Thursday, November 02, 2023

European Regulator Confirms Pfizer Did Not Highlight DNA Sequence in COVID-19 Vaccine

Pfizer did not highlight a DNA sequence in its COVID-19 vaccine, a European regulator has confirmed.

"While the full DNA sequence of the plasmid starting material was provided in the initial marketing authorization application for Comirnaty, the applicant did not specifically highlight the SV40 sequence," the European Medicines Agency (EMA) told The Epoch Times in an email.

The email came after Health Canada told The Epoch Times it expects sponsors to identify sequences such as the Simian Virus 40 (SV40) DNA enhancer but that Pfizer did not.

Pfizer and its partner, BioNTech, have not responded to requests for comment.

Pfizer did not highlight the inclusion of the enhancer in its vaccine because "it was considered to be a non-functional part of the plasmid," EMA said. "They have since clarified this information in response to questions raised by EMA."

The EMA said parts of the SV40 sequence are "commonly present in plasmids used for manufacturing of biological active substances," but neither authorities nor Pfizer have been able to say why the sequence was made part of the Pfizer shot.

Dr. Robert Malone, a vaccine expert whose work has been cited by Pfizer, told The Epoch Times "there is no reason" to include the sequence. He has urged U.S. regulators to recall the vaccine, but the regulators have declined.

Contested Claims

According to the EMA, the DNA sequences, including the SV40 sequence, are "broken down and removed" during the manufacturing process. "Fragments of the SV40 sequence may only be present as residual impurities at very low levels that are routinely controlled," the EMA claimed.

The agency did not provide any evidence to support the claim.

"The best independent estimates are 100-200B fragments of the plasmid exist in each dose," Kevin McKernan a microbiologist who first identified the sequence in the vaccine, told The Epoch Times in an email. "The EMA has offered no scientific evidence to make such a claim other than 'Trust our non-peer reviewed heavily redacted failure in transparency.'"

An EMA spokesperson said earlier this year that there was "no evidence to indicate the presence of SV40 ... in the formulation of COVID-19 vaccines."

The EMA is now acknowledging that statement was not correct.

But the regulator said it "has seen no evidence of an association between mRNA vaccines and adverse events that could be linked to the presence of DNA material, nor are we aware of any scientific evidence showing that the very small amounts of residual DNA that may be present in vaccine batches could integrate into the DNA of vaccinated individuals."

It also said, "we have not seen any reliable evidence of residual DNA exceeding approved/safe levels for" the Pfizer vaccine.

Dr. Malone said that the standards they're citing were not designed for the Pfizer and Moderna vaccines, which use modified messenger ribonucleic acid (RNA) technology.

"The safe threshold in the presence of these delivery complexes is something that must be established experimentally by performing genotoxicity studies," Dr. Malone said. "To say that just because we haven't detected it, or it's below the level that we normally accept with, say a flu vaccine, is completely irrelevant."

Fragments Act as Mutagens?

Some scientists say they're concerned because the DNA fragments could act as mutagens, or change the DNA sequence in a gene, even when taking into account how the SV40 sequence in the vaccine is not the cancer-causing large T antigen.
"The thing is that the smaller pieces actually could be very significant," David Wiseman, a former Johnson & Johnson scientist, told The Epoch Times. "They could actually get into your genome, potentially."

Mr. Wiseman was part of a team that recently detected levels of residual DNA in Pfizer's vaccine, as well as in Moderna's vaccine.

Patrick Provost, a professor in the Department of Microbiology, Infectious Diseases, and Immunology at the Faculty of Medicine at Laval University, told The Epoch Times that the danger of the SV40 enhancer being present in the vaccine is its possible integration into a cell's DNA genome.

"All it takes is a single integration at the wrong place in a single cell to initiate a cancerous process and kill a person," he said.

Responding to those concerns, the EMA said that "there is no scientific evidence that any of these SV40 fragments can act as insertional mutagens."

Dr. Malone said that was not true.

"Short DNA fragments and oligonucleotides are specifically used in modern biomedical research to experimentally alter the genomes of cells and embryos," he wrote in an email. "Such DNA fragments are well known to those skilled in the art to be useful for altering genomic information and genome integrity via both recombination and insertional mutagenesis."

Mr. McKernan, a former researcher and team leader for the Massachusetts Institute of Technology Human Genome Project, noted that scientists have found that SV40 sequences are optimal for gene therapy and that one paper described a rate of insertional mutagenesis with transfection being as high as 7 percent of the modified cells.

"Given the EMA waived all genotoxicity studies, their statement is nothing more than complicit wishful thinking," Mr. McKernan said.


FDA Medicare SafeRx Study—Elevated Risks of Stroke Detected from conjuction of COVID-19 & Influenza Vaccines

Thanks to funding from the SafeRx Project, a joint initiative of the Centers for Medicare & Medicaid Services and the Food and Drug Administration (FDA), a group of authors employed at the FDA (the Agency) and a government contractor called Acumen LLC recently completed a self-control case series (SCCS) study tapping into a vast Medicare database (SafeRx). The mission is to investigate any risks of ischemic stroke associated with the COVID-19 vaccine.

This study was prompted by a concern expressed January 2023, by both the FDA itself and the Centers for Disease Control and Prevention (CDC) for an increased risk of ischemic strokes in adults aged 65 years and up after receiving the COVID-19 vaccine (bivalent targeting BA.4/BA.5); plus, the prospect of such a possibility involving the COVID-19 vaccine and concomitant high-dose/adjuvanted influenza vaccine.

This presented analysis tapped into and analyzed data from the Medicare fee-for-service (FFS) population aged ≥65 years. The agency-sponsored study team sought to estimate the risk of incident stroke following COVID-19 bivalent vaccines among Medicare beneficiaries. The study team evaluated stroke risk among age groups, following influenza vaccines, and following concomitant influenza and COVID-19 bivalent vaccine administration from August 31 to November 6, 2022.

While the primary analysis found no elevated risk, specific subgroup analyses identified elevated risk including A) increased risk for persons age 85 years and up for both non-hemorrhagic stroke (NHS)—another term for ischemic stroke, and transient ischemic attack (TIA) with the Pfizer bivalent COVID-19 bivalent vaccine as well as B) an increased risk for both NHS and TIA for those Medicare beneficiaries who received a concomitant COVID-19 bivalent vaccine and a high-dose/adjuvanted influenza vaccine (NHS with Pfizer and TIA Moderna).

Finally, C) the authors found upon completion of secondary analysis a small increased risk of NHS linked to the high-dose or adjuvanted influenza vaccines. While the FDA-sponsored investigation detected such elevated levels of risk, the authors remain steadfast as to the substantial benefits of vaccination, mindful of the risks associated with viral infection leading to an overall reaffirmation as to the safety of these medical products.

What’s the Concern?

The study authors herein address endpoints including the linking of the COVID-19 vaccine as well as influenza vaccine and ischemic stroke. Specifically identified are both the non-hemorrhagic stroke (NHS) and the transient ischemic attack (TIA).

An NHS or ischemic stroke is a type of stroke that occurs when blood flow to a part of the brain is blocked. This blockage can be caused by a blood clot or atherosclerosis, which is the narrowing and hardening of the arteries. Importantly, Ischemic or NHS are the most common type of stroke, accounting for over 80%.

A TIA is often called a “mini-stroke” and represents a medical condition that mimics the symptoms of a stroke but is temporary and does not cause permanent brain damage. These occur due to a brief interruption of blood flow to the brain.

A Robust Study

Led by agency veterans including Stephen Johnson, Ph.D., Director, Office of Biostatistics and Epidemiology, and Richard Forshee, Ph.D. Deputy Director Office of Biostatistics and Pharmacovigilance, the study team included vaccinated individuals’ data only, leaving them not subject to bias due to underreporting of vaccination status in the claims data. Also, Johnson, Forshee and colleagues claim they mitigated any misclassification bias by conducting medical record reviews of the claims-based NHS definition.

The study authors here report on numerous study strengths, such as a robust, large, representative Medicare database, with minimal beneficiary attrition, ensuring highly generalizable findings to the elderly U.S. population.

They also point to the ability of this self-controlled study design to adjust for time-invariant confounders such as health conditions, socio-economic status, and health-seeking behavior. Such factors can inherently bias a study, drawing from between-individual comparisons.

Results Summary

As reported in the preprint server medRxiv, a primary analysis failed to detect elevated stroke risk post-COVID-19 bivalent vaccination.

However, while slicing and dicing the data, including analyses involving subgroups, the study authors report that the cohort of ≥85 year associated with a risk of non-hemorrhagic stroke “(NHS) (Incident Rate Ratio (IRR)=1.36, 95% CI 1.09 – 1.69 [1-21 days]) and NHS/ transient ischemic attack (TIA) (IRR=1.28, 95% CI 1.08 – 1.52 [1-21 days]) with BNT162b2 Bivalent WT/OMI BA.4/BA.5.”

When analyzing the data associated with the Medicare beneficiaries “that received a concomitant COVID-19 bivalent vaccine and a high-dose/adjuvanted influenza vaccine, an increased risk was observed for NHS (IRR=1.20, 95% CI 1.01 – 1.42 [22-42 days]) with BNT162b2 Bivalent WT/OMI BA.4/BA.5 and for TIA (IRR=1.35, 95% CI 1.06 – 1.74 [1-21 days]) with mRNA-1273.222.”

The authors summarized that once completing their secondary analyses, they detected “a small increased risk of NHS following high-dose or adjuvanted influenza vaccines (IRR=1.09, 95% CI 1.02 – 1.17 [22-42 days]).”




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