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
Last Updated on October 24, 2017