1/Americans were misled about all Covid-19 “countermeasures,” including those products marketed as “vaccines.” Covid policy was managed by the NSC acting on war footing & countermeasures were contracted for by the DoD & BARDA w/o any effective regulatory oversight at any stage.
2/The activities passing as “regulatory processes” appear to have been fraudulent attempts to create color of law & avoid liability for what were clearly criminal acts. These multiple overlapping & mutually reinforcing violations of federal law have imposed serious harms.
3/Fact pattern background:
Under Stafford Act authority, President Trump declared a Public Health Emergency (PHE) on March 13, 2020.
Under a PHE, medical “countermeasures” are not regulated or safeguarded as normal pharmaceutical products (21 USC 360bbb-3(k).
4/According to Operation Warp Speed/ASPR reports, DoD directed, oversaw & managed the development, manufacture & distribution of nearly all Covid countermeasures, utilizing DoD’s previously established network of military contractors.
5/DoD, BARDA & 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.
6/Although the DoD/BARDA contracts refer to “safety & efficacy requirements” and mention cGMP compliance, these items are explicitly carved out as not being paid for or ordered by the US Government.
7/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,
8/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
9/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
10/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.
11/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”
12/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.
13/These materials have harmed and killed and continue to harm and kill Americans and other people around the world.
14/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:
15/the FDA’s Medical Countermeasures Initiative (MCMi); BARDA; and the Medical Chemical, Biological, Radiological, Nuclear [CBRN] Defense Consortium (MCDC).
16/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;
17/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;
18/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;
19/Title 50, Chapter 32, §1511 et seq, “Chemical and Biological Warfare,” as established in 1969. - Overview in collaboration w/GB SL KW
"Those who would give up essential liberty, to purchase a little temporary safety, deserve neither liberty nor safety." - Benjamin Franklin
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Need a good laugh? I was writing up a legal summary and skimming the Motion to Dismiss by @pfizer.
I STAND BY EACH ONE OF THESE TWEETS!
1/She airs that dissent publicly and repeatedly on her Twitter profile (@iambrookjackson), which has accumulated more than 37,000 followers.
2/Her anti-vaccination and anti-Government views are unmistakable. For example, she has tweeted that “there’s no way in hell she would let a Covid jab” near her children, even though CDC recommends the vaccine for everyone 5 years of age and older.
3/She has tweeted that “booster” doses of the vaccine are “the immunological equivalent of heroin addiction,” even though CDC recommends boosters for many Americans.
1/
An NIH funded, interventional, randomized, parallel treatment assignment clinical trial completed enrollment of 17,828,769 subjects in just 37 days.
Were you "treated" and just don't know it?
2/ The study distributed videos of health professionals encouraging Covid-19 vaccination to a large sample of Facebook users to test the most effective ways to maximize diffusion of vaccine-related content to increase vaccination rates.
3/ Four groups were randomized at the county level where vaccination rates were low. There were 1402 counties in the states satisfying those criteria (AL, AK, AR, GA, ID, IA, IN, LA, MI, MS, MO, MT, ND, ND, OH, OK, SC, TN, WV, WY).
Moderna - why do you keep allowing Ventavia to conduct your clinical trials? Let's look at these monitoring reports! Why is @advarra not reporting these to @FDACBER or is FDA not in compliance?@moderna_tx@TheJusticeDept
Xavier Becerra, Secretary of Health and Human Services, preceded by Alex Azar and Norris Cochran hhs.gov/about/leadersh…
Dawn O'Connell,
Assistant Secretary for Preparedness and Response @ U.S. Department of Health and Human Services, preceded by Robert Kadlec [also of Emergent BioSolutions] and Nikki Bratcher-Bowman aspr.hhs.gov/AboutASPR/Lead…
An @OIGatHHS Report - 2008
•Serious gaps in NIHs oversight of researchers Financial Conflicts of Interest (FCOI)
•Could not provide accurate count of FCOI during FY 2004-2006
•NIH is not aware of the types of FCOI that exist w/in grantee institutions oig.hhs.gov/oei/reports/oe…
An @OIGatHHS Report - 2009
Increased oversight is needed to ensure that these conflicts are managed appropriately, the research conducted using Federal funds is not biased by any conflicting FCOI & human subjects are not subjected to unnecessary risks.
In 2018, @NIH issues a statement - failure by investigators to disclose substantial contributions of resources from other orgs, including foreign govts, threatens to distort decisions about the appropriate use of NIH funds.