By Chris Menahan | InformationLiberation | October 26, 2021
An FDA vaccine advisory panel on Tuesday voted unanimously 17-0 in favor shooting up kids aged 5-11 with Pfizer’s experimental mRNA injection with panelist Dr Eric Rubin stating, “we’re never going to learn about how safe this vaccine is unless we start giving it.”
Full context:
https://twitter.com/politicalwilli/status/1453082309201117199?ref_src=twsrc%5Etfw%7Ctwcamp%5Etweetembed%7Ctwterm%5E1453082309201117199%7Ctwgr%5E%7Ctwcon%5Es1_&ref_url=https%3A%2F%2Fwww.informationliberation.com%2F%3Fid%3D62628
“We’re never going to learn about how safe this vaccine is unless we start giving it,” Dr Rubin said, urging other panelists to vote for it. “That’s just the way it goes.”
The panel voted in favor of experimenting on tens of millions of helpless children with zero long-term data on side effects because 94 children between 5 and 11 have died with COVID-19 (they claimed “of”) and “all have names. All of them had mothers,” to quote the emotional gobbledegook uttered by panelist Patrick S. Moore.
From The Washington Post :
“To me, it seems that it is a hard decision but a clear one,” said Patrick S. Moore, a University of Pittsburgh microbiologist and committee member. He noted that 94 children between 5 and 11 have died of covid-19, and “all have names. All of them had mothers.”
As the WSJ reported:
Members of the FDA’s vaccine-advisory panel supported Moderna’s booster dose even though the evidence for it was from a small study and had mixed results.
“It’s more a gut feeling rather than based on really truly serious data,” said Patrick Moore, a member of the committee and a professor of molecular genetics and biochemistry at the University of Pittsburgh School of Medicine. “The data itself is not strong, but it is certainly going in the direction that is supportive of this vote.”
This is how they “follow the science.”
A deeper look at a decisive limitation of our adaptive immune systems
eugyppius | October 26, 2021
To review: We have now had ten months of mass vaccination against SARS-CoV-2. Nearly 7 billion doses have been administered worldwide. This unprecedented campaign has not eradicated Corona; it has not even suppressed infections. Instead, case statistics have ballooned almost everywhere. While the vaccinated appear to enjoy some protection against severe outcomes, skyrocketing transmission means most countries have seen little benefit, on balance, from their universal vaccination campaigns. The most pressing question has become, simply: What is going on?
I’ve explored a few different possibilities. First, there seems to be a Marek Effect at work. We might imagine that all viruses have an optimal level of population-wide virulence – an advantageous degree of aggression at which they can spread effectively, while not driving their hosts underground too soon. Certain Delta sub-strains, previously punished for their excessive aggression in unvaccinated populations, have likely been favoured by the vaccines, which reduce symptoms in the vaccinated without preventing infection for more than a few months. Our vaccines reduced the average virulence of SARS-2, and the virus adapted to reattain the prior, optimal balance.
But the virus and its interactions with human hosts constitute a complex system. In such systems, it is very unlikely that any effect can be put down to a single cause. The Public Health England data provide powerful reasons to suspect that the vaccines may be compromising immunity to SARS-2 via Original Antigenic Sin. This is not a crazy internet fantasy, but a well-observed limitation of human immunity. It is the primary reason that respiratory viruses like influenza return again and again. Despite multiple reinfections across the whole population, we are never quite immune to the flu, because its strategy is to exploit the way our immune systems learn.
The mechanisms of Original Antigenic Sin are not fully understood, but we have a rough idea of what might be happening. When a virus infects your body for the first time, your naive memory B cells imprint on specific virus proteins, or antigens, presented to them. These B cells then become either memory B cells or plasma cells. Forever after, they specialise in producing antibodies against those specific antigens. When a slightly mutated form of the virus arrives, these memory B-cells begin pouring forth the antibodies they learned to produce during the first infection. These antibodies bind to multiple epitopes on the virus particles, and in the process they give the slower-moving naive B-cells little chance to learn about any new, mutant virus features.
Original Antigenic Sin was most influentially described by Thomas Francis in 1960. He noted that, regardless of whatever influenza A strains were in circulation, subjects tended to have dominant antibody responses to the strains that were current in their early childhood:
The antibody of childhood is largely a response to … the virus causing the first Type A influenza infection of the lifetime. As the group grows older and subsequent infections take place, antibodies to additional families of virus are acquired. But … the antibody which is first established continues to characterize that cohort of the population throughout its life. The antibody forming mechanisms have been highly conditioned by the first stimulus, so that later infections with strains of the same type successively enhance the original antibody to maintain it at the highest level at all times in that age group. The imprint established by the original virus infection governs the antibody response thereafter. This we have called the doctrine of original antigenic sin.
An important consequence of this childhood conditioning, is that different age cohorts within the population have overlapping or layered immunity to different influenza strains. This is an important if subtle aspect of our population-wide immunity to influenza A. It looks like this:
As older cohorts die, their immunity to older strains dies with them. These old strains, long suppressed, are then positioned to return, for very few human immune systems remember them any longer. Francis believed this was the mechanism underlying periodic cycles of pandemic influenza. The 1957 influenza pandemic, for example, featured a strain of flu against which only the oldest cohorts – those in their 70s – had specific antibodies. As these “immunological veterans” disappeared, this older, long-suppressed type of influenza was free to return and cause another pandemic event.
In conclusion, Francis proposed that optimised influenza vaccines might be administered to children before their first infection. He envisioned vaccines designed to confer immunity against “known or anticipated recurrent strains” and hoped that “In this manner the original sin of infection could be replaced by an initial blessing of induced immunity.”
Strategic vaccination conferring immunity against likely future strains is of course exactly the opposite of our current efforts to give every last living human multiple vaccinations against an extinct strain of SARS-2.
*
The existence of Original Antigenic Sin has been confirmed by generations of research, and the literature is full of curious findings. A major reason flu shots don’t work, for example, is that they are powerless to redirect adult immune systems against novel influenza strains. Most people who get flu shots are adults, with immune systems long since primed by childhood infection. Hence this old Lancet case study of influenza outbreaks among boys at Christ’s Hospital in Sussex in the 1970s:
In each outbreak, the protective effect of inactivated influenza-A vaccine was limited to those boys, not already immune, who were vaccinated for the first time with the most up-to-date strain. Revaccination with the same strain did not increase the degree of protection, and revaccination with a later strain did not afford protection against subsequent challenge.
The flu vaccines, in other words, work great if you’ve never had the flu before. Otherwise they don’t do anything.
And consider these remarks, from a 2005 article in Nature Medicine:
It is often difficult to further increase antibody levels, specificity and the quality of the immune response in individuals who have been repeatedly immunized through either vaccination or recurrent exposure to infectious agents or cross-reacting microbial antigens. This has been a particular concern for aging adults in the context of the antigenic drift of influenza virus, in view of their annual exposure to antigens of new but related influenza variants through either infection or vaccination. After exposure to a new but cross-reacting antigenic variant, such individuals may respond by producing antibodies that are primarily directed at antigens characterizing influenza viruses encountered during earlier epidemics.
The authors go on to write that the “impact” of Original Antigenic Sin “on protection is far from established,” noting earlier research showing substantial all-cause mortality reductions from flu shots. Later work, though, has shown that the mortality reduction of influenza vaccines is largely an illusion of selection effects. For a variety of reasons, those most likely to die of influenza are far less likely than healthier groups to be vaccinated.
Original Antigenic Sin has been famously implicated in dengue fever. This is considered to be an extreme case of the phenomenon, with “considerable bearing on vaccine strategies.” Here the conclusions are ominous and full of implications for our own situation:
Once a response has been established, it is unlikely that repeat boosting will be able to change its scope, meaning that balanced responses against the four virus serotypes will need to be established with the first vaccine dose.
The danger is that immunity to one strain alone may lead to permanently impaired immune response to the three other serotypes, causing worse and longer illness.
*
Influenza had been infecting humans for generations before anybody came up with the notion of influenza vaccines. Despite the efforts of public health authorities everywhere, most people catch the flu before they are ever vaccinated, and so flu shots have little opportunity to undermine population-wide immunity to influenza A.
The complex system constituted by SARS-CoV-2 and its interactions with the human immune system, on the other hand, remains barely understood. In chasing an empty fantasy of herd immunity, authorities are denying human populations everywhere the opportunity to develop the layered, population-wide resistance against successive SARS-2 strains that is the foundation of our immunity against other respiratory viruses. Aside from the minority that have managed to recover from natural infection before the vaccinators got to them, most humans will have their crucial, primary immune response conditioned by the spike protein of SARS-2 in its vintage 2020 configuration.
It is a near certainty that this immunity will attenuate antibody responses to the spike protein of current and future variants, forever. Mutant spike proteins will increasingly escape vaccine-conferred immunity, and breakthrough infections will elicit only partial response to the new epitopes. Insofar as the data also suggest that our vaccines will attenuate immunity to other virus proteins beyond spike, mass vaccination will lead to ever more volatile waves of infection – in exchange for limited and fading protection against severe outcomes.
The most dangerous thing to do, at this point, would be to vaccinate children. The virus is not a threat to them, and if they are infected by the new forms of SARS-2 that are sure to emerge every winter, we will begin to establish – through them and the as yet unvaccinated – the layered immunity that is the only way of coming to terms with SARS-2 in the longer term. As long as the vaccinators are permitted to continue their radical and increasingly insane campaign, though, nothing will improve. Indeed, their policies threaten to bring about a semi-permanent pandemic state for generations to come.
By Toby Rogers | October 25, 2021
Where to even begin with the FDA’s preposterous risk-benefit analysis of Pfizer’s mRNA COVID-19 “vaccine” in children ages 5 to 11?
Let’s start with my bona fides. I have a year of undergraduate statistics at one of the best liberal arts colleges in America (Swarthmore). I have a year of graduate statistics at the masters program rated #1 for policy analysis (UC Berkeley). And I have a Ph.D. in political economy from one of the top universities in the world (University of Sydney). My research focus is on corruption in the pharmaceutical industry so I’ve read scientific studies in connection with vaccines nearly every day for 5 years. Earlier in my career I worked professionally tearing apart shoddy cost-benefit analyses prepared by corporations that were trying to get tax breaks, contracts, and other concessions from local government. Suffice it to say I’ve thought a lot about risk-benefit analysis and I’m better equipped than most to read one of these documents.
The FDA’s risk-benefit analysis in connection with Pfizer’s Emergency Use Authorization (EUA) application to inject children ages 5 to 11 with their COVID-19 vaccine is one of the shoddiest documents I’ve ever seen.
Let’s take it from the top:
🚩 COVID-19 rates in children ages 5 to 11 are so low that there were ZERO cases of severe COVID-19 and ZERO cases of death from COVID in either the treatment (n= 1,518) or control group (n= 750). So any claims you see in the press about the Pfizer vaccine being “90% effective” in children are meaningless because they are referring to mild cases from which children usually recover quickly (and then have robust broad spectrum immunity). So there is literally no emergency in this population for which one could apply for Emergency Use Authorization. Pfizer’s application should be dead on arrival if the FDA actually followed the science and their own rules. We will return to this topic below.
🚩 Pfizer’s clinical trial in kids was intentionally undersized to hide harms. This is a well known trick of the pharmaceutical industry. The FDA even called them out on it earlier this summer and asked Pfizer to expand the trial and Pfizer just ignored them because they can. (Pfizer fudged it by importing data from a different study but this other study only monitored adverse outcomes for 17 days so if anything the new data polluted rather than clarified outcomes). To put it simply, if the rate of particular adverse outcome in kids as a result of this shot is 1 in 5,000 and the trial only enrolls 1,518 in the treatment group then one is unlikely to spot this particular harm in the clinical trial. Voilà “Safe & Effective(TM)”.
🚩 Pfizer only enrolled “participants 5-11 years of age without evidence of prior SARS-CoV-2 infection.” Does the Pfizer mRNA shot wipe out natural immunity and leave one worse-off than doing nothing as shown in this data from the British government? Pfizer has no idea because children with prior SARS-CoV-2 infection were excluded from this trial. This was by design. Toxic polluters have learned to not ask questions that they do not want the answers to, lest they wind up staring at their own smoking gun in a future court case.
According to an analysis by Alex Berenson:
“What the British are saying is they are now finding the vaccine interferes with your body’s innate ability after infection to produce antibodies against not just the spike protein but other pieces of the virus. Specifically, vaccinated people don’t seem to be producing antibodies to the nucleocapsid protein, the shell of the virus, which are a crucial part of the response in unvaccinated people. This means vaccinated people will be far more vulnerable to mutations in the spike protein EVEN AFTER THEY HAVE BEEN INFECTED AND RECOVERED ONCE (or more than once, probably). It also means the virus is likely to select for mutations that go in exactly that direction because those will essentially give it an enormous vulnerable population to infect. And it probably is still more evidence the vaccines may interfere with the development of robust long-term immunity post-infection.”
🚩 Did Pfizer LOSE CONTACT with 4.9% of their clinical trial participants? The FDA risk-benefit document states: “Among Cohort 1 participants, 95.1% had safety follow-up ≥2 months after Dose 2 at the time of the September 6, 2021 data cutoff.” So what happened with those 4.9% who did not have safety follow-up 2 months after Dose 2? Were they in the treatment or control group? We have no idea because Pfizer isn’t saying. Given the small size of the trial, failing to follow up with 4.9% of the participants potentially skews the results.
🚩 The follow up period was intentionally too short. This is another well-know trick of the pharmaceutical industry designed to hide harms. Cohort 1 appears to have been followed for 2 months, cohort 2 was only monitored for adverse events for 17 days. Many harms from vaccines including cancer and autoimmune disorders take much longer to show up. As the old saying goes, “you can have it quick or you can have it done right, but you cannot have both.” Pfizer chose quick.
🚩 The risk-benefit model created by the FDA only looks at one known harm from the Pfizer mRNA shot — myocarditis. But we know that the real world harms from the Pfizer mRNA shot go well beyond myocarditis and include anaphylaxis, Bell’s Palsy, heart attack, thrombocytopenia/ low platelet, permanent disability, shingles, and Guillain-Barré Syndrome (GBS) to name a few. Cancer, diabetes, endocrine disruption, and autoimmune disorders may show up later. But the FDA does not care about any of that because they have a vaccine to sell so they just ignore all of those factors in their model.
🚩 Pfizer intentionally wipes out the control group as soon as they can by vaccinating all of the kids who initially got the placebo. They claim that they are doing this for “ethical reasons”. But everyone knows that Pfizer’s true aim is to wipe out any comparison group so that there can be no long term safety studies. Wiping out the control group is a criminal act and yet Pfizer, Moderna, J&J, and AZ do this as standard practice with the blessing of the FDA/CDC.
🚩 Given all of the above, how on earth did the FDA claim any benefits at all from this shot? You should probably sit down for this part because it’s a doozy! Here’s the key sentence:
Vaccine effectiveness was inferred by immunobridging SARS-CoV-2 50% neutralizing antibody titers (NT50, SARS-CoV-2 mNG microneutralization assay).
Wait, what!? I’ll explain. There were ZERO cases of severe COVID-19 in the clinical trial of children ages 5 to 11. So Pfizer and the FDA just ignored all of the actual health outcomes (they had to, there is no emergency, so the application is moot). INSTEAD Pfizer switched to looking at antibodies in the blood. In general, antibodies are a poor predictor of immunity. And the antibodies in the blood of these 5 to 11 year old children tell us nothing because again, there were zero cases of severe COVID-19 in this study (none in the treatment group, none in the control group). So Pfizer had to get creative! What they came up with is “immuno-bridging”. Pfizer looked at the level of antibodies in the bloodwork of another study, this one involving people 16 to 25 years old, figured out the level of antibodies that seems to be protective in that population, then figured out how many kids ages 5 to 11 had similar levels of antibodies in their blood, and then came up with a number for how many cases, hospitalizations, ICU admissions, and deaths would be prevented by this shot in the 5 to 11 population in the future, based on the antibody levels and health outcomes from the 16 to 25 year old population. If your head hurts from that tortured logic, it should, because such chicanery is unprecedented in a risk-benefit analysis.
So when the FDA uses this tortured logic at the beginning of their briefing document, all of the calculations that stem from this will be flat out wrong. Not just wrong but preposterous and criminally wrong.
The whole ballgame comes down to Table 14 on page 34 of the FDA’s risk-benefit document. And there the red flags come fast and furious.
🚩 The FDA model only assesses the benefits of vaccine protection in a 6-month period after completion of two doses. Furthermore it assumes constant vaccine efficacy during that time period. This is problematic on several counts.
First, reducing mild cases in children is not a desired clinical outcome. As Dr. Geert Vanden Bossche points out, mass vaccination turns kids into shedders of more infectious variants.
“Under no circumstances should young and healthy people be vaccinated as it will only erode their protective innate immunity towards Coronaviruses (CoV) and other respiratory viruses. Their innate immunity normally/ naturally largely protects them and provides a kind of herd immunity in that it dilutes infectious CoV pressure at the level of the population, whereas mass vaccination turns them into shedders of more infectious variants. Children/ youngsters who get the disease mostly develop mild to moderate disease and as a result continue to contribute to herd immunity by developing broad and long-lived immunity. If you are vaccinated and get the disease, you may develop life-long immunity too but why would you take the risk of getting vaccinated, especially when you’re young and healthy? Firstly, there is the risk of potential side effects; secondarily, there is the ever increasing risk that your vaccinal antibodies will no longer be functional while still binding to the virus, thereby increasing the likelihood of ADE or even severe disease….”
Second, we know that vaccine efficacy in the month after the first dose is negative because it suppresses the immune system and it begins to wane after 4 months so all of the FDA’s estimates of vaccine efficacy are inflated.
Third, the harms of myocarditis from these shots will likely unfold over the course of years. Robert Malone, the inventor of mRNA technology notes that the FDA is admitting that children will be injected twice a year forever (hence the six month time frame in the FDA risk-benefit model). But the risks of “adverse events such as cardiomyopathy will be cumulative.” So any model that only looks at a six month time frame is hiding the true adverse event rate.
🚩 The FDA/Pfizer play fast and loose with their estimates of myocarditis. First they estimate “excess” (read: caused by the shot) myocarditis using data from the private “Optum health claim database” instead of the public VAERS system (p. 32). So it’s impossible for the public to verify their claims. Then, when it comes to estimating how many children with vaccine-induced myocarditis will be hospitalized and admitted to the ICU they use the Vaccine Safety Datalink (see page 33). Why switch to a different database for those estimates? Finally, there is no explanation for how they calculated “excess” myocarditis deaths, so they just put 0. Red flag, red flag, red flag.
The FDA estimates that there will be 106 extra myocarditis cases per 1 million double-jabbed children 5-11. There are 28,384,878 children ages 5 to 11 in the U.S. The Biden administration wants to inject Pfizer mRNA shots into all of them and has already purchased enough doses to do just that (even though only 1/3rd of parents want to jab their kids with this shot). So (if the Biden administration has its way) 106 excess myocarditis cases per 1 million x 28.38 million people would be 3,009 excess myocarditis cases post-vaccination if the Pfizer vaccine is approved.
And over the course of several years many of those children will die.
Dr. Anthony Hinton (“Consultant Surgeon with 30 years experience in the NHS”) points out that myocarditis has a 20% fatality rate after 2 years and a 50% fatality rate after 5 years:
So the FDA has it exactly backwards — they want to prevent mild COVID in children which reduces herd immunity and they just flat out lie about the harms from myocarditis.
I’ve taken the liberty to correct the FDA’s Table 14 with actual real world data and extended it over 5 years. It looks like this:
A study by Harvard Pilgrim Healthcare for the U.S. Department of Health and Human Services estimated that VAERS only captured 1% of actual vaccine injuries. Steve Kirsch has done elaborate modeling that puts the Under-Reporting Factor of COVID-19 vaccine deaths at 41 (so multiply the above numbers by 41). And myocarditis is just one of a multitude of possible harms from COVID-19 vaccines. Dr. Jessica Rose recently calculated an Under-Reporting Factor of 31 for all severe adverse events following vaccination.
Conclusion
The Pfizer vaccine fails any honest risk-benefit assessment in connection with its use in children ages 5 to 11. The FDA’s risk-benefit analysis of Pfizer’s mRNA vaccine in children ages 5 to 11 is shoddy. It used tortured logic (that would be rejected by any proper academic journal) in order to reach a predetermined result that is not based in science. The FDA briefing document is a work of fiction and it must be withdrawn immediately. If the FDA continues with this grotesque charade it will cause irreparable harms to children and the FDA leadership will one day be prosecuted for crimes against humanity.
By Megan Redshaw | The Defender | October 26, 2021
The U.S. Food and Drug Administration’s (FDA) advisory committee today endorsed Pfizer’s COVID vaccine for children ages 5 to 11, despite strong objections raised during the meeting by multiple scientists and physicians.
The vote passed with 17 supporting it and one abstention.
Before the shots can be rolled out, the FDA will have to formally authorize the vaccine, and the Centers for Disease Control and Prevention (CDC) must also weigh in with its own recommendations — but the Biden administration’s announcement last week that it has already ordered 68 million doses of the pediatric vaccine suggests Pfizer’s request will sail through.
During today’s meeting, the Vaccines and Related Biological Products Committee (VRBPAC) heard evidence from Pfizer and regulators, and listened to concerns from numerous experts.
According to the FDA website, as of Oct. 25, the agency had received 139,470 comments from the public prior to today’s meeting — a number federal officials described as strikingly high.
As he opened the meeting, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), said, “I want to acknowledge the fact that there are strong feelings that have clearly been expressed by members of the public both for and against” authorization.
Marks stressed the only question before the experts was whether shots should be allowed, not whether to mandate them, the New York Times reported.
The dose for younger children would be one-third the strength given to people 12 and older, with two shots given three weeks apart.
Based on CDC data presented during the meeting, among children 5 to <12 years of age, there have been approximately 1.8 million confirmed and reported COVID cases since the beginning of the pandemic, and only 143 COVID-related deaths in the U.S. through Oct. 14.
In this same age group, there were 8,622 COVID-related hospitalizations through Sept 18.
“This translates to cumulative incidence rates of approximately 6,000 and 30 per 100,000 for confirmed COVID cases and COVID-related hospitalizations, respectively, among children 5 to <12 years of age,” Pfizer’s application said.
Children with underlying medical conditions, such as asthma, diabetes and obesity, made up two-thirds of severe COVID cases.
Pfizer provided safety data on two study cohorts of children ages 5 to 11, both of roughly equal size. The first group was followed only for about two months, the second for only two-and-a-half weeks.
The two-month cohort included 2,268 children ages 5 to 11. Of the 2,268 children, 1,518 received the vaccine and 750 received a placebo. Each received two shots spaced three weeks apart.
Pfizer’s study found its vaccine was about 91% effective against symptomatic COVID in children, based on 16 cases of COVID in the placebo group and three cases in the vaccinated group over the brief follow-up period.
Most side effects occurred within a couple of days and included pain at the injection site, fatigue, headache, muscle pains and chills, Pfizer said.
According to Pfizer, the number of participants in the current clinical development program was “too small to detect any potential risks of myocarditis associated with vaccination.”
Long-term safety of Pfizer’s COVID-19 vaccine “to evaluate long-term sequelae of post-vaccination myocarditis/pericarditis” in participants 5 to <12 years of age will not be studied until after the vaccine is authorized for children,” Pfizer’s application noted.
Pfizer data insufficient, kids’ risk of vaccine injury greater than COVID risk, experts say
Experts raised concerns over the lack of safety and efficacy data presented by Pfizer for use of its COVID vaccine in younger children, and they pointed to increasing safety signals based on reports to the Vaccine Adverse Event Reporting System (VAERS).
They also questioned the need to vaccinate children — whose risk of dying from COVID is “almost nil” — at all.
According to Dr. Meryl Nass, member of the Children’s Health Defense Scientific Advisory Panel, Pfizer once again did not use all of the children who participated in the trial in their safety study.
“Three thousand children received Pfizer’s COVID vaccine, but only 750 children were selectively included in the company’s safety analysis,” Nass said. “Studies in the 5-11 age group are essentially the same as the 12-15 group — in other words, equally brief and unsatisfying, with inadequate safety data and efficacy data, with no strong support for why this type of immuno-bridging analysis is sufficient.”
Nass said, “All serious adverse events were considered unrelated to the vaccine.”
During the meeting and in its FDA application, Pfizer argued children should be vaccinated to prevent SARS-CoV-2 transmission, yet the company did not assess asymptomatic transmission.
Dr. Ofer Levy, a VRBPAC member, asked for evidence that Pfizer’s vaccine prevents transmission.
Dr. William Gruber, senior vice president of Pfizer Vaccine Clinical Research and Development, said they did not assess whether the vaccine prevents transmission, but said there is evidence the vaccine prevents transmission in adults.
When questioned further, Gruber was unable to cite specific evidence to back his assertion.
Steve Kirsch, founder of the COVID-19 Early Treatment Fund, asked the panel how they could do a risk-benefit analysis with Pfizer’s COVID vaccine if they did not know the CDC’s VAERS under-reporting factor (URF).
Kirsch asked:
“How can you do a risk-benefit of analysis of COVID vaccines if you don’t know the URF? This is extremely, extremely important. You have been assuming it has been one. It is not one. Using a URF of 41, which is calculated using CDC methodology, we find over 300,000 excess deaths in VAERS. If the vaccine didn’t kill these people, what did?”
“How many Americans have to die before you pull the plug?” Kirsch asked.
Kirsch also questioned the panel on why Maddie de Garay’s severe adverse reaction to the Pfizer vaccine, which left her paralyzed, was not reported by the company to the FDA.
Dr. Jessica Rose, viral immunologist and biologist, told the panel EUA of biological agents requires the existence of an emergency and the nonexistence of alternate treatment.
“There is no emergency and COVID-19 is exceedingly treatable,” Rose said.
In a peer-reviewed study co-authored by Rose, myocarditis rates were significantly higher in people 13 to 23 years old within eight weeks of the COVID vaccine rollout.
In 12- to15-year-olds, Rose said, reported cases of myocarditis were 19 times higher than background rates.
“In an act of censorship, this paper has been temporarily removed and it has now been killed without criticism of the work,” Rose said, noting the timing of the removal was strange.
Rose said tens of thousands of reports have been submitted to VAERS for children ages 0 to 18.
Rose explained:
“In this age group, 60 children have died — 23 of them were less than 2 years old. It is disturbing to note that “product administered to patient of inappropriate age was filed 5,510 times in this age group. Two children were inappropriately injected, presumably by a trained medical professional, and subsequently died.”
Dr. Josh Guetzkow, a senior lecturer at the Hebrew University of Jerusalem, said expanding the EUA to children is unnecessary, premature and will do more harm than good.
Guetzkow said there is no emergency for children, especially healthy ones whose risk of severe illness and death is “almost nil.”
Guetzkow said kids with pre-existing conditions and prior COVID infections were not included in Pfizer’s study, so including them in the EUA is negligence.
“Pfizer’s trial is woefully underpowered to detect specific safety concerns, such as myocarditis, just like the adolescent study was, and if they weren’t able to detect an unexpected safety concern there, they wouldn’t be able to here,” Guetzkow said.
Guetzkow said:
“In Pfizer’s study, only .5% of controls were dropped due to important protocol violations, versus 3% in the treatment group. The odds of that happening by chance are 1 in 10,000. This deviation is poorly explained with no ITT analysis. The study is not double-blind and may be subject to bias. Most VSD safety monitoring programs have not reported results, why not wait?”
Guetzkow said, “from CDC reports, we can expect that for every 18 child hospitalizations prevented, at least 43 will end up in the hospital for all causes following vaccination,” yet, the “FDA’s risk-benefit analysis only counts myocarditis hospitalization.”
“Why ignore the V-safe data, and shouldn’t FDA verify Pfizer’s efficacy and immunobridging analysis first?” he asked.
Guetzkow said VAERS shows alarming safety signals, which cannot be attributed to increased vaccination, simulated reporting or COVID infections.
“We calculated the ratio of adverse events reported per million Pfizer vaccinations to reports per million flu vaccinations among teenagers to see what to expect in children. Serious events are reported 51% more often for Pfizer, deaths 47 times, life-threatening conditions 49 times,” Guetzkow said.
Guetzkow asked the panel to look at the data on COVID vaccines compared to flu vaccines. Pointing to the data on reproductive organs, Guetzkow asked, “why would we expect children to take these risks to protect adults?”
There are more than 900 types of adverse events reported after Pfizer vaccination that have never been reported after flu vaccines, including 11 cases of multisystem-inflammatory syndrome (MS-C) that occurred without previous history of COVID infection, Guetzkow said.
He added that if the panel was considering authorizing Pfizer’s COVID vaccine to prevent MS-C — as Pfizer’s application suggested as one of the reasons they should — the panel should reconsider.
During another part of the meeting, Julia Barnes-Weise, director of the Global Healthcare Innovation Alliance Accelerator, said pharmaceutical companies have concerns.
“One of them is, especially for a not-yet-approved vaccine, that they could be held liable for any injury that that vaccine seems to have caused,” Barnes-Weise said.
In a preliminary analysis last week, FDA reviewers said protection would “clearly outweigh” the risk of a very rare side effect in almost all scenarios of the pandemic, PBS News Hour reported.
Children’s Health Defense (CHD) said yesterday it would take legal action against the FDA if it granted EUA for the Pfizer-BioNTech vaccine for children 5- to 11- years old.
In a letter signed by Robert F. Kennedy, Jr., CHD chairman and chief legal counsel, and Nass, Kennedy and Nass wrote:
“CHD will seek to hold you accountable for recklessly endangering this population with a product that has little efficacy but which may put them, without warning, at risk of many adverse health consequences, including heart damage, stroke, and other thrombotic events and reproductive harms.”
Megan Redshaw is a freelance reporter for The Defender. She has a background in political science, a law degree and extensive training in natural health.
© 2021 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.
There is no justification for Vaccine Passports
By Martin Zandstra • THE EXPOSÉ • October 25, 2021
IT’S OFFICIAL: Most of the UK’s vaccinated population are suffering far higher rates of infection than the unvaccinated, and it is getting worse by the day.
The UK’s Health Security Agency publishes detailed Covid statistics, which, for the last 7 weeks, have been tabulated by age-group and vaccination status. This now allows important questions to be answered.
The Agency says most vaccinated suffer substantially higher rates of infection, and their latest chart provides a snap-shot:
All of the UK’s 30-and-over vaccinated now endure far higher rates of infection than their unvaccinated counterparts. But as a snap-shot, this tells us nothing of how this arose, or how it may yet develop. Here we re-present the agency’s data in a time-series, to promote better understanding of the trends and implications.
The UK has vaccinated its population mostly in age order, from oldest to youngest, and very recently began vaccinating its under-18-year-old cohort. Being the UK’s most freshly vaccinated, they exhibit a very high degree of resistance to Covid infection: –
This very recently vaccinated cohort benefits from a 90% improvement in their infection rates, meaning their case incidence is 10 times better than that of their unvaccinated counterparts. This is impressive, and leads us to ask how long this high degree of protection might last?
The answer, unfortunately, seems to be not very long:
The previous UK age-group to be vaccinated was the 18–29-year-old cohort, of which half was fully vaccinated by some 9 weeks ago. While still doing better than the unvaccinated of their age, they have nevertheless lost the greater part of their relative resistance to infection. If they continue their trajectory, week 12 will see that benefit completely gone.
The earlier vaccinated age-group was the 30–39 cohort. Half was fully vaccinated around week 27, and by week 39 (again some 12 weeks later) had lost their enhanced infection resistance. For at least for these two cohorts, it would seem their vaccine induced resistance reduced to zero in under 3 months.
Unfortunately, it does not stop there; Following the data shows the vaccinated descend well into negative territory, which may prompt us to ask how all earlier vaccinated cohorts are now doing?
In terms of vulnerability to infection, the answer is not so well:
The entire 40-79 vaccinated cohort is deeply negative, now below minus 50%, meaning they suffer more than double the infection rate of their unvaccinated counterparts, and there is no obvious end in sight; Given the consistent and strongly negative continuing trend for all adult cohorts, it is impossible to guess where or when these trajectories might bottom out.
But does the trend result from increased vulnerability amongst the vaccinated, or is improved resistance developing amongst the unvaccinated? The answer appears to be both:
Unvaccinated adults are enjoying significantly lowered infection rates, but the vaccinated are very clearly headed in the opposite direction:
This begs the question: Why should the vaccinated suffer mounting infection rates, while case-rates of the unvaccinated both declined and are lower? Surely, we should expect the vaccinated to do better – certainly no worse?
Yet, for all but one adult cohort, the exact opposite is true, and even for them, it seems likely for not much longer:
It has been suggested infection amongst the unvaccinated has induced robust natural immunity leading towards their herd-immunity. That may well be a factor, but, as we have seen, the vaccinated have similarly been infected, and at least for the 40-79 cohort, at much higher rates. Why should this not benefit the vaccinated as well?
Are we to understand infection after vaccination may not produce similar broad immunity?
Vaccination is intended to alter subsequent immune response to infection, which is, of course, the whole point; It is conceivable this altered response may mute the development of broad long-lasting immunity that otherwise typically results from natural infection. That might then leave the vaccinated more open to re-infection, and might help explain these results. But this remains speculation, we simply do not know today.
What we do know from the UK data, is that anyone vaccinated more than few months ago is at greatly higher risk of Covid infection, and is therefore greatly more likely to be infected than their unvaccinated counterparts.
Much has been said and written to show the vaccinated are equally capable of transmitting Covid. But because their symptoms are often muted, they are also more likely to be out and about; add this to escalating infection rates, and there can be little doubt the vaccinated now constitute by far the greatest Covid transmission risk.
In light of this, vaccine passports are clearly senseless; They are nothing more than an invitation to infection, for which no justification can now possibly remain.
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Sputnik – 15.02.2018
On February 13, 1960, France carried out its first nuclear test in Algeria’s southern Reggane region. According to official statistics, 17 nuclear tests were carried out in total over the next 6 years. The area remains affected, and local scientists say that radioactive contamination has caused genetic mutations and irreversibly changed the region.
There are no official statistics on the number of victims. The only figures can be found in the records kept by the French representative of the local church, which lists 42,000 victims of nuclear tests. Three years ago, the French Ministry of Defense issued a statement, putting the number at 27,000 people. The victims include French soldiers as well as local Algerians who lived in the surrounding areas. … continue
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