We have never witnessed a greater violation of the Nuremberg Code regarding human medical experimentation. The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) is set to approve all of Pfizer’s and Moderna’s shots for babies as young as six months today, even though learned experience and the manufacturer’s own trials now show zero net benefit, possible negative efficacy, and a degree of adverse reactions that would outweigh any hypothetical benefits.
For today, we will focus on Pfizer’s data, as represented in the FDA’s 66-page briefing document. Here are six points to consider:
1) To begin with, the entire premise of pursuing kids as candidates for these COVID shots at this juncture in the pandemic is illogical and unethical for a number of reasons.
2) Now we can move on to the Pfizer trial for young children ages 6 months through 4 years. From the get-go, as has been the case for all of the trials in younger people, researchers could not find any benefit from the shots against death or critical illness because nobody in either arm of the trial wound up getting critically ill and dying from COVID. So off the bat, any potential benefit would only be against the sniffles of Omicron, which, as has been demonstrated over and over, the shots never provided protection from mild illness, even for the original strain. In fact, every data point from every country that measures case rates by vaccination status shows negative efficacy. So for young children who don’t get critically ill, you are actually making it more likely that they will get the virus, as witnessed by HHS Secretary Xavier Baccara and Canadian Prime Minister Justin Trudeau, who actually both got COVID twice after getting multiple boosters.
3) Given the lack of efficacy of any clinical trial for children, Pfizer instead decided to make the primary endpoint of its trial immunobridging rather than clinical outcomes. In other words, the company merely measured antibody levels. To begin with, this is a meaningless measure. As Eric Rubin, editor of the New England Journal of Medicine, said at the April meeting of VRBPAC, “We know what kind of antibody response can be generated, we just don’t know if it works.” But it’s worse than that. Pfizer had to manipulate the sample size to even find a positive outcome in terms of antibody levels.
What in the world is going on? I think we can take a guess. Almost all kids today likely already have antibodies through natural infection regardless of vaccination status, so the company rigged the trial to have a fake control group from a past variant and adult population.
Moreover, the entire premise of using antibodies to indicate superior immunity from the shots is bogus. After finding numerous people with antibodies from the shots who were not really immune, an Italian study published in Frontiers in Immunology concluded that “evaluation of vaccine-induced immunity” in the immunocompromised population “should also include quantification of Ag-specific T cells.”
4) Sensing the public disquiet over its shell game with antibodies, Pfizer attempted to show that its trial did indeed indicate an 80% reduction in actual COVID cases among the trial group. As Alex Berenson points out, this is one of the greatest frauds of the entire two years of fraudulent clinical trials. In fact, there were many more total COVID cases in the trial group than placebo group – 225 in trial and 150 in placebo (among those 6 months to 2 years old, it was 98-58 trial vs. placebo; among 2 <5 it was 127-92). Thus, as witnessed by real-world experience, there is straight-up negative efficacy for several periods of time that will outweigh any isolated period of illusory efficacy. The data is from tables 19 and 20 on p. 39 of the briefing document.
So where did the researchers get the positive efficacy from? They ignored 365 of the 375 COVID cases and just focused on a total of 10 of them from one sub-cohort – those seven days after the third shot! So, it was clearly negative all along, and then they shut the music off in the game of clinical trial musical chairs for just a few weeks and find statistically underpowered numbers to say it works!
In fact, we have consistent data from the U.K. and from Walgreens in the U.S. showing that the vaccine is negatively effective for most of the time and also after several months, but there is a sweet spot shortly after the third shot (or shortly after the second shot). This is an unbelievable level of fraud. Also, keep in mind that they unblinded the groups in late April and then vaccinated the placebo group, so there is no way to monitor the long-term data past the third dose, which would likely wipe out any degree of efficacy at any stage.
5) While all the previous children’s studies did not show any case of death or critical illness, this trial does claim (p. 56) there were eight kids who had “serious” cases, with one having gone to the hospital. Six of the eight were among the vaccinated kids, as was the one who was hospitalized. The numbers are too low to draw any conclusions, but if anything, this would indicate some degree of negative efficacy. How this can get approval is astounding.
6) Now that we've established that, at best, there is no long-term benefit to these shots for anyone, much less babies, let’s go on to the adverse events. On the surface, Pfizer’s own report is an indictment of the shot’s safety. Table 21 on page 42 states that 61% of babies 6 months to 2 years old experienced a “systemic reaction within 7 days.” This means that it’s not just irritation of the injection site but something more along the lines of fever, chills, or muscle aches. Right off the bat, that should be disqualifying, because that is the upper bounds of discomfort the kids would suffer from the virus anyway. The only rebuttal to this is that almost as many placebo group patients experienced such reactions. But that in itself should be an indication there is something fraudulent with the placebo group. It’s understandable for even a saline injection to cause irritation at the injection site, but “systemic” reactions?
This point is further driven home by the number of severe adverse events reported, which is 1.4% of the trial group. Incidentally, that number would harmonize very well with several other data points around the world hinting at a 1%-1.5% severe adverse reaction rate among the general population. However, the chart bizarrely shows that the placebo group experienced an even higher level of severe adverse reactions! You tell me how a saline injection can cause that. Something is really off. At worst, their own study shows the shots are dangerous; at best, their data is worthless or fabricated.
Moderna’s safety data (p. 54) for its newly released adolescent trial also shows the same concept. A quarter of all kids injected experienced a Grade 3 or higher level of adverse reaction, which means they couldn’t go to school because of illness. Moreover, 78.4% reported headaches, 75.2% reported fatigue, 54.3% reported muscle aches, and 49.1% reported chills. Why would we give them the pathogen for the worst-case scenario … of getting the pathogen at that age?! This is even before we get to serious issues like blood clotting and myocarditis. Toby Rogers has a comprehensive analysis of the fraud of the efficacy data in Moderna’s trial as well, which is similar to the ploys used by Pfizer
The bottom line is it would be one thing to approve shots with such bad data in middle of an emergency. But how can they get emergency authorization when our other policies reflect the fact that the emergency is over, and particularly for the cohort of people for whom there was never an emergency?
It’s utterly senseless. Pfizer is now asking to authorize a dangerous, outdated shot for babies and toddlers, for whom the virus does not pose a statistical risk and for a virus against which the shots have failed to show any benefit. Yet, just as taxes and death are a certainty in life, you can bank on the FDA never turning down any Pfizer request. This is where Republican governors must serve as the safety net for the people. They must actively oppose expanding the shots to the final control group against the greatest experiment on mankind.
In one of the most shocking and immoral moves since the beginning of the pandemic, Pfizer is submitting its request this week for emergency use authorization of its COVID shot for babies as young as 6 months old through 5 years old. They are quite literally pushing a shot with the hopes of ameliorating symptoms (not stopping transmission) of a virus that is a cold for young children and much less dangerous than RSV. But here’s the kicker: The trial they conducted showed that two doses failed to even produce positive results, and they are still working on a trial for a three-dose regimen. Plus, we have a new variant. So, what exactly are they seeking authorization for?
As other countries are already recommending against vaccinating those under 12, our government will likely approve this shot for babies and young children based on a failed trial. There was never any efficacy in the shot because no child in the trial got seriously ill to begin with. So, they chose a trial endpoint around levels of antibody titers. Putting aside for a moment the premise that higher antibody titers (as opposed to T cells) are necessarily a good thing and won’t cause original antigenic sin, their own trial failed to achieve these endpoints in 2- to 4-year-olds. Which is why Pfizer announced in December that it was beginning a trial on a three-dose regimen. So how can they seek authorization of the failed two-dose trial for what is essentially a new virus?
One of the precepts of the Nuremberg Code: “The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.” There is no way pursuit of an already flawed vaccine can be justified on young children, even if it still had a degree of efficacy and wasn’t outdated. A recent study from the U.K. showed that even immunocompromised children were not at an elevated risk for severe COVID. The study of 1,527 immunocompromised children and young adults found “no increased risk of severe SARS-CoV-2 infection.” None of those even more vulnerable children died.
While there likely have been a tiny number of severely ill children who have died of the virus, it’s extremely hard to tell how many of the recorded deaths were legitimately caused by the virus itself. A large COVID study conducted in Germany found just three pediatric COVID deaths out of a million. The same analyst found zero deaths occurred in children under 5.
Already among older children, no positive benefit was found in the vaccine, even when the vaccine was working better. An Israeli study published in the New England Journal of Medicine found ZERO deaths or severe illnesses BOTH in the vaccinated and in the control (unvaccinated) groups of 12- to 18-year-olds in a 29-day follow-up of their vaccination. Under what pretext could the government possibly justify COVID as an emergency in this age group, and based on what evidence does this vaccine address that “emergency?”
On the flip side, the CDC, in a study in published in JAMA just conceded that the VAERS data on myocarditis was indeed an accurate reflection of an increased risk of heart inflammation following the vaccines. “Based on passive surveillance reporting in the US, the risk of myocarditis after receiving mRNA-based COVID-19 vaccines was increased across multiple age and sex strata and was highest after the second vaccination dose in adolescent males and young men,” concluded the CDC researchers. “This risk should be considered in the context of the benefits of COVID-19 vaccination.”
More broadly, over 22,600 vaccine deaths and over 1 million injuries have been reported to VAERS. We already know from previous studies that VAERS only captures 1% of adverse events, and no other shot has come with such a stigma against reporting it for harm, often at the threat of the physician losing his job. Medicare data seems to hint at a much broader cohort of vaccine casualties. The military’s epidemiological database also seems to indicate a very disturbing trend of neurological and cardiological disorders rising in association with the take-up of the vaccine.
How can this be foisted upon the youngest children — with no apparent benefit — when they concede, “Long-term outcome data are not yet available for COVID-19 vaccine–associated myocarditis cases”?
There are no long-term cancer studies, there are no long-term studies on what this does to one’s immune system, and there are no long-term studies on autoimmune diseases, even though the VAERS data and the Pfizer surveillance data from early 2021 raises some concerns. Plus the vaccine is for a virus that is not a threat to children.
Think about it: Monoclonal antibodies can get their existing EUA pulled based on the arrival of a new variant, yet shots that have already proven to be outdated – and are associated with greater infection rates – can secure official full approval and then EUA for babies with a new variant that was never run through a clinical trial.
As such, for a governors to merely take a neutral stance while allowing this travesty to plague the children of their states is unacceptable. Governors have a responsibility to direct their respective health departments to conduct the proper oversight that the FDA has abdicated and demand a moratorium on shots for children until a proper cost-benefit analysis can be conducted. At a minimum, they should join together in a lawsuit to enjoin the EUA because Pfizer has failed to prove the shots meet the eligibility thresholds in the EUA statute.
Moreover, Republican governors and legislators have an obligation to treat Pfizer like Planned Parenthood and cut all political ties with the company’s lobbying groups. Bio-medical fascism and the breach of informed consent is a greater pro-life cause than opposition to abortion right now, because its practitioners are encouraging all children to get something with only a potential downside. It is the equivalent of forcing abortions upon us, not just permitting them.
The final precept of the Nuremberg Code reads as follows: “During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.” If after everything we have learned, they won’t even discontinue this experiment on babies, then we truly have learned nothing since that dark era of history.
White House chief medical adviser Dr. Anthony Fauci said Wednesday that children 4-years-old and younger will likely need three shots of a COVID-19 vaccine to complete their regimen once the government grants approval for toddlers to be vaccinated.
Fauci informed reporters at the daily White House press briefing that clinical trials for Pfizer-BioNTech's vaccine are currently underway in children from 6 months to 2 years old and from 2 to 4 years old. But so far, these vaccine doses have not been shown to meet the same standards for effectiveness that the shots approved for adults have met.
"With regard to the clinical trials that are being done in children from 6 months to 24 months and from 24 months through 4 years: As you probably know, the original data that was done was determine if the doses that were given to those children reached what we call 'non-inferiority' with a more adult or adolescent population," Fauci said.
He continued: "And in the original data that was put forth, it looked like the dose and the regimen for the children who were 6 months to 24 months worked well, but it turned out that the other dose — namely the other group, from 24 months to 4 years — did not yet reach the level of non-inferiority. So, the studies are continued."
"It looks like it will be a three-dose regimen," Fauci said. "I don’t think we can predict when we will see an [emergency use authorization] with that, because the company is still putting the data before the FDA."
Fauci did not want to speak for the Food and Drug Administration as to when the vaccines would be approved for children aged 4 and younger.
"I think we just need to be patient and know one thing for sure that that’s why the system works," Fauci said. "Because the FDA is very scrupulous in their ability and in their effort to make sure that before something gets approved for people at any age — including and especially children, because of the special vulnerability of the children — that when these vaccines become available for children at those ages, we can be certain that they will be safe and that they will be effective."
Reporters also asked Fauci when the U.S. would be able to lift coronavirus restrictions and treat COVID-19 as an endemic virus, rather than a pandemic, similar to what the United Kingdom and other European countries are doing.
"We are not there right now," Fauci said, citing the latest number of COVID-19 cases, deaths, and hospitalizations provided by the Centers for Disease Control and Prevention. "As [CDC Director] Dr. Walensky said, when you have over 2,000 deaths, 150,000 hospitalizations, and you have people who are now getting infected to the tune of somewhere around 700,000 a day, we’re not there yet."
The CDC reported Wednesday that the current seven-day daily average of cases is about 692,400 cases per day, a decrease of about 6% over the previous week. The seven-day average of hospital admissions for COVID-19 is about 19,800 per day, a decline of 8% over last week.
The seven-day average daily deaths reported was about 2,200 per day, which is an increase of 21% over the previous week.
Fauci said that before the U.S. could consider COVID-19 endemic, there would needto be "sufficient control" over infections, cases, and deaths. He clarified he does not mean COVID-19 needs to be eradicated like smallpox, which he said was "unreasonable," nor does it need to be eliminated like polio or measles, "but a level of control that does not disrupt us in society, does not dominate our lives, does not prevent us to do the things that we generally do under normal existence."
"That would be a level of infection, but more importantly, concentrating on the severity of disease, hospitalizations, and deaths that fall within the category of what we generally accept — we don’t like it, but we accept it — with other respiratory viruses: RSV, para flu, and even influenza," Fauci said.
To get to that point, Fauci said the community needs to be immunized "either through infection plus boosting, either vaccine plus boosting, or just vaccine alone."
"Those are the things that will hopefully get us to the point when we have antivirals to be able to treat people who are at high risk — that we no longer are in a situation of threat — threat to our equanimity, threat to our economy, the threat to allow us to live a normal life," he said.
"We believe we can get there because we have the tools with vaccines, with boosts, with masks, with tests, and with antivirals. That’s what we talk about when we get to the point where we can, quote, 'live with the virus.' But, as Dr. Walensky emphasized, that is not where we are at this point. So, we still have a way to go."
On Monday, the Food and Drug Administration removed two monoclonal antibody therapies from the list of approved COVID-19 treatments, subsequently forcing treatment sites to close despite these locations being pivotol to Florida's COVID-19 response.
The FDA made this announcement Monday in a press release stating that the bamlanivimab-etesevimab cocktail and the REGEN-COV treatments were to be removed from the list of emergency use authorizations.
It continued by saying that these treatments should only be used “when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments” because “data show these treatments are highly unlikely to be active against the omicron variant.” The FDA did not elaborate or provide the data.
The FDA argued against the preventive treatments, stating that “treatments are not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended.”
The Washington Post reported that Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research and author of Monday’s press release, said that these monoclonal antibody treatments are “highly unlikely to be active against the omicron variant” and that “these treatments are not authorized to be used at this time.”
The FDA press release states that “these [monoclonal antibody] treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time.”
However, the press release did not mention that the Omicron variant can circumvent COVID immunity gained through vaccination.
In an interview with the French outlet Le Monde, Ugur Sahin, the CEO of BioNTech, the co-developer of the Pfizer vaccine, confirmed this by saying, “We must be aware that even triple-vaccinated are likely to transmit the disease. ... It is obvious we are far from 95% effectiveness that we obtained against the initial virus.”
The FDA’s decision will force monoclonal antibody treatment facilities around the country to close their doors to those seeking treatment for COVID-19 other than the mRNA vaccine.
In Florida, monoclonal antibodies proved to be a vital lifeline in the state’s approach to combatting COVID-19. Officials from the state of Florida condemned the FDA’s decision, claiming it was made without any warning and determined through analyzing clinical data not made available to the public.
After @HHSGov avoided communication with @HealthyFla regarding statewide allocations, without any warning, @US_FDA suspended the use of multiple MABs treatments. Such decisions should be made based on clinical data - which the FDA has not provided.pic.twitter.com/zpWl7ZGODQ— Joseph A. Ladapo, MD, PhD (@Joseph A. Ladapo, MD, PhD) 1643065270
The Florida Department of Health issued a statement countering the FDA. In it, the state’s Department of Health lamented being forced to shut down state-run monoclonal antibody treatment sites, stating, “Florida disagrees with the decision that blocks access to any available treatments in the absence of clinical data.”
As a result of the @US_FDA's abrupt decision to remove the EUAs for two monoclonal antibodies, monoclonal antibody treatment sites will be closed until further notice. Full press release is below.pic.twitter.com/RGeWTPwxCs— Florida Dept. of Health (@Florida Dept. of Health) 1643080563
Just like the COVID vaccines, use of masks (instead of respirators) to block transmission of a virus was only authorized as experimental use. As such, according to law, it must be optional. If we are going to passively allow governors and governments to make this medical device mandatory, what is to stop them from making the vaccine mandatory?
As I've mentioned before, both the FDA and OSHA have made it clear over the years that only respirators, not masks, are considered valid PPE to block transmission of a respiratory virus. Which is why mask manufacturers must continue to place a disclaimer on their labels that the product does not work for airborne viruses. The CDC is lying to the public and giving them a false sense of security by suggesting masks are valid medical devices for COVID. That is why the FDA was forced to use an Emergency Use Authorization – the same process used for the vaccines – to approve masks as medical devices to be used as source control to reduce the spread of COVID on April 24, 2020.
This is also why in the EUA statement, the FDA discloses, "A face mask is a device, with or without a face shield, that covers the user's nose and mouth and may or may not meet fluid barrier or filtration efficiency levels." Well, indeed, any industrial hygienist or exposure expert will tell you that anything less than a fit-tested N-95 could not even be considered to meet the filtration efficiency levels. Even then, OSHA's Reparatory Protection Guidance under 29 CFR 1910.134 would require fit testing, training, proper breaks, and a medical exam in order for governments or businesses to demand that people use them in various settings.
All this is to say that with no evidence masks work, and with endless evidence that they failed to stop the spread in a single part of the world for 12 months, this is why masks, according to law, must remain optional.
Federal law governing the conditions of authorization of unapproved emergency medical products (21 U.S.C. §360bbb–3(e)(1)(A)(ii)(III)) requires the secretary of HHS to "ensure that individuals to whom the product is administered are informed," among other things, "of the option to accept or refuse administration of the product."
There it is in plain English. This is the reason, among others, why the federal government or any other actor cannot mandate the COVID vaccines. For the CDC to make masks mandatory on all federal lands and places of travel, and possibly even for states to do it, violates the emergency authorization use of medical device statute that same way it would if they mandate vaccines.
This is especially true given the fact that they mandate it on almost everyone, even 2-year-olds, even people with disabilities, and even under harsh circumstances. The same statute requires that the secretary make it known to people that indeed the authorization was issued under emergency use and to inform the people "of the significant known and potential benefits and risks of the emergency use of the product, and of the extent to which such benefits and risks are unknown."
The government is violating this every day by refusing to even study the unknown effects on workers and children of wearing these things for hours and days on end. And not only are they not optional, but they are mandated without exception to the gates of hell. There are numerous examples, but here is a heartbreaking story from a listener of mine from eastern Pennsylvania.
I am writing you for the first time because I find myself in a difficult situation.
My fiancé recently had a cat scan that revealed a cyst and tumor near her brian/spinal cord. Severe facial pain was what prompted us to get the scan.
She made an appointment with a neurologist for today. She explicitly stated over the phone that she is unable to wear a mask due to breathing difficulties and this severe pain in her face. They assured her it wouldn't be a problem.
After driving 90 minutes, being checked in at 2 different stations, and being told we would be seen, they ultimately refused to bring her to the doctor without a face covering. We were asked to leave even with a written medical exemption in hand from her primary care doctor.
Do you know of a network of doctors or individual health care facilities who don't belong to the cult of the mask? I am in disbelief that I cannot find care for her on a time-sensitive issue like this without her wearing something that will cause her pain/difficulty breathing.
Folks, our government has made the people in this country, including those trained to save lives, act demonically towards others over this failed experiential of mask-wearing. The cruel irony is that health care workers are usually wearing medical-grade PPE. Somehow we are to believe that masks are so effective that it justifies torturing a person who has trouble breathing, but then again, they evidently are so worthless that the doctors' PPE is useless if the patient doesn't have a mask. But the minute that patient puts on a cheap cloth mask, then all is OK.
The FDA has failed to study the benefits of such a draconian experiment over an entire year. As the FDA says on its website until this very day, face masks do not work for airborne-transmitted viruses, only to "block large-particle droplets, splashes, sprays, or splatter," which is not the primary transmission method of the virus. Now that we know the virus spreads through aerosols, how can the FDA continue to obfuscate the degree of unknown (or downright ineffectiveness) of mask efficacy as an optional device, much less a mandatory one, and still operate within the confines of the law?
Citizens who want to fight back need to take the following three actions:
A group of Illinois health care workers agreed to settle their lawsuit against NorthShore University HealthSystem. Represented by Liberty Counsel, the plaintiffs filed a class-action lawsuit in federal court last fall on behalf of themselves and other NorthShore employees who were denied religious exemptions to the company’s Covid-19 vaccine mandate. If the court approves the […]
The FDA appears to have lost its high standard for drug safety and efficacy, and it is the American public who will suffer.
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