27 results found
- FDA Officials Resign Amid Booster Controversy
"a massive blow to confidence in the agency's ability to regulate vaccines" (BioCentury) In early September, two senior FDA officials resigned suddenly, without any sort of public statement or succession plan, as reported by BioCentury. Marion Gruber, director of FDA's Office of Vaccines Research & Review (OVVR) as well as her deputy, Dr. Philip Krause, both resigned in the wake of the controversial decision by the Biden Administration to push a third round of Covid-19 "Booster Shots". To date, neither Gruber or Krause have made statements on exactly why they left but there has been much speculation. COVID-19 vaccine boosters not widely needed, top FDA and WHO scientists say - Reuters Science Doesn’t Support Third Shot, Say Officials Who Left FDA in Spat With Biden Over Boosters - Defender "2 top FDA officials resigned over the Biden administration's booster-shot plan, saying it insisted on the policy before the agency approved it, reports say" - Business Insider FDA officials reportedly resign over Biden administration booster-shot plan On August 12th, health officials authorized a third booster shot. Dr. Jesse Goodman, a former chief scientist with the FDA stated, "Normally, what you do is lay out the data first, and then say how the data supports the decision. When the White House made its announcement on booster shots, it did essentially the opposite. This was a serious mistake in how it was handled." The White House was warned by federal health officials on September 3rd, that there still isn't enough data to ethically recommend boosters for all adults. While FDA doesn’t have to follow its advisers’ recommendations, it generally does — except this time around is unlike any other. Today is the day that top health officials and President Joe Biden said that broad booster rollout would begin. That vaccine experts and some FDA regulators themselves don’t believe it’s the right time for most adults, throwing another wrench in the Biden administration’s vaccine messaging. (Politico) Essentially, the FDA and even the openly-corrupt CDC, recommended against the rush to authorize booster shots, yet the White House plowed forward, causing worries throughout the medical community that health care providers may be putting themselves at risk by immunizing patients outside the FDA and CDC recommendations, according to ACIP's Helen Keipp Talbot. The fact that the Biden Administration pushed forward anyway in this regard is likely the main reason for the resignation of Gruber and Krause. FDA senior officials don't just resign unexpectedly in normal scenarios. On top of all that, drug company officials have stated that they fully expect their COVID shots will turn into an annual requirement as the pandemic morphs into a "perennial endemic". (The Intercept 3/18/2021) Intercept - DRUGMAKERS PROMISE INVESTORS THEY’LL SOON HIKE COVID-19 VACCINE PRICES If this massive profiteering is to continue, which those pulling the strings undoubtedly intend it to, a finite amount of shots would remove the vaccine manufacturers profitability as well as negate the "need" for vaccine passports, which are leading to the intended Agenda 2030 outcome of globalization and mobilization of everything from banking to a social credit score system. If you don't believe me, just wait and see what the next year has in store. By the time those 4 slots on your vaccination card are full, they will be rolling out a mobile vaccination compliance system which will be coupled with a social credit score and the complete loss of your personal freedom. Welcome to the New World Order.
- FDA Pfizer Approval Corruption
Approved! No Questions Asked! On August 23rd, 2021, the FDA approved the Pfizer COVID shot, "Comirnaty". The FDA press release states, "The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older." Short side note: The sub-heading of the FDA's news release states, "Approval Signifies Key Achievement for Public Health"...seems odd that the FDA gets to decide what their decision signifies to the public... “Based on the longer-term follow-up data we submitted, today’s approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,” Pfizer CEO Albert Bourla said in a statement. “I am hopeful this approval will help increase confidence in our vaccine.” (The Defender) Everything about this "key achievement" is shady and seemingly diabolical. This Covid-19 adventure we are all being drug through is the biggest vaccination campaign in history. According to The Washington Post, Pfizer’s vaccine approval was the fastest in the FDA's history, coming less than four months after Pfizer/BioNTech filed for licensing on May 7, 2021. Here are the facts: The Pfizer Covid-19 shot that has been injected into many American's arms over the past 4 months is not the same shot that the FDA just approved on August 23rd--legally, at least. Whether or not the ingredients are the same, the FDA pointed out in their approval document that there is a "supply shortage" for the new and approved "Comirnaty" injection, while there is "an abundant supply" of the Pfizer/BioNTech shot, authorized under emergency use authorization (EUA). This is important to understand because of the legality of each. The FDA says there is a "distinction" between the EUA authorized shot and the fully approved "Comirnaty" shot. Therefore, according to the FDA, they are separate and standalone products. But, they also state that both products "can be used interchangeably"...Let me break this down: Under Emergency Use Authorization (EUA), the patient is willingly subjecting themselves to an experimental injection and, therefore, bears all liability for any adverse reaction--including death, under the 2005 Public Readiness and Preparedness Act or "PREP Act". On the other hand, if a product has been fully FDA approved and is no longer considered "experimental", the patient has the right to sue the manufacturer for any adverse reactions under the Nuremberg code, as well as under Federal Regulation 21 U.S. Code Sec. 360bbb-3(e)(1)(A)(ii)(III). When you understand this, it should become more clear why this FDA approval seems shady: there is an alleged "shortage" of the FDA approved shot (the shot that, if injected into patients, would place a huge amount of liability onto Pfizer and enable the public to sue for damages) while, at the same time, there is an "abundance" of the experimental Pfizer vaccine (which, if injected into patients, provides Pfizer total freedom from any liability for injury or death)--and the FDA says they can be "used interchangeably"... Now, looking at this from a logical and critical thinking perspective: what do you think is going on here?...which one do you think they're going to be injecting into all the kiddies in the next month?... See also: COVID Vaccine Injury Reports Jump by 27,000 in One Week, FDA Pulls ‘Bait and Switch’ With Pfizer Vaccine Approval Link to VAERS results shown above Robert F. Kennedy, Children's Health Defense, states, "The FDA appears to be purposefully tricking American citizens into giving up their right to refuse an experimental product." Boosting Confidence by Rushing FDA Approval? “I am hopeful this approval will help increase confidence in our vaccine.” Pfizer CEO Albert Bourla said in a statement. "While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.” said Acting FDA Commissioner Janet Woodcock, M.D. (link) Logically, this decision couldn't possibly have been made with the intention to "boost confidence" in those who are still "vaccine hesitant". In fact, for those who don't want this injection, it does the complete opposite. There is no way the FDA thinks that approving a never-injected-into-humans-before, gene therapy, after only 4 months of trial, will boost confidence in those who are currently opposed to it... Since this idea is outrageous and nonsensical to anyone with a sound mind, the real reasons for this historically short trial and subsequent approval, seem to be clear: 1) furthering the ability to impose federal and state mandates, and 2) money...of course See also: Vaccine Mandates More Likely Once FDA Grants Full Approvals, Health Experts Say + More "Pfizer announced in July that it expects $33.5 billion in covid vaccine revenue this year. Its stock has risen 33% this year, closing at $48.80 Thursday" (KHN) The Insufficient Timeline Full FDA approval was based on only 6 months of data, for a clinical trial set up to produce results in 2 years. Furthermore, there was no public discussion of the data prior to approval, which critics have blasted as blatantly unethical. See also: Why we petitioned the FDA to refrain from fully approving any covid-19 vaccine this year In a pre-covid world, at least in the United States (the land of freedom), the public would be allowed to ask questions like, "how did a 2 year clinical trial meet the FDA's 'rigorous safety standards' in only 6 months?" or "Why was there no public discussion of the safety data prior to approval?". But today, in the authoritarian wonderland we find ourselves in, those kinds of questions just aren't allowed...those kinds of questions will get you labeled a "conspiracy theorist" and quickly blocked from social media. In fact, it has now been decided that if you even question public health measures, you "may be a terror threat". This means, in context, that if the "public health experts" say that every American should get the jab, those who do not want to are domestic terrorists. See also: Homeland Security Says Americans Upset by 'Public Health Safety Measures' Could Be Terror Threats Bonus Info: We Already Knew the FDA was Corrupt The curious revocation of Hydroxychloroquine (HCQ) FDA approval The FDA Emergency Use Authorization for hydroxychloroquine and chloroquine was revoked in June 2020. Why I believe the FDA revoked HCQ's full FDA approval: The FDA is not allowed to approve an experimental product if there is already an existing treatment. HCQ has been an FDA approved drug for decades and has had a very high level of success. Therefore, it is my belief that the FDA revoked the approval of HCQ just prior to mRNA vaccine development in order to enable Emergency Use Authorization for the experimental gene therapy shots for the "Covid-19 pandemic".
- Importance of Understanding Virus Isolation
August 6, 2021 NickiLeaks Research What does it mean to isolate and purify a virus? Isolating a virus means, in simple terms, that you’ve found the virus in nature, likely in an animal host, and you’ve been able to successfully examine and identify that finding as the virus. There is a strict protocol for virus isolation—at least there used to be, up until the discovery of the “novel Covid-19 virus”...Here’s a short explanation of the historical, tested, and accepted way to isolate and purify a virus: “In as concise terms as possible, here’s the proper way to isolate, characterize and demonstrate a new virus. First, one takes samples (blood, sputum, secretions) from many people (e.g. 500) with symptoms which are unique and specific enough to characterize an illness. Without mixing these samples with ANY tissue or products that also contain genetic material, the virologist macerates, filters, and ultracentrifuges i.e. purifies the specimen. This common virology technique, done for decades to isolate bacteriophages1 and so-called giant viruses in every virology lab, then allows the virologist to demonstrate with electron microscopy thousands of identically sized and shaped particles. These particles are the isolated and purified virus.” [Dr. Andrew Kaufman’s, Statement on Virus Isolation (SOVI)] (click for link) The term “Isolation” is defined as “the action of isolating; the fact or condition of being isolated or standing alone; separation from other things or persons; solitariness.” (Oxford English Dictionary) By this very definition and no other factors, the SARS-CoV-2 virus has never been isolated or purified. Why does it matter whether they’ve “isolated and purified” the virus? There are huge implications for this. Not having truly isolated the virus means they have never actually found the virus in nature. This means that we don’t truly know that the virus even exists. Now understand this: There are many who hear this and get very angry. But this is not an argument—it is provably true. The virus may exist, but no one has ever found it in nature. This is not my opinion, this is simply the truth, based on the evidence that has been produced by “the experts” thus far. Therefore, the virus itself is simply a computer-simulated, scientific postulation. There is no evidence that has ever been produced by anybody EVER, that proves that this virus exists. Period. Additionally, this “SARS-CoV-2 virus” is structurally almost exactly the same as the SARS virus of 2003. The only significant difference being transmissibility, by way of the ACE-2 binding receptor or Spike Protein… Coronavirus 2019-nCoV, able to enter and infect human cells’ ACE2 receptor via its spike protein. Keep this in mind when you consider the next complicating factor: The way in which the argument on the origin of the virus has been extremely polarized as well as the way those who believed the “lab leak theory” were so heavily scrutinized and even demonized—WHY?? Come with me down this rabbit hole and decide for yourself… The most probable theory of the origin of the virus, based on the evidence that exists, is that the virus was altered via gain-of-function research paid for with funding grants from the NIH/NIAID at the Wuhan Lab. There is no doubt that Fauci’s organization was a key player in the funding of this controversial research and there are several grants I will provide that prove it. (The Wuhan Institute of Virology wasn’t the only lab performing gain-of-function research that was funded by the Fauci-led NIAID. For more information about specific gain-of-function research funded by Fauci’s NIAID, see my upcoming post, “Tracking GOF Research Prior to Covid 19 Outbreak” at www.nickileaks.com.) Whether or not you believe Dr. Fauci did or didn’t know about the funding, the point is that there is a wealth of evidence that proves that the NIAID, the organization Fauci has run for decades, did, in fact, fund multiple gain of function research projects at the Level 4 Lab in Wuhan—to this there is no argument. Here’s a brief overview of some of the GOF contracts, to list a few (if there is significant interest in an exhaustive list, please reach out and I will provide everything I have): On January 6, 2014, Prof. Shi Zhengli received a US$665,000 grant from the National Institute of Health for a study named The Ecology of Bat Coronaviruses and the Risk of Future Coronavirus Emergence (NIAID R01 AI1 10964)…and then four days later on January 10, 2014, an additional US$559,500 grant from the United States Agency of International Development for research study entitled, Emerging Pandemic Threats PREDICT 2_China (Project No. AID-OAA-A-1400102). On October 31, 2019, Prof. Shi Zhengli had published a report entitled Filovirus-reactive antibodies in humans and bats in Northeast India imply zoonotic spillover, curiously funded by the U.S. Department of Defense, the U.S. Defense Threat Reduction Agency, the U.S. Biological Defense Research Directorate of the Naval Medical Research Center, and the Department of Atomic Energy of the Government of India and edited by a microbiologist employed by the U.S. Center for Disease Control. Of note is the fact that the Defense Threat Reduction Agency is an agency within the U.S. Department of Defense and is the official Combat Support Agency for countering weapons of mass destruction. (source) 12/12/2019 - “Molecular Mechanism for Antibody-Dependent Enhancement of Coronavirus Entry” “This work was supported by NIH grants R01AI089728 (to F.L), R01AI110700 (to F.L.), and R01AI139092 (to L.D. and F.L.).” October 16, 2014 Statement on Funding Pause on Certain Types of Gain-of-Function Research The White House Office of Science and Technology Policy announced(link is external) today that the U.S. government will undertake a deliberative process to assess the risks and benefits of certain gain-of-function (GOF) experiments with influenza, SARS, and MERS viruses in order to develop a new Federal policy regarding the funding of this research. During this deliberative process, U.S. government agencies will institute a pause on the funding of any new studies involving these experiments. For purposes of the deliberative process and this funding pause, “GOF studies” refers to scientific research that increases the ability of any of these infectious agents to cause disease by enhancing its pathogenicity or by increasing its transmissibility among mammals by respiratory droplets. NIH has funded such studies because they help define the fundamental nature of human-pathogen interactions, enable the assessment of the pandemic potential of emerging infectious agents, and inform public health and preparedness efforts. These studies, however, also entail biosafety and biosecurity risks, which need to be understood better. NIH will be adhering to this funding pause until the robust and broad deliberative process described by the White House — including consultation with the National Science Advisory Board for Biosecurity (NSABB) and input from the National Research Council of the National Academies — is completed. During this pause, NIH will not provide new funding for any projects involving these experiments and encourages those currently conducting this type of work — whether federally funded or not — to voluntarily pause their research while the government determines how to proceed. Public involvement in this deliberative process is key, and the process is thus designed to be transparent, accessible, and open to input from all sources. Consultation with the NSABB, the first step in this process, will take place October 22, and I encourage you to follow these deliberations closely. Francis S. Collins, M.D., Ph.D. Director, National Institutes of Health Consider this: Every mainstream media and “public health expert” is saying that they’ve “continuously and successfully isolated the virus”, but they neglect to inform us that they have changed the very definition of “virus isolation”. Why? I would encourage you to do your own research and come to your own conclusion(s) but, as for me, the most likely answer is simple: to benefit themselves by deceiving us (the mass population or, as some in the highest orders like to refer to us, the “ignorant and profane”). (To Be Continued...) Update: BOMBSHELL ADMISSION: “They never isolated the virus. That’s the issue” – Dr Wu Zunyou Sign up for my post notifications if you’d like to go with me on this journey! More to come very soon!
- About | NickiLeaks Research
Home About Research Blog Sources Search More ABOUT NICKILEAKS: My research aims to understand the big picture and the truth--sometimes sinister--lying behind the mask of social justice and "progressivism". Generally, I created this site to share my findings of the complexities of the world we all share today. I have a strong passion for research, knowledge, and independent investigation and realize others have other types of passions and may not have the time or the will to do the research I love doing. Therefore I have made the decision to share what I have learned with those who would like to hear. I will give you all the sources from which my facts and hypotheses have come and encourage you to do your own research and establish your own opinion. God bless you and God bless America.
- Research | NickiLeaks Research
Home About Research Blog Sources Search ... Home About Research Blog Sources Search More infographics, charts & graphs 1/2
- Independent Research | NickiLeaks Research
Home About Research Blog Sources Search More PHARMA-NATION 22 Write a comment 1 FDA Officials Resign Amid Booster Controversy 1 Write a comment FDA Pfizer Approval Corruption 7 Write a comment 2 "If a nation expects to be ignorant and free, in a state of civilization, it expects what never was and never will be." Thomas Jefferson COVID-19 RESEARCH