As new cancer vaccines—led by Moderna and Merck’s mRNA-4157—near pivotal trial readouts, the FDA’s vaccines czar Peter Marks, M.D., Ph.D., said the agency is ready to review the shots despite AI-related unknowns. “We are ready to review—we’re open for business,” Marks, director of the FDA’s Center for Biologics Evaluation and […]
FOIA’d FDA ‘Establishment Inspection Reports’ of Pfizer COVID Vaccine Manufacturing Facilities Reveal “Inadequate Quality Oversight,” Deficient Deviation Investigations, Ignored Standard Operating Procedures, and More.
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 […]
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 […]
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 […]
NAATs Used in Pfizer Clinical Trial to Test Asymptomatic Patients Despite Not Being Approved (or Even Emergency Use Authorized) for Asymptomatic Testing.
Nasal swab nucleic acid amplification tests (NAATs) are “a type of viral diagnostic test for SARS-CoV-2, the virus that causes COVID-19.” [https://www.cdc.gov/coronavirus/2019-ncov/lab/naats.html and https://www.fda.gov/consumers/consumer-updates/covid-19-test-basics] Although certain NAAT tests have now been authorized for emergency use (EUA) for screening purposes (in asymptomatic persons), the three NAAT tests used at the time […]
Losing Control of the Controlled Clinical Trial in These Times of Emergency Use Authorization (EUA) Vaccines
Do you remember your high school science teacher explaining what a controlled experiment is? It is when just one thing is changed in the group receiving the experimental intervention (compared to the “control” group receiving standard or no treatment), then one waits to see if there is a difference in […]
Letter to the FDA: COVID-19 ‘Vaccines’ and COVID-19 Infection Linked to Myocarditis – What Do They Have in Common?
Peter Marks, MD, PhD Director, Center for Biologics Evaluation and Research U.S. Food and Drug Administration 10903 New Hampshire Avenue WO71-7232 Silver Spring, MD 20993 Peter.Marks@fda.hhs.gov December 18, 2022 Dear Dr. Marks, I am troubled by the following, and look forward to your studied response on my single […]