Expert Group Defines Long COVID as “Infection-Associated,” Yet Also Acknowledges “Symptoms and Diagnosable Conditions Characteristic of Long COVID Can Have Alternative Origins” “As the number of cases of acute SARS-CoV-2 infection declines, an increasing fraction of patients with symptoms compatible with Long COVID will have their condition due to a […]
‘We’re open for business’: FDA’s Peter Marks says agency ready to review novel cancer vaccines despite unknowns
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 […]
Vaccine Compensation Meeting 2/15 10 AM in DC
WHAT: Hearing titled “Assessing America’s Vaccine Safety Systems, Part One” DATE: Thursday, February 15, 2023 TIME: 10:00 AM ET LOCATION: 2154 Rayburn House Office Building Wenstrup Announces Hearing on Vaccine Safety Reporting and Injury Compensation Systems Press Release WASHINGTON — Select Subcommittee on the Coronavirus Pandemic Chairman Brad Wenstrup (R-Ohio) will hold a hearing titled “Assessing America’s Vaccine Safety Systems, Part One” […]
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 […]
Follow-Up to “NAATs Used in Pfizer Clinical Trial to Test Asymptomatic Patients Despite Not Being Approved (or Even Emergency Use Authorized) for Asymptomatic Testing.”
Addendum: Since publication of this piece on April 25, 2023, a new Pfizer document tranche (dated April 3, 2023, but available publicly in late April 2023) has been released, and it included, “Report on Method Validation of a Cepheid Xpert® Xpress PCR Assay to Detect SARS-CoV-2.” The validation report states: “This report […]
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 […]
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 […]
FDA and Pfizer Data Allegedly Missing IMPORTANT Blood Brain Barrier Data – Letter
Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research (CBER) Food and Drug Administration Dept. of Health and Human Services (HHS) Peter.Marks@fda.hhs.gov April 16, 2022 Dear Dr. Marks, I’ve just read an article stating highly inflammatory lipid nanoparticles (LNP)s “could be responsible for adjuvanticity and some […]