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?


13.1 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.

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9 thoughts on “Are Vaccines Evaluated for Mutagenicity, Carcinogenicity or Impairment of Fertility?

  1. Harvard Medical School’s Dr. Marcia Angell is the former Editor-in-Chief at the New England Journal of Medicine, arguably one of the most respected medical journals on earth.
    She comments as follows: “It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.”


    13.1 – Carcinogenesis, Mutagenesis, Impairment of Fertility

    CERVARIX has not been evaluated for its carcinogenic or mutagenic potential.

    Vaccination of female rats with CERVARIX, at doses shown to be significantly immunogenic in the rat, had no effect on fertility.

    That is just one currently available FDA Approved HPV Vaccine, and it has NOT been evaluated for it’s carcinogenic or mutagenic potential.

    SO, your entire article here is just lies, and so is what that doctor said, because not all vaccines are tested in that way.

    Why are you actively lying to people?

  3. “All necessary pre-clinical or nonclinical testing is done on vaccines and their components.” – Really? So where are the results of this testing that shows all vaccines on the market have no risk of mutagenicity, carcinogenicity, or fertility impairment? Please do show us. Because as it stands you haven’t proven it exists at all in this post. You’ve made assumptions it does. Provide the study results, or just admit there’s barely a vaccine on the market tested for mutagenicity, carcinogenicity, or fertility impairment.

  4. What lies…. most cleraly state in english: “not been evaluated for its carcinogenic or mutagenic potential” how can you slyme balls spin that. FU

  5. Read! It’s not necessary, testing in animals didn’t show it, plus I’m willing to bet all your mother’s were vaccinated and they had you!

  6. .To see that vaccines did not cause infertility in rats and conclude that it will therefore not cause infertility in humans has to be the most scientifically and medically negligent phrase ever spoken or written. Given that vaccines of all sorts have been around for generations the only solid conclusion one can SCIENTIFICALLY reach is that vaccines do not cause MASS INFERTILITY in humans, not none. The theory that you can train your immune system like a dog by stimulatung it with a certain disease is not in itself absurd, its implementatiom and administration certainly are though. And the merits for mass vaccination are served to the public on a platform of irratjonal fear. A literal boogeyman. If the Australian government wants compulsory vaccination then it should provide a guarantee that it will not cause serious harm, open up to the possibiltiy of free civil litigation by anyone harmed by a compulsory vaccine and make a contractual pledge to provide the victims of vaccines with financial and material support for anyone seriously injured. To not do so is disingenuos. Anyone in the entire span of human history has only caught disease naturally with two exception, which are modern. The disease was airborn or waterborn and sexually transmitted.the exceptions are of course IV drug use and blood transfusions. If you do not engage in risky,frequently change partners and unprotected sexual practices or reuse needles you chances of contracting HEP are almost mathematically zero. Why does a baby who’ parents do not have the disease have to gett it before they have a fully developed immune system, INSANITY. the risk of an adverse reaction to the vaccine is orders of magnitude higher the risk of contracting the disease. The total lack of transparency on behalf of the advocates and administrators of this pseudo science is dishonest and negligent. It is experimental medicine. For a start its name should legally changed to something other than immunization, in order for tbat name to be valid you have to privide a guarantee that i have zero risk of contracting said disease on even a temporary basis. Live vaccines people even pass the disease on to unvaccinzted population, disgusting. The list of ingredients of any given vaccine, if you can read and understand that is, is enough cause for alarm as it is. Exposing people to diseases that in the modern world in a deveoped country they would most likely never encounter is intellectualy flawed. Polio didnt dissappear becuase of vaccines it disappeared because of enourmous advances in sanitation and nutrition and hygene and water treatment. They are not waiting around the corner to attack you when you are weak.nor is any disease. The flu kills elderley and young vaccinated or not, it always has and it always will, there will never be anything you or I can do about it. It is often said that if it saves even one life the risks are worth it, it is equally valid and more humanitarian to say if an artificial process harms , seriously harms even one person is it not ok. I am not talking pain or redness or swelling i am talking about the people who believing the advice of their doctors turned a loved one into a vegetable. It is extremely shady science at best and really doesnt hold up to serious scrutiny, added to the fact corruption and greed have set into the very institutions that are supposed to protect us and i dont blame people for not wanting to do it. In general i trust my doctor or doctors, by this does not and never will override my own due dilligence, regardless of any advice a medical practitioner will give i will question every single thing they say always and forever. Anyone who does not do this has taken leave of their senses. Lastly if they were honest when they advised you of the risk of vaccines when they were administered i am very doubtful most people would do it. At the very least when it comes to vaccines they have obligation to at least advice that you have little to no chance of naturally contracting a disease for which you are being vaccinated. And that can and never will be able to say that you 100% immunized against said disease. They are not honest about the risks because vaccines generate a truckload of money for everyone who is not the person or child being vaccinated, and if you sue them you are basically told to your wasting time, lest you can somehow raise the funds to take on a huge pharmaceutical company. They love to flog in the documentaries that the nazis experimented on prisoners and awful and unethical and inhumane it was, modern vaccination is not the same but its also not that far from it either. They really have no idea what the full consequences are going to especially in the longterm from a vaccination. If you really want to cause to the children of a population tell their mothers that they are failing to protect their children and you will cause great damage. Trust me im a doctor is no longer sufficient.

  7. So much bias, misinformation and lies.
    They determine that evaluating the vaccines for carcinogenic and mutagenic potential not being appropriate and necessary based on them containing such low doses of what could cause cancer, in accordance to safe ‘ingesting’ doses, ignoring the fact that injecting is completely different to what is a dose to ingest. There are a few mechanism in which vaccines can and do cause cancer.

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