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Sausage Making at FDA: How Human Cancer Cells Got Into Vaccines • Children’s Health Defense

Posted by M. C. on December 14, 2020

FDA decided to hide information about their use of tumor cells and omit it from package inserts.

Dr. Marion Gruber proposed this deception when he said: “The minute you describe something in the package insert in terms of potential clinical safety concerns, I think that really precludes using these cell substrates.”

Between 2000 and 2010, pharmaceutical companies paid the FDA $3.4 billion to gain rapid drug approvals. Today, Pharma companies underwrite three-quarters of FDA’s budget for scientific reviews (ProPublica) and fund nearly 50% of the FDA’s total annual budget through PDUFA fees. In exchange, the agency increasingly fast-tracks expensive drugs and vaccines with significant side effects and unproven health benefits.

https://childrenshealthdefense.org/defender/fda-cancer-cells-in-vaccines/

By

Robert F. Kennedy, Jr.

“If the American people knew some of the things that went on at the FDA, they’d never take anything but Bayer aspirin.” — Len Lutwalk, FDA scientist

“The FDA, by spinelessly knuckling under to every whim of the drug companies, has thrown away its high reputation, and in doing so, forfeited our trust.” — Drummond Rennie, deputy editor of JAMA

“[The] honest employee fears the dishonest employee. There is also irrefutable evidence that managers at CDER (Center for Drug Evaluation and Research of the FDA) have placed the nation at risk by corrupting the evaluation of drugs and by interfering with our ability to ensure the safety and efficacy of drugs. While I was at FDA, drug reviewers were clearly told not to question drug companies and that our job was to approve drugs … If we asked questions that could delay or prevent a drug’s approval — which of course was our job as drug reviewers — management would reprimand us, reassign us, hold secret meetings about us or worse … When you are able to dig in, if you found issues that would make you turn down a drug, you could be pressured to reverse your decision, or the review would then be handed off to someone who would simply copy and paste whatever claims the company made in the summary document … I believe I also have documentation of falsification of documents, fraud, perjury and widespread racketeering, including witnesses tampering and witness retaliation.” — Ronald Kavanagh, Ph.D., pharmacist who reviewed medications for the FDA from 1998 to 2008

Vaccines and related biological products advisory committee today

Today — Thursday, Dec. 10 — the Vaccines and Related Biological Products Advisory Committee (VRBPAC), which is the U.S. Food and Drug Administration’s (FDA) internal panel that licenses new vaccines as “safe and effective,” will meet to consider Pfizer’s COVID vaccine. VRBAC will meet in one week, Dec. 17, to consider approval of the Moderna vaccine.

The damning safety studies in Pfizer’s late release clinical trial data dump, and the severe (life-threatening) allergic reactions that bedeviled the vaccine’s UK rollout, have raised red flags and public anxiety about the safety of the companies’ mRNA vaccines. Anthony Fauci has addressed growing skepticism about COVID vaccines and the Operation Warp Speed program, by reassuring the public that “VRBPAC” is an “independent panel of leading experts” whom the public can absolutely trust to assure vaccine safety.

In order to help you make your own conclusion about how reliably VRBPAC will protect your health, I excerpt below the transcripts from the cavalier, ignorant and astonishingly unethical deliberations during the 2012 VRBPAC meeting where panelists voted unanimously to allow use of human tumor cells in vaccines. I urge you to read and make up your own mind whether you want to place your health — and perhaps your life — in the hands of these reckless charlatans and irresponsible clowns.

How FDA originally approved use of fetal cells in vaccines

FDA allows both human fetal cells and adult human tumor cells in vaccines. Both types have cancer risks. While both Pfizer and Moderna tested their mRNA vaccine using fetal cells, there are no fetal cells, cell debris or DNA in their final products.

However, according to company documents, Johnson and Johnson (Janssen) and Altimmune’s COVID vaccines are manufactured in the human fetal cell line PER-C6, and thus the final vaccine products will contain cellular debris and DNA fragments from these cells. Researchers harvested these cell lines from the eyeball of an 18-week-old human fetus aborted in 1985, and then rendered them immortal by making them cancerous.

The AstraZeneca, Cansino, Gamayela, Vaxart, LongComm and Upitt vaccines are manufactured in the human fetal cell line HEK293, and thus the final vaccine products will contain cellular debris and DNA fragments from the fetal HEK-293 cell line. Scientists harvested this cell line from the kidney of a female Dutch fetus legally aborted in 1973 and then immortalized the cells by rendering them cancerous.

Normal primary cells, which are unable to replicate indefinitely, ultimately die. Immortalized cell lines are derived from known malignant cancer cells such as those obtained from Henrietta Lacks (HeLa) or created in the laboratory by introducing viral oncogenes or chemical exposures capable of mutating normal primary cells into immortal tumor cells.

According to FDA’s “The Pink Sheet” dated Nov. 29, 1999, for two decades the agency has been acutely aware of the inherent risks of using immortalized cell lines for vaccine development. The FDA CBER Director Dr. Peter Patriarca, M.D. explained that continuous cell lines are used for their ability to self-propagate, making them an ideal substrate on which to grow viruses, “the worst thing we are concerned about is …  malignancy, because some of these continuous cells have the potential for growing tumors in laboratory animals.”

Patriarca further conceded that “the technology to make these vaccines actually exceeds the science and technology to understand how these vaccines work and to predict how they will work.” This dire “black box” conundrum that Patriarca described in 1999 is even more acute today with the urgent pressure to develop COVID vaccines before manufacturers have tested them in animals or subjected them to long-term safety studies.

We call vaccines “biologics” because vaccinologists have traditionally grown their antigens on biological substrates — usually animal tissue. Competing companies culture COVID vaccines on a variety of animal strata. The Merck and IAVA COVID vaccines are manufactured in vero monkey cells, and thus contain cellular debris and DNA fragments from vero monkeys in the final product. The Sanofi, GSK, and Novavax COVID jabs are manufactured in insect cells and thus contain insect cellular debris and DNA fragments in the final products.

Public health advocates criticize the use of animal tissues in vaccines due to risks that they carry endogenous viruses, microbes, parasites and lack safety testing. (Plague of Corruption, Mikovits 2020).The first use of human fetal cells in vaccines occurred around 60 years ago, but the practice is increasingly popular. It was always controversial. Immunologists long considered using cells from aborted human fetuses in vaccines to be a high-risk gambit; human DNA debris is much more likely to infiltrate cells in vaccinated individuals than insect or monkey DNA.

Researchers and regulatory agencies have worried for more than 50 years about the potential for injected DNA to cause cancer. According to Dr. Theresa Deisher, a research scientist, primitive (unmethylated) DNA chains from human fetuses have the ability to 1) activate immune receptors that could lead to autoimmune attacks in susceptible individuals who have genetic predispositions that cause their own DNA to be under-methylated, or 2) insert into cells where they could combine with host DNA and cause mutations.

Regulators have in the past predicted that the odds of that happening were less than 1 in a trillion. However, in early gene therapy trials this event did indeed occur in 4 of 9 boys, 1 of whom died from the leukemia the insertions caused.

“Researchers have long observed that when introduced DNA enters a cell, it chooses a region of the cell that gives it a survival advantage. These could be the regions that are most likely to produce long-living cancer cells,” Dr. Deisher told me. FDA has never made any effort to test the safety of this practice or to determine whether the epidemic of soft-tissue cancers is “vaccine-generation” children is related to the use of cancerous fetal cells in vaccines. Even worse, in 2002, FDA green-lighted vaccine companies to use cancerous tumor cells from adults in vaccines.

FDA as an arm of Big Pharma

Before reviewing the shocking transcript of the FDA meeting that approved this dubious practice, we need to understand the conflicts and corruption that pervade this rogue agency. If we are to ever develop safe, effective COVID vaccines, we need first to stop thinking of the FDA as a regulatory agency; it is an arm of the notoriously corrupt pharmaceutical industry.

According to a 2017 Emory University study entitled “Thick as Thieves? Big Pharma Wields Its Power with the Help of Government Regulation,” FDA bureaucrats act as “enablers, or perhaps worse still, [they are] complicit in questionable or ethically unsound activity as a result of being driven by self-serving motives ….” A 1992 law that allows drugmakers to buy fast-track approvals for new products from FDA has poured concrete on a regulatory dynamic already corrupted by all the ubiquitous mechanisms of “agency capture.”

Between 2000 and 2010, pharmaceutical companies paid the FDA $3.4 billion to gain rapid drug approvals. Today, Pharma companies underwrite three-quarters of FDA’s budget for scientific reviews (ProPublica) and fund nearly 50% of the FDA’s total annual budget through PDUFA fees. In exchange, the agency increasingly fast-tracks expensive drugs and vaccines with significant side effects and unproven health benefits.

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Robert F. Kennedy, Jr.'s avatar

Robert F. Kennedy, Jr.

Robert F. Kennedy, Jr.’s reputation as a resolute defender of the environment stems from a litany of successful legal actions….

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