Children Don’t Need COVID Vaccines, Canadian and Australian Groups Tell Public Health Officials
By Julie Comber, Ph.D. | The Defender | July 25, 2022
Groups in Canada and Australia are urging public health officials to reconsider rolling out COVID-19 vaccines for young children, following the authorization earlier this month in both countries of Moderna’s COVID-19 vaccine for children ages 6 months to 5 years.
The Australian Vaccine-risks Network (AVN) on July 19 sent an open letter to Dr. Brendan Murphy, secretary of Australia’s Department of Health and Aged Care, voting members of the Australian Technical Advisory Group on Immunisation and members of parliament threatening to “move forward with preparations for seeking the intervention of the Federal Court of Australia” if officials don’t respond.
The Canadian COVID Care Alliance (CCCA) on July 14 published an open letter to Canadian health officials stating their members would “be happy to meet you to discuss findings documented in this letter in greater detail.”
Both letters emphasized three arguments against authorizing the mRNA shots in young children and babies:
- Children don’t need COVID-19 vaccination because they are at extremely low risk of COVID-19.
- In any case, the mRNA shots don’t work well.
- The potential harm from the mRNA shots outweighs the benefits for young children.
Both letters also referenced the June 30 open letter to U.K. health officials from more than 70 physicians and scientists warning against vaccinating younger children against COVID-19.
The U.K. letter, written in response to the U.S. Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) in mid-June of the Moderna and the Pfizer-BioNTech COVID-19 shots for children as young as 6 months, urged U.K. health officials to not “make the same mistake” the FDA made.
All three letters referenced Søren Brostrøm, director of the Danish Health and Medicines Authority, who in June said, “We did not get much out of having children vaccinated against coronavirus last year.”
Australia’s Therapeutic Goods Administration on July 18 provisionally approved a pediatric dose of Moderna’s Spikevax COVID-19 shot for children ages 6 months to 5 years old. Rollout of the vaccines is contingent on input from the Australian Technical Advisory Group on Immunisation.
A few days earlier, on July 14, Health Canada authorized the use of Spikevax for children 6 months to 5 years of age. According to the statement, “As a result of this authorization, approximately 1.7 million children are now eligible for vaccination against COVID-19.”
Risks ‘far outweigh’ benefits for children
The 11-page CCCA letter contains 117 references and six pages of figures and graphs to support the group’s argument that “the data shows that, in the Omicron era, when population-based immunity is widespread, the risks associated with COVID-19 mRNA vaccines far outweigh the benefits in children.”
The authors of the CCCA letter criticized the FDA, stating, “no gold standard, placebo-controlled disease endpoint trials, large enough [with at least 800,000 participants] to categorically establish the clinical safety and long-term efficacy of the Pfizer COVID-19 mRNA vaccinations in children 12- to 15-years-old, 5- to 11-years-old, 2- to 4-years-old, and 6-months-old to 23-months-old have been undertaken.”
Instead, the EUA for Pfizer was “based on the preliminary results of four very small immuno-bridging trials, enrolling fewer than 3,000 participants each.”
The CCCA letter presented data from the Canadian province of Ontario, which “reported a negative dose-response effect for the COVID-19 vaccinations [original emphasis].”
The letter continued:
“In other words, the proportion of cases of COVID-19 were highest among those who had been ‘boosted,’ lower among the ‘fully inoculated’ and least among the ‘not fully inoculated’ (which includes the ‘uninoculated’).”
The authors presented graphs from the Public Health Ontario website, noting a similar pattern was observed in the 12- to 17-year-olds and the 5- to 11-year-old age groups.
“Additionally, a greater proportion of ‘boosted’ Ontarians have died, revealing that the vaccinations may be associated with serious secondary effects.”
The CCCA letter concludes:
“We trust that our research has provided you with evidence needed to adjust Canadian health policy to protect our children from undue harm. We would be happy to meet you to discuss findings documented in this letter in greater detail.”
‘Huge gap’ in Pfizer’s vaccine trial documentation
According to the authors of the AVN letter, the Pfizer documentation presented to the FDA had huge gaps in the evidence provided.
For example, the letter stated:
“The protocol was changed mid-trial. The original two-dose schedule exhibited poor immunogenicity with efficacy far below the required standard. A third dose was added by which time many of the original placebo recipients had been vaccinated.”
The AVN letter argued the Moderna shot for young children fails to meet Australia’s regulatory requirements to be granted “provisional determination” (similar to EUA in the U.S.) under regulation 10L(1)(a) of the Therapeutic Goods Regulations.
To receive provisional determination, there must be “an indication of the medicine is the treatment, prevention or diagnosis of a life-threatening or seriously debilitating condition,” the letter stated.
The authors said Australia’s health department and TGA did not “show any data or science to support a conclusion that COVID-19, and particularly the Omicron variant now widespread across Australia, is ‘life-threatening’ to infants aged 6 months up through 4 years, nor indeed that infants 6 months up through 4 years suffer ‘seriously debilitating’ symptoms when infected with COVID-19.”
The authors also addressed the issue of manipulative strategies used to promote COVID-19 vaccination of children, and said pushing unnecessary and novel mRNA-based vaccines onto young children risks undermining parental confidence in routine immunization programs.
Julie Comber is a freelance science reporter for The Defender.
© 2022 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.
How Pfizer Profited From the Pandemic
By Dr. Joseph Mercola | July 18, 2022
According to Kaiser Health News (KHN),1 the COVID-19 pandemic has been a real boon to Pfizer. Not only has it yielded “outsize benefits” in terms of profits, but it has also “given the drugmaker unusual weight in determining U.S. health policy.”
“Based on internal research, the company’s executives have frequently announced the next stage in the fight against the pandemic before government officials have had time to study the issue, annoying many experts in the medical field and leaving some patients unsure whom to trust,” KHN reporter Arthur Allen writes, adding:2
“When last year Bourla suggested that a booster shot would soon be needed, U.S. public health officials later followed, giving the impression that Pfizer was calling the tune.
Some public health experts and scientists worry these decisions were hasty, noting, for example, that although boosters with the mRNA shots produced by Moderna and Pfizer-BioNTech improve antibody protection initially, it generally doesn’t last.
Since January, Bourla has been saying that U.S. adults will probably all need annual booster shots, and senior FDA officials have indicated since April that they agree … The company’s power worries some vaccinologists, who see its growing influence in a realm of medical decision-making traditionally led by independent experts …
When President Biden in September 2021 offered boosters to Americans — not long after [Pfizer CEO Albert] Bourla had recommended them — Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia … wondered, ‘Where’s the evidence you are at risk of serious disease when confronted with COVID if you are vaccinated and under 50?’
Policies on booster recommendations for different groups are complex and shifting, Offit said, but the CDC, rather than Bourla and Pfizer, should be making them. ‘We’re being pushed along,’ he said. ‘The pharmaceutical companies are acting like public health agencies.’”
The fact that a vaccine-pusher like Offit — infamous for claiming a baby can safely tolerate 10,000 vaccines at once3 — is questioning and pushing back against Pfizer’s influence over health policy reveals just how brazen, unethical and potentially dangerous that is.
Massive Profits Made From Useless Products
According to Allen, Pfizer’s revenue in 2021 was $81.3 billion4 — approximately double that of 2020 — and the COVID shot accounted for $36.78 billion5 of that. For comparison, Lipitor, Pfizer’s previous top selling statin, generates roughly $2 billion a year,6 while their strep vaccine, Prevnar 13 rakes in $6 billion a year.7
Its mRNA gene transfer injection against COVID now dominates 70% of the U.S. and European markets, and Paxlovid, Pfizer’s COVID drug, has become a standard treatment choice in hospitals. This, despite researchers finding Paxlovid (molnupiravir) causes severe rebound and supercharges mutations.
In a rational scenario, that finding would have put a stop to its use, but no. In an official health advisory8 to the public, issued May 24, 2022, the U.S. Centers for Disease Control and Prevention first warns that Paxlovid is associated with “recurrence of COVID-19 or ‘COVID-19 rebound,’” and then in the very next sentence stresses in bold print a narrative supporting its use and enriching Pfizer with instructions saying:
“Paxlovid continues to be recommended for early- stage treatment of mild to moderate COVID-19 among persons at high risk for progression to severe disease.”
Allen also notes that, during an investor call, a Pfizer official highlighted reports of Paxlovid’s failure, but spun it into “good news” for investors, as patients may require multiple courses!9 Obviously the objective has long ago shifted from helping humans to raping them for as much profit as possible.
Similarly, while Pfizer’s COVID jab clearly doesn’t prevent infection or spread, and Americans are rejecting the shots in growing numbers — 82.2 million doses had expired and were chucked in the trash as of mid-May 202210 — the U.S. government still went ahead and ordered another 105 million doses at the end of June 2022.
These are intended for a fall booster campaign, at a cost to taxpayers of $3.2 billion.11 The U.S. is actually paying about 50% more for each of these new jab boosters this time around — $30.47 per dose compared to $19.50 per dose paid for the first 100 million doses.
The U.S. government has also promised to purchase another 20 million courses of Paxlovid, at an eye-watering cost of $530 per five-day course. Basically, Pfizer is being financially rewarded for producing products that are useless at best and dangerous at worst, and we’re all paying for it. In case you’re curious, that is another $10.6 billion transferred from U.S. taxpayers to Pfizer.
Future Boosters Won’t Undergo Human Clinical Trials
After you likely thought it couldn’t ever get any worse, KHN also touches on, but doesn’t delve into, the fact that Pfizer suggested they skip human trials as they move forward with jabs that are reformulated for newer variants. If this strikes you as crazy, you’d be right. It’s sheer madness, but the U.S. Food and Drug Administration — a clearly captured agency — has already surreptitiously agreed to this egregious miscarriage of science.
How this wicked scheme, known as the “Future Framework,”12 was adopted by the FDA without formal vote is explained by Toby Rogers, Ph.D. — a political economist whose research focus is on regulatory capture and Big Pharma corruption13 — in the video above. He also explained it in a June 29, 2022, Substack article:14
“Yesterday [June 28], the FDA’s Vaccines and Related Biological Products Advisory Committee approved a bivalent COVID-19 shot with the Wuhan strain and the Omicron variant … Wait, hold up, I thought the FDA was voting on the Future Framework yesterday?
The policy question was whether reformulated COVID-19 shots would be treated as new molecular entities (which they are) in which case they should be subject to formal review or whether reformulated shots would be treated as ‘biologically similar’ to existing Covid-19 shots and be allowed to skip clinical trials altogether.
Apparently the FDA did not have the votes to just pass this as a policy question. If you ask anyone whether reformulated mRNA represents a new molecular entity, well of course it is, so that would require formal regulatory review.
What the FDA did instead was to smuggle the policy question in disguised as a vote about reformulated ‘boosters’ for the fall.
In essence, the FDA just started doing the Future Framework (picking variants willy nilly, skipping clinical trials) and essentially dared the committee members to turn down a booster dose — knowing that all of the VRBPAC members are hand-picked because they’ve never met a vaccine they did not like.
So of course only two people on the committee had the courage to turn down a booster dose — even though it was based on this preposterous process (that was never formally adopted) where there was literally no data at all … By stealth, the FDA replaced a system based on evidence with a system based entirely on belief.”
Countries Held to Ransom
In 2021, secret details of Pfizer’s contracts came to light, showing they are essentially holding countries hostage to nonnegotiable demands for payment in full AND freedom from liability.15
In late February 2021, The Bureau of Investigative Journalism reported16 that Pfizer was demanding countries put up sovereign assets as collateral for expected vaccine injury lawsuits resulting from its COVID-19 jab.
Several countries, including Brazil, Chile, Colombia, the Dominican Republic and Peru, agreed to this demand, putting up bank reserves, military bases and embassy buildings as collateral. In short, theses governments are guaranteeing Pfizer will be compensated for any expenses resulting from injury lawsuits against it, so the company won’t lose a dime if its COVID shot injures people.
Shockingly, these terms are binding even if those injuries are the result of negligent company practices, fraud or malice!
In October that same year, Public Citizen published the secret contracts17,18 between Pfizer and Albania, Brazil, Colombia, Chile, Dominican Republic, the European Commission, Peru, the U.S. and the U.K., further revealing the extent to which these countries handed power over to Pfizer. In almost all scenarios, Pfizer’s interests come first.
For example, government purchasers must acknowledge that the effectiveness and safety of the shots are completely unknown, all while indemnifying Pfizer against any and all financial liability. This is the ultimate corporate maleficence, using their leverage to force the kill shot down these countries’ throats and avoiding any personal responsibility for damages.
Even if Pfizer eventually is convicted of fraud in the U.S. and loses all its liability protection from the COVID jabs because of it, that judgment would not impact these foreign contracts. These countries sold their souls to Pfizer and have absolutely no recourse but to pay even if the shots kill everyone.
The contracts for at least four countries also secure Pfizer’s intellectual property rights even if the company is found to have stolen intellectual property rights of others. In such case, the government purchaser becomes the liable party. As explained by Public Citizen :19
“For example, if another vaccine maker sued Pfizer for patent infringement in Colombia, the contract requires the Colombian government to foot the bill. Pfizer also explicitly says that it does not guarantee that its product does not violate third-party IP, or that it needs additional licenses.
Pfizer takes no responsibility in these contracts for its potential infringement of intellectual property. In a sense, Pfizer has secured an IP waiver for itself. But internationally, Pfizer is fighting similar efforts to waive IP barriers for all manufacturers.”
Equally shocking is that countries are forced to follow through on their vaccine orders even if other drugs or treatments emerge that can prevent, treat or cure COVID-19.20 Is it any wonder, then, that governments around the world have suppressed the use of safe and effective outpatient drugs like hydroxychloroquine and ivermectin?
If these drugs were allowed to be used and could be proven to work, the COVID injections would be completely unnecessary and their emergency use authorization would disappear, yet governments are on the hook for hundreds of millions of doses.
Pfizer Has ‘Habitual Offender’ Track Record
The fact that Pfizer has behaved like a criminal who works out a cover story for a planned murder before committing it is not surprising, considering its history. Pfizer, has been sued in multiple venues over unethical behavior, including unethical drug testing and illegal marketing practices.21
In his 2010 paper,22 “Tough on Crime? Pfizer and the CIHR,” Robert G. Evans, Ph.D., Emeritus Professor at Vancouver School of Economics, described Pfizer as “a ‘habitual offender,’ persistently engaging in illegal and corrupt marketing practices, bribing physicians and suppressing adverse trial results.”
Between 2002 and 2010 alone, Pfizer and its subsidiaries were fined $3 billion in criminal convictions, civil penalties and jury awards. They are recurrent criminal felons. None of these convictions has deterred their nefarious behavior.
In 2011, Pfizer agreed to pay another $14.5 million to settle federal charges of illegal marketing,23 and in 2014 they settled federal charges relating to improper marketing of the kidney transplant drug Rapamune to the tune of $35 million,24 as well as $75 million to settle charges relating to its testing of a new broad spectrum antibiotic on critically ill Nigerian children.
As reported by the Independent 25 at the time, Pfizer sent a team of doctors into Nigeria in the midst of a meningitis epidemic. For two weeks, the team set up right next to a medical station run by Doctors Without Borders and began dispensing the experimental drug, Trovan. Of the 200 children picked, half got the experimental drug and the other half the already licensed antibiotic Rocephin.
Eleven of the children treated by the Pfizer team died, and many others suffered side effects such as brain damage and organ failure. Pfizer denied wrongdoing. According to the company, only five of the children given Trovan died, compared to six who received Rocephin, so their drug was not to blame.
The problem was they never told the parents that their children were being given an experimental drug. What’s more, while Pfizer produced a permission letter from a Nigerian ethics committee, the letter turned out to have been backdated. The ethics committee itself wasn’t set up until a year after the trial had already taken place. Pfizer’s rap sheet also includes bribery, environmental violations, labor and worker safety violations and more.26
Wolves in Sheep’s Clothing
Now, despite Pfizer being one of the least ethical drug companies, we’re told to trust them with our very lives, and the lives of our precious children. They’re going to put out booster shots this fall that have undergone absolutely no testing whatsoever, and we’re to simply throw caution to the wind because Pfizer — which has no liability whatsoever — says so.
In 2014, Pfizer faced a surge of lawsuits that accused it of hiding known side effects of its anticholesterol drug Lipitor.27 They got off scot-free that time, as a federal judge dismissed thousands of cases alleging the drug caused Type 2 diabetes.28,29 But at least they had liability and could be sued.
When it comes to the COVID jabs, injured patients and family members of those killed by it won’t even have the ability to sue for damages, as governments around the world have indemnified them completely, and it looks as though they might not even be liable even if they’re found guilty of fraud. But we will have to see what the courts rule on that one. Still, that any nation would agree to a contract like that is just mindboggling.
Meanwhile, mounting evidence shows the COVID shots destroy immune function over time, and Pfizer’s own trial data reveal deaths and serious adverse events numbering in the tens of thousands.
It’s hard to tell who’s more deserving of punishment — Pfizer or the equally captured federal agencies, the FDA and the CDC, that go along with them and do nothing to protect the lives of the youngest members of our society. Clearly, it’s up to us to protect ourselves and our loved ones, because wolves in sheep’s clothing are ruling the roost — they’re making all the decisions, and captured agencies are simply doing their bidding.
Sources and References
- 1, 2, 4, 9 KHN July 5, 2022
- 3 Science Daily January 10, 2002
- 5 Washington Examiner February 8, 2022
- 6 Axios October 30, 2019
- 7 True Cost of Health Care
- 8 CDC Advisory May 24, 2022
- 10 NBC News June 6, 2022
- 11 Businesswire June 29, 2022
- 12 FDA Briefing Document June 28, 2022
- 13 Brownstone Institute June 22, 2022, Author’s Bio
- 14 uTobian June 29, 2022
- 15 STAT News February 23, 2021
- 16 The Bureau of Investigative Journalism February 23, 2021
- 17, 19 Public Citizen October 19, 2021
- 18 Twitter Zain Rizvi October 19, 2021
- 20 COVID19up.org August 17, 2021 (archived)
- 21 SGT Report January 7, 2021
- 22 Healthcare Policy 2010 May;5(4):16-25
- 23 DOJ October 21, 2011
- 24 Reuters August 6, 2014
- 25 The Independent March 23, 2014
- 26 Corporate Research Project Pfizer
- 27 Reuters August 8, 2014
- 28 Drugwatch Lipitor Lawsuits
- 29 Reuters May 12, 2021
More Deaths, Injuries Revealed in Latest Pfizer Vaccine Trial Document Dump
By Michael Nevradakis, Ph.D. | The Defender | July 14, 2022
This month’s release of Pfizer-BioNTech COVID-19 vaccine documents by the U.S. Food and Drug Administration (FDA) reveals three more reports of deaths among vaccine trial participants and further instances of Pfizer downplaying serious adverse events sustained by participants and listing the injuries as “not related” to the vaccine.
Of the approximately 80,000 pages released this month, the most revelatory is a 3,611-page “confidential” document with no title — only the file name “fa_interim_narrative_sensitive.”
The document contains information about vaccine trial participants who died, who sustained adverse events during the trial or who contracted COVID-19 during the trial.
All participants listed in the document received the 30 μg dose of the BNT162b2 candidate vaccine, which the FDA in August 2021 granted Emergency Use Authorization.
The FDA on July 1 released the documents as part of a court-ordered disclosure schedule stemming from an expedited Freedom of Information Act (FOIA) request filed in August 2021.
Public Health and Medical Professionals for Transparency, a group of doctors and public health professionals, initially submitted the FOIA request.
Document details deaths of three trial participants
The “interim narrative” document contains reports of three clinical trial participants who died — and in all cases, the investigator ruled out the possibility the deaths were related to Pfizer’s vaccines.
One instance pertains to a 56-year-old white female in the U.S. (unique Subject ID C4591001 1007 10071101), who suffered cardiac arrest on Oct. 18, 2021, and died three days later. She was vaccinated on July 30, 2020, and Aug. 20, 2020.
The “narrative comments” accompanying the report on the woman’s death stated her death could not have been related to the vaccine, due to the amount of time that had elapsed following her second dose:
“In the opinion of the investigator, there was no reasonable possibility that the cardiac arrest was related to the study intervention or clinical trial procedures, as the death occurred 2 months after receiving Dose 2.”
The woman’s medical history did not indicate any cardiovascular problems, although ongoing obesity, gastroesophageal reflux disease and sleep apnea syndrome were listed.
The second report of a death was that of a 60-year-old white male in the U.S. (unique Subject ID C4591001 1162 11621327), who received one dose of the vaccine (on Sept. 10, 2020) and died sometime in the following three days of atherosclerotic disease.
According to the document:
“The study site received a police report indicating that the police visited the subject’s home to perform a welfare check on 13 Sep 2020 (Day 4) and found him dead.”
The participant’s medical history indicated ongoing autoimmune thyroiditis, obesity and depression, and a prior craniocerebral injury and prior hip arthroplasty.
According to the report:
“It was reported that the subject’s body was cold and had visible lividity. According to the medical examiner, the probable cause of death was progression of atherosclerotic disease. Relevant tests were unknown. Autopsy results were not available at the time of this report.
“In the opinion of the investigator, there was no reasonable possibility that the arteriosclerosis was related to the study intervention, concomitant medications, or clinical trial procedures, but rather it was related to suspected [emphasis added] underlying disease. Pfizer concurred with the investigator’s causality assessment.”
In other words, the participant’s death was attributed to a “suspected” cause, while the possibility that it was vaccine-related in any way, was dismissed.
The third death listed in the “fa_interim_narrative_sensitive” documents was listed under the section in the document listing reports from trial participants who withdrew, not those who died.
The report pertained to a 72-year-old Hispanic/Latino male in the U.S. (unique Subject ID: C4591001 1152 11521497) who received one dose of the vaccine, on Oct. 7, 2020.
The subject sustained vasovagal syncope (a fainting incident) on Oct. 26, 2020, and was admitted to the hospital, causing him to miss his scheduled follow-up vaccination appointment on Oct. 28, 2020.
According to the document:
“The subject was transferred to the intensive care unit. Family medical history relevant to the syncope was unknown.
“On an unspecified date, the syncope resolved and the subject was discharged from the hospital.”
He was withdrawn from the study on Nov. 6, 2020. However, according to the subject’s sister, he died of “unknown” causes on Nov. 11, 2020.
As stated by the document (dated Nov. 22, 2020):
“The cause of death was reported as unknown. It was not reported if an autopsy was performed. A death certificate might be available at a later date.”
Nevertheless, this lack of information did not prevent the study investigator or Pfizer from dismissing the possibility that the participant’s death was vaccine-related. The document states:
“In the opinion of the investigator, there was no reasonable possibility that the syncope was related to the study intervention, concomitant medications, or clinical trial procedures.
“Pfizer concurred with the investigator’s causality assessment. Per Pfizer, the syncope was most likely coincidental and associated with underlying clinical conditions.”
The document contained no reports of deaths among trial participants who received the placebo.
Investigators attribute 4 serious adverse events to vaccine, Pfizer disagrees
According to the latest document release, investigators attributed the vaccine to serious adverse events in four cases, however, Pfizer disagreed with the investigators’ conclusions in three out of the four cases.
The incidents are:
• A 53-year-old white female in the U.S. (unique Subject ID: C4591001 1018 10181159), who developed “lower back pain and bilateral lower extremity pain with radicular paresthesia” on Oct. 20, 2020, which was ongoing as of the date of the document (Nov. 22, 2020).
She was vaccinated on Aug. 14 and Sept. 4, 2020.
The woman’s medical history did not indicate lower back or lower extremity pain, just ongoing migraines and a prior history including a right shoulder dislocation, fibrocystic breast disease and Vitamin D deficiency.
The study investigator and Pfizer disagreed on whether the serious adverse event she experienced was related to the vaccination. As stated in the document:
“In the opinion of the investigator, there was a reasonable possibility that the lower back pain and bilateral lower extremity pain with radicular paresthesia were related to the study intervention, but not related to concomitant medications or clinical trial procedures.
“Pfizer did not concur with the investigator’s causality assessment and considered that there is not enough evidence to establish a causal relationship with the study vaccine apart from a chronological association at this time of the report.
“Based on the information currently available, it was more likely that the lower back pain and bilateral lower extremity pain with radicular paresthesia was associated with the subject’s underlying known neurological condition.”
• A 71-year-old white female in the U.S. (unique Subject ID: C4591001 1142 11421247) sustained ventricular arrhythmias on Oct. 14, 2020 — the same day she received the second dose of the vaccine — and which continued until Oct. 21, 2020.
The woman received her first dose on Sept. 21, 2020. Her medical history indicated she was wearing a cardiac pacemaker and was experiencing ongoing atrioventricular block (complete), atrial fibrillation and supraventricular tachycardia.
Again, the study investigator and Pfizer could not agree as to whether this adverse event was related to the vaccination. The document states:
“In the opinion of the investigator, there was a reasonable possibility that the ventricular arrhythmia was related to the study intervention based on the temporal relationship since the arrhythmias began within 24 hours of Dose 2, but not related to concomitant medications or clinical trial procedures.
“Pfizer did not concur with the investigator’s causality assessment. Additionally, Pfizer commented that there was not enough evidence to establish a causal relationship with the study intervention apart from a chronological association at this time of the report.
“In absence of evidence for an inflammatory response to study intervention, it was more likely that the ventricular arrhythmia was associated with the subject’s underlying known cardiac conditions.”
Pfizer dismissed the possibility that the vaccine may have exacerbated the subject’s existing cardiac conditions.
• A 48-year-old white female in the U.S. (unique Subject ID: C4591001 1178 11781107), who received one dose of the vaccine on Sept. 4, 2020, and withdrew from the study on Sept. 25, 2020.
In the interim, the participant sustained right axilla lymphadenopathy, with “at least four enlarged lymph nodes” — a condition that was still ongoing as of the document date of Nov. 22, 2020.
Her medical history indicated ongoing positional vertigo, osteoarthritis, eczema, sinus headaches, seasonal allergies and a Pitocin allergy, as well as prior menorrhagia, uterine fibroids and a past hysterectomy. In addition, her body mass index (BMI) was listed as being 36.9.
Pfizer also in this case did not agree with the study investigator’s assessment:
“In the opinion of the investigator, there was a reasonable possibility that the lymphadenopathy was related to the study intervention. Pfizer did not concur with the investigator’s causality assessment.”
• A 30-year-old Asian female in the U.S. sustained a shoulder injury related to vaccine administration (SIRVA).
The documents did not list any severe adverse events occurring in anyone outside the U.S., even though the documents contain reports from trials in Argentina, Brazil and South Africa.
‘Unrelated’ adverse event reports habitually dismiss possibility injuries were vaccine-related
The documents reveal a large discrepancy between the number of adverse events deemed to be related to the vaccination (four) compared to those reported to be “not related” (113 non-placebo participants).
The reports associated with each incident reveal an ongoing tendency to dismiss any possibility injuries were vaccine-related — even in instances where no alternative cause was identified or where patients had no relevant prior medical history.
In still other instances, the cause of the adverse event was attributed to itself, while in several other cases, pre-existing conditions worsened following vaccination.
A significant number of accidents and falls — and subsequent injuries — also were reported.
Instances where severe adverse events were brushed over as being “not related” to the vaccination, despite no relevant medical history, include:
• A 75-year-old white male in the U.S. (unique Subject ID: C4591001 1013 10131176), who was vaccinated on Aug. 13 and Oct. 7, 2020, sustained 13 adverse events between Aug. 29 and Sept. 16, 2020, many of which were ongoing as of the document date of Nov. 22, 2020.
These adverse events included congestive heart failure, acute hypoxic respiratory failure, acute renal failure, aspiration pneumonia, anemia, hypokalemia, hyponatremia, leukopenia, sepsis, small bowel obstruction and mild concentric left ventricular hypertrophy.
The participant had ongoing gastroesophageal reflux disease, hiatus hernia, hypercholesterolemia, hypertension and constipation, in addition to prior small intestinal and knee surgery.
The report attributed the patient’s adverse events to his prior surgical history. The document stated:
“In the opinion of the investigator, there was no reasonable possibility that the abdominal adhesions, small intestinal obstruction, pneumonia aspiration, and acute respiratory failure were related to the study intervention, concomitant medications, or clinical trial procedures, but were rather likely related to subject’s previous surgery.
“Pfizer concurred with the investigator’s causality assessment.”
• A 73-year-old white female in the U.S. (unique Subject ID: C4591001 1079 10791246) sustained a “cerebrovascular accident” (stroke), as well as expressive aphasia, on Oct. 22, 2020. She was vaccinated on Sept. 4 and Sept. 25, 2020.
Her medical history listed osteoarthritis, seasonal allergies and being postmenopausal. Nevertheless, her stroke and aphasia were deemed to be “not related” to the vaccine, although no cause was listed. Instead, the document stated, “pending medical records” with regard to the cause of her adverse events.
• A 66-year-old white female in the U.S. (unique subject ID: C4591001 1021 10211190) suffered a stroke on Nov. 2, 2020, with ongoing symptoms as of the document date on Nov. 22, 2020. She was vaccinated on Sept. 10 and Oct. 1, 2020.
Her medical history indicated ongoing gastroesophageal reflux disease, seasonal allergies and postmenopause, as well as a BMI of 28.5.
Her stroke was dismissed as being “not related” to the vaccine, although no alternative cause was listed.
• A 68-year-old white male in the U.S. (unique Subject ID: C4591001 1092 10921015) sustained arrhythmia atrial fibrillation and elevated troponin on Aug. 26, 2020. He received his first dose on Aug. 19, 2020, and his second dose on Oct. 6, 2020, as it required “clearance from his cardiologist.”
His medical history did not specifically indicate heart conditions. Instead, it indicated ongoing basal cell carcinoma on his nose, as well as hypersensitivity, seasonal allergies, myopia, dyslipidemia, hypertension, actinic keratosis and gastroesophageal reflux disease.
Although the study investigator wrote, in reference to the cause of his injuries, that “medical records [are] being reviewed not able to answer at this time,” the report dismissed possibility that his adverse events were related to the vaccine.
• A 45-year-old Black male in the U.S. (unique Subject ID: C4591001 1156 11561006) with ongoing Type 1 diabetes sustained deep vein thrombosis and a pulmonary embolism on Aug. 31, 2020. He received one dose of the vaccine, on Aug. 20, 2020, and was discontinued from the study on Sept. 8, 2020, “because he no longer met the eligibility criteria.”
Both adverse events were deemed as being “not related” to his vaccination, and were instead indicated as being “related to medical history of Type 1 diabetes mellitus.”
• A 67-year-old white male in the U.S. (unique Subject ID: C4591001 1178 11781015) sustained several adverse events on Oct. 10-11, 2020, including ascending aorta ectasia, diastolic dysfunction of the left ventricle and transient global amnesia. These conditions were ongoing as of the document date of Dec. 4, 2020. He was vaccinated on Aug. 25 and Sept. 15, 2020.
The patient’s medical record indicated ongoing depression, attention deficit hyperactivity disorder, hypertension, insomnia and neck pain.
While the cause of his adverse events was deemed as being “not related” to the vaccination, the study did state a cause, listing it as “possibly” having been hypertension.
• A 58-year-old Hispanic/Latino female from Argentina (unique Subject ID: C4591001 1231 12313674) sustained adverse events including panlobular emphysema, pneumonitis, and left submaxillary sialadenitis beginning on Sept. 29, 2020. The first two conditions were indicated as continuing as of the document date of Dec. 4, 2020.
She was vaccinated on Aug. 24 and Sept. 13, 2020. Her medical record indicated ongoing Sjogren’s syndrome and insomnia.
The cause of these adverse events was deemed as being “not related” to the vaccines, although for the first two adverse events, the stated cause was listed as “unknown,” while for the third, the cause was listed as Sjogren’s syndrome.
• A 56-year-old Hispanic/Latino female from Argentina (unique Subject ID: C4591001 1231 12314001) was diagnosed with acute coronary syndrome on Nov. 8, 2020, which was still ongoing as of the document date of Dec. 4, 2020. She was vaccinated on Aug. 25 and Sept. 15, 2020.
Her medical history consisted of ongoing hypothyroidism, allergic rhinitis and asthma — but no coronary troubles.
Nevertheless, according to the study investigator, her condition was determined to be “not related” to the vaccination, although the cause was listed as “unknown.”
‘Cause unknown’ but no chance the vaccine was to blame
In other examples, adverse events were assigned no specific cause or only a “probable” cause, but investigators dismissed the possibility the vaccines may have caused the injuries.
For example:
• A 34-year-old Hispanic/Latino male from Brazil (unique subject ID: C4591001 1226 12261745) developed a Leydig cell tumor in his left testicle on Sept. 23, 2020. He received the first dose of the vaccine on Sept. 16, 2020, and second dose on Oct. 7, 2020.
His medical history listed only ongoing allergic rhinitis.
While the study investigator claimed that the adverse event was “not related” to the vaccination, the cause was listed as “unknown.”
• A 19-year-old Hispanic/Latino female from Brazil (unique Subject ID: C4591001 1231 12311281) with no indicated medical history was diagnosed with acute appendicitis and QT interval prolongation — a heart condition — on Sept. 18, 2020. She was vaccinated on Aug. 15 and Sept. 4, 2020.
These conditions were deemed to be “not related” to the vaccination, although the causes were indicated as “unknown.”
• A 41-year-old Hispanic/Latino female from Argentina (unique Subject ID: C4591001 1231 12311315) was diagnosed with anemia and malignant melanoma on Sept. 25, 2020, with symptoms continuing as of the document date of Dec. 4, 2020.
She was vaccinated on Aug. 15 and Sept. 3, 2020.
The adverse events were indicated as being “not related” to the vaccination, but instead due to a “probable relationship with [a] vaginal tumor under study.”
• A 44-year-old Hispanic/Latino male from Argentina (unique Subject ID: C4591001 1231 12312854) was diagnosed with supraventricular arrhythmia on Sept. 17, 2020. He received the two vaccine doses on Aug. 21 and Sept. 11, 2020.
His medical history listed only ongoing sleep apnea syndrome and a BMI of 50.4.
According to the study investigator, the arrhythmia was “not related” to the vaccines, but instead “probably” corresponded “to an accessory intraventricular line.”
• A 56-year-old mixed-race male from Brazil (unique subject ID: C4591001 1241 12411825) was diagnosed with acute pyelonephritis on Nov. 2, 2020, and hypochromic anemia two days later. Both conditions were still listed as ongoing as of the document date of Dec. 4, 2020.
The participant was vaccinated on Sept. 17 and Oct. 8, 2020. His medical history listed ongoing hypertension.
According to the study investigator, these adverse events were “not related” to the vaccination. Instead, his acute pyelonephritis was due to a “possible” bacterial urinary tract infection, while the hypochromic anemia cause was “to be clarified.”
Worsening of pre-existing conditions ‘not related’ to vaccine
In other instances, participants experienced a worsening of pre-existing conditions. However, in all instances, no relation to the COVID-19 vaccine was determined.
For instance:
• A 72-year-old white male in the U.S. (unique Subject ID: C4591001 1092 10921187) sustained congestive heart failure on Oct. 1, 2020. He received his first dose of the vaccine on Sept. 15, 2020, and his second dose on Oct. 6, 2020.
The participant’s medical history included ongoing coronary artery disease, atrial fibrillation, type 2 diabetes, asthma, obesity, dyslipidemia, hypertension, insomnia and seasonal allergies. Moreover, he had previously had a defibrillator installed.
The cause of his adverse event was simply indicated as “progression of cardiovascular disease” unrelated to the vaccine. The possibility that the vaccine may potentially have precipitated the worsening of his heart condition was not considered.
• A 73-year-old white female in the U.S. (unique Subject ID: C4591001 1111 11111095) was reported as having sustained an “undiagnosed mental disorder” on Sept. 25, 2020, which was still ongoing as of the document date of Dec. 4, 2020. She was vaccinated on Aug.11 and Sept. 1, 2020.
The participant’s medical history did not indicate any prior mental disorders or conditions. Nevertheless, the cause of the adverse event was indicated by the study indicator as being “not related” to the vaccination and instead simply due to “mental instability.”
• A 58-year-old white male from the U.S. (unique Subject ID: C4591001 1109 11091387), who sustained worsening osteoarthritis of the right knee on Oct. 14, 2020, and later also experienced deep vein thrombosis on Oct. 20, 2020, which was still ongoing as of the document date of Dec. 4, 2020.
The participant’s medical history indicated ongoing osteoarthritis, ongoing hypercholesterolemia, hypothyroidism, sleep apnea syndrome, rosacea and an enlarged prostate. A prior knee surgery was also listed.
Both adverse events were deemed to be “not related” to the vaccination and instead attributed to the patient’s prior knee surgery and “previous medical history.”
• A 70-year-old white female from the U.S. (unique subject ID: C4591001 1127 11271023) experienced a worsening of her asthma on Oct.1, 2020. She later also developed malignant invasive ductal carcinoma in her left breast, on Nov. 5, 2020. Both cases were still ongoing as of the document date of Dec. 4, 2020.
She received her two doses of the vaccine on July 30 and Aug. 18, 2020. Her medical history, aside from ongoing asthma, also indicated a recurrent urinary tract infection and ongoing bronchitis, seasonal allergies, myopia, migraines, hypothyroidism, hypertension, insomnia, hyperlipidemia, osteoarthritis, bilateral deafness and postmenopause.
According to the document, both adverse events were “not related” to the vaccination, and instead were attributed to an “allergy” and to a “malignancy,” respectively.
Reports of multiple adverse events ignored
Other examples include cases where patients sustained multiple adverse events, many of which were entirely ignored by the study investigators’ assessments.
These include:
• A 61-year-old white male from the U.S. (unique Subject ID: C4591001 1114 1114108), who sustained 10 vaccine injuries beginning on Sept. 12, 2020, after he received the first dose of the vaccine on Aug. 24, 2020, and his second dose on Sept. 30, 2020.
The adverse events he experienced included acute kidney injury, atrial fibrillation, chest pain, left ventricular hypertrophy, mitral valve regurgitation, bilateral hand pain, pulmonary hypertension, skin avulsion on his left finger, a Staphylococcal infection and tricuspid regurgitation. Several of these conditions were still ongoing as of the document date of Dec. 4, 2020.
The patient’s medical history indicated ongoing peripheral neuropathy, type 2 diabetes, anxiety, depression, asthma, Staphylococcal infection, hypertension, hyperlipidemia and a prior leg amputation.
According to the study investigator, “the staphylococcal infection” was “not related” to the vaccine, but instead was connected to the patient’s hypertension, musculoskeletal causes and an “infection.” No mention was made in this assessment as to the probable causes of the other adverse events.
Some adverse events ‘caused’ by … the adverse event
In still other cases, the “cause” of participants’ adverse events was indicated as being the same as the adverse event itself.
Examples include:
• A 68-year-old white male from the U.S. (unique Subject ID: C4591001 1095 10951204), who was diagnosed with bladder cancer on Nov. 2, 2020. He was vaccinated on Sept. 2 and Sept. 21, 2020.
According to the document, the participant’s ongoing medical history included hypertension, benign prostatic hyperplasia, hypercholesterolemia, angina pectoris, coronary arterial stent insertion, coronary artery disease, erectile dysfunction and osteoarthritis.
However, the cause of his bladder cancer was attributed as “cancer” and deemed to be “not related” to the vaccination and “most likely coincidental and associated with the underlying clinical conditions.”
• A 48-year-old white male from the U.S. (unique Subject ID: C4591001 1124 11241106) sustained an acute myocardial infarction on Sept. 27, 2020. He previously received two doses of the vaccine, on Aug. 26 and Sept. 16, 2020.
His medical history indicated ongoing high cholesterol, gastroesophageal reflux disease and back pain.
According to the study investigator, the adverse event sustained by the participant was “not related” to the vaccination, but instead “related to cardiovascular risk,” with no further elaboration provided.
• A 73-year-old white female in the U.S. (unique Subject ID: C4591001 1223 12231159) was found to have a pancreatic mass on Nov. 5, 2020. She was vaccinated on Sept. 10 and Oct. 1, 2020.
Her medical records indicated ongoing osteoarthritis, menopause, gastroesophageal reflux disease, hypertension, dyslipidemia, hypothyroidism, Eustachian tube dysfunction, prophylaxis, irritable bowel syndrome, osteoporosis and benign monoclonal hypergammaglobulinemia.
The cause of her adverse event, which was indicated to be “not related” to the vaccination, was listed as “new development of pancreatic mass” without any elaboration as to the factors that may have caused it to appear.
‘Cause unknown’ but no chance the vaccine was to blame
In other examples, adverse events were assigned no specific cause or only a “probable” cause, even as the possibility that they were related to the vaccination was dismissed.
For example:
• A 34-year-old Hispanic/Latino male from Brazil (unique Subject ID: C4591001 1226 12261745) developed a Leydig cell tumor in his left testicle on Sept. 23, 2020. He received the first dose of the vaccine on Sept. 16, 2020, and second dose on Oct. 7, 2020.
His medical history listed only ongoing allergic rhinitis.
While the study investigator claimed that the adverse event was “not related” to the vaccination, the cause was listed as “unknown.”
• A 19-year-old Hispanic/Latino female from Brazil (unique Subject ID: C4591001 1231 12311281) with no indicated medical history was diagnosed with acute appendicitis and QT interval prolongation — a heart condition — on Sept. 18, 2020. She was vaccinated on Aug. 15 and Sept. 4, 2020.
These conditions were deemed to be “not related” to the vaccination, although the causes were indicated as “unknown.”
• A 41-year-old Hispanic/Latino female from Argentina (unique Subject ID: C4591001 1231 12311315) was diagnosed with anemia and malignant melanoma on Sept. 25, 2020, with symptoms continuing as of the document date of Dec. 4, 2020.
She was vaccinated on Aug. 15 and Sept. 3, 2020.
The adverse events were indicated as being “not related” to the vaccination, but instead due to a “probable relationship with [a] vaginal tumor under study.”
• A 44-year-old Hispanic/Latino male from Argentina (unique Subject ID: C4591001 1231 12312854) was diagnosed with supraventricular arrhythmia on Sept. 17, 2020. He received the two vaccine doses on Aug. 21 and Sept. 11, 2020.
His medical history listed only ongoing sleep apnea syndrome and a BMI of 50.4.
According to the study investigator, the arrhythmia was “not related” to the vaccines, but instead “probably” corresponded “to an accessory intraventricular line.”
• A 56-year-old mixed-race male from Brazil (unique Subject ID: C4591001 1241 12411825) was diagnosed with acute pyelonephritis on Nov. 2, 2020, and hypochromic anemia two days later. Both conditions were still listed as ongoing as of the document date of Dec. 4, 2020.
The participant was vaccinated on Sept. 17 and Oct. 8, 2020. His medical history listed ongoing hypertension.
According to the study investigator, these adverse events were “not related” to the vaccination. Instead, his acute pyelonephritis was due to a “possible” bacterial urinary tract infection, while the hypochromic anemia cause was “to be clarified.”
Other explanations for participants’ vaccine injuries include:
• A 78-year-old white male from the U.S. (unique Subject ID: C4591001 1097 10971011), who suffered from pneumonia between Sept. 20 and Oct. 5, 2020. He had previously received two doses of the vaccine, on Aug. 20 and Sept. 9, 2020.
According to the document, the cause of his pneumonia was “not related” to the vaccines. Instead, the listed cause was “pt [patient] contracted pneumonia from somewhere.”
• An 84-year-old white male from the U.S. (unique Subject ID: C4591001 1097 10971084) contracted pneumonia on Oct. 7, 2020, symptoms of which were still ongoing as of the document date of Dec. 4, 2020. He had previously been vaccinated on Sept. 1 and Sept. 23, 2020.
Similar to the patient above, the cause of the participant’s pneumonia was indicated as being “not related” to the vaccination. The narrative comment instead stated that “Pt [patient] contracted pneumonia from unknown source.”
Very few severe adverse events — and no deaths — were reported in other countries, although Argentina, for instance, was home to the largest of the Pfizer vaccine trials in 2020.
The next 80,000-page cache of FDA documents pertaining to the FDA’s authorization of the vaccine is set to be released on Aug. 1.
Michael Nevradakis, Ph.D., is an independent journalist and researcher based in Athens, Greece.
© 2022 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.
‘Why the Rush for Toddler Vaccines?’ Asks Wall Street Journal Editorial Board Member
By Susan C. Olmstead | The Defender | July 5, 2022
A Wall Street Journal (WSJ) editorial board member Monday called into question the motives behind the U.S. Food and Drug Administration’s (FDA) decision to extend Emergency Use Authorization of Pfizer and Moderna’s COVID-19 vaccines to toddlers and infants as young as 6 months old, writing that the decision was motivated by politics and pressure rather than science.
In her WSJ opinion piece — “Why the Rush for Toddler Vaccines?” — Allysia Finley wrote:
“The FDA standard for approving vaccines in otherwise healthy people, especially children, is supposed to be higher than for drugs that treat the sick.
“But the FDA conspicuously lowered its standards to approve COVID vaccines for toddlers. Why?”
Finley started her piece with a quote from President Biden, which praised the FDA’s recommendation: “This is a very historic milestone. The United States is now the first country in the world to offer safe and effective COVID-19 vaccines for children as young as six months old.”
She responded, writing, “In fact, we don’t know if the vaccines are safe and effective.”
She continued:
“The rushed FDA action was based on extremely weak evidence. It’s one thing to show regulatory flexibility during an emergency. But for children, Covid isn’t an emergency.
“The FDA bent its standards to an unusual degree and brushed aside troubling evidence that warrants more investigation.”
“Mr. Biden’s hypocrisy is hard to stomach,” she wrote, listing many reasons for caution in vaccinating young children against COVID-19, including:
- Children are at low risk of dying from COVID-19: Only 209 kids between 6 months and 4 years old have died from COVID-19 — about 0.02% of all virus deaths in the U.S. About half as many toddlers were hospitalized with COVID-19 between October 2020 and September 2021 as were hospitalized with the flu during the previous winter.
- The two children in Pfizer’s trial who got sickest with COVID-19 also tested positive for other viruses. It’s possible that many hospitalizations attributed to COVID-19 this winter were instigated or exacerbated by other viruses.
- The FDA authorized vaccines for toddlers based on a comparison of the antibodies they generated to the original Wuhan variant with those in young adults who had received two doses. But two doses offer little if any protection against Omicron infection in adults, and even protection against hospitalization is only around 40% to 60%.
- Vaccinated toddlers in Pfizer’s trial were more likely to get severely ill with COVID-19 than those who received a placebo. Most children who developed multiple infections during the trial were vaccinated.
“FDA granted the Pfizer and Moderna vaccines for toddlers an emergency-use authorization allowing the agency to expedite access for products that ‘prevent serious or life-threatening diseases or conditions,’” wrote Finley.
“While adult COVID vaccines clearly met this standard in late 2020, the toddler vaccines don’t.”
As to why the FDA “rushed” and “bent its standards,” Finley suggested, “perhaps [the FDA] felt pressure from the White House as well as anxious parents.”
White House COVID-19 response coordinator Ashish Jha repeatedly told parents that he expected vaccines for toddlers would be available in June, she wrote.
© 2022 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.
Will Pfizer Be Charged for Mislabeling Vaccine Side Effects?
By Dr. Joseph Mercola | July 5, 2022
As the U.S. Food and Drug Administration continues to release Pfizer’s clinical trial documentation,1 we’re finding more and more evidence that very little has been done on the up-and-up, and the COVID jab trials may be among the most fraudulent in medical history.
Can All Serious Adverse Effects Be Written Off?
Importantly, Pfizer classified almost all severe adverse events that occurred during its Phase 3 trials as unrelated to the injection. As reported by The Defender, June 21, 2022:2
“The latest release by the U.S. Food and Drug Administration (FDA) of Pfizer-BioNTech COVID-19 vaccine documents reveals numerous instances of participants who sustained severe adverse events during Phase 3 trials. Some of these participants withdrew from the trials, some were dropped and some died.
The 80,000-page document cache includes an extensive set of Case Report Forms (CRFs) from Pfizer Phase 3 trials conducted at various locations in the U.S., in addition to other documentation pertaining to participants in Pfizer-BioNTech vaccine trials in the U.S. and worldwide …
The CRFs included in this month’s documents contain often vague explanations of the specific symptoms experienced by the trial participants. They also reveal a trend of classifying almost all adverse events — and in particular severe adverse events (SAEs) — as being ‘not related’ to the vaccine.”
The Defender article includes 11 examples3 of trial participants who experienced severe adverse effects that were classified as “unrelated” to the experimental gene transfer technology they’d received just days or weeks earlier.
A 2,566-page document4 catalogues the serious adverse events and six deaths that occurred during the trial. These events were all classified as “toxicity level 4,” which is the most serious, yet none of them were deemed related to the injection.
This simply isn’t believable. It’s completely unrealistic, especially when serious events occur in multiple participants. A handful of examples of Level 4 adverse events listed in this document — all of which were written off as “not related” to the mRNA injection — include:5
- Acute respiratory failure
- Cardiac arrest
- Brain abscess
- Adrenal carcinoma (adrenal cancer)
- Chronic myeloid leukemia (blood and bone marrow cancer)
The six deaths reported were listed as being caused by arteriosclerosis, cardiac arrest, hemorrhagic stroke and myocardial infarction.6 Many participants also dropped out or were excluded from the trial due to serious side effects involving the heart, cardiovascular system, cancer, stroke, hemorrhage and neurological impacts.
Examples of Level 3 Adverse Events
Most Level 3 adverse events were also dismissed as unrelated to the shot. As reported by The Defender, only a “small number” were listed as being related to the injection. Examples of Level 3 side effects include:7
- Deafness/hearing loss
- Tachycardia (disruption of the normal electrical impulses that control your heart rate — the very problem that underlies most cases of “sudden adult death syndrome” or SADS)
- Ventricular arrhythmia (abnormal heart rhythm that makes the lower chambers twitch rather than pump — another underlying cause of SADS)
- Neutropenia (low neutrophil level in your blood; neutrophils are a type of white blood cell made by your bone marrow that fight infections by destroying viruses and bacteria)
- Vertigo
45% Experienced One or More Adverse Events
Another document8 that raises suspicions of bias is one admitting that “40% to 45% of participants who received BNT162b1 and BNT162b2 across age groups and across dose levels reported one or more AEs [adverse events] from Dose 1 through 28 days (i.e., 1 month) after Dose 2.”
BNT162b2 was the candidate injection that went on to receive Emergency Use Authorization (EUA) from the FDA. Among those who got the highest dose (30 micrograms) of BNT162b2, 50% of younger participants 25% in the older age group reported one or more adverse events.
The most common adverse events were nervous system disorders, followed by musculoskeletal and connective tissue disorders. Yet despite high rates of side effects across dose levels, this document also insists that “most AEs were considered by the investigator as not related to study intervention.”
During the open-label period of the study, 12,006 participants were followed for a minimum of six months, and among those, 28.8% reported at least one adverse event at some point during that follow-up, and 2.1% reported one or more severe adverse events.
Incidence Rate in Treatment Group FAR Higher Than Placebo
As reported by The Defender :9
“The review provides data for participants from dose 3 … to the data cutoff date. The severe adverse event incidence rate (IR) was 6.0 per 100 PY (patient-years), with specific conditions reported including pulmonary embolisms, thrombosis, urticaria, a cerebrovascular accident and COVID-19 pneumonia.
Here, the review adds that the IR for original placebo participants who had at least 1 life-threatening AE from Dose 3 to the data cutoff date was 0.5 per 100 PY.
Only one such life-threatening event, an instance of anaphylactoid reaction, was considered to be related to the vaccination. Other life-threatening, serious adverse events included cardio-respiratory arrest, gastrointestinal necrosis, deep vein thrombosis and pulmonary embolism …
Notably, according to the review, ‘all … events of facial paralysis were considered by the investigator as related to study intervention.” [Editor’s note: these specifically refer to events that occurred during the open-label follow-up period when BNT162b2 Dose 3 or Dose 4 was offered to both placebo and initial treatment groups.]
Young Children Have Extremely Low Risk of Death From COVID
In the end, we all know what happened. Despite all the evidence to the contrary, Pfizer concluded the shot was safe and effective for everyone and the FDA went along with it. The vaccine manufacturers and the FDA have decided it isn’t even worth invoking the precautionary principle for the very youngest of children, which is nothing short of reprehensible, criminal maleficence.
In mid-June 2022, against strong objections from physicians, scientists and researchers, the FDA’s vaccine advisory panel — the Vaccines and Related Biological Products Advisory Committee (VRBPAC) — unanimously agreed to grant EUA to both Pfizer’s and Moderna’s COVID shots for infants and young children.10,11
Pfizer’s EUA is for a three-dose regimen (3-microgram shots) for children 6 months to 5 years old, while Moderna’s EUA is for a two-dose regimen (25-microgram shots) for children 6 months to 6 years.
According to the U.S. Centers for Disease Control and Prevention,12 an estimated 75% of American children ages birth to 11 already have some level of immunity, having been exposed to one of the several variants that have come into circulation over the past two-plus years.
This immunity level alone makes EUA for COVID shots questionable. CDC data also prove young children have a very low risk of hospitalization and death from COVID, which makes the EUAs even more questionable.
Data13 published in mid-March 2022 suggest babies and young children under the age of 4 have had a peak hospitalization rate for COVID of 14.5 per 100,000. That peak occurred after Omicron became predominant. The hospitalization rate for the Delta variant in this age group was 2.9 per 100,000.
In all, since March 2020, a total of 2,562 infants and young children (6 months to 4 years) have been hospitalized WITH COVID. Of those, 2,068 had COVID listed as the primary reason for admission (84.7% of the total), and only 624 required ICU admission.
The median length of hospital stay was 1.5 days (range: one to three days). Of the 2,562 children with suspected COVID infection, 16 of them (0.6%) died in the hospital. Death certificate data push that number a bit higher. The Vaccine Reaction notes,14 “According to death certificate data,15 202 deaths have been attributed to COVID-19 among children 6 months to 4 years of age through May 11, 2022.”
While any death is tragic, it’s worth noting that 923 (35.8%) of the children hospitalized with suspected COVID also had one or more underlying medical conditions.16 We don’t know for sure, but it’s quite possible that those who died with a COVID diagnosis actually died from whatever underlying condition was present or had brought them to the hospital in the first place.
What I’m trying to say is that 16 to 202 deaths over two-plus years aren’t cause for panic, and that’s true even if COVID was the primary cause of those deaths. The likelihood of your child getting injured by the mRNA shot is undoubtedly significantly greater than their risk of dying from COVID.
Jab More Likely to Put You in the Hospital Than Keep You Out
The same is true for adults, by the way. A June 2022 analysis17,18 of Pfizer and Moderna trial data found the shots are more likely to put you in the hospital than keep you out of it. As reported by The Daily Sceptic :19
“A new paper20 by BMJ Editor Dr. Peter Doshi and colleagues has analyzed data from the Pfizer and Moderna COVID vaccine trials and found that the vaccines are more likely to put you in hospital with a serious adverse event than keep you out by protecting you from COVID.
The pre-print (not yet peer-reviewed) focuses on serious adverse events highlighted in a WHO-endorsed ‘priority list21 of potential adverse events relevant to COVID-19 vaccines.’ The authors evaluated these serious adverse events of special interest as observed in ‘phase III randomized trials of mRNA COVID-19 vaccines’ …
Dr. Doshi and colleagues found that the Pfizer and Moderna mRNA COVID-19 vaccines were associated with an increased risk of serious adverse events of special interest of 10.1 events per 10,000 vaccinated for Pfizer and 15.1 events per 10,000 vaccinated for Moderna …
When combined, the mRNA vaccines were associated with a risk increase of serious adverse events of special interest of 12.5 per 10,000 vaccinated … The authors note that this level of increased risk post-vaccine is greater than the risk reduction for COVID-19 hospitalization in both Pfizer and Moderna trials, which was 2.3 per 10,000 participants for Pfizer and 6.4 per 10,000 for Moderna.
This means that on this measure, the Pfizer vaccine results in a net increase in serious adverse events of 7.8 per 10,000 vaccinated and the Moderna vaccine of 8.7 per 10,000 vaccinated.”
Doshi’s team wasn’t the first to reanalyze Pfizer’s trial data. The Canadian COVID Care Alliance has also published a clear and easy-to-read summary22 of the Pfizer trial results, and the many questions raised by it. As noted by Dr. Robert Malone:23
“The bottom line is that the Pfizer Phase 3 trial which was used by NIAID [the National Institutes of Allergy and Infectious Diseases], FDA and CDC to justify the emergency use authorization is pretty much a junk clinical trial which was inappropriately halted long before it even got close to meeting the intended follow up period, did not provide a sufficiently long follow up analysis of vaccination-associated adverse events, and in which the control group was intentionally eliminated.
This resulted in basically erasing any opportunity to ever get to the bottom of what the major true risks of the Pfizer mRNA inoculations were. In terms of more minor risks, the study was not powered (not big enough) to evaluate those.”
FDA and CDC Have Neglected Important Duties
Doshi and his coauthors also note the FDA also watered down results by including “thousands of additional participants with very little follow-up, of which the large majority had only received one dose.”
They then further diluted the appearance of risk by counting only the number of people affected rather than counting the total number of individual adverse events. This makes a big difference, as twice as many people in the treatment group reported multiple serious adverse events, as compared to the placebo group.
The FDA and CDC have both also failed to produce promised follow-up investigations. In July 2021, now a full year ago, the FDA said it would investigate four “potential adverse events of interest following Pfizer vaccination,” namely pulmonary embolism, acute myocardial infarction, immune thrombocytopenia and disseminated intravascular coagulation, but to date, no update has been issued.
Similarly, in early 2021, the CDC published a protocol on how to use proportional reporting ratios to detect signals in the U.S. Vaccine Adverse Event Reporting System (VAERS), but no study or report showing what that protocol might have found has ever been published.
As it turns out, the CDC hasn’t been looking for safety signals in VAERS — not with the proportional ratios protocol or any other. So, while they’ve publicly claimed they haven’t seen any signals of concern, the reason they haven’t seen any signals is very simple: They never looked at the data!24
That’s how ridiculous things are now. When a drug company or health agency claims they haven’t found a problem, you actually have to ask them, “where, when, how and how often did you look?” But of course, virtually no one would ever ask such questions because they would assume these agencies are competent, which of course is a false assumption.
Their Fraudulent Behavior Could Be Their Undoing
As you probably know, the makers of the COVID shots are indemnified against legal liability for any injuries and all deaths stemming from their products. No one is able to sue them for damages.
The only way to hold them responsible is to prove they’ve committed fraud. This would remove their liability immunity. As detailed at the beginning of the article, their consciously choosing to miscategorize adverse events during the initial trials and concealing the harms should be a slam dunk to convict them of fraud.
But there is also another fact they concealed: There’s evidence showing they knew the mRNA doesn’t stay in the injection site but, rather, distributes throughout the body,25 and this too could be a smoking gun that proves fraud. If convicted of fraud, Pfizer, Moderna and Janssen would likely face liabilities in the trillions of dollars in damages.
When I exposed Merck’s Vioxx scandal in 1999 in this newsletter, before they even released their drug on the market, I thought that was huge. Their drug killed more than 60,000 people, and they could have been liable for $25 billion in damages, but their clever lawyers reduced it to $5 billion.
Well, that catastrophe is a drop in the bucket compared to the COVID scam, which has likely killed between 600,000 and 750,000 Americans, disabled as many as 5 million, and injured an estimated 30 million Americans in one way or another.26,27 That’s just the estimated toll in the U.S., so you can imagine what the global numbers might be. It’s a catastrophe of unprecedented proportions. A June 2022 survey by Steve Kirsch also found:28
- 6.6% of COVID jabbed respondents suffered heart injury (about 10 million Americans, based on the national vaccination rate)
- 6.3% had to be hospitalized for their side effects (another 10 million Americans)
- 9.2% of those who took the jab had to seek medical help for their injury, which translated over the whole country would be about 18 million doctor’s visits
- People who got the shot were more likely to die from COVID than the unvaccinated
- 2.63% of the responders had lost someone in their household to COVID infection, and 2.03% had lost someone in their household to the COVID jab
Expect Depopulation
Whether intentional or not, mounting evidence now indicates the COVID-19 injections will result in depopulation through premature death and adverse effects on fertility in women and men alike. I’ve previously discussed the risk of pregnancy loss and infertility in women who get the shot, as the mRNA has an affinity for accumulating in the ovaries29 (as well as the adrenals, liver and bone marrow).
Research30,31 from Israel now also reveals the shot deteriorates sperm count and sperm motility in men for about three months. Considering the multidose mRNA shots are recommended at three-month intervals, you can see how this can really decimate a man’s prospects of fathering a child.
Fertility has been on a steady decline for decades in most parts of the world,32 but the worldwide COVID jab campaign may massively speed that up. Germany recently released data showing a 10% decline in birth rate during the first quarter of 2022.33
Other countries are also seeing a drop in birth rate, nine months after the start of the mass vaccination campaign against COVID. Between January and April 2022, Switzerland’s birth rate was 15% lower than expected, the U.K.’s was down by 10% and Taiwan’s was down 20%.34
What punishment could possibly be appropriate for company heads and health agency leaders responsible for causing massive depopulation worldwide through products that were based on fraudulent science and fictional claims? I doubt if there’s enough money in the world to set that right.
Future Trials To Be Skipped Altogether
As if matters weren’t already beyond horrible, the FDA is considering allowing manufacturers to reformulate their COVID injections in perpetuity without conducting any additional clinical trials!35 In other words, they’d allow drug companies to change the mRNA and/or other ingredients without any safety or efficacy testing whatsoever. As reported by Toby Rogers, Ph.D., in a June 27, 2022, article in The Defender :36
“FDA released a briefing document37 in connection with this scheme to end science as we know it in connection with future COVID-19 shots … The briefing document is 18 pages of text, 1.5 line spacing, with just 19 references — 9 of which are pre-prints or from the CDC’s in-house newsletter Morbidity and Mortality Weekly Report (MMWR) which means they are not peer-reviewed.
Any true believer in The Narrative(TM) could have written this in a few hours. To base the entire future of COVID-19 shots on this glorified undergrad term paper is madness …
The core argument of the briefing document is hilarious (or rather, it would be hilarious if it was not a plan to permanently institutionalize genocide and hide the evidence). In several places the FDA argues (colloquialisms mine):
1. These COVID-19 shots work great … Boosters too, total home run, the Israelis even have 10-weeks of data showing that they might help old people. What more evidence could you want?
2. Okay, well, it depends on what you mean by ‘work.’ These shots do not stop infection, transmission, hospitalization, or death, even though that’s why we licensed them. Any protection wears off fairly quickly, but It’s Not Our Fault(TM) because This Wily Virus(TM) mutates too fast and no one told us that it would ever mutate.
3. So these shots must be reformulated but we cannot possibly ask Lord Pharma to do proper clinical trials ever again because we already know that these shots work great (see point #1)!”
In short, the FDA argues that since there are time constraints, evaluation of effectiveness must rely on “measures other than actual health outcomes.” In other words, whether the shots actually lower your risk of severe illness, hospitalization and death will have no bearing.
The only measure they’ll take into account is whether or not the jab triggers a rise in antibody levels, which has never been proven to be beneficial. If anything, the increase in COVID antibodies actually increases your risk of infection. This also means that as long as antibody levels are through the roof, the death rate could be just about anything, because it’s not part of the safety equation.
Faith in Magic Has Officially Replaced Science
As noted by Rogers,38 “The ‘Future Framework’ is a plan to base the entire COVID-19 vaccine program on magical thinking rather than science.” Indeed, Dr. Deborah Birx recently confirmed that the whole vaccine push has been based in faith in magic.39
June 23, 2022, Birx answered questions from the House Select Subcommittee on the Coronavirus Crisis. Rep. Jim Jordan, R-Ohio, asked whether the government was lying or guessing when they stated that vaccinated individuals couldn’t catch or spread COVID. At first, she claimed she didn’t know, but when pressed, she replied, “I think it was hope that the vaccine would work in that way.”40
So, the government issued mandates and made unequivocal, absolute statements that were not allowed to be questioned because they HOPED the shots would work a certain way — all while insisting they were the ones following and trusting the science and anyone who questioned their logic was a dangerous nut job. Let that sink in. Hope is literally the diametrical opposite of science.
It’s an Insiders’ Plot
As explained by Rogers, the same old players are behind this brazen attempt to eliminate the need for clinical trials: CDC staffers, academics who are in the pockets of Bill Gates and the NIAID, the drug companies themselves and the World Health Organization. Rogers writes:41
“I did not understand until just yesterday (as I started to write this article) that this entire ‘Future Framework’ is actually coming from the WHO. The Bill & Melinda Gates Foundation is the biggest voluntary contributor to the WHO. So Gates is likely directing the play.
Gates requires that WHO use the McKinsey consulting firm so this is probably a McKinsey operation (and McKinsey also works for Pharma so this is a huge conflict of interest). As Naomi Wolf points out, the involvement of the WHO also raises troubling questions about the influence of the Chinese Communist Party over this process.
As far back as January, the WHO/Gates/McKinsey junta realized that these shots were terrible and so they decided to use that as an opportunity to seize even more power and control.
The WHO set up a Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) to implement these Orwellian ‘Future Frameworks’ across the developed world to lower manufacturing costs for Pharma and avoid bothersome health data that might hurt profits. All the messaging we have seen from the FDA and leaked to the press was initially developed and released by TAG-CO-VAC.”
No doubt, we live in unprecedented, precarious times. Logic, reason, science and sanity itself has been tossed aside by those who claim the right to make decisions for all mankind. If the FDA goes forward with this “Future Framework” scheme, the only safe assumption is that COVID shots will become more and more dangerous.
Worse, we can expect other vaccines and drugs to be allowed on the market without clinical trials as well. It truly could change the science of medicine as we know it.
Of course the WHO also wants to seize control over health care worldwide, which would eliminate medical rights everywhere. It’s a nightmare scenario with no end in sight as of yet. All we can do is continue to push back, to inform ourselves, to speak out, share facts and data, and refuse to comply with unscientific recommendations based on little more than hope in fabricated conclusions.
Sources and References
- 1 PHMPT.org Pfizer Documents Released by FDA
- 2, 3, 5, 6, 7, 9 The Defender June 21, 2022
- 4 PHMPT.org 16.2.7.1 Adverse Events Legend
- 8 PHMPT.org 2.5 Clinical Overview for BNT162b2
- 10 The Defender June 15, 2022
- 11, 14 The Vaccine Reaction June 21, 2022
- 12 CDC MMWR April 29, 2022; 71(17): 606-608
- 13, 16 CDC MMWR March 18, 2022; 71(11): 429-436
- 15 FDA. Briefing Document on EUA amendment request for Pfizer-BioNTech COVID-19 vaccine for use in children 6 months […]. VRBPAC Meeting June 15, 2022
- 17, 20 SSRN June 23, 2022
- 18, 23 Robert Malone Substack June 22, 2022
- 19 The Daily Sceptic June 22, 2022
- 21 SPEAC October 26, 2021
- 22 Canadian COVID Care Alliance, More Harm Than Good
- 24 Jackanapes Substack June 16, 2022
- 25, 29 Paul Alexander Substack June 27, 2022
- 26 the New American June 27, 2022
- 27, 28 Steve Kirsch Substack June 25, 2022
- 30 Andrology June 17, 2022 DOI: 10.111/andr.13209
- 31 Expose June 26, 2022
- 32 Bloomberg June 21, 2022
- 33 Twitter Jikkyleaks June 26, 2022
- 34 SWPRS June 2022
- 35, 36, 38, 41 The Defender June 27, 2022
- 37 FDA Briefing Document June 28, 2022
- 39, 40 Daily Caller June 23, 2022
U.S. Orders 2.5 Million More Monkeypox Vaccine Doses, as CDC Looks to Expand Vaccine for Kids
By Suzanne Burdick, Ph.D. | The Defender | July 1, 2022
The Biden administration today said it ordered 2.5 million more doses of Bavarian Nordic’s Jynneos monkeypox vaccine, bringing the total vaccine doses to be delivered in 2022 and 2023 to more than 4 million.
The news followed Tuesday’s announcement of the first phase of the U.S. government’s “national monkey vaccine strategy,” which will expand testing capabilities and make Bavarian Nordic’s Jynneos vaccines readily available to anyone exposed to the virus.
The U.S. Department of Health and Human Services (HHS) said the government’s “enhanced” nationwide strategy “will vaccinate and protect those at-risk of monkeypox,” as well as provide guidance to communities on how to respond to outbreaks.
“We are focused on making sure the public and healthcare providers are aware of the risks posed by monkeypox and that there are steps they can take — through seeking testing, vaccines and treatments — to stay healthy and stop the spread,” said Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC).
As part of the strategy, the CDC and HHS began shipping tests to five major laboratory companies across the country: Aegis Science, Labcorp, Mayo Clinic Laboratories, Quest Diagnostics and Sonic Healthcare.
The government, which for months has been buying more Jynneos doses to add to the national stockpile, is now distributing the vaccine. It’s currently making available 296,000 doses and expects to roll out 750,000 doses over the summer, with an additional 500,000 doses produced and released in the fall — for a total of 1.6 million doses this year.
The Jynneos vaccine is licensed for use in adults and is considered safer than Emergent BioSolutions Inc.’s ACAM2000 smallpox vaccine, which also can be used against monkeypox, the HHS said.
The vaccine will be made available to individuals “with confirmed and presumed monkeypox exposures,” said the HHS.
“This includes those who had close physical contact with someone diagnosed with monkeypox, those who know their sexual partner was diagnosed with monkeypox, and men who have sex with men who have recently had multiple sex partners in a venue where there was known to be monkeypox or in an area where monkeypox is spreading.”
Health officials seeking to expand use of monkeypox vaccine for kids, despite lack of safety data
U.S. health officials also are seeking to expand use of the monkeypox vaccine for children, Bloomberg reported.
The CDC is developing a protocol aimed at allowing use of the Jynneos vaccine in children “should cases in children occur,” Kristen Nordlund, a CDC spokesperson, said in an email to Bloomberg.
“I’m concerned about sustained transmission because it would suggest that the virus is establishing itself, and it could move into high-risk groups, including children, the immunocompromised, and pregnant women,” Tedros Adhanom Ghebreyesus, director-general of the World Health Organization (WHO) said in a Wednesday press briefing.
“We’re starting to see this with several children already infected,” he added.
There have been 350 cases so far of monkeypox in the U.S. — all adults — according to the CDC. The agency confirmed 5,115 cases worldwide.
The WHO confirmed two cases in children in the U.K. and said Wednesday it is following up on reports of cases in children in Spain and France.
No safety trials have been done in children for the Jynneos vaccine as of yet, partly because clinical research involving participants under the age of 18 must pose no more than “minimal risk” to children, which can be difficult for vaccine manufacturers to argue.
Commenting on the CDC’s actions, Dr. Meryl Nass, a member of the Children’s Health Defense scientific advisory committee, told The Defender, “It’s kind of extraordinary that they want to vaccinate everyone in the country before knowing what the safety issues are.”
Nass, an internist and biological warfare epidemiologist, said, “We don’t actually know” if the Jynneos vaccine prevents monkeypox in humans because it was developed as a smallpox vaccine, and prevention studies have been conducted using only animals.
“It is hard to believe that the [U.S. Food and Drug Administration (FDA)] gave this vaccine a license when you read the FDA reviewers’ comments in their own report,” Nass wrote in her June 23 substack newsletter.
“They could not test the vaccine for efficacy against smallpox because there is no smallpox, nor against monkeypox, because the disease is so rare,” Nass wrote. “So the FDA relied on neutralizing antibody titers.”
At the same time, the FDA admitted there is no established correlate of protection, Nass said.
“This means that there is no evidence that the titers represent actual immunity to infection,” Nass wrote. “So FDA relied on animal studies to simply guess the vaccine might be effective in humans.”
According to the FDA, the effectiveness of Jynneos for the prevention of monkeypox is “inferred from the antibody responses in the smallpox clinical study participants and from studies in non-human primates that showed protection of animals vaccinated with Jynneos who were exposed to the monkeypox virus.”
Jynneos, a replication-deficient live Vaccinia virus vaccine, was licensed in the U.S. in 2019, by the FDA for use in individuals 18 and over considered to be at high risk for smallpox or monkeypox.
In 2021, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted to recommend Jynneos as a safer alternative to the ACAM2000 vaccine because of ACAM2000’s propensity to cause serious adverse effects, including myocarditis and pericarditis — i.e., inflammation of the heart.
However, Nass noted, Jynneos also was linked to heart inflammation, according to the FDA licensure review of the Jynneos smallpox-monkeypox vaccine which reported:
“Up to 18.4% of subjects in 2 studies developed post-vaccination elevation of troponin [a cardiac muscle enzyme signifying cardiac damage]. However, all of these troponin elevations were asymptomatic and without a clinically associated event or other sign of myopericarditis.”
These higher levels of troponin were not studied further, and the reviewers admitted they did not know if the Jynneos vaccine caused myocarditis, Nass said.
The Jynneos manufacturers said they would conduct an “observational, post-marketing study” in which they would “collect data on cardiac events that occur and are assessed as a routine part of medical care.”
But myocarditis — particularly asymptomatic forms of myocarditis that lack outer signs of the condition — could fly under the radar of the “routine part of medical care,” noted Nass.
The manufacturers would need to test for heightened troponin levels — something that is not typically done in “routine” check-ups.
The authors of a 2015 study reported evidence of heart injury following vaccination in a sample of 1,445 individuals who received a smallpox or trivalent influenza vaccine.
They found that chest pain, shortness of breath and/or palpitations occurred in 10.6% of those who received the smallpox vaccine SPX-vaccinees and 2.6% of those who received the trivalent influenza vaccine within 30 days of immunization.
Additionally, the study authors reported levels more than double the upper limit of troponin — a protein that flags cardiac injury — in 31 of the individuals who received the smallpox vaccine.
“Passive surveillance significantly underestimates the true incidence of myocarditis/pericarditis after smallpox immunization,” they concluded.
The authors added:
“Evidence of subclinical transient cardiac muscle injury post-vaccine immunization is a finding that requires further study to include long-term outcomes surveillance. Active safety surveillance is needed to identify adverse events that are not well understood or previously recognized.”
Suzanne Burdick, Ph.D., is an independent journalist and researcher based in Fairfield, Iowa.
© 2022 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.
FDA Panel Votes to Waive Clinical Trials for New COVID Boosters
By Megan Redshaw | The Defender | June 29, 2022
The U.S. Food and Drug Administration’s (FDA) vaccine advisory panel on Tuesday voted 19 to 2 to recommend new COVID-19 booster shots that include the Omicron variant this fall.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) did not issue guidance on whether additional data would be needed to recommend an updated composition of the primary-series vaccines authorized for emergency use in the U.S., or whether it would be appropriate to continue to use a primary-series vaccine as a booster.
It is the first time VRBPAC has suggested vaccine makers modify their vaccines to target a different variant, according to CNBC, which also reported the FDA will likely accept the committee’s recommendation.
If so, the FDA would be authorizing a vaccine change without requiring additional data showing a bivalent vaccine — containing both the original 2019 Wuhan variant and one of the Omicron variants — is safe and effective for those age groups that are already authorized to receive a booster dose.
The FDA plans to decide by early July whether vaccines will target the now-dominant BA.4 and BA.5 Omicron subvariants or the BA.1 Omicron variant that led to a surge in infections last winter, Reuters reported.
At the beginning of the meeting, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, suggested a newly designed shot could begin in October, adding that it takes manufacturers around three months to choose a vaccine design and begin producing doses.
Dr. Paul Offit, director of the Vaccine Education Center and professor of pediatrics in the Division of Infectious Diseases at Children’s Hospital of Philadelphia, and Dr. Hank Bernstein, professor of pediatrics at Zucker School of Medicine, were the only two members who broke from the panel to vote against the initiative.
Offit acknowledged there’s a benefit to providing a booster in the fall to some age groups, but questioned whether Omicron was the right strain. He said the move to new-variant vaccines was happening too fast, with too little data.
“I think as a new product it should be handled as a new product,” Offit said. “I think we need a higher standard than what we’ve been given. …“I’m not comfortable enough to support the risk of a new product.”
Bernstein expressed concern over the lack of data used to justify changing the strain, and the potential that by the time a subsequent booster is approved, it will contain outdated strains.
“So, in sum, I think including an Omicron strain in the vaccine seems to have some potential, but data especially for BA.4 and BA.5 are limited at this time, and that’s why I’m struggling to even make a strain change at this time,” Bernstein said.
Bernstein also said he didn’t see a need to change the strain as the current vaccine being used is shown to be effective against severe disease — a claim made just two weeks earlier at a prior VRBPAC meeting.
Bernstein said the strain change would need to be supported by data showing improved vaccine effectiveness and he “didn’t think we really have the data to be able to say that” even though the panel looked at the immune response.
Dr. Ofer Levy, VRBPAC member and an infectious disease physician at Boston Children’s Hospital, voted “yes” to change the computation of COVID-19 boosters, despite Pfizer’s admission there is “no established correlate of protection,” referring to the level of antibodies needed to confer protection.
“You have a lot of data now,” Levy told Pfizer. “What is your relative protection?”
“I would say there is no established correlate of protection,” Kena Swanson, Ph.D., vice president of viral vaccines at Pfizer, told Levy.
Levy circled back during the meeting:
“I would like to hear from FDA what their overall approach will be around improving our understanding of correlate protection. We spend a good amount of time reviewing antibody data. We have no doubt antibody data is important. We don’t have a level of antibody that anybody is comfortable stating is correlated [with] protection.
“So yes, the antibodies are important but so are the T cells. We heard from Dr. Weir, yes, T-cell assays are trickier and they’re more diverse, but it’s not going to happen without federal leadership to have a standardization of the T-cell assay and encourage or in fact require the sponsors to gather that information.”
“So what is the effort to standardize the pre-clinical assays?” Levy asked. “This is an effort that’s critical not just now but for future cycles of vaccine revision. If we aren’t able to define a standard for correlate protection we are fighting with one arm behind our back.”
Marks acknowledged the importance of Levy’s question, but said T-cell-mediated immunity was “difficult to study” initially.
“We have been having conversations with our colleagues at the NIH [National Institutes of Health] and throughout government about how we might move forward here,” Marks said. “It is something that we don’t have an answer to yet.”
Marks said as vaccines are developed in the future, it will “become even more important” to define a standard of correlate protection because “we won’t be able to have a large naive population to vaccinate with newer vaccines.”
“We will need to understand the T-cell response better,” Marks said. “I take your point, it’s just that we haven’t solved the problem yet.“
Dr. Meryl Nass, a member of the Children’s Health Defense scientific advisory committee, told The Defender that in her opinion, Tuesday’s meeting was a “vote to essentially approve a future framework — the future framework being a dearth of evidence required to change the booster, without clinical evidence and without a correlation of protection.”
Nass added:
“They voted on using an Omicron variant in the next booster iteration — which could contain any Omicron variant and could be either mono- or bi-valent.
“But most likely they will keep the current version and add another — which might double the amount of mRNA, or not.”
The new formulation might be for adults alone or adults and children, or only older adults and the immunocompromised, Nass said.
Brian Hooker, Ph.D., Children’s Health Defense chief scientific officer and professor of biology at Simpson University, told The Defender :
“The proposed move by VRBPAC will increase the harm to the U.S. public to unprecedented levels, as this action will further circumvent necessary clinical trials even beyond the slapdash testing of COVID-19 vaccines under Emergency Use Authorization.
“This adds to a foundation of lies used to authorize the original COVID-19 vaccines without anywhere near proper testing.”
Dr. Cody Meissner, VRBPAC panel member and professor of pediatrics at Tufts University, expressed concern about the financial risk pharmaceutical companies “are taking by making these vaccines.”
“If there’s a low likelihood the vaccines will be recommended, then they could incur significant loss,” he said.
Marks responded:
“I guess I would say that I would make recommendations here knowing the vaccine manufacturers will be kept whole by the United States government at least for some vaccines. I could be wrong but I think that’s a reasonable assumption.”
During the meeting, Moderna told the panel it would be ready with a “couple of hundred million” bivalent, or double-targeted, vaccines designed to combat BA.1 by September, but it would be late October or early November if the company needs to design a new vaccine targeting subvariants.
Pfizer said it and partner BioNTech have a significant amount of vaccine doses designed for the BA.1 variant ready and are already preparing to produce a large number of doses targeting BA.4 and BA.5 Omicron subvariants.
Pfizer said either could be ready for an early October rollout.
Multiple concerns raised during the public comment session
During the public comment session of the meeting, experts raised concerns that were largely ignored by the advisory panel.
Dr. Dustin Bryce, with Interest of Justice, said the FDA, Centers for Disease Control and Prevention (CDC) and the World Health Organization are “usurping Congress’ definition of a vaccine — which is any substance designed for the prevention of one or more disease.”
“FDA actually classifies mRNA as gene therapy, which they say is to treat or cure an existing disease by modifying your genes,” Bryce said. “Gene therapies are still being studied and are experimental at this time.”
Citing FDA documents, Bryce said gene therapy, unlike a vaccine, is so inherently unsafe the FDA says it requires 15 years of research to follow up on safety due to known risks of antibody-dependent enhancement, alteration of DNA and delayed adverse effects, such as cancer.
Bryce said:
“FDA says that gene therapy use in the mass population represents an unreasonable risk and they should limit the number of subjects who might be exposed to risk. We require due process and forbid the FDA from authorizing the proposed changes.
“We are demanding that EUA [Emergency Use Authorization] is promptly revoked because unreasonable risks are inherent in gene therapy products, as evidenced by large numbers of reports of adverse serious events linked to or suspected of being caused by an EUA product, product failure and product ineffectiveness.”
Bryce said COVID-19 vaccines fail to meet the requirements of EUA because not a single mRNA vaccine has been found to be effective for the prevention or treatment of an existing disease.
Michael Briskin pointed out in his public comment that the FDA receives approximately 75% of its budget from pharmaceutical companies, which he believes represents a conflict of interest.
Briskin challenged the use of the phrase “safe and effective” to describe COVID-19 vaccines, given the FDA has done no long-term testing to determine whether these products are safe.
Briskin presented data showing a significant rise in reported deaths among working-age Americans following COVID-19 vaccine mandates.
He said:
“In the short-term, 2021 was a very interesting year. We saw a stark increase [in death] among working-age adults from 18 to 64 and specifically in Q3 and into Q4, so something new for the working-age demographic partly through 2021 would be the clear correlation.
“With comparable trends in BLS [Bureau of Labor Statistics] data, children’s health insurance data, Israeli ambulance data, and of course we have the [Vaccine Adverse Event Reporting System (VAERS)] data — which the CDC tried to minimize but a recent FOIA [Freedom of Information Act] request forced them to reveal that they never once did the PRR calcification that was supposed to be their tool for spotting safety signals, according to their posted documents.”
“And what do we do when people get injured from these vaccines?” Briskin asked the panel. “We leave them in the mud.”
Briskin chastised the panel for authorizing boosters for infants two weeks earlier when data showed two doses weren’t effective and only 10 cases were used to assess efficacy.
“Three-quarters of the severe COVID in the trial was in the vaccine arm, as was the only hospitalization case which was accompanied by a seizure,” Briskin said. “And Moderna is so dangerous in young people Nordic countries won’t allow it to be used in anyone under the age of 30.”
Briskin said:
“In fact, the director of health of Denmark just admitted that vaccinating children was a mistake, whereas our officials only ever doubled down. And now we’re about to double down so hard we are about to lose the pretense of holding these pharmaceutical companies to any statistically meaningful regulatory standards for formula modification.
“For people following at home, what this agency is proposing is not just modifying the genetic code in the vaccine and the structure of the proteins produced to chase variants, but even things like doubling the microgram count for Pfizer — all without doing any statistically powered safety studies.”
“And to be clear,” Briskin added, “the companies we’re giving carte blanche to include Pfizer, the world’s largest criminal organization having paid the world’s largest criminal fine, and Moderna, which never made a safe product before we did away with long-term safety testing.”
Dr. Eric Feintuch, a chiropractor, asked the FDA if the agency knows how long mRNA from COVID-19 vaccines and the spike protein stay in the body, whether they know what the rate of protein production is and whether the FDA is aware of the consequences of the methylpseudouridine substitutions at the codon optimization step.
“For anyone on this panel who says it doesn’t go anywhere, tell me what proof you have of that,” Feintuch said, referring to the spike protein.
Feintuch said COVID-19 vaccines are associated with prion disease, noting 26 people have reported experiencing sudden onset of a severe and fatal brain disorder within one month of the second mRNA vaccine dose.
“This information needs to be researched and seen,” Feintuch said.
“A thousand peer-reviewed studies question the safety of COVID-19 vaccines. Doesn’t anyone see the safety signals? Is there anyone here who will stand up?” he asked. “Some of you know this, you need to stand up and you need to help us.”
Dr. David Wiseman, a research scientist with a background in pharmacy, pharmacology and experimental pathology, said VRBPAC is once again being asked to opine on inadequate information.
Wiseman said the FDA recently waived efficacy requirements for COVID-19 vaccines and has ignored its experts, notably Levy, who “has called for federal efforts to validate and standardize a correlate of protection.”
“Recent vaccine decisions were based on irrelevant Wuhan immunobridging,” Wiseman said. “Omicron assays are unvalidated and unverified by FDA.”
Wiseman said safety questions surrounding COVID-19 vaccines remain unanswered:
“We have shown correlations between vaccination and all-cause mortality. FDA says VAERS is under- and misreported. A FOIA disclosure reveals that CDC has not conducted safety signal analyses, which we have provided to FDA. Neurologic adverse events are finally being acknowledged [but there are] still no cancer studies.”
Wiseman further pointed out that FOIA requests show vital studies involving the spike protein have not been done:
“A Stanford study in [the journal] Cell showed vaccine message and antigen persisting for at least eight weeks. Does spike accumulate? Is this why myocarditis rates after boosting match or best primary series rates for some ages?
“Does spike persistence contribute to immune suppression, imprinting and negative efficacy? What is the toxicity of multiple doses? How will sameness of the manufacturing process be defined? Are the guidelines talking about monovalents or bivalents?”
Pfizer has dismissed concerns about the spike protein as “academic,” Wiseman said, “but it is certainly not.”
Booster formulation should be changed to combat waning efficacy, committee said
During the meeting, which occurred two weeks after the panel signed off on the primary COVID-19 vaccine series for the nation’s youngest children, a change in booster composition was deemed necessary due to waning effectiveness.
Dr. Mahesh Shenai, neurosurgeon and data analyst, said in a tweet:
“After many months of extolling benefits of vax and booster, now they are criticizing its efficacy and durability. . . to set the stage for a new updated booster!?”
In a briefing document published ahead of Tuesday’s meeting, FDA officials predicted a major COVID-19 outbreak will occur in the fall “due to the combination of waning immunity, further evolution of variants and increased indoor activity.”
A similar committee that advises the WHO recently suggested COVID-19 vaccines be reformulated to include both the original SARS-CoV-2 Wuhan variant and the first version of Omicron, BA.1 — although this variant has since been replaced by other strains of BA.4 and BA.5.
Moderna and Pfizer studied Omicron-specific vaccines in preparation for fall boosters, but efforts have been complicated by new subvariants.
If the government decides it wants a booster shot that targets BA.4 and BA.5 — two strains derived from the Omicron variant that are becoming dominant — vaccine manufacturers will have to race to produce the doses by fall, The New York Times reported.
Vaccines produced by Pfizer, Moderna, Novavax and Johnson & Johnson were developed against the original Wuhan COVID strain that emerged in 2019, but as the virus has rapidly evolved, these vaccines have become less effective.
COVID-19 vaccines target the spike protein the SARS-CoV-2 virus uses to invade human cells, but as the virus mutates away from the original strain, it has trouble “recognizing and attacking the spike,” CNBC reported. The Omicron variant has more than 30 mutations.
Marks said during the meeting he hopes changing the booster will “convince people to go get that booster,” adding the FDA plans to begin a booster campaign in October.
Megan Redshaw is a staff attorney for Children’s Health Defense and a reporter for The Defender.
© 2022 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.
FDA ATTEMPTS TO “FLU SHOT” FUTURE COVID VACCINES
The Highwire with Del Bigtree | June 24, 2022
Public comment is needed NOW to stop the FDA from considering bypassing their already fractured process of Covid vaccine safety and efficacy testing to ‘Flu shot’ future Covid vaccines and boosters.
Make your comment before the hearing, June 27th, to stop the agency allowing plug and play updates to these mRNA shots lacking proper clinical trials.
Pfizer Classified Almost All Severe Adverse Events During COVID Vaccine Trials ‘Not Related to Shots’
By Michael Nevradakis, Ph.D. | The Defender | June 22, 2022
The latest release by the U.S. Food and Drug Administration (FDA) of Pfizer-BioNTech COVID-19 vaccine documents reveals numerous instances of participants who sustained severe adverse events during Phase 3 trials. Some of these participants withdrew from the trials, some were dropped and some died.
The 80,000-page document cache includes an extensive set of Case Report Forms (CRFs) from Pfizer Phase 3 trials conducted at various locations in the U.S., in addition to other documentation pertaining to participants in Pfizer-BioNTech vaccine trials in the U.S. and worldwide.
The FDA on June 1 released the documents, which pertain to the Emergency Use Authorization (EUA) of the vaccine, as part of a court-ordered disclosure schedule stemming from an expedited Freedom of Information Act (FOIA) request filed in August 2021.
Public Health and Medical Professionals for Transparency (PHMPT), a group of doctors and public health professionals, submitted the FOIA request.
CRFs show deaths, severe reactions to the vaccines during Phase 3 trials
The CRFs included in this month’s documents contain often vague explanations of the specific symptoms experienced by the trial participants.
They also reveal a trend of classifying almost all adverse events — and in particular severe adverse events (SAEs) — as being “not related” to the vaccine.
For example:
- A female in her early 50s (randomization number 86545) who participated in the trial at the Sterling Research Group in Cincinnati, Ohio, died of an apparent myocardial infarction on Nov. 4, 2020. She had received two doses of the vaccine, on Sept. 10 and Sept. 29, 2020.
The patient had a medical history of chronic obstructive pulmonary disease, hypertension, hypothyroidism, osteoarthritis of the knees and attention deficit disorder. Her death was listed as “not related” to the vaccine, and was instead attributed to “hypertensive cardiovascular disease.”
- A female in her late 50s (randomization number 220496), who participated in the trial at Cincinnati Children’s Hospital Medical Center, died of cardiac arrest on Oct. 21, 2020. Her death, however, was indicated as “not related” to her vaccinations (which occurred on July 30, 2020, and Aug. 20, 2020) as it “occurred 2 months after last receipt of study agent,” according to her CRF.
The participant’s medical history included obesity, placement of a gastric sleeve, gastroesophageal reflux, sleep apnea, supraventricular tachycardia, hypothyroidism, depression and asthma.
- A male in his mid-60s (randomization number 221076) who participated in the trial operated by the Texas-based Ventavia Research Group died of an apparent myocardial infarction on Nov. 28, 2020. He had received the two doses of the vaccine on July 31, 2020, and Aug. 19, 2020.
The participant had a medical history that included a previous myocardial infarction, high blood pressure, high cholesterol, anxiety, bilateral hip pain, type 2 diabetes, fluid retention, angina (intermittent), restless leg syndrome, Vitamin D deficiency, tobacco dependency and the placement of a coronary arterial stent in 2017.
According to the CRF, he sustained the myocardial infarction on Oct. 27, 2020, and was diagnosed with pneumonia the following day. While both diagnoses were classified as “serious” in his CRF, they were both listed as “not related” to the vaccination, with his myocardial infection attributed to a “failed cardiac stent” and the pneumonia simply attributed to “infection.”
- A female in her teens (randomization number 104650) was diagnosed with right lower extremity deep vein thrombosis on Nov. 15, 2020, which was still ongoing as of Mar. 29, 2021, the date of the CRF. She was hospitalized and her condition was classified as “serious,” but it was indicated as “not related” to the vaccine, instead attributed to a “fracture” occurring prior to her vaccination on Sept. 11, 2020.
The patient had a medical history including asthma, attention deficit hyperactivity disorder, Charcot-Marie-Tooth disease and obesity.
- A male in his mid-70s (randomization number 227629) participating in the trial at Clinical Neuroscience Solutions Inc. (operating in Florida and Tennessee) sustained a series of adverse events following his vaccinations on Aug. 13 and Oct. 7, 2020.
He was diagnosed with COVID-19 on Aug. 30, 2020, which coincided with several other diagnoses classified as “serious,” including abdominal adhesions (Aug. 29, 2020), altered mental status (Aug. 29, 2020, lasting through Sept. 16, 2020), and acute hypoxic respiratory failure (Aug. 30, 2020). These diagnoses required his hospitalization.
He was also listed as having suffered from congestive heart failure on Aug. 30, 2020, but this diagnosis was listed as “not serious” and as “not related” to the vaccine, but to “prior surgery,” with no further details given. Similarly, his other serious adverse events were listed as being related to “prior” or “previous” surgery, or to “concomitant non-drug treatment.”
Other “non-serious” adverse events listed in this patient’s CRF include hypokalemia, anemia, acute renal failure, sepsis, hyponatremia, leukopenia, small bowel obstruction, aspiration pneumonia, mild concentric left ventricular hypertrophy (symptoms of which were still ongoing as of the CRF date of Mar. 29, 2021) and urinary tract infection.
The patient had a medical history encompassing ongoing hypertension, hypercholesterolemia, gastroesophageal reflux disease, constipation, hiatal hernia and previous diagnoses of small bowel resection, small bowel perforation, inguinal hernia, osteoarthritis in both knees and knee replacement (both knees).
- A male in his mid-70s (randomization number 266982) participating in the trial at Boston Medical Center suffered a series of adverse events following vaccination, including pneumonia and peripheral edema. He had received two doses of the vaccine, on Oct. 2, 2020, and Oct. 27, 2020.
The patient was hospitalized for pneumonia on Jan. 20, 2021, in an event classified as “serious” but also as “not related” to the vaccine. However, the cause of his pneumonia was listed in the CRF simply as “un-related to vaccine,” while his peripheral edema diagnosis was attributed to “existing neuropathy.”
During his hospitalization with pneumonia, his blood pressure was measured as high as 179/72, with a heart rate reaching 105 beats per minute and an oxygen saturation level that fell to 92.0. In total, he had three emergency room visits during the observation period.
The patient had a medical history that included type 2 diabetes, alcoholic cirrhosis, hypothyroidism, asthma, sleep apnea, hypertension, diabetic neuropathy, congestive heart failure, generalized anxiety disorder, depression, insomnia, excessive urination, chronic obstructive pulmonary disease and HIV-positive status.
A protocol deviation also occurred involving this patient, as his diary was not activated following administration of the first dose of the vaccine.
- A male in his early 40s (randomization number 68489) who participated in the trial at Cincinnati Children’s Hospital Medical Center sustained chronic myelogenous leukemia on Sept. 24, 2020, with the condition ongoing as of the date of the CRF on Mar. 29, 2021.
This was classified as a “serious” and “life-threatening” adverse event, albeit one that did not require hospitalization, but it was listed as “not related” to the vaccination but instead to a “genetic change in stem cells.”
The patient had been vaccinated on Aug. 26, 2020, and Sept. 17, 2020, and had a medical history of asthma and seasonal allergies. Other “non-serious” adverse events he sustained included leukocytosis and thrombocytosis.
- A female in her mid-40s (randomization number 49018) who participated in the trial at Clinical Neuroscience Solutions Inc. was diagnosed with kidney stones on Jan. 4, 2021.
This was classified as a “serious” adverse event that required hospitalization, but was listed as “not related” to the vaccine, instead being related, again, to “kidney stone” (sic). She had received the two doses of the vaccine on Aug. 17, 2020, and Sept. 8, 2020.
The patient was diagnosed with COVID-19 on Jan. 27, 2021. Her prior medical history included migraine headaches, hypercholesterolemia and a Tarlov cyst.
- A female approximately 30 years old (randomization number 53307) participating in the trial at Boston Medical Center, with nothing to report in her medical history, sustained a shoulder injury related to vaccine administration (SIRVA) on Sept. 9, 2020, with symptoms continuing until Feb. 8, 2021.
This injury was listed as being related to the second dose of the vaccine, which she received on Sept. 9, 2020 (she had previously received her first dose on Aug. 17, 2020).
- A female in her late 50s (randomization number 260125) participating in the trial at Clinical Neuroscience Solutions Inc., suffered from acute exacerbation of asthma. The symptoms appeared in mid-December 2020, following her vaccination on Sept. 16, 2020, and Oct. 5, 2020.
Her symptoms were classified as serious but not life-threatening, and she was hospitalized. However, her asthma symptoms were listed as “not related” to the vaccine, instead being related to “asthma” with no further explanation provided. On Jan. 12, 2021, her blood pressure was recorded as 183/130, with a heart rate of 98 beats per minute.
Other less serious adverse events sustained by the patient included injection site pain, body pain, chills and a low-grade fever.
Her medical history included cholecystitis (and a cholecystectomy), herniated disc, total abdominal hysterectomy, bilateral oophorectomy, bilateral salpingectomy, endometriosis, hypertension, hypercholesterolemia, rheumatoid arthritis in remission, asthma, seasonal allergies, irritable bowel syndrome and obesity.
- A male in his late 20s (randomization number 48413) who participated in the trial at Clinical Neuroscience Solutions Inc., sustained a bilateral pulmonary embolism on Dec. 14, 2020, with symptoms still ongoing as of the CRF date of Mar. 29, 2021.
This was listed as a “serious” adverse event that required hospitalization, but was attributed to the patient’s habit of vaping and his “sedentary lifestyle.” He had received the two doses of the vaccine on Aug. 13, 2020, and Sept. 2, 2020.
Other post-vaccination symptoms listed for the patient included fever, fatigue, headache, chills, vomiting, diarrhea, new/worsened muscle pain, new/worsened joint pain and swelling.
The patient had a medical history that included elevated triglycerides, genital herpes and seasonal allergies, in addition to a vaping habit.
The many serious adverse events – and several deaths – recorded during the Phase 3 trials are also apparent in a separate, massive document, exceeding 2,500 pages, cataloging such adverse events.
This document lists a wide range of adverse events suffered by trial participants classified as toxicity level 4 — the highest and most serious such level.
However, not one of the level 4 (most severe) adverse events listed in this particular document is classified as being related to the vaccination.
Level 4 adverse events listed in the document include but are not limited to the following, many of which occurred in multiple patients:
- Acute cholecystitis
- Acute respiratory failure
- Adrenal carcinoma
- Anaphylactic shock
- Aortic valve incompetence
- Appendicitis
- Arrhythmia, supraventricular
- Arteriosclerosis
- Brain abscess
- Cardiac arrest
- Chronic myeloid leukemia
- Complicated appendicitis/acute appendicitis with necrosis
- Congenital heart disease/heart anomaly
- Coronary artery occlusion
- COVID-19 illness
- Deep vein thrombosis
- Diverticulitis
- Hemiplegic migraine
- Hemorrhagic stroke
- Interstitial lung disease
- Myocardial infarction
- Orthostatic hypotension/possible postural hypotension
- Osteoarthritis
- Pericolic abscess
- Peritoneal abscess
- Renal colic
- Ruptured diverticulum
- Small bowel obstruction/small intestinal obstruction
- Spontaneous coronary artery dissection
- Subarachnoid hemorrhage
- Suicidal ideation (and suicidal ideation with attempt)
- Syncope
- Type 2 diabetes
- Worsening of abdominal pain
- An “unevaluable event/“unknown of unknown origin”
Similarly, only a small number of toxicity level 3 adverse events were indicated as having been “related” to vaccination. Such adverse events included but are not limited to the following, some of which occurred in multiple trial participants:
- Arthralgia
- Blood glucose increase/glucose spike
- Deafness/hearing loss
- Dyspepsia
- Hypotension
- Lymph node pain
- Lymphadenopathy/lymph node swelling
- Musculoskeletal chest pain (non-cardiac)
- Neutropenia
- Pain in fingers/bilateral hands
- Pruritus
- Pyrexia/febrile syndrome
- Severe headache
- Shoulder injury related to vaccine administration
- Sleep disorder/sleep disturbance
- Tachycardia
- Urticaria
- Ventricular arrhythmia
- Vertigo
Page 2,525 of the document in question also lists six trial participant deaths, with causes of death including arteriosclerosis, cardiac arrest, hemorrhagic stroke and myocardial infarction.
The small number of adverse events listed as being connected to the vaccine follows a trend noted in the previous tranche of Pfizer-BioNTech documents, released in May.
An additional document released in this month’s tranche catalogs patients who discontinued their participation in the Phase 3 trial, or whose participation was discontinued by physicians or other medical professionals.
While many patients were discontinued because they could not be located, because of a physician’s orders, because they moved to another region or for other personal reasons, numerous patients ended their participation due to adverse events, including but not limited to the following symptoms:
- Acute myocardial infarction
- Amnesia
- Anorexia
- Atrial fibrillation
- Cerebral infarction
- Congestive cardiac failure
- Coronary artery disease
- Deafness (unilateral)
- Depression
- Diabetic foot
- Diverticular perforation
- Exposure during pregnancy
- Eye pain
- Gait instability
- Gastric adenocarcinoma
- Gastrointestinal hemorrhage
- Hypertension
- Irregular heart rate
- Loss of taste and smell
- Myalgia
- Paraparesis
- Parkinsonism
- Presyncope
- Pulmonary embolism
- Pyrexia
- Swelling face
- Tachycardia
- Transient ischaemic attack
- Urticaria
- Vaccine allergy
- Vertigo
In other instances, subjects withdrew because of fears connected to safety concerns related to the vaccine, or discomfort in receiving the second dose.
Clinical review document glosses over adverse events during trials
Also included in June’s FDA document dump was a 334-page “clinical review” document, which appears to have been approved by the FDA on Apr. 30, 2021, and which presents “pivotal data” from Phase 1/2/3 Study C4591001, conducted in the U.S., along with “supporting” Phase 1/2 data from Study BNT162-01, performed in Germany.
This document refers to both Pfizer-BioNTech vaccine, which received an EUA from the FDA, and the Pfizer Comirnaty vaccine, which received full FDA approval but is reportedly almost impossible to find at vaccination locations in the U.S.
As previously reported by The Defender, a federal judge found the Pfizer-BioNTech and Pfizer Comirnaty vaccines are legally distinct.
The clinical review document states:
“BNT162b2 has received temporary authorizations for emergency supply in 28 countries and conditional marketing authorizations in 39 countries globally.
“The name of the product supplied under emergency/temporary use authorization for all applicable regions is Pfizer-BioNTech COVID-19 Vaccine.
“The name of the product supplied under conditional marketing authorization for all applicable regions is COMIRNATY [COVID-19 mRNA Vaccine (nucleoside modified)].”
The document states that trial participants were administered one of two candidate vaccines, labeled BNT162b1 and BNT162b2 (the latter of which ultimately received an EUA from the FDA), or a placebo. A variety of dosage levels were also tested, ranging from 10 μg to 100 μg for BNT162b1, and 10 μg to 30 μg for BNT162b2.
In Phase 1 of Study BNT162-01, the clinical review reports that “40% to 45% of participants who received BNT162b1 and BNT162b2 across age groups and across dose levels reported one or more AEs [adverse events] from Dose 1 through 28 days (i.e., 1 month) after Dose 2.”
In what will turn out to be a general pattern throughout the clinical review, we are told that “most AEs were considered by the investigator as not related to study intervention and mild to moderate in severity, and all AEs were reported as resolved.”
Some specific adverse events highlighted in this part of the clinical review include:
“Among BNT162b1 recipients, 1 younger participant in the 10 μg group discontinued the study due to a moderate AE of malaise (considered as not related to study intervention) after Dose 1 and 1 younger participant in the 60 μg group discontinued due to a dose-limiting toxicity of pyrexia after Dose 1.
“One older participant in the 20 μg group had an SAE of severe syncope (considered as not related to study intervention) after Dose 1 and study treatment was withdrawn.
“Among BNT162b2 recipients, 1 younger participant in the 10 μg group discontinued the study due to a moderate AE of nasopharyngitis (considered as not related to study intervention) after Dose 1.
“One older participant in the 20 μg group had an SAE of ankle fracture (considered as not related to study intervention) after receiving both doses, was listed as recovering, and remains in follow-up.”
The clinical review also states “no deaths occurred in the Phase 1 part of Study BNT162-01.”
The review adds that “from Dose 1 of BNT162b2 30 μg to the unblinding date, 6 (50.0%) participants in the younger age group and 3 (25.0%) participants in the older age group reported at least 1 AE.”
Specifically, in this portion of the study, “two (16.7%) participants in the BNT162b2 30 μg younger age group and 1 (8.3%) participant in the BNT162b2 30 μg older age group reported at least 1 severe AE,” and “in the BNT162b2 30 μg younger age group, 3 (25.0%) participants reported at least 1 related AE and 1 (8.3%) participant reported 1 severe SAE.”
These specific adverse events, according to the review, were reported in “the system organ class (SOC) of nervous system disorders (3 [25.0%] participants in the younger age group and 1 [8.3%] participant in the older age group), followed by musculoskeletal and connective tissue disorders (1 [8.3%] participant in each age group). All AEs by preferred term (PT) were reported by no more than 1 participant.”
The review adds, “from Dose 1 to the unblinding date, 1 participant in the BNT162b2 30 μg younger age group reported a severe SAE (neuritis) that was assessed by the investigator as not related to study intervention,” and “there were no Phase 1 participants randomized to BNT162b2 30 μg or corresponding placebo who died through the data cutoff date of 13 March 2021.”
Review of results from Study C4591001
While “incidences in the BNT162b2 and placebo were similar within the age groups for younger (9.1% vs 11.1%) and older (4.3% vs 8.9%) participants, among those who received BNT162b2 instead of the placebo, “two severe events of myalgia and gastric adenocarcinoma (which was also an SAE) were reported for 2 participants in the … younger age group, both assessed by the investigator as not related to study intervention.”
It is further mentioned that “the only discontinuation due to an AE during this time was the participant in the BNT162b2 younger age group who reported an SAE of gastric adenocarcinoma (discontinued from the study on Day 23 after Dose 1 of BNT162b2).”
Ultimately, from dose 1 to 1 month after dose 2 for participants during the blinded safety follow-up of study C4591001, “the numbers of overall participants who reported at least 1 AE and at least 1 related AE were higher in the BNT162b2 group (30.2% and 23.9%, respectively) as compared with the placebo group (13.9% and 6.0%, respectively).”
Specifically, “severe AEs were reported by 1.2% and 0.7% in in the BNT162b2 and placebo groups respectively, and life-threatening AEs were similar (0.1% in both groups),” and “SAEs and “AEs leading to withdrawal were reported by ≤0.6% and ≤0.2%, respectively, in both groups,” while “discontinuations due to related AEs were reported in 13 participants in the BNT162b2 group and 11 participants in the placebo group (0.1% in both groups).”
Overall, as reported for this part of the study, “in the younger age group, the number of participants who reported at least 1 AE from Dose 1 to 1 month after Dose 2 was 4233 (32.6%) and 1871 (14.4%) in the BNT162b2 and placebo groups, respectively. In the older age group, the number of participants who reported at least 1 AE from Dose 1 to 1 month after Dose 2 was 2384 (26.7%) and 1177 (13.2%) in the BNT162b2 and placebo groups, respectively.”
The review specifies that “the most frequently reported AEs in the BNT162b2 group … were injection site pain (2915 [13.3%]), pyrexia (1517 [6.9%]), fatigue (1463 [6.7%]), chills (1365 [6.2%]), headache (1339 [6.1%]), and myalgia (1239 [5.7%]),” however, some more serious adverse events that were reported during this stage of the trial included facial paralysis, cardiac disorders, hepatic cirrhosis, cholecystitis/cholecystitis acute, biliary colic, bile duct stone, biliary dyskinesia, lymphadenopathy, appendicitis, optic neuritis and hypersensitivity/anaphylaxis.
Overall, according to the review, “from Dose 1 to 1 month after Dose 2, severe AEs reported during the blinded follow-up period were low in frequency, reported in 1.2% of BNT162b2 recipients and 0.7% of placebo recipients.”
During the “open-label follow-up period,” referring to the period when the initial trial has been completed but participants are invited to continue taking the study drug for an additional period, the review states “three participants originally randomized to BNT162b2 died during open-label follow-up.”
While one of these deaths was reportedly due to a road accident, the other two were attributed to lung metastases and myocardial infarction. However, none of these deaths “were assessed by the investigator as related to study intervention.”
Furthermore, according to the report, during this period “there were 12,006 participants who had at least 6 months of follow-up. Among these, 3,454 participants (28.8%) reported at least 1 AE and 2245 participants (18.7%) reported at least 1 related AE. Severe AEs and SAEs were reported by 2.1% and 1.6%, respectively.”
The review provides data for participants from dose 3 (first dose of BNT162b2) to the data cutoff date. The severe adverse event incidence rate (IR) was 6.0 per 100 PY (patient-years), with specific conditions reported including pulmonary embolisms, thrombosis, urticaria, a cerebrovascular accident and COVID-19 pneumonia.
Here, the review adds that the IR for original placebo participants who had at least 1 life-threatening AE from Dose 3 to the data cutoff date was 0.5 per 100 PY. Only one such life-threatening event, an instance of anaphylactoid reaction, was considered to be related to the vaccination. Other life-threatening, serious adverse events included cardio-respiratory arrest, gastrointestinal necrosis, deep vein thrombosis and pulmonary embolism.
The report also notes, “There were 15 deaths in the BNT162b2 group and 14 deaths in the placebo group from Dose 1 to the unblinding date during the blinded placebo-controlled follow-up period.”
However, the report does not appear to go into detail about the causes of death for either group, other than to state, “None of these deaths were assessed by the investigator as related to study intervention.”
In the “Blinded Follow-Up Period from Dose 1 Through 1 Month After Dose 2,” in the BNT162b2 group, “SAE [serious adverse events] was similar in the BNT162b2 group (0.6%) and in the placebo group (0.5%),” with three SAEs in the non-placebo group deemed to be related to the vaccine. These included ventricular arrhythmia, lymphadenopathy and SIRVA.
During the “open-label follow-up period” for “original BNT162b2 participants,” the report states “one younger participant with no past medical history had a life-threatening SAE of myocardial infarction 71 days after Dose 2 that was assessed by the investigator as related to study intervention.”
However, despite its life-threatening nature, this condition “lasted 1 day and resolved the same day.”
Overall, “from Dose 1 to 6 months after Dose 2, during the blinded and open-label follow-up periods, 190 (1.6%) participants in the BNT162b2 group reported at least 1 SAE,” and “the number of participants who reported at least 1 SAE was 73 (1.1%) and 117 (2.2%) in the younger and older age groups, respectively.”
These SAEs were categorized as neoplasms, infections and infestations, gastrointestinal disorders, hepatobiliary disorders, respiratory/thoracic/mediastinal disorders and injury/poisoning/procedural complications.
An original placebo participant who received BNT162b2 for Dose 3 experienced a severe adverse event that “was assessed by the investigator as related to study intervention; specifically, “an anaphylactoid reaction 2 days post Dose 3” leading to the participant’s withdrawal from the study, despite a reported resolution.
A separate subsection in the report specifically addressed cases of Bell’s palsy and facial paralysis among trial participants. Specifically, “during the blinded placebo-controlled follow-up period, 6 participants developed one-sided facial paralysis (Bell’s palsy): 4 were randomized to BNT162b2 (all male) and 2 were randomized to placebo (1 male; 1 female),” according to the review.
Regarding the four vaccinated trial participants, their ages ranged from 40 to 70, with symptoms appearing three to 48 days after their last dose. Their symptoms were recorded as “mild to moderate in severity,” with duration ranging “from 3 to 68 days,” and with two of these cases “considered by the investigator to be related to study intervention.”
Moreover, “during the open-label follow-up period, 3 participants who received BNT162b2 as Dose 3 or Dose 4 (after originally being randomized to placebo) experienced facial paralysis,” according to the review. These patients were all female, with an age range between 19 and 34. Events were recorded as beginning two to eight days after administration of the third dose, and “were mild to severe.” One case had a duration of 12 days, while the other two cases were ongoing as of the cutoff date of the trial.
Notably, according to the review, “all these events of facial paralysis were considered by the investigator as related to study intervention.”
The review adds, “during the open-label follow-up period for participants originally randomized to BNT162b2, a male participant 51 years of age developed Bell’s Palsy 154 days after receiving Dose 2.” No indication is given as to whether this was deemed to be related to the vaccination or not.
From dose 1 to the unblinding date, heart-related adverse events included “6 acute myocardial infarctions, 4 myocardial infarctions group, and 1 acute coronary syndrome” in the BNT162b2 group.
According to the review, “most of these events had onset distant (ie, >30 days following) to receipt of vaccine or placebo. None of these events were assessed by the investigator as related to study intervention.”
Moreover, “there was 1 participant in the older BNT162b2 age group with pericarditis. The event had an onset of 28 days after Dose 2, was ongoing at the data cutoff date, and was assessed by the investigator as not related to the study intervention.”
Additionally, “there were 8 cases of pulmonary embolism in the BNT162b2 group,” in addition to four hemorrhagic strokes and “2 ischemic strokes, 4 cerebral vascular accidents, 2 transient ischemic attacks” in this group, plus “1 case of thrombocytopenia and 1 case of platelet count decreased.”
Furthermore, “there were 9 thrombotic events in the BNT162b2 group,” including seven instances of deep vein thrombosis, one case of coagulopathy and one case of ophthalmic vein thrombosis.
Regarding autoimmune issues in the BNT162b2 group, the review states “there were 10 autoimmune disease cases identified,” with one case each of “autoimmune thyroiditis, ulcerative colitis, Crohn’s disease, reactive arthritis, fibromyalgia, systemic lupus erythematosus, alopecia areata, psoriasis,” and two cases of psoriatic arthropathy.
Pregnancies were largely glossed over in the review, which states:
“At the time of the data cutoff date (13 March 2021), a total of 50 participants who had received BNT162b2 had reported pregnancies, including 42 participants originally randomized to the BNT162b2 group and 8 participants originally randomized to the placebo group who then received BNT162b2.”
“In total, 12 participants (n=6 each in the randomized BNT162b2 and placebo groups) withdrew from the blinded placebo-controlled vaccination period of the study due to pregnancy, and 4 participants originally randomized to placebo who then received BNT162b2 withdrew from the open-label vaccination period due to pregnancy.
“These participants continue to be followed for pregnancy outcomes. No births have been reported from individuals who have become pregnant in Study C4591001 as of the time of this submission.
“All pregnancies have a risk of birth defect, loss, or other adverse outcomes. Available data on BNT162b2 administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.”
Pfizer concludes vaccines are ‘safe and well-tolerated’
Overall, despite the incidence of severe adverse events — some of which were admitted to be related to the vaccine — and deaths, as well as an admitted lack of data regarding outcomes for pregnant women who participated in the trial, the “safety conclusions” of the review indicate the following:
“Based on Phase 1 data from the FIH Study BNT162-01, BNT162b1 and BNT162b2 were safe and well-tolerated in healthy adults 18 to 55 years of age, with no unanticipated safety findings … and the AE profile and clinical laboratory results did not suggest any safety concerns.
“Based on Phase 1 data from Study C4591001 and Study BNT162-01, BNT162b1 and BNT162b2 were safe and well-tolerated in younger healthy adults 18 to 85 years of age, with no unanticipated safety findings … and the AE profile did not suggest any safety concerns, including up to approximately 6 months after Dose 2 for BNT162b2 30 μg groups.
“Based on Phase 2/3 data from approximately 44,000 participants ≥16 years of age with up to at least 6 months of follow-up after Dose 2 in Study C4591001, BNT162b2 at 30 μg was safe and well-tolerated across age groups … and the AE profile did not suggest any serious safety concerns. The incidence of SAEs and deaths were low in the context of the number of participants enrolled and comparable in BNT162b2 and placebo. The incidence of discontinuations due to AEs was also generally low and similar between BNT162b2 and placebo groups.
“Cumulative safety follow-up to at least 6 months after Dose 2 for approximately 12,000 Phase 2/3 participants originally randomized to BNT162b2, comprising the combined blinded and open-label periods, showed no new safety signals or suggested [any] new safety concerns arising from this period of follow-up.
“Similarly, open-label follow-up of participants originally randomized to placebo from the time of unblinding to receive BNT162b2 until the data cutoff date showed no new safety signals or concerns.
“The AE profile among approximately 44,000 participants ≥16 years of age enrolled to date as of the most recent safety cutoff date (13 March 2021), was mostly reflective of reactogenicity events with low incidences of severe and/or related events. The incidence of SAEs was low and similar in the vaccine and placebo groups. Few participants withdrew from the study due to AEs. Few deaths occurred overall in both the vaccine and placebo groups with no imbalance.
“For participants randomized to placebo and then unblinded to receive BNT162b2 vaccination, open-label data from the time of unblinding to the data cutoff date (13 March 2021) showed no new safety findings or signals.
“Taken together, efficacy and immunogenicity data suggest the BNT162b2 (30 μg) 2-dose regimen induces a strong immune response and provides durable protection from COVID-19 across a spectrum of individuals representative of the population at large for individuals ≥16 years of age: those with or without prior exposure to SARS-CoV-2 and those in higher-risk categories based on age, race, ethnicity, and/or comorbidity.”
As a result, and based on the above data, the review makes a case for the approval of BNT162b2:
“A vaccine program must be implemented expediently and rapidly expanded to have a significant impact on the pandemic course. Licensure of BNT162b2 is likely to enhance vaccine uptake by facilitating supply of vaccine from Pfizer/BioNTech directly to pharmacies and healthcare providers/facilities.
“The greatest impact of BNT162b2 licensure may be direct supply to healthcare providers who serve vulnerable populations such as elderly patients and those who live in rural and underserved communities (i.e., individuals who might be unable to navigate the challenges of securing vaccine access using the systems in place for EUA).
“Expansion of vaccine via licensure would ultimately improve the prospect of achieving population herd immunity to bring the pandemic under control.
“Overall, the potential risks and benefits, as assessed by the safety profile and the efficacy and immunogenicity of BNT162b2 (30 μg), are balanced in favor of the potential benefits to prevent COVID-19 in immunized individuals.
“Likewise, the BNT162b2 30 μg benefit and risk profile support further development in pediatric, maternal, and other at-risk populations.”
Michael Nevradakis, Ph.D., is an independent journalist and researcher based in Athens, Greece.
© 2022 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.
Covid vaccines more likely to put you in hospital than keep you out: BMJ editor’s analysis of Pfizer and Moderna trial data
BY WILL JONES | THE DAILY SCEPTIC | JUNE 22, 2022
A new paper by BMJ Editor Dr. Peter Doshi and colleagues has analysed data from the Pfizer and Moderna Covid vaccine trials and found that the vaccines are more likely to put you in hospital with a serious adverse event than keep you out by protecting you from Covid.
The pre-print (not yet peer-reviewed) focuses on serious adverse events highlighted in a WHO-endorsed “priority list of potential adverse events relevant to COVID-19 vaccines”. The authors evaluated these serious adverse events of special interest as they were observed in “phase III randomised trials of mRNA COVID-19 vaccines”.
A serious adverse event was defined as per the trial protocols as an adverse event that results in any of the following conditions:
- death;
- life-threatening at the time of the event;
- inpatient hospitalisation or prolongation of existing hospitalisation;
- persistent or significant disability/incapacity;
- a congenital anomaly/birth defect;
- medically important event, based on medical judgement.
Dr. Doshi and colleagues found that the Pfizer and Moderna mRNA COVID-19 vaccines were associated with an increased risk of serious adverse events of special interest of 10.1 events per 10,000 vaccinated for Pfizer and 15.1 per 10,000 for Moderna (95% CI -0.4 to 20.6 and -3.6 to 33.8, respectively). When combined, the mRNA vaccines were associated with a risk increase of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95% CI 2.1 to 22.9).
The authors note that this level of increased risk post-vaccine is greater than the risk reduction for COVID-19 hospitalisation in both Pfizer and Moderna trials, which was 2.3 per 10,000 participants for Pfizer and 6.4 per 10,000 for Moderna. This indicates that the Pfizer vaccine results in a net increase in serious adverse events of 7.8 per 10,000 vaccinated and the Moderna vaccine of 8.7 per 10,000 vaccinated.
Addressing the difference between their findings and those of the FDA when it approved the vaccines, the authors note that the FDA’s analysis of serious adverse events “included thousands of additional participants with very little follow-up, of which the large majority had only received one dose”. The FDA also counted people affected rather than individual events, despite there being twice as many individuals in the vaccine group than the placebo group who experienced multiple serious adverse events.
The authors wonder where the U.S. Government’s own studies of adverse events are. They note that in July 2021 the FDA reported detecting four potential adverse events of interest following Pfizer vaccination – pulmonary embolism, acute myocardial infarction, immune thrombocytopenia and disseminated intravascular coagulation – and stated it would further investigate the findings. However, no update has yet appeared.
They also note that “while CDC published a protocol in early 2021 for using proportional reporting ratios for signal detection in the VAERS database, the agency has not yet reported such a study”.
Their results are compatible, they point out, with a recent pre-print analysis of COVID-19 vaccine trials by Benn et al., which found “no evidence of a reduction in overall mortality in the mRNA vaccine trials”, with 31 deaths in the vaccine arms versus 30 deaths in the placebo arms (3% increase; 95% CI 0.63 to 1.71).
Noting that their study is limited by the fact that the raw data from COVID-19 vaccine clinical trials are not publicly available, they stress that “given the global public health implications, there is an urgency to make all COVID-19 trial data public, particularly regarding serious adverse events, without any further delay”.
They conclude that there is a need for formal harm-benefit analyses for Covid vaccines, taking into account the different levels of risk of serious Covid and adverse events that exist between demographic groups. Ideally, this would be based on individual participant data, they add, though such data remain frustratingly unavailable.
Featured Video
What is AZAPAC? Why is it important?
or go to
Aletho News Archives – Video-Images
From the Archives
Chris Matthews got it: Neocons want to destroy the Middle East for Israel
By Jonas E. Alexis | Veterans Today | August 4, 2107
Chris Matthews attacked the Neocon project in 2015 by saying that the Neocons and warmongers in the United States aspire to create complete chaos in the Middle East, presumably for Israel. His words are worth quoting in full:
“Why were the people in the administration like [Paul] Wolfowitz and the others talking about going into Iraq from the very beginning, when they got into the white house long before there was a 911 long before there was WMD. It seemed like there was a deeper reason. I don’t get it. It seemed like WMD was a cover story.
“The reason I go back to that is there’s a consistent pattern: the people who wanted that war in the worst ways, neocons so called, Wolfowitz, certainly Cheney.. it’s the same crowd of people that want us to overthrow Bashar Assad, .. it’s the same group of people that don’t want to negotiate at all with the Iranians, don’t want any kind of rapprochement with the Iranians, they want to fight that war. They’re willing to go in there and bomb.
“They have a consistent impulsive desire to make war on Arab and Islamic states in a never-ending campaign, almost like an Orwellian campaign they will never outlive, that’s why I have a problem with that thinking. … we’ve got to get to the bottom of it. Why did they take us to Iraq, because that’s the same reason they want to take us into Damascus and why they want to have permanent war with Iran.”
Yours truly and many others have been saying the same thing for years. We would not have perpetual wars in the Middle East if the Neocons did not take their orders from Israel. Even George W. Bush implicitly admitted this.
George W. Bush once asked his father to define Neoconservatism. “‘What’s a neocon?’ ‘Do you want names, or a description?’ answered [the elder Bush]. ‘Description.’ ‘Well,’ said the former president of the United States, ‘I’ll give it to you in one word: Israel.’”[1] … continue
Blog Roll
Recent Comments
loongtip on When Threats Replace Evid… loongtip on Zelensky tried to kill the cha… eddieb on I might get killed for posting… Bill Francis on I might get killed for posting… loongtip on Beijing cancels Panama deals a… loongtip on Showdown loongtip on New York Bans Israel-Linked Te… loongtip on Trump tells India to stop purc… eddieb on The Old Testament and the Geno… papasha408 on Trump’s war posturing against… Coronistan on This is How We Should Have Res… Coronistan on NO MANDATES, NO PROFITS: MODER…
Aletho News- What is AZAPAC? Why is it important?
- The Toxic Border: How Israel’s Chemical Spraying is Reshaping Life in South Lebanon
- Zelensky tried to kill the chance for Russia-Ukraine peace, again
- Somalia president warns against Israeli interference, vows to prevent any military base in Somaliland
- Iranian FM says uranium enrichment to continue ‘even at cost of war’
- No, Al-Jazeera, Climate Change Hasn’t Altered African Flood and Drought Patterns
- Bad Science, Big Consequences
- New Study Rebuts The Assumption That Anthropogenic CO2 Molecules Have ‘Special’ Properties
- Racketeering Scheme?: Vaccine Makers Profit Twice by Selling Drugs to Treat Vaccine Injuries
- When Threats Replace Evidence
- If Americans Knew
- In Gaza, marriage is a form of resistance – Not a ceasefire Day 121
- Israel returns bodies with evidence of organ theft and severe mutilation – Not a ceasefire Day 120
- AIPAC Coordinates Donors in Illinois House Primaries
- Geneva Academy warns Gaza death toll could top 200,000
- Media ignore allegations that Israel raped German journalist
- Former Israeli PM: Settlers are Aiding and Abetting Jewish Rioters in the West Bank
- Tucker Carlson sheds light on Christian-Muslim harmony in Palestine, Jordan
- Revealed: Private jet owned by Trump friend used by ICE to deport Palestinians to West Bank
- Bypassing Oversight to Rush Billions in Arms to Israel
- Aid trickles into Gaza, medical evacuations trickle out – Not a ceasefire Day 119
- No Tricks Zone
- Germany’s Natural Gas Storage Level Dwindles To Just 28%… Increasingly Critical
- New Study Rebuts The Assumption That Anthropogenic CO2 Molecules Have ‘Special’ Properties
- Climate Scientist Who Predicted End Of “Heavy Frost And Snow” Now Refuses Media Inquiries
- Polar Bear Numbers Rising And Health Improving In Areas With The Most Rapid Sea Ice Decline
- One Reason Only For Germany’s Heating Gas Crisis: Its Hardcore-Dumbass Energy Policy
- 130 Years Later: The CO2 Greenhouse Effect Is Still Only An Imaginary-World Thought Experiment
- New Study Affirms Rising CO2’s Greening Impact Across India – A Region With No Net Warming In 75 Years
- Germany’s Natural Gas Crisis Escalates … One Storage Site Near Empty …Government Silent
- Polar Colding…Antarctica Saw Its Coldest October In 44 Years!
- New Study: Sea Levels Rose 20 Times The Modern Rate During The Roman Warm Period
Aletho News 