INTRODUCTION “5.3.6 Cumulative Analysis of Post-Authorization Adverse Event Reports of PF-07302048 (BNT162b2) Received Through 28-Feb-2021,” Pfizer’s post-marketing report, a required U.S. Food and Drug Administration (FDA) compliance document, is one of the ways in which the FDA assessed patients’ risks associated with Pfizer’s COVID-19 vaccine, BNT162b2. The data within the […]
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 […]