Posted on 12/04/2023 9:41:47 PM PST by SeekAndFind
The recent findings of DNA fragments in the Pfizer and Moderna Covid-19 vaccines has led many to question why the FDA, which is responsible for monitoring the quality and safety of the vaccines, has failed to sound the alarm.
For years, the FDA has known about the risk posed by residual DNA in vaccines. Its own guidance to industry states:
“Residual DNA might be a risk to your final product because of oncogenic and/or infectivity potential. There are several potential mechanisms by which residual DNA could be oncogenic, including the integration and expression of encoded oncogenes or insertional mutagenesis following DNA integration.”
Put simply, the FDA acknowledges the possibility that fragments of DNA left over by the manufacturing process can be incorporated into a patient’s own DNA, to potentially cause cancer.
FDA and WHO guidelines consider the amount of residual DNA in a single dose of traditional vaccine should not exceed 10 ng (one billionth of a gram).
But this limit – used for traditional vaccines – is unlikely to be relevant to the mRNA vaccines whose lipid nanoparticles can penetrate inside cells to deliver the mRNA efficiently.
A recent preprint paper by Speicher et al analysed batches of the monovalent and bivalent mRNA vaccines in Canada.
The authors found “the presence of billions to hundreds of billions of DNA molecules per dose in these vaccines. Using fluorometry all vaccines exceed the guidelines for residual DNA set by FDA and WHO of 10 ng/dose.”
Speicher et al also reported finding fragments of DNA larger than 200 base pairs (a measure of the length of the DNA) which also exceeds FDA guidelines.
Notably, the authors commented that for the Pfizer product, the higher the level of DNA fragments found in the vaccine, the higher the rate of serious adverse events.
Some experts say the risk of genome integration in humans is very low, but a recent publication in Nature found that around 7 percent of cells are integrated when mixed with a transfection solution containing linear pieces of DNA.
The US Food and Drug Administration (FDA) continues to insist that any residual DNA contamination in the Covid vaccines is not a problem and that it “stands behind its findings of quality, safety, and efficacy for the mRNA vaccines.”
“While concerns have been raised previously as theoretical issues, available scientific evidence supports the conclusion that the minute amounts of residual DNA do not cause cancer, or changes to a person’s genetic code,” added the FDA.
The FDA would not provide the “available scientific evidence” to support its claim, but it’s worth noting that the vaccines’ own product labels show that genotoxicity and carcinogenicity tests were not carried out prior to their use.
David Wiseman, a research bioscientist involved in medical product development and co-author on the study by Speicher et al said the FDA’s claim that there is no evidence of a cancer link is becoming “untenable.”
“The CDC’s own analysis on the vaccine’s safety signal in VAERS shows there could be a signal for some cancers,” said Wiseman pointing to a report he co-authored and sent to the National Academies.
In the table (highlighted in yellow), a safety signal is considered to be significant, and worthy of further investigation, if the value in the column marked PRR exceeds 2 and the value in the Chi-Square column exceeds 4.
The FDA would not confirm if it found levels of DNA that exceeded acceptable levels, nor if it was investigating further.
Instead, after months of enquiries, the FDA sent boilerplate responses to me (and other media) saying, “With over a billion doses of the mRNA vaccines administered, no safety concerns related to residual DNA have been identified.”
In response to a list of questions about its testing and oversight, the FDA said it “does not have any additional information to provide at this time.”
We now know that Pfizer’s vaccine used in the clinical trials (PROCESS 1) was manufactured differently to the vaccine that was injected into the wider population (PROCESS 2).
This switch from PROCESS 1 to PROCESS 2 is what introduced the plasmid DNA impurities (see red circles), which could change the safety profile of the vaccine.
I asked the FDA if it had any human data on the comparison of the two processes.
The agency pointed me to the FDA’s EUA review memo dated 20 Nov 2020 which suggested that the testing was “ongoing.”
The three-year old document stated that “A more comprehensive comparability assessment encompassing additional lots from multiple DP manufacturing nodes is ongoing and the results will be provided to the EUA upon completion of the study.”
When I asked the FDA for access to the “ongoing” results, I was instructed to obtain the information from Pfizer, but the drug company did not respond to my enquiries.
A Freedom of Information request by Nick Hunt of the Daily Sceptic may explain why.
Pfizer promised the regulator that it would compare the safety and immunogenicity of the two processes in participants and report back by February 2021, but it seems those studies were never done.
The FOI stated:
…in October 2020 an exploratory objective was added in the C4591001 study to describe safety and immunogenicity of vaccines produced by manufacturing “Process 1” or “Process 2” in participants 16 to 55 years of age. This exploratory objective was removed and documented in protocol amendment 20 in September 2022 due to the extensive usage of vaccines manufactured via “Process 2”. Thus, this process comparison was not conducted as part of the formal documentation within the protocol amendment.[emphasis added]
Wiseman said, “Given the magnitude of the process change, from my experience in medical product development, these sorts of biological comparability studies would certainly have been expected to be undertaken by Pfizer.”
He added, “the fact that Pfizer was given a free pass indicates a significant lapse in regulatory oversight.”
Kevin McKernan, the genomics expert who made the discovery of DNA fragments in the vaccines earlier this year, says there’s “no incentive” now for Pfizer to carry out this comparative testing.
“It’s speculation on my part, but I suspect they might’ve seen increased adverse events with the commercial batch and buried the data knowing the train had left the station at that point,” said McKernan.
“There was no political will to stop vaccinating, and Pfizer probably knew the regulators would let them get away with not testing the commercial batches for the population,” he added.
* * *
Republished from the author’s Substack
A follow-on which is even more horrifying than the New Zealand numbers.
https://expose-news.com/2023/12/05/death-sentence-covid-vaccine-1-million-deaths/
“So much so, that there were 965,609 deaths among the vaccinated compared to just 60,903 deaths among the unvaccinated between July 2021 and May 2023. Meaning there was a grand total of 1,026,512 deaths in England during this period and the vaccinated accounted for 94% of them, whereas the unvaccinated accounted for just 6% of them.”
“But it’s the fact that these deaths aren’t among the one-dose and two-dose vaccinated population that is truly horrifying. The vast majority are among the 4x vaccinated, with this population accounting for 80% of all COVID-19 deaths, and 83% of all COVID-19 deaths among the vaccinated. (Source)”
In this case, mRNA-LNPs were capable of going for hematopoietic stem cells (HSCs)… …in order to produce a “gene editor” within the cell:
Source: Chemical & Engineering News (a real trade journal/publication, I used to have a subscription)
via
https://thedailybeagle.substack.com/p/exclusive-plasmids-can-integrate
But...but...the $hot $hills INSISTED there was absolutely NO gene editing OR cell reprogramming going on, with these terrible $hots.
Remember that?
Never forget what the $$s (FRAUDci minions) did to/said to those who sounded the alarms.
Remember, these are only the ones *reported* to the CDC.
While surfing last night, I found a quote from a doctor who said they tracked the status of their CDC VAERS reports (hazy 1AM memory, 26 total cases, 13 severe. All 13 severe were dropped by VAERS/ the CDC).
Things that make you go hmmmmm....
That’s exactly right....they not only have removed reports...but, stopped reporting, altogether!
And....made entering reports hard as heck frustrating, that MANY medical assistants gave up, entirely.
"Put simply, the FDA acknowledges the possibility that fragments of DNA left over by the manufacturing process can be incorporated into a patient’s own DNA, to potentially cause cancer.
FDA and WHO guidelines consider the amount of residual DNA in a single dose of traditional vaccine should not exceed 10 ng (one billionth of a gram).
But this limit – used for traditional vaccines – is unlikely to be relevant to the mRNA vaccines
whose lipid nanoparticles can penetrate inside cells to deliver the mRNA efficiently."
"A recent preprint paper by Speicher et al analysed batches of the monovalent and bivalent mRNA vaccines in Canada.
"The authors found “the presence of billions to hundreds of billions of DNA molecules per dose in these vaccines.
Using fluorometry all vaccines exceed the guidelines for residual DNA set by FDA and WHO of 10 ng/dose.”
Speicher et al also reported finding fragments of DNA larger than 200 base pairs (a measure of the length of the DNA) which also exceeds FDA guidelines. "
" Notably, the authors commented that for the Pfizer product, the higher the level of DNA fragments found in the vaccine, the higher the rate of serious adverse events."
"Is the FDA Concerned?
The US Food and Drug Administration (FDA) continues to insist that any residual DNA contamination in the Covid vaccines is not a problem
and that it “stands behind its findings of quality, safety, and efficacy for the mRNA vaccines.”
“While concerns have been raised previously as theoretical issues, available scientific evidence supports the conclusion
that the minute amounts of residual DNA do not cause cancer, or changes to a person’s genetic code,” added the FDA."
"The FDA would not provide the “available scientific evidence” to support its claim, but it’s worth noting that the vaccines’ own product labels
show that genotoxicity and carcinogenicity tests were not carried out prior to their use."
"David Wiseman, a research bioscientist involved in medical product development and co-author on the study by Speicher et al
said the FDA’s claim that there is no evidence of a cancer link is becoming “untenable.”
“The CDC’s own analysis on the vaccine’s safety signal in VAERS shows there could be a signal for some cancers,”
said Wiseman pointing to a report he co-authored and sent to the National Academies. “
"The FDA would not confirm if it found levels of DNA that exceeded acceptable levels, nor if it was investigating further.
Instead, after months of enquiries, the FDA sent boilerplate responses to me (and other media) saying, “With over a billion doses of the mRNA vaccines administered,
no safety concerns related to residual DNA have been identified.”
(My Opinion) : This latter statement, alone, would explain why the FDA ignored their own VAERS website and complaints of adverse events.
H/T Seek and Find< & Grey Whiskers
BTTT!!!
BTTT!
No, the FDA is NOT concerned.
They were in on it.
Unfortunately our government appeared to become our enemy in early April, 2020. On March 23, 2020, Dr. Zelenko sent President Trump and his assistant Mark Meadows information about a successful EARLY treatment of Covid. This was composed of ZINC to fight Covid virus inside of infected cells, HCQ to serve as an IONOPHORE (Google this) that would help zinc get into the infected cells, and Azithromycin, an antibiotic to help proetect the lungs from bacterial infection. For about 10 days I heard Dr. Fauci and President Trump talking about these 3 items in daily pressers about the Covid situation. Then, abruptly, all mention of ZINC was eliminated. Did Fauci make this happen???
In early May, 2020, Fauci announced an important NIH study of the LOW COST drugs, HCQ and Azithromycin to treat hospitalized Covid patients. NO EARLY treatment and NO ZINC. A test designed to fail. Not long after, Fauci announced that the NEW drug Remdesivir was ready to save lives of hospitalize Covid patients. But it was not LOW COST. It would cost around $3,000 per treatment course, when subsidized by our tax dollars. Is this why no LOW COST, EARLY treatment was ever offered to the American people. THen, of course, in 2021 the “vaccine” for Covid was ready for our enjoyment, and big drug company profits as it was provided using our tax dollars.
One bit of confusion was caused by the fact that HCQ did show some signs of helping Covid illness. If taken early before a body used up all it’s ZINC reserves, then it could help that zinc get into infected cells. However, all Fauci wanted to do was use HCQ on seriously ill patients with NO ZINC RESERVES. Late last winter after two months of a severe respiratory illness (RSV?) I suddenly lost my sense of smell. This is a sign of zinc deficiency. I had been taking 50 mg of zinc oxide most days during that illness, but apparently it was not enough. I then took 150mg of zinc for 5 days and my sense of smell was fully restored.
One source of Dr. Zelenko’s letter: https://www.nairaland.com/5761296/open-letter-dr-zelenko-successfully/2
I had to prove I was human before being given the letter. Also, the actual letter is below a lot of clutter of advertizing.
https://www.clarkcountytoday.com/news/dr-zelenko-we-could-have-ended-pandemic-long-ago/
This article gives many details regarding some of what I have written above, including:
“Zelenko has explained that the KEY VIRUS KILLER is zinc, which has a known antiviral effect, and it’s drugs like hydroxychloroquine, ivermectin and quercetin that ‘open the door to the cell and let the zinc in.’”
“The objective, he said, has always been to prevent a COVID-19 infection from progressing to the catastrophic lung injury called acute respiratory distress syndrome, or ARDS, which requires hospitalization and often a ventilator. He found early on that more than 80 percent of the people with COVID who were put on a respirator were dying. His protocols don’t treat ARDS, but they can keep people from ever developing it.”
“His approach has been to identify high-risk COVID patients, start treatment immediately with an antiviral and anti-inflammatory combination and tailor the treatment to each patient.”
When “WND (News Center) asked Zelenko what he thinks has happened in the meantime”, Zelenko responded, “Well, in the meantime 850,000 Americans are dead, and we could have prevented probably 730,000 of them from even going to the hospital and ended this pandemic globally,” he replied, alluding to the finding of his paper. “That’s what happened.”
But then, Pfiser and Moderna, and others would not be $billions richer, and happier. And multi-millions worldwide would not be dead and their families grieving.
Are the FDA and CDC just incompetent or evil. I’m voting incompetent. Federal employees can stay way past their useful time. I think we are seeing how they react under pressure. Fail!
No, the FDA is NOT concerned.
They were in on it.
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BINGO!
I think it would be horrible if we knew what the Chinese might be/probably are, slipping into medicines they manufacture for Americans.
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