SOME CRITICAL EXTRACTS OF PFIZER DOCUMENTS RELEASED BY FDA – BY A COURT ORDER
Compiled and Comments by Megan Redshaw – 13.12.2023
Uploaded by Matthias Chang
The recent documents disclosed as part of a Freedom of Information Act (FOIA) lawsuit against the U.S. Food and Drug Administration (FDA) show the agency:
… knew its safety monitoring system was “not sufficient” for assessing the risk of heart conditions associated with Pfizer’s COVID-19 vaccine when it licensed the company’s “Comirnaty” vaccine…. Documents also reveal numerous manufacturing problems in Pfizer batches released to the public and show the FDA knew about a phenomenon known as vaccine-associated enhanced disease (VAED) in those vaccinated who experience breakthrough COVID-19….
The final documents [Matthias Chang comments: “documents” are not the same as the number of “pages”. Pages will be more than “documents”] released from Pfizer’s biologic product file reveal the agency knew its safety monitoring program was not sufficient to assess the serious risks of myocarditis and pericarditis associated with Pfizer’s COVID-19 vaccine.
“The CBER Sentinel Program is NOT sufficient to assess the serious risks of myocarditis and pericarditis, and subclinical myocarditis associated with COMIRNATY (BNT162b2) in lieu of PMR safety studies under FDAAA [Food and Drug Administration Amendments Act].
“At the time of BLA [Biologics License Application] approval, the data sources in the CBER Sentinel Program are not sufficient to identify the outcomes due to lack of sufficient power to assess the magnitude of risk in patients 12-30 years of age. In addition, CBER Sentinel Program is not sufficient to follow up cases for recovery status and long-term sequelae, or for identification and characterization of subclinical myocarditis cases.”
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