Contributed to TLB By: Cynthia A. Janak
After seven plus years of researching the HPV vaccines I still want to cry myself to sleep every night because:
- 1) Of the parents that are reporting how their sons and daughters are affected.
- 2) Of reading yet another young person who mysteriously dies with no known cause.
- 3) Of talking to another parent who has lost everything because of mounting doctor’s bills and not working because they are taking care of their child who is now suffering after the vaccine.
- 4) Of reading all of the posts of parents who are trying their best to deal with a medical system that has failed their children.
- 5) Of hearing about doctors that are still pushing this vaccine.
- 6) Of hearing about doctors that still do not know about vaccine injury and how to report.
- 7) Of trying to console a parent who recommended this vaccine after their child has been adversely affected with side effects.
- 8) Of reading about Merck getting ready to push a new and more potent HPV vaccine on an unsuspecting populace.
- 9) Of reading about how the profit margins are for all the vaccine drug pushers.
- 10) Of hearing from parents who have gotten a divorce over the injuries their child is suffering.
- 11) Etc., etc., etc………..
I am sick and tired of this but I will keep on until this vaccine is STOPPED DEAD in its tracks just like all the children that have passed on in my opinion because of it. From my present research it is becoming very clear that they all suffered from a cytokine storm that affected their hearts and lungs. I am working on writing that article now.
What I am going to do with this article is just focus on one report to the FDA from Merck and that is the Clinical Review of Biologics License Application for Human Papillomavirus 6, 11, 16, 18 L1 Virus Like Particle Vaccine (S. cerevisiae), (STN 125126 GARDASIL), manufactured by Merck, Inc., BLA STN# 125126, June 6, 2006. I am going to feature what I consider to be important facts to explore.
Note: Definitions and the link to this report are at the end of this article.
Let’s start at the beginning. (page 2)
1.2.1 Proper Name: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18)
1.2.2 Trade Name: GARDASIL
1.2.3 Product Formulation: Each 0.5 mL dose of the vaccine contains:
20 mcg of HPV 6 L1 protein
40 mcg of HPV 11 L1 protein
40 mcg of HPV 16 L1 protein
20 mcg of HPV 18 L1 protein
225 mcg 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
water for injection
1.3 Applicant: Merck, Inc.
1.4 Pharamcologic Category: Vaccine
There is nothing special here because you can find these ingredients in any vaccine that is presently being administered (injected) to our children. I explored the ingredients in my article titled HPV vaccine cocktail targets not only HPV, October 7, 2011, which is published on Renew America.
Next item: There is an important point I need to make with regards to Table 7 on page 12. A major topic of contention with the individuals that tout that the vaccine’s safe is because of the placebo participants. I want you to take note here that the so called real placebo was only given to 594 individuals in study 018. This is only .05% of the so called placebo group.
Next item of interest is what they say about the placebo group in this section (page 12). I want you to take note of the Gardasil group reactions and the AAHS (amorphous aluminum hydroxide sulfate) group. To me the percentages of those who suffered from a ‘systemic event’ are rather high, 83% and 77%. What I question here is the reactions in the saline placebo recipients. Saline is supposed to be nothing more than salt water which normally there is no reaction to. How could participants have any reaction at all? The only thing that comes to mind would be the origin of the water used to create the solution. If it was tap water or any other water that was not distilled and pure then we have tainted solutions.
Injection Site Reactions: In 4 placebo controlled trials in which solicited local and systemic events were monitored using Vaccine Report Cards, a higher proportion of Gardasil recipients experienced local injection site reactions (app. 83%) within the 5 days after any dose, as compared to aluminum adjuvant placebo recipients (77%) or saline placebo recipients (50%).
Take note this is where they start calling all the groups bunched together a placebo group. Typically a placebo is considered nothing more than a saline formula but here it encompasses the AAHS carrier solution in this category with the questionable saline formula.
Systemic Reactions: In studies in which solicited local and systemic adverse events were monitored using Vaccine Report Cards, the proportion of subjects with a systemic adverse event within 15 days after any dose was comparable between the Gardasil recipients (59%) and combined placebo recipients (60%). In study 018, the rates of systemic adverse events were assessed following administration of Gardasil or saline placebo, and the rates of systemic adverse events were lower than observed in other studies but comparable between study groups. Overall, the most common systemic adverse events in both Gardasil and placebo recipients included headache, pyrexia (most low-grade [fever]), and nausea.
Now, I want you to remember what I questioned in regards to the saline placebo. As you can see here they lied in my opinion about this being a saline placebo in this group. In reality this group had the “carrier solution.” What that means is that all the “saline placebos” were filled with these chemicals:
9.56 mg of sodium chloride
0.78 mg of L-histidine
50 mcg of polysorbate 80
35 mcg of sodium borate
water for injection
With this being known any reference to this being a saline placebo by anyone just means that they have not educated themselves with regards to the vaccine study components. So, when you come across one of these individuals on a message board, please instruct them to go to page 301, Table 210 of this report. This study never, ever used a saline placebo ever and this in my opinion was to falsify the results in the favor of Merck in showing that there is not much difference between the outcomes proving a totally inaccurate report of safety.
The other give away as to the composition of the so called placebo is in this table because it states “Non-Alum Placebo” which means that the only thing missing in this placebo solution is the AAHS.
Now you know why these participants suffered systemic adverse reactions. Tsk tsk
What I am going to do now is go to the end of the document and show you the results of all the different studies that they performed for the approval of this vaccine. This will astound you. I will start on page 371 of the document.
10 Overview of Safety Across Trials
10.1. Safety Database-Number of Subjects, Types of Subjects, and Extent of Exposure
There are several things that I want to point out here and that is the total amount of males per females that participated in this original study. Rather enlightening isn’t it. In my opinion because the study population is so low this does not prove the safety of this vaccine in males at all. Also because of what I consider lower numbers of participants for the females within the 9 to 15 target age group for administration of this vaccine it is also not indicative of a good population sample in regards to safety.
Now you see why there is a real possibility of why so many young people are being affected by this vaccine at such a young age. I have read other studies on different subjects where because of the participant amounts were considered low the study was discounted as showing appropriate results to validate the findings.
You can find this next gem on page 372.
The numbers of subjects who received at least one dose of the Gardasil formulation or placebo are shown in Table 289 below. A total of 21,480 subjects were vaccinated in 7 clinical trials. Subjects are counted only once in the integrated summary. A total of 11,792 were randomized and received at least 1 dose Gardasil and 9688 were randomized and received at least 1 dose of placebo. (2 of the placebo recipients received mixed regimens so are not included in Table 289 below). Placebo recipients include those who received alum (vast majority received 225 mcg and 146 subjects in Protocol 007 received 450 mcg doses) and non-alum placebo (N=594).
What I believe we have here is Merck telling the reviewers of this study that many of the 21,480 participants received not only the vaccine but a placebo also. This would contribute to the high rates of adverse events reported in the so called placebo group. In essence, Merck never ever provided a true only placebo group for this study. BUT, what this tells me is that in order to make the results look comparatively equal the results of those that were initially designated to be in the placebo groups were entered under that category even though they did receive at least one dose of the vaccine. In my opinion this is fraud and this study should be discounted as all past and future studies from Merck. If they did it with this vaccine then all other vaccines and medications that come from their studies have the real potential to have the study data manipulated the same way.
The other item of interest is that they did say that 594 subjects did receive the “non-alum placebo” (remember this is the chemicals in the carrier solution so it is not pure saline.)
I just have to add this gem. This shows how Merck lied in this table, in my opinion.
In protocol 018 Merck states that a saline placebo was administered where in fact earlier I showed you that it was in reality a solution filled with the chemicals of the vaccine without the aluminum concoction.
This table also shows you the disparity of male to female subjects in protocol 016 and none of them received a so called placebo. This is the age group that the vaccine is heavily pushed on. This proves that the safety of this vaccine in this age group was NEVER, NEVER studied. That is the way I see it.
This is also something to think about. This next section is going to bring to light some interesting facts that were listed by the reviewer. Read it and weep. I got so angry I could just about cry over how cold this was written. This all starts on page 387.
JRA … According to the sponsor, the annual incidence rates are noted to vary from 0.8–22.6/100,000. In the UK, the annual incidence of JRA is estimated to be 10/100,000 children under the age of 16 years of age. In the US, the incidence is reported to be 50-100/100,000. The sponsor calculated the incidence in the trials to be 55/100,000 (although there was only 1 incident case).
I want you to understand that the sponsor of the trials was Merck. They came up with the numbers not some independent entity.
Rheumatoid Arthritis … The sponsor calculated with the 2 incident cases reported above, the incidence was 10.4 cases /100,000. The annual incidence rate for RA in women 15-25 years of age is calculated to be app. 10-15 cases/100,000. The annual overall incidence is 70 per 100,000 subjects, and the prevalence in the US population is 1-2%. The incidence in the study was therefore what would be expected in a young female population. Most of the subjects who developed RA (although not all) had pre-vaccination complaints of joint pain. Post-marketing commitments will focus on similar adverse events in a larger population.
On to the next good one that you will find at the bottom of page 392. Enjoy the wording on this one.
10.3.5 New Medical History (Day 1 through Month 7)
• The most commonly reported new medical conditions were nasopharyngitis, headache, and vaginal candidiasis.
• The proportions of subjects who developed new medical conditions were generally comparable between the 2 groups.
What I want you to take note of here is that it is a persistent infection that can cause HPV associated cervical cancer. Let me explain with this study so you can see that this vaccine is expected to cause a bacterial infection (vaginal candidiasis).
“Despite the similar eﬀects of bacterial vaginosis and trichomoniasis on the vaginal environment, there is increasing evidence only for an association between HPV and bacterial vaginosis, albeit of unknown directionality [7–9]. Bacterial vaginosis and trichomoniasis are categorized, along with vulvovaginal candidiasis, under the somewhat misnomer of vaginitis. (1) page 1.
“In summary, the current study suggests bacterial vaginosis may predispose a woman to HPV infection and delayed HPV clearance, underscoring the importance of prevention and successful treatment of bacterial vaginosis.” (1) page 7.
In conclusion, increasing dietary intake of lutein/zeaxanthin, â-cryptoxanthin, and vitamin C appear to be associated with reduced risk of persistence of type-specific HPV infection, a strong determinant of risk of cervical cancer. Correspondingly, consumption of papaya, a major source of dietary carotenoids, was associated with reduced risk of persistent infection. These results suggest that, among populations with low levels of intake of antioxidant nutrients, increasing dietary consumption of certain fruits may confer protection against cervical neoplasia. (2)
I found this and thought it would be of interest to you because it shows how the diet can influence the production of HPV related cervical cancer. So, in essence, if you eat a diet that is nutritionally insignificant you have a greater chance of not being able to naturally rid your body of any HPV related viruses. The HPV vaccines are not formulated to correct nutritional deficiencies. Only you can.
To finish this long article I am going to give you this tidbit.
As you can see here, in the initial study of this vaccine that was given to the FDA and they approved the administration of the HPV vaccine Gardasil based on this information, the FDA and Merck expect that at least 50% will have a “New Medical Condition.”
The impact on the finances of each family that is going have to deal with their child going from doctor to doctor in efforts to mitigate the side effects of the vaccination will and is horrendous. The impact on our Medicaid system will be astronomical.
The real impact is on the quality of life of the 50% of our young people. Many, many have had to give up going to school, scholarships, sports, etc. Just having a normal life with friends and family is now non-existent for some. I know firsthand this to be true because I communicate in some form with them daily.
This is why I say “STOP THE HPV VACCINE MADNESS!” This report was nothing more than a pack of lies from the get go, in my opinion. You decide for yourself. You and/or your child have 50/50 chance of having some type of “New Medical Condition” even after the first injection. Do you feel lucky?
Candidiasis – Candidiasis is a fungal infection caused by yeasts that belong to the genus Candida. There are over 20 species of Candida yeasts that can cause infection in humans, the most common of which is Candida albicans. Candida yeasts normally live on the skin and mucous membranes without causing infection; however, overgrowth of these organisms can cause symptoms to develop. Symptoms of candidiasis vary depending on the area of the body that is infected.
Candidiasis that develops in the mouth or throat is called “thrush” or oropharyngeal candidiasis. Candidiasis in the vagina is commonly referred to as a “yeast infection.” Invasive candidiasis occurs when Candida species enter the bloodstream and spread throughout the body.
Nasopharyngitis – Inflammation of the nasal passages and of the upper part of the pharynx.
Systemic – Systemic means affecting the entire body, rather than a single organ or body part.
For example, systemic disorders such as high blood pressure or systemic diseases such as influenza affect the entire body.
An infection that is in the bloodstream is called a systemic infection.
(1) Bacterial Vaginosis and the Natural History of Human Papillomavirus, Hindawi Publishing Corporation, Infectious Diseases in Obstetrics and Gynecology, Volume 2011, Article ID 319460, 8 pages, doi:10.1155/2011/319460, http://stacks.cdc.gov/view/cdc/4002/cdc_4002_DS1.pdf
(2) Dietary Intake and Risk of Persistent Human Papillomavirus (HPV) Infection: The Ludwig-McGill HPV Natural History Study, J Infect Dis. (2003) 188 (10): 1508-1516. doi: 10.1086/379197, http://jid.oxfordjournals.org/content/188/10/1508.full
Clinical Review of Biologics License Application for Human Papillomavirus 6, 11, 16, 18 L1 Virus Like Particle Vaccine (S. cerevisiae), (STN 125126 GARDASIL), manufactured by Merck, Inc., BLA STN# 125126. June 6, 2006
HPV vaccine cocktail targets not only HPV, October 7, 2011.
See more by : Cynthia A. Janak