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FDA-Led Peer-Reviewed Study by High School Students Uncovers Alarming DNA Contamination in Pfizer’s mRNA COVID-19 Vaccine at FDA’s Own Lab.

FDA-Led Peer-Reviewed Study by High School Students Uncovers Alarming DNA Contamination in Pfizer’s mRNA COVID-19 Vaccine at FDA’s Own Lab.

A group of high school students from Centreville High School in Virginia, in collaboration with the FDA, has uncovered alarming DNA contamination in both Pfizer’s experimental and commercial mRNA COVID-19 shots.

Their peer-reviewed study, published in the Journal of High School Science on December 29th, has sparked renewed debate over vaccine manufacturing standards and quality control processes.

The researchers, led by Tyler Wang, Alex Kim, and Kevin Kim, developed a novel method to detect replication-competent DNA impurities at FDA’s own research facility at the White Oak Campus, Children’s Health Defense reported.

Their technique involves extracting DNA from vaccine samples, ligating it into a circular form, and then transforming it into Escherichia coli cells.

If transformation results in antibiotic-resistant bacterial colonies, it indicates the presence of replication-competent DNA, which should ideally be absent or minimal in the final vaccine product.

The findings were based on analyses of two separate lots of Pfizer’s mRNA vaccines, including monovalent and bivalent formulations.

The students uncovered significant levels of DNA contamination in the vaccines, with some samples exceeding the WHO threshold by up to 470 times, the amount of residual DNA detected ranged between 40 to 110 nanograms per dose.

While no replication-competent DNA was detected in commercial Pfizer vaccine batches, smaller DNA fragments—approximately 35 base pairs in length—were consistently present.

Interestingly, the study reported sporadic instances of replication-competent DNA in an in-house mRNA vaccine and a biosimilar vaccine.

Investigative medical reporter, Maryanne Demasi, Ph.D. first reported:

Kevin McKernan, a former director of the Human Genome Project, described the findings as a “bombshell,” criticising the FDA for its lack of transparency.

“These findings are significant not just for what they reveal but for what they suggest has been concealed from public scrutiny. Why has the FDA kept these data under wraps?” McKernan questioned.

While commending the students’ work, he also noted limitations in the study’s methods, which may have underestimated contamination levels.

“The Qubit analysis can under-detect DNA by up to 70% when enzymes are used during sample preparation,” McKernan explained. “Additionally, the Plasmid Prep kit used in the study does not efficiently capture small DNA fragments, further contributing to underestimation.”

Nikolai Petrovsky, a Professor of Immunology and director of Vaxine Pty Ltd, described the findings as a “smoking gun.”

“It clearly shows the FDA was aware of these data. Given that these studies were conducted in their own labs under the supervision of their own scientists, it would be hard to argue they were unaware,” he said.

Prof Petrovsky praised the quality of work carried out by the students at the FDA labs.

“The irony is striking,” he remarked. “These students performed essential work that the regulators failed to do. It’s not overly complicated—we shouldn’t have had to rely on students to conduct tests that were the regulators’ responsibility in the first place.”

This first appeared in The Defender, and Gateway Pundit.

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Will this go anywhere? Attorney General Ken Paxton Files Lawsuit Against Pfizer for Misrepresentation of COVID-19 Vaccine Efficacy and Information Censorship.

Will this go anywhere? Attorney General Ken Paxton Files Lawsuit Against Pfizer for Misrepresentation of COVID-19 Vaccine Efficacy and Information Censorship. Another lawsuit against one of the COVID 19 drug makers. This time it’s Pfizer.

We have this from the governor.

In a press statement, Paxton claimed that his office would look into whether or not “profit motive or political pressure” played a role in any “pandemic interventions forced on the public.”

“The development of the Covid-19 vaccine, and the representations made by and knowledge of Pfizer, Moderna, and Johnson & Johnson, are of profound interest to the public’s health and welfare. This investigation aims to discover the truth,” said Attorney General Paxton in the news release.

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Biden Pandemic COVID Politics Reprints from others. Science Uncategorized

Pfizer quietly admits it will never manufacture original FDA approved COVID vaccines Company claims it is manufacturing Comirnaty product with new formula.

This article is from The Dossier.

The August 23, 2021 FDA approval of Pfizer’s Comirnaty vaccine was a cause for celebration. Marked as a turning point in the battle against COVID19, the announcement was highly publicized by the Biden Administration with the clear intention to extinguish “vaccine hesitancy” and boost uptake.

It was celebrated as a cause for national relief, and many Americans arrived at their local pharmacies under the impression, via government and pharmaceutical propaganda, that they were receiving an FDA-approved COVID vaccine. Yet that legally distinct product, as we know it, never existed. And now we know, via Pfizer, that it will never exist.

 

For the uninitiated:

Comirnaty is a legally distinct product from the emergency use authorization (EUA) shots, and It has never made its way to market. For months on end, no such vaccine has ever become available. Those who received the “Pfizer shot(s)” have been injected with the emergency use authorization (EUA) version of the shots. See my piece in The Dossier for more info:

 
Shell Game? There remains no FDA approved COVID vaccine in the United States
I fact checked the fact checkers and couldn’t believe what I found. Despite the corporate press, Big Pharma, and the federal government telling us otherwise, it is absolutely true that there is no FDA approved COVID-19 vaccine available in the United States today. And there are no plans to make one available any time soon…

Read more

The information operation succeeded. There was indeed an FDA approved vaccine, at least on paper, but you couldn’t get it.

When originally confronted with this ordeal, Pfizer labeled this issue an inventory question that had nothing to do with the legal distinction between an experimental EUA product and an FDA-approved vaccine. Up until just weeks ago, this was the statement up on the CDC website via Pfizer:

“Pfizer received FDA BLA license on 8/23/2021 for its COVID-19 vaccine for use in individuals 16 and older (COMIRNATY).  At that time, the FDA published a BLA package insert that included the approved new COVID-19 vaccine tradename COMIRNATY and listed 2 new NDCs (0069-1000-03, 0069-1000-02) and images of labels with the new tradename.

At present, Pfizer does not plan to produce any product with these new NDCs and labels over the next few months while EUA authorized product is still available and being made available for U.S. distribution.  As such, the CDC, AMA, and drug compendia may not publish these new codes until Pfizer has determined when the product will be produced with the BLA labels.”

In May, Pfizer updated its statement to mention a December 2021 licensed Comirnaty product, which was granted a license four months after the highly-publicized August FDA press release.

And just last week, Pfizer finally acknowledged that its original licensed product will never be distributed. In an unreported update on the CDC website, Pfizer told the agency:

“Pfizer received initial FDA BLA license on 8/23/2021 for its COVID-19 vaccine for use in individuals 16 and older (COMIRNATY). At that time, the FDA published a BLA package insert that included the approved new COVID-19 vaccine tradename COMIRNATY and listed 2 new NDCs (0069-1000-03, 0069-1000-02) and images of labels with the new tradename. These NDCs will not be manufactured. Only NDCs for the subsequently BLA approved tris-sucrose formulation will be produced.”

The key distinction between the originally approved formulation and the tris-sucrose formulation is that — according to manufacturers — the latter can be held for a much longer period of time outside of an ultra cold freezer. These freezers cost over $10,000 a piece and each unit uses as much energy per day as an average American household. Improper storage can render the mRNA unstable.

Notably, the clinical trials for the Pfizer shot were conducted without the modified tris-sucrose ingredient. Given the partisan nature of Pfizer, the corporate media, government health bureaucracies, and your correspondent’s lack of expertise in this area, it is unclear whether this is significant.

Another notable thing to look out for in the coming days and weeks is the possibility that the subsequently FDA approved product finally becomes available in the United States. In recent days, the CDC removed the language of “not orderable at this time” above the description of both Comirnaty and Moderna’s Spikevax.

Additionally, as reported by Uncover DC, the Defense Department appears to be in the early stages of ordering what it has interpreted as a legally required minimum of Comirnaty in order to continue its mRNA mandate of American service members.

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Why Pfizer and Barr were wrong to withhold information.