FDA’s Catastrophic Safety and Quality Oversight Failures on COVID Vaccines

by Elizabeth Lee Vliet MD

Since its inception in 1934, The Food and Drug Administration (FDA) has regulatory to oversee drug and medical products manufacturing processes and quality control to protect the public from unsafe products.

Recent research revelations from career pharma insider whistleblowers, Alexandra Latypova and Hedley Rees, provide chilling information on catastrophic safety and manufacturing oversight failures for the still experimental COVID-19 injections that are linked to the skyrocketing deaths and complications happening to people around the world.  Dr. Michael Yeadon, former Pfizer Chief Scientist Worldwide for Respiratory Pharmacology, has reported that Pfizer documents showed the FDA knew of the death risks.

Making the mRNA for the product is a complex, multistage process. Each step entails potential errors that can be amplified at later stages. Scaling up any process is problematic. To make millions of doses required scaling up at breakneck speed. One batch may contain up to 900 liters; problems were encountered at 37 liters, and it appears nothing has been done to resolve them.

Theoretically, every vial of vaccine is supposed to have uniform content. But

independent analysis reveals more than 10,000% variability in potency from batch to batch. Other violations of safety and quality control include the following:

Not a single vial tested had ingredients or doses that conformed to FDA labeling requirements.

  • Some vials contained NO mRNA, others contained massive doses far exceeding stated amounts. Is this a cause of “sudden death” soon after vaccination?
  • Some vials contain high concentrations of DNA and protein impurities in quantities far exceeding allowed limits specified by the manufacturer. Numerous other contaminants have been described.
  • Some batch numbers of Pfizer and Moderna are associated with more than 5000 adverse event reports in the CDC’s Vaccine Adverse Event Reporting System (VAERS). Yet other batch numbers show zero to only a small number of adverse events. Such variance should not be happening if consistency and quality manufacturing standards were followed.
  • Almost all vials examined contain high contamination levels of various metals that are toxic to the human body. 

Additionally, frozen vaccines are delivered to vaccination centers in an UNFINISHED state. This means multi-step “finishing” procedures have to be carried out on sites that are not equipped or qualified to do such procedures safely and properly.

Any of these problems should have stopped production lines. Shockingly, the normal Good Manufacturing Practices (GMP) standards and pharmacovigilance oversight have been flagrantly ignored by all of the COVID injection manufacturers. The U.S. and European oversight agencies (FDA, EMA) have turned a blind eye to the fact that GMP standards are not being followed. This is unprecedented in the history of the FDA and is an outrageous violation of public trust.

The implausible scale of Pfizer mRNA manufacturing, based on documents received from Freedom of Information Act (FOIA) requests, suggests to experts that Pfizer is either combining batches, diluting to an unprecedented degree, relabeling older products, or something even more fraudulent. There simply is no way with current production capability to reach that scale of production and maintain reliable safety or quality.

Another stunning revelation from pharma insider Hedley Rees from the UK is that “over a period of 40 years, Big Pharma has outsourced every physical activity it possibly could, until it has lost its ability to develop new drugs—drug development, manufacture and distribution is now in the hands of third party organisations.”

In his INSIDE PHARMA article, “The One Thing Big Pharma Can’t Outsource—Culpability,” Rees explains: “Outsourcing manufacture can work so long as the development process and control are in the hands of the developer and the developer allows detailed instructions and specifications to be handed down to contractors and suppliers.” However, Big Pharma has lost control, and out-sourcing has brought it to the brink of failure, he states. “The only way to deliver blockbuster revenues in an acceptable timescale, was to cheat. To deceive and falsify in the most cynical way possible, hang the consequences.”

Disregarding the many questions raised about the safety of the mRNA technology itself, the dangerous violations of regulatory oversight of manufacturing and distribution revealed by courageous whistleblowers should alone halt the program.

Your shot may contain virtually no active ingredient—perhaps helping to explain apparent lack of efficacy. Or it may contain a massive overdose—perhaps explaining the high frequency of “sudden death syndrome.” You have no way to know which you get when you take “the jab” or get a “booster.”

For those who suffer adverse side effects and prolonged complications of the experimental COVID shots, there are integrated treatment approaches to help patients restore health. Combinations of anti-inflammatory and anti-coagulant prescription medications, nutraceuticals, vitamins and minerals ,and lifestyle strategies help alleviate the inflammation, micro-blood clotting, oxidative stress and immune system damage.

COVID injection manufacturers—Pfizer, Moderna, Johnson and Johnson, and AstraZeneca—should all be held accountable for their negligence, but we must not stop there. Americans and people around that world must hold our taxpayer-funded regulatory agencies accountable for their gross failures to protect a trusting public.

Dr. Vliet is the President and CEO of Truth for Health Foundation, a faith-based human rights 501(c)(3) public charity, and the creator of the Foundation’s innovative six initiatives that advocate for early outpatient COVID treatment, treatment and resources for vaccine-injured patients including the Citizens Vaccine Injury Reporting System™ (CVIRS™), legal defense grants for military service members and others denied medical and religious freedom, medical and legal help for families of hospitalized patients denied effective treatment, and the Health and Resilience Initiative to empower people with steps to improve health and avoid the restrictions on freedom with Big Medicine, Big Pharma and Big Government. The Foundation provides international educational and training programs focused on effective strategies for COVID and many other medical conditions, and on the interconnections of health, faith and lifestyle approaches for restoring resilience and quality of life.

Since February 2020, Dr. Vliet has been part of the team of frontline physicians treating COVID early at home to reduce hospitalizations and death. She is the lead author of the Foundation’s Vaccine Injury Treatment Guide – Your Road Map to Recovery.  She is the co-author/editor of the Guide to COVID Early Treatment: Options to Stay Out of Hospital and Save Your Life, with Dr. Peter McCullough, that is available to download as a PDF here: (https://www.truthforhealth.org/patientguide/patient-treatment-guide/). 

Dr. Vliet is a 2014 Ellis Island Medal of Honor recipient for her national and international educational efforts in health, wellness, and endocrine aging in men and women. She is also the 2007 recipient of the Voice of Women from the Arizona Foundation for Women, a past director of the Association of American Physicians and Surgeons (AAPS) and a member of the AAPS Editorial Writing Team since 2009. Dr. Vliet received her M.D. degree and internship in Internal Medicine at Eastern Virginia Medical School and completed specialty training at Johns Hopkins.  She earned her B.S. and master’s degrees from the College of William and Mary. 

Dr. Vliet has been a leader in patient centered, individualized medical care. Since 1986, she has practiced medicine independent of insurance contracts that interfere with patient-physician relationships and decision-making. Dr. Vliet is the founder of Vive Life Center with medical practices in Tucson AZ and Dallas TX, specializing in preventive and climacteric medicine with an integrated approach to evaluation and treatment of women and men with complex medical-endocrine problems from puberty to late life.   Dr. Vliet’s consumer health books include: It’s My Ovaries, Stupid; Screaming To Be Heard: Hormonal Connections Women Suspect– And Doctors STILL  Ignore; Women, Weight and Hormones; The Savvy Woman’s Guide to PCOS,  The Savvy Woman’s Guide to Great Sex, Strength, and Stamina.  Dr. Vliet has presented hundreds of professional CME programs for physicians and allied health professionals on many medical topics; consumer seminars and radio shows on integrated approaches to Men’s Health and Women’s Health; and Town Halls addressing the economic and medical impact of government intrusion into medicine.

Dr. Vliet speaks as an independent physician, not as a spokesperson for health systems, pharmaceutical companies, insurance plans, or political parties. Her allegiance and advocacy is to and for patients. Dr. Vliet’s public charity website is www.TruthForHealth.org  and her medical practice is www.ViveLifeCenter.com.

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