COVID-19
There are no licensed COVID shots for kids under 12 – but CDC wants babies to get 3 Pfizer shots by 9 months
From LifeSiteNews
By and
“This is an insult to people’s intelligence,” she said, “I pray that parents will have the good sense to say no to these dangerous and unnecessary shots for babies.”
Nine-month-old babies must receive multiple doses of an unlicensed mRNA COVID-19 vaccine to be considered “up to date” with their COVID-19 vaccination, according to the Centers for Disease Control and Prevention (CDC).
The CDC’s updated guidance, issued August 30, states that children – as young as 6 months old – should get either two doses of the 2024-2025 Moderna vaccine or three doses of the 2024-2025 Pfizer-BioNTech vaccine.
If getting the new Pfizer shot, the baby is supposed to receive the first dose at 6 months, the second dose three weeks later and the third dose at least eight weeks after the second dose – meaning, that by 9 months old, babies are supposed to have received three Pfizer shots.
If getting the latest Moderna shot, the CDC recommends babies get the first dose at age 6 months and the second dose a month later.
The latest Pfizer and Moderna COVID-19 shots for children under 12 are unlicensed in the U.S. The U.S. Food and Drug Administration (FDA) has granted only emergency use authorization (EUA) for the vaccines.
Children’s Health Defense (CHD) CEO Mary Holland told The Defender, “The earlier COVID shots have been proven unsafe and ineffective. Now we’re asked to believe that newer versions are miraculously safe and effective?”
“This is an insult to people’s intelligence,” she said, “I pray that parents will have the good sense to say no to these dangerous and unnecessary shots for babies.”
As of July 28, 37,814 deaths following COVID-19 vaccination had been reported to VAERS, the Vaccine Adverse Event Reporting System, run by the FDA and CDC.
Of those, 187 reports were for children and teens under 18. Nearly 13,000 reports listed the age as “unknown.”
VAERS analyst and expert Albert Benavides recently told The Defender he believes VAERS is “throttling” and underreporting deaths of all ages following COVID-19 vaccination.
Meanwhile, the CDC continues to tell the public that COVID-19 vaccines are “safe and effective.”
CDC ‘absolutely misleading’ public on safety of EUA vaccines
Holland said the CDC is “absolutely misleading” the public by asserting that COVID-19 EUA vaccines are safe and effective because EUA vaccines are not held to the same safety or efficacy standards as licensed vaccines.
“By law,” she explained, “EUA products ‘may be effective,’ and they have not undergone the safety testing required to permit licensing.”
“This is one more horrific example of the CDC putting profits before people and acting as an unethical arm of Big Pharma’s marketing operation,” Holland added.
CHD Chief Scientific Officer Brian Hooker agreed. “It is criminal that these untested vaccines are being recommended to infants and children, especially given the fraudulent tactics to market them to an unsuspecting public,” Hooker told The Defender.
There’s no licensed COVID vaccine for kids under 12
There are still no licensed COVID-19 vaccines available for children under 12, Hooker said – so all COVID-19 vaccines given to young kids are EUA products.
The FDA’s website on EUA for medical products states that EUA vaccines only have to meet the standard of “may be effective” as long as if, “based on the totality of the scientific evidence, it is reasonable to believe that the product may be effective for the specified use.”
“The ‘may be effective’ standard for EUAs provides for a lower level of evidence than the ‘effectiveness’ standard that FDA uses for product approvals,” the website states.
Before a vaccine can be fully licensed, the vaccine maker typically is required to conduct numerous clinical trials to demonstrate that the product is safe. However, the safety requirements for EUA are more flexible.
According to the FDA:
The amount and type(s) of safety information that FDA recommends be submitted as part of a request for an EUA will differ depending upon a number of factors, including whether the product is approved for another indication and, in the case of an unapproved product, the product’s stage of development.
Despite this, the first statement on the CDC’s “6 Things to Know about COVID-19 Vaccination for Children” says, “COVID-19 vaccination for children is safe.”
Risks outweigh benefits for kids
Hooker said the CDC’s actions are especially problematic as, historically, the meaning of “safe” has been interpreted by regulatory authorities as meaning that the benefits of a drug outweigh its risks.
“With the risk to children of dying from a COVID-19 infection being statistically zero, it is unclear if there is any benefit,” he said.
Meanwhile, the CDC still claims that “while adverse reactions are rare, the benefits of COVID-19 vaccination outweigh the known risks of COVID-19 and possible severe complications.”
Pfizer fact sheet more forthcoming about risks
For licensed vaccines, the CDC typically provides an official vaccine information statement (VIS) that describes the vaccine’s risks and potential benefits.
According to the CDC website, “Federal law requires that healthcare staff provide a VIS to a patient, parent, or legal representative before each dose of certain vaccines.”
However, for EUA COVID-19 vaccines, the CDC directs people to “fact sheets” – produced by the vaccine manufacturer, not the CDC, and authorized by the FDA – which detail the product’s risks and benefits.
There is no federal law requiring healthcare providers to share these fact sheets with patients, or parents of minors, before a COVID-19 vaccination.
“Pfizer’s own ‘fact sheet’ for its latest COVID-19 vaccine appears to give a more accurate picture [of the vaccine’s risks] than the CDC’s own websites,” Hooker said. “Shouldn’t the CDC be more a watchdog than Pfizer?”
For example, Pfizer’s fact sheet states, “A product authorized for emergency use has not undergone the same type of review by FDA as an FDA-approved product.”
The Pfizer fact sheet also acknowledges that its vaccine “may not protect everyone” and that reported side effects associated with the Pfizer vaccines include myocarditis and pericarditis.
Hooker pointed out that research has shown that vaccine-induced myocarditis, inflammation of the heart, and pericarditis, inflammation of the tissue surrounding the heart, can be fatal.
He urged parents to “read between the lines” when assessing the CDC’s COVID-19 vaccination recommendation for babies and children.
“Most of all,” he added, “use common sense to decide if the CDC’s and the FDA’s logic is sound.”
This article was originally published by The Defender – Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
Brownstone Institute
The Trump Administration Must Bring Moderna to Heel
From the Brownstone Institute
Moderna’s European filing also revealed that the company withheld trial results demonstrating that children under 12 who received the vaccine were ten times more likely than those who received the placebo to suffer “serious side effects.”
Last week, independent journalist Alex Berenson reported that a preschool-aged child died of “cardio-respiratory arrest” after taking a dose of Moderna’s Covid mRNA vaccine during its clinical trials. Despite federal requirements to report all trial information, the company withheld the truth for years as it raked in billions from its Covid shots.
The extent of the cover-up remains unknown, but Moderna, headed by CEO Stéphane Bancel, disregarded federal law requiring companies to report “summary results information, including adverse event information, for specified clinical trials of drug products” to clinicaltrials.gov. The company, not the government, is responsible for posting all results, and failure to report the death of a child constitutes a clear breach of US law, which threatens civil action against any party that “falsifies, conceals, or covers up by any trick, scheme, or device a material fact.”
To this point, pharmaceutical companies have remained largely immune for their role in perpetrating globally-scaled deception resulting in thousands of vaccine injuries and billions in profits. They have enjoyed a liability shield courtesy of the PREP Act, which offers protections for injuries resulting from vaccines; that indemnity, however, does not extend to non-compliance with federal regulations, material misstatements or omissions of fact, or other offenses.
The death of the child only became known because of an obscure European report released last year, which revealed that Moderna has known about the death for over two years while it continues to advertize Covid shots to children as young as six months old.
Moderna’s European filing also revealed that the company withheld trial results demonstrating that children under 12 who received the vaccine were ten times more likely than those who received the placebo to suffer “serious side effects.” Without any evidence, Moderna claimed that the side effects, including the death of a child, were unrelated to the shots.
The incoming Trump administration offers a rare opportunity to hold pharmaceutical companies accountable and to investigate the depth of the cover-up.
The FDA is responsible for enforcing the reporting of vaccine trial results, but recent heads of the agency such as Scott Gottlieb and Robert Califf have been fanatical supporters of Big Pharma. Trump’s choice for FDA, Dr. Marty Makary, presents a stark contrast to his predecessors. Makary has criticized the US Government’s reluctance to acknowledge the role of natural immunity in preventing Covid infection, and he opposed the widespread vaccination of children. He testified to Congress, “In the U.S. we gave thousands of healthy kids myocarditis for no good reason, they were already immune. This was avoidable.”
President-elect Trump has tapped Robert F. Kennedy, Jr., perhaps the most well-known critic of the Covid vaccines, to lead the Department of Health and Human Services, which oversees the FDA. He has named Dr. Jay Bhattacharya, an author of the Great Barrington Declaration, as his choice to head the National Institutes of Health. Further, Senator Ron Johnson (R-WI) told Berenson that he plans to subpoena the FDA once Republicans become the majority party in the Senate this month.
President Trump’s first term was ultimately defined by his failure to fulfill his pledge to “drain the swamp.” A corrupt bureaucracy, personified in many ways by Dr. Anthony Fauci, aided and abetted by advisors like his son-in-law, Jared Kushner, hijacked the president’s agenda. Now, the Trump administration has an unlikely yet monumental opportunity for health reform, which can start on January 20 with an investigation into Moderna’s cover-up.
The Covid response doomed Trump 1.0. Whether one regards this as a monumental error, the betrayal of a president by his advisors, an event beyond the president’s control, or a deeper and more complex plot involving everything and everyone associated with the government, both in the US and around the world, there is no question of the scale of the calamity for the public. The shots are part of that, the capstone failure of a long line of foreshadowing with lockdowns and all that was associated with pre-pharmaceutical interventions. The antidote came not as a cure but, for many, the disease itself.
There must be truth if not justice.
COVID-19
Calls for COVID-19 vaccine recall – FDA’s own study finds DNA contamination in Pfizer vaccines
From LifeSiteNews
By Dr. Michael Nevradakis for The Defender
“It is alarming that the public is made aware of this contamination in an obscure journal that features high school science research. One has to ask, ‘Where is the FDA now?’ and ‘Why hasn’t the public been alerted of this?’”
The peer-reviewed study in the Journal of High School Science was authored by three high school students and performed at an FDA lab under the supervision of FDA scientists. The findings prompted renewed calls for a moratorium on COVID-19 vaccines.
A peer-reviewed study performed at a U.S. Food and Drug Administration (FDA) laboratory by high school students has confirmed the presence of a high level of DNA contamination in Pfizer’s mRNA COVID-19 vaccine.
The study, published December 29, 2024, in the Journal of High School Science, was authored by three students at Centreville High School in Clifton, Virginia, and performed under the supervision of FDA scientists.
Maryanne Demasi, Ph.D., an investigative medical reporter, was the first to report on the study.
READ: British doctor has medical license revoked over warning of COVID shot dangers
The research, performed at the FDA’s White Oak Campus in Maryland, found that levels of residual DNA in the Pfizer COVID-19 vaccine were 6 to 470 times higher than regulatory safety limits. The students tested two lots of the vaccine, finding they contained “residual DNA to a level that exceeds 10 ng [nanograms] per dose.”
“The potential health risk posed by residual small DNA fragments is currently unknown,” the study stated. However, the authors also said that DNA contamination may result in insertional mutagenesis – or DNA mutations – that can cause cancer.
Speaking last month on “The Defender In-Depth,” Kevin McKernan, who first identified DNA contamination in the shots in 2023, said DNA in vaccines can pose health risks because the DNA “could integrate into the genome and cause disruption of the genome … or it could disrupt other genes that are related to cancer.”
The FDA did not respond to multiple requests for comment on the study.
COVID vaccines ‘must be immediately recalled’
The new findings challenge “years of dismissals by regulatory authorities, who had previously labelled concerns about excessive DNA contamination as baseless,” Demasi wrote on Substack.
The findings also align with earlier reports from independent laboratories in the U.S., Canada, Australia, Germany, and France, she said.
McKernan, founder of Medicinal Genomics, told The Defender that eight studies have found DNA over the limit. “Very few studies are surveying a large number of lots, so each study is additive,” he said.
Epidemiologist Nicolas Hulscher said that in “light of this evidence, the COVID-19 genetic injections must be immediately recalled, to protect the public from further harm.”
Nikolai Petrovsky, Ph.D., director of biotechnology company Vaxine Pty Ltd., told Demasi that the findings are a “smoking gun” and that the new study “clearly shows the FDA was aware of these data.”
Christof Plothe, D.O., a member of the World Council for Health steering committee, agreed. He said:
So far, the European, Australian, and American health regulatory boards have denied any risks from plasmid DNA contamination in the COVID-19 injections despite nine studies by internationally known research teams.
All teams concluded that this contamination poses an unacceptable risk to three-quarters of the world’s population.… Three teams so far have demonstrated the integration into human cells. To what extent this is happening to everybody who was injected needs to be investigated.
READ: Children who got COVID shots more likely to catch the virus than those who didn’t, study finds
McKernan said that the FDA has long ignored evidence of the dangers posed by mRNA COVID-19 vaccines.
“The criteria for pulling these shots was established long before DNA contamination was first discovered,” he said. “I would hope that evidence of highly variable manufacturing would be grounds for immediate class 1 recall from the FDA. They are currently distracted with performing class 1 recalls on non-lethal hairspray.”
A Class 1 recall involves “a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
According to Demasi, “The FDA is expected to comment on the findings this week. However, the agency has yet to issue a public alert, recall the affected batches, or explain how vials exceeding safety standards were allowed to reach the market.”
Plothe noted that Demasi presented evidence of DNA contamination to the FDA in September 2024, asking if the agency had launched an investigation or requested further testing of the mRNA vaccines by their manufacturers.
“Nothing resulted from this request,” Plothe said. “As nine studies have proven this severe contamination and repeated requests to health regulatory boards have not led to any consequence, we must ask about the motive.”
Brian Hooker, Ph.D., chief scientific officer for Children’s Health Defense (CHD), noted the irony of high school students discovering what the FDA has seemingly missed in the four-plus years since the vaccines’ introduction.
“It is ironic that it takes student researchers at the FDA to do the work of the FDA regulators,” Hooker said. “It is alarming that the public is made aware of this contamination in an obscure journal that features high school science research. One has to ask, ‘Where is the FDA now?’ and ‘Why hasn’t the public been alerted of this?’”
Demasi said that the significance of the new study’s findings is that they came from research performed at an FDA facility.
“Now that DNA contamination of the mRNA vaccines has been verified in the laboratory of an official agency and published in a peer-reviewed journal, it becomes difficult to ignore,” Demasi wrote. “It also places vaccine manufacturers and regulators in a precarious position.”
This article was originally published by The Defender – Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
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