Tag: carcinogenicity

Are Rates of Cancer in Children Skyrocketing?

Why do some folks think that rates of cancer in children are skyrocketing?

If you want to do something during Childhood Cancer Awareness Month, encourage folks to get vaccinated and protected so that they don't put people with cancer, who are likely immunosuppressed at risk to get a vaccine-preventable disease.
If you want to do something during Childhood Cancer Awareness Month, encourage folks to get vaccinated and protected so that they don’t put people with cancer, who are likely immunosuppressed at risk to get a vaccine-preventable disease.

Oh, the usual suspects…

Are Rates of Cancer in Children Skyrocketing?

Cancer is actually one of the leading causes of death, but it is not the leading causes of death in children.

Childhood cancer is not the leading cause of death.

And cancer rates in children are not skyrocketing.

“We identified 120,137 childhood and adolescent cancer cases during 2001-2009 with an age-adjusted incidence rate of 171.01 per million. The overall rate of all cancers combined remained stable over time.”

Siegel et al on Cancer incidence rates and trends among children and adolescents in the United States, 2001-2009.

They have been very stable for many years.

So much for the anti-vax theory that vaccines can cause cancer

There’s more.

Not only are cancer rates in children not skyrocketing, fewer kids today are dying of cancer.

The death rate from childhood cancer has been decreasing.
The death rate from childhood cancer has been decreasing.

And now that they are actually getting vaccines that can prevent cancer, these children have an even lower risk of getting several cancers when they get older!

Even worse than pushing the idea that cancer rates are skyrocketing and that vaccines cause cancer, many of these same folks steer people with cancer away from life-saving medical treatments!

How can these folks publish advice that people with cancer should stop chemotherapy and radiation?!?
How can these folks publish advice that people with cancer should stop chemotherapy and radiation?!?

Surprised?

You shouldn’t be.

This is the modern anti-vaccine movement.

More on Cancer and Vaccines

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

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

 

Vaccine Testing and Development Timeline and Myths

New vaccines must go through a long journey before they are finally approved by the FDA and get added to the recommended immunization schedule.

vaccine-dev-testing

Vaccine Testing and Development Myths

There are many myths and much misinformation surrounding vaccine testing and development that is used to scare parents away from vaccinating their kids.

Have you heard that vaccines aren’t tested together?

Or that flu vaccines or Tdap were never tested on pregnant women?

Then there are the myths about fast-tracking, and that important steps are skipped when a vaccine is on fast track for FDA approval, or that the whole vaccine testing and development process happens very quickly.

Vaccine Testing and Development Timeline

The vaccine development process is anything but quick.

“Vaccine development is a long, complex process, often lasting 10-15 years and involving a combination of public and private involvement.”

The History of Vaccines on Vaccine Development, Testing, and Regulation

During this time of the exploratory and pre-clinical stage research and then phase 1,2, and 3 trails, vaccines are:

  • tested on animals
  • tested on small groups of people
  • tested on larger groups of people
  • tested alone
  • tested together with other vaccines
  • tested for safety
  • tested for efficacy (to make sure they work)

This often includes double-blind, placebo controlled vaccine trials.

Fast tracking does speed the process up, but not because any of the testing is skipped. The researchers just get more frequent meetings and communication with the FDA and “Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met.”

“Vaccine development is a complex multidisciplinary activity, combining understanding of host-pathogen interactions at the molecular level, with clinical science, population-level epidemiology and the biomechanical requirements of production.”

Anthony L. Cunningham, et al on Vaccine development: From concept to early clinical testing

Testing doesn’t stop once a vaccine is approved by the FDA and is added to the immunization schedule either. We often continue to see testing for vaccine safety and efficacy using phase 4 trials and with our post-licensure vaccine safety system, including VAERS and the Vaccine Safety Datalink.

And of course testing continues long after we begin using vaccines to see how long their protection will last. For example, because of continued testing, we now know that Gardasil and Cervarix are providing protection that lasts at least 8 and 9 years.

What To Know About Vaccine Testing and Development

From pre-clinical studies and years of phase 1, 2, and 3 trials to continued monitoring after a vaccine is approved and added to the immunization schedule, the vaccine testing and development process helps make sure that vaccines are safe and that they work.

More About Vaccine Testing and Development