HPV Strains

HPV

  

The Human Papilloma Virus (HPV) is the cause of both genital and non-genital warts. This is a very common family of viruses.  There are actually more than 100 different strains of HPV.  Of these, approximately 30 exist in the genital area and can cause genital warts (condyloma acuminata).  These 30 strains can be further broken down to “high” and “low” risk strains.

 

 

High risk strains may show up in a Pap smear and may rarely develop into cancer.  There are approximately 13 high-risk strains of HPV. Two strains (16 & 18) are believed to cause about 70% of all cervical cancer.

Low risk strains can sometimes cause changes in a Pap smear, but do not progress to cancer. Two of the low risk-risk strains (6 and 11) are most likely to cause genital warts.

There are 40 strains of HPV that can affect the anal and genital tracts and these are further divided into low risk and high risk strains.

 

Thirteen strains are considered high risk, or more likely to progress to high grade lesions (HSIL, CIN 2 or 3) and possibly cancer, if not cleared by the immune system. These strains are: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68. Strains 16 and 18 are by far the most common types, and one or both are present in approximately 70% of cervical cancers worldwide. Despite this strong link, only a very small percentage of high risk HPV infections will ever become invasive cancer (estimated at 2%). The time between initial exposure and the development of cancer can vary from months to years, but the average time is thought to be 15 years. Unfortunately, the high risk HPV strains do not usually cause any symptoms to alert someone that they have the infection. The low risk strains are not considered a risk for cervical cancer, but they can cause low grade lesions (CIN 1) and several of these strains can cause genital warts.

GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]

 

GARDASIL is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by Human Papillomavirus (HPV) types included in the vaccine:

Cervical, vulvar, and vaginal cancer caused by HPV types 16 and 18

Genital warts (condyloma acuminata) caused by HPV types 6 and 11

And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18:

Cervical intraepithelial neoplasia (CIN) grade 2/3 and Cervical adenocarcinoma in situ (AIS)

Cervical intraepithelial neoplasia (CIN) grade 1

Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3

Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3

GARDASIL, Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant, is a non-infectious recombinant quadrivalent vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, and 18. The L1 proteins are produced by separate fermentations in recombinant Saccharomyces cerevisiae and self-assembled into VLPs. The fermentation process involves growth of S. cerevisiae on chemically-defined fermentation media which include

vitamins, amino acids, mineral salts, and carbohydrates. The VLPs are released from the yeast cells by cell disruption and purified by a series of chemical and physical methods. The purified VLPs are adsorbed on preformed aluminum-containing adjuvant (Amorphous Aluminum Hydroxyphosphate Sulfate). The quadrivalent HPV VLP vaccine is a sterile liquid suspension that is prepared by combining the adsorbed VLPs of each HPV type and additional amounts of the aluminum-containing adjuvant and the final

purification buffer.

GARDASIL is a sterile suspension for intramuscular administration. Each 0.5-mL dose contains approximately 20 mcg of HPV 6 L1 protein, 40 mcg of HPV 11 L1 protein, 40 mcg of HPV 16 L1 protein, and 20 mcg of HPV 18 L1 protein.

Each 0.5-mL dose of the vaccine contains approximately 225 mcg of aluminum (as Amorphous Aluminum Hydroxyphosphate Sulfate adjuvant), 9.56 mg of sodium chloride, 0.78 mg of L-histidine, 50 mcg of polysorbate 80, 35 mcg of sodium borate, < 7 mcg yeast protein/dose, and water for injection.

The product does not contain a preservative or antibiotics.

CERVARIX® PRODUCT INFORMATION  Human Papillomavirus Vaccine Types 16 and 18

(Recombinant, AS04 adjuvanted)

 

CERVARIX contains recombinant C-terminally truncated L1 proteins from human papillomavirus (HPV) type-16 and type-18 each assembled as virus-like particles (VLPs)…

The HPV-16 and HPV-18 L1 antigens are prepared by recombinant DNA technology using a Baculovirus expression system in Trichoplusnia ni cells.

HPV-16 and HPV-18 L1 antigens in CERVARIX are adjuvanted with AS04. This AS04 adjuvant system comprises aluminium hydroxide (Al(OH)3) and 3-O-desacyl-4’-monophosphoryl lipid A (MPL). The MPL within AS04 enhances the initiation of the immune response through the activation of innate immunity, leading to an improved cellular and humoral adaptive immune response.

Each 0.5ml dose of CERVARIX contains 20 micrograms each of HPV-16 L1 and HPV-18 L1 proteins, 0.5 milligrams of Al(OH)3 and 50 micrograms of MPL. CERVARIX also contains sodium chloride (NaCl) 4.4 mg, sodium phosphate – monobasic (NaH2PO4.2 H2O) 624 micrograms and water for injection as excipients. CERVARIX does not contain a preservative.

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Cervarix vaccine causing severe reactions

Cervarix vaccine causing severe reactions

MORE than 1300 schoolgirls have experienced adverse reactions to the controversial cervical cancer jab.

Doctors have reported girls aged just 12 and 13 have suffered paralysis, convulsions and sight problems after being given the vaccine.

Dozens were described as having pain “in extremity” while others suffered from nausea, muscle weakness, fever, dizziness and numbness.

The vaccine is being given to girls under a government program to prevent women from developing cervical cancer. Ministers say it will ultimately save 700 lives a year.

Some have dubbed it the “promiscuity jab” because it is given to girls to protect against the sexually-transmitted HPV virus, which causes 70 per cent of cervical tumours.

Last night campaigners called for the vaccination campaign to be suspended.

But government health experts insisted the Cervarix vaccine was safe and that the 1340 reports was to be expected, given that more than 700,000 girls were vaccinated last year.

They also said many of the reactions resulted from the act of injection, and said there was no evidence that the jab caused any of the serious conditions, such as paralysis.

Cancer charities urged parents to continue allowing their daughters to have the jabs, saying any risks were so minor and unproven that they could not outweigh the benefit of possibly saving lives.

The vaccination program of young secondary school girls began in September last year following clinical trials on more than 18,000 women under the age of 26.

Critics have claimed that not enough pre-pubescent girls were involved.

The vaccine, which is administered in three doses, is also being given to girls aged 17 and 18. By 2011, all those under the age of 18 will have been vaccinated.

The drug safety watchdog, the Medicines and Healthcare products Regulatory Agency, said doctors had made 1340 reports listing 2891 different adverse effects.

Most were minor complaints such as rashes, swelling on the injection site, pain or allergic reactions, but there were many more worrying problems.

Four girls had convulsions, one had a seizure and one had an epileptic fit. There were several cases of paralysis.

There were almost 20 cases of blurred vision and one girl was reported as developing anorexia.

Researchers Suggest Insufficient Evidence of Efficacy of HPV Vaccine

Researchers Suggest Insufficient Evidence of Efficacy of HPV Vaccine

(NaturalNews) There is not enough evidence to confidently state that two popular vaccines against the human papillomavirus (HPV) will reliably prevent against the development of cervical cancer, according to two articles published in the New England Journal of Medicine.

“Despite great expectations and promising results of clinical trials, we still lack sufficient evidence of an effective vaccine against cervical cancer,” wrote Charlotte J. Haug, editor of The Journal of the Norwegian Medical Association, in the first article. “With so many essential questions still unanswered, there is good reason to be cautious.”

Haug noted that Merck’s Gardasil and GlaxoSmithKlein’s Cervarix have only been studied clinically for six and a half years at the most, and have only been on the market since 2006. This means that researchers still do not know if the vaccines are effective against HPV over the long term, or what cancer-related side effects they might have. For example, protecting the body from infection with certain HPV strains might have unforeseen immunological side effects, reducing the body’s resistance to other varieties.

Due to the newness of both vaccines, it is also not yet been possible to see whether they actually reduce cervical cancer rates. Normally, it takes years of HPV infection before cancer can develop – more time than either drug has been studied.

In the second article, a pair of Harvard researchers noted that HPV vaccination is not necessarily a cost-effective way to protect against cervical cancer. Current screening methods such as Pap smears have been very effective in reducing the death rate of cervical cancer already, but such tests must continue even after receiving an HPV vaccine. Even at their best, the vaccines do not protect against all cervical cancer strains that can cause cancer; a woman who has already been exposed to one of the strains in the vaccine will get no benefit from it.

“I believe the vaccine is a great advance,” said Philip Davies of the European Cervical Cancer Association, “but we have to implement it properly to get the benefits, and that hasn’t happened.”

Well, Well, Well: Bad is bad

Well, Well, Well: Bad is bad

I’m honoured, and not at all surprised, to hear from Dr Mansi (“Merck Frosst responds,” Letters, Feb 5 – Feb 11, 2009). He obviously cares a lot about Gardasil and has put out some highly sensitive radar for commentary on it, which is good—this is a conversation we need to be having. 
Cervical cancer and other HPV-linked diseases are horrible, on that he and I agree—but that’s probably where our agreement ends. And despite his authoritative tone, I offered no misinformation. 
 
Mansi cites a US Centers for Disease Control (CDC) study that found no significant difference in adverse events between a Gardasil-vaccinated group and a non-Gardasil group. But a very recent study published in the Canadian Medical Association Journal found Gardasil to cause adverse reactions five to 26 times more often than other vaccines. That’s 500 per cent more, at the low end. The study was based on 114 000 young women who had received Gardasil compared to young women who had received other vaccines. 
 
But to bring in the perspective of someone with a little more credibility than I as a journalist might have, I spoke with neuroscientist and UBC professor Chris Shaw. Dr Shaw’s research has turned up some alarming links between aluminum hydroxide (used in vaccines) and neurological damage—something called neuro-inflammation, which is linked to autism, epilepsy, Alzheimer’s, Parkinson’s, ALS and autoimmune disease.
 
Gardasil contains aluminum, and although aluminum adjuvants—the non-viral component of vaccines, designed to stimulate immune response—have been used in vaccines for decades, Shaw says they either haven’t ever been properly tested for safety, or the evidence has been tossed aside. 
 
“Attenuated microbes alone don’t give a sustained immune response, but aluminum does,” he explains. “Without an adjuvant that stimulates a long-lasting immune response, vaccines just don’t work all that well.” 
 
But aluminum generates molecules called tau proteins, which form the clumps in the brain that we see with neurological disease. “What I’ve seen in the lab is the reason my daughter’s never had a vaccine,” he tells me. “The way the aluminum danger is usually dismissed is that we ingest aluminum all the time, but digestive systems have ways to excrete it. When it is injected, it’s an entirely different thing.”
 
Which brings me back to Gardasil and double-blind trials. When we’re comparing two groups, and the control group has been given other vaccines or an aluminum-containing placebo, reactions between the two groups will be similar. And that’s exactly the kind of comparison that has mostly been made in clinical trials. What we need for an accurate picture is to compare vaccinated with completely unvaccinated groups over a long period of time. 
 
As to approval given by Health Canada and other health agencies, we need only to have a look at history, to read accounts like that of former Health Canada employee and whistleblower Dr Shiv Chopra to be reminded of how things work. 
 
“Vaccines are a business, like any other,” the Cochrane Library Review reminds us. “The only difference is that governments are co-sponsors with industry … overestimation of the threat by the target diseases, suppression of data on adverse events and exaggeration of effectiveness are frequent. In the case of population vaccination programs, both governments and industry have conflicts of interest.” 
 
And financial interests, as we all know, tend to trump safety. “Merck lobbied every opinion leader, women’s group, medical society, politician, and went directly to the people—it created a sense of panic that says you have to have this vaccine now,” Dr Diane Harper—cervical cancer researcher, vaccine developer and professor of medicine at Dartmouth Medical School—told the New York Times last August.
 
Mansi insists that the full burden of disease prevented by Gardasil is being overlooked, but we may in fact not be decreasing the burden of disease at all. By continually over-stimulating the immune systems of our children we may be trading one tragedy for another, much greater one. 

As to the comment encouraging readers to consult physicians—absolutely, but it is fair to remind the public where physicians get their information on drugs and vaccines.

Vaccinating teens during menstrual phase may increase adverse reactions

Vaccinating teens during menstrual phase may increase adverse reactions

Why has there not been any mention of the potentially adverse effects of Merck’s cervical cancer vaccination, Gardasil® in relationship to the timing of the inoculation and where a young woman is in her menstrual cycle? This information is especially critical considering the vaccination is recommended for adolescent girls from the age of nine to young women up to 26-years.

SHAME, SHAME, SHAME ON BOTH INDSUTRIES

Gardasil®, as well as other immunizations administered to adolescent women, are dispensed without regard to where a woman is within her menstrual cycle. During Gardasil®’s, clinical trial period, FDA approval, and during the two years it has been on the market, not one article has been written about how a young woman might tolerate the injection during premenstruum; nor is there any information in the Patient Product Information or the Prescribing Information on the Gardasil® web site, that cites any corollary to adverse reactions to the injection in relationship to the menstrual cycle.

Withholding this information is nothing less than a crime against women

Earlier this month the Center for Disease Control (CDC) released report on the number of adverse reactions to Merck Pharmaceutical’s Gardasil® vaccine for cervical cancer. According to the report over 14,796 adverse events have been reported to the Vaccine Adverse Events Reporting System (VAERS) since 2006 when the controversial vaccine for cervical cancer was approved by the Food and Drug Administration (FDA) and introduced to the mass market. Since the 2006 approval, nearly 8-million adolescent girls and young women have currently received the Gardasil® vaccination.

While Wall Street reported Merck’s 1.5-billion dollar revenue3 windfall from the sale of the Gardasil®, fifteen deaths and two lawsuits are amongst the nearly 8,000 reports, according to the CDC. On August 14, 2008 the National Vaccine Information Center (NVIC) sent out an email blast with more shocking statistics; there are now 35 confirmed deaths. On July 22, 2008, The Board of Directors of Merck & Co., declared a quarterly dividend of $0.38 per share on the Company’s common stock for the fourth quarter of 2008.

If one does the quick math, it becomes obvious that nearly 10% of the women who received the Gardasil® vaccination experienced an adverse reaction. In our humble opinion, that is an incredibly high percentage. Add that to the number of unknown and unreported incidents of an adverse reaction to Gardasil®, and the percentage could actually be far greater. David Kessler, former Commissioner of the FDA reported in an article in JAMA — June 2,1993, Vol. 269, No.21; “…it is estimated that only between 1-10% of immunization events are reported to the Vaccine Adverse Events Reporting System;” a figure supported by two NVIC investigations.

NVIC also reported that “In New York, only one out of 40 doctor’s offices or 2.5% confirmed that they report a death or injury following vaccination” leaving 97.5% of vaccine related deaths and disabilities unreported.

The percentage of adverse reactions to Gardasil® could indeed, be significantly higher than researchers have estimated.

ADVERSE REACTIONS

It is possible and probable that some of the adverse reactions to the Gardasil® vaccine are due to the shot being administered during the paramenstrum. It is also possible and probable that some of the adverse reactions to the vaccination may be hormonally related to the premenstrual phase — and not due to the vaccination.

Based on the current research and the unacceptable number of adverse reactions and unexplained fatalities “coincidentally” related to the Gardasil® inoculations, it would behoove Merck Pharmaceuticals to include menstrual cycle evaluation with the overall guidelines in the Gardasil® Patient Product Information and the Prescribing Information. For that matter, every pharmaceutical company producing and marketing drugs to women should also have this information in their product and patient information.

Full Article

The Role of Male Circumcision in the Prevention of Human Papillomavirus and HIV Infection

Effect of Male Circumcision on the Prevalence of High-Risk Human Papillomavirus in Young Men: Results of a Randomized Controlled Trial Conducted in Orange Farm, South Africa (The Journal of Infectious Diseases 2009;199:14–19)

Background.  A causal association links high-risk human papillomavirus (HR-HPV) and cervical cancer, which is a major public health problem. The objective of the present study was to investigate the association between male circumcision (MC) and the prevalence of HR-HPV among young men.

Methods.  We used data from a MC trial conducted in Orange Farm, South Africa, among men aged 18–24 years. Urethral swab samples were collected during a period of 262 consecutive days from participants in the intervention (circumcised) and control (uncircumcised) groups who were reporting for a scheduled follow-up visit. Swab samples were analyzed using polymerase chain reaction. HR-HPV prevalence rate ratios (PRRs) were assessed using univariate and multivariate log Poisson regression.

Results.  In an intention-to-treat analysis, the prevalences of HR-HPV among the intervention and control groups were 14.8% (94/637) and 22.3% (140/627), respectively, with a PRR of 0.66 (0.51–0.86) ( ). Controlling for propensity score and confounders (ethnic group, age, education, sexual behavior [including condom use], marital status, and human immunodeficiency virus status) had no effect on the results.

Conclusions.  This is the first randomized controlled trial to show a reduction in the prevalence of urethral HR-HPV infection after MC. This finding explains why women with circumcised partners are at a lower risk of cervical cancer than other women.

Trial registration.  ClinicalTrials.gov identifier: NCT00122525.

Full Study

Commentary: The Role of Male Circumcision in the Prevention of Human Papillomavirus and HIV Infection (The Journal of Infectious Diseases 2009;199:1–3)

 

Cervarix

CERVARIX Human papillomavirus (HPV) vaccine

“This report summarises the adverse reactions suspected to have been caused by Cervarix human papillomavirus (HPV) vaccine in the UK. This includes reports received between 14 April 2008 and 3rd December 2008.”

 Suspected Adverse Reaction Analysis (pdf)