Tag: gardasil

I’m Not Anti-Vaccine, I Just Don’t Believe in the HPV Vaccine

Believe it or not, there are some parents who get their kids each and every vaccine, but skip the one that protects them from cancer.

I’m Not Anti-Vaccine, I Just Don’t Believe in the HPV Vaccine

Why?

HPV Vaccine is Cancer Prevention.

That’s a good question.

And although they won’t have a good answer, some of their reasons include that:

  • the HPV vaccine is too new – even though Gardasil was first approved in 2006 and the first phase 1 and phase 2 trials began in 1997!
  • they don’t think it is necessary – even though about 4,200 women die of cervical cancer each year (that’s just in the United States), even in this age of routine pap tests
  • it might lead their kids to have early sex or unprotected sex – even though studies show it won’t
  • Michele Bachmann once said it caused mental retardation – even though she had no evidence to support her claim
  • the HPV vaccine is too controversial – any “controversy” about Gardasil and Cervarix is made up by anti-vaccine folks
  • HPV vaccines can cause POTS, ASIA, primary ovarian failure, venous blood clots, behavior problems, or multiple sclerosis, etc. – even though over and over, studies have found HPV vaccines to be safe and to not cause any of the other serious side effects or vaccine induced diseases you read about on the Internet that scare you away from vaccinating and protecting your kids
  • it is banned in Utah – even though that isn’t true
  • it doesn’t provide life-long protection – even though the protection has been found to be long-lasting, as long as we have been giving the vaccine so far
  • it is banned in Japan and France – even though HPV vaccines aren’t banned anywhere and are actually on the immunization schedule in at least 64 countries
  • Katie Couric once did a scary segment on HPV vaccines – well, she did but later apologized… after being called out for pushing anti-vaccine misinformation
  • an HPV vaccine researcher says it’s dangerous – no, the HPV vaccine researcher, Diane Harper, actually says it is a safe vaccine
  • HPV vaccines are just for girls – even though there are around 11,000 cases of HPV induced cancer in men each year, including anal cancer and cancers of the mouth/throat and penis
  • their kids are too young and can get it later, when they are older – even though protection is likely better when they get the vaccine when they are younger, and you don’t want to wait too long, when you increase the chance that they will have had sex and will already be exposed to HPV

So why aren’t you getting your kids vaccinated and protected… against cancer?

Need to do more research? Read the links below and then schedule your kids for their HPV vaccine.

More on HPV Vaccine Safety

Who Is Judy Mikovits?

Dr. Judy Mikovits has a PhD in Biochemistry and Molecular Biology, doing her thesis on Negative Regulation of HIV Expression in Monocytes.

She had several papers published with Dr. Frank Ruscetti, with whom she continues to work.

Instead of research, it seems that they now do:

  • Advocacy for vaccine injury legal cases worldwide. 
  • Research and documentation on medical exemptions for vaccinations.

What happened?

Who Is Judy Mikovits?

After working at the National Cancer Institute, it seems that Judy Mikovits became research director of the Whittemore Peterson Institute (WPI).

A paper by Mikovits and Ruscetti was retracted because no one else could replicate the work.

She was eventually fired after a paper she was lead author on, which found xenotropic murine leukemia virus-related virus (XMRV) in patients with CFS, was retracted and the institute accused her of stealing notebooks and manipulating data.

“But the leader of the team that authored the 2009 paper, researcher Judy Mikovits, apparently presented the same figure — carrying different labels and supporting a different point — in a talk given at a conference on Sept. 23 in Ottawa.”

Manipulation alleged in paper linking virus, chronic fatigue syndrome

An even larger study found no evidence of XMRV infections in patients with chronic fatigue syndrome, even as she had claimed the virus could cause CFS, Parkinson’s disease, autism and multiple sclerosis.

The source of XMRV in her patients?

“Well-controlled experiments showed that detection of XMRV was due to contaminated samples and was not a marker of or a causal factor in prostate cancer or CFS.”

Johnson et al on Xenotropic Murine Leukemia Virus-Related Virus (XMRV) and the Safety of the Blood Supply

The virus was in a contaminated cell line in which she and others were doing research. The virus wasn’t in the actual patients themselves.

Judy Mikovits on Vaccines

Before her paper was retracted and she was fired from her lab, Judy Mikovits did actually do research on viruses and she is a scientist. She didn’t do research on vaccines though.

Judy Mikovits is still finding retroviruses wherever she looks for them...
Judy Mikovits is still finding retroviruses wherever she looks for them…

That seems to be something she talks about a lot now though:

  • at anti-vaccine rallies
  • at anti-vaccine conferences
  • in anti-vaccine videos

Her claim to fame seems to be talking about contaminated vaccines and bashing Gardasil. And deep state conspiracy theories about why she was arrested and lost her job.

To be clear, a rotavirus vaccine was found to be contaminated with DNA of porcine circovirus type 1.  While that might sound a little scary, it is important to keep in mind that the PCV1 virus doesn’t actually cause disease in people and these weren’t even “biologically active virus particles.”

PCV1 isn’t a retrovirus though and Judy Mikovits wasn’t even the researcher who discovered the contamination, which has since been resolved. 

“These findings do not indicate the presence of either ALV or EAV infection in MMR vaccine recipients and provide support for current immunization policies.”

Hussain et al on Lack of Evidence of Endogenous Avian Leukosis Virus and Endogenous Avian Retrovirus Transmission to Measles Mumps Rubella Vaccine Recipients

Studies have looked at retrovirus contamination of vaccines, but they were  done over 17 years ago. And not by Mikovits. Studies that confirmed that vaccines are safe.

None of this has kept Judy Mikovits from scaring people about vaccines, especially the HPV vaccine.

“Cervical cancer is not a public health threat. It’s not an infectious disease. Why is it in the Department of Public Health? Why are we mandating every child over 9 years old, and I heard soon to be pregnant women, to get this vaccine? It makes no sense.”

Judy Mikovits

It is really hard to understand how someone who worked at the National Cancer Institute could make these statements. Cervical cancer is one of the most common cancers in women.

There is, of course, no mandate for 9-year-olds to get the HPV vaccine. In the United States, HPV vaccination is recommended, beginning at age 11 to 12 years. The HPV vaccine is not recommended for pregnant women and while several vaccines are recommended, no vaccines are actually mandated in pregnancy.

“It was never developed to prevent cancer. It was developed and approved to prevent warts. Warts are not a public health threat. It’s beyond… When scientists like myself, and I work in cancer and AIDS hear this, we are just…”

Judy Mikovits

Gardasil and Cervarix were developed to prevent HPV infections, which cause cervical cancer. HPV can also cause genital warts.

“I think we need to ban… Japan and India have, all HPV vaccinations now, until the appropriate studies are done, until the patients are tested…”

Judy Mikovits

Neither Japan nor India have banned HPV vaccinations.

Why should we? The HPV vaccines are safe, effective, and necessary.

And why would anyone listen to Judy Mikovits? 

More on Judy Mikovits

Should You Get an Extra Dose of Gardasil9?

Believe it or not, the first human papillomavirus (HPV) vaccine was approved way back in 2006.

HPV Vaccine is Cancer Prevention.

And believe it or not, we are now on our third version of the vaccine, which provides protection against even more strains of HPV.

HPV Vaccine Timeline

So we have gone from:

  • Cervarix – HPV serotypes 16, 18 (2006)
  • Gardasil – HPV serotypes 6, 11, 16, 18 (2006)
  • Gardasil9 – HPV serotypes 6, 11, 16, 18, 31, 33, 45, 52, and 58 (2014)

And with each new vaccine, there comes more protection against anal and genital warts and anal, genital, head and neck, and cervical cancers.

Gardasil9, the only HPV vaccine available in the United States, increases the protection level against cervical cancer from 70 to 90%!

Should You Get an Extra Dose of Gardasil9?

Has your child already finished their HPV vaccine series?

With which HPV vaccine?

To be clear, if they have finished the series, then they are considered to be fully vaccinated and protected.

“Persons who have completed a valid series with any HPV vaccine do not need any additional doses.”

National Cancer Institute on Human Papillomavirus (HPV) Vaccines

Remember, the key, high-risk strains that cause most HPV-associated cancer are HPV-16 and 18, which are present in all of the HPV vaccines.

The extra coverage in Gardasil9 to HPV strains 31, 33, 45, 52, and 58 could prevent an additional 10% of invasive HPV associated cancers or about 3,800 cases each year though, mostly in women.

Should you get any extra doses of Gardasil9 for this extra coverage?

“Administration of a 3-dose regimen of 9vHPV vaccine to adolescent girls and young women 12-26 years of age who are prior qHPV vaccine recipients is highly immunogenic with respect to HPV types 31/33/45/52/58 and generally well tolerated.”

Garland et al on Safety and immunogenicity of a 9-valent HPV vaccine in females 12-26 years of age who previously received the quadrivalent HPV vaccine.

While safe to do and it works, there is no formal recommendation that anyone actually get any extra doses of Gardasil9 at this time.

It is something to consider if you want the extra protection though.

Will we get even more coverage in future HPV vaccines? The future might come in different types of vaccines or even in therapeutic vaccines. There doesn’t seem to be a new version of Gardasil with expanded strain coverage in the immediate pipeline though.

More on Getting an Extra Dose of HPV9

Did the FDA Approve a New HPV Vaccine for Adults?

What do you know about the HPV vaccine?

Hopefully you know that it can prevent cervical cancer and that lots of folks spread misinformation that is intended to confuse and scare you away from getting vaccinated and protected with it and other vaccines.

Did the FDA Approve a New HPV Vaccine for Adults?

News that the approved ages for Gardasil have been expanded will likely add to that confusion for a little while.

The FDA simply approved the expanded use of the existing Gardasil 9 vaccine – not a new vaccine.
The FDA simply approved the expanded use of the existing Gardasil 9 vaccine – not a new vaccine.

The first thing to understand is that the FDA did not approve a new Gardasil vaccine for older adults.

They very simply expanded the age recommendations for who should get the existing Gardasil 9 vaccine, which was approved back in 2014, replacing the original Gardasil vaccine, which was approved in 2006.

“The U.S. Food and Drug Administration today approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved use of the vaccine to include women and men aged 27 through 45 years.”

Why the new age indication?

“In a study in approximately 3,200 women 27 through 45 years of age, followed for an average of 3.5 years, Gardasil was 88 percent effective in the prevention of a combined endpoint of persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV types covered by the vaccine.”

But isn’t the whole point of giving the HPV vaccine to preteens that you want to get them vaccinated and protected before they are sexually active and exposed to and infected by HPV?

Sure, but if you didn’t, and unless you are sure that you have been exposed to and have been infected by all 9 types of HPV strains that Gardasil 9 protects you against, then the vaccine is still a good idea when you are older.

Except FDA approval doesn’t automatically mean that your insurance company will pay for it.

That usually comes once a vaccine is formally added to the immunization schedule by the ACIP.

“In a 2005 study, 92% of insurance plans reported following Advisory Committee on Immunization Practices recommendations to determine covered vaccines; of those, 60% could extend coverage within 3 months after issuance of recommendations and 13% in 1 month.”

Lindley et al on Financing the Delivery of Vaccines to Children and Adolescents: Challenges to the Current System

And Obamacare still requires insurance plans to provide ACIP-recommended vaccines at no charge.

Will Gardasil 9 be added to the immunization schedule for adults?

The extended age indication for Gardasil 9 will be discussed at the next ACIP meeting.
The extended age indication for Gardasil 9 will be discussed at the next ACIP meeting.

We should know sooner, rather than later. It is on the agenda for the next ACIP meeting on October 25…

More on Gardasil for Older Adults

Vaccine Fast Tracking

Like a few other vaccines, Gardasil underwent Fast Track approval by the FDA.

“This is the first vaccine licensed specifically to prevent cervical cancer. Its rapid approval underscores FDA’s commitment to help make safe and effective vaccines available as quickly as possible. Not only have vaccines dramatically reduced the toll of diseases in infants and children, like polio and measles, but they are playing an increasing role protecting and improving the lives of adolescents and adults.”

Jesse Goodman, MD, MPH, Director of FDA’s Center for Biologics Evaluation and Research

But that doesn’t mean that any corners were cut in getting it quickly approved or that the vaccine isn’t safe.

Vaccine Fast Tracking

The Fast Track process can help get new drugs and vaccines approved more quickly by the FDA because they have:

  • more frequent meetings with the FDA to discuss the drug’s development plan and to help ensure the collection of appropriate data needed to support drug approval
  • more frequent written communication from the FDA about such things as the design of the proposed clinical trials and the use of biomarkers
  • eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
  • a Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.

In very simple terms, it is kind of like having a VIP pass at an amusement park. It gets you a guide and helps you jump to the front of many of the lines, but you still don’t get to operate the rides yourself.

Vaccine fast tracking doesn't mean that a vaccine gets approved too fast.
It is a myth that vaccine fast tracking means that a vaccine gets approved too fast.

Which vaccines have had Fast Track approval?

They include Gardasil, Vaxchora, a cholera vaccine, the MenB vaccines, and FluBlock, the flu vaccine that is made in insect cells.

Others that have Fast Track designation include vaccines for  anthrax (NuThrax anthrax vaccine adsorbed with CPG 7909 adjuvant), chikungunya, Clostridium difficile (Clostridium difficile toxoid vaccine), malaria, RSV, Zika, Ebola, Invasive
Staphylococcus aureus infections in surgical populations, Shigella (Flexyn2a), and Lyme disease. None are approved yet though.

And that all of these vaccines have Fast Track designation is a good reminder that it isn’t a guarantee of approval.

“With Fast Track designation, early and frequent communication between the FDA and the biopharmaceutical company is encouraged throughout the entire drug development and review process to help to quickly resolve any questions or issues that arise, potentially leading to an earlier approval and access by patients.”

Encouraging Vaccine Innovation: Promoting the Development of Vaccines that Minimize the Burden of Infectious Diseases in the 21st Century

It just puts them on a Fast Track to get approved if they meet all of the FDA requirements for safety and efficacy.

The ability to develop and approve new vaccines quickly is also important as we continue to face new emerging disease threats. Faced with a deadly global pandemic, everyone will be glad that we have the ability to Fast Track vaccines and other drugs.

More on Vaccine Fast Tracking

Who Is Chris Exley?

Are you worried about aluminum in vaccines?

If you are, the chances are good that you have been reading something by or about Professor Christopher Exley recently.

Who Is Chris Exley?

To those in the anti-vaccine movement, Professor Chris Exley is one of the worlds’ leading experts on the subject of aluminum toxicity.

“I am a Biologist (University of Stirling) with a PhD in the ecotoxicology of aluminium (University of Stirling). My research career (1984-present) has focussed upon an intriguing paradox; ‘how come the third most abundant element of the Earth’s crust (aluminium) is non-essential and largely inimcal to life’. Investigating this mystery has required research in myriad fields from the basic inorganic chemistry of the reaction of aluminium and silicon to the potentially complex biological availability of aluminium in humans. I am also fascinated by the element silicon in relation to living things which, as the second most abundant element of the Earth’s crust, is also almost devoid of biological function. One possible function of silicon is to keep aluminium out of biology (biota) and this forms a large part of the research in our group. We are also interested in biological silicification.”

Professor Chris Exley Keele University Staff Profile

What do other people think of Dr. Exley and his work?

“Let me put this straight, this is not a paper that has evidence of scientific fraud or data manipulation. There is no duplicated images, no suspicious blots. The problem I have with this paper is its deep experimental flaws and data analysis that nonetheless should not have passed through the peer-review filter.”

Does the latest paper from Exley show a link between ASD and aluminum?

While it is typically strange to talk about fraud and data manipulation when starting to review a scientific study, remember that other aluminum studies, including other aluminum studies that were also funded by the Children’s Medical Safety Research Institute (CMSRI), were recently retracted.

In addition to performing deeply flawed studies about aluminum, Chris Exley gives lectures about aluminum toxicity at so-called vaccine safety conferences. At one 2011 conference, in addition to Exley talking about The systemic toxicity of aluminium adjuvants, you could have heard presentations by:

  • Russell Blaylock, MD on The central role of immunoexcitotoxicity in aluminum and mercury-containing adjuvant-triggered neurodevelopmental and neurodegenerative disorders
  • Shiv Chopra, MSc, PhD on Vaccination programs: prevention or corruption?
  • John Barthelow Classen, MD on Vaccine induced epidemics of type 1 diabetes and type 2 diabetes/obesity/metabolic syndrome, and their relationship to the epidemic of autoimmune autism
  • Barbara Loe Fisher, President & Founder of NVIC on Medical science & public trust: the policy, ethics and law of vaccination in the 20th & 21st Centuries
  • Lawrence Palevsky, MD, FAAP on Rethinking the germ theory
  • Christopher Shaw, PhD on Aluminum as a neurotoxin: the evidence from cell culture, in vivo, and human studies
  • Yehuda Shoenfeld, MD, FRCP on ASIA – Autoimmune (Auto-inflammatory) Syndrome induced by Adjuvant: a new syndrome to be defined
  • Lucija Tomljenovic, PhD on Gardasil: prophylaxis or medical misconduct? and Aluminum adjuvants and immunization science: a matter of pervasive uncertainty
  • Andrew Wakefield, MB, BS on Autism and vaccines: a research strategy focused on cause

Chris Exley keeps interesting company if he doesn’t want to be thought of as someone who is anti-vaccine…

Interestingly, he also believes that we are living in The Aluminum Age.

“The human race has inadvertently agreed to participate in a clinical trial to assess and understand the toxicity of human exposure to aluminium. This is an experiment which is, of course, ongoing as I write and you read this essay. It is an experiment which has neither been submitted for independent peer review nor received ethical approval.”

And he seems fairly sure that aluminum is responsible for a whole host of diseases, from Alzheimer’s and autism to diabetes.

Why hasn’t research been done to figure out whether or not aluminum is safe?

“While there are thousands of scientific publications over many decades demonstrating the toxicity of aluminium in all living things the larger questions concerning aluminium and common human diseases such as Alzheimer’s disease or diabetes remain unanswered or at best equivocal. These questions remain unanswered primarily because neither the global aluminium industry nor governments which have allowed the unfettered growth of the use of aluminium products are prepared for an answer. Try to imagine the immediate and short term economic consequences of human exposure to aluminium being directly linked as causal or even contributory in just one disease, for example Alzheimer’s disease.”

Of course, it’s a conspiracy!

“The ensuing chaos and stock market crashes would be unpalatable but they would just be the beginning of a world which would now have to change to address and accommodate such knowledge. Now that the tip of the iceberg has become visible the remainder would have to be investigated and the inevitable consequences of human exposure to aluminium would be revealed, piece by piece, and a new jigsaw of life on Earth would slowly be pieced together.”

Just like it was a conspiracy that there was a “tsunami of silence perpetuated by all mainstream media, almost globally” following his deeply flawed study that he thought linked aluminum adjuvants in vaccines and autism.

chris-exley-conspiracy
More than the criticism, it seems that Chris Exley was really bothered that his latest research was ignored…

What’s next for Exley?

You can be sure it will be something about aluminum toxicity…

What to Know About Chris Exley

Professor Chris Exley is an expert on telling folks that aluminum is toxic.

More About the Chris Exley

Can Vaccines Cause ITP?

ITP is an abbreviation for idiopathic thrombocytopenic purpura.

It is a condition in which our platelets get destroyed, leading to excessive bruising and bleeding, since platelets are needed for normal blood clotting.

What Causes ITP?

To understand what causes ITP, it is important to know it is also often referred to as immune thrombocytopenic purpura, because it is typically the cells of our own immune system that destroys our platelets.

Why?

Well, that’s where the idiopathic part comes in.

We don’t know why people develop ITP, although classically, ITP is thought to follow a viral infection, including Epstein-Barr virus (mono), influenza, measles, mumps, rubella, and varicella (chicken pox). ITP has also been associated with many other viral infections, from Dengue fever to Zika.

“Often, the child may have had a virus or viral infection approximately three weeks before developing ITP. It is believed that the body’s immune system, when making antibodies to fight against a virus, “accidentally” also made an antibody that can stick to the platelet cells. The body recognizes any cells with antibodies as foreign cells and destroys them. Doctors think that in people who have ITP, platelets are being destroyed because they have antibodies.”

Pediatric Idiopathic Thrombocytopenia Purpura (ITP)

These children with ITP, usually under age 5 years, develop symptoms a few days to weeks after their viral infections. Fortunately, their platelet counts usually return to normal, even without treatment, within about 2 weeks to 6 months. Treatments are available if a child’s platelet count gets too low though.

Can Vaccines Cause ITP?

The measles vaccine is the only vaccine that has been clearly associated with ITP.

“The available data clearly indicate that ITP is very rare and the only vaccine for which there is a demonstrated cause-effect relationship is the measles, mumps and rubella (MMR) vaccine that can occur in 1 to 3 children every 100,000 vaccine doses.”

Cecinati on Vaccine administration and the development of immune thrombocytopenic purpura in children

Even then though, the risk of ITP after a measles containing vaccine, like MMR or ProQuad, is much less than after getting a natural measles infection, so worry about ITP is a not a good reason to skip or delay getting vaccinated.

What about other vaccines?

There is no good evidence that other vaccines, including the chicken pox vaccine, DTaP, hepatitis B vaccine, or flu vaccine, etc., cause ITP.

What about Gardasil? ITP is listed in the package insert as an adverse reaction for Gardasil, but only in the postmarketing experience section, so it does not mean that the vaccine actually caused the reaction, just that someone reported it.

Although ITP is listed in the PI for Gardasil, studies have shown that there is no association.
Although ITP is listed in the PI for Gardasil, studies have shown that there is no association.

Several large studies have actually been done that found no increased risk for ITP after getting vaccinated with Gardasil.

What to Know About Vaccines and ITP

Although measles containing vaccines can rarely cause ITP, vaccines prevent many more diseases that can cause ITP.

More on Vaccines and ITP