ANd Now, A “Sprayable” Covid Vaccine

Sprayable COVID Vaccine Trial Raises ‘Significant Safety Concerns’

Several scientists and researchers questioned the design of the trial for the CVXGA1 nasal vaccine, suggesting the trial did not examine “if shed materials can be spread to others.” The trial also included just 72 participants and lacked an unvaccinated control group.

women getting nasal vaccine

A sprayable intranasal mRNA COVID-19 vaccine demonstrated effectiveness in its Phase 1 clinical trial, according to a study published last week in the journal Science Advances.

However, critics questioned the trial’s design and limited sample size. And some suggested that the sprayable vaccine — CVXGA1, produced by CyanVac LLC — could pose a risk to the public.

Investigative journalist Sonia Elijah noted that CVXGA1, which enters the mucus membranes and lungs through the nose, has the “potential for shedding viral particles through intranasal secretions, which could expose unvaccinated individuals.”

Elijah said the study didn’t examine if shed materials can be spread to others. “This raises significant safety concerns about replication and shedding risks,” she said.

Karl Jablonowski, Ph.D., senior research scientist for Children’s Health Defense, said the platform CVXGA1 uses as a vector is parainfluenza virus type 5, a “communicable respiratory virus between humans and non-human animals that is evading our immune system.”

Jablonowski said this platform exacerbates the risk of shedding. “Since it is self-spreading, there is no informed consent or medical precautions as the ‘vaccine’ may infect infants, children, pregnant women, immunocompromised or medically frail.”

Karina Acevedo Whitehouse, Ph.D., professor of microbiology at the Autonomous University of Querétaro in Mexico, agreed. Citing studies involving similar vaccines, Whitehouse said there are “high chances” this vaccine will result in “persistent shedding.”

Whitehouse cited a 2023 study of an intranasal RSV (respiratory syncytial virus) vaccine, which detected virus shedding in 17% of participants.

CVXGA1 produces the SARS-CoV-2 virus spike protein — which was also contained in the mRNA COVID-19 vaccines produced by Pfizer and Moderna.

Medical experts and peer-reviewed studies have suggested the spike protein poses potentially serious risks to human health.

“Genetically modifying an infectious respiratory virus to express a spike protein is a familiar and really bad idea,” Jablonowski said. “The immune system will be antagonized by the presence of the spike protein.”

Clinical trial flawed, experts say

According to the CVXGA1 Phase 1 study, CVXGA1 “is a potentially effective intranasal COVID-19 vaccine” that produces an immune response with minimal adverse reactions.

The clinical trial included just 72 participants, ages 12-53, split into two groups. One group received a “high dose” of the vaccine, the other received a smaller dose.

Findings showed the high-dose group demonstrated “Significantly lower rates of symptomatic COVID-19 infection” and that the vaccine was “well tolerated without serious adverse events (AEs) or fever reported.”

However, several scientists and researchers noted that the trial lacked an unvaccinated control group.

“There is absolutely no way that this paper can be considered evidence that this intranasal gene-therapy based product is safe or effective,” Whitehouse said. “No group was used as a control with which to compare the results … as well as adverse events. This in itself invalidates any interpretation of safety and effectiveness of this product.”

According to Elijah, the lack of a control group and the small sample size “weakens the trial’s ability to accurately assess safety and immunogenicity,” but these aren’t the only flaws.

Elijah said:

“The study lacks data on RNA detection levels and did not perform infectivity assays to confirm if shed materials can be spread to others.

“The lack of specific safety and immunogenicity data for the adolescent group raises concerns about the vaccine’s effects in younger individuals.

“The open-label design, where both participants and researchers knew who received the vaccine, introduces potential bias in reporting and assessing outcomes, such as adverse events.”

Whitehouse noted that the study’s researchers claimed they didn’t identify any serious adverse events. However, they tracked adverse events only “during a limited time frame,” which “reduces the chances of detecting serious events that may occur after this time period.”

Researchers plan to enroll 10,000 participants for the next phase of the clinical trial.

According to immunologist and biochemist Jessica Rose, Ph.D., if clinical trials for CVXGA1 are deemed a success, “this could be used to push gene-based (mRNA, RNA and DNA) products on us via intranasal (breathing) routes.”

Clinical trial site previously hosted Pfizer COVID vaccine trials for adolescents

Experts also noted that the clinical trials were not performed independently but were fully funded by CyanVac.

According to the study’s disclosure statement, several of the researchers are CyanVac employees or equity holders, are under contract with the company, or have received research grants from other pharmaceutical companies, including COVID-19 vaccine manufacturers AstraZeneca, Moderna and Pfizer.

Investors such as Bill Gates have previously shown interest in inhalable and sprayable vaccines, although it is unclear whether Gates is involved with the development of CVXGA1.

Elijah noted that Cincinnati Children’s Hospital ran the trial and Dr. Paul Spearman, the hospital’s vice chair of clinical and translational research and education, led it. The hospital was one of the sites for adolescent clinical trials of Pfizer’s COVID-19 vaccine.

In 2021, a participant in one of those trials, 12-year-old Maddie de Garay, was severely injured after she received the second dose of the Pfizer vaccine. She sustained several serious adverse events and ended up in a wheelchair.

According to Elijah, doctors at the hospital dismissed any connection between de Garay’s injuries and the Pfizer vaccine, and instead classified her injuries as “neuralgia and functional abdominal pain.”

from:  https://childrenshealthdefense.org/defender/sprayable-covid-vaccine-trial-raises-safety-concerns/

A Little Shot of Cancer, Perhaps?

(Please note that I have excerpted a good deal of the text which is available at the link below)

Sausage Making at FDA: How Human Cancer Cells Got Into Vaccines

In a 2012 meeting, the FDA voted to allow the use of human fetal cells and adult human tumor cells in vaccines, despite acknowledging the many risks, including that vaccine recipients might later develop cancer.

“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


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.

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.”   …

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). …

Researchers and regulatory agencies have worried for more than 50 years about the potential for injected DNA to cause cancer.  …

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.

FDA as an arm of Big Pharma

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.

Corrupt vaccine approval panels

But as corrupt as FDA is, the internal panels — VRBAC — that approve new vaccines make the rest of the agency look like a Sunday church picnic.

When Dr. Fauci, Paul Offit, Peter Hotez and Bill Gates tell you that you needn’t worry because FDA is the “gold standard” for vaccine safety and that the ultimate licensing decision will be made by an “independent panel of experts,” they are talking about VRBPAC. But VRBPAC is far from “independent.” It is not even comprised exclusively of public officials. Instead, it is populated by outside “experts” who are almost all pharmaceutical industry insiders.

In 2003, following a 3-year investigation, the United States Congress’s House Oversight Committee found VRBAC was completely dominated by the vaccine industry.

“Examples of Conflicts of Interest:

  1. “For instance, 3 out of 5 FDA advisory committee (VRBPAC) members who voted to approve the rotavirus vaccine in December 1997 had financial ties to pharmaceutical companies that were developing different versions of the vaccine.
  2. “One out of five voting members’ employer had a $9,586,000 contract for a rotavirus vaccine.
  3. “One out of five voting members was the principal investigator for a Merck grant to develop a rotavirus vaccine.
  4. “One out of five voting members received approximately $1 million from vaccine manufacturers toward vaccine development.”

Congressional investigators concluded that, “Altogether, four out of the five committee members had conflicts of interest that required waivers, and their recommendation for approval of the vaccine was unanimous.”

Here’s what happened at the 2012 FDA meeting on fetal cells

HHS acknowledges that the FDA and Centers for Disease Control committees that contract and review new vaccines have historically not used “evidence-based medicine.” To illustrate what this means, one only need read (below) the astonishing transcript of the 2012 panel that first approved the use of adult cancer tumor cells in vaccines.

This transcript shows what the public is never supposed to see: the behind-the-scenes sausage-making of federal vaccine approvals. Here, you will read for yourself how the “independent,” “gold standard” panelists entrusted with protecting your children made monumentally consequential decisions, not on evidence-based science, but by rolling the dice and taking what they knew was a horrendously risky bet on public health

In any other realm, this transcript would be proof of negligent homicide. … We are all lab rats in their high-risk population-wide experiment. At FDA’s vaccine division, that sort of reckless decision-making is routine.

In 2012, most live virus vaccines were from animal tissue and the idea of putting potentially cancerous tumor cells from adult “donors” in vaccines was still a daring and audacious gamble. That September, the FDA VRBPAC committee met to discuss this risky innovation. The transcript of that meeting — showing captive FDA officials considering a proposal by the pharma cabal to allow the use of human cancer cells (HeLa) to replace animal tissue in the manufacture of vaccines — is proof of reckless criminal conduct.

The HeLa cells are well known to cause cancer in animals, but Big Pharma wanted to lower production costs of vaccines and this method is cheaper and faster than using animal tissue for the cultivated media. …

Unbelievably, FDA voted to allow pharmaceutical companies to produce vaccines using human cells without reviewing a single scientific study to determine if the outcome would be safe.

Before, I quoted some of the criminally reckless statements from the meeting directly. A more detailed account appears in this article.

This was a full meeting of FDA’s VRBPAC in 2012 to decide on the use of human tumor cell lines for the production of vaccines. I list these speakers and their titles at that time:

  • Dr. Philip Krause, Acting Deputy Director of OVRR (Office of Vaccine Research and Review) and FDA’s CBER (Center for Biologics Evaluation and Research). Also, Principal Investigator for Vaccine Safety: Virus Detection and Latency.
  • Dr. Doug Lowy, Director of the National Cancer Institute of the NIH.
  • Dr. Robert Daum, Chair of the VRBPAC.
  • Donald W. Jehn M.S., Designated Federal Officer for VRBPAC.
  • Keith Peden, PhD, Chief of LDNAV, DVP/OVRR/CBER.
  • Dr. Marion Gruber, Director of the FDA’s Office of Vaccines.
  • Dr. Nathanial Brady, a self-described clinician.
  • Dr. Pamela McInnes, a vaccine development expert and the Director of the Division of Extramural Research at the NIH’s National Institute of Dental and Craniofacial Research, and previously a Deputy Director under Anthony Fauci at the National Institute of Allergy and Infectious Diseases.

Pharma knew that their tumorigenic vaccines might cause tumors in recipients.

FDA officials knew that tumors might occur decades after vaccination.

FDA openly acknowledged that its primary objective was not to assure public safety but to help vaccine manufacturers.

FDA officials knew that they could not prove vaccine safety using test animals to assess oncogenicity.

FDA officials deliberately terminated animal safety tests too early in order to conceal consequences.

FDA decided to keep the tumor cell lines secret, because doctors and the public may be alarmed and say “Oh, my God!” if they knew the truth.

FDA decided to use deceptive language to convince doctors and the public that the vaccines were safe even when they, themselves, were unconvinced of safety.

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

Health authorities were skeptical about safety of the tumor lines, but they decided to subject the public to the risk, so that they could perform a global population-wide live human experiment.

FDA officials opted to toss the dice, perform the population-wide human experiment, and learn about the risks as time goes by.

The committee formally approves the method of making vaccines from human cancer tumors.

..

Prior to voting to go forward, the committee made the following conclusions:

  • Making vaccines with cells that are directly derived from human cancer tumors is faster and cheaper than breeding animals for the culture media.
  • Millions of potentially cancer-causing vaccines will be produced.
  • The vaccines may possibly cause genetic mutations.
  • Millions of dollars will be made by vaccine promoters.
  • The health of millions of consumers may be jeopardized.
  • Information about how vaccines are made will be hidden from doctors and

Finally, it’s worth considering that cancer treatment drugs like Keytruda are among pharmaceutical companies’ largest profit makers. Precipitating a cancer epidemic in human populations only benefits vaccine makers’ bottom line.

Remember, these are the same companies and the same FDA regulators that brought us the opioid epidemic.

from:    https://childrenshealthdefense.org/defender/fda-cancer-cells-in-vaccines/?utm_source=salsa&eType=EmailBlastContent&eId=8fc80363-cace-4de1-bcd2-9e309b779ac5