By Dr. Yuhong Dong M.D, PH.D. and Qinyang Jiang
Pfizer’s COVID-19 vaccine contains mRNA fragments called “truncated mRNA.” This is a serious issue on top of the vaccine’s life-threatening safety events. Stunningly, Pfizer submitted falsified mRNA analytical reports to multiple health authorities.
The issue of truncated mRNA led the European Medicines Agency (EMA) to raise a “major objection” before its December 2020 conditional approval of the vaccine. What has happened? How have these issues been considered resolved? This two-part series article will address the matter in depth and examine its potential consequences for human health.
Summary of Key Facts
- Pfizer’s COVID-19 vaccine contains truncated mRNA, which the EMA flagged as a reason for its “major objection,” indicating a preclusion of their approval.
- Pfizer has not investigated the detrimental outcomes of truncated mRNA in its vaccines.
- Pfizer submitted Western blot figures to the Food and Drug Administration (FDA) and the EMA that were digitally generated—not from actual experiments.
- There has been an alarming lack of action taken by health authorities on this issue.
- Truncated mRNA potentially contributes to multiple vaccine-related injuries, including misfolded spike protein-induced fibrous blood clots, autoimmune disorders, and cancer.
- These problems with the Pfizer vaccine could have resulted in drastic product quality variations from batch to batch. This could explain the difference in adverse events experienced by vaccine recipients.
- The root cause of such irresponsible conduct by pharma and health authorities is a lack of ethics.
When you go to a supermarket and want to buy 10 bottles of whole milk for your children, you usually assume the chemicals and concentrations in these 10 bottles are the same or similar. No one would expect five of the bottles to be filled with watered-down milk while the other five were filled with yogurt.
Most store-bought foods meet our expectations because of regulations and quality control. The same criteria also exist in the pharma industry, including vaccine products.
We expect consistent physical and chemical parameters of key ingredients across different batches of drug or vaccine products. Consistency is the foundation that allows patients and consumers to have confidence in the safety and effectiveness of medications.
The CMC process—short for chemistry, manufacturing, and controls—involves defining manufacturing practices and product specifications that must be followed to ensure product safety and consistency between batches. This is a mandatory criterion for global health authorities to approve a drug or vaccine.
Controlling the quality of a traditional chemical product is relatively straightforward, but for a biological product, like an mRNA, things become more complicated.
What Is Truncated mRNA? Why Does it Matter?
Our DNA contains gene codes composed of nucleotides. DNA makes proteins consisting of amino acids. Between the gene code and protein, there is a bridge molecule, a “translator”—called messenger RNA (mRNA).
The full-length mRNA sequence of the Pfizer vaccine coding for the spike protein is 4,284 nucleotides in length.
It consists of a 5′ CAP structure to prime its translation into a spike protein. It works like an ignition box of a car. At the end of the translatable region, the open reading frame, there is a stop codon, which is like a car’s brakes. If a truncated mRNA does not contain a stop codon, it fails to give a “brake” signal. The protein translation process will continue endlessly.
Truncated mRNA’s missing stop codon is highly detrimental to humans. It can lead to the production of toxic protein products.
Pfizer’s COVID-19 Vaccine Contains Truncated mRNA
The EMA is responsible for approving all medicinal products for human use in Europe, including drugs and vaccines. The Committee for Medicinal Products for Human Use (CHMP) is the EMA’s committee responsible for interpreting the agency’s opinions.
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.
EMA Flagged Truncated mRNA as a ‘Major Objection’
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.”
In June 2022, Trial Site News published an investigative report revealing a leaked slide presented at a meeting between Pfizer-BioNTech and the EMA. Alexandra (Sasha) Latypova, a former pharmaceutical industry executive who has worked with many companies, including Pfizer, shared the same slide in her Substack on Jan. 10, 2023.
The EMA demanded that Pfizer address these issues: “The truncated forms should be sufficiently characterized, i.e. they should be described, and it should be discussed if the fragmented species are expected to be similar between batches. In addition, the possibility of translated proteins other than the intended spike protein (S1S2), resulting from truncated and/or modified mRNA species should be addressed, and relevant protein characterization data should be provided, if available.”
Pfizer Recognized Truncated mRNA in Its Vaccines
Pfizer fully recognized the truncated mRNA in its vaccines. Most truncated mRNA is 1,500 to 3,500 nucleotides long with 5’ CAP, missing the Poly(A) tail and the stop codon. They can be translated into a partial spike protein.
Unfortunately, when the mRNA goes to the end of translation, the amino acid chain does not stop prolongation, as no stop signal has been given to them. There are lots of mRNA in the cell. As there is no stop signal, in theory, another mRNA in a cell will take over and continue the unfinished job, prolonging the “spike protein.”
If the same spike mRNA takes over, prolonged spike-like proteins with multiple repeats will form. If different mRNA takes over, unknown types of proteins will be created.
The annotated graph below is based on a screenshot from page 15 of the EMA report from August 2021.
Pfizer also admitted that the truncated mRNA was missing a Poly(A) tail. The annotated graph below is based on a screenshot from page 17 of the EMA report from August 2021.
Strikingly, the precise proportion of impurities of peak 1 was blacked out in this downloaded EMA report.
The annotated table below is based on a screenshot from page 17 of the same EMA report.
Pfizer Submitted Digitized Western Blot Figures to FDA and EMA
A “Western blot” method is used to identify specific proteins, allowing researchers to verify the size and abundance of a protein of interest.
Because of concerns that incorrect spike protein can cause unexpected injury, the EMA required Pfizer-BioNTech to submit experimental results to demonstrate that truncated COVID-19 vaccine RNA would not produce fragment proteins.
The EMA’s request is a basic, minimal concern to be addressed for any mRNA product intended for human use.
However, as this is the first instance of using mRNA as the preventive vaccine for a large population, this is also the first time such a quality issue emerged. We are unsure if there was previously any regulatory quality standard to manage the risk of truncated mRNAs.
The only way to characterize these RNA fragments is by sequencing. Pfizer has not reported the detailed sequence of its truncated mRNAs in its report, only the rough number of nucleotides.
In December 2020, Pfizer provided the FDA with images of Western blots that expressed the levels of COVID-19 vaccine-induced spike proteins and asserted that the vaccine did not produce any other proteins.
An example figure generated by Pfizer is shown below, based on a screenshot from page 39 of a 2020 FDA report. Pfizer represented that it had evaluated the protein size expressed by the mRNA vaccine and concluded: “The expressed protein size is consistent with the expected size of the translated mRNA vaccine substance and comparable across all tested batches.”
However, the graph appears digital or computerized. We will explain the reason for our assessment later in this article.
Three other examples of Western blots submitted in 2021 by Pfizer to the EMA are provided below.
One Western blot showed that the truncated mRNA in Peak 1 does not generate proteins in vitro. The annotated figure below is based on a screenshot from page 19 of the EMA report. However, the Western blots are digital or computerized results similar to those presented in December 2020.
Pfizer used the two graphs below to explain that full-length transcripts require Poly(A) for expression; however, the Western blots are computerized results. The annotated figure below is based on screenshots from page 18 of the August 2021 EMA report.
Pfizer’s phony Western blots were submitted to global regulatory agencies, including at least the FDA, EMA, and Australia’s Therapeutic Goods Administration (TGA).
How Do We Know These Western Blots Are Not Real?
The first step in the Western blotting technique is to separate the proteins in a sample using a molecular biological process called “gel electrophoresis.”
As different proteins have different sizes and molecular weights, when they are put in the same electric field, they will run at different speeds from one pole to the other, like a running race.
At the starting point, the proteins are together in one line, like in a 400-meter running race. Given a certain amount of time, the smaller proteins go faster than the larger ones, and gradually, different proteins will separate at different locations, called “bands.” This is similar to what happens in a running race: different runners will be separated one after another per their speed in a 400-meter running race.
Factors that determine the appearance of Western blots include the speed of protein transfer, incubation time, and antibody concentration.
As a result, in real life, Western blots are rarely perfect; there are always some distortions.
Western blots typically “smile” (curve upward at the edges) a bit, bleed with a tail, and have rounded edges and uneven bars. These are often caused by salt in the samples or by a high concentration of the proteins carrying electric charges, thereby modifying the electric field strength in their vicinity and affecting their migration.
For example, the Western blot graph (below) from the 2021 EMA report appears to be from a real experiment. A common artifact, such as an air bubble between the gel and the blot membrane, probably caused the light spot near the center of Fig. 8 during the real experiment. Lighter and darker areas are common.
This is the only Western blot graph in the EMA report that appeared to be from a “real” experiment. However, Pfizer does not explain why it submitted two sets of Western blot graphs to the EMA in the same report regarding the same issue.
Many of the Western blots provided by Pfizer-BioNTech for their COVID-19 vaccine-induced spike proteins appeared to be spotlessly clean and perfectly rectangular.
All three (figures 5, 6, and 7) Western blots cited above appear fake—perfectly regular, with all bands staying nicely in their lane; the blots are entirely noise-free.
The Epoch Times reached out to Pfizer for comment.
The Lack of Experimental Data Does Not Permit a Definitive Conclusion; Nevertheless, the EMA Approved It
In the same report, EMA also wrote: “It is likely that the fragmented species will not result in expressed proteins, due to their expected poor stability and poor translational efficiency (see below). However, the lack of experimental data on the truncated RNA and expressed proteins do not permit a definitive conclusion and need further characterisation. Therefore, additional characterisation data remain to be provided as a specific obligation (SO1).”
Would anyone interpret fake reports as reliable experimental data and trust them to support regulatory approval?
Nevertheless, on pages 22 and 23 of the August 2021 EMA report, the EMA stated these issues were considered resolved. How is it considered resolved? Was this decision based on those phony Western blots?
The EMA granted Pfizer/BioNTech conditional marketing authorization on Dec. 12, 2020.
In Part 2 of this series, we will continue to discuss the implications of this quality issue and the potential outcome of vaccine-related injuries.
Acknowledgment: Thanks to Dr. Joe Wang for his review and comments on this article.