA. There are more than 40 HPV sub-types that can infect the genital areas of males and females. These same HPV types can also infect the mouth and throat. They are transmitted from personal contact during vaginal, anal or oral sex.

Some HPV subtypes, such as HPV-6 and HPV-11, can cause warts around the genitals or anus, but have low (but not 0) risk of causing cancers. However, the higher risk subtypes, such as HPV 16 and 18, not only cause approximately 70% of cervical cancers, but they cause most HPV-induced anal (95% linked to HPV), vulvar (50% linked), vaginal (65% linked), oropharyngeal (60% linked) and penile (35% linked) cancers. HPV is estimated to be the cause of nearly 5% of all new cancers across the world.

According to the CDC, roughly 79 million Americans are infected with HPV–approximately 14 million Americans contract HPV every year. Most individuals don’t even know they have the infection until the onset of cancer.

The HPV quadrivalent vaccine, also known as Gardasil (or Silgard in Europe) can prevent infection by human papillomavirus, substantially reducing the risk of these types of cancers. An HPV bivalent vaccine, known as Cervarix, is used in some countries, but only provides protection again two of the subtypes most associated with cervical cancer.

Currently in the United States, the Advisory Committee on Immunization Practices (ACIP) recommends that preteen girls and boys aged 11 or 12 are vaccinated against HPV. The immunization is also recommended for teenage girls and young women up to the age of 26 who did not receive it when they were younger, and teenage boys and young men up to the age of 21.

cdc-hpv-infographic

Despite these ACIP recommendations, the CDC reported, in this week’s Morbidity and Mortality Weekly Report, that only 57% of girls and 35% of boys, aged 13-17 years, have received at least one of the three recommended doses of the HPV vaccine. The vaccine uptake rate was developed from the CDC’s National Immunization Survey-Teen (NIS-Teen), which determined vaccination information, via telephone survey, from adolescents aged 13-17 years across the USA. (By a show of hands, how many people reading about this survey wondered if antivaccination cultists were certain that the CDC was trying to identify unvaccinated children so that they could send in the black booted CDC Vaccination Shock Troops to force vaccines on poor little kids?) The goal of Healthy People 2020, the CDC’s initiative to set clear objectives and strategies to improve the health of Americans, has set a goal that 80% of American teens have received all three doses of the HPV vaccine by 2020.

There is some good news. Even though the vaccine uptake rate is much lower than other vaccines, it is growing. From 2012-13, the vaccine update grew for girls from 53.8% to 57.3%–unfortunately, only a third had received the full three doses. On the other hand, vaccine uptake for teenage boys grew from 20.8% to 34.6% in the same period of time.

According to the lead author of the report, Shannon Stokley, assistant director for science at the CDC’s Immunization Services Division, still believes that the 80% goal is still realistic:

The data on missed vaccination opportunities tells us that it is possible. When we look at the most recent cohort of girls that turned 13, 91% of them had a health care encounter where they could have started the HPV vaccine series before their 13th birthday. Also, 86% of 13-17 year-olds have received the Tdap vaccine. What these numbers tell us is that preteens and teens are getting to the doctor and they are getting vaccinated, but they aren’t always receiving the HPV vaccine.

The report also identified some reasons why uptake is so low:

  • Given that 86% of this same group have received their Tdap vaccine, it’s clear that these teenagers have regular encounters with their health care providers. One can only assume that physicians (or others) are not providing appropriate information about the HPV vaccine, including the cancer statistics. It’s hard for me to ignore numbers, like 14 million Americans contracting HPV every year, which leads to significantly higher risk of some awful cancers, so physicians need to provide that data to their patients and their parents. The HPV vaccine should be near the top priority of immunizations given to teens.
  • Parents are also part of the reason of the low vaccination rate against HPV. Many parents believe that their child isn’t sexually active (which may or may not be true), but eventually they may become so. And even if one had a belief that their child will never have sex until she’s married, with the high rate of sexual violence against men and women, contracting HPV could, in some cases, be unavoidable. Protecting your child with an effective and safe vaccine against a cancer causing disease is the wise choice.

Which leads me to one of the most important points in the article. The CDC and authors stress that, after reviewing and analyzing 8 years of post-licensure safety data, including studies that involved several hundred thousand to over a million teens, no serious safety concerns have been linked to the HPV vaccine since it became available. When you go looking for issues in epidemiological studies that include well over one million subjects, and you find no serious adverse effects, published the results for review, and the consensus from real scientists says “there are no serious adverse effects,” then we’ve reached the point that there should be no hesitancy about the HPV vaccine.

Some of the antivaccine cult will go dumpster diving in the Vaccine Adverse Event Reporting System (VAERS),  which is a program for vaccine safety, managed by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS functions as a post-marketing safety surveillance program (similar to other programs for almost every regulated medical device and pharmaceutical) which collects information about adverse events (whether related or unrelated to the vaccine) that occur after administration of vaccines.

VAERS has numerous limitations, including lack of scientifically designed questions, unverified reports, underreporting, inconsistent data quality, and absence of an unvaccinated control group. VAERS is basically a collector of information, but has limited value in making conclusions since it does not provide information that is obtained in a controlled manner.  However, it does have some usefulness, in that certain trends may be spotted given enough time and data points.

I’ll be a cheerleader here. Go get your kids vaccinated with Gardasil. It’ll save their lives. It’ll prevent cancer. And the vaccine is probably the best studied for adverse events, and there simply are no bad ones. None. None. None. Here is another vaccine that truly saves lives.

 

Visit the Science-Based Vaccine Search Engine.

 

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The Original Skeptical Raptor
Chief Executive Officer at SkepticalRaptor
Lifetime lover of science, especially biomedical research. Spent years in academics, business development, research, and traveling the world shilling for Big Pharma. I love sports, mostly college basketball and football, hockey, and baseball. I enjoy great food and intelligent conversation. And a delicious morning coffee!
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  • Judith

    Genetically modified HPV dna in our body – may or may not cause problems for people – for some it may cause cancer or auto-immune disease. For other vaccines as well – It is clear the FDA has concerns about the carcinogenicity of immortal cell lines in vaccines and have clearly expressed it:

    “The next tumorigenic cell line under consideration was the Madin-Darby canine kidney (MDCK) cell line, which was proposed for the production of inactivated influenza virus vaccines (VRBPAC 2005). The MDCK cell line is a spontaneously immortalized cell line established from the kidney of an apparently normal dog. Some variants of MDCK cells are highly tumorigenic, while others are not [reviewed in Omeir et al. (64)]. The Committee accepted the use of tumorigenic MDCK cells for inactivated influenza vaccines and their evaluation in clinical trials.

    The tumorigenic transformation of normal cells can be caused by infectious agents (i.e., oncogenic viruses), somatic mutations, and epigenetic changes. The fact that multiple oncogenic events are required to establish a tumor has been considered to provide an additional safety margin for vaccines manufactured using a tumor-derived cell substrate for virus growth.”

    Flucelvax contains MDCK dog kidney cells

    http://preview.tinyurl.com/8mo2s98

    http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3750t1_01.pdf

  • Judith

    There are obviously a lot of unanswered questions: In an article in the New England Journal of Medicine “ Human Papilloma Virus Vaccination – Reasons for Caution”, Dr. Haug poses the question of replacement:

    “How will the vaccine affect other oncogenic strains of HPV? If HPV-16 and HPV-18 are effectively suppressed, will there be selective pressure on the remaining strains of HPV? Other strains may emerge as significant oncogenic serotypes”. (4)

    http://www.nejm.org/doi/full/10.1056/NEJMe0804638
    A sexually naive girl developed acute juvenile rheumatoid arthritis at age 13 within 24 hours after the third Gardasil injection and her blood sample – tested two years later – was found to be positive for HPV DNA by a local clinical laboratory.

    In a quest for more information by her mother the Sanevax team contracted an independent laboratory for analysis of 13 samples of Gardasil, all from different lots.

    The results showed that all the samples contained recombinant (genetically modified) HPV DNA which was firmly attached to the aluminium adjuvant

    Unanswered questions:

    Lack of carcinogenicity testing of the vaccine

    Increase in cancer risk for those previously exposed to human papilloma virus

    Presence of recombinant DNA (rDNA)

    • Vaccines are not carcinogenic. But you know if you actually have evidence that they are, please bring it.

      Increase in cancer risk or those previously exposed to HPV? Well, yeah, they are.

      Recombinant DNA? WTF are you talking about? What you think that DNA from something else magically gets incorporated in human DNA? You need to actually take a class in biochemistry, and maybe you’d not seem so ignorant about this subject.

      You provided a wonderful but totally useless anecdote. Anecdotes do not equal data, never will. So, more scientific ignorance on your part.

      So, you’ve got nothing. I’ve got dozens of large scale epidemiological studies that show that the vaccine works and it’s completely safe. You really are very ignorant.

      • sabelmouse

        how would you know if they’ve not been tested for it ?

      • Judith

        From the FDA’s own briefing document – link supplied on previous post. If you think you being injected with animal dna derived from continuous (aka Cancerous) cells is safe – go ahead and shoot up but don’t try to give it to my children.

        4.2.1 Background: DNA Oncogenicity, DNA Infectivity, and DNA Integration

        “Small amounts of residual cell substrate DNA unavoidably occur in all viral vaccines as well as other biologics produced using cell substrates. There are several potential ways DNA could be a risk factor. DNA can be oncogenic or infectious; in addition, it can cause insertion mutagenesis through integration into the host genome.

        It is the potential presence of such activated dominant oncogenes in the genomes of certain cell substrates, such as continuous cell lines and tumorigenic cells, that has raised concern over residual DNA in vaccines prepared using such cell substrates, since complete removal of DNA from vaccines is not possible. Therefore, the issue has been whether the low levels of residual cell-substrate DNA in vaccines could be a risk factor in recipients of these vaccines. This issue has been debated over many years with the conclusion that residual DNA amount and size should be controlled. A summary of these discussions is presented in Appendix 4.”

    • Judith

      You can’t say vaccines are not carcinogenic if they have never been tested for it. Personally I would not expose myself to dog kidney (MDCK) immortal cell lines (aka carcinogenic) or monkey kidney or aborted fetal cells as no long term studies have been done on carcinogenicity. Animal models are not the same as humans and it states in the package inserts that vaccines are not tested for their ability to cause cancer. A certain number of these cells are allowed in vaccines as it is not possible to remove them all.
      Measles fetal bovine serum, chick embryo cell
      Polio Green monkey kidney cells, newborn calf serum, human diploid tissue.
      Rubella and polio W1-38 aborted fetal cells from lung tissue
      chickenpox aborted fetal cells
      Flu – can contain MDCK cells from dog kidneys (Flucelvax) chicken
      kidney, chicken embryo
      TDaP Bovine Casein, monkey kidney cells
      Rotavirus – Monkey Kidney cells
      MMR human diploid tissue (WI-38)
      Hep B – human diploid tissue, monkey kidney cells,
      This along with formaldehyde, mercury (multidose flu) aluminium hydroxide,
      antibiotics etc.

  • Sandy Perlmutter

    Isn’t it wonderful? After all the war on cancer shouting, at last there is a vaccine against some forms of cancer. There should be people out in the street with banners, a parade up Broadway, medals being given out. Oh, there is some connection with sexual activity? Never mind…

  • Dorit Reiss

    Thank you for, again, providing this valuable information about HPV and the vaccines. It’s really, really sad that people deny their children protection against an infection that causes cancer and kills because of these false notions, and even sadder if providers buy into them.