Bailiwick News Katherine Watt and I and several other people attended a zoom call on December 13, 2022 with Senator Johnson (R-WI). The call was scheduled by his staffers. We subsequently worked for several weeks to prepare this memo, upon his request. The references and exhibits for this memo can be found in the linked package of materials [see Countermeasures Evidence 775 MB expanded local mirror of package at protonmail —ed.].
This memo and document package are based on publicly available sources. This is largely mine and Katherine’s work over the past several years. It is not our job to do this, we never signed up to be government watchdogs, nor were we aiming to act as consumer safety protection agencies for the US and global public. Yet, here we are. Given that legislators from other countries, such as Senator Roberts from Australia, are talking about this material (all from publicly available sources), I think it is high time the US Congresspeople start speaking about this, too.
Here is the text of the memo:
IN RE: Evidence of Covid-19 Regulatory Failures, Criminal Wrongdoing and Attempts to Avoid Liability by Senior Executive Service Officials in Multiple Federal Agencies
Americans were misled about all Covid-19 “countermeasures,” including those products marketed as “vaccines.” Covid policy was managed by the National Security Council (NSC) acting on war footing and countermeasures were contracted for by the Department of Defense (DoD) and Biomedical Advanced Research and Development Authority (BARDA) without any effective regulatory oversight at any stage along the process.
The activities passing as “regulatory processes” appear to have been fraudulent attempts to create color of law and avoid liability for what were clearly criminal acts. These multiple overlapping and mutually reinforcing violations of federal law have imposed serious harms on the American people, including severe injury and death.
Fact pattern background:
- Under Stafford Act authority, President Trump declared a Public Health Emergency (PHE) on March 13, 2020 (Stafford Act, P.L. 93-288 as amended).
- Under a PHE, medical “countermeasures” are not regulated or safeguarded as normal pharmaceutical products (21 USC 360bbb-3(k).
- According to Operation Warp Speed / Administration for Strategic Preparedness and Response (ASPR) reports, the United States Department of Defense (DoD) directed, oversaw and managed the development, manufacture and distribution of nearly all Covid countermeasures, largely utilizing DoD’s previously established network of military contractors and consortia.
- DoD, the Biomedical Advanced Research and Development Authority (BARDA) and the Department of Health and Human Services (HHS) contracted for Covid countermeasures, including “vaccines,” as “prototype demonstrations” of “large-scale manufacturing.”
- These agencies avoided nearly all relevant legal and transparency requirements by using Other Transaction Authority (OTA) contracts.
- Although the DoD/BARDA contracts refer to “safety and efficacy requirements” and mention cGMP compliance, these items are explicitly carved out as not being paid for or ordered by the U.S. Government.
- The contracts for countermeasures include a liability shield for manufacturers and contractors along the supply and distribution chains, under the PREP Act.
- As prototypes under Emergency Use Authorization (EUA) during a PHE, Covid countermeasures need not comply with laws governing clinical trials, manufacturing quality, safety or labeling (21 USC 360bbb-3(k)). The result: we have a chaotic mess of everything from sham injections that may be mostly just saline all the way to extremely dangerous/deadly shots, all of which are being distributed under the same product brands and labels.
- The underlying FDA authorizations and approvals under EUA statutory authority and Investigational New Drug regulatory frameworks all violated drug safety laws governing clinical trials, product labeling, product serialization, importation, product distribution, product quality control testing, dispensing and other parts of the national drug supply oversight system.
The implications of the above can not be overstated. Senior Executive Service officials within the U.S. Government authorized and funded the deployment of noncompliant biological materials on Americans and others without clarifying their “prototype” and “large scale demonstration” legal status, making the materials not subject to normal regulatory oversight, all while knowingly and willfully maintaining a fraudulent pseudo-“regulatory” presentation to the public.
These materials have harmed and killed and continue to harm and kill Americans and other people around the world.
The Covid countermeasures deployment program has been partially coordinated through the Public Health Emergency Medical Countermeasures Enterprise and via several other public, private, hybrid and quasi-governmental entities, including but not limited to: the FDA’s Medical Countermeasures Initiative (MCMi); BARDA; and the Medical Chemical, Biological, Radiological, Nuclear [CBRN] Defense Consortium (MCDC).
Six primary enabling statutes include:
- Title 21 - Federal Food and Drugs Act, at §360bbb et seq, “Expanded access to unapproved therapies and diagnostics,” as established in 1997;
- Title 42 - Public Health Service Act, at §247d et seq, “Public health emergencies,” as established in 1983;
- Title 42 - Public Health Service Act, at §300hh et seq, “National All-Hazards Preparedness for Public Health Emergencies,” as established in 2002;
- Title 42 - Public Health Service Act, at §300aa-1 et seq, “Vaccines,” as established in 1986;
- Title 10 - Armed Forces Act, at §4021 et seq, “Research projects: transactions other than contracts and grants,” as established for DoD use for “prototype” contracting in 2015;
- Title 50, Chapter 32, §1511 et seq, “Chemical and Biological Warfare,” as established in 1969.
Enclosed are detailed summaries and background supporting documentation of the clinical trial, manufacturing and contracting violations, as well as the legal histories of statutes, regulations and executive orders that have attempted to grant “color of law” to this misconduct, which is likely responsible for millions of injuries and deaths.
These references and source documents are found in the linked data file at the beginning of the article.
 21 USC 360bbb-3(k): use of EUA-covered medical countermeasure (MCM) products, once designated as such by the Secretary of Health and Human Services (March 10, 2020, retroactive to February 4, 2020) “shall not be considered to constitute a clinical investigation.”
 See “VRBPAC-10.22.20-Meeting-Presentation-COVID19-Vaccine-Development-Portfolio.pdf” in Attachment for EXHIBIT 2.
 42 USC 300hh-10a. PHEMCE membership shall include: (1) The Assistant Secretary for Preparedness and Response; (2) The Director of the Centers for Disease Control and Prevention; (3) The Director of the National Institutes of Health; (4) The Commissioner of Food and Drugs; (5) The Secretary of Defense; (6) The Secretary of Homeland Security; (7) The Secretary of Agriculture; (8) The Secretary of Veterans Affairs; (9) The Director of National Intelligence; (10) The Director of the Office of Pandemic Preparedness and Response Policy; (11) Representatives of any other Federal agency, which may include the Director of the Biomedical Advanced Research and Development Authority, the Director of the Strategic National Stockpile, the Director of the National Institute of Allergy and Infectious Diseases, and the Director of the Office of Public Health Preparedness and Response, as the [HHS] Secretary determines appropriate.