Tag: gardasil

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

 

About Those HPV Vaccine Trials in Infants…

Gardasil is already on the immunization schedule, but are they going to make it one of your baby’s first vaccines?

That’s what some anti-vaccine websites are saying…

About Those HPV Vaccine Trials in Infants…

So is this just more anti-vaccine propaganda?

The clinical trial's inclusion criteria makes it clear that they are not studying the HPV vaccines on infants.
This clinical trial’s inclusion criteria makes it clear that they are not studying the HPV vaccines on infants.

Of course it is.

And like most anti-vaccine propaganda, there isn’t even a teeny tiny kernel of truth in their statements about Gardasil being “pushed on infants.”

While there was a study about giving Gardasil to kids who have already had at least three relapses of respiratory papillomatosis caused by HPV 6 or 11, those kids had to be between 1 and 17 years old.

No infants (children under 12 months old) were ever in this study which was supposed to start in 2014 in Budapest, Hungary.

“Recurrent respiratory papillomatosis in children caused by HPV 6,11 can be a life threatening condition resulting in surgical interventions. The maturing and disintegrating papillomas are the sources for the subsequent HPV relapses and immunization might slow down or even prevent this ongoing process.

After an initial immunological and ear-nose-throat (ENT) assessment children with at least 3 relapses in their patient history will be vaccinated with 4-valent HPV vaccine according to the following schedule: 0., 2., 6. months. It will be followed by an immunological and 3 ENT examinations to assess response to vaccination.”

4-valent HPV Vaccine to Treat Recurrent Respiratory Papillomatosis in Children

Will Gardasil work for kids who already have recurrent respiratory papillomatosis, even though they got the HPV infection when they were born?

Hopefully it will.

“Any child presenting with a voice disturbance with or without stridor is recommended to have diagnostic flexible fiber-optic laryngoscopy. Recurrent respiratory papillomatosis should be considered in children when other common pediatric airway diseases either do not follow the natural history or do not respond to treatment of the common disorder.”

Zacharisen et al on Recurrent Respiratory Papillomatosis in Children: Masquerader of Common Respiratory Diseases

But there is already good news about Gardasil and recurrent respiratory papillomatosis.

A papilloma caused by HPV on the vocal cords of a child with recurrent respiratory papillomatosis.
A papilloma caused by HPV on the vocal cords of a child with recurrent respiratory papillomatosis. (CC BY 4.0)

The widespread use of the Gardasil in teens and adults is already decreasing the number of kids being diagnosed with recurrent respiratory papillomatosis!

That makes sense, because if their mom doesn’t have an HPV infection when they are born, the infection can’t be passed on to them, later causing recurrent respiratory papillomatosis.

That’s another benefit of getting vaccinated!

What to Know About Those HPV Vaccine Trials in Infants

The idea that the HPV vaccines are now being tested on infants is just another example of anti-vaccine propaganda. They are using a clinical trial of children and teens with recurrent respiratory papillomatosis to scare you away from vaccinating and protecting your children.

More on Those HPV Vaccine Trials in Infants

Et Tu, Slate? Flaws with Their Questions About Gardasil

Questioning vaccines doesn’t make someone anti-vaccine.

Something is missing in this article about Gardasil testing in Slate...
Something is missing in this article about Gardasil testing in Slate…

Doing a poor job of it and making folks scared to get vaccinated and protected?

I’ll let you decide what to call them…

Slate Investigates the Gardasil Clinical Trials

So after an eight-month long investigation, a journalist for Slate thinks he has evidence that the clinical trials that helped get Gardasil approved by the European Medical Agency were flawed.

What was the problem?

The way that they recorded possible side effects after folks were vaccinated.

“To track the safety of its product, the drugmaker used a convoluted method that made objective evaluation and reporting of potential side effects impossible during all but a few weeks of its years long trials.”

What made the method convoluted?

“In an internal 2014 EMA report about Gardasil 9 obtained through a freedom-of-information request, senior experts called the company’s approach “unconventional and suboptimal” and said it left some “uncertainty” about the safety results.

Merck, which is known as Merck Sharp & Dohme outside the U.S. and Canada, did not address the EMA’s safety concerns.”

When you read the internal 2014 EMA report about Gardasil 9, it is clear that Merck has a thorough response to each and every question that the EMA asked.

And those other quotes?

The EMA does state that:

  • “At all other time points in the study medical events were reported as “new medical history”. This is an unconventional and suboptimal study procedure.”
  • “While it is considered that the required safety data eventually has been made available for assessment, this feature of the study protocol brings some degree of uncertainty into safety assessment.”

So the EMA got the required safety data they were looking for, which is likely why Gardasil was approved in Europe.

They also said that “As the AE reporting procedure as seen at the inspection sites was in line with the approved protocol, the inspectors did not comment on it in the inspection reports. It was discussed with assessors during the course of the inspections, as in the inspectors’ opinion it is not an optimal method of collecting safety data, especially not systemic side effects that could appear long after the vaccinations were given.”

This case of a subject with POTS was reported as being "well characterized" by the EMA, even though it likely wasn't caused by her Gardasil shots.
This case of a subject with POTS was reported as being “well characterized” by the EMA, even though it likely wasn’t caused by her Gardasil shots.

But if it was suboptimal, how come they were able to record someone getting diagnosed with POTS 1,389 days after their third dose of vaccine?

I’m starting to understand why Dr. Yehuda Shoenfeld wasn’t quoted in the piece. He likely knew how it was going to be perceived…

“Imagining a link between HPV vaccination and CFS is not all that far-fetched, according to Dr. Jose Montoya, a professor of medicine at Stanford University and a CFS expert.”

Not far-fetched at all, which is why studies are done to see if there really is a link.

So even if part of the study design was suboptimal, the Slate piece shouldn’t have cherry picked those quotes and should have included these other big pieces of information:

  • A study in the UK using the MHRA’s Yellow Card passive surveillance scheme found no increase in reports of chronic fatigue syndromes following the introduction of Cervarix (another HPV vaccine)
  • In 2015, the EMA confirmed evidence that HPV vaccines do not cause complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS)
  • A large, nationwide register-based study from Norway found no indication of increased risk of chronic fatigue syndrome/myalgic encephalomyelitis following HPV vaccination
  • A large cohort study of over 2 million young girls in France found no risk for autoimmune diseases (including neurological, rheumatological, hematological, endocrine, and gastro-intestinal disorders)
  • A large cohort study of girls in Sweden with pre-existing autoimmune diseases found that HPV vaccination was not associated with increased incidence of new-onset autoimmune disease (49 types of autoimmune diseases)
  • A review of VAERS reports that “did not detect any unusual or unexpected reporting patterns that would suggest a safety problem” with HPV vaccination

The Slate piece does mention two of these studies, but just barely. One gets a single sentence and the other, half a sentence.

We see page after page of anecdotes of folks with supposed vaccine injuries, but the evidence that shows the vaccine is safe is almost buried and easy to miss. Many of the other studies seem to be left out.

And just because these patients have agonistic auto-antibodies, it doesn’t mean that they are from a vaccine.

“Five of the 14 POTS subjects and 2 of the 10 “healthy controls” recalled a respiratory infection in the 6 months prior to onset of their symptoms or inclusion in the study for the healthy controls.”

Li et al on Autoimmune Basis for Postural Tachycardia Syndrome

Lastly, what’s with calling cervical cancer uncommon???

“Cervical cancer is the 4th most common cause of cancer death in women worldwide, with tens of thousands of deaths in Europe each year despite the existence of screening programmes to identify the cancer early.”

European Medicines Agency

Downplaying the risks of vaccine-preventable diseases, while trying to scare folks about vaccines – that’s what gets you labeled as anti-vaccine.

The HPV vaccines are safe. They work and they are necessary. Don’t skip them.

What to Know About the Slate Gardasil Investigation

Although the study design for Gardasil used for licensing in Europe might have been suboptimal, that doesn’t really come across in this Slate piece, as it seems clear that it didn’t result in safety data being missed, and as post-licensure tests have confirmed, Gardasil is safe.

More on the Slate Gardasil Investigation

Did Utah Ban the HPV Vaccine?

The Gardasil vaccine seems to provoke a lot of controversy and still more misinformation, even as compared to typical anti-vaccine rhetoric.

Maybe since it is a newer vaccine or because it is for an STD, but for whatever reason, some folks can’t get over the fact that study after study has proven that the HPV vaccines are safe and effective.

Did Utah Ban the HPV Vaccine?

So if it is so safe and effective, then why did Utah ban the use of Gardasil?

They didn’t.

There is a very small sliver of truth to the story though.

“Citing low demand, high costs — and questioning the benefits, Utah’s Southwest Public Department of Health does not stock or recommend Gardasil, the vaccine against HPV, the cancer-causing human papilloma virus.”

The Salt Lake Tribune

In most states, a decision like that by the Department of Health would be a big deal, because it would likely have to come from the state health department.

Not so much in Utah, where their 13 local health departments are independent of the Utah Department of Health. And they are each governed by local boards of health using a decentralized organizational model.

So the decision to ‘ban Gardasil’ wasn’t made by “Utah,” where the Department of Health has actually been recommending the vaccine since 2006.

It wasn’t even made by the Board of Health for the Southwest Public Department of Health.

The decision was made by one person – the agency’s director, Dr. David Blodgett.

Where Else Has Gardasil Not Been Banned

Even then, Gardasil wasn’t actually banned in the Beaver, Iron, Garfield, Kane and Washington counties of southern Utah that are served by the Southwest Public Department of Health where he is the director. The vaccine just wasn’t available at health department clinics in the area.

The Utah Department of Health actively encourages kids to get their HPV vaccine as a way to help prevent them from getting cancer.
With the exception of David Blodgett, the Utah Department of Health actively encourages kids to get their HPV vaccine as a way to help prevent them from getting cancer.

You could still get the vaccine at a doctor’s office or clinic, including free HPV vaccines from clinics that participate in the Vaccines for Children program.

So again, Gardasil wasn’t banned in Utah or even this part of southern Utah.

And do you know where else you can still get an HPV vaccine?

The 2016 routine and voluntary immunization schedule in Japan.
The routine and voluntary immunization schedule in Japan still includes the HPV vaccine.

Gardasil is still available in Japan, India, France, Spain, and all of the countries where anti-vaccine folks say it was also banned.

Even in Japan, where governmental authorities did withdraw support for the vaccine while the Ministry of Health, Labour, and Welfare in Japan further investigated safety and efficacy claims, an Expert Council on Promotion of Vaccination consisting of 17 Japanese academic societies recommends “renewed proactive support for the widespread use of the HPV vaccine.”

That’s no big surprise, because like other vaccines, the HPV vaccines are safe, effective, and necessary.

What To Know About the Myth of a Gardasil Ban in Utah

Gardasil was never banned in Utah. The director of one local health department has decided to not make it available at local health department clinics in southern Utah since 2013.

More About the Myth of a Gardasil Ban in Utah