The long-term health impacts of our current vaccine program are inadequately studied, and our regulatory bodies face conflicts of interest. Childhood health issues have surged alongside the expanding vaccine schedule. Vaccines contain numerous ingredients, some of which are known to be neurotoxic, carcinogenic, and can cause autoimmune diseases. Vaccine injuries, though rare, do happen. The National Vaccine Injury Compensation Program of Health and Human Services (HHS) has awarded almost $4 billion for vaccine injuries since 1988.

• Subject vaccines to a scientifically rigorous approval process. Vaccines, regulated by the FDA’s CBER division as “biologics,” do not always undergo the same level of safety testing as new pharmaceuticals under CDER. Given to healthy individuals, vaccines should be tested more rigorously than drugs, which treat existing diseases. Currently, inadequate testing prevents accurate calculation of the true risk/benefit assessments for vaccine safety and cost. Approximately 4 million American infants receive these vaccines annually.

• Typical Drug Approval ProcessTypical Vaccine Approval ProcessPrelicensure follow-up for adverse events often takes years. For example: Lipitor – 4.8 years, Enbrel – 6.6 years, Botox – 4.25 yearsPrelicensure follow-up for adverse events may take as little as 2-5 days. For example: HepB (Engerix – GSK) – 4 days, HepB (Recombivax – Merck) – 5 days, Polio (PVI – Sanofi Pasteur) – 2 days, Hib (Pedvax – Merck) – 3 days, Hib (Hiberix – GSK) – 4 days, Hib (ActHib – Sanofi Pasteur) – 30 daysTrials require an inactive placebo, except for drugs for life-threatening diseases.Trials are not done against an inactive placebo. Trials of vaccinated compared to unvaccinated children are not performed. Placebos are often another vaccine, an adjuvant, or preservative like aluminum or mercury.Safety follow-up is incentivized by education and lawsuits. There are free market checks and balances to produce safer drugs.The National Childhood Vaccine Injury Act eliminates market incentives to produce safer vaccines by removing product liability for manufacturers.

• Typical Drug Approval Process
  Typical Vaccine Approval Process
  Prelicensure follow-up for adverse events often takes years. For example: Lipitor – 4.8 years, Enbrel – 6.6 years, Botox – 4.25 years
  Prelicensure follow-up for adverse events may take as little as 2-5 days. For example: HepB (Engerix – GSK) – 4 days, HepB (Recombivax – Merck) – 5 days, Polio (PVI – Sanofi Pasteur) – 2 days, Hib (Pedvax – Merck) – 3 days, Hib (Hiberix – GSK) – 4 days, Hib (ActHib – Sanofi Pasteur) – 30 days
  Trials require an inactive placebo, except for drugs for life-threatening diseases.
  Trials are not done against an inactive placebo. Trials of vaccinated compared to unvaccinated children are not performed. Placebos are often another vaccine, an adjuvant, or preservative like aluminum or mercury.
  Safety follow-up is incentivized by education and lawsuits. There are free market checks and balances to produce safer drugs.

• Require reporting of vaccine adverse events. Automate VAERS and VSD databases for research. The current reporting and study of adverse events after vaccination are inconsistent and outdated. These databases are primary sources of U.S. post-licensure surveillance, meaning serious side effects that were unclear or not seen in clinical trials may be missed.The Vaccine Adverse Events Reporting System (VAERS) likely records only about 1% of actual adverse events. Despite a study showing the feasibility of automating reports using electronic medical records, the Centers for Disease Control (CDC) has been non-responsive to requests to proceed with testing and evaluation.Clinical trials for vaccines typically enroll only a few thousand patients. When vaccines are approved for use in millions of healthy individuals, monitoring known and new adverse events is crucial. Without adequate safety follow-up, serious side effects may be missed, endangering the public. There has never been a comparative study of broad health outcomes in vaccinated vs. unvaccinated populations.The National Childhood Vaccine Injury Act (NCVIA) requires healthcare providers to report specific adverse events, but there is no consequence for failing to report an injury, and no mechanism for prosecution of non-compliance.
• Ensure all parties involved with federal vaccine approvals and recommendations are free from conflicts of interest. The FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) licenses vaccines, while the CDC’s Advisory Committee on Immunization Practices (ACIP) adds vaccines to the recommended schedules.CDC or NIH employees with vaccine patents can receive up to $150k in licensing fees per year. The House OGR Committee Report found that most VRBPAC members have substantial ties to the pharmaceutical industry, and members with these ties have been given waivers to participate in committee proceedings.A similar report on the ACIP found that the CDC grants blanket waivers to ACIP members, allowing them to deliberate on any subject despite their conflicts. A 2009 HHS Office of the Inspector General report revealed systemic lack of oversight of the ethics program, with numerous conflict disclosures having omissions or unresolved conflicts. Vaccine regulatory agencies must enforce ethics policies to ensure the program is free from financial conflicts of interest.
• Reevaluate all vaccines recommended by ACIP prior to the adoption of evidence-based guidelines. A vote by ACIP results in mandating the vaccine to millions of children, immunity from liability for manufacturers, and inclusion in the Vaccines for Children program. However, prior to 2012, ACIP did not use evidence-based guidelines for evaluating vaccine recommendations.Evidence-Based Practice integrates clinical expertise with the best available external clinical evidence from systematic research. The CDC’s infant schedule, given to approximately 4 million babies annually, was largely adopted before these guidelines were in place. Vaccines recommended before the adoption of evidence-based guidelines should be thoroughly reviewed in light of the new guidelines and current research.
• Study what makes some individuals more susceptible to vaccine injury. The Institute of Medicine (now National Academy of Medicine) has issued reports on the evidence for suspected and/or reported vaccine adverse events. For 80% of the suspected vaccine adverse conditions investigated, there wasn’t enough research evidence to accept or reject vaccine causation. Of the reviews with sufficient evidence, 72% found that the vaccine likely caused the injury.The 2013 IOM study of the entire Childhood Immunization schedule stated that no studies have compared health outcomes between entirely unimmunized and fully immunized children. The Vaccine Injury Compensation Program has paid over $3.8 billion in compensation to victims of vaccine injury. Preventing vaccine injuries should be tackled as zealously as preventing infectious diseases. Vaccine safety science, particularly long-term safety science, is inadequate to ensure children’s safety or accurately assess risks for informed consent.
• Support fully-informed consent and individual rights to refuse vaccination. The American Academy of Pediatrics emphasizes the importance of informed consent, requiring explanations of risks, benefits, and alternative treatments in understandable language. In practice, informed consent is often ignored in real-world settings. Many parents report receiving Vaccine Information Sheets (VIS) only after vaccines are administered, with no prior explanation of the information. Medical history is rarely thoroughly discussed to identify contraindications to a vaccine.Vaccine advertising also lacks disclosure of side effect risks, unlike television drug ads. Patients are at a disadvantage without fully informed consent.