DNA in Pfizer COVID-19 Vaccine Is ‘Several Hundred Times’ Over Limit: Report

By Naveen Athrappully

DNA contamination in Pfizer’s COVID-19 vaccines was found to be hundreds of times higher than permissible limits, according to a recent analysis that says this poses potential safety risks after mRNA vaccinations.

The peer-reviewed commentary, published in the Methods and Protocols journal on May 8, investigated DNA contamination in Pfizer’s mRNA COVID-19 vaccine Comirnaty.

DNA impurities in vaccines pose significant safety issues such as cancers, blood microclots, and autoimmune diseases.

The World Health Organization (WHO) has set a DNA contamination limit of 10 nanograms (ng) DNA per dose, which is also the limit set for Comirnaty as part of its authorization.

The mRNA vaccines use large quantities of DNA templates during production. An analysis of Comirnaty samples by a German microbiologist and an independent researcher found that DNA impurities in the Pfizer vaccine exceeded permitted limits “by several hundred times and, in some cases, even more than 500 times.”

After the vaccine was authorized, it was generally accepted that the contamination limit was met during production.

However, the procedure used to determine this compliance was not reliable.

“In fact, the manufacturer of the mRNA vaccine Comirnaty (BioNTech/Pfizer) only measures DNA impurities in the active substance by means of a quantitative polymerase chain reaction (qPCR),” said the commentary.

For analyzing DNA in the vaccine, the presence of 69 base pairs were checked out of a total 7,824-base-pair-long template.

“Therefore, only the presence of this sequence is checked; the remaining 7755 base pairs, and thus 99 percent of the template, and any remaining genomic DNA of the host bacterium remain undetermined.”

The measured value from 69 base pairs was then extrapolated to arrive at the final limit value to see whether it complied with the 10 ng DNA per dose restriction.

According to researchers, this process misses several key components necessary for a comprehensive analysis of DNA contamination. They asked several questions related to the issue in the commentary.

For the recent analysis, researchers used their own methods to determine DNA contamination. They tested seven batches of Comirnaty and found that DNA contamination in these batches ranged from 3,600 to 5,340 ng per dose—revealing a 360 to 534 times increase from the WHO threshold.

Comirnaty uses lipid nanoparticles to transport mRNA into cells of a vaccinated person. Since DNA impurities present in the vaccine are apparently integrated into the lipid nanoparticles, it indicates that DNA fragments are also “transported directly into the cells of a vaccinated person” together with the mRNA, the researchers wrote.

“What this means for the safety risks, particularly the possible integration of this DNA into the human genome, i.e., the risk of insertional mutagenesis, should be a secondary focus of the discussion required, which must go far beyond what could have been considered years before the so unexpected introduction of mRNA pharmaceuticals into the global market.”

Insertional mutagenesis refers to a gene mutation triggered by the introduction of foreign DNA sequences.

“Among genetically engineered drugs, those with mRNA active ingredients are a special case, as their cell-free biosynthesis requires high concentrations of DNA templates, which must be removed before the products can be used as drugs,” said the research paper.

Usually, DNA contamination while manufacturing genetically-engineered drugs is not a big issue. This is because the active ingredients of such drugs are mostly proteins that are chemically distinct from DNA and can thus be easily separated.

However, the situation is different when it comes to mRNA vaccines. Both mRNA and DNA are nucleic acids and therefore chemically similar, which makes separating them far more difficult.

The researchers declared no external funding for the research. One individual declared a potential conflict of interest as the CEO of Magdeburg Molecular Detection GmbH & Co. The paper claimed the company played no role in the study.

Residual Fragments

The presence of excessive DNA contamination in COVID-19 mRNA vaccines has been confirmed in other studies. A preprint study from last year found billions of residual DNA fragments in vaccine vials.

“In our study, we measured DNA copies of spike, ori (origin of replication), and SV40 enhancer genes. … The loads of SV40 enhancer-promoter, ori, and virus spike in Pfizer are up to 186 billion copies per dose,” molecular virologist David Speicher, lead author of the study, told The Epoch Times.

SV40 enhancer genes and ori are DNA used to facilitate the replication of the vaccine spike proteins. These DNA are supposed to be removed from the final vaccine.

In October, Health Canada confirmed to The Epoch Times that SV40 DNA sequences were present in the Pfizer COVID-19 vaccine. The manufacturer had not disclosed this information previously.

“Although the full DNA sequence of the Pfizer plasmid was provided at the time of initial filing, the sponsor did not specifically identify the SV40 sequence,” Health Canada said.

Meanwhile, the U.S. Food and Drug Administration (FDA) dismissed concerns about DNA contamination in COVID-19 vaccines, saying such residual DNA “do not cause cancer, or changes to a person’s genetic code.”

However, David Wiseman, a research bioscientist involved in medical product development, said that the FDA’s denial of cancer risk was “untenable.”

“The CDC’s [Centers for Disease Control and Prevention] own analysis on the vaccine’s safety signal in VAERS shows there could be a signal for some cancers,” he said. VAERS stands for the Vaccine Adverse Event Reporting System, which is co-managed by the CDC and the Food and Drug Administration.

In November, Dr. Robert Malone, who helped invent the messenger RNA (mRNA) technology, briefed members of the U.S. Congress about DNA fragments in the Pfizer vaccine.

“That’s a proven genotoxicity risk,” he said, referring to the presence of SV40 in the vaccines. Dr. Malone noted there was a possibility the fragments are behind the unusual types of cancers that are appearing since the COVID-19 vaccine rollout.

“And by the way, these DNA fragments may also be shown to contribute to genetic anomalies in fetuses, which is one of the most prominent causes of premature abortion,” he said.