It’s time to publicly speak out against the FDA’s 5-year track history of sacrificing safety (the health of adults and children) in the name of science. And yes, this is about mRNA gene-editing shots.
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Dear FDA VRBPAC Members for the 2025–26 COVID-19 Boosters,
My name is Karen Kingston. I am a former marketer, regulatory advisor, and analyst in the BioPharma industry with over 25 years of experience.
Over the past five years, thousands of dedicated doctors, medical experts, journalists, analysts, concerned citizens and injured vaccine victims have conducted and published their own research, utilizing data from government websites, peer-reviewed publications, and even conducting their own lab work and clinical patient research. Their findings document the unprecedented health hazards caused by the COVID-19 mRNA-LNP injections to Americans and global citizens. Many have called for the removal of these injections from the market or at least a reassessment of their use. Among these courageous individuals are HHS Secretary Robert F. Kennedy Jr., NIH Director Dr. Jay Bhattacharya, FDA Commissioner Dr. Marty Makary, and CBER Director Dr. Vijay Prasad.
“Sacrificing Safety in the Name of Science”
Although the FDA was established to ensure that human clinical research, drugs, devices, and biologics are safe (per 21 USC §393 (a)(b)(1)(2)(B)(C)), under the leadership of former FDA Commissioner Janet Woodcock and CBER Director, Operation Warp Speed Vaccine Chief, Dr. Peter Marks, the agency underwent an ideological transformation, adopting the mantra of “sacrificing safety in the name of science.”
On October 22, 2020, the FDA, Pfizer, Moderna, and other manufacturers met to discuss how they would track the “working list” of unreasonable and significant risks of illnesses, injuries, diseases, and deaths that the COVID-19 mRNA-LNP injections could cause across multiple vital systems, including:
(REF: Anderson Steven, PhD, MPP – Dir. Office of Biostats & Epidemiology, CBER. Slide 16, FDA/CBER Plans for Monitoring COVID-19 Vaccine Safety & Effectiveness VRBPAC Meeting” October 22, 2020.
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The harmful effects of the COVID-19 mRNA-LNP injections causing nervous system disease, cardiac disease, blood and circulatory disease, musculoskeletal disease, reproductive and pregnancy disorders (e.g., miscarriages, stillbirths, birth defects, and sterility), autoimmune disease, and death are now well-documented, well-established, and well-known thanks to some of the current leaders at HHS.
The COVID-19 mRNA-LNP Injection Clinical Trials Should Have Been Terminated. The Injections Should Have Never Been Authorized, Approved or Deployed
Based on the knowledge that the FDA and manufacturers had on October 22, 2020, the COVID-19 injections’ clinical trials should have been terminated. Per 21 USC §312.42 (b)(1)(i), “human subjects are not to be exposed to unreasonable and significant risk of illness or injury during clinical trials.”
The LNP technology delivery platform used in the COVID-19 mRNA-LNP injections has a well-established history of causing severe diseases, injuries, and deaths in animal and human studies because the highly immunogenic LNPs cross the barrier membranes of the cardiovascular, respiratory, reproductive, renal, lymphatic, and central nervous system (including the blood-brain barrier), accumulate in major organs and tissues, causing a broad spectrum of diseases, disabilities, infertility, and death, as per peer-reviewed publications.
Based on the known reproductive harm caused by the mRNA-LNP technology injections, infants, children, men and women of childbearing age, and pregnantwomen, all of these demographics should have been excluded from the trials and the FDA should have never authorized or approved their use in these populations per 21 USC 312.42(v)(A-C).
Evidence of reproductive harm was most recently demonstrated by the study Impact of mRNA and Inactivated COVID-19 Vaccines on Ovarian Reserve, published in Vaccines, demonstrating that a human-equivalent dose of the Pfizer COVID-19 mRNA-LNP injections in female Wistar rats caused more than a 60% reduction in the finite egg supply of females.
The CFR for Emergency Use Authorization Requires Known Benefits of the Vaccines Outweigh Risks
Based on the known dangers and high-risks of the mRNA-LNP technology platform, the COIV-19 injections never should have been authorized or approved to be injected into an adult, child, pregnant woman, or infant.
Per page 8, Sec III.B.1 ‘Criteria for Issuance’: 2017 Emergency authorization of Medical Products and Related Authorities, HHS, FDA, Office of Counterterrorism and Emerging Threats), the Secretary and FDA may grant emergency use authorization (EUA) when “the known and potential benefits of the product, when used to diagnose, prevent, or treat the identified disease or condition, outweigh the known and potential risks of the product.”
mRNA-LNP Injections Caused Inevitable Harmful Outcomes, Disease, and Death
However, by following the mantra of ‘sacrificing safety in the name of science,’ the FDA granted emergency use authorization of the Pfizer COVID-19 mRNA-LNP injections on December 11, 2020, and full FDA approval on August 23, 2021. While there are thousands of analyses, publications, and data sets, demonstrating the unprecedented disease, disabilities, and deaths these shots have caused, here are a select few examples for the sake of brevity.
June 2022: Pfizer Documents 5 Million Harmful Outcomes in Nearly 1.5 Million Individuals
Per an internal Pfizer document released under FOIA, as of June 18, 2022, Pfizer recorded nearly 5 million harmful clinical effects, specifically; 696,605 nervous system disorders, 539,299 musculoskeletal and connective tissue disorders (92,942 pain in extremities), and 317,811 gastrointestinal disorders, 224,633 skin, hair and nail disorders, 190,720 respiratory and chest disorders, 178,353 female and male reproductive system disorders (erectile dysfunction, infertility, heavy menstrual bleeding), 167,382 bacterial, viral, or parasitic infections (24,9010 herpetic infections), 126,993 cardiac disorders, 100,970 blood and lymphatic system disorders, 77,148 psychiatric disorders, 73,542 vascular disorders, 61,518 eye disorders, 47,038 ear and labyrinth disorders (15,833 tinnitus), 31,895 autoimmune disorders, 13,647 kidney and urinary disorders, 3,711 cancers and benign cysts, 4,056 pregnancy complications (1,859 spontaneous abortion complications, 1,143 genetic disorders, and 3,814 deaths across nearly 1.5 million victims (independent of the VAERS System).
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CDC’s V-Safe Data: Over 40% of Americans Reported Severe Symptoms After COVID-19 Injections
According to data from the CDC’s V-Safe program—a voluntary smartphone-based health monitoring system for COVID-19 vaccination recipients—over 40% of participants reported symptoms that significantly impacted their daily activities or required emergency medical attention. This data was collected from approximately 10 million U.S. residents during the early phases of the COVID-19 vaccination rollout.
Notably, Texas exhibited a significant deviation from the national average, with 15% of recipients experiencing Grade 3 or 4 adverse events, indicating a lower incidence of severe reactions compared to other states. V-Safe was launched at the onset of the COVID-19 vaccination campaign, and the data referenced in this report was last updated on July 31, 2022.
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VAERS Reports 22,231 Deaths and 11,917 Serious Adverse Events in Children in 2021
As of May 12, 2025, data from the Vaccine Adverse Event Reporting System (VAERS) indicates that 22,231 deaths occurred in 2021 following COVID-19 vaccinations, surpassing the total number of vaccine-related deaths reported in the previous 20 years combined. Approximately one-third of these fatalities occurred within the first three days post-vaccination.
Additionally, 11,917 serious adverse events were reported in children and infants in 2021, marking a nearly 400% increase from 2020. These figures raise significant concerns about the safety profile of COVID-19 vaccines.
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NCVIA Provides Additional Legal Basis for Immediate Recall
Under the National Childhood Vaccine Injury Act of 1986, specifically §300aa–27(a)(1)(2), vaccines introduced after December 1987 are mandated to result in fewer and less serious adverse reactions than those available on the market at that time. Given the substantial increase in reported adverse events, there is a compelling legal argument for the immediate withdrawal of COVID-19 mRNA vaccines from the market.
FDA’s Authority to Issue a Class 1 Recall
According to 21 CFR § 7.41, the FDA has the authority to issue a Class 1 recall when:
Given the substantial number of adverse events and deaths reported, the criteria for a Class 1 recall have been met, warranting immediate action to protect public health.
Under the Biden administration, instead of taking the lawful and moral action to recall the COVID-19 mRNA-LNP injections from the market, CBER Director Peter Marks fought to cover-up data showing that the shots caused greater harm than benefit, keep the mRNA injections on the market, and continued to “sacrifice safety (the safety of adults, children and infants) in the name of science.”
“We (The FDA) Have a Void of Science” (for the Past 4 Years) – FDA Commissioner Makary
FDA Commissioner Marty Makary appeared on Morning Joe on May 9, 2025, asserting that “We (the FDA) has had a void of science at the FDA explaining how the COVID-19 injections have been granted annual FDA approval and/or authorization with zero scientific rigor or common-sense evaluation over the past 4 years.
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Click here to watch the video
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In his closing statements about the COVID-19 mRNA-LNP injections, Commissioner Makary asserted, “In a void of data, opinions fill that void. And this administration is committed to gold-standard science. So that’s what we’re going to deliver on.”
Brooke Jackson Pfizer Whistleblower Case
In an appellate brief filed by the U.S. government in the Brooke Jackson whistleblowercase against Pfizer, the government acknowledged awareness of clinical trial irregularities reported by Jackson to the FDA. The government had ongoing access to Pfizer’s records, including documentation of 5 million adverse effects, and maintained that “Pfizer vaccines are safe.” This admission highlights significant concerns regarding the transparency and integrity of the vaccine approval process.
Judicial Oversight: 9th Circuit Court of Appeals
The claim that the “COVID-19 vaccines and boosters are safe and effective,” is not only false, but also a fraudulent claim grossly misrepresenting the well-known dangers of the mRNA-LNP gene-editing technology injection which are NOT vaccines.
In June 2024, the 9th Circuit Court of Appeals remanded the Los Angeles Unified School District (LAUSD) COVID-19 vaccine mandate lawsuit back to the district court. The appellate court asserted that plaintiffs have the right to reasonably challenge the government’s claim that “COVID-19 injections are ‘safe and effective vaccines.’” This ruling underscores the judiciary’s role in scrutinizing government assertions and upholding public accountability.
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The authorization, approval, and aggressive promotion of COVID-19 mRNA vaccines and boosters by the medical community, biopharmaceutical industry, and federal government have raised significant ethical and safety concerns.
I respectfully request that under the leadership of HHS Secretary Robert F. Kennedy, FDA Commission Marty Makary and CBER Director Vinay Prasad, take the lawful, moral, ethical and humane actions needed to issue a Class 1 Recall of the Pfizer and Moderna COVID-19 mRNA-LNP injections and revoke the emergency use authorization for all COVID-19 ‘vaccines.’
Respectfully,
Karen Kingston
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Submit Your Comment by May 22, 2025
Here is the link to submit your public comment to the FDA. Comments are limited to 5,000 characters, but you can also attach files.
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The Worldwide Corona Crisis, Global Coup d’Etat Against Humanity
by Michel Chossudovsky
Michel Chossudovsky reviews in detail how this insidious project “destroys people’s lives”. He provides a comprehensive analysis of everything you need to know about the “pandemic” — from the medical dimensions to the economic and social repercussions, political underpinnings, and mental and psychological impacts.
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Professor Chossudovsky exposes the truth that “there is no causal relationship between the virus and economic variables.” In other words, it was not COVID-19 but, rather, the deliberate implementation of the illogical, scientifically baseless lockdowns that caused the shutdown of the global economy. –David Skripac
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