Tag: gardasil

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

Is the HPV Vaccine a Savior or the Most Dangerous Vaccine Ever Made?

I’m still surprised at the responses some parents have when I mention that it is time for their kids to get their HPV vaccine.

Despite what you might read on the Internet, the HPV vaccines are safe and necessary.
Despite what you might read on the Internet, the HPV vaccines are safe and necessary.

While most say things like, “good, I was wondering when they would start it,” a minority still use arguments that could come straight off of any anti-vaccine website or forum.

Is the HPV Vaccine Dangerous?

The HPV isn’t dangerous, but it is easy to see why some parents still think that it is.

How many myths about the HPV vaccine have you heard?

“I don’t like this vaccine… Heaven help us if we have a generation of kids who get a hepatitis B vaccine and a HPV vaccine and they think that now unprotected sex is okay…

I don’t think it is really clear that this vaccine is really as safe as they say it is and it is certainly not as dangerous as they say it is, but I recommend against it in my practice.”

Dr. Jay Gordon discussing the HPV vaccine on the Ricki Lake Show

You can rest assured that they aren’t true.

Deciding to Get an HPV Vaccine

The HPV vaccines are well studied and in continuing studies have only been found to cause mild side effects, just like most other vaccines.

Still undecided?

“The manufacturers of Cervarix and Gardasil are following patients in Scandinavia for at least 15 years to verify that protection from both vaccines lasts at least that long.”

National Cancer Institute on HPV Vaccines

Parents who are still hesitant should know that:

  • Gardasil, the first HPV vaccine, was approved by the FDA in 2006. The first phase 1 and phase 2 trials began in 1997. It has been given to over 200,000,000 children, teens, and young adults for over 10 years now all over the world.
  • while fainting might occur after vaccination, it is also not uncommon after other vaccinations and medical procedures, especially in teens. It is not a specific issue caused by the HPV vaccine or any vaccine, for that matter.
  • the HPV vaccine does not cause primary ovarian failure, venous blood clots, behavior problems, multiple sclerosis, autoimmune disorders, or any of the other serious side effects you read on the Internet
  • while the HPV vaccine won’t protect against all forms of HPV, it protects against the forms that are most likely to cause cervical cancer. Just two types of HPV, types 16 and 18, cause 70% of cervical cancers, and another two types, types 6 and 11, cause 90% of genital warts. All are included in the Gardasil vaccine and Cervarix includes the types most likely to cause cervical cancer.
  • HPV is not rare – in fact, it is the most common sexually transmitted infection in the United States. While many infections do go away on their own, spontaneously, others linger and can cause cervical cancer.
  • HPV doesn’t just cause cervical cancer though, it can also cause vaginal, vulvar, penile, and anal, and oropharyngeal cancer, and genital warts
  • the HPV vaccines seem to provide long lasting protection, although, as with any new vaccine, we won’t know just how long the true duration of protection is until the vaccines have been out even longer. So far, Gardasil and Cervarix are providing protection that lasts at least 8 and 9 years.
  • boys need the HPV vaccine too, as 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.
  • you want your child to get the HPV vaccine before they are having sex, to prevent them from ever getting infected with HPV, which is why it is routinely recommended when kids are 11 to 12 years old. That they are not sexually active yet is the whole point! As with other vaccines, if you continue to wait, you might eventually wait too long, although you can still get the vaccine if they are already sexually active, even if they are already infected with HPV, as it might protect them against another strain that they don’t have yet.
  • getting the HPV vaccine does not make it more likely that a teen will have sex
  • using condoms will not prevent all HPV infections. HPV can also spread through nonpenetrative sexual contact.
  • cervical cancer is serious, with about 4,200 women dying of cervical cancer each year, even in this age of routine pap tests
  • although you may hear that the HPV vaccine has been banned in some places, it is still offered in Japan, Utah, and other places where they talk about these bans, and since 2014, at least 64 countries have added the HPV vaccine to their immunization schedule

Get educated about vaccines and get your kids their HPV vaccine series. Remember that if you start the series before your kids are 15 years old, they only need two doses of the vaccine. After 15 years, they need 3 doses.

What To Know About Deciding to Get an HPV Vaccine

The HPV vaccines are safe, they work, and are necessary, which are beliefs shared by experts and most parents who decide to get their kids vaccinated and protected against HPV.

More Information on Deciding to Get an HPV Vaccine

 

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Cancer Vaccines Can Prevent and Treat Many Cancers

The CDC recommends HPV vaccination for 11 and 12 year olds.
The CDC recommends HPV vaccination for 11 and 12 year olds.

When you think about a cancer vaccine, what do you imagine?

Hopefully it isn’t the anti-vaccine myth that the polio vaccine causes cancer – it doesn’t.

Is it a vaccine that prevents all cancer, a so-called universal cancer vaccine? Or vaccines that target specific types of cancer?

Or do you get thoughts of a cancer vaccine that targets and kills cancer cells, treating patients once they already have cancer?

Sound too futuristic?

While a universal cancer vaccine is likely for than a few years away, many people are surprised that some of the vaccines in the current childhood and adolescent immunization schedule can actually prevent cancer.

Another vaccine is approved to treat cancer.

And that’s good news, as cancer is now the leading cause of death in the United States.

Current Cancer Vaccines

When cancer is caused by an infection, it makes sense that you can prevent the cancer by preventing the infection in the first place. That is the rationale for the current preventive cancer vaccines for the human papillomavirus (HPV) and hepatitis B:

  • Gardasil – an HPV vaccine that can be given to preteen boys and girls to protect against most genital warts and anal cancer. Gardasil also protects women against most cervical cancers.
  • Hepatitis B – the hepatitis B vaccine prevents hepatitis B infections, which when they become chronic, can develop into liver cancer.

For these vaccines to be effective, they have to be given before you are exposed to the virus. That is why it is critical for preteens to get the HPV vaccine before they become sexually active teens and young adults.

Since babies can get hepatitis B if their mother is infected and they are more likely to develop chronic hepatitis B infections, it is also important that all infants be vaccinated with the hepatitis B vaccine. Vaccination programs that instead try to target just those newborns of mothers already known to be infected with hepatitis B are much less successful than universal vaccination programs.

In addition to a preventive cancer vaccine, another type of cancer vaccine is the therapeutic or cancer treatment vaccine. This type of cancer vaccine actually helps your body fight the cancer.

So far, only one cancer treatment vaccine has been approved by the FDA.

Provenge is approved for some men with metastatic prostate cancer, increasing their survival by about 4 months. Provenge works by stimulating T lymphocytes, a part of our immune system, to kill prostate cancer cells.

Cancer Vaccines in Development

Although there are just four approved cancer vaccines in use today, there are many more in development, including:

  • DCVax(R)-L – in phase III trials to treat certain patients with glioblastoma multiforme, a type of brain tumor.
  • NeuVax – in multiple phase II trails, including one for certain patients with breast cancer to help prevent breast cancer recurrence.
  • Rindopepimut – in phase III trial to treat certain patients with glioblastoma.
  • Tecemotide – in phase III clinical trials for certain patients with non-small cell lung cancer.

Even more cancer vaccines are in phase I and phase II trials, such as WDVAX, which is in phase I clinical trials to treat certain patients with melanoma.

Although perhaps not as far along and still in early exploratory or pre-clinical research stages, there are other preventive cancer vaccines being developed too. These new vaccines would provide protection against hepatitis C (liver cancer), Epstein-Barr virus (Burkitt lymphoma, non-Hodgkin lymphoma, and Hodgkin lymphoma, etc.), Helicobacter pylori (stomach cancer), schistosomes (bladder cancer), and liver flukes (liver cancer).

What To Know About Cancer Vaccines

In addition to the hepatitis B and HPV vaccines that can prevent cancer, multiple vaccines are being developed to actually treat cancer.

For More Information On Cancer Vaccines