Consent to Immunization

There are NO Federal requirements for informed consent specifically relating to immunization. Federal law requires that healthcare staff provide a Vaccine information Statement (VIS) to a patient, parent, or legal representative before each dose of certain vaccines.

Thimerosal (Mercury) Law

Thimerosal, used to prevent contamination of multi-dose vials of vaccines, contains mercury. California law prohibits administering mercury-containing vaccines to pregnant women or to children younger than three years of age. All routine vaccines are available in formulations that meet the law.

Informed Consent: An Ethical Principle

The National Vaccine Information Center (NVIC) has always endorsed the right to informed consent as an overarching ethical principle in the practice of medicine for which vaccination should be no exception. We maintain this is a responsible and ethically justifiable position to take in light of the fact that vaccination is a medical intervention performed on a healthy person that has the inherent ability to result in the injury or death of that healthy person.

In consideration of:

1. The fact that there can be no guarantee that the deliberate introduction of killed or live microorganisms into the body of a healthy person will not compromise the health or cause the death of that person either immediately or in the future. 

2. With very few predictors having been identified by medical science to give advance warning that injury or death may occur.

3. With no guarantee that the vaccine will indeed protect the person from contracting a disease. 

4. In the absence of adequate scientific knowledge of the way vaccines singly or in combination act in the human body at the cellular and molecular level

vaccination is a medical procedure that could reasonably be termed as experimental each time it is performed on a healthy individual.

5. The FDA, CDC and vaccine makers openly state that often the number of human subjects used in pre-licensing studies are too small to detect rarer adverse events, making post-marketing surveillance of new vaccines a de facto scientific experiment. In this regard, the ethical principle of informed consent to vaccination attains even greater importance.

Defending Informed Consent: