Needle in a Data Stack: The 2024 COVID-19 Vaccine Study Shaking Up the Narrative

2024 Covid-19 Vaccine Study Summary

The article critically examines the safety and efficacy of COVID-19 mRNA vaccines, focusing on discrepancies in trial data, adverse events (AEs), and the real-world effectiveness of the vaccines. It highlights concerns about the rapid authorization process, underreporting of serious AEs, potential bias in trial execution and reporting, and the need for more rigorous safety evaluations. The authors argue for a reevaluation of the use of mRNA vaccines, especially in children, until more comprehensive safety studies are conducted. They also call for a global moratorium on these vaccines pending further investigation into their long-term effects and safety profiles.

Please specify each concern discussed in the document. Include the nature of each concern along with a description of the data associated with each concern.

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The document outlines several critical concerns regarding the safety and efficacy of COVID-19 mRNA vaccines, backed by data analyses and findings:

1. Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs): A re-analysis of Pfizer and Moderna trial data revealed about 125 SAEs per 100,000 vaccine recipients, translating to one SAE for every 800 vaccinated individuals. This rate is significantly higher than the SAEs reported in the population-wide rollouts, suggesting underreporting or misrepresentation of safety data.
2. Discrepancies in Death Counts: The Pfizer Six-Month Interim Report revealed 38 total deaths, which was significantly lower than the expected number based on US mortality rates, indicating potential underreporting or loss of follow-up subjects, compromising the trial’s validity.
3. Increased Mortality and Cardiac SAEs Post-Vaccination: Analysis indicated a significant association between mortality rates and time since injection, with a notable increase in mortality and cardiac SAEs around the 100-day mark post-injection, suggesting potential long-term risks not accounted for in initial trial reports.
4. Substandard Research Practices: Whistleblower reports raised concerns about data integrity and safety of trial participants, including issues like improper vaccine storage, mislabeling of specimens, and lack of timely follow-up for adverse events.
5. Underreporting of Harms and Data Integrity Issues: The trials demonstrated a significant underreporting of severe harms and adverse events, particularly those occurring beyond the solicited events reporting period. This underreporting, combined with the early unblinding of trial participants, may have obscured late-occurring harms associated with the vaccines.
6. Lack of Transparency and Independent Verification: The public was denied access to the raw data from the registrational trials, preventing independent verification of adverse events and potentially leading to an inflated perception of vaccine benefits and minimized risks.
7. Forensic Analysis Revealing Concealed Mortality Data: A forensic analysis of Pfizer’s six-month trial data indicated that many deaths occurred after the cutoff date used for the FDA briefing, suggesting that mortality data may have been intentionally concealed from the regulatory review process.
8. Analysis of Drug Safety Reporting Systems: Analyses of two large drug safety reporting systems in the US and Europe revealed over 7.8 million adverse events reported following COVID-19 vaccination, with older age groups exhibiting a higher frequency of death, hospitalizations, and life-threatening reactions.
9. Autopsy Studies: Comprehensive systematic reviews of autopsy findings indicated a significant proportion of deaths were caused by mRNA vaccine products, highlighting severe cardiovascular system impacts.

These concerns, underpinned by substantial data and analyses, underscore the need for a more thorough and transparent evaluation of COVID-19 mRNA vaccine safety and efficacy.

Let’s break down the recent COVID-19 vaccine study’s findings into simpler terms:

1. More Serious Side Effects Than Reported: When looking back at the data from Pfizer and Moderna’s vaccine trials, it was found that for every 100,000 people vaccinated, about 125 had serious side effects. This means out of every 800 people who got the vaccine, 1 person experienced a serious side effect. This number is higher than what was reported when the vaccine was given to the general public, suggesting that some serious side effects might not have been fully reported.
2. Fewer Deaths Reported Than Expected: In a Pfizer report covering six months, 38 deaths were noted among the vaccine participants. This number was lower than what you’d expect based on how many people typically pass away in the US, hinting that some deaths might not have been reported or some people were lost track of, which could make the study’s results less reliable.
3. More Deaths and Heart Problems After 100 Days: Looking closer at when people died or had serious heart issues after getting the vaccine, there was an increase around 100 days after vaccination. This suggests there might be long-term risks from the vaccine that weren’t caught in the initial studies.
4. Issues With How the Study Was Run: There were reports from people involved in the study about problems like vaccines not being stored correctly, labels being mixed up, and not checking in quickly with people who had side effects. These issues could make the data less trustworthy.
5. Not Reporting All Side Effects: The vaccine trials didn’t report all the severe side effects, especially those that happened after a certain period. Also, revealing who got the vaccine and who didn’t (unblinding) early on might have hidden some of the side effects that appeared later.
6. Keeping Data Secret: The general public couldn’t see the detailed data from the vaccine studies, which means independent experts couldn’t check the results themselves. This might lead to people thinking the vaccine is safer and more effective than it might actually be.
7. Hidden Death Data: An in-depth look into Pfizer’s data found that more people died after the study’s official end date than was shared with the FDA. This suggests that the true number of deaths might have been hidden.
8. Millions of Reported Side Effects: When looking at safety reports from the US and Europe, over 7.8 million side effects were reported after the COVID-19 vaccine, with older people reporting more serious issues like death or needing to go to the hospital.
9. Autopsies Show Vaccine Impact: Reviews of autopsies (examinations of bodies after death) showed that a significant number of deaths were linked to the vaccine, with many affecting the heart.

COVID-19 Vaccine DNA Contamination Findings

Discuss the findings related to the DNA particles found in some vials of the vaccine and the potential impacts.

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The document raises significant concerns about the presence of DNA particles in some vials of COVID-19 mRNA vaccines, focusing on the following findings and potential impacts:

1. High Levels of DNA Contamination: An analysis of multiple vials of the Pfizer and Moderna mRNA vaccines revealed high levels of DNA contamination in both monovalent and bivalent vaccines, significantly exceeding the limits set by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). The contamination levels were orders of magnitude higher than the EMA’s limit of 330 nanograms of DNA per milligram of RNA and also exceeded the FDA’s safety limits.
2. Contamination with Plasmid DNA: Further investigations confirmed contamination with the plasmid DNA vector used as the template for mRNA vaccine production, with substantial quantities of plasmid DNA (200 billion DNA fragments per vial) found in the vaccines. This raises questions about the manufacturing process and quality control measures.
3. Presence of Simian Virus 40 (SV40) Promoter: Particularly alarming was the discovery of the SV40 promoter in Pfizer vaccine samples, a sequence associated with an oncogenic DNA virus known to induce tumors in laboratory animals. Although SV40 exposure alone is not conclusively linked to human malignancy, its presence in vaccines is concerning due to its cocarcinogenic potential and historical association with contaminated polio vaccines.
4. Potential Integration into the Human Genome: The packaging of DNA fragments into lipid particles may increase the likelihood of these fragments integrating into the human genome. This carries risks of disrupting natural genetic sequences and potentially leading to diseases, including cancer.
5. Regulatory and Safety Implications: These findings have led to calls for a halt on the use of COVID-19 mRNA vaccines by some health officials and experts, citing the need for thorough investigations into the DNA contamination, its sources, and potential long-term effects on human health.
6. Process-Related Impurities: The DNA contamination highlights issues with process-related impurities that were not present in the vaccine doses used during the clinical trials. It suggests that the rapid scale-up of vaccine production for emergency supply may have compromised the integrity and safety of the vaccines distributed to the public.

These concerns emphasize the need for rigorous quality control, transparency in the manufacturing process, and independent investigations to assess the implications of DNA contamination in mRNA vaccines. The potential health risks, including the integration of foreign DNA into the human genome and the presence of oncogenic sequences, warrant immediate attention and action from regulatory bodies and the scientific community.

Can you outline the previously provided bullet points in layman’s terms and suggest a course of action for individuals to protect their health given the results of the attached article?

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The findings from the document regarding DNA particles in some COVID-19 mRNA vaccine vials can be explained in simpler terms as follows:

1. Unexpected Ingredients: Some vaccine vials were found to contain more DNA bits than expected. These bits were not supposed to be in the vaccine at such high levels, based on safety guidelines.
2. Source of the DNA: The DNA found in the vaccines comes from a specific type of DNA used in making the vaccines. The amount detected was much higher than safety standards allow.
3. Concerning DNA Element: Researchers found a DNA piece that can potentially cause cancer in animals. Although it’s not proven to do the same in humans, its presence in vaccines is worrying because of its association with cancer in the past.
4. Risk of DNA Affecting Our Genes: There’s a possibility that these DNA bits could blend into our DNA. This could mess up how our genes work and might lead to health problems, including the risk of developing diseases like cancer.
5. Questions on Vaccine Safety: These discoveries have led some health experts to suggest stopping the use of these vaccines until more is understood about these DNA bits and their effects on health.
6. Quality Control Issues: The findings suggest that the rush to produce vaccines quickly may have led to shortcuts in ensuring the vaccines were free from unwanted ingredients.

For individuals concerned about their health in light of these findings, consider the following course of action:

1. Stay Informed: Keep up-to-date with the latest research and recommendations from reputable health organizations and regulatory bodies regarding COVID-19 vaccines.
2. Consult Healthcare Professionals: Talk to your doctor or a healthcare provider about your concerns and the benefits and risks of COVID-19 vaccination, especially in light of new findings. They can provide personalized advice based on your health history and current health status.
3. Consider Risk Factors: Evaluate your personal risk of COVID-19 exposure, and potential severe outcomes from the disease, and weigh them against the concerns raised about the vaccine. Your decision might differ based on your age, health condition, and the rate of virus spread in your community.
4. Report Adverse Events: If you’ve been vaccinated and experience unusual symptoms, report them to your healthcare provider and the appropriate health authorities. This contributes to the monitoring of vaccine safety.
5. Advocate for Transparency and Safety: Support calls for transparent research and the rigorous testing of vaccines. Public access to vaccine research data can help ensure that vaccines are safe and effective.
6. Healthy Lifestyle: Maintain a healthy lifestyle that supports your immune system, including a balanced diet, regular exercise, adequate sleep, and stress management.

It’s crucial to balance the need for protection against COVID-19 with concerns about vaccine ingredients and potential side effects. Making informed choices is key, and consultation with healthcare professionals is essential to navigate these complex issues.

Disclosures by Study Authors and Contributors

What information is available about the study’s authors?

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The study was contributed to by several authors, each with specific roles in its creation. Here’s a summary of their contributions and disclosures:

Authors and Contributions:

• M. Nathaniel Mead, Stephanie Seneff, Russ Wolfinger, and Peter A. McCullough were responsible for the concept and design of the study.
• M. Nathaniel Mead, Stephanie Seneff, Russ Wolfinger, Jessica Rose, Kris Denhaerynck, Steve Kirsch, and Peter A. McCullough participated in the acquisition, analysis, or interpretation of data.
• M. Nathaniel Mead and Stephanie Seneff drafted the manuscript.
• M. Nathaniel Mead, Stephanie Seneff, Russ Wolfinger, Jessica Rose, Kris Denhaerynck, Steve Kirsch, and Peter A. McCullough critically reviewed the manuscript for important intellectual content.
• Peter A. McCullough also had a supervisory role in the study.

Disclosures:

• All authors declared that no financial support was received from any organization for the submitted work.
• Stephanie Seneff declared a grant from Quanta Computer Inc., which had no influence over the content of the review paper.
• Peter A. McCullough declared employment and stock/stock options from The Wellness Company, which had no role in the creation of the paper.
• Steve Kirsch is the founder of the Vaccine Safety Research Foundation (VSRF) but receives no income from this entity.

Acknowledgements:

• Simon Thornley, a New Zealand epidemiologist, for insightful comments, analytical expertise, and confirmation of risk-based calculations.
• Scott Sutton was thanked for assistance with graphics.

These details provide insight into the expertise and perspectives of the authors, as well as their financial disclosures and the support they received in preparing the study.

Media Mentions and Trends Related to Recent COVID-19 Vaccine Research Findings

What information can you offer as to recent trends in media related to the article “COVID-19 mRNA Vaccines: Lessons Learned from the Registrational Trials and Global Vaccination Campaign”

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The search did not yield specific recent trends or media coverage directly related to the article “COVID-19 mRNA Vaccines: Lessons Learned from the Registrational Trials and Global Vaccination Campaign.” It appears there may not be widely discussed or highlighted media trends specifically focusing on this article at the moment. The coverage and discussion of COVID-19 vaccines in the media continue to evolve, focusing on various aspects such as vaccine development milestones, advances in mRNA vaccine technology, and discussions on vaccine safety and efficacy. For the most current trends and discussions, it might be beneficial to look at recent publications in scientific journals and reputable news outlets that cover health and science topics.

What is the latest guidance from the CDC and other health organizations tasked with protecting public health regarding COVID-19 vaccines?

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The latest guidance from the CDC regarding COVID-19 vaccines includes several key updates:

1. Vaccine Recommendations for Ages 12 and Older: Individuals aged 12 years and older who have not previously received any COVID-19 vaccine doses and choose to get Novavax are advised to receive 2 doses of the updated Novavax vaccine to be considered up to date​​.
2. 2023-2024 COVID-19 Vaccine Recommendations: The CDC recommends the updated COVID-19 vaccines from Pfizer-BioNTech, Moderna, or Novavax to protect against serious illness from COVID-19. Everyone aged 6 months and older who is moderately or severely immunocompromised is recommended to receive at least 1 dose of a 2023-2024 updated COVID-19 vaccine​​.
3. Interim Clinical Considerations: Healthcare providers administering the Moderna COVID-19 Vaccine (2023-2024 Formula) to individuals aged 6 months through 11 years should ensure the correct volume of the vaccine (0.25 mL) is withdrawn from the vial and administered to the recipient​​.
4. FDA Authorization of Updated Vaccines: The FDA has authorized the emergency use of the Novavax COVID-19 Vaccine, Adjuvanted for the prevention of Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)​​.
5. Updated mRNA COVID-19 Vaccines: Individuals aged 6 months through 4 years who have previously been vaccinated against COVID-19 are eligible to receive one or two doses of an updated mRNA COVID-19 vaccine, depending on the timing and number of doses they have previously received​​.

These updates reflect ongoing efforts by health organizations to adapt COVID-19 vaccination recommendations based on the latest evidence and developments. For the most current and specific guidance, individuals are encouraged to visit the official CDC website or consult healthcare providers.

Has any public health organization directly addressed the findings from the study we’ve been discussing in this chat?

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None of the search results directly indicate a public health organization’s response specifically addressing the findings from the study “COVID-19 mRNA Vaccines: Lessons Learned from the Registrational Trials and Global Vaccination Campaign.” The articles and studies found in the search discuss various aspects of COVID-19 vaccines, such as their safety, effectiveness, and the impact of vaccination campaigns, but do not appear to respond directly to the concerns raised in the study we have been discussing.

Public health organizations like the CDC, WHO, and others regularly publish guidance and updates on COVID-19 vaccines based on a broad range of studies and data. For specific responses to the study’s findings, it would be necessary to consult the websites or official communications of these organizations directly.