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Del Bigtree - CDC ACIP testimony - August 26, 2020
As well this is the latest email I received from ICAN:
EMERGENCY PETITION TO HALT CLINICAL TRIAL OF MODERNA AND NIH'S COVID-19 VACCINE UNLESS ALL ADVERSE REACTIONS ARE TRACKED
The NIH and Moderna have rigged the clinical trial of their COVID-19 vaccine, mRNA-1273, to avoid capturing adverse reactions that occur more than 28 days after injecting this experimental vaccine. ICAN’s legal team has filed an emergency petition to stop this unethical conduct.
ICAN previously filed a petition to the FDA demanding that this clinical trial include a placebo. The clinical trial for this vaccine was then delayed and when its design was finally issued, it included a placebo. But it appears that NIH and Moderna have decided to play a different game to avoid capturing safety issues that could prevent licensure of their mRNA-1273 vaccine.
Their trick is to only capture adverse reactions that occur more than 28 days after injection if the participant withdraws from the clinical trial. This is nonsensical, since there is little for a participant to withdraw from after getting two doses during the first 28 days of the clinical trial. Once a participant has received both doses, if anything, a participant would have an incentive to remain part of the follow-up check-ups to address any adverse effects.
There could be many autoimmune, neurological and chronic health disorders which have a major impact on the quality of life that this experimental vaccine could cause. All of which may only arise more than 28 days after the injection. But yet, as long as the participant does not withdraw from the clinical trial, these will nonsensically be ignored as if they did not occur. This is unethical and renders vacuous any claim of safety for this product based on this trial.
Given that efficiency in this trial will be tracked for two years, the only reason to not track safety for this same duration is to avoid detecting safety issues that would prevent licensure.
ICAN’s legal team, headed by Aaron Siri, has therefore filed a citizen petition and an emergency stay petition demanding that the clinical trial design for this vaccine be updated to require that all adverse reactions for the entire period of the clinical trial be tracked. These petitions also demand that the number of participants in this trial be increased and that they be tested before and after injection for any T-cells to SARS-CoV-2. ICAN intends to take further legal action if its rational and sensible requests are not met.
EMERGENCY PETITION TO HALT CLINICAL TRIALS OF PFIZER AND BIONTECH'S COVID-19 VACCINE UNLESS ALL ADVERSE REACTIONS ARE TRACKED
Pfizer and BioNTech have also rigged the clinical trial of their COVID-19 vaccine, BNT162b, to avoid capturing many potential life-altering adverse reactions that may occur from this experimental vaccine. ICAN’s legal team again filed an emergency petition to stop this unethical conduct.
While Pfizer and BioNTech have now included a placebo control group in their clinical trial, these companies have decided to play a different game to avoid capturing safety issues that could prevent licensure of their COVID-19 vaccine, BNT162b.
The study design for the clinical trial for BNT162b provides that -- despite reviewing efficacy for at least 2 years -- it will only capture “adverse events” for 1 month and “serious adverse events” for only 6 months after each dose.
The adverse events captured beyond a month after injection should not be limited to “serious adverse events,” since there are many autoimmune, neurological, and chronic health disorders which have a major impact on the quality of life, yet are categorized by the FDA as “adverse reactions” and not categorized as “serious adverse reactions.” To wit, there are a myriad of post-licensure adverse reactions reported by consumers and physicians and are also listed in the package inserts for one or more vaccines that any individual living with would categorize as “serious”; yet the FDA, under its current guidelines, may not. These include, but are not limited to: alopecia, autoimmune disease, lupus erythematosus, vasculitis, Bell’s Palsy, hypotonia, migraine, myelitis, neuropathy, seizures, mental disorders, rhinitis, and vertigo.
The study design for BNT162b nonetheless provides that these adverse events should be captured for only 1 month after vaccination while “serious adverse events” are captured for 6 months. These artificial limitations are unethical and make any claim of safety for this product based on this trial specious at best.
Incredibly, the efficiency of Pfizer and BioNTech’s vaccine in this trial will be tracked for two years. As such, the only reason to not track safety for this same duration is to avoid detecting any safety issues that would prevent licensure. If BNT162b causes a systemic autoimmune issue to arise two months after vaccination, it would be irresponsible and unethical not to capture that reaction just because an
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