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?”
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
- Package Inserts
- FDA – PLR Requirements for Prescribing Information
- FDA – Format and Content of the Nonclinical Pharmacology/ Toxicology Section of an Application
- FDA – Draft Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines
- EPA – Guidelines for Mutagenicity Risk Assessment
- FDA – Guidance for Industry M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
- WHO – Guidelines on the nonclinical evaluation of vaccine adjuvants and adjuvanted vaccines
- HPV vaccine does not destroy fertility, it helps protect it
- Study – Evaluation of the intramuscular administration of Cervarix vaccine on fertility, pre- and post-natal development in rats
- Argument by Vaccine Package Inserts – debunking myths
- Package Inserts – Understanding What They Do (and Don’t) Say
- Vaccine Package Inserts: Not all you should be reading
- Anti-vaccine parents and the package insert paradox
- Debunking anti-vaccine arguments: VAERS, package inserts, and the VICP do not prove that vaccines are dangerous
- The vaccine package insert paradox
- Antivax Myth: “Vaccine inserts prove that vaccines are dangerous”
- Study – Intramuscularly administered herpes zoster subunit vaccine has no effects on fertility, pre- and post-natal development in Sprague-Dawley rats.
- Book – A Comprehensive Guide to Toxicology in Nonclinical Drug Development (Second Edition), Chapter 27 – Preclinical Toxicology of Vaccines
- Book – Plotkin’s Vaccines (Seventh Edition), Chapter 79 – Regulation and Testing of Vaccines
- Cancer Vaccines
13 thoughts on “Are Vaccines Evaluated for Mutagenicity, Carcinogenicity or Impairment of Fertility?”
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.”
Vincent iannelli MD do you understand what Freemasonry is and that every single doctor on this planet belongs to that club or they simply couldn’t become a doctor I know firsthand. Do you know that that same Club requires every single member from the first initiation stage through every stage of the 33 sworn to secrecy and sworn to lie to every human being they see about what they do except for to each other punishable by Death. I’m not afraid to die for the truth we’ve been fighting Romans since Yeshua did it and told us to do the same. Every single government agency every College everything The Who the CDC obviously with this coronavirus bullshit blown way out of proportion can you not see now who runs this world and how close they are to complete one government one religion one currency control this was just a test to see how far they could push the 60 gigahertz is fully installed this fall or winter and they get your kids back in the schools they will fire this up and make no mistake about it 2.4 gig vibrated the water molecules and has caused problems 60 gig effects the oxygen molecules ability to bind with hemoglobin causing symptoms relative to air sickness high altitude sickness that’s exactly what the Coronavirus supposedly does so when they fire that up in a few months they’re going to kill a lot of people and they’re going to tell all of us we told you there would be a second wave and we told you we should have stayed quarantined with social distancing this has nothing to do with a virus religion or race this is a class issue they hate the middle class I have enough information on this to start a college of my own a real learning facility not an indoctrination and I had smashed against a desk for 12 years and sworn to lie all the symbols on their jacket the two snakes of medicine come on man the Red Cross it’s repulsive disgusting and it’s going to be the end of the middle-class on this planet they do not need us slave sheeple anymore if this last round of absolute bulshit prove it to you because they’re not hiding it anymore they’re rubbing it in your face the left eye pirate patch Skull and Bones 322 what day did the president announced that we were on lockdown 322 this is a satanic spell that will be enforced until may day may day may day may day socialism got their foot in the door especially in the overwhelmingly Democratic legalize pot smoking shithole States I mean come on Michigan that Governor wouldn’t allow them to do anything everything was closed that was not non-essential except for the liquor stores the marijuana stores and the lottery ticket kiosks got to keep that the state money coming in from the cattle or the sheeple even though they can’t work this lady from the Harvard Medical School is a hero dr fauci I know the spelling is wrong I’m voice texting please excuse the spelling and grammatical errors because I don’t have time for that anyway the doctor put in the prestigious New England medical journal that the fatality rate was 0.1% to 0.3% for the C virus and that was an I don’t know exactly middlemarch March twenty-something I know a couple days later is when he announced to the public that it was 3.4% which is a humongous difference and we were locked down because of that everyone who has two brain cells to rub together knows what’s going on they will not pull this off 1% beat the British down we’ve got way more than that I don’t promote violence but being nevermind I was taught the only way to stop socialism and communism and that kind of evil in general was by force who taught me that the government thank you so much I have so much more to say please excuse me once I have so much more to say please excuse me once again for the misspellings and grammatical errors and I didn’t even really read this I’m so used to having to hurry and being threatened by Ivy League psychologists and lawyers why would they threaten a peon like me why am I not allowed to share any videos on social media anymore because I’m over the target dead-center if I have a heart attack a car wreck and I don’t drive anymore I’m not suicidal I have not been sick and over 7 years I don’t drink or do drugs if I turn up dead I’ve got a couple false triggers more than a couple these people don’t care about that they blew the president’s head off two of them for trying to take us off the Federal Reserve System those Zionist bankers run this country and they are of the Freestone Templar Trump also pulled this beginning stunt on March 13th what happened on Friday March 13th in 1307 France there’s no such thing as coincidence I can go on forever conspiracy that word was invented in 1967 by our government to shut people like me up that did have two brain cells and told the effing truth my love for the truth has left me with not one friend and only my mother out of my family speaks to me I don’t care about friends family any material items whatsoever that should tell you who walks beside me I will do whatever I can to maintain Liberty without Liberty Lord help us it’s over for Humanity without freedom We Are The Last Vestige we have to be the bearers of the light an dthe saviors of the human race I did notice the green symbol beside my name and Gmail suddenly turned red when I typed in my Gmail green to red I mean come on this symbolism is retarded I speak fluent symbolism and a couple more languages not indoctrinated I’m not College corrupted inthat aspect nor have I been shot full of a pig bat bird virus spliced to a human virus I don’t get sick I built up immunity is like humans were supposed to do I understand some vaccinations are good with not one friend in this world and no family no vehicle no home and just what I can carry obviously I’m not afraid whatsoever to be extinguished over this I was married 17 years and have three children none of them speak to me either I don’t lie ma’am i might make a mistake but I walk it back I will admit that when I do I am not a conspiracy pusher strictly the facts as much as the medical community the scientific community the governmental community and my own community want to discredit and smear my name they don’t bother me much I am very much under the radar because of my lack of status and complete lack of friends once they hear my story thank you so much for your time may God bless you and your family and keep them safe during this time of crisis
Any product that is not tested for safety simply because it is deemed unnecessary is no candidate for any market. You are full of shit and you know it. Get ready to eat that shit while you burn in the Lake of Fire….
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?
Read the article…
“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.
What lies…. most cleraly state in english: “not been evaluated for its carcinogenic or mutagenic potential” how can you slyme balls spin that. FU
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!
Yeah my wife was vaccinated and my son was born with Autism my other two kids were not vaccinated I fought like hell for that and they are fine you guys are not God and stop pretending to be so I’m willing to bet that you seemed pretty angry people only get angry when they can’t stand the truth Shining Light all over the medical community’s draconian drug pushing agenda may God bless you ma’am oops I’m sure Yeshua is a conspiracy theory as well the coronavirus is a complete and total joke morons
.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.
So, if you believe vaccines are “safe and effective”, link your studies. You did not provide links, nor have the articles you sited provided links.
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.
I see the Mental Giant and sworn to lie Freemason just below this reply doing what they do lying to the world to spread fear these people are terrorists what they’re doing is called terrorism we would not be allowed to walk onto a plane and yell bomb but yet they can go on the news on any social media platform and lie and push fear porn and scare the living crap out of the world’s people believe me when this doesn’t work they will try to force you these people are the scum of the Earth a drug dealer with a license horrible people not all of them but these ones are this one below is his rewrote the King James and told you the Earth was a ball full of water flying through space spending a thousand miles an hour it’s absolute nonsense only a wizard or magician can perform such tasks their time is up as well as the mainstream media the truth is not a national security threat the truth will set you free the truth you go to heaven may God bless each and everyone of you and keep you safe