Tag: formaldehyde

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

What Are the Pro and Con Arguments for Vaccines?

Is it still OK to “debate” vaccines and vaccine safety?

Sure.

pro-con-vaccines
Using fallacious arguments and anti-vaccine propaganda can not be part of any real debate about vaccines.

What’s not up for debate anymore is the idea that vaccines aren’t safe or necessary or that vaccines don’t work.

Folks who use those arguments against vaccines aren’t debating, they are pushing anti-vaccine talking points.

What Are the Pro and Con Arguments for Vaccines?

Why talk about pro and con arguments if we know that vaccines are safe and necessary?

It’s because vaccines aren’t perfect.

 Pro Con
Vaccines save lives. Shots hurt.
Vaccines are cost effective. Vaccines are expensive.
Vaccines work most of the time. Vaccines aren’t 100% effective.
You are much more likely to get shingles after having a natural chickenpox infection. You can get shingles after having the chickenpox vaccines.
Vaccine preventable diseases are much more likely to cause febrile seizures, non-febrile seizures, and worse. Some vaccines cause febrile seizures.
Most vaccine side effects are mild and they prevent life-threatening diseases. Vaccines aren’t 100% safe.
Vaccines can create herd immunity. Some people can’t be vaccinated.
Kids can get protected against at least 16 vaccine-preventable diseases. Kids get at least 13 different vaccines.
Immunity from some vaccine preventable diseases isn’t lifelong either and some diseases, like tetanus, don’t even provide immunity. Immunity from some vaccines isn’t lifelong.
Some vaccine-preventable diseases, like polio, only provide protection against a single serotype, not against all forms of the disease (there are three serotypes of polio). Some vaccines require booster doses.

And sometimes it doesn’t make sense to recommend a vaccine, except in specific circumstances.

“A MenB vaccine series may be administered to adolescents and young adults aged 16–23 years to provide short-term protection against most strains of serogroup B meningococcal disease. The preferred age for MenB vaccination is 16–18 years.”

ACIP on Use of Serogroup B Meningococcal Vaccines in Adolescents and Young Adults: Recommendations of the Advisory Committee on Immunization Practices, 2015

The MenB vaccine, for example, unlike most other vaccines, only has a permissive recommendation – parents may get it for their kids, but they don’t have to.

“First-year college students living in residence halls should receive at least 1 dose of MenACWY before college entry. The preferred timing of the most recent dose is on or after their 16th birthday.”

ACIP on Prevention and Control of Meningococcal Disease: Recommendations of the Advisory Committee on Immunization Practices

In contrast, the recommendation for most other vaccines state that kids “should” receive them.

Why the difference?

Experts aren’t yet sure that the pros of the MenB vaccine, helping avoid MenB disease, outweigh the cons, which include the high cost of the vaccine, short duration of protection, and that it doesn’t cover all MenB subtypes. The cons aren’t about safety.

The Real Vaccine Cons

What about the “cons” you see on some websites about toxins, vaccine-induced diseases, and vaccine deaths?

Beware of folks trying use anti-vaccine talking points to scare or con you when talking about vaccines.
Beware of folks trying use anti-vaccine talking points to scare or con you when talking about vaccines.

This is when it becomes helpful to understand that the word “con” has multiple definitions.

vaccine-conThese sites use anti-vaccine experts and other anti-vaccine websites as sources, present anecdotes as real evidence, and cherry pick quotes when they do use real sources.

They also work hard to:

Worst of all, they talk about informed consent and choice, all of the while taking away many parents’ choice to make an informed decision by confusing them with misinformation, myths, and propaganda.

Of course, parents who have taken the time to get educated about vaccines don’t fall for any of these arguments.

They know that the evidence overwhelmingly shows that vaccines work, vaccines are safe, and vaccines are necessary.

What to Know About the Pro and Con Arguments for Vaccines

In any real debate, getting vaccinated and protected wins every time, because vaccines work and they are safe and necessary.

More About the Pro and Con Arguments for Vaccines

Vaccines and Autism Redux

Is it true that only one ingredient (thimerosal) and one vaccine (MMR) has ever been looked at for its relationship to autism?

No, as you can probably guess, it is not.

“This meta-analysis of five case-control and five cohort studies has found no evidence for the link between vaccination and the subsequent risk of developing autism or autistic spectrum disorder. Subgroup analyses looking specifically at MMR vaccinations, cumulative mercury dosage, and thimerosal exposure individually were similarly negative, as were subgroup analyses looking specifically at development of autistic disorder versus other autistic spectrum disorder.”

Taylor et al on Vaccines are not associated with autism: An evidence-based meta-analysis of case-control and cohort studies

Since much of the original focus about vaccines and autism was on the MMR vaccine and thimerosal, that’s where a lot of the research to reassure parents went first.

Other research has been done though too, so it really is safe to say that vaccines are not associated with autism, even though some may continue to see a correlation.

“To try to isolate the effects of thimerosal from other vaccine constituents, we performed a subanalysis comparing risks associated with diphtheria-tetanus-whole cell pertussis vaccine or diphtheria-tetanus-acellular pertussis vaccine and Haemophilus influenzae type b vaccine given separately or combined.”

Verstraeten et al on Safety of Thimerosal-Containing Vaccines: A Two-Phased Study of Computerized Health Maintenance Organization Databases

The great majority of parents know that:

  • it is not the MMR vaccine
  • it is not thimerosal or thimerosal containing vaccines
  • it is not the overall number of vaccines that are given to a child
  • it is not the timing of when the vaccines are given to children

And it hasn’t been just one or two studies that have shown that there is no association between vaccines and autism. There are dozens. There is also a comprehensive review by the Institute of Medicine and a very large meta-analysis that have come to the same conclusion.

Vaccines are not associated with autism.

Vaccines and Autism Redux

Could it be aluminum though?

Why aluminum? Because anti-vaccine experts cite some poorly done studies that try to say it is.

Bob Sears appeared on Fox & Friends in 2010 for the segment "Vaccines: A Bad Combination?"
Bob Sears appeared on Fox & Friends in 2010 for the segment “Vaccines: A Bad Combination?”

Aluminum has become the new formaldehyde, which used to be the new thimerosal. It is apparently where the goalposts have shifted when some folks talk about vaccines and autism now that every knows it is not the MMR vaccine, thimerosal, vaccine overload, or the timing of vaccines.

But if studies have shown that it is neither the number of vaccines nor the timing of vaccines, then how could it be aluminum, an adjuvant in many vaccines?

It isn’t.

Aluminum is not the smoking gun or the missing puzzle piece that anti-vaccine folks will continue to look for.

What other myths about vaccines and autism have been coming up lately?

Have you heard the one about the court ruling confirming a vaccine autism link? It didn’t.

Did you know that the FDA officially announced that vaccines are causing autism? They didn’t, but do you know why some folks are now saying they did? Because of the old package insert for the Tripedia vaccine, which lists autism as a possible adverse event (without evidence of causation). The vaccine was discontinued years ago, but it continues to pop up as ‘new’ evidence for some as an association between vaccines and autism.

Or maybe you have heard these other new theories from the anti-vaccine movement as they desperately try to prove an association between vaccines and autism:

  • vaccines block folate uptake
  • MTHFR gene mutations
  • maternal immune activation
  • cytokine storms
  • glutathione depletion
  • glyphosate
  • DNA fragments
  • microbiota alterations
  • GI barrier defects
  • blood brain barrier permeability problems

You don’t even have to pick just one theory anymore (the fact that the MMR vaccine doesn’t contain thimerosal or aluminum kind of puts these theories into opposition with each other, doesn’t it?). You can choose for any or all of them to be true if you want. Using synergistic toxicity, you pick a few of your favorite theories and make them 100 times more likely to damage your child! Not really, but that’s how some anti-vaccine folks think.

“Autism is not an immune-mediated disease. Unlike autoimmune diseases such as multiple sclerosis, there is no evidence of immune activation or inflammatory lesions in the CNS of people with autism. In fact, current data suggest that genetic variation in neuronal circuitry that affects synaptic development might in part account for autistic behavior. Thus, speculation that an exaggerated or inappropriate immune response to vaccination precipitates autism is at variance with current scientific data that address the pathogenesis of autism.”

Gerber et al on Vaccines and Autism: A Tale of Shifting Hypotheses

Of course, none of them are true.

Vaccines are still not associated with autism.

What to Know About Vaccines and Autism

Vaccines are still not associated with autism, even though anti-vaccine folks continue to come up with new ideas for how it might be, from glyphosate and DNA fragments in vaccines to MTHFR mutations and maternal immune activation.

More on Vaccines and Autism

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.

More on How to Read a Package Insert for a Vaccine:

Vaccine Ingredients

From antigens and adjuvants to preservatives, learn about common ingredients in vaccines and why they are safe.

What’s in Vaccines?

It is no secret what’s in our vaccines.

A list of ingredients is included on the vaccine’s package insert and can be found on a number of articles on the Internet.

In addition to other ingredients, a vaccine's package insert includes the viral or bacterial antigens that are in the vaccine.
In addition to other ingredients, a vaccine’s package insert includes the viral or bacterial antigens that are in the vaccine.

In addition to the active ingredients, the viral or bacterial antigens in the vaccine that you generate antibodies against, vaccines are made with a number of excipients, inactive substances or manufacturing by-products that are used to produce the vaccine:

  • preservatives – prevent bacterial and fungal contamination in multi-dose vials – thimerosal, 2-phenoxyethanol, phenol
  • adjuvants – help stimulate a stronger immune response so fewer antigens can be used – aluminum salts
  • stabilizers – maintain the potency of the vaccine and include sugars, amino acids, and proteins – lactose, MSG, gelatin
  • cell culture materials – what the vaccine antigens grow in – chicken egg proteins, yeast proteins, fetal bovine serum proteins
  • inactivating materials – kills viruses, inactivates toxins – formaldehyde
  • antibiotics – prevents bacterial contamination of the vaccine – neomycin, polymyxin B
  • suspending fluid – saline, etc.

Many of these excipients are removed from the final vaccine product and might only remain in residual amounts.

What’s Not in Vaccines?

Despite what myths you might have heard or read, many things are not in vaccines:

  • a vaginal spermacide
  • antifreeze
  • thimerosal – almost all vaccines, including over 130,000,000 flu vaccines this year, are thimerosal free!
  • aborted fetal tissue – there is no aborted fetal tissue or fetal parts in any vaccine, although some vaccines are made with fetal embryo fibroblast cells from cell lines that are derived (they can replicate infinitely) from two electively terminated pregnancies in the 1960s
  • Adjuvant 65 – an adjuvant that contained peanut oil that was tested with flu vaccines in the 1960s and continues to be blamed for causing peanut allergies, even though it has never been used in a vaccine

Vaccines are safe. Vaccine ingredients are safe.

What to Know About Vaccine Ingredients

Vaccines contain a number of ingredients that help them work stimulate a good immune response against particular viral and bacterial antigens to protect us against vaccine-preventable diseases.

More on Vaccine Ingredients

Formaldehyde in Vaccines

While formaldehyde is an ingredient in many vaccines and other products, it is also naturally found in all of our bodies and in some foods.

“Formaldehyde also occurs naturally in the environment. It is produced in small amounts by most living organisms as part of normal metabolic processes.”

National Cancer Institute

Doctors get to be familiar with formaldehyde in medical school. It is the preservative that is used in mortuaries and in gross anatomy lab and students often leave the lab with the “pungent, suffocating odor” of formaldehyde on their clothes.

Formaldehyde in Vaccines

So why is formaldehyde in the vaccines that we give our children?

Formaldehyde is present in some of the vaccines on the childhood immunization schedule, including the flu shot, polio vaccine, and DTaP vaccine, because it works to eliminate any possible harmful effects of these bacterial toxins (like diphtheria toxin) and makes the viruses unable to replicate or reproduce themselves.

The very small amount of formaldehyde that is left over in the vaccines that are given to kids is less than the amount naturally found in children and much less than that amount safely given to animals in research studies.

And that formaldehyde is quickly broken down by our bodies and then excreted in urine.

The residual amount (most is removed) of formaldehyde in vaccines is safe.

Formaldehyde vs Formaldehyde

But even if your body makes formaldehyde, is that the same thing as the formaldehyde that is in a vaccine?

“When the body breaks down formaldehyde, it does not distinguish between formaldehyde from vaccines and that which is naturally produced or environmental.”

FDA Common Ingredients in U.S. Licensed Vaccines

While you may be shaking your head wondering why this is even being questioned, some folks are debating the differences between synthetic copies of natural chemicals and the original chemicals. Are they really the same?

If they are a true copy, with the same exact chemical structure, then yes.

For some chiral compounds or stereoisomers, like d-α-tocopherol and dl-α -tocopherol, which are both vitamin E, they might have different effects. One is natural, while the other is synthetic. They have the same molecular formula, but they are different, much like your right and left hands are different.

Formaldehyde is not a chiral compound though, so formaldehyde is formaldehyde.

Does Formaldehyde Cause Cancer?

Exposure to formaldehyde is known to cause cancer in rats and it is now classified as a known human carcinogen.

“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 though. Those most at risk would be workers, who are hopefully protected with the latest OSHA standards that limit exposure to formaldehyde.

What To Know About Formaldehyde in Vaccines

The small amount of formaldehyde in vaccines is safe and is not toxic.

More Information About Formaldehyde in Vaccines: