Like prescription drugs, vaccines are commercial pharmaceutical products that carry two risks: a risk the vaccine product will fail to work 9 10 and a risk the vaccine product will cause harm. 11 12 However, unlike with prescription and over the counter drugs, manufacturers of vaccines and doctors who administer vaccines have no liability when a person is injured or dies after being given a recommended childhood vaccine licensed by the U.S. Food and Drug Administration (FDA) as safe and effective.
In 1986, Congress passed the National Childhood Vaccine Injury Act and codified into law government acknowledgement that federally licensed and recommended and state mandated vaccines can and do unpredictably cause injury and death. The Act created a federal vaccine injury compensation program (VICP) alternative to a vaccine injury lawsuit against drug companies. 13 By 2019, the VICP had awarded more than $4 billion in federal compensation to vaccine injured children and adults. 14
Learn more about how to file a claim in the federal vaccine injury compensation program.
In 2011 in a split decision in Bruesewitz v. Wyeth, the US Supreme Court majority ruled that vaccines are “unavoidably unsafe” and effectively removed all liability from drug companies, even if there was evidence a drug company could have made a vaccine safer. 15 16
In a series of reports published between 1991 and 2013, the Institute of Medicine affirmed that scientific evidence demonstrates that vaccines can cause injury and death and that some people are genetically, biologically and environmentally at higher risk for being harmed by vaccines but doctors do not know how to identify who they are before vaccination. 17 18 19 20 21 Even so, federal health officials have narrowed contraindications to vaccination and eliminated almost all health conditions from qualifying for a medical exemption to vaccination. 22
When liability free pharmaceutical products can cause injury and death, especially when some people are biologically more vulnerable to suffering harm but doctors do not know how to predict who they are, protection of the human right to informed consent to medical risk taking becomes even more important. 23 The legal right to exercise flexible medical, religious and conscientious belief exemptions to vaccination ensures that human rights are protected in public health policies and laws. 24