Tag: cancer

Does HPV Vaccination Decrease the Chances You Will Get a Pap Test?

HPV vaccines, including Gardasil and Cervarix, can reduce your risk of developing cervical cancer.

That doesn’t mean that you can stop getting Pap tests to screen for cervical cancer though.

Why not?

Vaccines are not 100% effective and while the HPV vaccines protect against the strains of HPV that are most likely to cause cervical cancer, they don’t include every single strain.

Does HPV Vaccination Decrease the Chances You Will Get a Pap Test?

Again, HPV vaccines don’t replace pap tests.

Whether or not a woman is vaccinated, if they have no extra risk factors (can mean extra screening), they should have:

  • their first Pap test at age 21 years, to look for cell changes on the cervix that can be a sign of precancers (was previously at age 18 years if sexually active)
  • a Pap test every 3 years from age 21 through 29 years (was previously done every year)
  • a Pap test with HPV cotesting (actually tests for the presence of HPV in cervical cells) every 5 years or a Pap test alone every 3 years from age 30 through 65 years

This routine testing can help find precancers before they turn into cervical cancer.

Why would anyone stop getting a pap test after getting vaccinated?

They shouldn’t.

Some folks worry that they might though, because those who are vaccinated might think they are at lower risk to get HPV and cervical cancer.

#SaidNoDoctor, except Dr. Jay Gordon, who made this statement about the HPV vaccine on the Ricki Lake Show.
#SaidNoDoctor, except Dr. Jay Gordon, who made this statement about the HPV vaccine on the Ricki Lake Show.

Fortunately, most studies show that this doesn’t happen. Not surprisingly, studies have also confirmed that HPV vaccines are safe and they don’t encourage kids to have unprotected sex.

And data from the National Center of Health Statistics show that a steady number of women over age 18 years have been getting Pap tests since 1987. Numbers did drop a bit recently for young women between the ages of 18 to 24 years, but that coincides with the 2003 and 2012 changes for when to get Pap testing.

What makes this all a bit confusing is that there are actually some suggestions that women who have been vaccinated at an early age (before they are sexually active), with the newest HPV vaccines (cover more HPV types) might actually be able to get HPV testing instead of a Pap test, can start getting tested at a later age, and can get fewer tests.

None of those are formal recommendations though, so women should keep getting their Pap tests on schedule, whether or not they have been vaccinated.

What about reports of increased rates of cervical cancer in Sweden that are linked to an increase in HPV vaccination rates?

Lars Adersson became a pseudonym when he was outed as not being associated with Karolinska Institute.
Lars Andersson became a pseudonym when he was outed as not being associated with Karolinska Institute.

 

In addition to fake credentials, the author came to bogus conclusions, as although there has been an increase in rates of cervical cancer in some of the smaller counties in Sweden, it is thought to be due to differences in regional cancer prevention. To put it more simply, if it was due to getting vaccinated, then since immunization rates aren’t that different in those counties (just like immunization rates vs autism rates in the United States), then why didn’t rates of cervical cancer go up everywhere?

“Joakim Dillner, professor of infectious epidemiology at Karolinska Institute and register holder for the National Quality Register for Cervical Cancer Prevention and Analysis, says, however, to the Medical Journal that there is nothing in the allegations that the increase would be due to HPV vaccination.”

KI investigates suspected false scientist: “Extremely serious”

Of note, Sweden, recently had the highest participation in their cervical cancer screening program ever, at 82.4% of the population.

“HPV-vaccination is so far associated with equal or higher attendance to cervical screening in Sweden in a cohort of opportunistically vaccinated young women.”

Herweijer et al on The Participation of HPV-Vaccinated Women in a National Cervical Screening Program: Population-Based Cohort Study

So much for the idea that getting an HPV vaccine decreases your likelihood of getting a Pap test…

What to Know About HPV Vaccines and Pap Testing

Although HPV vaccines can decrease your risk of cervical cancer, that shouldn’t influence your decision to get a Pap test.

More on HPV Vaccines and Pap Testing

Can Vaccines Cause Cancer?

We know that several vaccines can prevent cancer, including the human papillomavirus (HPV) vaccines and hepatitis B vaccine.

A cancer treatment vaccine, Provenge, has also been approved by the FDA to treat metastatic prostate cancer. Others are in development.

What Causes Cancer?

It seems like everything causes cancer, doesn’t it?

Did you see the media reports about coffee?

“Cancer is a complex group of diseases with many possible causes.”

American Cancer Society on What Causes Cancer?

Some of the most common causes of cancer include:

  • genetic mutations
  • smoking and tobacco
  • heavy alcohol use
  • unprotected exposure to UV rays in sunlight
  • infections

Fortunately, we can protect ourselves from many of these common causes of cancer.

Can Vaccines Cause Cancer?

Vaccines don’t cause cancer, but that doesn’t stop anti-vaccine websites from saying that they do.

“Cancer is part of our new normal. One in two men and one in three women will receive a cancer diagnosis in their lifetimes. But it’s not just adults. If you can’t bring yourself to focus on this topic for you, please do it for your children.”

Louise Kuo Habakus (Fearless Parent) on Do Vaccines Cause Cancer?

Cancer can definitely become part of your “new normal” if you or a friend or family member gets diagnosed.

National Cancer Institute Surveillance, Epidemiology, and End Results Program cancer statistics.
National Cancer Institute’s Surveillance, Epidemiology, and End Results Program cancer statistics.

Fortunately, cancer rates have been stable, with declining mortality rates. In children, cancer rates have been rising, but only slightly, and nothing like the boom in rates that some folks describe.

Anti-vaccine folks promote the idea that more people are sick, more people have cancer, and in general, everyone is unhealthy, because it fits with their idea that vaccines are dangerous for everyone.

How do they link vaccines and cancer?

They often push the idea that vaccines cause cancer because the original polio vaccines were found to be contaminated with SV40, or simian virus 40. SV40 has not been linked to cancer though.

What about formaldehyde?

Some vaccines contain formaldehyde and formaldehyde is carcinogenic, so how can you say that vaccines don’t cause cancer?

While some vaccines do contain formaldehyde, remember that it is also naturally found in our bodies.

“Carcinogens do not cause cancer at all times, under all circumstances.”

American Cancer Society

It is the long-term exposure to high amounts of formaldehyde, usually inhaled formaldehyde, that is the big concern. Those most at risk would be workers who might be exposed to inhaled formaldehyde. The small amount of formaldehyde in vaccines is safe and does not cause cancer.

Another anti-vaccine talking point? Misusing vaccine package inserts to make you think that vaccines aren’t properly evaluated for mutagenicity and carcinogenicity.

“To ensure the safety of new vaccines, preclinical toxicology studies are conducted prior to the initiation of, and concurrently with, clinical studies. There are five different types of preclinical toxicology study in the evaluation of vaccine safety: single and/or repeat dose, reproductive and developmental, mutagenicity, carcinogenicity, and safety pharmacology. If any adverse effects are observed in the course of these studies, they should be fully evaluated and a final safety decision made accordingly. ”

M.D. Green on the Preclinical Toxicology of Vaccines

They are.

Vaccines are safe and necessary. They don’t cause cancer.

What to Know About Vaccines and Cancer

Several vaccines can prevent cancer and there is even a vaccine that can treat cancer. Vaccines don’t cause cancer though.

More on Vaccines and Cancer

America’s New Normal: Propaganda About the Unhealthiest Generation

My son started to have migraines when he was about 11 years old.

Must be stress, BPA, poor eating habits, all of the screen time, or vaccines, right?

“Americans spend the least on food, the most on health care, have the most highly vaccinated kids, and have the sickest kids of any industrialized country. More kids than not are now chronically ill, developmentally delayed, and eating or injecting prescription medications from cradle to grave – which is going to be a quicker trip for them than it was for their parents, according to data on life expectancy in the US. We are inured to childhood autism, epilepsy, allergy, asthma, diabetes, obesity, Crohn’s disease and cancer. We are dying younger. We are going backwards.”

Judy Converse on America’s New Normal: Chronically Ill Kids

That likely seems like a young age to get migraines and would fit well with the narrative that kids today are part of the unhealthiest generation ever.

Except that I started to get migraines at about the same age, and so did my mother. Like many of the other conditions that seem to be ballooning today, migraines have a genetic component.

The Unhealthiest Generation?

The CDC has long kept statistics on everything from asthma and cancer rates to diabetes and life expectancy rates and helps folks see how healthy kids really are today.
The CDC has long kept statistics on everything from asthma and cancer rates to diabetes and life expectancy rates and helps folks see how healthy kids really are today.

Who says that today’s kids are part of the unhealthiest generation ever?

Mostly anti-vaccine folks who blame vaccines for making kids unhealthy and alternative medical providers who think their holistic remedies will fix all of the problems they see in our unhealthy kids who they claim are full of “toxins.”

Toxins? If you are going to believe that our kids are all sick, then you have to buy into the narrative that toxins are everywhere, especially in vaccines, and they are making kids sick.

Of course, none of that is true.

Vaccines are safe and work to prevent us from getting sick and there are 2 to 3 million fewer deaths in the world each year because people are vaccinated and protected.

“From developing groundbreaking treatments for deadly chronic diseases to saving babies who are born premature, pediatric researchers have increased the ability of children to live full and fulfilling lives that only a few decades before would have been tragically cut short.”

Sandra G. Hassink, MD on the 7 Great Achievements in Pediatric Research

And today’s kids, all 73.6 million of them in the United States, aren’t the unhealthiest. They are actually a very healthy generation, being born with the lowest child and infant mortality rates ever, low rates of hospitalizations, and one of the highest life expectancies in history.

Our Healthy Kids

How do we know today’s kids are healthy?

One easy way is to compare them to kids in the past…

If you have only been listening to the alarmists who talk about the unhealthiest generation all of the time, you likely wouldn’t know that:

  • while 2.6% of kids were thought to be in fair or poor health in 1991, that is down to just 1.8% today (2015)
  • fewer kids today (4.5%) report having had an asthma attack in the previous year than they did in 1997 (5.4%), and that fewer kids have asthma today (8.5%) than in 2003 (8.7%)
  • since 1997, fewer children, whether or not they have insurance, are visiting the emergency room
  • fewer children are requiring overnight hospital stays, down from 5.5% to just 2.1% today (2015)
  • rates of hay fever or respiratory allergy are down since 1997, from 17.5% of kids to 15.6% of kids today (2015)
  • rates of epilepsy have been stable in children for at least 40 years
  • fewer kids have multiple ear infections since 1997, when 7.1% of kids had 3 or more ear infections, to just 5% of kids today (2015)
  • fewer kids are being prescribed antibiotics
  • childhood cancer rates have been rising, but only slightly, and mortality rates have been declining
  • suicide rates are rising, but only from historic lows – they used to be about the same or higher in the early 1990s

Of course, some conditions are on the rise, including ADHD, type 1 diabetes, food allergies, eczema,  obesity, and most autoimmune diseases.

“A few conditions have decreased because of prevention (eg, lead encephalopathy), a few represent relatively new conditions (eg, human immunodeficiency virus type 1 infection), and some have increased after dramatic improvements in survival for individually low-prevalence childhood conditions that previously had high fatality rates (eg, leukemia, cystic fibrosis, congenital heart diseases). Most growth, however, reflects dramatic increases in incidence of a few high-prevalence conditions.”

James M. Perrin, MD on The Increase of Childhood Chronic Conditions in the United States

And autism rates have been up, but we mostly know why.

“…the numbers of people born with autism aren’t necessarily increasing dramatically. It’s just that we’re getting better and better at counting them.”

Emily Willingham

Although we don’t know why most other conditions are trending up (it isn’t vaccines), we will hopefully continue to develop new theories and reverse those trends.

It should be reassuring that many of the trends do show that our kids are indeed healthy.

What to Know About Our Healthy Kids

From gun violence and climate change to the threat of emerging infections, out children do face many threats and are certainly under a lot of stress. There is no evidence that this is the unhealthiest generation though. If anything, they are on track to be one of the healthiest.

More on Our Healthy Kids

Who Is Kelly Brogan?

Kelly Brogan is a holistic psychiatrist.

Why am I writing about a holistic psychiatrist?

More specifically, Kelly Brogan is a women’s health holistic psychiatrist who doesn’t seem to believe that vaccines are safe, that vaccines work, or that vaccines are necessary.

They are.

“…we have been recently convinced through the promise of technology and corporate prowess that processed food is more reliable, nutritious, and beneficial. We’ve been convinced that Hamburger Helper is better for our families than a homemade Bolognese.”

Kelly Brogan

For some reason, she does not seem to be vegan, as one might expect. Not even vegetarian…

She does seem to believe that people with mental health conditions not should be treated with medication. In fact, she thinks the medications that are routinely used to treat common mental health conditions are behind some of the biggest tragedies happening today.

“The records also listed attention deficit hyperactivity disorder as one of his medical conditions” the proverbial smoking gun of every mass shooting in this country.”

Kelly Brogan on the Sutherland Church Shooting

And she was mentored, not by a psychiatrist, but by a doctor who pushed “a largely dietary treatment for cancer including an individualized organic diet, large amounts of supplements, and pancreatic enzymes,” a regimen that was actually studied and found to be harmful and reduced the quality of life for people with a deadly form of cancer.

Who Is Kelly Brogan?

Kelly Brogan is a holistic psychiatrist.

“Eastern wisdom tells us that when we think we know, we don’t. But when we admit ignorance, we achieve enlightenment. The most profound part of my departure from conventional medicine has been the depths of my surrender to all that we do not, cannot, and must not understand about the body and its experience. Humble awe and wonder are truly the only appropriate states for approaching the complexity of the human condition.”

Kelly Brogan

Do holistic psychiatrists use a different definition for the word humble?

“All suffering is caused by ignorance. People inflict pain on others in the selfish pursuit of their own happiness or satisfaction.”

Dalai Lama XIV

Kelly Brogan, a holistic psychiatrist, also pushes a lot of anti-vaccine talking points about epigenetics, germ theory denialism, MTHFR, and the need for detoxing from vaccines.

These beliefs can cause suffering if she can get others to believe them too, as can pushing the idea that babies shouldn’t get their hepatitis B vaccine or a vitamin K shot.

I’m actually surprised that she hasn’t written about RhoGAM. Maybe she hasn’t gotten around to it. But she doesn’t disappoint. She has shared an article on her Facebook page that claims that the RhoGham shot is just a “Big Pharma Profit Ploy.”

Kelly Brogan is a holistic psychiatrist that wants you to live a medication free life. I guess that could have made her some kind of psychoanalysist, but that doesn’t seem to be the route she went.

“In fact, ‘treatment’ with chemotherapy and radiation not only disrupts a complex process that needs to actually be supported, but also it induces secondary harm, both psychically and physiologically. When we interfere and war with the body, we keep the fight alive – you can’t win the battle against yourself.”

Kelly Brogan

Is she telling people to stop their cancer treatments?

Do folks get a lot of training in treating cancer in their psychiatry residency these days?

And she advises that you “think long and hard about vaccination.”

“As we discover more about the near infinite sophistication of your interconnected bodily systems, and the hyper-individuality of any cause and effect process resulting from a healthcare decision, the one-size-fits-all, indemnified vaccine program may begin to make less and less sense to you. Educate yourself before you make a choice that could change everything for you and your family. Trust your body. Invest in your immunity. And explore a mindset shift that offers you a fear-free way to understand health and wellness.”

Kelly Brogan

Shortly after talking about informed consent, she lets you know how she really feels about vaccines.

“Don’t buy into the lore, don’t make assumptions, and understand that the philosophical underpinnings of the vaccination program are predicated on an antiquated perspective: warring against and attempting to eradicate bad germs. Science has left that childlike notion in the dust, and so should we.”

Kelly Brogan

I think Dr. Brogan misspelled pseudoscience

Why don’t you need to get your kids vaccinated and protected? Because Kelly Brogan has a “tremendous faith in the potential for the body to heal when naturally supported.”

Do you?

Will you during a measles outbreak?

“One of my favorite medical terms, anosognosia, means lack of awareness of a deficit. I have come to find this useful in description of so many of my colleagues who practice the medicine they were trained to practice without conscious acknowledgement of its gross limitations and even hazards.”

Kelly Brogan

Kelly Brogan didn't make history in getting a case report published in a low impact journal who's editorial board includes a Reiki Master, chiropractors, and naturopaths.
Kelly Brogan didn’t make history in getting a case report published in a low impact journal who’s editorial board includes a Reiki Master, chiropractors, and naturopaths.

Does anyone else think that it is wildly ironic that anosognosia is Kelly Brogan’s favorite medical term?

Psychiatry explains Kelly Brogan well.

Actually, it might be cognitive psychology that explains her actions.

Can a psychiatrist be suffering from the Dunning-Kruger effect?

I don’t know, but I’m pretty sure that a holistic psychiatrist can.

A history-making case report? Considering that case reports are the weakest type of scientific evidence, just above YouTube videos and articles on her website, that’s not likely.

Kelly Brogan is a holistic psychiatrist who has flirted with HIV denialism.

You can get educated about vaccines if you are on the fence, but it won’t be from Kelly Brogan, a women’s health holistic psychiatrist.

What to Know About Kelly Brogan

Kelly Brogan is a holistic psychiatrist who seems to charge folks a lot of money in private consultations to help them know that she has faith in their potential to heal themselves naturally – with her help.

More About Kelly Brogan

Updated December 2, 2017

Are Vaccines Evaluated for Mutagenicity, Carcinogenicity or Impairment of Fertility?

Spend much time on anti-vaccine websites or forums and you will soon be warned that vaccines are not evaluated for mutagenicity, carcinogenicity or impairment of fertility.

Actually, you can often read that simply by reading a vaccine’s package insert.

Mutagenicity, Carcinogenicity and Impairment of Fertility

What are these term exactly?

  • mutagenicity – being known or suspected of causing mutations in our DNA, which can lead to cancer
  • carcinogenicity – being known or suspected of being able to cause cancer
  • impairment of fertility

And why are they listed in Section 13 of a vaccine’s package insert?

The Section 13 Vaccine Conspiracy?

More importantly, why do some folks talk about Section 13.1 of a vaccine’s package insert like it is Area 51 or Agenda 21?

“13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, mutagenesis, impairment of fertility. This subsection must state whether long term studies in animals have been performed to evaluate carcinogenic potential and, if so, the species and results. If results from reproduction studies or other data in animals raise concern about mutagenesis or impairment of fertility in either males or females, this must be described. Any precautionary statement on these topics must include practical, relevant advice to the prescriber on the significance of these animal findings. Human data suggesting that the drug may be carcinogenic or mutagenic, or suggesting that it impairs fertility, as described in the “Warnings and Precautions” section, must not be included in this subsection of the labeling.”

CFR – Code of Federal Regulations Title 21

So no material for a vaccine conspiracy?

Just information on studies in animals?

“The goals of the nonclinical safety evaluation generally include a characterization of toxic effects with respect to target organs, dose dependence, relationship to exposure, and, when appropriate, potential reversibility. This information is used to estimate an initial safe starting dose and dose range for the human trials and to identify parameters for clinical monitoring for potential adverse effects. The nonclinical safety studies, although usually limited at the beginning of clinical development, should be adequate to characterize potential adverse effects that might occur under the conditions of the clinical trial to be supported.”

FDA on Guidance for Industry M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals 

It still sounds important though…

Are Vaccines Evaluated for Mutagenicity, Carcinogenicity or Impairment of Fertility?

As important as vaccines are, no one wants them to mutate our children, cause cancer, or keep them from having babies.

Fortunately, they don’t!

“To ensure the safety of new vaccines, preclinical toxicology studies are conducted prior to the initiation of, and concurrently with, clinical studies. There are five different types of preclinical toxicology study in the evaluation of vaccine safety: single and/or repeat dose, reproductive and developmental, mutagenicity, carcinogenicity, and safety pharmacology. If any adverse effects are observed in the course of these studies, they should be fully evaluated and a final safety decision made accordingly. ”

M.D. Green on the Preclinical Toxicology of Vaccines

And that’s because vaccines are safe and well tested.

Then why do anti-vaccine folks scare parents into thinking that vaccines are missing necessary testing when the package insert states that they are “not evaluated for mutagenicity, carcinogenicity or impairment of fertility?”

Cancer is caused by a host of factors. Vaccines have a role in preventing and potentially treating some types of cancer. Components of vaccines and their associated cell lines that viruses are grown in are safe and have not been shown to induce cancer in the vaccinated host.
“Cancer is caused by a host of factors. Vaccines have a role in preventing and potentially treating some types of cancer. Components of vaccines and their associated cell lines that viruses are grown in are safe and have not been shown to induce cancer in the vaccinated host.”

Probably because it sounds scarier than saying that vaccines have a low risk of inducing tumors and that there are very specific guidelines and rules for when a manufacturer needs to perform fertility studies.

That means that if  a package insert says that it has “not been evaluated,” it is simply because it was not necessary or appropriate. It is not because they just didn’t want to do it and left those tests out.

That doesn’t sound as scary though.

All necessary pre-clinical or nonclinical testing is done on vaccines and their components. You just don’t see long term testing that would be listed in the package insert unless the initial tests found a problem.

Also remember that vaccines are monitored through several passive and active safety systems that would detect issues with mutagenicity, carcinogenicity, and impairment of fertility.

And several vaccines actually prevent cancer!

What to Know About Vaccines and Mutagenicity, Carcinogenicity and Impairment of Fertility

Vaccines are appropriately evaluated for mutagenicity, carcinogenicity and impairment of fertility, when necessary, as a part of pre-clinical or nonclinical studies that occur even before the first phase one studies on people.

More About Vaccines and Mutagenicity, Carcinogenicity and Impairment of Fertility

 

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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How to Read a Package Insert for a Vaccine

The highlights of prescribing information of the package insert offers a nice summary of each section, with more details in the full prescribing information section that follows.
The Highlights of Prescribing Information of the package insert offers a nice summary of each section, with more details in the Full Prescribing Information section that follows.

Show me the package insert!

If you are going to ask for a package insert, you should know what’s in it and how it should be read.

Otherwise, it is easy to get misled by antivaccine propaganda, like when Mike Adams claimed he discovered “a vaccine document on the FDA’s own website that openly admits vaccines are linked to autism.”

He really just found the widely available vaccine package insert that said no such thing.

How to Read a Package Insert for a Vaccine

What goes into a package insert is dictated by the FDA, specifically the Code of Federal Regulations Title 21, and Section 314 of the NCVIA, after consultation with the Advisory Commission on Childhood Vaccines.

Much like the package inserts for other medicines, a vaccine package insert includes up to 17 major sections, including:

  1. Indications and Usage – what the vaccine is used for
  2. Dosage and Administration – the recommended dose of vaccine, when and where it should be given, and how to mix it
  3. Dosage Forms and Strengths – available dosage forms
  4. Contraindications – all situations when the vaccine should not be given
  5. Warning and Precautions – all adverse reactions and safety hazards that may occur after getting the vaccine and what you should do if they occur
  6. Adverse Reactions – this section includes clinical trials experience, postmarketing experience, and voluntary reports, and it is very important to understand that it is not always possible to establish a causal relationship to vaccination for these adverse effects. So just because something is listed here, whether it is SIDS, autism, drowning, or a car accident, doesn’t mean that it was actually caused by the vaccine.
  7. Drug Interactions – any reactions you might expect between the vaccine and other drugs
  8. Use in Specific Populations – can include recommendations for use in pregnancy, nursing mothers, pediatric use, and geriatric use
  9.  Drug abuse and dependence – usually blank
  10.  Overdosage – usually blank
  11. Description – general information about the vaccine, including how it was made and all vaccine ingredients.
  12. Clinical Pharmacology – how the vaccine works, including how long you might expect protection to last
  13. Nonclinical Toxicology – must include a section on carcinogenesis, mutagenesis, impairment of fertility, even if it is to say that the vaccine “has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility.”
  14. Clinical Studies – a discussion of the clinical studies that help us understand how to use the drug safely and effectively
  15. References – when necessary, a list of references that are important to decisions about the use of the vaccine
  16. How Supplied/Storage and Handling
  17. Patient Counseling Information – information necessary for patients to use the drug safely and effectively

In addition to not having sections 9 and 10, some vaccines don’t have a section 13. It is not a conspiracy. Some older vaccines, like Varivax, do not have to have a section 13 per FDA labeling rules.

Myths About Package Inserts

Just as important as what’s listed in a vaccine package insert, is what the package insert doesn’t say.

Or what you might be led to believe it says.

“To ensure the safety of new vaccines, preclinical toxicology studies are conducted prior to the initiation of, and concurrently with, clinical studies. There are five different types of preclinical toxicology study in the evaluation of vaccine safety: single and/or repeat dose, reproductive and developmental, mutagenicity, carcinogenicity, and safety pharmacology. If any adverse effects are observed in the course of these studies, they should be fully evaluated and a final safety decision made accordingly. ”

M.D. Green on the Preclinical Toxicology of Vaccines

When reading a package insert, don’t be misled into thinking that:

  • you should be worried if a package insert states that a vaccine has not been evaluated for carcinogenic (being known or suspected of being able to cause cancer) or mutagenic (being known or suspected of causing mutations in our DNA, which can lead to cancer) potential or impairment of male fertility. Vaccines don’t cause cancer or impair male fertility, or female fertility for that matter. And as you probably know, many vaccines actually prevent cancer. Formaldehyde is the only vaccine ingredient on the list of known carcinogens, but it is the long-term exposure to high amounts of formaldehyde, usually inhaled formaldehyde, that is carcinogenic, not the residual amounts you might get in a vaccine over short amounts of time.
  • any vaccine actually causes SIDS or autism
  • pediatricians are trying to keep parents from reading package inserts. Your pediatrician is probably just confused as to why you want it, as the VIS is designed for parents, not the package insert. But if even if your pediatrician doesn’t hand you a package insert for each and every vaccine your child is going to get, they are readily available from the FDA and many other websites.

Better yet, just don’t be misled by anti-vaccine misinformation.

“Based on previous experience, carcinogenicity studies are generally not needed for adjuvants or adjuvanted vaccines.”

WHO Guidelines on Nonclinical Evaluation of Vaccine Adjuvants and Adjuvanted Vaccines

Vaccines are thoroughly tested for both efficacy and safety before they are approved.

It is also important to understand that the WHO Guidelines on Nonclinical Evaluation of Vaccine Adjuvants and Adjuvanted Vaccines and the European Medicines Evaluation Agency both state that mutagenicity and carcincogenicity studies are typically not required for vaccines.

Why not?

It is because vaccines have a low risk of inducing tumors.

There are also very specific guidelines and rules for when a manufacturer needs to perform fertility studies.

So, as expected, there are no surprises in vaccine package inserts. You can be sure that everything that needs to be tested to show that a vaccine is safe has been done. If it has “not been evaluated,” it is simply because it was not necessary.

Get educated about vaccines and get your family vaccinated and protected against vaccine preventable diseases.

What to Know About Reading Vaccine Package Inserts

Learn how to read vaccine package inserts so that you aren’t misled by many of the myths about what they do and don’t say, including why they are likely missing information on the vaccine’s potential to cause carcinogenicity, mutagenicity, or impairment of fertility.

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