Amy Kelly, COO of DailyClout.io and Project Director for the WarRoom/DailyClout Pfizer and Moderna Documents Analysis Project, received a partial production of documents in response to her Freedom of Information Act (FOIA) request submitted to the Food and Drug Administration (FDA) for “all FDA inspection reports from inspections of Pfizer manufacturing facilities, both domestically and […]
Carol Taccetta, MD: “Boxed Warning,” the FDA’s Most Serious Warning, Is Absent from All COVID-19 Vaccine Fact Sheets
Introduction There are some adverse reactions in a product label that are so serious, and possibly even preventable, that special labeling is required to highlight this warning information: a “BOXED WARNING.” https://www.fda.gov/media/71866/download https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=201.57 This boxed warning information, “critical for a prescriber to consider,” is commonly referred to as a “black box.” (https://www.fda.gov/media/71866/download) Boxed Warnings […]
Report 73: Pfizer Knew by November 2020 That Its mRNA COVID Vaccine Was Neither Safe Nor Effective. Here Is What Pfizer’s Employees and Contractors Knew and When They Knew It.
Introduction Through the review of two documents – Pharmacovigilance Plan for Biologic License Application #125742 Of Covid-19 mRNA vaccine (nucleoside modified) (BNT162b2, PF-07302048) and 5.3.6 Cumulative Analysis of Post-Authorization Adverse Event Reports of PF-07302048 (BNT162b2) Received Through 28-Feb-2021 – referred to below as “PV” and “5.3.6,” the contributors to this report came to understand Pfizer […]