The Most Revolutionary Act

Uncensored updates on world events, economics, the environment and medicine

The Most Revolutionary Act
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About stuartbramhall

Retired child and adolescent psychiatrist and American expatriate in New Zealand. In 2002, I made the difficult decision to close my 25-year Seattle practice after 15 years of covert FBI harassment. I describe the unrelenting phone harassment, illegal break-ins and six attempts on my life in my 2010 book The Most Revolutionary Act: Memoir of an American Refugee.

How the Wealthiest Avoid Income Tax

ProPublica has obtained a vast cache of IRS information showing how billionaires like Jeff Bezos, Elon Musk and Warren Buffett pay little in income tax compared to their massive wealth — sometimes, even nothing.

In 2007, Jeff Bezos, then a multibillionaire and now the world’s richest man, did not pay a penny in federal income taxes. He achieved the feat again in 2011. In 2018, Tesla founder Elon Musk, the second-richest person in the world, also paid no federal income taxes.

Michael Bloomberg managed to do the same in recent years. Billionaire investor Carl Icahn did it twice. George Soros paid no federal income tax three years in a row.

ProPublica has obtained a vast trove of Internal Revenue Service data on the tax returns of thousands of the nation’s wealthiest people, covering more than 15 years. The data provides an unprecedented look inside the financial lives of America’s titans, including Warren Buffett, Bill Gates, Rupert Murdoch and Mark Zuckerberg. It shows not just their income and taxes, but also their investments, stock trades, gambling winnings and even the results of audits.

Taken together, it demolishes the cornerstone myth of the American tax system: that everyone pays their fair share and the richest Americans pay the most. The IRS records show that the wealthiest can — perfectly legally — pay income taxes that are only a tiny fraction of the hundreds of millions, if not billions, their fortunes grow each year.

Many Americans live paycheck to paycheck, amassing little wealth and paying the federal government a percentage of their income that rises if they earn more. In recent years, the median American household earned about $70,000 annually and paid 14% in federal taxes. The highest income tax rate, 37%, kicked in this year, for couples, on earnings above $628,300.

The confidential tax records obtained by ProPublica show that the ultrarich effectively sidestep this system.

[…]

Via https://www.propublica.org/article/the-secret-irs-files-trove-of-never-before-seen-records-reveal-how-the-wealthiest-avoid-income-tax

Pfizer, Moderna Say Kids as Young as 5 Could Get COVID Vaccines by September

By  Megan Redshaw

Pfizer and Moderna say children as young as 5 could be eligible for COVID vaccines by early September, as both companies complete trials.

Pfizer said Tuesday it is advancing late-stage clinical trials of its COVID vaccine, in lower doses, on children ages 5 to 11 years old and expects to apply for approval early this fall.

Pfizer’s vaccine is already being administered to children 12 and up, who receive the same 30 microgram dose as adults.

Moderna said it also expects its COVID vaccine will be available for kids as young as 5 by early fall. CEO Stéphane Bancel said Monday he thinks the data will become available sometime in September, CBS Boston reported.

Earlier this month, Moderna applied to the U.S. Food and Drug Administration (FDA) for full approval of its COVID vaccine for adults 18 and older, which is being administered now under Emergency Use Authorization. The company said it plans to seek expanded emergency use approval in the U.S. for the vaccine for ages 12 and up early this month.

Pfizer plans trials on children as young as 6 months

The Pfizer study on children 5 to 11 will enroll up to 4,500 children at more than 90 clinical sites in the U.S., Finland, Poland and Spain, the company said.

Based on safety, efficacy and tolerability data from the 144 children included in Pfizer’s phase 1 trial, the company will use 10 micrograms of each vaccine dose for kids between the ages of 5 and 11 in phase 2/3 trials, and 3 micrograms of each dose for those 5 and younger.

[…]

Via https://childrenshealthdefense.org/defender/pfizer-moderna-kids-5-years-covid-vaccines-september/

1 in 9 Vaccinated Adolescents Suffered Adverse Event After COVID Shot

Home — Physicians for Informed Consent

Madison Area Lyme Support Group

Physicians for Informed Consent (PIC), an educational nonprofit organization focused on science and statistics, recently published an update of its Pfizer-BioNTech COVID-19 Vaccine Risk Statement, which includes key questions and answers about the clinical trial data. The Pfizer COVID-19 vaccine is the first COVID-19 vaccine to receive expanded emergency use authorization (EUA) for adolescents; however, the vaccine is still not FDA-approved.

The PIC Pfizer-BioNTech COVID-19 Vaccine Risk Statement (VRS) answers important questions such as:

• How effective is the vaccine in children, adults, and the elderly?
• Is the vaccine effective in preventing hospitalizations and deaths?
• Is the vaccine effective and safer than the COVID-19 virus?
• Does the vaccine prevent the spread of the virus?

The updated document indicates that for children 12 to 15 years of age, the Pfizer COVID-19 vaccine clinical trial found the

  • overall incidence of severe adverse events during the two-month observation period to be 10.7% or 1 in 9 in the vaccinated group
  • the incidence of COVID-19 in the unvaccinated group was 1.6%; therefore, there were almost seven times more severe adverse events observed in the vaccinated group than there were COVID-19 cases in the unvaccinated group

Furthermore, since only about 1,100 vaccinated children 12 to 15 years of age were observed in the clinical trial, there were not enough children included in the trial to be able to prove the vaccine is safer than the disease in children 12 to 15 years of age.

[…]

Via https://madisonarealymesupportgroup.com/2021/06/09/1-in-9-vaccinated-adolescents-suffered-adverse-event-after-covid-shot/

Vaccinated Blood – The Dilemma Of COVID’s Experimental Transfusions

’Sullivan | Principia Scientific | June 8, 2021

Should we have the right to refuse a blood transfusion from the vaccinated for COVID-19? What about organs donated by the vaccinated?

In most nations anyone vaccinated for COVID-19 can donate blood immediately or shortly after being vaccinated despite the fact that the experimental product may induce life-threatening disorders in the recipients.

Donated blood will mix with yours and the worrisome injected spike proteins  from the donor blood will circulate and merge into your body.

The vast majority of people, especially the media, are not addressing this issue. Concerned citizens should be writing to all health authorities, politicians and public health bodies and demand screening and separate blood banks and clear identification of vaccinated and unvaccinated blood. No one knows the long term safety data. This is a global experiment on humanity and it must be stopped!

Watch the video below to discern the level of threat.

Does anyone remember the fallout from the AIDS pandemic when infected donated blood destroyed the lives of thousands?

In the late 1970s and early 1980s, sufferers of the blood-clotting disorder haemophilia in the UK were given blood donated – or sold – by people who were infected with the HIV virus and hepatitis C.

According to The Guardian newspaper (July 11, 2017) haemophiliacs pressed for compensation after:

“4,800 of them were infected with hepatitis C, a virus that causes liver damage and can be fatal. Of those, 1,200 were also infected with HIV, which can cause Aids. Half – 2,400 – have now died.”

In 1991, when campaigners were threatening to take the government to court, it made ex-gratia payments to those infected with HIV, averaging £60,000 each, on condition that they dropped further legal claims. The extent of infection with hepatitis C was not discovered until years later.

Today, with the COVID19 experimental vaccines being blamed for over one million adverse reactions, we can be sure this story is another ticking time bomb in government failure.

[…]

Via https://alethonews.com/2021/06/08/vaccinated-blood-the-dilemma-of-covids-experimental-transfusions/

Monopoly – Follow the Money

Monopoly – Follow the Money

Directed by Tim Gielen (2021)

Translated by Vrouwen voor Vrijeid (Women for Freedom)

Film Review

This Dutch documentary attempts to pinpoint the main corporations and individuals responsible for the Covid plandemic.

It begins by examining the key institutional investors that own the vast majority of the global share market. Going company by company, filmmakers reveal that approximately 8-10 institutional investors own 80% of the stock of nearly all global corporations. Some of the smaller institutional investors include mutual and pension funds. However the top three of every corporation they examine include BlackRock* and the Vanguard Group.**

The film looks at the institutional shareholdings of company after company, including Google, Twitter, Apple, Microsoft, Sony, Phillips, Boeing, Airbus, Coca Cola, Pepsi, all the mining companies, all the oil companies, Cargill, ADM, Bayer (the largest seed producer in the world since their acquisition of Monsanto), all the textile and fashion brands, Amazon, Ebay, Master Card, Visa, Paypal, and all the banks, tobacco companies, defense contractors, insurance companies, processed food companies, cosmetic brands and publishers and media outlets.***

In every case, both Vanguard Group and BlackRock are both within the top three institutional investors.

They also own stock in each other’s companies. In fact, Vanguard is  the biggest shareholder in BlackRock, which Bloomberg refers to as the “fourth branch of government” because it both advises central banks and lends them money.

We don’t know exactly who owns shares in Vanguard as it’s not a publicly traded company. However we do know that it’s a safe place for many of the most powerful families in the world to hide their wealth (eg the Rockefellers, Rothschilds and British royal family).

The film also explores how wealthy families use nonprofit foundations to shape global politics in their own interest without attracting public attention. The big three featured in the film are George Soros’s Open Society Foundation, the Clinton Foundation and the Bill and Melinda Gates Foundation.

All these rich and powerful elites meet at the World Economic Forum in Davos Switzerland every January and mingle with world leaders and significant non-profit groups, such as Greenpeace and UNESCO.

Chairman and founder of the WEF is Klaus Schwab, a Swiss professor and businessman. In his book, The Great Reset, he states that the coronavirus is a great “opportunity” to reset our societies. According, to Schwab, our old society must switch to a new one because the consumption society the elite has forced on us is no longer sustainable. Under the new society he proposes, people will own nothing and rely primarily on the state to get their needs met.


*BlackRock, Inc. is an American multinational investment management corporation based in New York City. Founded in 1988, initially as a risk management and fixed income institutional asset manager, BlackRock is the world’s largest asset manager, with $8.67 trillion in assets under management as of January 2021.

**The Vanguard Group, Inc. is an American registered investment advisor based in Malvern, Pennsylvania with about $7 trillion in global assets under management, as of January 13, 2021. It is the largest provider of mutual funds and the second-largest provider of exchange-traded funds in the world after BlackRock’s iShares.

***What this means, In essence, is that a handful of individuals control all public information.

 

 

Traces of COVID-19 found in Barcelona in March 2019, according to university report

Challenge

According to a study by the University of Barcelona that has recently gained traction, SARS-CoV-2 (the virus that causes the COVID-19 disease) was detected in the wastewaters of Barcelona on 12 March 2019. This would mark 9 months before the virus was found in the People’s Republic of China in December 2019.

What has followed has been a glaring silence from anti-China ideologues spanning the western world. Conspiracy theories that the Communist Party of China (CPC) created the virus in a Wuhan laboratory to wreak havoc upon the west have suddenly come to a bitter close in the face of scientific reality. Over the past year, verbal as well as violent attacks against China and Chinese people have taken place in the name of vengeance for ‘causing’ the COVID-19 crisis. 

Originally pushed by President Trump coining it the ‘Chinese virus‘ and ‘Wuhan flu‘, this anti-China campaign has pushed Sinophobia (anti-Chinese sentiment) to a decades-long high. According to a 2020 Pew Research study, 73% of US and 74% of UK citizens now have a negative view of China.

The new findings from Barcelona revealed by the study have not induced a surge in anti-Spanish or anti-Catalan sentiment in the west, further unveiling the ideological nature behind the sinophobic attacks. The US and UK do not blame COVID-19 on China with a well-meant intention to bring about justice for the pandemic, but rather to further their own geopolitical motives. 

Spain, which has now been discovered as the earliest location yet to inhabit the virus, is an EU and NATO member-state as well as a strong US ally. To push for an investigation as to how SARS-CoV-2 made its way into Barcelona’s sewage system would be the logical next step at this stage; such a step has not been publicly called for. This is because scapegoating China for one of the biggest crises of the 21st century remains a most valuable tool in US and NATO foreign policy, and publicising the facts that contradict that tool would be imperialistically counter-productive.

Via https://challenge-magazine.org/2021/06/08/traces-of-covid-19-found-in-barcelona-in-march-2019-according-to-university-report/

27 Experts Launch Citizen Petition Demanding FDA ‘Slow Down and Get the Science Right’ Before Approving COVID Vaccines

By  Megan Redshaw

A group of 27 prominent health experts and scientists are inviting public comment on their petition calling on the FDA to withhold full approval of COVID vaccines until efficacy and safety measures are met.

“Premature FDA approval of any COVID-19 vaccine could negatively impact the health and safety of U.S. residents, with global ramifications considering the international importance of FDA decisions,” the group said.

The FDA citizen petition process, described in Title 21 of the Code of Federal Regulations (21 CFR Part 10), allows individuals and community organizations to request the agency make changes to health policy. At any time, any “interested person” can request the FDA “issue, amend or revoke a regulation or order,” or “take or refrain from taking any other form of administrative action.”

In their petition, the group outlined many unanswered questions surrounding the efficacy and safety of COVID vaccines, and detailed how data must be collected before the FDA considers granting any vaccine full approval.

“We are concerned that the premature licensure of a COVID-19 vaccine can seriously undermine public confidence in regulatory authorities, particularly if long-term safety issues were to emerge following licensure,” petitioners wrote.

 In an op-ed published today in The BMJ, four of the petition’s signatories, writing on behalf of the group, said:

“The message of our petition is ‘slow down and get the science right — there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.’ We believe the existing evidence base — both pre- and post-authorization — is simply not mature enough at this point to adequately judge whether clinical benefits outweigh the risks in all populations.”

The petition states a COVID vaccine should be fully approved only when substantial evidence demonstrates the benefits of a specific product outweigh the harms for the indicated, recipient population. The petitioners “respectfully” requested the FDA act on the petition by June 11. They plan to seek judicial relief if the petition is denied.

The FDA granted Emergency Use Authorization (EUA) to three COVID vaccines — Pfizer, Moderna and Johnson & Johnson (J&J) — allowing rapid and widespread vaccine rollout across the U.S. However, the EUAs were granted without a built-in expiration date, which means they can lawfully be distributed even after a “public health emergency” no longer exists.

The 20-page citizen petition and supporting documents are filed under Docket ID FDA-2021-P-0521 on regulations.gov. Anyone can comment on the petition, or read others’ comments, including the FDA’s official reply once it arrives.

[…]

Via https://childrenshealthdefense.org/defender/petition-fda-get-science-right-before-approving-covid-vaccines/

Lawyer Sue Grey to NZ government: Failure to cease Covid vaccination programme may constitute homicide

Nelson lawyer Sue Grey takes government to High Court over ...

Outdoors Party

URGENT REQUEST FOLLOWING RESEARCH SHOWING “S PROTEIN” IS A TOXIN

To: Rt Hon Jacinda Ardern <jacinda.ardern@parliament.govt.nz>, Hon David Parker <david.parker@parliament.govt.nz>, Hon Andrew Little <andrew.little@parliament.govt.nz>, Hon Chris Hipkins <chris.hipkins@parliament.govt.nz>, <ashley_bloomfield@moh.govt.nz>, Chris James <Chris.James@health.govt.nz>, <ayesha.verrall@parliament.govt.nz>

Dear Prime Minister, Attorney-General, Minister of Health, Minister of Covid, Minister or Seniors, Director General of Health and Chris

I attach below some new and very important research which I must assume your advisors have not yet provided to you, or the experimental Pfizer injection rollout would surely already have been suspended.

It is now clearly established that the S-Protein [spike protein] is a toxin that causes the harmful symptoms known as “Covid”.

I surely don’t need to explain the legal, ethical and human rights consequences of a government knowingly promoting a program which intentionally injects a life threatening toxin into healthy people.

I also attach a report indicating that injected nanoparticles (and the S-Protein) do not remain in the arm muscle but instead circulate throughout the whole body.

The combined effect is that the Pfizer jab injects mRNA to take over cells to manufacture the deadly S-Protein toxin and this spread throughout much of the body, manufacturing the S-Protein toxin for days and in some cases many weeks.

This explains why even the limited available research from the two months of study as summarised in the Comirnaty Data Sheet identifies possible harm to many different parts of the body including the heart, blood, brain, musculoskeletal system, nervous system, fainting and dizziness etc.

This is no longer just a shocking experiment. Everyone involved is now on notice of this “injection roulette” which may result in death or serious injury to previously healthy people. The health and safety implications for employers and those who push this jab, are significant.

No post injection death can legitimately be ruled out as being caused or contributed by the injection, at least not without a full coroner’s report. Certainly any post vax stroke, heart attack, other blood disorder, nervous system disorder or even suicide or car accident (known overseas as “vaccidents”) must prima facie be assumed to be caused or contributed to by the jab, at least until a full coroners report is undertaken.

Similarly it is not good enough to claim that our seniors who die post jab were frail and likely to die. Surely if they were that frail they should have been spared from the jab. Anyway, surely “deaths post Jab” should be treated consistently with “deaths post Covid”.

Despite the secretive, flawed and very passive official post jab injury reporting process ( CARM), and as a result of the more active community led follow up, you are already on notice of a number of deaths and life threatening and life changing harm from this injection. The deaths and harm will inevitably continue if there are any further injections. Perhaps initially you had an excuse that you thought the S-Protein was “safe”. However now you are on notice that it is not “safe” by any definition.

[…]

Via https://www.outdoorsparty.co.nz/lawyer-sue-grey-to-nz-government-failure-to-cease-covid-vaccination-programme-may-constitute-homicide/

“I Don’t Know of a Bigger Story in the World” Right Now Than Ivermectin: NY Times Best-Selling Author

Zimbabweans Warned Against Using Ivermectin To Cure Corona ...

By 

Naked Capitalism

So why are journalists not covering it?

Michael Capuzzo, a New York Times best-selling author , has just published an article titled “The Drug That Cracked Covid”. The 15-page article chronicles the gargantuan struggle being waged by frontline doctors on all continents to get ivermectin approved as a Covid-19 treatment, as well as the tireless efforts by reporters, media outlets and social media companies to thwart them.

Because of ivermectin, Capuzzo says, there are “hundreds of thousands, actually millions, of people around the world, from Uttar Pradesh in India to Peru to Brazil, who are living and not dying.” Yet media outlets have done all they can to “debunk” the notion that ivermectin may serve as an effective, easily accessible and affordable treatment for Covid-19. They have parroted the arguments laid out by health regulators around the world that there just isn’t enough evidence to justify its use.

For his part, Capuzzo, as a reporter, “saw with [his] own eyes the other side [of the story]” that has gone unreported, of the many patients in the US whose lives have been saved by ivermectin and of five of the doctors that have led the battle to save lives around the world, Paul Marik, Umberto Meduri, José Iglesias, Pierre Kory and Joe Varon. These are all highly decorated doctors. Through their leadership of the Front Line COVID-19 Critical Care (FLCCC) Alliance, they have already enhanced our treatment of Covid-19 by discovering and promoting the use of Corticoid steroids against the virus. But their calls for ivermectin to also be used have met with a wall of resistance from healthcare regulators and a wall of silence from media outlets.

“I really wish the world could see both sides,” Capuzzo laments. But unfortunately most reporters are not interested in telling the other side of the story. Even if they were, their publishers would probably refuse to publish it.

That may explain why Capuzzo, a six-time Pulitzer-nominated journalist best known for his New York Times-bestselling nonfiction books Close to Shore and Murder Room, ended up publishing his article on ivermectin in Mountain Home, a monthly local magazine for the of the Pennsylvania mountains and New York Finger Lakes region, of which Capuzzo’s wife is the editor. It’s also the reason why I decided to dedicate today’s post to Capuzzo’s article. Put simply, as many people as possible –particularly journalists — need to read his story.

As Capuzzo himself says, “I don’t know of a bigger story in the world.”

Total News Blackout

On December 8 2020, FLCCC member Dr Pierre Kory gave nine minutes of impassioned testimony to the US Homeland Security Committee Meeting on the potent anti-viral, anti-inflammatory benefits of ivermectin. A total of 9 million people (myself included) saw the video on YouTube before it was taken down by YouTube’s owner, Google. As Capuzzo exhaustively lays out, both traditional and social media have gone to extraordinary lengths to keep people in the dark about ivermectin. So effective has this been that even in some of the countries that have benefited most from its use (such as Mexico and Argentina) many people are completely unaware of its existence. And this is no surprise given how little information is actually seeping out into the public arena.

A news blackout by the world’s leading media came down on Ivermectin like an iron curtain. Reporters who trumpeted the COVID-19 terror in India and Brazil didn’t report that Ivermectin was crushing the P-1 variant in the Brazilian rain forest and killing COVID-19 and all variants in India. That Ivermectin was saving tens of thousands of lives in South America wasn’t news, but mocking the continent’s peasants for taking horse paste was. Journalists denied the world knowledge of the most effective life-saving therapies in the pandemic, Kory said, especially among the elderly, people of color, and the poor, while wringing their hands at the tragedy of their disparate rates of death.

Three days after Kory’s testimony, an Associated Press “fact-check reporter” interviewed Kory “for twenty minutes in which I recounted all of the existing trials evidence (over fifteen randomized and multiple observational trials) all showing dramatic benefits of Ivermectin,” he said. Then she wrote: “AP’S ASSESSMENT: False. There’s no evidence Ivermectin has been proven a safe or effective treatment against COVID-19.” Like many critics, she didn’t explore the Ivermectin data or evidence in any detail, but merely dismissed its “insufficient evidence,” quoting instead the lack of a recommendation by the NIH or WHO. To describe the real evidence in any detail would put the AP and public health agencies in the difficult position of explaining how the lives of thousands of poor people in developing countries don’t count in these matters.

Not just in media but in social media, Ivermectin has inspired a strange new form of Western and pharmaceutical imperialism. On January 12, 2021, the Brazilian Ministry of Health tweeted to its 1.2 million followers not to wait with COVID-19 until it’s too late but “go to a Health Unit and request early treatment,” only to have Twitter take down the official public health pronouncement of the sovereign fifth largest nation in the world for “spreading misleading and potentially harmful information.” (Early treatment is code for Ivermectin.) On January 31, the Slovak Ministry of Health announced its decision on Facebook to allow use of Ivermectin, causing Facebook to take down that post and removed the entire page it was on, the Ivermectin for MDs Team, with 10,200 members from more than 100 countries.

In Argentina, Professor and doctor Hector Carvallo, whose prophylactic studies are renowned by other researchers, says all his scientific documentation for Ivermectin is quickly scrubbed from the Internet. “I am afraid,” he wrote to Marik and his colleagues, “we have affected the most sensitive organ on humans: the wallet…” As Kory’s testimony was climbing toward nine million views, YouTube, owned by Google, erased his official Senate testimony, saying it endangered the community. Kory’s biggest voice was silenced.

[…]

Via https://www.nakedcapitalism.com/2021/05/i-dont-know-of-a-bigger-story-in-the-world-right-now-than-ivermectin-ny-times-best-selling-author.html

Pfizer Skipped Critical Testing and Cut Corners on Quality Standards

By  Megan Redshaw

New documents obtained by TrialSite News suggest routine quality testing issues were overlooked in the rush to authorize use of the Pfizer COVID vaccine.

New documents obtained by TrialSite News suggest routine quality testing issues were overlooked in the rush to authorize use of the Pfizer/BioNTech COVID vaccine, and that U.S. and other governments are conducting a massive vaccination program with an incompletely characterized experimental vaccine.

Regulatory documents revealed Pfizer didn’t thoroughly examine biodistribution and pharmacokinetics issues relating to its vaccine before submitting the vaccine to the European Medicines Agency (EMA) for review.

In fact, in key studies — called biodistribution studies, which are designed to test where an injected compound travels in the body, and which tissues or organs it accumulates in  — Pfizer did not use the commercial vaccine (BNT162b2) but instead relied on a “surrogate” mRNA that produced the luciferase protein.

According to TrialSite News, the EMA reviewers shared this explicit admission: “No traditional pharmacokinetic or biodistribution studies have been performed with the vaccine candidate BNT162b2.”

Pharmacokinetics refers to the study of what the body does with a drug and the drug’s  movement throughout the body — the time course of its absorption, bioavailability, distribution, metabolism and excretion.

Regulatory documents also show Pfizer did not follow industry-standard quality management practices during preclinical toxicology studies of its vaccine, as key studies did not meet good laboratory practice (GLP).

Good laboratory practice or GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies used as the basis for research or marketing permits for products regulated by government agencies. The term GLP is most commonly associated with the pharmaceutical industry and the required non-clinical animal testing that must be performed prior to approval of new drug products.

 “The implications of these findings are that Pfizer was trying to accelerate the vaccine development timeline based on the pressures of the pandemic,” said TrialSite founder and CEO Daniel O’Connor. “The challenge is that the processes, such as Good Laboratory Practices, are of paramount importance for quality and ultimately for patient safety. If such important steps are skipped, the risk-benefit analysis would need to be compelling.”

O’Connor pointed to the example of generic repurposed drugs that when under evaluation, even if they are approved, must go through “ever more studies to prove their worth.” Yet in the case of the Pfizer vaccine, O’Connor said, “Pfizer was given more discretion even with a radically new life science-based technology.”

According to TrialSite News, it’s standard practice for the EMA to disclose its assessment of investigational new drug submissions. In the case of Pfizer’s vaccine, the EMA assessment included a summary of the agency’s evaluation of the non-clinical vaccine distribution studies reported to EMA by Pfizer — but the EMA did not disclose the results of Pfizer’s biodistribution studies in its public EMA summary.

Studies submitted to the EMA were carried out using two methods: use of mRNA that produces the luciferase protein and use of a radioactive label to mark the mRNA.

The studies revealed the majority of radioactivity initially remained near the injection site. But within hours, a subset of the stabilized mRNA-containing particles became widely distributed throughout the bodies of test animals.

Rapporteur Filip Josephson, (a person appointed by an organization to report on the proceedings of its meetings) and Co-Rapporteur Jean-Michael Race suggested Pfizer used “a qualified LC-MS/MS method to support quantitation of the two novel LNP excipients” and “the bioanalysis methods appear to be adequately characterized and validated for use in the GLP studies.”

However, the studies performed and submitted by Pfizer were non-GLP.

Additionally, the EMA document states, “Biodistribution: Several literature reports indicate that LNP-formulated RNAs can distribute rather nonspecifically to several organs such as spleen, heart, kidney, lung and brain. In line with this, results from the newly transmitted study 185350 indicate a broader biodistribution pattern.”

This EMA observation corresponds with a growing number of adverse events and aligns with data TrialSite obtained through FOIA showing concentrations of LNP-formulated RNAs in the spleen, ovaries, other tissues and organs.

[…]

Via https://childrenshealthdefense.org/defender/pfizer-skipped-critical-testing-quality-standards-covid-vaccine/