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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 The study, which is not yet peer-reviewed, calls for “further investigation” to corroborate the findings.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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COVID-19

Study finds Pfizer COVID vaccine poses 37% greater mortality risk than Moderna

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From LifeSiteNews

By Nicolas Hulscher, MPH

A study of 1.47 million Florida adults by MIT’s Retsef Levi and Surgeon General Joseph Ladapo finds significantly higher all-cause mortality after Pfizer vaccination compared to Moderna

A new study of 1.47 million Florida adults by MIT’s Retsef Levi and Surgeon General Joseph Ladapo finds significantly higher all-cause, cardiovascular, and COVID-19 mortality after Pfizer vaccination.

The study titled “Twelve-Month All-Cause Mortality after Initial COVID-19 Vaccination with Pfizer-BioNTech or mRNA-1273 among Adults Living in Florida” was just uploaded to the MedRxiv preprint server. This study was headed by MIT Professor Retsef Levi, with Florida Surgeon General Dr. Joseph Ladapo serving as senior author:

Study Overview

  • Population: 1,470,100 noninstitutionalized Florida adults (735,050 Pfizer recipients and 735,050 Moderna recipients).
  • Intervention: Two doses of either:
    • BNT162b2 (Pfizer-BioNTech)
    • mRNA-1273 (Moderna)
  • Follow-up Duration: 12 months after second dose.
  • Comparison: Head-to-head between Pfizer vs. Moderna recipients.
  • Main Outcomes:
    • All-cause mortality
    • Cardiovascular mortality
    • COVID-19 mortality
    • Non-COVID-19 mortality

All-cause mortality

Pfizer recipients had a significantly higher 12-month all-cause death rate than Moderna recipients — about 37% higher risk.

  • Pfizer Risk: 847.2 deaths per 100,000 people
  • Moderna Risk: 617.9 deaths per 100,000 people
  • Risk Difference:
    ➔ +229.2 deaths per 100,000 (Pfizer excess)
  • Risk Ratio (RR):
    ➔ 1.37 (i.e., 37% higher mortality risk with Pfizer)
  • Odds Ratio (Adjusted):
    ➔ 1.384 (95% CI: 1.331–1.439)

Cardiovascular mortality

Pfizer recipients had a 53% higher risk of dying from cardiovascular causes compared to Moderna recipients.

  • Pfizer Risk: 248.7 deaths per 100,000 people
  • Moderna Risk: 162.4 deaths per 100,000 people
  • Risk Difference:
    ➔ +86.3 deaths per 100,000 (Pfizer excess)
  • Risk Ratio (RR):
    ➔ 1.53 (i.e., 53% higher cardiovascular mortality risk)
  • Odds Ratio (Adjusted):
    ➔ 1.540 (95% CI: 1.431–1.657)

COVID-19 mortality

Pfizer recipients had nearly double the risk of COVID-19 death compared to Moderna recipients.

  • Pfizer Risk: 55.5 deaths per 100,000 people
  • Moderna Risk: 29.5 deaths per 100,000 people
  • Risk Difference:
    ➔ +26.0 deaths per 100,000 (Pfizer excess)
  • Risk Ratio (RR):
    ➔ 1.88 (i.e., 88% higher COVID-19 mortality risk)
  • Odds Ratio (Adjusted):
    ➔ 1.882 (95% CI: 1.596–2.220)

Non-COVID-19 mortality

Pfizer recipients faced a 35% higher risk of dying from non-COVID causes compared to Moderna recipients.

  • Pfizer Risk: 791.6 deaths per 100,000 people
  • Moderna Risk: 588.4 deaths per 100,000 people
  • Risk Difference:
    ➔ +203.3 deaths per 100,000 (Pfizer excess)
  • Risk Ratio (RR):
    ➔ 1.35 (i.e., 35% higher non-COVID mortality risk)
  • Odds Ratio (Adjusted):
    ➔ 1.356 (95% CI: 1.303–1.412)

Biological explanations

The findings of this study are surprising, given that Moderna’s mRNA-1273 vaccine contains approximately three times more mRNA (100 µg) than Pfizer’s BNT162b2 vaccine (30 µg). This suggests that the higher mortality observed among Pfizer recipients could potentially be related to higher levels of DNA contamination — an issue that has been consistently reported worldwide:

The paper hypothesizes differences between Pfizer and Moderna may be due to:

  • Different lipid nanoparticle compositions
  • Differences in manufacturing, biodistribution, or storage conditions

Final conclusion

Florida adults who received Pfizer’s BNT162b2 vaccine had higher 12-month risks of all-cause, cardiovascular, COVID-19, and non-COVID-19 mortality compared to Moderna’s mRNA-1273 vaccine recipients.

Unfortunately, without an unvaccinated group, the study cannot determine the absolute increase in mortality risk attributable to mRNA vaccination itself. However, based on the mountain of existing evidence, it is likely that an unvaccinated cohort would have experienced much lower mortality risks. It’s also important to remember that Moderna mRNA injections are still dangerous.

As the authors conclude:

These findings are suggestive of differential non-specific effects of the BNT162b2 and mRNA-1273 COVID-19 vaccines, and potential concerning adverse effects on all-cause and cardiovascular mortality. They underscore the need to evaluate vaccines using clinical endpoints that extend beyond their targeted diseases.

Nicolas Hulscher, MPH

Epidemiologist and Foundation Administrator, McCullough Foundation

www.mcculloughfnd.org

Please consider following both the McCullough Foundation and my personal accounton X (formerly Twitter) for further content.

Reprinted with permission from Focal Points.

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COVID-19

Canada’s health department warns COVID vaccine injury payouts to exceed $75 million budget

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Fr0m LifeSiteNews

By Clare Marie Merkowsky

A Department of Health memo warns that Canada’s Vaccine Injury Support Program will exceed its $75 million budget due to high demand, with $16 million already paid out.

COVID vaccine injury payments are expected to go over budget, according to a Canadian Department of Health memo.

According to information published April 28 by Blacklock’s Reporter, the Department of Health will exceed their projected payouts for COVID vaccine injuries, despite already spending $16 million on compensating those harmed by the once-mandated experimental shots.

“A total $75 million in funding has been earmarked for the first five years of the program and $9 million on an ongoing basis,” the December memo read. “However the overall cost of the program is dependent on the volume of claims and compensation awarded over time, and that the demand remains at very high levels.”

“The purpose of this funding is to ensure people in Canada who experience a serious and permanent injury as a result of receiving a Health Canada authorized vaccine administered in Canada on or after December 8, 2020 have access to a fair and timely financial support mechanism,” it continued.

Canada’s Vaccine Injury Support Program (VISP) was launched in December 2020 after the Canadian government gave vaccine makers a shield from liability regarding COVID-19 jab-related injuries.

While Parliament originally budgeted $75 million, thousands of Canadians have filed claims after received the so-called “safe and effective” COVID shots. Of the 3,060 claims received to date, only 219 had been approved so far, with payouts totaling over $16 million.

Since the start of the COVID crisis, official data shows that the virus has been listed as the cause of death for less than 20 kids in Canada under age 15. This is out of six million children in the age group.

The COVID jabs approved in Canada have also been associated with severe side effects such as blood clots, rashes, miscarriages, and even heart attacks in young, healthy men.

Additionally, a recent study done by researchers with Canada-based Correlation Research in the Public Interest showed that 17 countries have found a “definite causal link” between peaks in all-cause mortality and the fast rollouts of the COVID shots as well as boosters.

Interestingly, while the Department of Health has spent $16 million on injury payouts, the Liberal government spent $54 million COVID propaganda promoting the vaccine to young Canadians.

The Public Health Agency of Canada especially targeted young Canadians ages 18-24 because they “may play down the seriousness of the situation.”

The campaign took place despite the fact that the Liberal government knew about COVID vaccine injuries, according to a secret memo.

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