FDA is trying to legalize its illegal approvals of COVID vaccines without human trials
Now one animal trial will do the trick to “prove” efficacy?

BY MERYL NASS | MARCH 26, 2024
You can’t prove efficacy with an animal trial. You can’t prove safety with an animal trial. The anthrax vaccine studies PROVED that even when a vaccine seemed to work in animals, it was unclear what the right dose was and equally unclear how antibody levels related to protection, because they didn’t. Maybe because no one knew which antibody to measure?
Surrogate markers for approval of vaccines (or anything else) became a total joke when FDA began ignoring the requirement that “correlates of protection” were a essential before you could use antibodies, T cells, animals or anything besides humans to assess a vaccine. This means that you have to prove the surrogate marker or animal model actually duplicates the human response, since usually they don’t.
FDA officials ditched this absolutely necessary standard (imho illegally) and now want to a) cover their tracks, and b) foist more untested and possibly deadly injections on us going forward.
Who needs them? They are simply a Potemkin Village of a regulatory agency at this point. Thankfully ICAN is watching.
With public faith in FDA continuing to decline, the agency published draft guidance stating that a single animal study could be sufficient to demonstrate a vaccine’s effectiveness. ICAN’s attorneys submitted a comment in opposition to this draft guidance which comes shortly after FDA approved a COVID-19 booster based on trials performed solely in mice.
Back in 2007, an FDA advisory committee met to re-review the safety, effectiveness, and dosing of phenylephrine (Sudafed PE), a drug which has been on the market for nearly 50 years. At the 2007 meeting, the committee considered its efficacy data “borderline” but nonetheless voted 11-1 in favor of its efficacy, although it did vote in favor of additional studies being done.
On September 12, 2023, the same FDA committee, possibly attempting to bolster its image as a tough regulatory watchdog, voted unanimously to label phenylephrine “ineffective” as a nasal decongestant. The committee noted “significant methodological and statistical issues with the design and conduct of the original studies submitted to and evaluated by the Panel… All but one evaluated extremely small sample sizes, none adequately controlled for bias … and none performed appropriate sample size calculations,” and observed, “After a thorough review of all the available evidence, it is also possible that there may have been bias and/or data integrity issues at [at] least one study center … where five of the seven positive oral PE studies were conducted.”
If FDA follows the panel’s advice, the drug will be pulled from the market, despite the long-standing indications of its inefficacy, most of which were known in 2007. It’s too bad the committee didn’t perform this “thorough review” at any point prior to the last 50 years, before Americans wasted billions of dollars on an ineffective treatment (nearly $2 billion in 2022 alone) that apparently only exposed them to potential harm without benefit.
Ironically, on September 11, 2023, just one day before the committee met to clamp down on this “ineffective drug” with shoddy clinical trials, FDA issued draft guidance stating that, under certain circumstances, a manufacturer can show evidence of effectiveness for a biological product with a single clinical investigation conducted in animals, giving the example of “[w]hen the product is a preventive vaccine, and there is a well-established model of infection for a relevant infectious disease, and use of the vaccine in the animal model demonstrates prevention of disease.” Notably, this occurred shortly after FDA authorized the newest Pfizer COVID-19 vaccines, which are as Dr. Paul Offit notes, “new product[s],” even though Pfizer tested this brand-new shot only in mice — not humans.
Thus, on December 18, 2023, ICAN, through its attorneys, filed a formal comment in opposition to the draft guidance. In it, ICAN points out that, despite urging by ICAN in its November 2020 petition, FDA refused to amend the Phase III trials of the COVID-19 vaccines to ensure they met the required standard of “substantial evidence” of effectiveness. As a result, we now have generations of new vaccines being approved based on those original ineffective products.
Now, FDA is doubling down on its malfeasance by authorizing COVID-19 vaccines without human trials while simultaneously creating guidance to excuse its lack of oversight. As ICAN’s comment notes:
[I]t is apparent that FDA is tailoring guidance based on the vaccine manufacturers’ clinical trials instead of requiring that these trials comply with what any reasonable licensing agency should and would require. FDA has seemingly forgotten that its function is to regulate the pharmaceutical industry, not rubber stamp it. The Draft Guidance does not provide oversight, and even worse lends illegitimacy to the FDA when there is clearly insufficient evidence to support authorization or licensure. This is especially troubling for products that will be injected into healthy humans including babies, children, and pregnant women.
Rest assured that ICAN’s legal team will continue to serve as a watchdog for FDA and ensure it is held accountable for improperly wielding its regulatory authority and fulfilling its responsibilities.
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You can read more about ICAN’s work serving as watchdog for our federal health agencies at the links below:
Fired Harvard Professor: ‘All the Basic Principles of Public Health Were Thrown Out the Window’
By Michael Nevradakis, Ph.D. | The Defender | March 21, 2024
Martin Kulldorff, Ph.D., co-author of the Great Barrington Declaration said Harvard University’s decision to fire him for non-compliance with the university’s COVID-19 vaccine mandate is just one example of the consequences faced by anyone who questioned the official COVID-19 narratives.
In an appearance on “The Defender In-Depth” podcast, Kulldorff, an epidemiologist, said his firing is part of a broader trend of censorship and intolerance toward people who express diverging views in the broader fields of science, medicine and academia.
Kulldorff is one of the five individual plaintiffs in a lawsuit against the Biden administration alleging key administration officials and government agencies coerced social media platforms to remove content, in violation of the First Amendment.
Kulldorff discussed the latest developments in the suit — Murthy et al. v. Missouri et al. — whose plaintiffs also include the attorneys general of Missouri and Louisiana.
On Monday, the U.S. Supreme Court heard arguments on an injunction, previously granted by lower courts, barring the administration and certain federal agencies from communicating with social media platforms for the removal of content.
He also discussed the COVID-19 pandemic response of his native Sweden, which bucked the global trend by eschewing lockdowns, vaccine and mask mandates, making the country the target of global pressure and widespread media criticism. Yet, Sweden now demonstrates better public health outcomes than most other countries.
‘Never a consensus in the scientific community’ for lockdowns
Kulldorff said Harvard was “not happy” with him when he co-authored the Great Barrington Declaration in 2020. However, it was Kulldorff’s decision not to get a COVID-19 vaccine that ultimately led Harvard to fire him.
“We had a disagreement about infection-acquired immunity,” Kulldorff said. “I was fired because I didn’t want to take the vaccine because I didn’t need it. I had better immunity from having had [COVID-19] already, and so, there was no medical reason for me to do it. And there was certain risk, because with every vaccine and drug, there’s some risk.”
Yet, many of his colleagues at Harvard and other institutions “sort of kept quiet” and “went along with it,” Kulldorff said. He attributed their cooperation to the federal funding many scientists and researchers receive from agencies such as the National Institutes of Health (NIH) and the National Institute of Allergy and Infectious Diseases.
“They sit on the biggest pile of medical research money in the world,” Kulldorff said. “So, it’s pretty scary for a scientist to speak up against their wishes, because you risk losing the resource funds that you depend on to support your family, and also to support the other people that work in your laboratory.”
Still, in personal contacts with fellow epidemiologists, Kulldorff said “The majority were arguing for focused protections over better protecting the older people, by letting kids go to school and so on. So, there was never a consensus in the scientific community, at least not in the epidemiological community, for these lockdown measures.”
Kulldorff said that during the pandemic, “all the basic principles of public health were thrown out the window.” His former institution, Harvard, was no exception, “going to online teaching before there was any government incentive or push to do so.”
This, Kulldorff said, “set the stage, and a lot of other colleges and even high schools and elementary schools sort of followed Harvard’s lead” in locking down.
Similarly, Harvard later imposed a COVID-19 vaccine mandate — which it finally ended on March 5. “There was no public health reason to mandate vaccines for students” in particular, Kulldorff said, because most of them “had COVID, so they have superior immunity. But even those few that haven’t [caught COVID-19] face minuscule risk from COVID.”
Children ‘will never fully recover’ from school closures
Kulldorff cited his native Sweden as an example of a country that bucked the trend and kept schools — and society more broadly — open during the pandemic.
“If you look at the elementary and high school students, we know that the test results went down” in countries that closed their schools, Kulldorff said. “The kids were hurt by this, and they will never fully recover from the damage that we did to them.”
Sweden was the only major Western country that kept schools open for ages 1-15, according to Kulldorff who said test results in Sweden have shown “no comparable drop — it’s just as normal, slightly going up.”
Among 1.8 million children who went to school in Sweden throughout the virus wave during the spring of 2020, “there were exactly zero COVID deaths and only a few hospitalizations,” he said.
Public health outcomes in Sweden also were positive for other population groups. “Sweden has low COVID mortality, less than the average in Europe [and] the lowest excess mortality in the Western world.”
Kulldorff said Swedish authorities were able to resist global pressure to impose lockdowns and mandates because they “had very strong support from other epidemiologists in Sweden” and “very strong support by the public” for their approach.
He noted that Sweden’s then-prime minister, Stefan Löfven, had a working-class background, having begun his career as a welder. Noting that lockdowns favored “the upper class,” Kulldorff said Löfven’s background might have made a difference as he could “understand what the effect these lockdowns had on regular people.”
Science will ‘dwindle down’ without freedom of speech
Yet, in other countries, including the U.S., dissenting views were silenced, Kulldorff said.
“Those of us who tried to speak up were either silenced or, after they couldn’t silence us anymore, we were slandered,” he said, noting that after the Great Barrington Declaration was published, Francis Collins, M.D., Ph.D., then the director of the NIH, called for “a devastating published takedown” in response.
“With scientific or other logical arguments, they have two options: They can sort of silence it by ignoring it or censoring it, which was done, or they can attack it through slander and smears,” Kulldorff said. He said postings he made on Twitter and YouTube critical of mask mandates and school closures, were removed by those platforms.
“They didn’t want the science to be known, the true science, and the true principles of public health,” Kulldorff said.
That’s why Kulldorff joined the Missouri et al. v. Biden et al. (now known as Murthy et al. v. Missouri et al.) lawsuit. He said the central argument the plaintiffs are making in this case “is that the federal government should not be allowed to coerce social media to censor people like myself.”
“They actually censored accurate, correct scientific information from scientists at Harvard and other places. And to me that’s pretty astonishing,” Kulldorff said.
Kulldorff said that during Monday’s Supreme Court hearing, “There were clearly some justices who seemed to be very sympathetic” to the plaintiffs’ position, and “seemed very concerned about the First Amendment.”
But other justices argued that “the government should be allowed to coerce social media to censor” in some instances.
By June, the Supreme Court will issue a ruling on whether or not to uphold the injunctions lower courts previously granted in this case. Kulldorff said the case will then return to the lower courts and is expected to “take years” to resolve, proceeding “in tandem” with Kennedy et al. v. Biden et al. — a similar lawsuit in which Children’s Health Defense is a plaintiff. The two lawsuits were consolidated in July 2023.
“I thought we were in agreement, as a country, as a society, that freedom of speech is important, that it is the foundation for us,” Kulldorff said. “It saddens me greatly that that’s not the case.”
“If we don’t have this freedom of speech, then gradually, science is going to dwindle down … Academia would go there also and society as a whole.”
Watch ‘The Defender In-Depth’ here.
Michael Nevradakis, Ph.D., based in Athens, Greece, is a senior reporter for The Defender and part of the rotation of hosts for CHD.TV’s “Good Morning CHD.”
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
Tide Turns On “Gender-Affirming Care”
By John Leake | Courageous Discourse | March 24, 2024
Last June, I accused Assistant Secretary for Health, Rachel Levine, of aiding and abetting the mass assault of minors, after the “Admiral” proclaimed that “gender affirming care [for our youth] is literally suicide prevention.”
This is a proclamation from hell—the blackest of emotional blackmail for prodding parents to consent to the butchering of their children. To be sure, one wonders what kind of parents would take advice in medical, psychiatric, or sexual matters from Admiral Levine.
At last, the tide is turning against this criminal enterprise of mentally ill adults advocating the butchering of children. Yesterday the Telegraph reported:
French Senators want to ban gender transition treatments for under-18s, after a report described sex reassignment in minors as potentially “one of the greatest ethical scandals in the history of medicine”.
This news comes on the heels of the UK NHS telling clinicians to stop routine prescribing of puberty blockers. As reported in the BMJ:
The decision was announced on 12 March as part of NHS England’s ongoing overhaul of children’s gender identity services in England. In new guidance NHS England said, “We have concluded that there is not enough evidence to support the safety or clinical effectiveness of PSH [puberty suppressing hormones] to make the treatment routinely available at this time.”
I would characterize this as a Pyrrhic victory because it stops short of banning gender reassignments for minors altogether. Moreover, it’s long been evident to anyone with a shred of common sense that puberty suppressing hormones are terrible medicine.
Dr. McCullough’s colleague, Dr. Stanley Goldfarb, has been raising the alarm about this for years. His Do No Harm organization has been trying to protect minors from predatory weirdo adults since it was founded in April 2022.
Though Dr. Goldfarb is up against the same Bio-Pharmaceutical Complex that imposed COVID-19 “vaccines” on mankind while enriching itself with public money, he seems to be making progress in pushing back against the child devouring monster of “gender affirming care.”
‘Kind of Terrifying’: Critics Slam Claim That First Amendment Shouldn’t Constrain Government’s Ability to Censor
By John-Michael Dumais | The Defender | March 21, 2024
Journalist Matt Taibbi denounced statements made by liberal Justice Ketanji Brown Jackson during a U.S. Supreme Court hearing suggesting the First Amendment should not constrain the government’s ability to combat misinformation during a crisis.
“That was kind of terrifying because the entire purpose of the First Amendment is to restrain the government — it’s not to restrain the public from getting in the way of government action,” Taibbi said Tuesday during an interview on The Hill’s “Rising.”
Taibbi, who has reported extensively on the government’s censorship efforts, also said the plaintiffs in the case — including Drs. Jay Bhattacharya, Martin Kulldorff and Aaron Kheriaty — had their speech suppressed because they contradicted a false government opinion.
“The entire purpose of the First Amendment is to prevent the government from creating a hegemonic opinion that cannot be challenged,” Taibbi said.
The Supreme Court heard arguments on Monday pertaining to an injunction, granted in September 2023 by a federal appeals court, in Murthy v. Missouri. The case centers on whether the federal government violated the First Amendment by pressuring social media companies to censor content that ran counter to official government narratives on such topics as COVID-19 origins, vaccines, elections and other controversial topics.
Responding to Solicitor General of Louisiana J. Benjamin Aguiñaga during oral arguments, Justice Jackson said:
“So my biggest concern is that your view has the First Amendment hamstringing the government in significant ways in the most important time periods. I mean, what would you have the government do? I’ve heard you say a couple of times that the government can post its own speech, but in my hypothetical, you know, ‘Kids, this is not safe, don’t do it,’ is not going to get it done.
“And so I guess some might say that the government has a duty to take steps to protect the citizens of this country. And you seem to be suggesting that that duty cannot manifest itself in the government encouraging or even pressuring platforms to take down harmful information.”
Government set up ‘private highway’ to social media execs
“Rising” host Briahna Joy Gray asked Taibbi which was the primary issue: the government’s actions or the companies’ choices to succumb to pressure?
Taibbi compared the situation to the government hypothetically threatening to pull a mainstream media outlet’s Federal Communications Commission license unless it held a story, which he argued would be highly inappropriate.
“They didn’t just do that in this case,” Taibbi explained. “They went straight to the heads of the company” using an “industrial-scale operation … a sort of private highway to all of these companies where they were funneling mass requests.”
Taibbi noted that Renée DiResta, research director of the Election Integrity Partnership that was sponsored by both the U.S. Department of State and the U.S. Department of Homeland Security, “talked about using Section 230 to bring these companies to heel.”
“This was an overt threat,” Taibbi said.
Taibbi suggested it would be appropriate for the government to use its bully pulpit to say, “I don’t like what’s on Facebook. They made a mistake here, here and here. Here’s what I think the truth is, and we see these posts that say something else.”
“The president has an enormous megaphone to counter” what it considers misinformation, Tabbi said. “What’s not appropriate is doing it in private and coupling it with a threat.”
Justices missed the point on First Amendment
On his Racket News Substack Tuesday, Taibbi provided further context on the government’s pressure on social media companies.
During oral arguments, Principal Deputy Solicitor General Brian Fletcher — referring to instances where government officials publicly criticized social media platforms and called for changes to Section 230 protections — said, “I think it’s really troubling, the idea that those sorts of classic bully pulpit exhortations, public statements urging actors to behave in different ways, might be deemed to violate the First Amendment.”
Taibbi lamented the lack of a strong response from the other eight justices.
“That a line about ‘the First Amendment hamstringing the government’ was uttered by one Supreme Court Justice is astonishing enough,” he wrote. “[But] listening as none of the other eight pointed out that the entire purpose of the First Amendment is to ‘hamstring’ government from interfering in speech was like watching someone drive a tank back and forth over Old Yeller.”
As evidence of the justices’ confusion over First Amendment rights, Taibbi pointed to Justice Elena Kagan’s statement that the government intervening in news organizations’ activities “happened all the time” decades ago, especially when issues of national security were at stake.
As to her question, “Was that coercion?” Taibbi wrote:
“The situations aren’t remotely analogous. What’s happening now is a wide-scale partnership agreement between intelligence/enforcement agencies and media distributors, not media outlets themselves.”
Rep. Jordan: ‘That is scary where we’re headed’
Some Congress members were quick to criticize Justice Jackson’s statements from the Murthy v. Missouri hearing.
Rep. Jim Jordan (R-Ohio), in an interview with Fox News Monday, said, “The big takeaway today was Katanji Brown Jackson, when she said to the Solicitor General from Louisiana, ‘You’ve got the First Amendment hamstringing the government’ — well, that’s what it’s supposed to do, for goodness sake!”
“That is frightening because she really believes that,” Jordan added. “That is scary where we’re headed.”
Rep. Dan Bishop (R-N.C.) suggested that if the Supreme Court does not intervene, it could allow the FBI to “embed itself with social media companies” and “take down” issues like “the Hunter Biden laptop in election after election after election.”
Bishop argued that the government should not be able to suppress legal, protected speech on public platforms. “I just don’t think the government ever has a valid interest in doing that,” he said.
“[The government] can … come out publicly and say, ‘We don’t agree that there could have been a lab leak, that we think that’s a ridiculous theory,’” said Bishop. But he argued it was a “bad idea” to allow the government to pressure social media because “We see from what has happened afterward … they were wrong.”
Jordan also alleged that the Biden administration abused its power by censoring political opponents, citing its pressure to remove a tweet by Robert F. Kennedy Jr., Children’s Health Defense chairman on leave, despite the tweet containing true statements about Hank Aaron’s vaccination and passing.
“Oh, by the way, who was that individual [requesting the censorship]?” Jordan asked, before answering, “The guy running against him in the [Democratic] primary [at the time]. That is as scary as it gets, but that’s what this White House was doing.”
Will ‘traceability’ derail free speech case?
One of the central questions before the Supreme Court in Murthy v. Missouri is whether the government’s actions, including vague threats and pressure on social media companies, constitute illegal coercion.
Taibbi pointed out in the “Rising” interview that the “Twitter Files” showed “both overt and less obvious evidence” of correspondence among Twitter’s executives describing how they understood proposed regulatory changes as a threat they must answer to get the government off their back.
“That’s not missing from the case — that’s a feature of the case,” Taibbi said, adding that he thought the government publicly airing those threats “was sending a very strong message so that not only the companies would hear it, but the public would hear it.”
Taibbi acknowledged the difficulty of establishing “traceability” — a direct causal relationship between government pressure and the censorship of individual plaintiffs’ posts — saying their evidence “didn’t show a soup-to-nuts progression.”
However, he noted that shortly after the government told social media companies, ‘We don’t want anybody who is creating content that would promote vaccine hesitancy,’” people like Dr. Bhattacharya and Dr. Kulldorff were “deamplified or removed from platforms.”
Taibbi highlighted the lower court rulings that established or upheld injunctions against the government’s use of coercive tactics with social media companies.
“Two judges compared it to a mob movie,” he said. Characterizing the government in this metaphor, the judges said, ‘Hey, it’s a nice tech company you’ve got there. Be a shame if something happened to it,” Taibbi said.
“Rising” host Robby Soave asked Taibbi whether a legislative remedy could prevent government censorship. Taibbi said that while he felt there was ample evidence that what the government engaged in was already against the law, he thought it would be “difficult” to get a new law passed “absent a judicial ruling that this kind of behavior is illegal.”
But even if such a law were passed, “The problem is the enforcement mechanism is absent here,” he said.
In his Racket News article, Taibbi said the Supreme Court hearing “felt like a gut punch.” He expressed concern that if the court rules against the plaintiffs based on “traceability” issues, it could be interpreted as an endorsement of the government’s “plainly abusive” surveillance and censorship programs.
He wrote:
“Murthy [v. Missouri] already represents a major public relations victory for the Executive Branch.
“After roughly two years in which momentum for shutting down government censorship programs seemed to be gaining, and episodes like Bhattacharya’s punctured the myth that such bureaucracies only targeted ‘misinformation,’ yesterday’s hearing will help restore the basic narrative that the activities revealed earlier in this suit and in the Twitter Files was little more than good-faith efforts by a concerned government trying to stop ‘harm’ in a unique historical emergency.
“As Brown Jackson put it, ‘What would you have the government do?’”
John-Michael Dumais is a news editor for The Defender. He has been a writer and community organizer on a variety of issues, including the death penalty, war, health freedom and all things related to the COVID-19 pandemic.
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
Major Studies Find No Evidence of Brain Injury in Alleged ‘Havana Syndrome’ Patients
By Kyle Anzalone | The Libertarian Institute | March 18, 2024
Two studies conducted by the National Institute of Health (NIH) on scores of people claiming to have Havana Syndrome did not find any evidence of brain damage. Purported victims of Havana Syndrome claim they were targeted by a foreign power with a mysterious weapon that caused undetectable neurological issues.
Havana Syndrome was first reported among American diplomats in Cuba in 2016 who claimed to be exposed to a sonic weapon that caused headaches. An investigation published by JASON, a group of scientists who advise the US government, concluded that crickets native to Cuba were making the noise, causing neurological symptoms among American officials in Havana.
Since, scores of diplomats have reported symptoms in a range of countries including Vietnam, Russia, and China. The self-identified victims claim they were targeted with some form of microwave, sonic, or direct energy weapon that caused a myriad of symptoms, including headaches, as well as problems with sleep, vision, and hearing.
On Monday, NIH published two studies that concluded Havana Syndrome was not caused by directed energy weapons. Additionally, in both investigations, researchers were unable to detect any signs to indicate the patients had suffered neurological damage.
“In this exploratory neuroimaging study, there was no significant MRI-detectable evidence of brain injury among the group of participants who experienced [anomalous health incidents] compared with a group of matched control participants,” the authors wrote. However, researchers did not dismiss the possibility that somehow the claimed victims were actually targeted with a mysterious weapon.
Robert E. Bartholomew and Dr. Adam Gaffney argued that Havana Syndrome, rather than being caused by weapons, is a mass psychogenic illness. In an essay published in the Journal of the Royal Society of Medicine, Bartholomew explains, “As is typical in mass psychogenic illness outbreaks, as news of the ‘attacks’ spread among the diplomatic community, more US Embassy staff were affected, including members of the Canadian Embassy.”
He continues, “The irregular patterning of the ‘attacks’ is not typical of an infectious agent. Many ‘incidents’ were said to have occurred in homes and hotels. Why were some people affected, while others either standing or sleeping next to the ‘victim,’ were not?”
Still, allegations of attacks causing Havana syndrome continued to impact American officials around the world into the first years of the Joe Biden administration. The claims of attacks have led to the demonization of Russia, the breakdown of diplomatic relations with Cuba, and the delay of high-level visits to foreign nations.




