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COVID-19

Florida Surgeon General’s Call to Halt Use of the Vaccines Sparks Debate

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Dr Joseph Ladapo, Florida’s Surgeon General at the microphone

From the Brownstone Institute

BY Maryanne DemasiMARYANNE DEMASI   

On January 3, 2024, Florida Surgeon General Joseph Ladapo called for a halt in the use of the mRNA Covid-19 vaccines after US health agencies failed to adequately address his concerns about DNA contamination in the products.

In a statement on X, Ladapo accused the FDA and CDC of always playing it “fast and loose” with Covid-19 safety, but their failure to test whether DNA fragments in the vaccine could integrate into a person’s genome was “intolerable.”

As I and others have pointed out on numerous occasions, the FDA’s own guidance on regulatory limits for residual DNA in vaccines states “there are several potential mechanisms by which residual DNA could be oncogenic [cause cancer], including the integration and expression of encoded oncogenes or insertional mutagenesis following DNA integration.”

In a letter, Ladapo had also asked the two agencies if they’d carried out any risk assessment regarding the presence of the “SV40 promoter” in the vaccines, which is thought to enhance DNA integration into host cells.

But the FDA’s top vaccine official Peter Marks responded to Ladapo’s demand for answers with intransigence and obfuscation.

Similar to how the FDA shut down my previous enquiries into this matter, the agency failed to provide Ladapo with any evidence that it had even conducted tests to address the risk of genomic integration.

In fact, Marks had the temerity to imply that ongoing discussion about this topic was perpetuating misinformation “which results in vaccine hesitancy that lowers vaccine uptake.”

Ladapo explained;

DNA integration poses a unique and elevated risk to human health and to the integrity of the human genome, including the risk that DNA integrated into sperm or egg gametes could be passed onto offspring of mRNA Covid-19 vaccine recipients. If the risks of DNA integration have not been assessed for mRNA Covid-19 vaccines, these vaccines are not appropriate for use in human beings.

He also recommended that providers concerned about health risks of Covid-19 should prioritise patient access to non-mRNA Covid-19 vaccines and treatment.

Quick to dismiss Ladapo’s concerns was Paul Offit, director of the Vaccine Education Centre at Children’s Hospital of Philadelphia, who serves on the FDA’s vaccine advisory committee.

Offit hit back in a video published on MedPage Today saying, “It is hard to believe that Dr Ladapo actually issued that statement…[DNA fragments] can’t possibly do harm. So scaring people unnecessarily like this has been hard to watch.”

Professor Paul Offit, Children’s Hospital of Philadelphia

Unfortunately, Offit’s video contains a series of erroneous statements that exposes his fundamental misunderstanding of the manufacturing and regulation of Covid vaccines.

For example, Offit says it’s unlikely that DNA fragments enter the cytoplasm of cells, or survive, once they’re inside.

“Our cytoplasm hates foreign DNA and it has a variety of mechanisms, including innate immunological mechanisms and enzymes, to destroy foreign DNA,” says Offit.

“That DNA, which would never survive the cytoplasm, would have to then cross the nuclear membrane into the nucleus, which would require a nuclear access signal that these DNA fragments don’t have…So the chance that DNA could affect your DNA is zero,” he adds.

But this statement is disingenuous on multiple fronts.

Offit talked about DNA fragments as if they were not encapsulated in lipid nanoparticles, which specifically ferry the genetic material into the cell cytoplasm. Indeed, without the lipid nanoparticles, the vaccines would never have made it to market.

A recent publication in Nature found that within hours, around 7% of cells are integrated when mixed with a transfection solution containing linear pieces of DNA.

Offit also said that DNA wouldn’t cross into the cell’s nucleus, but scientists have known that foreign DNA can be delivered into mammalian cells to modify a host cell’s genetic makeup in a process called “DNA transfection.”

It also ignores the fact that the DNA fragments contain the “SV40 promoter” which includes a nuclear targeting signal (NTS) to aid its entry into the nucleus.

A full critique of Offit’s commentary was recently published by Dr Robert Malone who pioneered some of the early work into mRNA technology.

Phillip Buckhaults, a cancer genomics expert, and professor at the University of South Carolina, has confirmed the presence of DNA fragments in the vaccines after replicating the work of McKernan et al.

Buckhaults has welcomed Ladapo’s announcement.

“I’m glad Dr Ladapo is taking a firm leadership stance to protect the people under his care. I think he is taking a lot of heat over genuinely looking out for others. I think he is acting in good faith and that is to be respected,” says Buckhaults.

Professor Phillip Buckhaults, University of South Carolina

He also believes that Ladapo’s stance on the mRNA vaccines is “based on solid scientific reasoning” because the long-term genomic safety has not been demonstrated for fragments of DNA that are encapsulated in lipid nanoparticles.

However, rather than completely halting the vaccines, Buckhaults says he would err on the side of caution and still “recommend the vaccine to select populations who are at high risk for death from [Covid-19].”

Buckhaults hopes that Ladapo can use his authority to compel the FDA to request an extra “cheap and easy step” in the processing of the vaccines to remove the vast majority of DNA from upcoming batches.

“Then we would not even need to have this argument about DNA anymore. The risk of the DNA would be essentially gone and the crisis in confidence in leadership would be addressed,” he says.

Buckhaults has testified before a South Carolina Senate hearing about his alarm over the “very real hazard” that these fragments of foreign DNA can insert themselves into a person’s genome and become a “permanent fixture of the cell.”

He has also discussed with me at length the potential harms to people’s health caused by DNA contamination in the mRNA vaccines. Last year, Buckhaults notified the FDA of his concerns via email but never received a response.


Supplementary information: reading:

FDA shuts down enquiries about DNA contamination in [Covid] vaccines

EXCLUSIVE: An interview with Buckhaults about DNA contamination in [Covid] vaccines

Republished from the author’s Substack

Author

  • Maryanne Demasi

    Maryanne Demasi, 2023 Brownstone Fellow, is an investigative medical reporter with a PhD in rheumatology, who writes for online media and top tiered medical journals. For over a decade, she produced TV documentaries for the Australian Broadcasting Corporation (ABC) and has worked as a speechwriter and political advisor for the South Australian Science Minister.

COVID-19

Senator Demands Docs After ‘Blockbuster’ FDA Memo Links Child Deaths To COVID Vaccine

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From the Daily Caller News Foundation

By Emily Kopp

Sen. Ron Johnson said in a letter Monday that he will continue to push for documents about deaths following the COVID-19 vaccine after the “blockbuster” revelation in November that the Trump administration had verified deaths in children.

The letter, exclusively shared with the Daily Caller News Foundation, seeks more details about those deaths and the passive U.S. vaccine safety surveillance system and complacent Food and Drug Administration (FDA) bureaucracy under the Biden administration that delayed their reporting for years.

“Nobody wanted to admit that these things were causing death. This is absolutely a case of willful ignorance,” Johnson said in an interview with the DCNF.

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The senator’s inquiry builds on a Nov. 28 memo by top vaccine regulator FDA Center for Biologics Evaluation and Research Director Vinay Prasad announcing the topline results of an investigation that he tasked career staff with completing on pediatric deaths following the COVID vaccine. Prasad called for stiffer vaccine approval standards, including a requirement that most new approvals require a randomized clinical trial.

The letter requests from the Department of Health and Human Services (HHS) “all records referring or relating to the review of the 96 reports of death following a COVID-19 vaccine … including but not limited to, any memorandum or report created following that review and the data underlying the reports.”

“I am grateful that we now have individuals at our federal health agencies who care about vaccine safety and efficacy. I am, however, disappointed that despite having subpoenaed HHS for the type of data and information described in Dr. Prasad’s memo, it does not appear to have been provided to my office,” the letter reads.

HHS did not immediately respond to a request for comment.

“This is a profound revelation. For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children. Healthy young children who faced tremendously low risk of death were coerced, at the behest of the Biden administration, via school and work mandates, to receive a vaccine that could result in death. In many cases, such mandates were harmful. It is difficult to read cases where kids aged 7 to 16 may be dead as a result of covid vaccines,” Prasad wrote. “There is no doubt that without this FDA commissioner [Marty Makary], we would not have performed this investigation and identified this safety concern. This fact also demands serious introspection and reform.”

“One reason I’m writing this letter is that this memo needs much greater attention. This should be a blockbuster,” the Wisconsin senator told the DCNF.

Johnson, who has investigated the issue of COVID vaccine-linked adverse events since June 2021, also seeks more clarity about why FDA only examined a fraction of total reports to the Vaccine Adverse Event Reporting System (VAERS). He noted that the 96 deaths scrutinized by FDA staff in its investigation represents a sliver of the raw VAERS reports of 9,299 deaths worldwide within two days of vaccination.

Distinguishing which VAERS reports indicate genuine fatal side effects and which represent mere coincidences requires autopsy reports, which regulators and physicians often do not request because of a ideological reluctance to acknowledge that vaccines can carry risks, Johnson told the DCNF. Johnson said he has spoken to families who suspected a vaccine injury but struggled to obtain autopsies.

“With some of these officials at federal health agencies and within the medical establishment, vaccines are religion. The do not want to muddy the water with facts,” he said.

Johnson’s letter notes that Prasad acknowledged a culture at FDA “where vaccines are exculpated rather than indicted in cases of ambiguity,” and that the true number of deaths is likely higher.

Johnson has as chair of the Senate Permanent Subcommittee on Investigations investigated the Biden administration’s headlong expansion of COVID vaccines and booster shots to healthy young adults and children.

His committee uncovered internal federal documents showing the Centers for Disease Control and Prevention never updated its vaccine surveillance tool “V-Safe” to include cardiac symptoms, despite naming myocarditis as a potential adverse event by October 2020, per a May report. The investigation also found that top officials at FDA obstructed a warning to pediatricians and other providers about the risk of myocarditis after the May 2021 authorization of the Pfizer vaccine for 12 to 15-year-olds, months after Israeli health officials first detected the safety signal in February 2021.

Johnson’s letter highlights missing safety studies that the drugmakers never conducted.

Under the Biden administration, the FDA waived the responsibility of the drugmakers to conduct post-market studies that they had pledged to regulators, scientific advisors on the FDA Vaccines and Related Products Advisory Committee, and the public that they would complete. These uncompleted studies include promised research into subclinical myocarditis, undocumented rates of heart inflammation without obvious symptoms, Prasad’s memo states.

Johnson’s letter reveals the committee has not received any records from HHS about the liability shield for COVID-19 vaccines.

A public health media personality reported on Dec. 11 that FDA staff had downgraded the certainty with which it can attribute some the deaths to the vaccine in the weeks since Prasad received their top line results — echoing prior leaks from career officials aimed at undermining FDA’s new bosses.

Center for Drug Evaluation and Research Acting Director Tracy Beth Hoeg first concluded in a separate analysis that there were in fact deaths in children in the summer, but career staff leaked the results to reporters who “portrayed the incident as Dr. Hoeg attempting to create a false fear regarding vaccines” soon after, per Prasad’s memo.

Johnson’s letter seeks documentation of Hoeg’s meeting, including “a list of all attendees.”

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COVID-19

China Retaliates Against Missouri With $50 Billion Lawsuit In Escalating Covid Battle

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From the Daily Caller News Foundation

By Melissa O’Rourke

China is escalating its legal fight with Missouri after the state secured a massive court victory earlier this year over Beijing’s role in the COVID-19 pandemic, according to the state attorney general’s office.

Missouri Attorney General Catherine Hanaway announced Tuesday that the People’s Government of Wuhan Municipality, the Chinese Academy of Sciences and the Wuhan Institute of Virology have filed a $50 billion lawsuit against the state, claiming Missouri poses an “economic and reputational threat” to the People’s Republic of China (PRC). The suit comes as Missouri moves to seize Chinese-owned assets to collect on a historic federal court judgment the state won in March.

Missouri first sued China in 2020, seeking $25 billion in damages “for causing and exacerbating the COVID-19 pandemic” and for hoarding critical medical supplies while the virus spread, according to the state attorney general’s office. China and several affiliated entities were ordered to pay Missouri roughly $24.49 billion, plus post-judgment interest. Senior U.S. District Judge Stephen Limbaugh ruled that China and the other defendants “failed to appear or otherwise answer after being properly served,” resulting in the default judgment.

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Missouri maintained that China was attempting to shield itself from legal consequences by relying on proxy organizations to speak on its behalf — an accusation Beijing now disputes in its own lawsuit against the state.

 

In its lawsuit, China alleges that Missouri’s actions have had “negative effects on the soft power” of Wuhan and have “belittled the social evaluation” as well as adversely affected the “productivity and commercialization of scientific and technological achievements” of the Chinese Academy of Sciences and the Wuhan Institute of Virology. The filing further alleges that Missouri’s “vexatious litigation” has “defamed Plaintiffs’ reputation, resulting in huge economic losses of the Plaintiffs, and deeply endangering sovereignty, security and development interests of China.”

The suit names the state of Missouri, Republican Missouri Sen. Eric Schmitt and the former Missouri Attorney General Andrew Bailey as the defendants.

China’s lawsuit demands the defendants “issue public apologies on New York Times, CNN, Wall Street Journal, Washington Post, YouTube and other American media or internet platforms, and People’s Daily, Xinhuanet and other Chinese media or internet platforms.”

Hanaway rejected the demand and said the state remains focused on enforcing the federal judgment.

“I find it extremely telling that the Chinese blame our great state for ‘belittling the social evaluation’ of The Wuhan Institute of Virology. This lawsuit is a stalling tactic and tells me that we have been on the right side of this issue all along,” Hanaway said in a statement. “We stand undeterred in our mission to collect on our $24 billion judgment that was lawfully handed down in federal court.”

Schmitt described China’s suit as “frivolous lawfare, attempting to absolve themselves of all wrongdoing in the early days of the pandemic.”

“This is their way of distracting from what the world already knows, China has blood on its hands. China lied about the origins of COVID virus, they tried to cover it up, and they upended the world by creating a global pandemic that resulted in immense human loss,” Schmitt added.

Missouri, Hanaway said, is continuing efforts to obtain certification that would allow the state to seize Chinese-owned assets, including real estate, financial interests, and other holdings tied to the defendants.

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