Pfizer and BioNTech have 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 autoimmune issue falls into the artificially defined zone of being an “adverse event” or “non-serious adverse event,” rather than what the FDA has decided to label a “serious adverse event.”
ICAN’s legal team 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.
