Fact: Vaccine package inserts are not a suitable form of proof of harm from vaccines.
Why the Myth Exists
Each vaccine vial is packaged along with a paper insert written by its manufacturer, as other drugs are. The insert provides drug administering and manufacturing data. The vaccine insert also includes a list of “adverse reactions” which can sound scary. Inserts are interpreted by some people as the alarming and likely results of vaccination.
Variations on this Myth
- “The package inserts prove that vaccines cause autism and SIDS.”
- “Package inserts are never given to patients or parents, so that they don’t know how dangerous vaccines are.”
- “They wouldn’t list so many adverse reactions if they didn’t exist and happen a lot.”
Examples Found Online
The Real Deal: What the Evidence Shows
Vaccine package inserts are not a suitable form of proof of harm from vaccines.
The information on drug inserts meets FDA labeling requirements to provide a “summary of the essential scientific information needed for the safe and effective use of the drug.” It is intended for healthcare professionals and is easily misinterpreted by non-medical people. Inserts are freely available to everyone from the doctor or online.
Inserts do not give a complete account of the risks and benefits of drugs or vaccines. Instead, they provide legal protections to the manufacturer in the case of a poorly-administered drug resulting in a lawsuit. These include a list of adverse reactions, not to be confused with side effects.
Adverse reactions as provided on the inserts can be anything adverse that occurred subsequent to the vaccine shot during clinical trials or post-marketing studies. No causal relationship has been proven for the adverse reactions listed on inserts, though it may exist.
Side effects are undesirable effects of a drug or medical treatment where cause has been established by review of extensive evidence. These are often listed under Warnings.
Importantly, inserts do not indicate the relative risk of adverse reactions. They don’t even provide evidence that the adverse reactions actually occurred, how frequently, or any causal relationship. They are not designed to do this.
Finally, the risk of vaccine injury for most individuals is minuscule compared to the risk of injury from the diseases that vaccines prevent.
What Package Inserts Include
Generally, the information provided on a vaccine insert includes:
- Description of the vaccine and its manufacture, including notable ingredients
- Clinical Pharmacology: the nature of the disease(s) being immunized against, and the effectiveness of the vaccine
- Indications and Usage: recommendations for scheduling vaccines for routine childhood, during outbreaks, during pregnancy, and other considerations and populations
- Contraindications: a list of conditions for which it is not advised to administer this particular vaccine (e.g. allergies to specific ingredients, or the use of immunosuppressive therapy)
- Warnings: a list of conditions for which some caution should be exercised when administering this particular vaccine (e.g. mild egg or neomycin sensitivity), as well as adverse events that have evidence supporting their causal association with the vaccine
- Precautions: additional information and guidelines regarding the vaccine (e.g. monitoring of HIV-positive patients who have been vaccinated, or delaying the vaccine in the cases of blood transfusions)
- Adverse Reactions: unfavorable conditions which were reported “without regard to causality”
- Dosage and Administration: specific instructions for administering this vaccine to a patient
- How Supplied: information on how vaccines are packaged in quantity, and instructions for storage and timely use
- References: citations in clinical research
References and Further Reading
- “VAERS, package inserts, and the VICP do not prove that vaccines are dangerous” | The Logic of Science
- “Argument by Vaccine Package Inserts – they’re not infallible” | Skeptical Raptor
- “A Shot in the Dark: Autism has not just been listed as a known side effect of the DTaP vaccine” | by Kim LaCapria | Snopes
- “Package Inserts for US Licensed Vaccines” | Immunize.org
- “VAERS Data” | U.S. Department of Health and Human Services