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COVID-19

Florida surgeon general asks FDA for answers after study allegedly finds DNA fragments in COVID shots

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Florida’s Surgeon General Dr. Joseph Ladapo speaks during a press conference

From LifeSiteNews

By Ashley Sadler

‘The American people and the scientific community have a right to have all relevant information pertaining to the COVID-19 vaccines to properly inform individual decision making’

Florida Surgeon General Joseph Ladapo on Wednesday pushed the head of the FDA for answers regarding a preprint study that alleged the contamination of mRNA COVID-19 shots with plasmid DNA.

“The American people and the scientific community have a right to have all relevant information pertaining to the COVID-19 vaccines to properly inform individual decision making,” Dr. Ladapo wrote in the December 6 letter addressed to FDA Commissioner Robert M. Califf, MD, MACC.

Ladapo, who has frequently resisted the prevailing narrative on COVID-19 vaccination — even warning young men not to get the shots at all — previously wrote to the CDC in May to share concerns about the safety and efficacy of the COVID-19 jabs, particularly in the context of their accelerated approval. He said he has not received a response to his inquiry.

In his December 6 letter to the FDA, the Sunshine State’s surgeon general wrote to share his concern about “the recent discovery of host cell DNA fragments within the Pfizer and Moderna COVID-19 mRNA vaccines. This raises concerns regarding the presence of nucleic acid contaminants in the approved Pfizer and Moderna COVID-19 mRNA vaccines.”

As LifeSiteNews reported in October, a new preprint study claimed to have discovered “significant levels” of “plasmid DNA” in expired COVID-19 vaccines, impurities the researchers say may be linked to adverse events. The study, which is not yet peer-reviewed, calls for “further investigation” to corroborate the findings.

Authors David J. Speicher, Jessica Rose, L. Maria Gutschi, David M. Wiseman, Ph.D., and Kevin McKernan said in the 31-page study they had found “billions to hundreds of billions of DNA molecules per dose” that they gathered from “[e]xpired unopened vials of Pfizer-BioNTech [shots] … and Moderna Spikevax mRNA” jabs “obtained from various pharmacies in Ontario, Canada.”

READ: Researchers report finding ‘significant levels of plasmid DNA’ in COVID shots, call for ‘further investigation’

According to the researchers, the “preliminary evidence … warrant[s] confirmation and further investigation.”

An earlier preprint in June published by McKernan and his fellow researchers alleged that a fragment of a “monkey virus” genome, SV40, had been discovered in the COVID-19 jabs. The study noted that SV40 had previously been discovered in polio vaccines in the 1950s and 1960s and was linked to cancer. However, Health Feedback has noted that the DNA found in the COVID jabs was only a “fragment” of that genome, and that it’s unclear whether SV40 causes cancer in humans (current research only supports risk of cancer in certain animals), LifeSiteNews previously reported. 

In Ladapo’s letter to the FDA, he cited 2007 guidance from the FDA itself that, he stated, raised the possibility that “DNA integration could theoretically impact a human’s oncogenes – the genes which can transform a healthy cell into a cancerous cell,” and could therefore “result in chromosomal instability.”

“The Guidance for Industry discusses biodistribution of DNA vaccines and how such integration could affect unintended parts of the body including blood, heart, brain, liver, kidney, bone marrow, ovaries/testes, lung, draining lymph nodes, spleen, the site of administration and subcutis at injection site,” he summarized.

RELATED: Florida surgeon general Joseph Ladapo warns against taking new COVID-19 shots

After laying out the guidance from the FDA on the potential risks of DNA contamination, Ladapo asked the agency to answer whether manufacturers of the drugs have “evaluated the risk of human genome integration or mutagenesis of residual DNA contaminants from the mRNA COVID-19 vaccines alongside the additional risk of DNA integration from the lipid nanoparticle delivery system and SV40 promoter/enhancer?”

“Has [the] FDA inquired any information from the drug manufacturers to investigate such risk?” he asked.

Ladapo also asked whether “FDA standards for acceptable and safe quantity of residual DNA (present as known contaminants in biological therapies) consider the lipid nanoparticle delivery system for the mRNA COVID-19 vaccines?” Pfizer and Moderna’s COVID-19 jabs contain lipid nanoparticles (LNPs), which are “tiny balls of fat” that act as delivery mechanisms for the mRNA vaccine.

Florida’s surgeon general further inquired whether, given “the potentially wide biodistribution of mRNA COVID-19 vaccines and DNA contaminants beyond the local injection site,” the FDA has “evaluated the risk of DNA integration in reproductive cells with respect to the lipid nanoparticle delivery system?”

Citing “the urgency of these questions due to the mass administration of these vaccines and currently unavailable data surrounding possible genomic effects,” Ladapo closed his letter by asking the FDA to respond to his questions in one week’s time (December 13) by sending a written response to both his “previous letter and the concerns I have outlined above.”

Dr. Ladapo, who earned his MD from Harvard Medical School and his Ph.D. from Harvard University, was appointed to lead Florida’s health department by Florida Republican Gov. Ron DeSantis in 2021. He quickly made a name for himself as something of a maverick among state health department officials for his resistance to the prevailing COVID-19 narrative, and he has consistently and publicly spoken out against COVID-19 jabs, lockdowns, and mask mandates.

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Freedom Convoy

Court Orders Bank Freezing Records in Freedom Convoy Case

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A Canadian court has ordered the release of documents that could shed light on how federal authorities and law enforcement worked together to freeze the bank accounts of a protester involved in the Freedom Convoy.
Both the RCMP and TD Bank are now required to provide records related to Evan Blackman, who took part in the 2022 demonstrations and had his accounts frozen despite not being convicted of any crime at the time.
The Justice Centre for Constitutional Freedoms (JCCF) announced the Ontario Court of Justice ruling. The organization is representing Blackman, whose legal team argues that the actions taken against him amounted to a serious abuse of power.
“The freezing of Mr. Blackman’s bank accounts was an extreme overreach on the part of the police and the federal government,” said his lawyer, Chris Fleury. “These records will hopefully reveal exactly how and why Mr. Blackman’s accounts [were] frozen.”
Blackman was arrested during the mass protests in Ottawa, which drew thousands of Canadians opposed to vaccine mandates and other pandemic-era restrictions.
Although he faced charges of mischief and obstructing police, those charges were dismissed in October due to a lack of evidence. Despite this, prosecutors have appealed, and a trial is set to begin on August 14.
At the height of the protests, TD Bank froze three of Blackman’s accounts following government orders issued under the Emergencies Act. Then-Prime Minister Justin Trudeau had invoked the act to grant his government broad powers to disrupt the protest movement, including the unprecedented use of financial institutions to penalize individuals for their support or participation.
In 2024, a Federal Court Justice ruled that Trudeau’s decision to invoke the act had not been justified.
Blackman’s legal team plans to use the newly released records to demonstrate the extent of government intrusion into personal freedoms.
According to the JCCF, this case may be the first in Canada where a criminal trial includes a Charter challenge over the freezing of personal bank accounts under emergency legislation.
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COVID-19

FDA requires new warning on mRNA COVID shots due to heart damage in young men

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From LifeSiteNews

By Doug Mainwaring

Pfizer and Moderna’s mRNA COVID shots must now include warnings that they cause ‘extremely high risk’ of heart inflammation and irreversible damage in males up to age 24.

The Trump administration’s Food and Drug Administration (FDA) announced it will now require updated safety warnings on mRNA COVID-19 shots to include the “extremely high risk” of myocarditis/pericarditis and the likelihood of  long-term, irreversible heart damage for teen boys and young men up to age 24.

The required safety updates apply to Comirnaty, the mRNA COVID shot manufactured by Pfizer Inc., and Spikevax, the mRNA COVID shot manufactured ModernaTX, Inc.

According to a press release, the FDA now requires each of those manufacturers to update the warning about the risks of myocarditis and pericarditis to include information about:

  1. the estimated unadjusted incidence of myocarditis and/or pericarditis following administration of the 2023-2024 Formula of mRNA COVID-19 shots and
  2. the results of a study that collected information on cardiac magnetic resonance imaging (cardiac MRI) in people who developed myocarditis after receiving an mRNA COVID-19 injection.

The FDA has also required the manufacturers to describe the new safety information in the adverse reactions section of the prescribing information and in the information for recipients and caregivers.

Additionally, the fact sheets for healthcare providers and for recipients and caregivers for Moderna COVID-19 shot and Pfizer-BioNTech COVID-19 shot, which are authorized for emergency use in individuals 6 months through 11 years of age, have also been updated to include the new safety information in alignment with the Comirnaty and Spikevax prescribing information and information for recipients and caregivers.

In a video published on social media, Dr. Vinay Prasad, director of the Center for Biologics Evaluation & Research Chief Medical and Scientific Officer, explained the alarming reasons for the warning updates.

While heart problems arose in approximately 8 out of 1 million persons ages 6 months to 64 years following reception of the cited shots, that number more than triples to 27 per million for males ages 12 to 24.

Prasad noted that multiple studies have arrived at similar findings.

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