Regulatory Vacuum

A major piece of legislation and a later court ruling have created a “Regulatory Vacuum” in which no one is responsible for ensuring the safety or effectiveness of vaccines.

Legislation: The National Childhood Vaccine Injury Act of 1986

  • Under Section 22(b)(1) of the NCVIA:
  • No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.
  • The NCVIA also created a no-fault administrative scheme, or “Vaccine Court”, to provide compensation to children with certain vaccine-related injuries.
Ruling: On October 12, 2011, in Bruesewitz v. Wyeth (No. 09-152), the Court decided Section 22(b)(1) of the 1986 NVICA categorically barred state-law claims alleging that a vaccine was defectively designed.

Justice Sotomayor (and Ginsberg) dissented

“Its decision leaves a regulatory vacuum in which no one ensures that vaccine manufacturers adequately take account of scientific and technological advancements when designing or distributing their products.”


This means that discoveries about the microbiome, immune system, central nervous system, neurological disorders, genetics, epigenetics, environmental factors that impact mitochondria, and more, are not required to be incorporated into vaccine design or administration.

As an example, in 2015 it was discovered that the lymphatic system is directly connected to the brain.

“It’s a stunning discovery that overturns decades of textbook teaching: researchers at the School of Medicine have determined that the brain is directly connected to the immune system by vessels previously thought not to exist.”

 “The brain and the adaptive immune system were thought to be isolated from each other, and any immune activity in the brain was perceived as sign of a pathology. And now, not only are we showing that they are closely interacting, but some of our behavior traits might have evolved because of our immune response to pathogens,” explained Jonathan Kipnis, chair of UVA’s Department of Neuroscience.”

Everything about vaccines and vaccine administration should be reevaluated based on this and other recent scientific discoveries. Yet rather than pause to reconsider vaccination in this new light, the science is not just ignored, but denied.

Example of False Statements

As an example of denial and false statements by those who are sponsored by and benefit from vaccination, consider this statement in the American Academy of Pediatrics (AAP) “Countering Vaccine Hesitancy” guide, published August 2016, which states:

“THE CURRENT VACCINE SCHEDULE IS THE ONLY RECOMMENDED SCHEDULE It is extremely important that the pediatrician remain up to date on the current recommended vaccine schedule and support it as the only evidence-based schedule that has been tested and approved by multiple authoritative experts for safety and efficacy.”

their footnote citation, the 2013 IOM Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies, refutes this conclusion. It states:

“Providers are encouraged to explain to parents how each new vaccine is extensively tested when it is approved for inclusion in the recommended immunization schedule. However, when providers are asked if the entire immunization schedule has been tested to determine if it is the best possible schedule, meaning that it offers the most benefits and the fewest risks, they have very few data on which to base their response.” And: “Although the committee identified several studies that reviewed the outcomes of studies of cumulative immunizations, adjuvants, and preservatives (see Chapter 5), the committee generally found a paucity of information, scientific or otherwise, that addressed the risk of adverse events in association with the complete recommended immunization schedule, even though an extensive literature base about individual vaccines and combination immunizations exists.”

The same AAP guide explains how to calm parents who ask about vaccine safety. AAP advises:

“The opposition to the presence of aluminum as an adjuvant in some vaccines can be addressed by providing evidence for both the necessity of the aluminum for a vigorous immune response and the lack of evidence for its toxicity.”

This deliberately false statement is currently misleading pediatricians who rely upon the AAP for guidance. See the Aluminum page for studies on neurotoxicity

Removal of Fully Informed Consent for Clinical Trials

Another major piece of legislation has now further removed responsibility and impinged on rights to fully informed consent. The 21st Century Cures Act states:

“(Sec. 2263) Clinical testing of medical devices or drugs no longer requires the informed consent of the subjects if the testing poses no more than minimal risk and includes safeguards.”

Who defines “minimal risk” and do we really want to allow anyone, other than ourselves, to make the decision as to whether we take that risk or not? This passage of legislation must be overturned. Contact your federal representatives.

Clinical trial rules and regulations pertain to vaccine administration. In pre-licensure trials of vaccines, trial subjects are carefully controlled, therefore it is not known how the general population will respond to vaccines until aftermarket adverse events begin to be reported. Post-licensure is the uncontrolled, experimental study phase, and the data gathered in this phase is necessary for understanding real-world effectiveness and risk. Yet the United States lacks a rigorous and mandatory reporting system, and so data critical to evaluating safety and efficacy is not adequately gathered. Section 2263 of the Cures Act attempts to make the administration of vaccines (and other drugs) without fully informed medical consent legal, but regulations elsewhere contradict this. Despite the language of any act or regulation, the Nuremberg Code ensures you must be granted your right to fully informed consent. Demand it. Your doctor or pediatrician may not have all the information you need to know to make an informed decision. Independent research is required. We have provided resources on our Studies page to help you begin.

Examples of conflicts of interest

  • Julie Gerberding, who headed up the CDC—which is charged with overseeing vaccines—from 2002 to 2009 before becoming the president of Merck’s vaccine division. She’s still at Merck, as Executive VP, Strategic Communications, Global Public Policy and Population Health.
  • Elias Zerhouni, former Director of National Institutes of Health (NIH) now head of Sanofi-Aventis’ research labs.
  • Robert M. Califf, MD, now head of FDA, reports receiving research grant support from Novartis Pharmaceuticals, Johnson & Johnson/Scios, Lilly, Merck, and Schering Plough, and consulting fees from Annenberg, Aterovax, Bayer / Ortho McNeil, BMS, Boehringer Ingelheim, GSK, WebMd /, Johnson and Johnson / Scios, Kowa Research Institute, McKinsey & Company, Medtronic, Merck, Novartis Pharmaceuticals, Sanofi Aventis, and Schering Plough, and has an equity position with NITROX, LLC

The Regulatory Vacuum Exists inside a Corrupt Industry

Fraud is Rampant: Vaccine makers are included in the top 100 False Claim Act cases, and the fines/settlements are in the billions, and hundred-millions. Some cases were also assessed with criminal penalties: GlaxoSmithKline, Pfizer, Merck, Novartis, and Sanofi.


August 27, 2014

“My name is William Thompson.  I am a Senior Scientist with the Centers for Disease Control and Prevention, where I have worked since 1998.

I regret that my coauthors and I omitted statistically significant information in our 2004 article published in the journal Pediatrics. The omitted data suggested that African American males who received the MMR vaccine before age 36 months were at increased  risk for autism. Decisions were made regarding which findings to report after the data were collected, and I believe that the final study protocol was not followed.” Statement of William W. Thompson, Ph.D.

CDC whistle blower group called SPIDER:

“The letter to CDC Chief of Staff, Carmen Villar, expressed alarm “about the current state of ethics at our agency.” The scientists complained that “our mission is being influenced and shaped by outside parties and rogue interests” and “circumvented by some of our leaders.

The scientists told Villar that, “questionable and unethical practices, occurring at all levels and in all of our respective units, threaten to undermine our credibility and reputation as a trusted leader in public health.” The letter charged that staff level scientists “are intimidated and pressed to do things they know are not right,” and that, “Senior management officials at CDC are clearly aware and even condone these behaviors.” ECOWATCH by Robert F. Kennedy, Jr.