🚨1/These agreements exist between the US & most govts and their drug regulators-just ask the Argentine MOH.
What the MHRA & FDA are discussing is BREAKING. The EUA dated 11Dec2020 references 2 cases of anaphylaxis in the UK but claim none were identified in the clinical trials.
2/THIS IS A LIE. Pfizer & FDA were hiding the cases of anaphylaxis in the clinical trials. In the same EUA document, they do acknowledge adverse events, those that are defined as serious & 6 deaths. There are 7 actually-they forgot about subject 11521497. fda.gov/media/144416/d…
3/Fast forward to 16Oct2022-the manuscript reporting the definition for myocarditis and pericarditis, entitled: Anaphylaxis: revision of the Brighton Collaboration case definition was published. brightoncollaboration.us/wp-content/upl…
A few criteria re-evaluations that I point to are:
4/ * The emphasis on reporting of observable clinical signs, rather than subjective symptoms.
* Mimics of anaphylaxis - abstract highlights that vasovagal syncope w/collapse & loss of consciousness after a vaccination is "consistent" w/an anxiety or stress-related response.
5/Defined, severe allergic reactions to the COVID-19 mRNA products were purposefully not reported in the clinical trials. What about the adverse events that were reported where there may be a causal link to severe allergic reactions?
Legal Theory 2: The mRNA products are bioweapons, not pharmaceutical, gene therapy, biologics or vaccines w/in the purview of FDA regulation. We have evidence to demonstrate they were never subject to FDA procedures regulating/monitoring certified Good Clinical Practice (cGCP) 1/
certified Good Manufacturing Practice (cGMP), certified Good Laboratory Practice (cGLP), certified Good Distribution Practice (cGDP) dispensing, labeling, etc.
To defend, US Govt must take one of two positions:
1. The products ARE pharmaceutical drugs, gene therapy or 2/
vaccines, but none of the FDA regulatory standards for safety and efficacy testing, manufacturing, distribution, dispensing, & labeling were followed prior to dispensing and during use.
OR
2. The products are bioweapons, and none of the FDA regulatory standards for safety 3/
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).
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