In 1986, Congress passed the National Childhood Vaccine Injury Act of 1986  (42 U.S.C. §§ 300aa-1 to 300aa-34, NCVIA) in response to the pharmaceutical industry and the American Academy of Pediatrics (AAP) requests to shield both vaccine manufacturers and doctors from civil product liability and malpractice lawsuits for permanent disabilities and deaths caused by federally recommended and state mandated vaccines. NCVIA acknowledged that vaccines can cause serious harm, and created a federal program to review vaccine injury claims called the Vaccine Injury Compensation Program  (VICP). Because this federal program rejects a majority of claims and compensations are rare, parents assume all risks for any vaccine-induced injury.

NCVIA requires that vaccine providers give parents and consumers the complete vaccine benefit and risk information before vaccination per informed consent. The VIS information is lacking the drug risk information from the manufacturers’ product inserts  including: ingredients  (adjuvants , excipients , and allergens), contraindications, severe adverse reactions, safety testing results, and effectiveness data. Many vaccines contain ingredients which cause a variety of reactions and poor health outcomes for individuals who are susceptible to these known toxic ingredients such as aluminum, ethyl mercury, formaldehyde, and squalene.

Vaccines have a significantly lower standard of informed consent than all other pharmaceutical drugs.

NCVIA requires vaccine providers to inform consumers in reporting health problems following vaccination to the federal Vaccine Adverse Events Reporting System (VAERS) . However, most consumers remain unaware of VAERS. Many consumers and parents of children who have reactions (serious health problems, hospitalizations, neurological injuries, and subsequent deaths) share that their doctor would not report adverse vaccine outcomes to VAERS. The Colorado Board of Health and Immunizations Department (under CDPHE) do not review or publicly disclose the frequency and severity of Colorado citizens’ reports to VAERS to determine problematic vaccine lots, as VAERS was designed to monitor.

NCVIA requires vaccine providers to inform consumers prior to vaccination about the Vaccine Injury Compensation Program (VICP) , a specialized federal court handling vaccine claims through the US Department of Health and Human Services. Doctors are not liable for any adverse reaction or injury caused by a vaccine.

NCVIA provides a Vaccine Injury Table  for the injuries which can be submitted in claim petitions which includes: anaphylaxis, encephalopathy, seizure disorder, convulsions, shock-collapse, partial or complete paralysis, narcolepsy, cardiovascular and respiratory arrest, disability, and death.

Contraindications  are another part of informed consent lacking regarding vaccines. The Colorado Board of Health and Immunizations Department (under CDPHE) are not enforcing vaccine providers to follow the Colorado Immunization Manual guidance regarding screening for consumer contraindications for vaccines. The Colorado Immunization Manual (2011, page 6-7, 6-8)  require vaccine providers to utilize the screening form to screen patients for general contraindication for vaccination. The Colorado Immunization Manual, Section 12: Special Situations and Conditions requires vaccine providers to screen people with conditions who cannot be vaccinated. The Colorado Immunization Manual, Section 13: Contraindications provides guidance to vaccine providers indicating that a reaction to a previous vaccine is a specific contraindication for future vaccines. Currently no federal or state health agencies are warning of susceptibilities like the MTHFR genetic mutation which may affect up to 15% of the population and can indicate a contraindication for vaccination.

Safety trials are lacking in many of the vaccines recommended. Vaccines are only safety tested in healthy 12-year-old or older subjects with no health conditions. Vaccines are not tested on infants, pregnant women, or any populations with chronic health problems. Retrospective studies exist on health outcomes of vaccines from medical record reviews in these susceptible populations, but this type of retrospective research is flawed by design with confounding variables. Furthermore, there are no safety trials on the cumulative effect of the aggressive US vaccine schedule on developing children. The vaccine schedule has expanded from 25 doses in 1986 to 70 doses in 2015. According to Institute of Medicine (2013) , “Thus, key elements of the entire schedule – the number, frequency, timing, order and age at administration of vaccines – have not been systematically examined in research studies.” For that reason, more and more parents are utilizing their vaccine exemption rights for their children.

Vaccine providers are not required to tell consumers that they might not actually need booster shots on the vaccine schedule which now includes 70 doses . Consumers can opt for a titer blood test for positive antibodies to a virus which can be provided as acceptable documentation in lieu of taking an additional booster vaccine.

Colorado consumers have the legal right to opt-out  of any mandated vaccine based on medical, religious, or philosophical exemptions and still attend schools, daycares, and colleges. Consumers also have the legal right to opt-out their medical information and their children’s information from the Colorado Immunization Information System (CIIS) vaccine tracking database.

Since the CDC approves, regulates, and recommends the US vaccine schedule, then the CDC cannot also function as the watchdog for the safety of the vaccine schedule due to a conflict of interest. Vaccine providers who profit from vaccines also have a conflict of interest when providing vaccine information to consumers. This leaves parents as the only watchdogs for vaccine safety in a very profitable industry bolstered by mandates.

In 2015, California set a draconian precedent for all states with the passage of Senate Bill 277. This Bill eliminated all parental vaccine exemptions with the exception of extreme medical necessity. Children in California cannot attend schools or day care centers without receiving all mandated vaccines.

Colorado Health Choice Alliance works to educate lawmakers and the public on vaccine risks, injuries, deaths in order to protect vaccine exemptions.