by Brian Shilhavy
Editor, Health Impact News
Gardasil vaccine manufacturer, Merck, announced earlier this month (June, 2018) that the U.S. Food and Drug Administration (FDA) has granted them a “Priority Review” to approve the dangerous and controversial Gardasil 9 vaccine to women and men, ages 27 to 45.
The Gardasil vaccine is currently approved for girls and boys, ages 9 through 26.
The request by Merck to expand its market to women and men, ages 27 to 45, and the FDA’s approval to grant it a Priority Review by October 6, 2018, follows 10 years after the FDA struck down a similar request to expand the older version of Gardasil to the same age group.
FiercePharma, the marketing publication for pharmaceutical drugs, reports:
Back in 2008, after agreeing to a faster review in the age group, the FDA decided against Merck’s case for an additional Gardasil approval in females 27 to 45. The agency in 2009 issued a second complete response letter for that application, demanding Merck to provide longer-term efficacy data in the age group.
That set of data apparently didn’t turn things around for Merck. In both Gardasil’s and Gardasil 9’s current labels, information about a study on 3,253 women 27 through 45 years of age states that there was “no statistically significant efficacy” demonstrated by the vaccine in preventing high-grade cervical lesions or cervical cancer.
So what has changed that Merck now wants the FDA to act on their request again? According to FiercePharma:
Observational and clinical data over the past decade demonstrate that women 27 to 45 are also at risk of acquiring new HPV infections, Merck spokeswoman Pamela Eisele told FiercePharma.
Even though many people have already been exposed to HPV at an younger age, they have not been exposed to all nine HPV types targeted by Gardasil 9.
Besides, a follow-up of the long-term study with Gardasil in women ages 27-45 showed no additional cases of HPV disease for at least 10 years following vaccination, a result that can be extended to Gardasil 9, she said.
Will the FDA Look at Published Data on Gardasil Side-effects?
Besides the hundreds of stories of young women being injured or even killed by the Gardasil vaccine, as well as the lawsuits mounting in countries outside the U.S., the published data regarding Gardasil just keeps getting worse.
Will the FDA consider these studies in determining if Gardasil should be expanded to a larger population? Shouldn’t the FDA instead be determining if Gardasil should even stay in the market, as other countries are beginning to ask?
Two recent studies published this year (2018) on the Gardasil vaccine should put an immediate halt on increasing the vaccine’s market, and should, instead, prompt investigations into the safety of this dangerous vaccine and whether or not it should remain on the market.
A study published earlier this month (June, 2018) in the Journal of Toxicology and Environmental Health looked at declining fertility rates among eight million U.S. women, aged 25 to 29, during a 7-year period.
The title of study, published by Gayle DeLong, Ph.D., from the Department of Economics and Finance, Baruch College/City University of New York, is “A lowered probability of pregnancy in females in the USA aged 25–29 who received a human papillomavirus vaccine injection.”
From the abstract:
This study analyzed information gathered in National Health and Nutrition Examination Survey, which represented 8 million 25-to-29-year-old women residing in the United States between 2007 and 2014.
Approximately 60% of women who did not receive the HPV vaccine had been pregnant at least once, whereas only 35% of women who were exposed to the vaccine had conceived.
Using logistic regression to analyze the data, the probability of having been pregnant was estimated for females who received an HPV vaccine compared with females who did not receive the shot.
Results suggest that females who received the HPV shot were less likely to have ever been pregnant than women in the same age group who did not receive the shot. If 100% of females in this study had received the HPV vaccine, data suggest the number of women having ever conceived would have fallen by 2 million. (emphasis added)
We did not find a single corporate-sponsored “mainstream” media report on this study, and based on previous studies shedding a negative light on Gardasil, one wonders if this study will remain published or eventually be retracted due to pressure from outside influences.
Given the fact that many women in the U.S. are waiting longer to begin a family and conceive children, the expansion of Gardasil to this older age group could have even more devastating consequences to fertility rates. Learn more about this study:
Study: HPV Gardasil Vaccine Linked to Decline in Fertility Rates in U.S. Women Aged 25–29
Another study published earlier this year in the Indian Journal of Medical Ethics examined cervical cancer rates among women in Sweden and discovered a link between increased cervical cancer rates among women, aged 20-49, during a two-year period between 2014 and 2015, corresponding to increased HPV vaccination rates in this population group, years earlier, when mass HPV vaccinations started in Sweden.
The study has been retracted subsequent to being published, due to the fact that the study author claimed his life was in danger for publishing such a study and had to use a pseudonym, but in publishing the retraction, the Journal affirmed the validity of the data and study conclusion:
Further we reconfirmed the reviewers’ conclusions: that the article used publicly available data with a simple statistical method; made a fair attempt to report a possible association of the increased incidence of carcinoma cervix with HPV vaccination; and suggested more research. We felt that the data and analysis could be scientifically appreciated and critiqued without reference to the author.
The data that this study examines is obviously very important when considering whether or not to expand the Gardasil vaccine to ages 27 – 45, as that is the same age group of the study subjects in Sweden, and it suggests that Gardasil not only does not prevent cervical cancer in that age group, but might, in fact, increase their risk of cervical cancer. See:
Study: Increased Rates of Cervical Cancer in Sweden Linked to Increase in HPV Vaccinations
The U.S. FDA Should Follow Japan’s Example of Questioning the Risk of the Gardasil Vaccine Versus Perceived Benefits
We recently published an investigative report written by Vera Sharav of the Alliance for Human Research Protection, titled:
Japan Leading the World in Exposing Fraud with Gardasil HPV Vaccine Injuries and Deaths
Sharav showed how the Japanese Government does not have strong ties with pharmaceutical companies producing HPV vaccines and is, therefore, more prone to conduct honest investigations into the dangers of the HPV vaccines. Japan has not only rescinded its recommendation for the Gardasil vaccine, it has actually helped facilitate clinics to deal with Garsasil vaccine injuries:
In Japan, young women and girls suffering from severe chronic generalized pain following vaccination with Merck’s Gardasil® or GSK’s Cervarix®, have organized and are speaking out.
The issues are being debated at public hearings, at which scientific presentations have been made by independent medical experts who validated the women’s suffering with documented evidence of the severe nature of the pain related to the HPV vaccine.
The opposing view, presented by scientists aligned with the vaccine establishment, disregarded the scientific plausibility of the evidence and declared the pain was a “psychosomatic reaction.”
Such public debates do not take place where vaccine stakeholders are in full control of vaccine safety information. (Like in the U.S., for example.)
Following a public hearing (February 2014), at which scientific evidence was presented by independent scientists, the Japanese government, not only rescinded its recommendation that girls receive the HPV vaccine, but established guidelines and special clinics for evaluating and treating illnesses caused by the vaccine.
It is a scenario that Merck, GSK, and vaccine stakeholders globally are extremely anxious to suppress.
The Merck-commissioned, CSIS report, co-authored by Dr. Larson, paints a picture of an all-out war over media coverage – not over the high rate of serious adverse reactions.
Comment on this VaccineImpact.com.
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After 3 Years of Suffering 19 Year Old Girl Dies from Gardasil Vaccine Injuries
Gardasil: The Decision We Will Always Regret
The Gardasil Vaccine After-Life: My Daughter is a Shadow of Her Former Self
Gardasil: An Experience no Child Should Have to Go Through
I Want my Daughter’s Life Back the Way it was Before Gardasil
Gardasil Vaccine: Destroyed and Abandoned
15-Year-Old Vaccinated by Force with Gardasil now Suffers from Paralysis and Pain
Recovering from my Gardasil Vaccine Nightmare
Gardasil: We Thought It Was The Right Choice
“HPV Vaccine Has Done This to My Child”
13 Year Old World Championship Karate Student Forced to Quit After Gardasil Vaccine
If I Could Turn Back Time, Korey Would not Have Received any Gardasil Shots
What Doctors Don’t Tell You: Our Gardasil Horror Story
Family Fights U.S. Government over Compensation for Gardasil Vaccine Injuries
Gardasil: When Will our Nightmare End?
HPV Vaccine Injuries: “I Cannot Begin to Describe What it is Like to Watch your Daughter Live in Such Agony”
Gardasil: Don’t Let Your Child Become “One Less”
The Gardasil Vaccine Changed Our Definition of “Normal”
Gardasil: I Should Have Researched First
“They’ve Been Robbed of Their Womanhood” – Local Milwaukee Media Covers Gardasil Vaccine Injuries
Gardasil: The Day Our Daughter’s Life Changed
Gardasil: The Decision I will Always Regret
Gardasil Vaccine: One More Girl Dead
Gardasil: A Parent’s Worst Nightmare
After Gardasil: I Simply Want my Healthy Daughter Back
Gardasil: My Family Suffers with Me
Gardasil Changed my Health, my Life, and Family’s Lives Forever
Gardasil: Ashlie’s Near-Death Experience
Gardasil: My Daughter’s Worst Nightmare
My Personal Battle After the Gardasil Vaccine
Gardasil: The Worst Thing That Ever Happened to Me
A Ruined Life from Gardasil
HPV Vaccines: My Journey Through Gardasil Injuries
The Dark Side of Gardasil – A Nightmare that Became Real
Toddler Wrongly Injected with Gardasil Vaccine Develops Rare Form of Leukaemia
More information about Gardasil
Leaving a lucrative career as a nephrologist (kidney doctor), Dr. Suzanne Humphries is now free to actually help cure people.
In this autobiography she explains why good doctors are constrained within the current corrupt medical system from practicing real, ethical medicine.
One of the sane voices when it comes to examining the science behind modern-day vaccines, no pro-vaccine extremist doctors have ever dared to debate her in public.
Medical Doctors Opposed to Forced Vaccinations – Should Their Views be Silenced?
One of the biggest myths being propagated in the compliant mainstream media today is that doctors are either pro-vaccine or anti-vaccine, and that the anti-vaccine doctors are all “quacks.”
However, nothing could be further from the truth in the vaccine debate. Doctors are not unified at all on their positions regarding “the science” of vaccines, nor are they unified in the position of removing informed consent to a medical procedure like vaccines.
The two most extreme positions are those doctors who are 100% against vaccines and do not administer them at all, and those doctors that believe that ALL vaccines are safe and effective for ALL people, ALL the time, by force if necessary.
Very few doctors fall into either of these two extremist positions, and yet it is the extreme pro-vaccine position that is presented by the U.S. Government and mainstream media as being the dominant position of the medical field.
In between these two extreme views, however, is where the vast majority of doctors practicing today would probably categorize their position. Many doctors who consider themselves “pro-vaccine,” for example, do not believe that every single vaccine is appropriate for every single individual.
Many doctors recommend a “delayed” vaccine schedule for some patients, and not always the recommended one-size-fits-all CDC childhood schedule. Other doctors choose to recommend vaccines based on the actual science and merit of each vaccine, recommending some, while determining that others are not worth the risk for children, such as the suspect seasonal flu shot.
These doctors who do not hold extreme positions would be opposed to government-mandated vaccinations and the removal of all parental exemptions.
In this article, I am going to summarize the many doctors today who do not take the most extremist pro-vaccine position, which is probably not held by very many doctors at all, in spite of what the pharmaceutical industry, the federal government, and the mainstream media would like the public to believe.
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