Education Library

Children & Families · Article

Vaccines

Ingredients, adjuvants, and the informed consent conversation that rarely happens in a 15-minute visit.

Rev. Dr. Allie Johnson, DNM, DIM, PNM

Sanctified Healer · Monastic Medicine Practitioner

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A note before you read

Many of the documentaries, interviews, and independent research referenced in this lesson have been removed from YouTube and major platforms. Allie has archived key content. The primary sources cited throughout — VAERS data, package inserts, VICP statistics, FDA communications — are all public documents available directly from government databases, even where they have been editorially suppressed in media coverage.

Start With the Insert

Every vaccine licensed by the FDA has a package insert — a legal document submitted by the manufacturer containing the full ingredient list, trial design, adverse event data, and specific safety sections required by law. These inserts are publicly available on the FDA website. They are almost never provided to patients. They are almost never read by the clinicians who administer the products.

If you read nothing else from this lesson, read the insert for any vaccine you or your child has received or is scheduled to receive. Not the Vaccine Information Statement (VIS) — the one-page CDC summary handed out in clinics. The full FDA package insert. There is a substantial difference between the two.

What follows focuses on the sections of those inserts that are never mentioned in any vaccine conversation you have ever had with a healthcare provider.

Section 13: Carcinogenesis, Mutagenesis, Impairment of Fertility

Every vaccine package insert contains a section titled Section 13 — Nonclinical Toxicology. Subsection 13.1 is required by the FDA to address three specific questions: Has this product been evaluated for its potential to cause cancer? Has it been evaluated for its potential to cause genetic mutations? Has it been evaluated for its potential to impair fertility?

The answers — stated verbatim in the manufacturers' own legally submitted documents — are consistent across the childhood vaccine schedule:

"GARDASIL 9 has not been evaluated for its carcinogenic or mutagenic potential." Gardasil 9 (HPV) — FDA Package Insert, Section 13.1

"INFANRIX has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility." Infanrix (DTaP) — FDA Package Insert, Section 13.1

"PEDIARIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility." Pediarix (DTaP-IPV-Hepatitis B combination) — FDA Package Insert, Section 13.1

"Engerix-B has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility." Engerix-B (Hepatitis B) — FDA Package Insert, Section 13.1

"Prevnar 13 has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility." Prevnar 13 (Pneumococcal) — FDA Package Insert, Section 13.1

"COMIRNATY has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility." Comirnaty (Pfizer-BioNTech COVID-19 mRNA) — FDA Package Insert, Section 13.1

This language is not a technicality. It is a statement that the tests were never run. Not that the tests were run and the results were negative. That the tests were never conducted.

Every pharmaceutical drug approved by the FDA is required to undergo carcinogenicity and mutagenicity testing before being placed on the market. Vaccines are exempt from this requirement under 21 CFR 610. The Section 13.1 statement in vaccine inserts is not a surprise — it is a built-in regulatory exception that the manufacturers simply state in plain language, in a document almost no one reads.

Informed consent requires that a patient understand what a medical product has and has not been tested for. If a doctor or nurse providing a vaccine has never read Section 13.1 of the package insert — and the vast majority have not — they cannot give informed consent on behalf of their patient. They can give administration, but not consent.

How Vaccine Trials Differ From Drug Trials

Every new pharmaceutical drug is tested against an inert saline placebo in double-blind randomized controlled trials. This design allows researchers to see the true adverse event profile against a biological baseline. Vaccine pre-licensure trials have operated differently.

  • Active-control placebos — many vaccine trials use a previously licensed vaccine or the adjuvant alone as the "control." When both groups are receiving biologically active substances, adverse events in both groups may appear similar — obscuring the true rate relative to a genuine inert baseline
  • Short follow-up — pre-licensure trials typically track adverse events for 30–60 days. Autoimmune conditions, neurological changes, and chronic health effects that develop over months or years are not captured. COVID-19 mRNA vaccines received EUA based on approximately two months of follow-up.
  • The schedule has never been studied as a whole — each vaccine is tested individually. No randomized controlled trial has evaluated the safety of the full CDC childhood immunization schedule administered simultaneously and cumulatively over the first two years of life. When asked, the CDC confirms this study has not been conducted.
  • No vaccinated vs. unvaccinated study — no large randomized controlled trial has compared long-term health outcomes in fully vaccinated versus completely unvaccinated children. Several observational studies suggesting this comparison warrants investigation have faced significant resistance to publication.

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