MCViewPoint

Opinion from a Libertarian ViewPoint

Posts Tagged ‘FDA’

Fauci Flips On Boosters, Now Says It’s Not A ‘Mistake’ For FDA To Limit Recommendations | The Daily Caller

Posted by M. C. on September 22, 2021

On Sunday, Fauci appeared to backtrack on CNN – and anchor Jake Tapper called him out on it.

Does Tapper still have a job?

https://dailycaller.com/2021/09/19/fauci-boosters-fda-limit-recommendations/

Shelby Talcott

White House chief medical adviser Dr. Anthony Fauci said Sunday it isn’t a “mistake” for the Food and Drug Administration (FDA) to limit booster recommendations, but his comments on the subject differed just days ago.

The FDA’s Vaccines and Related Biological Products Advisory Committee voted against approving boosters for all Americans aged 16 and over on Friday. The panel instead approved the booster only for Americans aged 65 and older as well as those at risk of serious illness from the virus.

The decision was a loss for President Joe Biden’s administration, as officials had originally claimed the booster shot would be available to all Americans mid-September, pending FDA approval. Fauci was pushing approval for the booster shots as recently as Wednesday when he told KHN that “there’s very little doubt that the boosters will be beneficial.” (RELATED: Top Health Officials Tell White House To Pause Vaccine Booster Plan: REPORT)

“If they say, ‘We don’t think there’s enough data to do a booster,’ then so be it. I think that would be a mistake, to be honest with you,” Fauci said at the time.

On Sunday, Fauci appeared to backtrack on CNN – and anchor Jake Tapper called him out on it. Tapper highlighted Fauci’s recent comments, noting he said it “would be a mistake” and wondering if now he was saying he doesn’t “think it was a mistake.”

“No, I mean, I – you know, what I was saying that mistake, my own personal looking at this, again, just because I look at the data and say I would do it this way, that’s the reason why we have qualified groups of people who together as a committee examine all the data and make a decision,” Fauci responded. “So I have no problem at all with their decision. The thing that I’m saying is that data will continue to come in and I believe you’re going to see an evolution of this process as we go on in the next several weeks to months.”

WATCH:

Fauci continued on to say it’s “entirely conceivable” that, in order to protect against COVID-19, “the proper regimen … would be more than just the prime and the boost followed by three to four weeks.”

“That it might actually entail a third boost,” he said. “That is entirely conceivable because, remember, Jake, when we did the initial studies what we did was we had to move very, very quickly because we were dealing – and still are – with an emergency situation.”

Be seeing you

Posted in Uncategorized | Tagged: , , | Leave a Comment »

Watch “Fauci: ‘Wanna Fly? Take The Shot!'” on YouTube

Posted by M. C. on September 21, 2021

With Fauci’s strong endorsement, the White House is reportedly giving serious consideration to a “no shot, no fly” rule to prohibit Americans who have not taken the covid shot from traveling by air within the United States. Will Biden destroy civilian air travel to punish those who do not want his preferred medical treatment? Also today, former FDA chief admits that the “six foot” social distancing rule was not “the science” but in fact made up out of thin air. And: Biden’s antibodies war on Texas and Florida.

https://youtu.be/f0trUdRAqQA

Be seeing you

Posted in Uncategorized | Tagged: , , , | Leave a Comment »

A Legacy of Corruption in the FDA and Big Pharma | Mises Wire

Posted by M. C. on September 14, 2021

  • Moderna has never developed an approved drug, yet one of their board members was placed in charge of Operation Warp Speed. This certainly is unrelated to the fact that they received the most federal vaccine research and development funding and have received over $6 billion from our government since the start of the pandemic.
  • https://mises.org/wire/legacy-corruption-fda-and-big-pharma

    Liam Cosgrove

    Our healthcare system is broken, a fact nobody would have disputed in precovid days. Regulatory capture is a reality, and the pharmaceutical industry is fraught with examples. Yet we trusted private-public partnerships to find an optimal solution to a global pandemic, assuming a crisis would bring out the best in historically corrupt institutions.

    Here is a brief list of less-than-savory behavior demonstrated by our titans of healthcare: 

    • Pfizer and Johnson & Johnson plead guilty to “misbranding with the intent to defraud or mislead” and paying “kickbacks to health care providers to induce them to prescribe [their] drugs,” resulting in fines of $2.3 billion in 2009 and $2.2 billion in 2013, respectively. 
    • Pfizer settled another lawsuit for “manipulating studies” and “suppressing negative findings” just a few years later. 
    • Moderna has never developed an approved drug, yet one of their board members was placed in charge of Operation Warp Speed. This certainly is unrelated to the fact that they received the most federal vaccine research and development funding and have received over $6 billion from our government since the start of the pandemic.
    • Gilead Sciences paid $97 million in fines, because it “illegally used a non-profit foundation as a conduit to pay the Medicare co-pays for its own drug.”
    • In 2005, AstraZeneca’s drug Crestor was shown to be linked to a life-threatening muscle disease while the company withheld evidence of this and two dozen other effects from the public.
    • In 2012, GlaxoSmithKline paid $3 billion in fines, as it “failed to include certain safety data” relating to their drug, since labeled as connected to heart failure and attacks.

    Thankfully, our public health guardians are in place to protect us from the greed and deceit of the private sector, right? Wrong. Enjoy another brief list:

    • The Food and Drug Administration (FDA) worked behind the scenes with company Biogen to alter previously conducted trials of their $56,000 per year Alzheimer’s treatment, and “by removing the subset of people for whom the drug didn’t work, they found a slight statistical effect in favor of the drug.” Even after doing this, an advisory committee voted 10–0 against approving the drug. The FDA approved the drug anyway, causing three committee members to resign.
    • In that case, the third-party advisors did the right thing. This is not always the case: a study by Science Magazine tracking 107 FDA advisors for four years found that 62 percent received money from related drug makers, with 25 percent receiving over $100,000 and 6 percent receiving over $1 million. It only takes a few corrupt advisors to fix a panel and feign medical consensus.
    • In 2017, it was revealed that the acting Centers for Disease Control and Prevention (CDC) director for heart disease and stroke prevention had been secretly communicating with Coca-Cola, providing guidance on how “to influence world health authorities on sugar and beverage policy matters.”

    The American healthcare system remains mired in good old-fashioned crony capitalism, fascism, corporatism, mercantilism, protectionism … fancy words for when private companies work with governments to subvert the forces of competition. The suppression of research into off-patent drugs is a nasty symptom of this problem.

    While there are countless drugs to which this applies, we will discuss ivermectin. First, addressing the drug’s dismissal by its own manufacturer, Merck, let it be known that ivermectin is no longer under patent. Merck no longer owns exclusive rights to the drug’s production. The forces of competition have been bestowed upon the drug, thus making it far cheaper. Meanwhile, Merck is also currently rolling out an oral covid treatment, which the US government is providing $1.2 billion in funding to research. This would be under patent and may explain the company’s opposition to using ivermectin.

    The usefulness of ivermectin remains debatable. However, it’s important to note that in early April 2020,  a study at the University of Monash in Australia suggested it can be effective. Moreover, the drug is FDA approved, has existed for forty years, won a Nobel Prize, and is extremely safe when used at recommended levels. Given the crisis and ivermectin’s safety—safe even if not conferring big benefits for covid sufferers—the rush to condemn use of the drug appears suspect. Indeed, a week after the Australian study was published, the FDA advised against using ivermectin for COVID-19 treatment, forcing desperate people to the black market and to self-prescribe versions of the drug intended for animals.

    The FDA noted subsequently that “additional testing is needed.” Yet, to date, there has not been a single completed government-funded study on the effectiveness of ivermectin against covid-19. Meanwhile, they have funneled billions toward research into vaccines and patented treatments. The National Institutes of Health (NIH) funded trials for remdesivir, still under patent with Gilead, despite it being less effective and having more severe side effects than ivermectin. The FDA approved remdesivir under emergency use authorization (EUA) despite published trials, later stating “remdesivir was not associated with statistically significant clinical benefits.”

    One would think that if “additional testing” is so important, the US government might be interested in funding research to examine the potential benefits of cheap, safe, and proven drugs that have shown some promise in treating covid. But that’s clearly not what going on. Funding is geared toward helping huge pharmaceutical companies develop new patented drugs. As long Big Pharma wants it, and if there’s a profit to be made, apparently our government will be there to provide funding. Author:

    Liam Cosgrove

    Be seeing you

    Posted in Uncategorized | Tagged: , , , , | 2 Comments »

    Scandal Behind the FDA Fake Approval of Pfizer Jab

    Posted by M. C. on September 10, 2021

    There is no control group after Pfizer offered the product to placebo participants before the trials were completed.” Read that again, slowly. Pfizer tests destroyed their own control group mid-stream! And its six month rollout of the mRNA jab worldwide has resulted in catastrophic side effects which have been totally officially ignored. Is this “science” Dr Fauci?

    US vaccinologist and a developer of the mRNA technique, Dr Robert Malone, has accused the FDA of playing a “bureaucratic shell game” with their supposed early approval of the Pfizer Covid-19 vaccine. He cites the two separate FDA letters, “There is a letter for Pfizer and a letter for BioNTech. The New York Times and the Washington Post got it wrong. The authorization is not for Pfizer. The authorization is for BioNTech, and it will only be initiated at the time BioNTech product becomes available…”

    http://www.williamengdahl.com/englishNEO30August2021.php

    By F. William Engdahl

    Scandal Behind the FDA Fake Approval of Pfizer Jab

    Image: Janet Woodcock M.D. ACTING COMMISSIONER OF FOOD AND DRUGS – FOOD AND DRUG ADMINISTRATIONAttribution: Credit: US FOOD AND DRUG ADMINISTRATION. Unless otherwise noted, the contents of the FDA website (www.fda.gov) — both text and graphics — are not copyrighted. They are in the public domain and may be republished, reprinted and otherwise used freely by anyone without the need to obtain permission from FDA. Credit to the U.S. Food and Drug Administration as the source is appreciated but not required. https://www.fda.gov/about-fda/fda-organization/janet-woodcock

    The US Government regulator for drugs, the Food and Drug Administration, has just announced that it has voted full approval for the mRNA genetic vaccine of Pfizer and BioNTech, or did they? This supposed new status is being used by the Biden Administration and many states and companies to impose mandatory vaccinations. The notoriously conflicted Biden covid adviser, Tony Fauci of the NIAID, using that ruling, is calling for national mandatory vaccination for the country. What is not being revealed is the cesspool of corruption and conflicts of interest between the FDA and the major drug companies, including Pfizer, that stand behind the rushed approval. And it’s not full approval for Pfizer’s jab, only for BioNTech’s legally different vaccine. .

    “…final stamp of approval”?

    On August 23 as the FDA announced full approval for the Pfizer mRNA gene-edited substance. Or not quite, when the full papers of FDA are studied. Fauci, whose NIAID has financial interest in the vaccine, referred to the FDA decision as the “final stamp of approval.” It is however anything but final or an impartial, scientific rigorous medical evaluation. Rather it is a politically-motivated decision by an FDA that is corrupt beyond the imagination of most people.

    Backtracking on its statement in 2020 that it would hold normal FDA advisory committee hearings with independent experts to discuss the Pfizer application for full approval, now the FDA told the British Medical Journal that they did not believe a meeting was necessary ahead of granting full approval of what is the most controversial vaccine in modern history. The BMJ quotes Kim Witczak, a drug safety advocate who serves as a consumer representative on the FDA’s Psychopharmacologic Drugs Advisory Committee, “These [FDA] public meetings are imperative in building trust and confidence especially when the vaccines came to market at lightning speed under emergency use authorization.”

    Witczak continued with the alarming note, “It is already concerning that full approval is being based on 6 months’ worth of data despite the clinical trials designed for two years. There is no control group after Pfizer offered the product to placebo participants before the trials were completed.” Read that again, slowly. Pfizer tests destroyed their own control group mid-stream! And its six month rollout of the mRNA jab worldwide has resulted in catastrophic side effects which have been totally officially ignored. Is this “science” Dr Fauci?

    The refusal of the FDA and its Acting Director, Janet Woodcock, to convene its Drugs Advisory Committee for discussion of the Pfizer and BioNTech decisions is even more shocking as in June three members of that same panel resigned in protest for being disregarded in another drug approval. NPR network reported, “Three experts have now resigned from a Food and Drug Administration advisory committee after the agency approved an Alzheimer’s drug called Aduhelm against the wishes of nearly every member on the panel.” One of the three, Dr. Aaron Kesselheim, in his resignation letter from the FDA Advisory Committee (June 10, 2021), wrote: “For both eteplirsen and aducanumab, the decisions by FDA administrators to ignore the Advisory Committee’s clear recommendations led to their approval of two highly problematic drugs that offered little evidence that they would meaningfully benefit patients…With eteplirsen, the AdComm (Advisory Committee) and FDA’s own scientific staff reported that there was no convincing evidence that the drug worked; both groups were overruled by FDA leadership… “

    Now the FDA refusal to convene their advisory committee for the Pfizer decision is all the more astonishing in light of the fact that the Government Centers for Disease Control (CDC) in its official VAERS data bank for recording vaccine negative effects has recorded 8,508 reports of fatalities following the Pfizer mRNA shot in the past seven months, a number more than for all vaccines combined in the past 30 years. By denying a public hearing the FDA avoided any discussion of these alarming fatality numbers, let alone the tens of thousands of serious side-effects including heart attacks, blood clots, miscarriages, permanent paralysis following the Pfizer-BioNTech jabs. The public declaration by Fauci before approval that he expected it, is also unethical influencing, but that is the least of the crimes.

    Faked Approval

    It seems the FDA executed a clever ruse in which it issued separate rulings for a Pfizer Inc.-BioNTech vaccine which is widely used in the USA, and another ruling for the similar vaccine of Pfizer’s German-based partner and developer of the mRNA platform, BioNTech of Mainz. It is only BioNTech that got FDA approval, but conditioned on completion of a series of further tests on select groups including infants, pregnant women and youth, by 2027. The US vaccine, Pfizer-BioNTech Covid-19 vaccine, only got extension of its Emergency Use Authorization (EUA), not full approval!

    In their separate letter to Pfizer, the FDA stated, “…On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter of (Emergency Use) authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses…”(emphasis added).

    Buried in a footnote in the letter the FDA admits there are two legally separate entities and vaccines—Pfizer-BioNTech Covid-19 Vaccine and BioNTech GmbH of Mainz with its own vaccine trade-named Comrinaty. The FDA writes that “The products are legally distinct with certain differences…” Legally distinct means two separate vaccines. If you find this confusing it is meant to be. Only under an EUA ruling is Pfizer presently exempt from vaccine liability. Some lawyers are calling the FDA ruse a classic “bait and switch” tactic, a form of fraud based on deception.

    US vaccinologist and a developer of the mRNA technique, Dr Robert Malone, has accused the FDA of playing a “bureaucratic shell game” with their supposed early approval of the Pfizer Covid-19 vaccine. He cites the two separate FDA letters, “There is a letter for Pfizer and a letter for BioNTech. The New York Times and the Washington Post got it wrong. The authorization is not for Pfizer. The authorization is for BioNTech, and it will only be initiated at the time BioNTech product becomes available…”

    Adding to the bizarre irregularities, in their two separate letters, one to BioNTech and another to Pfizer, the FDA repeatedly deletes the location of the vaccine manufacturing they approve. Why that? Is it in China where BioNTech has a joint agreement with Fosun Pharma of Shanghai to jointly produce and market Comirnaty vaccine for COVID-19? Why do they need to hide that location data from the public? Would it expose the entire fraud?

    FDA-Pfizer Conflicts of Interest

    In 2019 Pfizer made a very conflicted appointment to its board of directors. It took Scott Gottlieb, who had just resigned as head of the FDA three months earlier. If this gives an appearance of a huge conflict of interest, it is. Alongside Gottlieb at Pfizer’s Board of Directors sits Dr Susan Desmond-Hellmann, who headed the Bill and Melinda Gates Foundation until 2020. The Gates Foundation is behind every single key part of the covid vaccine rush and owns stock in Pfizer to boot.

    Another person who links Pfizer and Gates is Prof. Holly Janes, a bio-statistical expert in Gates’ hometown Seattle, at the Fred Huff cancer research center. Janes is also a member of the FDA Vaccine Committee until 2023. Notably, she co-designed the controversial trials for both Pfizer and Moderna mRNA vaccines for Fauci’s NIAID from her Seattle center, which is also funded by the Gates Foundation.

    Janes is Professor at the Fred Hutchinson Cancer Research Center, Vaccine and Infectious Disease Division, known as Fred Hutch. Earlier she received Gates Foundation research money for a six year period when she worked for the Gates Foundation from 2006 to 2012 to develop “statistical and study design support for pre-clinical vaccine performance trials.” Prof. Janes also helped develop the program that tracks vaccine data at John Hopkins University.

    The person who runs FDA as “Acting Director” is Janet Woodcock. To call her tainted is mild. She has been at FDA since 1986, almost as long as Fauci at NIAID. Woodcock was Biden’s choice to head FDA, but a massive opposition from 28 groups including state attorneys general and citizen groups forced him to name her “acting,” which does not need Congressional scrutiny.

    Woodcock was directly responsible for the FDA approval of deadly opioids over the objections of her own scientists and other advisors. Two decades ago as head of the FDA unit responsible, Woodcock was instrumental in the approval of a powerful opioid, Zohydro, even though the FDA’s own scientific advisory committee voted 11-2 to keep the drug off the market because it was unsafe. The online Drugs.com writes, “Hydrocodone (Zohydro) can slow or stop your breathing. Never use Zohydro ER in larger amounts, or for longer than prescribed. .. Swallow it whole to avoid exposure to a potentially fatal dose. Hydrocodone may be habit-forming, even at regular doses.” Woodcock later approved the sale of a high-strength narcotic pill, OxyContin, as “safer and more effective than other painkillers” based on the false claims of the now bankrupt manufacturer, Purdue Pharma. Some 500,000 Americans have since died as a result of opioid addiction.

    Woodcock clearly is the key FDA person behind the duplicitous August 23 Pfizer decision, seeing to it that there were no public advisory hearings to review relevant data. It would be relevant to know what discussions or communications went on with her former boss, now Pfizer director, Scott Gottlieb.

    Why?

    There are many unanswered questions in this twisted tale of corruption at FDA and Pfizer. Was this theater rushed through by the Biden Administration to accelerate the forced vaccination of millions of Americans uncertain or skeptical of taking an emergency or experimental jab? Why is there such an incredible pressure from mainstream media and politicians to vaccinate every man, woman and now child in the US? Are the vaccines really safe if there are so many dire cases of adverse events after the Pfizer jab? Why did the FD refuse to allow its independent vaccine committee to weigh in?

    It is worth noting that as of August 14 Pfizer does not mandate vaccines for its own employees. Also the Biden White House does not mandate vaccines for its staff. These are all serious issues that demand serious and honest answers.

    F. William Engdahl is strategic risk consultant and lecturer, he holds a degree in politics from Princeton University and is a best-selling author on oil and geopolitics, exclusively for the online magazine “New Eastern Outlook”

    Be seeing you

    Posted in Uncategorized | Tagged: , , , | Leave a Comment »

    Regulatory Capture in the Age of COVID-19 – Liam’s Blog

    Posted by M. C. on September 1, 2021

    https://williamcosgroveblog.wordpress.com/2021/08/28/regulatory-capture-in-the-age-of-covid-19/

    By Liam Cosgrove (https://twitter.com/cosgrove_iv)

    Our healthcare system is broken, a fact nobody would have disputed in pre-COVID days. Regulatory capture is a reality, and the pharmaceutical industry is fraught with examples. Yet we trusted private-public partnerships to find an optimal solution to a global pandemic, assuming a crisis would bring out the best in historically corrupt institutions.

    Here is a brief list of less-than-savory behavior demonstrated by our titans of healthcare: 

    • Pfizer and J&J plead guilty to “misbranding with the intent to defraud or mislead” and paying “kickbacks to health care providers to induce them to prescribe [their] drugs”, resulting in fines of $2.3 billion in 2009 and $2.2 billion in 2013, respectively. 
    • Pfizer settled another lawsuit for “manipulating studies” and “suppressing negative findings” just a few years later. 
    • Moderna has never developed an approved drug yet one of their board members was placed in charge of Operation Warp Speed. This certainly is unrelated to the fact that they received the most federal vaccine R&D funding and have received over $6 billion from our government since the start of the pandemic.
    • Gilead Sciences paid $97 million in fines because it “illegally used a non-profit foundation as a conduit to pay the Medicare co-pays for its own drug”.
    • In 2005, AstraZeneca’s drug Crestor was shown to be linked to a life-threatening muscle disease while the company withheld evidence of this and two dozen other effects from the public.
    • In 2012, GlaxoSmithKline paid $3 billion in fines as it “failed to include certain safety data” relating to their drug, since labeled to be connected to heart failure and attacks.

    Thankfully our public health guardians are in place to protect us from the greed and deceit of the private sector, right? Wrong. Enjoy another brief list:

    • FDA worked behind the scenes with company Biogen to alter previously conducted trials of their $56,000 per year Alzheimer’s treatment, and “by removing the subset of people for whom the drug didn’t work, they found a slight statistical effect in favor of the drug.” Even after doing this, an advisory committee voted 10-0 against approving the drug. The FDA approved the drug anyways, causing three committee members to resign.
    • In that case, the third-party advisors did the right thing. This is not always the case… A study by Science Magazinetracking 107 FDA advisors for four years, found that 62% received money from related drug makers with 25% receiving over $100k and 6% receiving over $1 million. It only takes a few corrupt advisors to fix a panel and feign medical consensus.
    • The WHO has come to be dominated by China over the last 17 years by bribing poor nations and altering the organization’s voting structure to ensure their candidates obtain high positions (most notablydirector-general). The WHO parroted false claims made by the CCP in Jan 2020 that COVID-19 had “no clear evidence of human-to-human transmission” (still on Twitter!), despite receiving contrary evidence from Taiwanese health monitors in December 2019 and during which time Chinese hospitals were overrun, requiring mass disinfections across villages:

    See the rest here

    Posted in Uncategorized | Tagged: , , , , , , | Leave a Comment »

    2 Things Mainstream Media Didn’t Tell You About FDA’s Approval of Pfizer Vaccine • Children’s Health Defense

    Posted by M. C. on August 26, 2021

    Second, the FDA pointed out that the licensed Pfizer Comirnaty vaccine and the existing, EUA Pfizer vaccine are “legally distinct,” but proclaims that their differences do not “impact safety or effectiveness.”

    There is a huge real-world difference between products approved under EUA compared with those the FDA has fully licensed.

    And because adults injured by the vaccine will be able to show that the manufacturer knew of the problems with the product, jury awards could be astronomical.

    Pfizer is therefore unlikely to allow any American to take a Comirnaty vaccine until it can somehow arrange immunity for this product.

    https://childrenshealthdefense.org/defender/mainstream-media-fda-approval-pfizer-vaccine/

    By  Robert F. Kennedy, Jr. Meryl Nass, M.D.

    Buried in the fine print of Monday’s approval by the U.S. Food and Drug Administration of the Pfizer Comirnaty COVID vaccine are two critical facts that affect whether the vaccine can be mandated, and whether Pfizer can be held liable for injuries.

    The Defender is experiencing censorship on many social channels. Be sure to stay in touch with the news that matters by subscribing to our top news of the day. It’s free.

    Monday, the U.S. Food and Drug Administration (FDA) approved a biologics license application for the Pfizer Comirnaty vaccine.

    The press reported that vaccine mandates are now legal for military, healthcare workers, college students and employees in many industries. New York City Mayor Bill de Blasio has now required the vaccine for all teachers and school staff. The Pentagon is proceeding with its mandate for all military service members.

    But there are several bizarre aspects to the FDA approval that will prove confusing to those not familiar with the pervasiveness of the FDA’s regulatory capture, or the depths of the agency’s cynicism.

    First, the FDA acknowledges that while Pfizer has “insufficient stocks” of the newly licensed Comirnaty vaccine available, there is “a significant amount” of the Pfizer-BioNTech COVID vaccine — produced under Emergency Use Authorization (EUA) — still available for use.

    The FDA decrees that the Pfizer-BioNTech vaccine under the EUA should remain unlicensed but can be used “interchangeably” (page 2, footnote 8) with the newly licensed Comirnaty product.

    Second, the FDA pointed out that the licensed Pfizer Comirnaty vaccine and the existing, EUA Pfizer vaccine are “legally distinct,” but proclaims that their differences do not “impact safety or effectiveness.”

    There is a huge real-world difference between products approved under EUA compared with those the FDA has fully licensed.

    EUA products are experimental under U.S. law. Both the Nuremberg Code and federal regulations provide that no one can force a human being to participate in this experiment. Under 21 U.S. Code Sec.360bbb-3(e)(1)(A)(ii)(III), “authorization for medical products for use in emergencies,” it is unlawful to deny someone a job or an education because they refuse to be an experimental subject. Instead, potential recipients have an absolute right to refuse EUA vaccines.

    U.S. laws, however, permit employers and schools to require students and workers to take licensed vaccines.

    EUA-approved COVID vaccines have an extraordinary liability shield under the 2005 Public Readiness and Preparedness Act. Vaccine manufacturers, distributors, providers and government planners are immune from liability. The only way an injured party can sue is if he or she can prove willful misconduct, and if the U.S. government has also brought an enforcement action against the party for willful misconduct. No such lawsuit has ever succeeded.

    The government has created an extremely stingy compensation program, the Countermeasures Injury Compensation Program, to redress injuries from all EUA products. The program’s parsimonious administrators have compensated under 4% of petitioners to date — and not a single COVID vaccine injury — despite the fact that physicians, families and injured vaccine recipients have reported more than 600,000 COVID vaccine injuries.

    At least for the moment, the Pfizer Comirnaty vaccine has no liability shield. Vials of the branded product, which say “Comirnaty” on the label, are subject to the same product liability laws as other U.S. products.

    When the Centers for Disease Control and Prevention’s (CDC) Advisory Committee for Immunization Practices places a vaccine on the mandatory schedule, a childhood vaccine benefits from a generous retinue of liability protections.

    But licensed adult vaccines, including the new Comirnaty, do not enjoy any liability shield. Just as with Ford’s exploding Pinto, or Monsanto’s herbicide Roundup, people injured by the Comirnaty vaccine could potentially sue for damages.

    And because adults injured by the vaccine will be able to show that the manufacturer knew of the problems with the product, jury awards could be astronomical.

    Pfizer is therefore unlikely to allow any American to take a Comirnaty vaccine until it can somehow arrange immunity for this product.

    Given this background, the FDA’s acknowledgement in its approval letter that there are insufficient stocks of the licensed Comirnaty, but an abundant supply of the EUA Pfizer BioNTech jab, exposes the “approval” as a cynical scheme to encourage businesses and schools to impose illegal jab mandates.

    The FDA’s clear motivation is to enable Pfizer to quickly unload inventories of a vaccine that science and the Vaccine Adverse Events Reporting System have exposed as unreasonably dangerous, and that the Delta variant has rendered obsolete.

    They know they can’t win this argument on the science and that’s why they had to abolish the public process and independent oversight.

    SIGN UP #TheDefender: https://t.co/zL66Edfiw5https://t.co/b6oj4bmnEo

    — Robert F. Kennedy Jr (@RobertKennedyJr) August 23, 2021

    Americans, told that the Pfizer COVID vaccine is now licensed, will understandably assume COVID vaccine mandates are lawful. But only EUA-authorized vaccines, for which no one has any real liability, will be available during the next few weeks when many school mandate deadlines occur.

    The FDA appears to be purposefully tricking American citizens into giving up their right to refuse an experimental product.

    While the media has trumpeted that the FDA has approved COVID vaccines, the FDA has not approved the Pfizer BioNTech vaccines, nor any COVID vaccines for the 12- to 15-year age group, nor any booster doses for anyone.

    And the FDA has not licensed any Moderna vaccine, nor any vaccine from Johnson & Johnson — so the vast majority, if not all, of vaccines available in the U.S. remain unlicensed EUA products.

    Here’s what you need to know when somebody orders you to get the vaccine: Ask to see the vial. If it says “Comirnaty,” it’s a licensed product.

    If it says “Pfizer-BioNTech,” it’s an experimental product, and under 21 U.S. Code 360bbb, you have the right to refuse.

    If it comes from Moderna or Johnson & Johnson (marketed as Janssen), you have the right to refuse.

    The FDA is playing bait and switch with the American public — but we don’t have to play along. If it doesn’t say Comirnaty, you have not been offered an approved vaccine.

    Robert F. Kennedy, Jr.'s avatar

    Robert F. Kennedy, Jr.

    Robert F. Kennedy, Jr.’s reputation as a resolute defender of the environment stems from a litany of successful legal actions.

    Meryl Nass, M.D.'s avatar

    Meryl Nass, M.D.

    Meryl Nass, MD, ABIM, is an internist with special interests in vaccine-induced illnesses, chronic fatigue syndrome, Gulf War illness, fibromyalgia and toxicology.

    Be seeing you

    Posted in Uncategorized | Tagged: , , , , , | Leave a Comment »

    100 Million Vaccine-Hesitant Americans Will Get The Shot Now That A Government Agency Said It’s OK

    Posted by M. C. on August 25, 2021

    https://babylonbee.com/news/100-million-vaccine-hesitant-americans-will-get-the-shot-now-that-a-government-agency-said-its-ok

    U.S.—100 million Americans who were previously hesitant to get vaccinated are rejoicing today after the FDA approved it, proving that everything is totally safe. 

    According to sources, the Food and Drug Administration is completely trustworthy and has never approved harmful drugs for the public before. Those sources further confirmed that the FDA is a part of the government, which has never lied or been incompetent or corrupt in any way. 

    “Yeah, I’ve always trusted the government and drug companies, so I guess I’m ok to get the vaccine now,” said Bubba Snugglebrugg, who was previously a militant anti-vaxxer. “I can’t wait to get my ‘Fauci Ouchie’ and wear my Pfizer sticker! Thanks, FDA!”

    Sources within the FDA say the vaccine went through a rigorous approval process of various government bureaucrats saying “Oh well, what the heck—we may as well approve this now”, and signing a very important-looking document with a government seal and some big words on it. 

    “That’s good enough for me!” said Snugglebrugg. 

    Bee seeing you

    Posted in Uncategorized | Tagged: | Leave a Comment »

    Fauci: ‘I Respect People’s Freedom But…’

    Posted by M. C. on August 24, 2021

    In the wake of yesterday’s FDA approval of the Pfizer shot, Biden’s Covid advisor Anthony Fauci has blasted back onto the television screens, screeching that while he likes freedom there are times we must give up freedom…and take the shot! Meanwhile Biden is demanding that the private sector turn into the shot police and install mandates on their workers and customers. As Afghanistan unravels, is this dramatic ramping up of authoritarianism at home meant to be a distraction?

    Be seeing you

    Posted in Uncategorized | Tagged: , , | Leave a Comment »

    Here Come The Mandates: FDA Approves Covid Shot

    Posted by M. C. on August 23, 2021

    CDC flip/flops/flips on masks, the new religion.

    Australia kills rescue dogs to keep people from leaving homes.

    The Food and Drug Administration has just approved the Pfizer covid shot, paving the way for the roll-out of vaccine mandates across the public and private sector. Will there be push-back? Also today, the FBI shoots down Jan 6th “insurrection” myth and former head of CIA and NSA calls for unvaccinated Trump supporters to be sent to Afghanistan to be killed…

    Be seeing you

    Posted in Uncategorized | Tagged: , , , , , | Leave a Comment »

    US Investigates Moderna Jab After Data Show 2.5x Higher Risk Of Heart Inflammation | ZeroHedge

    Posted by M. C. on August 21, 2021

    https://www.zerohedge.com/covid-19/us-investigates-moderna-jab-after-data-show-25x-higher-risk-heart-inflammation

    Tyler Durden's Photoby Tyler Durden

    The Internet’s social-media censors have been extremely vigilant at suppressing every tidbit of COVID vaccine “misinformation” that comes their way. So, as readers might imagine, drawing attention to publicly released data about the rare (but sometimes deadly) side effects associated with both mRNA and adenovirus-vector jabs has been…a challenge.

    Hey @jack what happens to all those who were banned for warning about this?https://t.co/E9mFoFLqGS — zerohedge (@zerohedge) August 20, 2021

    But let’s back up: over the past couple of months, health authorities in the US and Israel connected rare instances of myocarditis – that is, inflammation of the heart – to the mRNA jabs produced by Pfizer and Moderna. After a hurried secret meeting with its advisors in late June, the FDA reluctantly released a warning about a “likely association” between incidences of myocarditis and the new side effects.

    And now, a new twist: On Thursday evening, the Washington Post published a report claiming that the Moderna coronavirus vaccine may be associated with a higher risk of myocarditis in younger adults than previously believed. The report relies on new data from a Canadian study that has yet to be released.

    How much more dangerous is the Moderna jab than the Pfizer? Well, the preliminary data leaked to WaPo show the risk of myocarditis might be as much as 2.5x higher for the Moderna jab.

    The news represents the latest bump in the road for Moderna’s high-flying stock, as patients (especially younger men in their 20s and 30s deemed at highest risk to suffer the side effect) now have an incentive to prefer Pfizer’s jab over Moderna’s (if they still have any confidence in the mRNA jabs at all, that is).

    WaPo’s sources stressed that the new research hasn’t yet been concluded, and that there’s still plenty of work to be done before the FDA decides whether to attach another warning label to the Moderna jabs. The sources also claimed that the new data “are not slam bang”.

    The investigation, which involves the Food and Drug Administration and the Centers for Disease Control and Prevention, is focusing on Canadian data that suggests the Moderna vaccine may carry a higher risk for young people than the Pfizer-BioNTech vaccine, especially for males below the age of 30 or so. The authorities also are scrutinizing data from the United States to try to determine whether there is evidence of an increased risk from Moderna in the U.S. population.

    The two people who described the investigation spoke on the condition of anonymity to discuss an ongoing review because they were not authorized to discuss it.

    One of the people familiar with the review emphasized it is too early to reach a conclusion. The person said the agencies must do additional work before deciding whether to issue any kind of new or revised warning or recommendation about the situation. In June, the FDA added a warning label for the Pfizer and Moderna shots — both known as mRNA vaccines — about increased risk of myocarditis.

    “We have not come to a conclusion on this,” one of the people familiar with the investigation said. “The data are not slam bang.”

    The FDA and CDC both said they’re looking into the data. To be sure, WaPo notes that the side effects remain “extremely rare” – or at least “very uncommon.” Probably…

    The myocarditis side effect is extremely rare and even if it is more likely in people receiving the Moderna vaccine, it probably is still very uncommon. Officials want to be careful not to cause alarm among the public, especially when officials are trying to persuade more people to be vaccinated amid a surge of cases fueled by the fast-moving delta variant.

    So far, the FDA and CDC’s official position is that the threat posed by COVID is far worse than any threat posed by vaccine side effects, and that all Americans over the age of 12 should get the jab. But as with any recent scientific judgment, there are others in the community who disagree – some who believe that the risk of side effects for young people might just outweigh the risk of harm from contracting COVID, which – as we have reviewed before – is virtually nil.

    “There might be a 2.5 times higher incidence of myocarditis in those who get the Moderna vaccine compared with Pfizer’s vaccine.” Any risk at all for young people under 17 is unacceptable https://t.co/vz1REfaaj8 — Sue Cook (@SueC00K) August 20, 2021

    The Internet’s social-media censors have been extremely vigilant at suppressing every tidbit of COVID vaccine “misinformation” that comes their way. So, as readers might imagine, drawing attention to publicly released data about the rare (but sometimes deadly) side effects associated with both mRNA and adenovirus-vector jabs has been…a challenge.
    Hey @jack what happens to all those who were banned for warning about this?https://t.co/E9mFoFLqGS
    — zerohedge (@zerohedge) August 20, 2021
    But let’s back up: over the past couple of months, health authorities in the US and Israel connected rare instances of myocarditis – that is, inflammation of the heart – to the mRNA jabs produced by Pfizer and Moderna. After a hurried secret meeting with its advisors in late June, the FDA reluctantly released a warning about a “likely association” between incidences of myocarditis and the new side effects.



    And now, a new twist: On Thursday evening, the Washington Post published a report claiming that the Moderna coronavirus vaccine may be associated with a higher risk of myocarditis in younger adults than previously believed. The report relies on new data from a Canadian study that has yet to be released.
    How much more dangerous is the Moderna jab than the Pfizer? Well, the preliminary data leaked to WaPo show the risk of myocarditis might be as much as 2.5x higher for the Moderna jab.
    The news represents the latest bump in the road for Moderna’s high-flying stock, as patients (especially younger men in their 20s and 30s deemed at highest risk to suffer the side effect) now have an incentive to prefer Pfizer’s jab over Moderna’s (if they still have any confidence in the mRNA jabs at all, that is).
    WaPo’s sources stressed that the new research hasn’t yet been concluded, and that there’s still plenty of work to be done before the FDA decides whether to attach another warning label to the Moderna jabs. The sources also claimed that the new data “are not slam bang”.
    The investigation, which involves the Food and Drug Administration and the Centers for Disease Control and Prevention, is focusing on Canadian data that suggests the Moderna vaccine may carry a higher risk for young people than the Pfizer-BioNTech vaccine, especially for males below the age of 30 or so. The authorities also are scrutinizing data from the United States to try to determine whether there is evidence of an increased risk from Moderna in the U.S. population.
    The two people who described the investigation spoke on the condition of anonymity to discuss an ongoing review because they were not authorized to discuss it.
    One of the people familiar with the review emphasized it is too early to reach a conclusion. The person said the agencies must do additional work before deciding whether to issue any kind of new or revised warning or recommendation about the situation. In June, the FDA added a warning label for the Pfizer and Moderna shots — both known as mRNA vaccines — about increased risk of myocarditis.
    “We have not come to a conclusion on this,” one of the people familiar with the investigation said. “The data are not slam bang.”
    The FDA and CDC both said they’re looking into the data. To be sure, WaPo notes that the side effects remain “extremely rare” – or at least “very uncommon.” Probably…
    The myocarditis side effect is extremely rare and even if it is more likely in people receiving the Moderna vaccine, it probably is still very uncommon. Officials want to be careful not to cause alarm among the public, especially when officials are trying to persuade more people to be vaccinated amid a surge of cases fueled by the fast-moving delta variant.
    So far, the FDA and CDC’s official position is that the threat posed by COVID is far worse than any threat posed by vaccine side effects, and that all Americans over the age of 12 should get the jab. But as with any recent scientific judgment, there are others in the community who disagree – some who believe that the risk of side effects for young people might just outweigh the risk of harm from contracting COVID, which – as we have reviewed before – is virtually nil.
    “There might be a 2.5 times higher incidence of myocarditis in those who get the Moderna vaccine compared with Pfizer’s vaccine.” Any risk at all for young people under 17 is unacceptable https://t.co/vz1REfaaj8
    — Sue Cook (@SueC00K) August 20, 2021

    Be seeing you

    Posted in Uncategorized | Tagged: , , , , | Leave a Comment »