Reader 02/21/2023 (Tue) 14:17 Id: f7ecf8 No.19772 del
In an EMA assessment report coded EMA/CHMP/448917/2021, the EMA requested that Pfizer address the impurities of its vaccine product, which the EMA report described as “truncated and modified mRNA.”

Pfizer’s report to the EMA clearly showed that Pfizer’s vaccine contained impurities, as indicated by “Peak 1” in the graph below, based on a screenshot from page 14 of the EMA’s August 2021 report:

The EMA demanded that Pfizer provide monthly data on the potential of generating truncated spike proteins/peptides or other proteins/peptides causing autoimmune conditions due to molecular mimicry mechanisms. A deadline was set for July 2021, and an interim report should have been submitted by March 2021.

In an EMA assessment report on “Comirnaty, COVID-19 mRNA vaccine (nucleoside-modified),” coded as EMA/707383/2020, dated Feb. 19, 2021, on page 15 under the section “Manufacturer, process controls and characterisation,” it is stated that “During the procedure, several issues were highlighted relating to the GMP status of the manufacture of the active substance and the testing sites of the finished product for the purpose of batch release. These issues were classified as a Major Objection (MO).”

A “major objection” is a formal regulatory red flag by the EMA. If major objections remain unresolved, they preclude granting the marketing authorization.

The truncated mRNA has been discussed at length as a “Major Objection” raised by EMA in the two EMA reports we have analyzed above. Before these biological agents were deployed on the global population, EMA reviewers identified the issue of truncated mRNA and brought it up as a “major objection.”