By Megan Redshaw | The Defender | October 29, 2021
Data released Friday by the Centers for Disease Control and Prevention (CDC) showed that between Dec. 14, 2020, and Oct. 22, 2021, a total of 837,595 adverse events following COVID vaccines were reported to the Vaccine Adverse Event Reporting System (VAERS).
The data included a total of 17,619 reports of deaths — an increase of 491 over the previous week. There were 127,457 reports of serious injuries, including deaths, during the same time period — up 4,624 compared with the previous week.
Excluding “foreign reports” to VAERS, 622,743 adverse events, including 8,068 deaths and 51,532 serious injuries, were reported in the U.S. between Dec. 14, 2020, and Oct. 22, 2021.
Of the 8,068 U.S. deaths reported as of Oct. 22, 11% occurred within 24 hours of vaccination, 15% occurred within 48 hours of vaccination and 27% occurred in people who experienced an onset of symptoms within 48 hours of being vaccinated.
In the U.S., 411.6 million COVID vaccine doses had been administered as of Oct. 15. This includes: 242 million doses of Pfizer, 154 million doses of Moderna and 15 million doses of Johnson & Johnson (J&J).
The data come directly from reports submitted to VAERS, the primary government-funded system for reporting adverse vaccine reactions in the U.S.
Every Friday, VAERS makes public all vaccine injury reports received as of a specified date, usually about a week prior to the release date. Reports submitted to VAERS require further investigation before a causal relationship can be confirmed.
Historically, VAERS has been shown to report only 1% of actual vaccine adverse events.
This week’s U.S. data for 12- to 17-year-olds show:
The most recent death involves a 12-year-old girl (VAERS I.D. 1784945) who died from a respiratory tract hemorrhage 22 days after receiving her first dose of Pfizer’s vaccine.
Another recent death includes a 15-year-old male who died six days after receiving his first dose of Pfizer’s COVID vaccine. According to his VAERS report (VAERS I.D. 1764974), the previously healthy teen complained of brief unilateral shoulder pain five days after receiving his COVID vaccine. The next day he played with two friends at a community pond, swung on a rope swing, flipped into the air, and landed in the water feet first. He surfaced, laughed and told his friends “Wow, that hurt!” He then swam toward shore underwater, as was his usual routine, but did not re-emerge.
An autopsy showed no external indication of a head injury, but there was a small subgaleal hemorrhage — a rare, but lethal bleeding disorder — over the left occiput. In addition, the boy had a mildly elevated cardiac mass, increased left ventricular wall thickness and small foci of myocardial inflammation of the lateral wall of the left ventricle with myocyte necrosis consistent with myocardial infarction.
This week’s U.S. VAERS data, from Dec. 14, 2020, to Oct. 22, 2021, for all age groups combined, show:
FDA grants Emergency Use Authorization for Pfizer Vaccine for 5- to 11-year-olds
The U.S. Food and Drug Administration (FDA) today granted Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID vaccine for children 5 to 11 years old, The Associated Press reported.
The announcement followed Tuesday’s recommendation by the FDA’s vaccine advisory committee that the agency grant Pfizer’s request. The advisory committee vote passed with 17 in support, and one abstention.
Reporting on today’s news, STAT noted:
“The vaccine was not granted FDA approval, but instead an emergency use authorization. Emergency authorizations are used when the secretary of health and human services has declared a public health emergency to more quickly clear the use of vaccines, treatments, and diagnostic tests. These authorizations lapse when the state of emergency ends. Pfizer’s vaccine was fully approved for those age 16 and older in August, and was previously granted an emergency use authorization for use in adolescents ages 12 to 15.”
The dose for younger children will be one-third the strength given to people 12 and older, with two shots given three weeks apart. Before the shots can be rolled out, the CDC must weigh in with its own recommendations.
During Tuesday’s meeting, the Vaccines and Related Biological Products Committee heard evidence from Pfizer and regulators, and listened to concerns raised by multiple scientists and physicians.
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.
Pfizer provided safety data on two study cohorts of children ages 5 to 11, both of roughly equal size. The first group was followed for only about two months, the second for only two-and-a-half weeks.
Pfizer said “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 vaccine ‘failed any reasonable risk-benefit calculus in connection with children,’ scientist says Brian Dressen, Ph.D., is one of the scientists who testified Tuesday during the FDA advisory committee’s 8-hour hearing. Dressen is also the husband of Brianne Dressen, who in 2020 developed a severe neurological injury during the Utah-based portion of the U.S. AstraZeneca COVID vaccine.
During his 3-minute testimony, Dressen, a chemist with an extensive background in researching and assessing the degree of efficacy in new technologies, told the FDA advisory panel Pfizer’s vaccine “failed any reasonable risk-benefit calculus in connection with children.”
Dressen said the decision to authorize for 5- to 11-year-olds is being rushed and is based on “incomplete data from underpowered trials, insufficient to predict rates of severe and long-lasting adverse reactions.”
Dressen urged the committee to reject the EUA modification and direct Pfizer to perform trials that decisively demonstrate the benefits outweigh the risks for children.
Dressen’s wife was severely injured last November after receiving her first and only dose of a COVID vaccine administered during a clinical trial.
“Because study protocol requires two doses, she was dropped from the trial, and her access to the study app deleted,” Dressen said. “Her reaction is not described in the recently released clinical trial report — 266 participants are described as having an adverse event leading to discontinuation, with 56 neurological reactions tallied.”
CDC updates guidance allowing immunocompromised to get a fourth COVID shot
Immunocompromised adults who received a third dose of either the Pfizer-BioNTech or Moderna COVID vaccine will become eligible for a fourth booster shot six months after receiving their third dose, according to CDC guidance issued Monday.
“In such situations, people who are moderately and severely immunocompromised may receive a total of four vaccine doses,” with the fourth coming at least six months after the third, the CDC’s new guidelines said.
In August, the CDC authorized a third dose of either Pfizer-BioNTech or the Moderna mRNA vaccine — but not Johnson and Johnson’s (J&J) adenovirus vaccine — for certain immunocompromised people 18 and older.
However, a third dose is now considered part of the primary series, rather than a booster. The earliest that immunocompromised people who received a third mRNA vaccine shot can get a fourth shot as a booster would be February.
The agency said people could select that booster from any of the three COVID vaccines available in the U.S, including J&J, but specified a fourth dose of Moderna’s vaccine should be half the size of a normal dose.
Double-vaccinated can still spread the virus at home
Fully vaccinated people are catching COVID and passing it on to those they live with, warn experts in the UK. A British study published in the Lancet Oct. 29, showed individuals who have had two vaccine doses can be just as infectious as those who have not been jabbed.
Even if they are asymptomatic or have few symptoms, the chance of transmitting the virus to other unvaccinated housemates is about two in five, or 38%. This drops to one in four, or 25%, if housemates are also fully vaccinated.
“By carrying out repeated and frequent sampling from contacts of COVID-19 cases, we found that vaccinated people can contract and pass on an infection within households, including to vaccinated household members,” said Dr. Anika Singanayagam, co-lead author of the study.
“Our findings provide important insights into … why the Delta variant is continuing to cause high COVID-19 case numbers around the world, even in countries with high vaccination rates.
Vaccinated contacts who tested positive for COVID on average received their shots longer ago than those who tested negative, which the authors said was evidence of waning immunity and supported the need for booster shots.
Neil Ferguson, an Imperial epidemiologist, said the transmissibility of Delta meant that it was unlikely Britain would reach herd immunity for long.
“That may happen in the next few weeks: If the epidemic’s current transmission peaks and then starts declining, we have by definition in some sense reached herd immunity, but it is not going to be a permanent thing,” Ferguson told reporters.
16-year-old girl develops severe vulvar ulcers after second Pfizer shot
A case report published Oct. 25 in the Journal of Pediatric and Adolescent Gynecology revealed a new potential novel side effect of Pfizer’s COVID vaccine that doctors say warrant further investigation.
According to the report, a 16-year-old non-sexually active female presented to the pediatric gynecology clinic with vaginal pain six days after receiving her second dose of Pfizer’s COVID vaccine.
Within 24 hours of receiving the vaccine, the girl developed fever, fatigue, myalgias and “sores” in her vaginal area. Over the next two days, right-sided lesions in her vaginal area coalesced and became more painful. The teen went to the urgent care with a fever of 105 degrees. She was diagnosed with a Bartholin gland abscess.
Despite antibiotic therapy, her symptoms worsened and her lesions were covered in exudate with a necrotic, ring-like border. In the gynecology clinic, the patient’s lesions were exquisitely painful, resulting in difficulty with urination, defecation and walking. She had no respiratory symptoms and no history of COVID exposure.
The report said the findings “were consistent with vulvar aphthous ulcers in association with influenza-like symptoms following Pfizer BioNTech (BNT162b2) COVID-19 vaccination.”
“Our patient had typical clinical features of aphthous ulcer, including an influenza-like prodrome and characteristic dermatologic manifestations which occurred after receiving the Pfizer COVID vaccine,” the authors wrote. According to the report, the girl’s case was submitted to VAERS “due to the temporal relationship with COVID vaccine administration.”
Children’s Health Defense asks anyone who has experienced an adverse reaction, to any vaccine, to file a report following these three steps.
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.
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.”
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.
By Helen Buyniski | RT | October 26, 2021
The rediscovery of a series of grisly experiments on beagle puppies has galvanized social media users into demanding the arrest of “America’s doctor” Anthony Fauci. But where was everyone when his work was harming humans?
Images of a sad pair of beagle puppies, their heads encased in square cages as they lie hopelessly on a table, have yanked at America’s heartstrings since they were shoved back into the national spotlight by White Coat Waste Project, a group that calls out US government labs for animal cruelty and other misuse (and abuse) of citizens’ money.
Millions of taxpayer dollars were used to essentially torture the puppies to death in labs in and out of the US, according to the organization, which unearthed evidence of the cruelty in the form of over $21 million spent on a total of four experiments – none of which was medically necessary. One involved severing 44 puppies’ vocal cords so that their pained barking and whining wouldn’t bother the scientists; another deliberately infected them with sand flies over the course of 22 months, restricting their movements by locking their heads in boxes so that they could not even swat the insects away as they were being eaten alive.
It’s horrific stuff by any measure, beyond cartoonish levels of evil. Indeed, even Texas Senator Ted Cruz (R) claimed he thought the tweets he’d read about Fauci “literally ‘torturing puppies’” had to be “metaphorical.”
But while the outrage is justified, it’s also old news. One could ask why the masses have turned against Fauci only now, when his National Institute for Allergies and Infectious Diseases has been funding the torture of puppies for years, with one of the horrific experiments dating from 2016. The most recent grant dated from 2020, meaning Fauci’s agency was vivisecting helpless furry animals at the University of Georgia even while he was being worshiped as America’s Doctor™ and posing for photos with other people’s dogs.
Even White Coat Waste Project refers to its own revelations as “Fauci’s other international scandal,” implying knowledge of a better-known episode in the fame-hungry doctor’s life.
One must ask why the popular outrage against Fauci over animal cruelty is not matched by an equal (if not more forceful) outrage over the doctor’s crimes against humanity. From his enthusiastic support of gain-of-function studies to his efforts to sideline a cheap, effective drug that could have saved thousands of lives during the AIDS epidemic in favor of a highly toxic alternative, Fauci’s hands are covered in the blood of humans as well as that of canines.
Indeed, Fauci’s behavior during the Covid-19 outbreak – trashing cheap but effective treatments in favor of expensive alternatives lacking proof of efficacy – eerily mirrors his actions during the early years of AIDS. Thousands of people have died in both cases after Fauci pushed deadly or ineffective medications – most notably the failed cancer drug AZT in the 1980s and the failed Ebola drug remdesivir in the last two years – while safer and more efficacious remedies sat on the shelf.
Indeed, the high-priced antiviral remdesivir, which has been pushed for Covid-19 despite no clinical proof it saves lives, has instead been associated with multiple organ failure in several studies.
Discoveries that members of the National Institutes of Health, parent of Fauci’s NIAID, had hefty investments in Gilead, maker of remdesivir, as well as in Moderna, one of the manufacturers of an mRNA vaccine for Covid-19, have only raised more questions about Fauci’s motives during the coronavirus pandemic.
Fauci has also been caught lying repeatedly about his involvement in gain-of-function research aimed at making bat coronaviruses more infectious in humans. Despite his profuse denials of even funding such research in recent months, he previously defended the work by arguing that any knowledge gained from bolstering the infectious potential of such pathogens was “worth the risk” of unleashing a pandemic. Whether or not his NIAID-funded research played a part in the Covid-19 outbreak has not been proven, but Fauci’s furious tap-dancing around any questions regarding the Wuhan lab or gain-of-function research in general does him no favors.
Yet, somehow, none of this elicits anything like the howls of rage coming from dog-lovers on social media. The same outrage-on-demand contingent who demand countries like China and Vietnam stop eating dog meat, signing a petition with one hand while biting into a well-done burger with the other, insist on the closure of “barbaric” wet markets like the one we were told spawned the novel coronavirus in late 2019. This group’s problem is less animal cruelty than being reminded of that cruelty. They’d rather wait until their meat is shrink-wrapped and frozen in a supermarket than pick out the tastiest-looking chicken in the bunch and have it slaughtered then and there.
Ultimately, Fauci being arrested is an endpoint that animal rights activists, human rights activists, and the normally comatose members of Congress – 24 of whom actually signed a letter demanding answers from the once-untouchable Coronavirus Pope – should see eye-to-eye on. But the diminutive doctor must not be permitted to skate on his real crimes – whether it’s pandemic profiteering, bankrolling gain-of-function research in China that was at the time illegal to perform in the US, or allegedly perjuring himself in congressional testimony. Fauci has much to answer for. Dozens of dead puppies are just the tip of the iceberg.
Unfortunately, like other gleeful architects of the Covid-19 police state who’ve been caught in the midst of scandal – former New York Governor Andrew Cuomo, for example – arresting Fauci on the basis of popular rage over dead puppies is likely to close the book on further prosecution, no matter how heinous his “real” crimes.
Just as Cuomo is unlikely to ever be held to account for the thousands of elderly New Yorkers who died because of his nursing-home order to house Covid-positive patients with the helpless elderly, Fauci will be permitted to enjoy his retirement – and big fat pension – in peace. Americans who have lost everything to his mismanagement of the Covid-19 pandemic must not let that happen.
Helen Buyniski is an American journalist and political commentator at RT. Follow her on Telegram
The mortality stats are truly disturbing
By Chris Waldburger | October 25, 2021
There was no pandemic for European citizens younger than 45 in 2020.
The mortality data from the very reputable and reliable Euromomo, the European mortality monitoring site, is unequivocal:
There is no variation from the prior years for mortality for young people.
The same is not true for older Europeans – although mortality compared to prior virus season/winters is not as high as you would expect:
As I have written before, it is far from certain this excess mortality is only due to covid.
To quote the most haunting covid piece of writing:
It wouldn’t take much to push a population of such elderly and frail people into a life-threatening situation. Lock them up for months on end. Deny them human contact on pain of arrest and fines they couldn’t hope to pay. Withdraw medical treatment. Quarantine their carers. Terrorise them with propaganda about a civilisation-ending disease. Order them to stay at home and avoid the contact of other people like the plague. Tell them hospitals standing empty are on the verge of being overwhelmed. Turn medical centres into places to fear, the breeding grounds of a deadly new disease. That should be more than enough. It has been more than enough.
To preserve the elderly, the world has used the young – who suffered no pandemic – as a shield.
The young have lost their jobs, their childhoods, their right to breathe air freely, their right to say no to experimental medicine they do not need.
And now they appear to be dying for the elderly too:
Please can somebody explain why deaths are rising so steeply in European youth?
They did not suffer from historically excess death in the middle of the pandemic.
Why are they dying now?
And it is not only them – US young people are suffering the same fate:
What changed?
Are these deaths of despair? Myocarditis?
More importantly, why does nobody care?
Do only the elderly rich count?
By Meryl Nass, MD | October 25, 2021
Here come jabs in schools without parental consent.
“Bonnie J. Fraser Henry OBC FRCPC is a Canadian physician who is the Provincial Health Officer for British Columbia, the first woman in this position. Henry is also a clinical associate professor at the University of British Columbia. She was a family doctor and is a specialist in public health and preventive medicine.”
In fact, the politicians have worked on this for years, and enshrined it in legislation, she says.
Watch her talk about it. https://www.librti.com/page/view-video?id=781
Looks like you can garner lots of awards when your heart is a stone, Bonnie.
And, like Presidential wannabe Governor Cuomo, she even had time to write a book about her leadership in the pandemic, titled Be Kind, Be Calm, Be Safe. Do these people know what they are, or are they high on their own supply?
Here someone collected her telling the truth about masks last year and flip-flopping later:
RT | October 24, 2021
A Pakistani taxi driver will leave US detention at Guantanamo Bay after 17 years behind bars. Mistaken for a wanted terrorist, the man suffered horrific torture in American custody, despite never being charged with any crime.
Ahmed Rabbani’s release was announced on Friday by Reprieve, a human rights NGO. Rabbani had been unanimously cleared for release by the prison’s Periodic Review Board, made up of senior officials from six US agencies, including the State Department and Department of Homeland Security.
Rabbani’s journey through the underbelly of the US’ post-9/11 security infrastructure began in Karachi, Pakistan, in 2002. Mistaken for wanted terrorist Hassan Ghul, the taxi driver was arrested by Pakistani authorities outside Ghul’s apartment complex and sold to American personnel in the country.
Information gleaned from an associate of Rabbani arrested on the same day was used to arrest several suspected Al-Qaeda operatives, including a supposed member of Osama Bin Laden’s security detail. However, Rabbani was never charged with any crime, and is not believed to be involved in terrorism.
Nevertheless, he spent more than 545 days after his arrest being tortured in a CIA ‘black site’ in Afghanistan. The torture inflicted there on Rabbani was detailed in the US Senate’s 2014 torture report, and included long periods of being shackled with his hands outstretched over his head, an agonizing position that led Rabbani to try to cut off his own hand to end the pain.
Testimony from multiple detainees held in the same CIA prison describes permanent darkness, cells flooded with excrement and infested with vermin, beatings, sleep deprivation, being buried in simulated graves, being stripped naked and doused with cold water, and being denied bathing facilities for months on end.
According to Reprieve, Rabbani’s interrogators knew that “they had the wrong man,” but tortured him anyway. After more than a year in the CIA facility, Rabbani was transferred to the Guantanamo Bay detention camp on US territory in Cuba. He would spend the next 17 years there, without a charge or trial date.
His case attracted international attention, and in 2018, Rabbani wrote an op-ed published in the Los Angeles Times describing physical and sexual abuse by guards, force-feeding, and repeated hunger strikes to protest the conditions of his imprisonment. At the time of the op-ed, Rabbani said that he was suffering from “stomach problems so acute that I cannot consume hard food without vomiting blood,” and was being denied digestible food.
Conditions in Guantanamo chipped away at Rabbani’s mental health. “There is no morning and no evening,” he wrote. “There is only despair.”
“Ahmed’s clearance is long overdue,” said Reprieve attorney Mark Maher. “For those of us who have supported him, the feeling is one of relief, tempered with sadness for all he has lost… but we won’t celebrate until he is back with his family in Pakistan and able to hug his 19-year-old son for the first time.”
Of the 780 people detained in Guantanamo Bay since the facility opened in 2002, 732 have been transferred elsewhere or released, 38 remain there, and nine have died in custody. President Joe Biden has promised to close the notorious prison before he leaves office, a promise that was made, but not kept, by his former boss Barack Obama.
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By SASAN FAYAZMANESH | March 17, 2008
It is now nearly three decades since the Unites States adopted the policy of dual containment of Iran and Iraq. While much has been written about the containment of Iraq, there has been very little in-depth analysis of this policy when it comes to Iran. In a book that is going to be released on March 31, 2008, entitled The United States and Iran: Sanctions, Wars and the Policy of Dual Containment (Routledge), I attempt to address this shortcoming by investigating when and why the US policy of containment of Iran came about, how it evolved, and where it stands today.[1] To the extent that Israel has been involved in US policy making, the study will also include the role that Israel has played in the containment of Iran. Also, since the fate of Iran has been inextricably linked to that of Iraq, occasionally the investigation will overlap with the containment of Iraq.
The policy of dual containment of Iran and Iraq originated during the Carter Administration, but it was not until the Clinton Administration that the expression “dual containment” became popular. … continue
Aletho News If Americans Knew No Tricks Zone
