Tag: hpv vaccine

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

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

 

HPV Vaccine Update

merck-hpv-vaccination-large-9
A new commercial is raising awareness about the importance of getting kids vaccinated against HPV.

How often does an update from the Advisory Committee for Immunization Practices (ACIP) mean that your kids will need fewer shots?

Not that often…

But at their October meeting, the ACIP did recommend that preteens needed only two rounds of HPV vaccine, instead of three.

This follows FDA approval for Gardasil 9 on a 2-dose regimen for individuals 9 through 14 years of age in early October.

Remember that children who are at least 9 years old (traditionally 11 or 12 year old boys and girls) have traditionally gotten three doses of Gardasil, with:

  • the second dose at least 1 to 2 months after the first dose, and
  • the third dose at least 6 months after the first dose

With the new recommendations, if your child is under 15 years old when getting the first dose, then he or she will need only two doses of HPV vaccine to complete the series, with the second dose 6 to 12 months after the first.

What if your child has already gotten three doses? Then your child is well protected against HPV.

If your child has already gotten a second dose 1 to 2 months after the first, then they will have to wait to get the third dose following the 3 dose original schedule. The same goes if your child is already at least 15 years old. Neither will benefit from the new recommendation.

In other news about the HPV vaccines:

And remember that it is no longer news that Gardasil, a vaccine that can prevent cancer, was approved by the FDA. That happened over ten years ago – June 2006.

It should also no longer be news that the HPV vaccines are well studied and in continuing studies have only been found to cause mild side effects, just like most other vaccines.

In other vaccine news, GSK will no longer sell its HPV vaccine Cervarix in the United States because of low market demand – i.e. competition from Gardasil.

For More Information On HPV Vaccines:

HPV Vaccine Myths

Few vaccines have generated as many myths as the HPV vaccine. Well at least not since folks falsely started to blame the MMR vaccine for causing an autism epidemic.

The HPV vaccines get their own myths though, from the idea that they encourage kids to have unprotected sex (they don’t) to the creation of a new disorder – ASIA (which most people think doesn’t exist).

Discussing the HPV vaccine on the Ricki Lake Show, Dr. Jay Gordon said that:

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.

Not surprisingly, studies have confirmed that HPV vaccines are safe and they don’t encourage kids to unprotected sex.

And this is the vaccine that Rep. Michele Bachmann said caused mental retardation:

She told me that her little daughter took that vaccine, that injection. And she suffered from mental retardation thereafter.

The president of the AAP had to correct her on that one.

Most parents now understand that the HPV vaccines are well studied and in continuing studies have only been found to cause mild side effects, just like most other vaccines.

For more information:

HPV Vaccines

The first HPV vaccine, Gardasil, was licensed in 2006. It protected against 4 types of human papillomaviruses (HPV4), including the types that most commonly cause cervical cancer.

A second HPV vaccine, Cervarix, was approved in 2009. Together with an improved version of Gardasil (HPV9), they are given to all boys and girls beginning when they are 11 to 12 years old.

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

For more information: