A Pfizer ad on Twitter claims that 3 out of 4 US adults are at “high risk” for severe Covid-19.
This ad is highly misleading or, arguably, outright false.
Problem 1: What is “high” risk?
We don’t know because Pfizer doesn’t define it.
The graphic in the ad cites a study as the source of its claim “3 out of 4 US adults are at high risk for severe Covid-19.” Except the study never uses the term “high risk.” Rather, the study is on people at “increased risk.”
“Increased risk,” of course is quite different from “high risk.” Obviously, high risk is worse than merely increased risk. I need not explain why Pfizer would choose language in its ad that exaggerates the risk of Covid.
Problem 2: The cited study itself doesn’t even define “increased risk.” Does that mean a 0.1% increase, a 1% increase, 20% increase, 1000% increase? On this point, the study includes the following caveat: “the effect size of each risk factor was not taken into account in our analysis, so this report does not address degree of risk. Effect estimates of severe COVID-19 risk factors are widely variable and ultimately unreliable.”
Digging a little deeper, the study links to a CDC webpage that gives a list of conditions for people who are “more likely to get very sick with COVID-19” and uses “higher risk,” “increased risk,” “greater risk” and “high risk” in its text, seemingly interchangeably. The page gives a long list of medical conditions—from cancer to diabetes to depression. Still, we don’t know what “more likely” or “increased risk” actually means. This webpage, in turn, links to another CDC webpage that describes “Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19.”
We’ve gone from the scary “high” risk (not defined), to “increased” risk (also not defined), to “higher risk.” How is “higher risk” defined? Here is what the page says:
Higher risk is defined as an underlying medical condition or risk factor that has a published meta-analysis or systematic review or underwent the CDC systematic review process. The meta-analysis or systematic review demonstrates a conclusive increase in risk for at least one severe COVID-19 outcome.
So we are now three layers deep and we still don’t have a quantifiable definition for what, exactly, “high,” “increased,” or “higher” even means, nor a clear differentiation of what the first study acknowledges is a wide variability in estimates of risk factors. I’m sure there is a quantifiable threshold defined somewhere, but I stopped digging because this isn’t even the main problem.
Problem 3 (the main problem): The data from the cited study in the Pfizer ad saying 3 out of 4 US adults are at high (aka increased) risk of severe Covid are from 2015-2018. But this ad is being run in July 2023—after nearly the entire population has either already been infected, vaccinated, or both, each circumstance, we have been told, decreases one’s risk of severe Covid. In other words, Pfizer’s own ad suggests that prior infection and vaccination have not reduced the number of people at high risk of severe Covid. Does Pfizer want us to believe that its product—the vaccine—did not lower the rate of people at high risk of severe Covid?
The fact is, 3 out of 4 US adults are not at “high” risk of severe Covid. This statement is based on data from before accounting for the protective effect of infection and vaccination. Moreover, “high risk” is not defined and appears to simply be a made up description.
We’ve heard a lot about “misinformation” in the past few years. Generally, the government and media have pointed the finger at so-called “anti-vaxxers” and “conspiracy theorists.” A critical spotlight from the government has rarely seemed to shine on claims made by Pfizer. Advertisements like this misinform and unnecessarily scare people, perhaps pushing some of them into taking additional doses of the vaccine, or therapeutics like Paxlovid (also made by Pfizer), that have potential harms, and for many people, especially now, without clear benefit.
August 2, 2023
Posted by aletho |
Deception, Science and Pseudo-Science | Covid-19, COVID-19 Vaccine, Pfizer, United States |
1 Comment
Documents released by BioNTech to the European Medicines Agency (EMA) reveal tens of thousands of serious adverse events and thousands of deaths among people who received the Pfizer-BioNTech mRNA COVID-19 vaccine.
The documents, dated Aug. 18, 2022, and marked “confidential,” show that cumulatively, during the clinical trials and post-marketing period up to June 18, 2022, a total of 4,964,106 adverse events were recorded. The documents included an appendix with further details about the specifics about the identified adverse events.
Among children under age 17, 189 deaths and thousands of serious adverse events were reported.
The documents present data collected between Dec. 19, 2021, and June 18, 2022 (the “PSUR #3 period”), in addition to cumulative data on adverse events and deaths that occurred among those who received the vaccine during clinical trials and during the post-marketing period, beginning December 2020 up until June 18, 2022.
During this time, Pfizer-BioNTech said it identified almost no safety signals and claimed the vaccine demonstrated over 91% “efficacy.”
Remarking on the documents, Brian Hooker, Ph.D., P.E., senior director of science and research for Children’s Health Defense, told The Defender :
“These adverse event reports are ‘off the charts,’ with myocarditis reports at over 10,000 and pericarditis reports at over 9,000.
“Historically, we know that this would be an under-ascertainment of the actual numbers. It is criminal for the EMA to keep this vaccine on the market.”
According to an analysis by commentator and author Daniel Horowitz, the percentage of adverse events classified as serious was “well above the standard for safety signals usually pegged at 15%,” and women reported adverse events at three times the rate of men.
Sixty percent of cases were reported with either “outcome unknown” or “not recovered,” suggesting many of the injuries “were not transient,” Horowitz said.
The highest number of cases occurred in the 31-50 age group, of which 92% did not have any comorbidities, making it very likely it was the vaccine causing “such widespread, sudden injury.”
There were 3,280 fatalities among vaccine recipients in the combined cumulative period including the clinical trials and post-marketing, up to July 18, 2022.
According to Horowitz, the documents “show that Pfizer knew about a sickening level of injury early on,” yet continued to distribute its COVID-19 vaccine.
The documents are not part of the ongoing court-ordered release of the so-called “Pfizer documents” in the U.S., but according to Horowitz, are pharmacovigilance documents requested by the EMA, the EU’s drug regulator.
The documents were made available to an Austrian science and politics blog, TKP, following “a FOIA [Freedom of Information Act] request from an anonymous reader.” They were subsequently published on March 4. However, once published, no European English-language media outlet appears to have reported on them.
As a result, they remained under the radar until recently, when several independent English-language bloggers discovered and published the documents.
Thousands of pediatric serious adverse events and deaths
The main Pfizer-BioNTech document revealed 9,605 adverse events (3,735 serious) during the PSUR #3 and 25 cases during the clinical trials among children ages 11 and younger. These included 20 fatalities, in children as young as 5 years old.
Causes of these fatalities included dyspnea, cardiac arrest, cardio-respiratory arrest, pyrexia and myocarditis, though “all events were assessed as unrelated” to the vaccine.
In one example listed in the document, an 11-year-old boy died of acute respiratory failure two days after the first dose of the vaccine. In another case, a 6-year-old girl died seven days following her initial dose of complications that included renal impairment, epilepsy, apnea, seizure and “sudden death.”
The document lists another case, that of a 6-year-old boy whose listed causes of death are myocarditis, cardio-respiratory arrest and COVID-19. He died seven days after the first dose of the vaccine, and although autopsy results were “pending,” “the reporter concluded that the death ‘had nothing to do’ with the administration of BNT162b2 [the Pfizer-BioNTech vaccine] and was due to natural causes.”
For children ages 12-17, the document listed 21,945 adverse eventss (19,558 serious) in the post-marketing period and 15 cases during clinical trials. A total of 169 deaths were recorded, with listed causes including dyspnea, pyrexia, cardiac arrest, myocarditis, cardiac failure, seizure and shock.
Nevertheless, the document states “No new significant safety information was identified based on the review of the cases reported in the overall paediatric population.”
‘No safety signals’ despites deaths, injuries of pregnant women and newborns
Pregnant and lactating women also were significantly affected. There were 3,642 post-authorization adverse events and 697 clinical trial adverse events in this population, including spontaneous abortion, fetal death, postpartum hemorrhage, premature separation of the placenta, premature labor or delivery, live birth with congenital anomalies and stillbirths.
Nevertheless, the documentation again states, “There were no safety signals regarding use in pregnant/lactating women that emerged from the review of these cases or the medical literature,” despite two key admissions elsewhere in the documentation.
In one instance, the document stated, “The safety profile of the vaccine in pregnant and/or breastfeeding women was not studied in the pivotal clinical trial and the maternal clinical trial was terminated early due to participant recruitment difficulties.”
And in another instance, Pfizer-BioNTech identified the following as “missing information”:
“Use in pregnancy and while breastfeeding; Use in immunocompromised patients; Use in frail patients with co-morbidities … Use in patients with autoimmune or inflammatory disorders; Interaction with other vaccines; Long term safety data.”
Pfizer-BioNTech stated a “commitment” to track “pregnancy outcome[s] in clinical trials.”
Myocarditis and pericarditis deaths among children, young adults
A notable discrepancy appears in terms of reported cases of myocarditis in the clinical trials as compared to the post-marketing period — one myocarditis case (0.15% of all cases) is listed for the clinical trial period, while 5,422 cases (1.1% of all cases) and 5,458 serious events were reported in the PSUR #3 period.
Of these, 87 cases were fatal and 1,608 were listed as “not resolved.” Among children and young adults, 48 cases were reported for those between the ages of 5 and 11 (two deaths), 366 among 12-15-year-olds (three deaths), 345 among 16-17-year-olds and 968 among 18-24-year-olds (four deaths).
In one instance, an 11-year-old girl developed myocarditis two days after her first dose and subsequently died, with the listed causes of death including myocarditis, respiratory failure, acute cardiac failure and cardio-respiratory arrest.
Separately, a 13-year-old boy developed myocarditis five days after his second dose, and subsequently died of myocarditis, cardiac arrest, multiple organ dysfunction syndrome, ventricular tachycardia and renal failure.
A 13-year-old girl with no medical history developed myocarditis six days after her first dose and also later died.
In the case of a 19-year-old male who developed myocarditis three days after his third dose and who eventually died, an autopsy “revealed extensive necrosis of the left ventricular myocardium (myocardial necrosis); myocarditis/fulminant myocarditis.”
And a 26-year-old male who also took the flu vaccine developed myocarditis four days after his third dose of the Pfizer-BioNTech COVID-19 vaccine, and subsequently died. The listed causes of death included myocarditis, arrhythmia, inflammation and left ventricular dysfunction. Autopsy results “showed myocarditis.”
Similarly, while no cases of pericarditis were recorded during the clinical trial, 4,156 were recorded during the PSUR #3 period, including 4,164 serious adverse events and 19 fatalities. This included 30 cases among 5-11-year-olds, 118 cases among 12-15-year-olds, 106 cases among 16-17-year-olds, 479 cases among 18-24-year-olds (and one death), and 417 cases among 25-29-year-olds, again including one death.
In one example, a 22-year-old male developed pericarditis 31 days after his second dose and eventually died of pericarditis and other causes, including multiple organ dysfunction syndrome, pericardial mass, pericardial effusion, malignant pericardial mesothelioma and right ventricular failure.
Numerous other cardiovascular adverse events were recorded, totaling 32,712 cases during the PSUR #3 period (496 fatal) and 27 during the clinical trials (two fatal — with none of the events listed as “related” to vaccination).
Causes of death included in this category include arrhythmia, cardiac failure and acute cardiac failure, cardiogenic shock, coronary artery disease, postural orthostatic tachycardia syndrome (POTS) and tachycardia.
Nevertheless, “No new significant safety information was identified.”
Many ‘very severe and very rare’ adverse events identified
The 393-page confidential Pfizer document shows that Pfizer observed more than 10,000 categories of diagnosis, many “very severe and very rare,” Horowitz wrote.
These include 73,542 cases of 264 categories of vascular disorders from the shots, many of which “are rare conditions,” hundreds of categories of nervous system disorders, totaling 696,508 cases and 61,518 adverse events from well over 100 categories of eye disorders, “which is unusual for a vaccine injury,” according to Horowitz.
In addition, “there were over 47,000 ear disorders, including almost 16,000 cases of tinnitus,” “roughly 225,000 cases of skin and tissue disorders,” “roughly 190,000 cases of respiratory disorders” and “over 178,000 cases of reproductive or breast disorders, including disorders you wouldn’t expect, such as 506 cases of erectile dysfunction.”
“Over 100,000 blood and lymphatic disorders, for both of which there’s a wealth of literature linking them to the spike protein” were indicated, as well as “almost 127,000 cardiac disorders, running the gamut of about 270 categories of heart damage, including many rare disorders, in addition to myocarditis.”
There were also “3,711 cases of tumors — benign and malignant,” and “there were over 77,000 psychiatric disorders observed.”
“What is so jarring is that there are hundreds of very rare neurological disorders that reflect something so systemically wrong with the shots, a reality that was clearly of no concern to the manufacturers and regulators alike,” Horowitz wrote, referencing 68 listed cases of a rare diagnosis, chronic inflammatory demyelinating polyneuropathy.
In another example, the “Pharma Files” Substack identified 3,092 neoplasms, noting that ”malignant neoplasms means cancer.”
Pfizer-BioNTech usually identified ‘no safety signal’ despite thousands of deaths
Numerous deaths and serious adverse events were recorded for a wide range of other conditions:
- Stroke: 3,091 cases and 3,532 serious adverse events during PSUR #3, including 314 fatalities, and 19 cases during the clinical trial (one death).
The document stated, “Cerebral venous sinus thrombosis … and Cerebrovascular Accident/Stroke were evaluated as signals during the reporting period and were not determined to be risks causally associated with the vaccine … No additional safety signals … have emerged based on the review of these cases.”
- Respiratory: 2,199 cases and 1,873 serious adverse events during PSUR #3, including 363 fatalities, and 33 cases during the clinical trial (four deaths). Serious adverse events included cardio-respiratory arrest, pneumonia, respiratory failure, acute respiratory failure, hypoxia and acute respiratory distress syndrome. Yet, “No safety signals have emerged based on the review of these cases.”
- Bell’s palsy: 733 cases were reported during PSUR #3, in addition to 1,428 cases of facial paralysis. Six cases were fatal, with all victims over age 60. One additional case of Bell’s palsy, in a 75-year-old female from the U.S., was recorded in the clinical trial but was deemed “not related” to her vaccination. Again, “No new significant safety information was identified.”
- Neurological: 5,111 cases and 4,973 serious adverse events during PSUR #3, including 67 fatalities, and 15 cases during the clinical trial. Once more, “No safety signals have emerged based on the review of these cases.”
- Immune-mediated/autoimmune adverse events: 11,726 cases and 8,445 serious adverse events during PSUR #3, including 133 fatalities, and 19 cases during the clinical trial. Serious adverse events included thrombocytopenia, interstitial lung disease, cerebral hemorrhage, encephalitis, multiple organ dysfunction syndrome, renal failure, pneumonia and pulmonary embolism. Yet, “No new safety signals have emerged.”
- Multisystem inflammatory syndrome: 207 cases and 210 serious adverse events during PSUR #3, including 56 deaths, with 35 involving the elderly. In addition, 38 cases were reported in children. Nevertheless, “No new safety signals have emerged based on a review of these cases [or] literature.”
Pfizer-BioNTech stated a “commitment” for “closely monitoring multisystem inflammatory syndrome in children and in adults … and reporting of new cases.”
- Thromboembolic adverse events: 6,102 cases and 6,724 serious adverse events during PSUR #3, including 265 fatalities, and 17 cases during the clinical trial (one death). Serious adverse events included pulmonary embolism, thrombosis and deep vein thrombosis. Again, “No safety signals have emerged based on the review of these cases.”
Elsewhere in the document, the case of a 14-year-old male who died of peripheral swelling after getting the COVID-19 vaccine was mentioned, with no additional details.
In another example, a 67-year-old male “with a history of diabetes and idiopathic thrombocytopenic purpura” suffered chest and gastrointestinal discomfort less than 30 minutes after receiving his third dose of the vaccine. A diagnosis of anaphylaxis was made, while an electrocardiogram showed “signs of a myocardial infarction.” He later sustained cardiac arrest and died 12 days following his vaccination.
Moreover, 204 fatalities (and 24,077 cases) of vaccination failure, 81 deaths from “vaccination stress,” 24 deaths (and 1,402 cases) of suspected vaccination failure, two deaths from glomerulonephritis and nephrotic syndrome, two deaths (1,326 cases) from “medication error” and 166 deaths from “other” adverse events — mostly pyrexia — were recorded.
Pfizer-BioNTech and EMA: ‘nothing to see here’
Pfizer and BioNTech claimed that the overall efficacy of their COVID-19 vaccine for the PSUR #3 period was 91.3% — and 100% for some populations.
Moreover, only one safety signal was definitively identified: hearing loss, with Pfizer-BioNTech committing to perform a “safety evaluation of tinnitus and hearing loss.”
Two other conditions, myocarditis and pericarditis, were determined to be an “important identified risk,” while irritability was determined to be an “identified risk (not important).”
“A statement regarding the reporting rates of myocarditis and pericarditis after primary series and booster doses” was added to their vaccine’s European product label.
Labeling was changed for Guillain-Barré syndrome, but in Japan. The document stated:
“Although not considered by definition a regulatory action taken for safety reasons because it does not significantly impact the benefit risk balance of use of the product in authorised populations, due to the receipt of spontaneous reports of Guillain-Barre syndrome (GBS) after vaccination with mRNA COVID-19 vaccines including BNT162b2 … Japan has required class changes to include GBS in the important precautions section of the Japan package insert.”
Despite the large number of deaths and serious adverse events, Pfizer and BioNTech wrote, “Based on the available safety and efficacy/effectiveness data from the reporting interval for BNT162b2, the overall benefit-risk profile of BNT162b2 remains favorable” and that “no further changes … or additional risk minimization activities are warranted.”
The EMA appears to have agreed with this conclusion. In its “assessment report,” its Pharmacovigilance Risk Assessment Committee (PRAC) wrote that “The benefit-risk balance for the use of Comirnaty in its authorized indication remains unchanged.”
“The PRAC considers that the risk-benefit balance of medicinal products containing tozinameran (Comirnaty) remains unchanged and therefore recommends the maintenance of the marketing authorisation(s),” the PRAC added.
However, Horowitz argues that the documents “show that Pfizer knew about a sickening level of injury early on,” yet continued to distribute its COVID-19 vaccine.
Earlier this month, BioNTech was sued in Germany by a woman alleging injuries from the Pfizer-BioNTech COVID-19 vaccine. The lawsuit demands at least 150,000 euro ($161,500) in damages for bodily harm and unspecified compensation for material damages.
Michael Nevradakis, Ph.D., based in Athens, Greece, is a senior reporter for The Defender and part of the rotation of hosts for CHD.TV’s “Good Morning CHD.”
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
June 23, 2023
Posted by aletho |
Deception, Timeless or most popular, War Crimes | COVID-19 Vaccine, European Union, Pfizer |
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Pharmaceutical giant Pfizer in 2021 made numerous grants to medical associations, consumer groups and civil rights organizations for the purpose of creating the appearance of widespread support for COVID-19 vaccine mandates, investigative journalist Lee Fang reported.
As the vaccine mandates rolled out in 2021, Pfizer stayed quiet on the question of mandates — but public health groups, patient advocacy groups, doctors’ associations, community groups and others, along with the Biden administration, actively advocated for vaccine mandates as a key measure to protect public health.
New disclosures from Pfizer, posted by Fang on his Substack, show that many of these same groups were taking money from Pfizer while they promoted the idea that the COVID-19 mRNA vaccines were “safe and effective,” despite a lack of scientific data to back those claims.
Prominent groups on the extensive list of those who took Pfizer funding while pushing the mandates included the Chicago Urban League, the American Academy of Pediatrics (AAP), the National Consumers League, The Immunization Partnership, the American Pharmacists Association, the American College of Preventive Medicine, the Academy of Managed Care Pharmacy, the American Society for Clinical Pathology and the American College of Emergency Physicians.
Many groups did not disclose their ties to Pfizer.
“[These groups] set the nature of the debate,” Fang told comedian and political commentator Russell Brand on a recent episode of “Stay Free.” “They appear in the news media, they create events and they create a discourse that looks authentic, that looks organic, but it benefits the bottom line of their benefactors, of companies like Pfizer.”
Fang said many of these organizations, particularly civil rights organizations like the Chicago Urban League or the National Consumers League — which actually has a Pfizer lobbyist on its board — have powerful influence precisely because of their independent status.
When these groups speak out, Fang said:
“It affects how regulators see these issues and how the public sees them. When they see these third-party groups that have some credibility — these are famous organizations that are known for standing up for the public interest.
“When they say ‘hey these mandates are a good idea for the American public,’ it seems genuine.
“But they aren’t disclosing the Pfizer money, which is a relevant factor when you are talking about a policy that compels Americans to take this product.”
After the COVID-19 vaccines became widely available in early 2021, vaccine mandates followed in different forms across the country.
At the federal level, the U.S. Department of Defense mandated vaccines for military personnel, and the Biden administration mandated vaccines for federal contractors and for all employers with 100 employees or more — the latter was struck down in federal court.
Universities mandated vaccination for students and staff, and many public and private employers across the country mandated vaccination for their employees.
Several school districts across the country planned to mandate vaccination for children to attend school, but most of those plans have since been rolled back.
Those who instituted mandates justified them by asserting that mass vaccination — and only mass vaccination — would “stop the spread” of COVID-19.
But it has since been revealed that in March 2021, when Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky publicly and unequivocally stated on MSNBC that vaccinated people would not get sick, there was no evidence to support her statement.
In fact, the CDC had to walk back the statement a few days later.
Biden also falsely claimed that the vaccinated would not get infected — in July 2021, just before COVID-19 vaccine mandates went into effect.
The vaccine makers have since acknowledged they never tested whether the vaccines would stop transmission, and the U.S. Food and Drug Administration (FDA) reported that vaccinated people in both Pfizer and Moderna’s clinical trials contracted the virus.
Big Pharma’s big reach
Pfizer isn’t the only actor in Big Pharma that quietly funds third parties to do its work.
Fang told The Defender that “Many pharmaceutical firms covertly shape public opinion and regulations through the use of front groups and financial relationships with community organizations.”
For example, Purdue Pharma covertly funded third-party advocacy groups to encourage looser criteria for prescribing its highly addictive opioid painkillers, he reported.
As for Pfizer, Fang said, third-party funding is just one of the many strategies the drugmaker deployed to drive COVID-19 policymaking.
“Pfizer flexed its lobbying muscles around many COVID-19 policies, including efforts to curb drug-pricing initiatives and a bid to prevent the creation of generic COVID medications,” he said, adding, “The vaccine mandate debate is yet another example of Pfizer’s reach into public policy.”
Big Pharma — along with the Biden administration and its intermediaries — also lobbied to suppress those who questioned the vaccine program.
Pfizer BioNTech and Moderna pressured Twitter and other social media platforms to set moderation rules that would flag purported COVID-19-related “misinformation,” as part of the effort to drive the national conversation about the COVID-19 vaccines, Fang reported as part of the “Twitter files.”
“Pharma is unique in the raw amount of money they spend to control the entire public sector on regulatory, on policy, on everything in terms of how it affects medicine as it is practiced in the United States,” Fang said.
The pharmaceutical and health products lobby is one of the biggest industry lobbies. According to OpenSecrets.org, last year alone the industry spent $372 million lobbying Congress and federal agencies, outspending every other industry — and each year it increases its spending.
Pfizer CEO Albert Bourla is on the board of Pharmaceutical Research and Manufacturers of America (PhRMA), the top individual lobbying spender in the industry, which spent $29.2 million last year. Pfizer itself spent more than any other drug company.
The industry also spends massive amounts of money on advertising. Pfizer alone spent nearly $2.8 billion on advertising for all of its products in 2022.
The COVID-19 vaccines netted $37.8 billion for Pfizer in 2022, up from $36.7 billion in 2021. The company’s overall earnings hit a record $100 billion.
Big Pharma and the CDC did similar work to promote mandates and vaccination
There is a “revolving door” between pharma industry lobbyists and the government — nearly 65% of lobbyists formerly worked for the government.
And the strategies used to build support for Big Pharma’s products are some of the same strategies used by federal government agencies like the CDC.
Since 2021 — the same time Pfizer started funding community groups — the CDC has doled out hundreds of millions of dollars in grants for the creation of “culturally tailored” pro-vaccine materials and for training “influential messengers” to promote COVID-19 and flu vaccines to communities of color in every state across the country.
For those grants, the CDC sought out community organizations that would communicate the CDC’s message without the CDC’s trademark, so the messages would appear to come organically from within local communities rather than from the government, particularly among communities of color.
In another case, the CDC hired a public relations firm to write what looked like news articles but were actually ad placements created to persuade parents of young children and elderly people — with a focus on Spanish speakers — to get vaccinated.
Both Pfizer and the CDC used their funding to target black and Latino communities that had lower vaccination rates. In one case, they both funded the same organization — the National Hispanic Medical Association (NHMA).
According to Fang, the organization worked with a public relations firm called Culture ONE World to distribute “press releases and media placements” that “called on employers of essential workers to mandate COVID-19 vaccines.”
Fang also wrote that the NHMA also signed joint statements lobbying in favor of Biden’s vaccine mandate and that “it received $30,000 from BIO [Biotechnology Innovation Organization], a vaccine industry lobby group that represents Pfizer and Moderna, IRS filings show.”
The Defender found that NHMA received $2,070,000 in two annual grants so far for their “Vacunas! Si Se Puede, Immunization Campaign for Hispanics” program, which later became “We Can Do This,” to create culturally tailored content to be circulated throughout Latino communities.
American Academy of Pediatrics received multiple grants from Pfizer in 2021
The AAP also appeared on Fang’s list of notable organizations that received direct Pfizer funding.
According to Fang:
“The American Academy of Pediatrics was one of the most visible organizations working to build public support for vaccine mandates. The organization received multiple, specialized grants from Pfizer in 2021.
“Pfizer also provided grants to individual state chapters of the AAP earmarked for lobbying on vaccine policy. The Ohio AAP chapter, for instance, lobbied the Ohio legislature against bills to curb coercive COVID-19 vaccine policies, while receiving an ‘immunization legislation’ advocacy grant from Pfizer.”
Beyond its COVID-19 vaccine mandate work, the organization also was a public advocate for COVID-19 vaccines for children. Its then-president, UCLA professor Moira Szilagyi, M.D., Ph.D., publicly advocated, on media outlets such as CNN, for vaccinating children.
The organization, “dedicated to the health of all children,” previously issued policy guidance to its members stating that it is an “acceptable option to pediatric care clinicians to dismiss families who refuse vaccines.”
And in June 2022, the AAP issued a press release applauding the CDC’s recommendation of “safe, effective COVID-19 vaccines” for babies as young as 6 months old, despite concerns raised — by the FDA vaccine advisory commission, among many others — regarding a lack of clinical data for the vaccines in children.
In addition to the Pfizer funding, the AAP receives much of its funding directly from the CDC, raising questions about the organization’s ability to act independently, particularly with respect to vaccine recommendations, BMJ editor Peter Doshi wrote in 2017.
Brenda Baletti Ph.D. is a reporter for The Defender. She wrote and taught about capitalism and politics for 10 years in the writing program at Duke University. She holds a Ph.D. in human geography from the University of North Carolina at Chapel Hill and a master’s from the University of Texas at Austin.
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
April 26, 2023
Posted by aletho |
Corruption, Deception | CDC, COVID-19 Vaccine, Pfizer, United States |
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People who receive Pfizer’s respiratory syncytial virus (RSV) vaccine should be monitored for Guillain-Barré syndrome, according to the authors of a Pfizer-funded study published this week in the New England Journal of Medicine (NEJM).
The paper — one of several published Wednesday reporting interim analyses for Pfizer’s phase 3 clinical trials for the RSV vaccine — concluded the vaccine was effective in preventing RSV in adults age 60 and over “without evident safety concerns.”
But that same article also flagged Guillain-Barré syndrome as a safety concern moving forward with the vaccine.
“If RSVpreF vaccine [Pfizer’s RSV vaccine] is approved and recommended, these adverse events warrant close monitoring in future studies and with real-world data and post-marketing surveillance,” the authors of the NEJM study said.
The U.S. Food and Drug Administration (FDA) is expected to approve Pfizer’s RSV vaccine for older adults in May.
Safe and effective?
Guillain-Barré syndrome is a rare disorder in which the body’s immune system attacks its own nerves. Symptoms can range from brief weakness to paralysis.
The FDA asked Pfizer to include the condition as an “important potential risk” of the vaccine and to develop a safety study to monitor for potential cases if the shot is approved, CNBC reported.
When the FDA vaccine advisory panel met in February to review Pfizer’s data pre-publication, there was substantial disagreement about the data on safety and effectiveness, although the majority of the committee voted to recommend the vaccine for approval.
Four of 12 committee members voted that the safety data was not adequate for approval — and one abstained — because of their concerns with the Guillain-Barré cases.
Four committee members also voted the evidence of vaccine effectiveness was not adequate for approval, while seven said it was and one member abstained.
In the NEJM study, one person developed Guillain-Barré syndrome and another developed Miller Fisher syndrome, a subset of Guillain-Barré. The symptoms appeared six and seven days post-vaccination, respectively.
The person with Miller Fisher syndrome recovered. The person diagnosed with Guillain-Barré continues to suffer from loss of motor function.
CNBC reported:
“In the New England Journal of Medicine article, the scientists said the two cases occurred in patients who were in an age group that has an increased risk of developing Guillain-Barré. Potential factors other than the vaccine also could have caused the individuals to develop the syndrome, they added.
“But the FDA said the agency views the Guillain-Barré cases as possibly related to the vaccine because the patients developed the syndrome shortly after receiving the shot, according to briefing documents published in February.
“Pfizer concluded that the cases were unrelated, and the clinical trial’s data monitoring committee did not identify any safety concerns with the vaccine.”
Dr. Hana El Sahly, the FDA committee chair and professor of molecular virology and microbiology and infectious diseases at the Baylor College of Medicine, said Guillain-Barré has an incidence of about 1 in 100,000 among people ages 60 and older. But in the vaccine trial, the rate was closer to 1 in 9,000, which is significantly higher.
“It’s significant in terms of incidence,” she said. The FDA advisors told Pfizer that safety monitoring for Guillain-Barré after FDA approval “would be crucial,” CNBC reported.
There is currently no vaccine approved to prevent RSV, a lower respiratory disease that is one of the most common causes of childhood cold-like illness and was first discovered in humans in 1956.
The illness is mild for most people.
In children under age 5, RSV causes 58,000 to 80,000 hospitalizations per year and 100 to 300 deaths.
In adults ages 65 and older, RSV causes 6,000 to 10,000 deaths and 60,000 to 160,000 hospitalizations per year, according to the Centers for Disease Control and Prevention.
Research shows the virus originated in monkeys housed in a Maryland facility where they were used to conduct polio vaccine research.
Brian Hooker, Ph.D., P.E., chief scientific officer for Children’s Health Defense (CHD), told The Defender :
“I find it ironic that Pfizer is creating a vaccine for RSV, an illness that was created due to the development of the polio vaccine. It seems like vaccine manufacturers are paid to prevent diseases that they already created.
“The incidence of Guillain-Barré is very troubling and although many patients recover, there is nerve damage associated with it leading to permanent weakness, numbness and fatigue.”
The NEJM study reported that the vaccine was 86% effective at preventing lower respiratory tract illness with three or more symptoms, and 66% effective at preventing the illness with two or more symptoms, among adults over age 60.
The study determined there were not enough cases of severe RSV-associated lower respiratory tract illness — meaning cases needing hospitalization or ventilation or extra oxygen — to determine whether the vaccine was effective for those cases, CNN reported.
RSV vaccines for pregnant women failed to meet major goal in trials
Pfizer is also seeking FDA approval for its vaccine to protect infants from RSV by vaccinating pregnant mothers.
However, in the interim data on clinical trials, also published Wednesday in the NEJM, the vaccine failed to meet one of its two main goals.
Last year, Pfizer reported that its vaccine was highly effective at protecting newborns from RSV. The drugmaker also sought rapid FDA approval for the vaccine for pregnant mothers.
The FDA is expected to decide by August.
According to the study published Wednesday, the vaccine was 82% effective in preventing severe lower respiratory tract illness — such as very low oxygen levels or need for ventilator support — in infants in the first 90 days of life, but that dropped to 69% efficacy up to 180 days after a baby is born.
But the vaccine failed to meet its second big goal: reducing non-severe RSV-associated lower respiratory illness in infants.
The study enrolled 7,128 women — half received the RSV vaccine and half received the placebo.
Severe illness occurred within three months in six infants whose mothers received the vaccine, compared with 33 infants from the placebo group who contracted serious RSV infections.
The company evaluated 3,570 infants as part of the study, Reuters reported.
Big Pharma’s race for the RSV vaccine
The RSV virus causes annual outbreaks of respiratory illnesses in all age groups, typically during the fall, winter and spring in most regions of the U.S. It has existed for decades and doesn’t usually spark alarm.
But RSV made headlines last fall as part of a “tripledemic” — COVID-19, flu and RSV — scare, just as these new RSV products were preparing to come on the market.
Robert F. Kennedy, Jr., CHD chairman-on-leave, said at the time, “fear sells,” tweeting:
As The Defender reported, pharmaceutical companies have been working on the development of a vaccine for RSV since the 1960s — at times with deadly outcomes.
After a disastrous attempt at producing a vaccine, where 80% of vaccinated children were hospitalized, RSV vaccine development was put on hold.
Over the last several years, “lured by the prospect of a large untapped global RSV vaccine market,” four manufacturers set their sights on RSV vaccine development for infants, pregnant women and the elderly.
Initially, Johnson & Johnson and Bavarian Nordic also were developing RSV vaccines, but the former dropped out of the race last month and Bavarian Nordic’s clinical trials are in progress.
That leaves Pfizer and GlaxoSmithKline (GSK), who have been in a tight race to be the first Big Pharma player to tap into the RSV vaccine market, which is estimated to be over $5 billion and could exceed $10 billion by 2030, Reuters reported last month.
Both companies have RSV vaccines under regulatory review with the FDA.
The FDA advisory committee voted unanimously in favor of GSK’s vaccine’s effectiveness in preventing lower respiratory tract disease caused by RSV in adults aged 60 and above, and voted 10 to 2 for its safety last month, based on interim data presented last October, Reuters reported.
Brenda Baletti Ph.D. is a reporter for The Defender. She wrote and taught about capitalism and politics for 10 years in the writing program at Duke University. She holds a Ph.D. in human geography from the University of North Carolina at Chapel Hill and a master’s from the University of Texas at Austin.
This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. Please consider subscribing to The Defender or donating to Children’s Health Defense.
April 7, 2023
Posted by aletho |
Science and Pseudo-Science | FDA, GlaxoSmithKline, Pfizer, United States |
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Data continues to emerge according to which not only were the mRNA shots ineffective at preventing infection and transmission of COVID-19, but they may have caused widespread harm to persons cajoled or coerced into undergoing vaccination, despite their own relative invulnerability to the worst effects of the virus. Anecdotal cases abound, but diehard regime narrative devotees continue to dismiss such “incidents”—thousands of which are recorded in the government’s own VAERS (Vaccine Adverse Effects Reporting System) database—as purely coincidental. It is more difficult to downplay reports involving entire cohorts, such as the increased incidence of myocarditis among young males, which the CDC itself has acknowledged. Some critics have suggested that a disproportionately high percentage of pregnant women in Pfizer’s initial trial of the shots suffered miscarriages.
Back in November 2021, in the midst of the widespread and aggressive “Vaccinate everyone!” campaign, I spoke with a woman in Oregon who matter-of-factly mentioned that her (vaccinated) daughter had suffered three recent miscarriages. Recognizing that it was too late to do anything anyway, given that the daughter had already been vaccinated, I did not dare to suggest that her troubles may have been caused by the shots she had no doubt been exhorted by her doctor to take. At that time, following the lead of CDC director Rochelle Walensky, health officials everywhere were in the midst of a marketing blitz according to which COVID-19 vaccination would protect mothers and their babies alike.
I said nothing to the woman in Oregon about the dangers of introducing foreign substances into pregnant women (although I had written about it), but I did naturally wonder at the time whether there might be a causal connection between the poor daughter’s miscarriages and the shots, given the biological activity of the spike protein already known to induce blood clotting and heart troubles. The mother of the young woman—who was pregnant again, for a fourth time—seemed optimistic that somehow there was nothing to worry about, even after three failed attempts to bring a baby into the world. It is possible, I realized then and continue to own, as I must, that the woman was simply unable, for unrelated reasons, to carry a child to term. But given that the biologically active spike protein is what the original virus used to access cells, and production of lots of it was induced by the injected mRNA, it would not take a tinfoil hat conspiracy theorist to surmise that the pregnancies may have been sabotaged by the shots.
Critics such as feminist scholar Naomi Wolf, who early on in the pandemic raised questions about the shot’s safety, given many reports of irregular menstrual cycles in women who under went vaccination, were denounced as purveyors of misinformation and immediately deplatformed by the social media giants. Only recently have such “conspiracy theorists” been permitted to articulate their concerns in the public sphere once again—and only on some platforms, including Twitter, which to Elon Musk’s credit reinstated thousands of accounts shut down for the crime of deviating from the narrative favored by the pharma-government alliance. If the shots are indeed dangerous to fetuses, it is needless to say too late for all of the pregnant women tricked into believing that because the CDC insisted that there was no evidence of risk to them and their offspring, they should therefore roll up their sleeves.
That Pfizer knew all along that their mRNA shots had effects upon women’s hormonal systems was corroborated through Project Veritas’ sting operation involving a Pfizer research director, Jordon Triston Walker. In the recorded interview thought by him to be a friendly conversation with a date, Walker observed that the shots seemed somehow to be affecting the endocrine systems of women. The delicate hormonal balance needed to maintain a pregnancy suggests an immediate connection between the widely reported menstruation irregularities of women and the incidence of miscarriages in some of the initial trial subjects.
The data interpreted by some critics to imply that miscarriage was one of the many possible side effects of the Pfizer shot were made public only recently, with the release of a large trove of court-ordered documents which the company is now required by law to provide, despite its initial insistence that it would take seventy-five years to do so. Setting aside the question of whether miscarriage is in fact a side effect of the shots, the very idea that it would take so many years to make public the documents said to have served as the basis for the FDA’s (Food and Drug Administration’s) decision to grant the Pfizer product Emergency Use Authorization (EUA), so that it could forego the customarily stringent multi-year testing program required of pharmaceutical products more generally, struck many people as absurd.
To my mind, the situation constituted a classic Charybdis and Scylla. If it was humanly impossible to process and assess all of the data (all 451,000 pages of it) in the short period between the creation of the vaccines and December 11, 2020, when the EUA was granted, this could be taken to imply that the persons on the committee incompetently executed their role and indeed based their decision to approve the shots primarily on Pfizer’s obvious wish that they do so. Alternatively, it was always possible to process the documents for publication, and the company’s resistance to doing so was due to the content of the documents themselves, which might harm the ambitious sales program to vaccinate everyone on the planet with the new product.
The director of the CDC, Rochelle Walensky, encouraged pregnant women from the beginning to get the shots, quite deceptively claiming that there was no cause for worry about possible health risks to fetuses. The safety information provided with the original shots itself indicated that pregnant women had been excluded from the initial trials, as they are for most pharmaceutical products. The reason why pregnant women are not included in early stage clinical trials of products intended for the general population is because they represent a special case, given the fragile chemical environment enveloping the fetus. It is a matter of common knowledge that developing human beings are highly sensitive to and often endangered by foreign substances—alcohol and nicotine being two well-documented examples. The vulnerability of fetuses was most notoriously and unforgettably demonstrated when pregnant women were prescribed Thalidomide on the basis of clinical trials which, again, excluded pregnant women. As in the case of the COVID-19 vaccines, Thalidomide was distributed by doctors under the misleading marketing line that there was no evidence that it would harm fetuses. Thalidomide killed thousands of babies and deformed thousands more before it was finally withdrawn from the market.
We now know from Pfizer safety data recently released that some of the women in the initial trial were in fact pregnant—apparently without having known that this was the case at the time, which was why they were not excluded from the trial. The vaccines may or may not have caused their reported miscarriages, but the fact that the CDC would encourage pregnant women, on the basis of nearly no data, to undergo vaccination betrays a reckless disregard and their true goals in injecting everyone everywhere, even members of low risk cohorts, with the mRNA treatment. Ignorance is bliss for pharmaceutical companies, which can continue to market and sell products for years, reaping billions of dollars of profits, before finally halting sales on the basis of widely reported and what come eventually to be undeniable post-launch problems, as in the cases of Vioxx, Belviq, Baycol, etc.
Above and beyond the profit motive was plausibly the desire to test the newfangled mRNA technology on the largest sample of human beings possible—whether or not they actually needed any treatment whatsoever in contending with COVID-19. Of course, if the desire on the part of Pfizer CEO Albert Bourla and Moderna CEO Stéphane Bancel was to make strides ahead in the research and development of other lucrative medications, then the quest for data, too, was ultimately driven by the profit motive—albeit looking forward, to future possible blockbuster drugs.
Certainly, the steadfast resistance, indeed, the outright refusal on the part of public health authorities such as Dr. Anthony Fauci and Dr. Rochelle Walensky, for more than a year after the launch of the COVID-19 vaccines, to acknowledge the relevance of natural immunity in those persons previously infected, and to recommend appropriate adjustments to the U.S. government’s mandates—for both health care workers and military personnel—supports the hypothesis that one of the overarching aims of the aggressive, relentless vaccine campaign was not to save the lives of the small percentage of human beings vulnerable to the virus, but to amass data.
Corroborating this interpretation, according to which the companies hoped not only to reap a windfall of profits but also to collect a huge amount of data, is the explanation by many critics (including Robert F. Kennedy, Jr. and Dr. Peter McCullough) of the assiduous suppression of any and every other therapeutic which the vaccine salespersons recognized would compete with and diminish the uptake of the newly patented products. Most importantly of all, ivermectin and hydroxychloroquine were dismissed and denounced by public health authorities, and ridiculed by parroting pundits throughout the media, because EUA cannot be granted to products when alternative therapies are available.
In his conversation with a Project Veritas reporter, Dr. Jordon Triston Walker also shared the potentially explosive piece of information that Pfizer executives had floated ideas such as mutating the COVID-19 virus so as to be able to develop vaccines preemptively. It was not entirely clear from Walker’s remarks whether the intention would be to release those mutated viruses so as to direct the course of the disease in populations, or simply to predict which variants would pop up on the scene naturally, through mutations of the virus in its effort to self-propagate by evading the antibodies induced by the latest shots.
Pfizer responded to the bombshell revelation by effectively minimizing the story through suggesting that the process described by their (now former, I presume) employee was essentially part of the normal, necessary research conducted in producing, for example, the flu shot each year. Nearly everyone by now is more or less aware that the flu shot is a gamble, involving researchers predicting which strains will be most prevalent and virulent. People who undergo inoculation against those versions may still fall ill because they may or may not come in contact with the predicted dominant strains. Some individuals report anecdotally that they were never more ill than during a year when they opted for the “free” flu shot, which clearly indicates that they encountered versions of the pathogen not expected by the researchers who determined the ingredients for the products distributed during that particular flu season. Unsurprisingly, neither anecdotal reports, nor adverse effects, nor even consistently poor efficacy rates have deterred pharmaceutical firms from pushing for widespread uptake of their mediocre flu shot products in very public and misleading advertising campaigns fronted by government health authorities.
Needless to say, if the intention of Pfizer in mutating the COVID-19 virus was to release it into the human population in order to induce countless numbers of persons to seek protection by purchasing (or obtaining from their government) the “vaccine” developed in order to stop that strain, then that would constitute a flagrant violation of any decent person’s basic sense of ethics. Such a possibility would moreover, and disconcertingly, be taken by some to accrue a degree of plausibility to the conspiratorial notion according to which the original COVID-19 virus was not only a gain-of-function product, created by researchers in a lab, but also intentionally released into the world in order to initiate The Great Reset being promoted by members of the World Economic Forum (WEF), led by Klaus Schwab.
More plausible, I believe, is that Pfizer and Moderna, et al., are primarily focused on the future of their other new mRNA products in the works. It is not at all far-fetched to surmise that the relentless, divisive push to vaccinate everyone everywhere with the first mRNA treatment ever tested on a population of human beings, made possible only by the FDA’s EUA, was spearheaded by companies with much broader goals in mind. The CEOs of these companies have publicly vaunted their plans to use mRNA to cure cancer and other intractable diseases, which in fact best explains their manifest fervor to acquire as much data as possible, by all means necessary. Such a program, albeit less explicitly heinous than creating illnesses in order to be able to sell patented cures for the symptoms caused by them, nonetheless involved using all of the people coerced into undergoing treatments for which they had no need as the means to the companies’ mercenary ends.
Further evidence for this admittedly unsavory interpretation can be seen in the push to vaccinate children, even infants, despite the minimal danger posed to them by the COVID-19 virus. If, in reality, the chances of a child dying from COVID-19 is less than the chance of their being hit by a bolt of lightning, then it is hard to see why anyone would push for uptake under a public health pretext. Yet those who wish to foist the product on young persons, including infants, have continued to press the line according to which the virus poses a serious health risk to everyone, and the vaccine will help to protect children along with their parents, this despite data according to which the protection provided by the shots, even to the vulnerable persons who might be said to benefit, plummets to nothing after only a few months. (Preposterously enough, according to one recent study at the Cleveland Clinic, in the longterm, the more shots one has received, the greater become one’s chances of contracting COVID-19!)
A second reason why children have been important for the product companies is peculiar to the United States, where the PREP Act (Public Readiness and Emergency Preparedness Act) protecting companies from liability in the event of adverse effects covers any product approved as a part of the child immunization schedule. Demonstrating their complete capture by pharmaceutical industry forces, on February 9, 2023, the CDC added the COVID-19 shots to the long list of those recommended in the childhood vaccination schedule (which now includes dozens of shots), thus ensuring the product companies massive profits for years to come through the inoculation of persons not at significant risk from the virus, using a product whose already nearly negligible protective capacity for invulnerable persons (a risk reduction of ~1%—or less) spans less than a few months.
Unbelievably enough, the new CDC recommendation for children (beginning at six months) includes the original COVID-19 vaccine, though the wild strain of the virus may no longer exist, along with booster shots, for which the only clinical trial on human beings is currently underway—on the millions of persons who rolled up their sleeves on the basis of safety data gathered from only animal trials. The results are trickling in on the first-round of “bivalent” booster shots, which have so far been demonstrated to have only middling (30%) efficacy in preventing infection by the variant they are attended to address. But the virus will continue to mutate, thus serving as the pretext for producing new booster formulas. This implies that, under the CDC’s immunization guidelines, each new booster shot will of necessity constitute yet another experimental trial, to be conducted, shockingly enough, upon children throughout the years of their development into adults. In other words, children have been set up to serve as test subjects (i.e., human guinea pigs) for each newly developed “booster” to follow in the future as the virus continues to mutate, despite the fact that they make up the least vulnerable cohort of them all.
Why should “vaccines” which do not offer longterm immunity to anyone and are not even necessary for children—the CDC itself explicitly claims that most children will experience only mild symptoms from COVID-19—be included in the battery of time-tested vaccines such as those against polio, measles, etc.? Along with the desire to sell products, and to be able to test new products on children, is, again, scandalously enough, the fact that the CDC’s addition of the mRNA shots to the children’s immunization schedule protects the manufacturers in perpetuity from lawsuits, even after the State of Emergency has ended. President Biden has announced that the State of Emergency will be lifted on May 11, 2023, two months after the CDC added the COVID-19 shots to the children’s immunization schedule.
Because state and local officials follow the cues of the CDC, we can expect to see its recommendation for childhood inoculation by the COVID-19 shots swiftly transformed into mandates for public school children in states throughout the country. This will likely happen in places such as Massachusetts, California, and New York, where health authorities have persisted in retaining laws which restrict the behavior of residents even as new data continues to refute the erroneous premises widely embraced by officials in the spring of 2020 regarding masks, social distancing, etc. Although states such as Florida rescinded the COVID-19 emergency laws, and have passed legislation to protect children, the fact remains: with the federal level CDC recommendation in place, the product companies will retain their protection from future litigation arising from adverse effects, even if the data currently being collected and analyzed eventually demonstrate widespread harm to either children or adults.
It would be a mistake to judge corporations by the moral standards appropriate to individual persons. Corporations are beholden only to their stockholders, and their sole goal is to maximize profit. But the spokespersons for such companies are themselves individual human beings, as are all of the authorities representing public health organizations whose ostensible raison d’être is to protect members of society, not to maximize the profits of their sponsors. When institutions such as the FDA are coopted by mercenary forces, they cease to perform the function which citizens are depending upon them to execute. Because this already happened in the case of the opioid crisis, the fact that people fell for the trick once again in the case of the COVID-19 “vaccines” is best and perhaps only explained by the fearmongering campaign used to psychologically traumatize them to the point where they lost all critical bearings and agreed to undergo an experimental treatment of which most of them had no need.
Every healthy, nonobese person under the age of seventy who underwent COVID-19 vaccination was deceived into serving as a pro bono experimental subject in a pharmaceutical product trial. That millions of well-meaning parents, believing that they are doing the right thing, will on the basis of the CDC’s addition of the COVID-19 shots to the children’s immunization schedule, enroll their progeny in an entire series of such experimental trials, using substances never before tested on human beings, is nothing less than tragic.
Laurie Calhoun is the author of We Kill Because We Can: From Soldiering to Assassination in the Drone Age, War and Delusion: A Critical Examination, Theodicy: A Metaphilosophical Investigation, You Can Leave, Laminated Souls, and Philosophy Unmasked: A Skeptic’s Critique, in addition to many essays and book chapters.
February 27, 2023
Posted by aletho |
Corruption, Deception, Science and Pseudo-Science, Timeless or most popular, War Crimes | Covid-19, COVID-19 Vaccine, FDA, Moderna, Pfizer, United States, WEF |
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Studies, trials by Pfizer Biontech were “seriously flawed” and fraught with “many irregularities” German journalist finds. It’s all beginning to dawn on the media…
Emergency approval based on sloppy and deceptive trials and studies?
At Germany’s flagship daily Die Welt, journalist Elke Bodderas recently penned an investigative article: The Many Irregularities In The Pfizer Approval Study
Until recently, Germany’s mainstream media had refused to report on the glaring number of side effects of the COVID 19 mRNA vaccines, dismissing them has disinformation spread by rightwing crackpots. But now there’s no denying something has gone terribly awry, and that the “crackpots” had been right all along.
Cover-up?
In her article, Bodderas concedes that the Biontech/Pfizer’s mRNA vaccine appears to have been “based on incorrect documentation”, that there is “growing doubt about the data from the pivotal Phase 3 trial” and that “Pfizer is dodging the accusations and refusing to be scrutinized.”
The metropolis Buenos Aires was a key area for test phase with almost 6000 of the 43,548 test subjects worldwide, and things there, according to Die Welt’s Bodderas, “did not go as they should have”.
The “significant, consequential irregularities” that arose during the trials “cast the entire study of the efficacy and side effects of the Biontech/Pfizer vaccine in a different light.”
No one believes “safe and effective”, not even the media
In Germany, the days of believing the new mRNA vaccines by Biontech and Pfizer are “safe and effective” are finally disappearing as a reluctant mainstream media begins to report on the glaring adverse effects and the now well-known inadequately conducted trials.
In other parts of the world, it’s been long known that these new experimental vaccines not only did not work like they once had been claimed to do, but that they also never prevented the transmission of the virus and had numerous, dangerous side effects. Only now, months later, are these now well-known facts beginning to dawn on Germany’s mainstream media.
Shoddily conducted trials
Die Welt reports on how Argentine test candidate Augusto Roux, a 36-year old lawyer, felt unwell after having received his second dose in the trials, then “experienced shortness of breath, burning chest pain, nausea, and fever” and that “his urine turned black like cola” before passing out. After having been admitted to a hospital, physician Gisela di Stilio suspected an “adverse reaction to coronavirus vaccine (high probability).” But Roux was simply dropped from the December 2020 study, and never appeared in subsequent evaluations. Instead he was counted as having suffered from COVID-19.
Suppression of unwelcome results?
In total, “In one fell swoop, the test administration [in Buenos Aires] had said goodbye to 53 subjects on August 31, 2020. The test candidates had been ‘unblinded.’” reports Die Welt’s Bodderas.
Die Welt adds: “A total of 302 subjects of the vaccine group were deleted from the study after the second vaccination and thus not included in the evaluation. 200 of them came from Buenos Aires. Have unwelcome results been suppressed here?”
According to Bodderas, “Deaths were concealed, serious side effects were not registered, and the study protocol was violated several times.”
“The case casts a bad light on Pfizer, a company that has often been plagued by scandal in the past, but also on the regulatory agencies EMA and FDA.”
Bodderas also appeared on Bild’s Viertel Nach Acht: “Serious Flaws in Pfizer BioNTech Vaccine Study.”
February 26, 2023
Posted by aletho |
Deception, Science and Pseudo-Science, Timeless or most popular | COVID-19 Vaccine, EMA, FDA, Germany, Pfizer |
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In an interview with CNBC News in September 2020, Dr. Albert Bourla, the veterinarian Chief Executive Officer of Pfizer — the second largest pharmaceutical company in the world by revenue — said that anyone refusing to take the BioNTech vaccine will become “the weak link that will allow the virus to replicate”, and assured the public that “we will develop our product, develop our vaccine using the highest ethical standards”.
It was a dangerous claim to make, even for a CEO and investor making billions out of the experimental mRNA gene therapy product. Pfizer has a long history of paying out vast sums in out-of-court settlements to avoid not only claims in civil cases but also prosecution on criminal charges resulting from the fraudulent promotion, unapproved prescription and injury, including death, from use of its products. It has also offered millions in payments to doctors and scientists to prescribe, test, approve and recommend them to the public. So let’s have a look at what Dr. Albert Bourla means by Pfizer’s ‘ethical standards’.
- In 1992, Pfizer agreed to pay between $165 million and $215 million to settle lawsuits arising from the fracturing of the Bjork-Shiley Convexo-Concave heart valve, which by 2012 has resulted in 663 deaths.
- In 1996, Pfizer conducted an unapproved clinical trial on 200 Nigerian children with its experimental anti-meningitis drug, Trovafloxacin, without the consent of their parents and which led to the death of 11 children from kidney failure and left dozens more disabled. In 2011, Pfizer paid just $700,000 to four families who had lost a child and set up a $35 million fund for the disabled. This cover-up was the basis of the John Le Carré book and film The Constant Gardener.
- In 2004, Pfizer’s subsidiary Warner-Lambert was fined $430 million to resolve criminal charges and civil liabilities for the fraudulent promotion of its epilepsy drug, Neurontin, paying doctors to prescribe it for uses not approved by the Food and Drug Administration.
- In 2009, Pfizer spent $25.8 million lobbying Congressional lawmakers and federal agencies like the Department of Health and Human Services. Its expenditure on federal lobbying between 2006 and 2014 came to $89.89 million. In 2019 it spent $11 million lobbying the federal Government.
- In 2009, Pfizer set a record for the largest health care fraud settlement and the largest criminal fine of any kind, paying $2.3 billion to avoid criminal and civil liability for fraudulently marketing its anti-inflammatory drug, Bextra, which had been refused approval by the FDA due to safety concerns.
- In 2009, Pfizer paid $750 million to settle 35,000 claims that its diabetes drug, Rezulin, was responsible for 63 deaths and dozens of liver failures. In 1999, a senior epidemiologist at the Food and Drug Administration warned that Rezulin was “one of the most dangerous drugs on the market”.
- In 2010, Pfizer was ordered to pay $142.1 million in damages for violating a federal anti-racketeering law by its fraudulent sale and marketing of Neurontin for uses not approved by the FDA, including for migraines and bi-polar disorder.
- In 2010, Pfizer admitted that, in the last six months of 2009 alone, it had paid $20 million to 4,500 doctors in the U.S. for consulting and speaking on its behalf, and $15.3 million to 250 academic medical centres for clinical trials.
- In 2012, Pfizer paid $45 million to settle charges of bribing doctors and other health-care professionals employed by foreign Governments in order to win business. The Chief of the Securities and Exchange Commission Enforcement Division’s Foreign Corrupt Practices Act Unit said: “Pfizer subsidiaries in several countries had bribery so entwined in their sales culture that they offered points and bonus programs to improperly reward foreign officials who proved to be their best customers.”
- By 2012, Pfizer had paid $1.226 billion to settle claims by nearly 10,000 women that its hormone replacement therapy drug, Prempro, caused breast cancer.
- In 2013, Pfizer agreed to pay $55 million to settle criminal charges of failing to warn patients and doctors about the risks of kidney disease, kidney injury, kidney failure and acute interstitial nephritis caused by its proton pump inhibitor, Protonix.
- In 2013, Pfizer set aside $288 million to settle claims by 2,700 people that its smoking cessation drug, Chantix, caused suicidal thoughts and severe psychological disorders. The Food and Drug Administration subsequently determined that Chantix is probably associated with a higher risk of heart attack.
- In 2013, Pfizer absolved itself of claims that its antidepressant, Effexor, caused congenital heart defects in the children of pregnant woman by arguing that the prescribing obstetrician was responsible for advising the patient about the medication’s use.
- In 2014, Pfizer paid a further $325 million to settle a lawsuit brought by health-care benefit providers who claimed the company marketed its epilepsy drug, Neurontin, for purposes unapproved by the FDA.
- In 2014, Pfizer paid $35 million to settle a law suit accusing its subsidiary of promoting the kidney transplant drug, Rapamune, for unapproved uses, including bribing doctors to prescribe it to patients.
- In 2016, Pfizer was fined a record £84.2 million for overcharging the NHS for its rebranded and deregulated anti-epilepsy drug Phenytoin by 2,600% (from £2.83 to £67.50 a capsule), increasing the cost to U.K. taxpayers from £2 million in 2012 to about £50 million in 2013.
- In May 2018, Pfizer still had 6,000 lawsuits pending against claims that its testosterone replacement therapy products cause strokes, heart attacks, pulmonary embolism and deep vein thrombosis, and were fraudulently marketed at healthy men for uses not approved by the FDA.
- In June-August 2020, the U.S. Securities and Exchange Commission and the Department of Justice said they were looking at Pfizer’s activities in China and Russia under the Foreign Corrupt Practices Act, which forbids U.S. firms from bribing foreign officials.
- In November 2021, the British Medical Journal revealed that the Ventavia Research Group had falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in the phase 3 trial for Pfizer’s ‘vaccine’.
- Since 2000, Pfizer has incurred $10.268 billion in penalties, including $5.637 billion for safety-related offences; $3.373 billion for unapproved promotion of medical products; $1.148 billion for government contract-related offences; $60 million under the Foreign Corrupt Practices Act; and $34.7 million for ‘kickbacks and bribery’.
Given this record of ongoing corruption and malpractice from, which only its enormous profits have saved it from criminal prosecution by means of out-of-court settlements, it seems extraordinary that Pfizer Inc. is still permitted to manufacture and sell any health-care products. Yet this is the pharmaceutical company we were asked by the U.K. Government, the Scientific Advisory Group for Emergencies, the Joint Committee on Vaccination and Immunisation, the U.K. Health Security Agency and the National Health Service to trust with the mass vaccination of 68 million people with a product that was rushed through clinical trials in seven months, employing experimental mRNA biotechnology whose clinical trials are not due to be completed until March 2023, for a disease with the infection fatality rate not much above seasonal influenza, which statistically is no threat to those under 50 years old, and for which there is no evidence that it prevents infection by the virus.
That was three years ago, during which the British people have paid with their freedoms, their health and their lives for believing the lies of their Government, their National Health Service and international pharmaceutical companies. Subsequent retractions by Pfizer, however, are an opportunity to revisit its claims in more detail.
On December 10th 2020, the U.S. Vaccines and Related Biological Products Advisory Committee met to evaluate the trial data on the efficacy and safety of Pfizer/BioNTech’s mRNA COVID-19 vaccine contained in the briefing document produced by Pfizer itself titled ‘Pfizer-BioNTech COVID-19 Vaccine (BNT162, PF-07302048) Vaccines and Related Biological Products Advisory Committee Briefing Document‘. It was on the basis of this evaluation that, on December 11th, the Food and Drug Administration (FDA) granted Emergency Use Authorisation to its mRNA gene therapy product. And given the subsequent debate about what Pfizer claimed its ‘vaccine’ would do, it might be useful to review the contents of this document.
The FDA’s Emergency Use Authorisation, which requires less data than standard approvals and is based on a lower standard of proof, was issued for a vaccine “intended to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2”. It was issued for prevention, therefore, not for reduction of the severity of symptoms, as was claimed when it became clear the gene therapy product did not prevent infection. Pfizer’s claim was that its product had a ‘vaccine efficacy’ of 95% protection against COVID-19 occurring after second days from injection with the second dose. In its clinical trials, a ‘case’ of COVID-19 was defined as a positive RT-PCR test for SARS-CoV-2 and the presence of at least one of the following symptoms: fever, cough, shortness of breath, chills, muscle pain, loss of taste or smell, sore throat, diarrhoea or vomiting. Nothing was said about asymptomatic ‘cases’ of COVID-19, or claimed about the ability of the gene therapy product to stop ‘asymptomatic transmission’ of the virus.
Pfizer’s benefit assessment was that its mRNA vaccine may be able to induce “herd immunity”, induces strong “immune responses”, and “confers strong protection against COVID-19”. This clearly indicates protection against both infection with the virus and the disease. Since transmission of a virus from person to person requires prior infection, Pfizer’s claim that its vaccine protects against infection, and the suggestion that sufficient injections will induce ‘herd immunity’, is also, by extension, a claim that it stops transmission from the injected.
The subsequent claim by Janine Small, Pfizer’s President of International Developed Markets, during her testimony before the European Union Parliament in October 2022, that Pfizer never tested whether its ‘vaccine’ stopped transmission appears, therefore, to rest on the myth of ‘asymptomatic transmission’. The implication of her statement was that Pfizer’s product only stops infection with SARS-CoV-2 and symptoms of COVID-19. However, the FDA’s Emergency Use Authorisation for Pfizer’s vaccine was based on prevention of both infection and disease. Pfizer’s claim is not evidence, as many afterwards claimed, for the lack of justification for making injection a condition of lifting lockdown or imposing vaccine passports, but rather an attempt to deny responsibility for the failure of its product (from which it has made $69 billion) to meet either of its claims.
An indication of just how unscientific was the FDA’s Emergency Use Authorisation of Pfizer’s vaccine is that it was granted on the basis of protection from infection and disease, while conceding there is no evidence that the vaccine “prevents transmission from person to person“. This is the way the ‘Science’ we mustn’t question or deny but blindly follow is conducted in what I call the global biosecurity state. Indeed, three years after it announced the pandemic in March 2020, the World Health Organisation can still only offer the following justifications for the four vaccines authorised for use in the U.K.
- Pfizer/BioNTech: “There is modest vaccine impact on transmission.”
- AstraZeneca/Oxford: “No substantive data are available related to impact of the vaccine on transmission or viral shedding.”
- Moderna: “There is only modest impact on preventing mild infections and transmission.”
- Novavax: “There is not currently sufficient evidence to date to evaluate the impact of the vaccine on transmission.” (See World Health Organisation, ‘COVID-19 advice for the public: Getting vaccinated’.)
Failure to offer protection against infection or transmission, however, are the least of the failings of Pfizer’s ‘vaccine’. As the evidence of the harms and deaths caused by this experimental gene therapy product injected into the U.K. public becomes too overwhelming for all but the Covid-faithful, the British press, the U.K. Parliament and our Government to ignore, there have been no end of doctors, nurses and medical professionals protesting they thought Pfizer’s biotechnology was ‘safe and effective’. But aren’t they trained to spot when something is going medically very wrong?
As of January 25th 2023, the Medicines and Healthcare Products Regulatory Agency, responsible for authorising the injection of the Pfizer/BioNTech vaccine into U.K. citizens, has received 180,005 reports of 517,779 adverse reactions to the injections, over 70% of which reports (127,405) have been classified as ‘serious’, including 884 deaths following injection. Including AstraZeneca’s viral-vector gene therapy product and Moderna’s mRNA gene therapy, the MHRA has received a total of 477,553 reports of 1,555,433 adverse reactions to the COVID-19 gene therapies, 74 per cent of which (355,052 reports) are categorised as ‘serious’, including 2,436 deaths following injection.
By the MHRA’s own estimation, only 10% of serious adverse reactions and 2-4% of non-serious reactions are reported, so the actual tally of injuries, autoimmune disease, reproductive and breast disorders, miscarriages and premature births, facial paralysis, blood clotting, amputations, myocarditis, pericarditis, heart attacks and deaths — all of which were recorded in Pfizer’s own analysis of post-authorisation adverse events as early as February 2021 — is far higher, undoubtedly many times higher. Indeed, this — and not the risible excuses with which the U.K. public has been fobbed off by the U.K. media — is likely a major cause of the huge increase in mortality in the U.K. since the ‘vaccine’ programme was implemented, contributing to the more than 60,000 excess deaths in 2022.
Given which, it is my contention that any medical professional that authorised or administered the injection of U.K. citizens with the Pfizer/BioNTech gene therapy product is at risk of being found guilty in a court of law for failure to give sufficient warning of adverse effects and obtain informed consent.
Simon Elmer is the author of two new volumes of articles on the U.K. biosecurity state, Virtue and Terror and The New Normal, which are available in hardback, paperback and as an ebook. This article is an extract from an article in Volume 2, ‘Bowling for Pfizer’. Please click on these links for the contents page and purchase options. On March 11th, to mark the third anniversary since the declaration of the pandemic by the World Health Organisation, he will be holding a book launch at the Star & Garter, 62 Poland Street, W1F 7NX, upstairs in the William Blake room from 6-8pm. Entry is free, with book signings, a reading and open-mic discussion.
February 25, 2023
Posted by aletho |
Corruption, Deception, Science and Pseudo-Science, Timeless or most popular, War Crimes | COVID-19 Vaccine, FDA, Pfizer, UK |
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Don’t listen to those rumors!
Sitrep:
It seems that the Thai Royal family had a Princess who was a good global citizen. She took 3/three of the Pfizer shots. She went into a coma a while back.
The Thai Royal family was/is very distressed. Investigations were ordered.
The distress of the Royals was increased by the reports coming back from their investigators. It seems that Pfizer, apparently, did NO safety studies on this shot. Shortly thereafter, Thailand cancels the covid contracts with Pfizer on the basis of fraud.
As may be expected, all this has taken weeks. The investigators are still at work as this is a giant, global scam/fraud with many threads to trace back to sources.
People known to me for decades are living as ex-pat Americans in Thailand. Two of them are outstanding, though now ‘retired’ into a different life, investigators. One worked for over 30 years as a US Naval officer, the last 15 of which were involved in criminal fraud cases. The other was an investigator for the Washington State Patrol, again, Criminal investigations.
Both are in resident in Bangkok these last few years. My ex-Navy friend is a serious linguist, concentrating on 7 Asian languages. That’s how I know him.
Rumors:
They have revealed to me that several, different, sources, are reporting to them, that ‘something’, a really big ‘something’, is disturbing the Bangkok ‘underworld’. My guys have contact with it through a couple of martial arts dojos. Both are hearing the same rumors, ‘disturbance in the force’ kind of rumors.
The rumor to NOT listen to says that ‘assassins’ are being ‘recruited’ out of very deep holes in the martial arts world.
Me? I would NOT want to have this logo on my letterhead as an executive:
February 5, 2023
Posted by aletho |
Deception, Timeless or most popular, War Crimes | Pfizer |
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The inside story of how we held Pfizer to account for misleading parents about Covid vaccine safety
Free pass promotional opportunity given by BBC to Pfizer
On 2 December 2021, the BBC published on its website, its popular news app and in the BBC News at One programme, a video interview and an accompanying article under the headline ‘Pfizer boss: Annual Covid jabs for years to come’.
The interview by the BBC’s medical editor, Fergus Walsh, conducted as a friendly fireside chat, gave Dr Albert Bourla, the Chairman and CEO of Pfizer, a free pass promotional opportunity that money cannot buy — as the UK’s national public service broadcaster, the BBC is usually prohibited from carrying commercial advertising or product placement.
Perhaps unsurprisingly, Pfizer made the most of that astonishing opportunity to promote the uptake of its vaccine product. As the BBC’s strapline suggests, the key message relayed by Dr Bourla, responding to an obediently leading question from Mr Walsh, was that many more vaccine shots would need to be bought and jabbed to maintain high levels of protection in the UK. He was speaking shortly before the UK Government bought another 54 million doses of Pfizer vaccines.
Misleading statements about safety
Among his explicit and implicit encouragements for the UK to order more of his company’s shots, Dr Bourla commented emphatically about the merits of vaccinating children under 12 years of age, saying “[So] there is no doubt in my mind that the benefits, completely are in favour of doing it [vaccinating 5 to 11 year olds in the UK and Europe]”. No mention of risks or potential adverse events, nor indeed the weighing of any factors other than apparent benefits: Dr Bourla was straightforwardly convinced that we should immunise millions more children in the UK. In fact, it later emerged that the BBC’s article had misquoted Dr Bourla who in the full video interview recording had ventured the benefits to be “completely completely” in favour of vaccinating young children.
Despite the strength of Dr Bourla’s unconditional and superlative pitch for vaccinating under-12s, the UK regulatory authorities would not authorise the vaccine for use with those children until the very end of 2021; and indeed this came just a few months after the JCVI — the body which advises the Government on whether and when to deploy vaccines in the UK — had already declined to advise the Government to roll out a mass vaccination programme for healthy 12 to 15-year-olds on the basis that “the margin of benefit, based primarily on a health perspective, is considered too small to support advice on a universal programme of vaccination of otherwise healthy 12 to 15-year old children…”.
In response, soon after the interview aired, UsForThem submitted a complaint to the UK’s Prescription Medicines Code of Practice Authority (PMCPA) — the regulator responsible for policing promotions of prescription medicines in the UK. The complaint cited the overtly promotional nature of the BBC’s reports and challenged the compliance of Dr Bourla’s comments about children with the apparently strict rules governing the promotion of medicines in the UK.
A year-long, painful process
More than a year later, following a lengthy assessment process and an equally lengthy appeal by Pfizer of the PMCPA’s initial damning findings, the complaint and all of the PMCPA’s findings have been made public in a case report published on the regulator’s website.** Though some aspects of that complaint ultimately were not upheld on appeal, importantly an industry-appointed appeal board affirmed the PMCPA’s original findings that Dr Bourla’s comments on vaccinating 5 to 11-year-olds were promotional, and were both misleading and incapable of substantiation in relation to the safety of vaccinating that age group.
Even after UsForThem involved a number of prominent Parliamentarians, including Sir Graham Brady MP, to help accelerate the complaint, the process was dragged on — or perhaps ‘out’ — while the roll-out of Pfizer’s vaccine to UK under-12s proceeded, and the BBC’s interview and article stayed online. Even now the interview remains available on the BBC’s website, despite the PMCPA in effect having characterised it as ‘misinformation’ as far as vaccinating children is concerned.
When news of the appeal outcome was first revealed in November 2022 by a reporter at The Daily Telegraph newspaper, Pfizer issued a comment to the effect that it takes compliance seriously and was pleased that the “most serious” of the PMCPA’s initial findings — that Pfizer had failed to maintain high standards and had brought discredit upon and lowered confidence in the pharmaceutical industry — had been overturned on appeal.
It must be an insular and self-regarding world that Pfizer inhabits, that discrediting the pharmaceutical industry is considered a more serious matter than making misleading and unsubstantiated statements about the safety of their products for use with children. This surely speaks volumes about the mindset and priorities of the senior executives at companies such as Pfizer.
And if misleading parents about the safety of a vaccine product for use with children does not discredit or reduce confidence in the pharmaceutical industry, it is hard to imagine what standard can have been applied by the appeal board which overturned that initial finding. Perhaps this reflects the industry’s assessment of its own current reputation: that misinformation promulgated by one of its most senior executives is not discrediting. According to the case report, the appeal board had regard to the “unique circumstances” of the pandemic: so perhaps the view was that Pfizer can’t always be expected to observe the rules when it gets busy.
Multiple breaches. No meaningful penalty
Indeed, a brief look at the PMCPA’s complaints log confirms that Pfizer has been found to have broken the UK medicines advertising rules in relation to its Covid vaccine a further four times since 2020. Astonishingly, though, for their breaches in this most recent case, and in each of the other cases decided against it, neither Pfizer nor Dr Bourla will suffer any meaningful penalty (the PMCPA will have levied a small administrative charge to cover the cost of administering each complaint). So in practice, neither has any incentive to regret the breach, or to avoid repeating it if it remains commercially expedient to do so.
And this is perhaps the crux of the issue: the PMCPA, the key UK regulator in this area, operates as a division of the Association of the British Pharmaceutical Industry, the UK industry’s trade body. It is therefore a regulator funded by, and which exists only by the will of, the companies whose behaviour it is charged with overseeing. Despite Pharma being one of the most lucrative and well-funded sectors of the business world, the largely self-regulatory system on which the industry has now for decades had the privilege to rely has been under-resourced and has become slow, meek and powerless.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) in principle has jurisdiction to hold the BBC accountable for what seems likely to have been mirroring breaches of the medicines advertising rules when it broadcast and promoted Dr Bourla’s comments, but no action has yet been taken.
This case, and the apparent impunity that companies such as Pfizer appear to enjoy, evidence that the system of oversight for UK Pharma is hopelessly outdated and that the regulatory authorities are risibly ill-equipped to keep powerful, hugely well-resourced corporate groups in check. The UK regulatory system for Big Pharma is not fit for purpose, so it is time for a rethink. Children deserve better, and we should all demand it.
** Endnote: an undisclosed briefing document
As part of its defence of UsForThem’s complaint, Pfizer relied on the content of an internal briefing document that had been prepared for the CEO by Pfizer’s UK compliance team before the BBC interview took place. Pfizer initially asked for that document to be withheld from UsForThem on the grounds that it was confidential. When UsForThem later demanded sight of the document (on the basis that it was not possible to respond fully to Pfizer’s appeal without it), UsForThem was offered a partially redacted version, and only then under terms of a perpetual and blanket confidentiality undertaking.
Without knowing the content of that document, or the scope of the redactions, UsForThem was unwilling to give an unconditional perpetual blanket confidentiality undertaking, but reluctantly agreed that it would accept the redacted document and keep it confidential subject to one limited exception: if UsForThem reasonably believed the redacted document revealed evidence of serious negligence or wrongdoing by Pfizer or any other person, including evidence of reckless or wilful damage to the public health of children, UsForThem would be permitted to share the document, on a confidential basis, with members of the UK Parliament.
This limited exception to confidentiality was not accepted. Consequently, UsForThem never saw the briefing document and instead drew the inference that it contained content that Pfizer regarded as compromising and which it therefore did not wish to risk ever becoming public.
February 3, 2023
Posted by aletho |
Deception, Fake News, Mainstream Media, Warmongering | BBC, COVID-19 Vaccine, Pfizer, UK |
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https://www.bitchute.com/video/SeVzU4k6EHgW/
Will Thailand become the first country to take Pfizer to court claiming fraud and declare the contracts null and void?
Professor Sucharit Bhakdi seems to think so. He claims to have talked to officials high up in government and told them that the contracts were fraudulent. According to him, the Thais want to be the first country in the world to declare the contracts null and void. If this goes ahead and found to be true in the courts, it will mean a significant sum of damages will have to be paid by Pfizer and set off a chain of events that will likely bankrupt the company.
23 days after the Thai King’s daughter had her booster, she collapsed and is still in a coma. Officially she has a bacterial infection but many claim she is the victim of vaccine damage. If the Thais do take Pfizer to court, will this have been the reason?
The National Institute of Health’s grant AI23946-08 issued to Dr. Ralph Baric at the University of North Carolina at Chapel Hill (officially classified as affiliated with Dr. Anthony Fauci’s NIAID by at least 2003) began the work on synthetically altering the Coronaviridae (the coronavirus family) for the express purpose of general research, pathogenic enhancement, detection, manipulation, and potential therapeutic interventions targeting the same. As early as May 21, 2000, Dr. Baric and UNC sought to patent critical sections of the coronavirus family for their commercial benefit.1 In one of the several papers derived from work sponsored by this grant, Dr. Baric published what he reported to be the full length cDNA of SARS CoV in which it was clearly stated that SAR CoV was based on a composite of DNA segments. “Using a panel of contiguous cDNAs that span the entire genome, we have assembled a full-length cDNA of the SARS-CoV Urbani strain, and have rescued molecularly cloned SARS viruses (infectious clone SARS-CoV) that contained the expected marker mutations inserted into the component clones.”2 On April 19, 2002 – the Spring before the first SARS outbreak in Asia – Christopher M. Curtis, Boyd Yount, and Ralph Baric filed an application for U.S. Patent 7,279,372 for a method of producing recombinant coronavirus. In the first public record of the claims, they sought to patent a means of producing, “an infectious, replication defective, coronavirus.” This work was supported by the NIH grant referenced above and GM63228.
In short, the U.S. Department of Health and Human Services was involved in the funding of amplifying the infectious nature of coronavirus between 1999 and 2002 before SARS was ever detected in humans.
This dossier is by no means exhaustive. It is, however, indicative the numerous criminal violations that may be associated with the COVID-19 terrorism.
All source materials are referenced at https://archive.org/details/the-fauci-covid-19-dossier_202109
January 30, 2023
Posted by aletho |
Science and Pseudo-Science, Timeless or most popular, Video, War Crimes | COVID-19 Vaccine, Pfizer, Thailand |
2 Comments
US drugmaker Pfizer admitted on Friday that it “engineered” treatment-resistant variants of Covid-19 in order to test its antiviral medicine. The admission partially backs up earlier claims by an executive with the company who told an undercover reporter that Pfizer was deliberately “mutating” the virus to “preemptively develop new vaccines.”
In a statement posted on its website, Pfizer said that it “has not conducted gain of function or directed evolution research,” referring to the practice of amplifying a virus’ ability to infect humans and the process of selecting ‘desirable’ traits of a virus to reproduce, respectively.
However, the pharma giant said that it combined the spike proteins of new coronavirus variants with the original strain in order to test its vaccines, and that it created mutations of the virus to test Paxlovid, its antiviral drug.
“In a limited number of cases… such virus may be engineered to enable the assessment of antiviral activity in cells,” the company said, adding that this work was carried out in a secure laboratory. The work also sought to create “resistant strains of the virus,” it added, describing a process commonly understood as being ‘gain of function’ research.
Pfizer’s statement came two days after Jordon Trishton Walker, an executive involved in the firm’s mRNA division, told an undercover reporter that the company was “exploring” ways to “mutate [covid] ourselves so we could create, preemptively develop, new vaccines.” Walker said that scientists were considering infecting monkeys with the virus, who would then “keep infecting each other.”
“From what I’ve heard, they [Pfizer scientists] are optimizing it, but they’re going slow because everyone is very cautious,” he explained. “Obviously they don’t want to accelerate it too much. I think they are also just trying to do it as an exploratory thing because you obviously don’t want to advertise that you are figuring out future mutations.”
Pfizer’s statement makes no mention of the supposed plan to infect monkeys, instead explaining that any work on live viruses is carried out in vitro, meaning inside test tubes or other lab equipment.
Walker was told on camera that he was speaking to a journalist with Project Veritas, a conservative outlet known for its hidden-camera sting operations. After hearing this, Walker insisted that he was lying to impress his date, before attempting to steal an iPad from Project Veritas CEO James O’Keefe.
January 29, 2023
Posted by aletho |
Deception | Covid-19, COVID-19 Vaccine, Pfizer, United States |
2 Comments
Covid-19 injections are dangerous, non-compliant biological materials. Their production must be stopped until a full investigation can be done.
Many of us are familiar with the following conundrum: on one hand, highly credentialed scientists and doctors have written numerous research papers explaining the dangerous mechanisms of action underlying mRNA/DNA “platform” technologies. The papers are meticulously researched and depict, correctly in my opinion, many terrifying consequences of the technology that breaches the innate protective mechanisms of human cells. Furthermore, these theoretical papers are validated by the observed outcomes, such as for example, increases in all-cause mortality in high correlation with increases in rates of vaccination in a given territory, unprecedented increases in the adverse events and deaths recorded by various passive reporting (https://openvaers.com/), astonishingly high reports of the adverse events and deaths from the pharmas’ own pharmacovigilance systems, and autopsy findings in vaccinated post-mortem showing the mechanisms of mRNA technology damage in histopathologic evaluations. On the other hand, many who have received the injections report no adverse effects and deem the data points above a “crazy conspiracy”. The question from the uninjured seems to be – why don’t we see MORE deaths if what you say about mRNA products is true? Setting aside ethical limitations of this question, here is a possible answer why:
The mRNA shots do not conform to their label specifications. In practice both “blank” and “lethal” vials and anything in between is produced. Without full compliance, nobody, not even the manufacturers or regulators, know exactly what ends up being produced.
Vials of mRNA injections are not routinely tested by the manufacturers for conformity to the label. The only vial-level tests specified by Pfizer in leaked Chemistry Manufacturing and Controls (CMC) documents are the vial weight at filling, manual inspection for large visible particles, and some tests related to integrity such as vial capping. However, no vial or dose, i.e., “unit-level as dispensed” tests verifying the ingredients are described as routine. How is the public assured that each Pfizer dose contains 30 mcg of mRNA as stated on the label? What level of variability of this key ingredient and other ingredients is acceptable? The ingredient conformity tests described in Pfizer CMC package are based on the bulk product batch testing – an upstream manufacturing process step. It is a regulatory requirement to retain samples of each batch produced, and these samples of vials should exist and be available for examination. Per contracts with the US Government, the product is shipped to the DOD who retains the ownership of the vials until the product is injected into people. These contracts are very detailed and specify manufacturing data to be delivered to the DOD, however, I did not find any descriptions of sampling of the vials for purposes of verification of their contents vs the label. Furthermore, it is expressly forbidden by the international vaccine supply contracts to perform the vial tests for label conformity.
Despite the disturbing prohibition of the independent vial testing, covert random testing of the mRNA vials has been ongoing worldwide. Reported thousands of vials have been obtained and tested by dozens of research groups working independently of each other. The quality of these studies varies and depends on the conditions of the samples acquired, access to the lab equipment and the experience of the investigators. However, the consistent finding among all is that there is yet a single vial to be found in full conformance to the manufacturer’s label. A review of these independent testing efforts has been published recently. Another high-quality report summarizes experiences testing vials from various manufacturers in Germany. These studies use different techniques ranging from optical to electron microscopy, spectroscopy, as well as isolation of genetic and protein components and in some cases sequencing of the RNA.
Some vials contain RNA as well as high concentrations of DNA and protein impurities in quantities far exceeding allowed limits specified by the manufacturer. When RNA was sequenced, the sequences did not fully match the specified BNT162b2 sequence, and a large quantity of RNA fragments was found. In other instances, vials are found apparently without RNA or DNA in them (evidently absent nitrogen and phosphorus).
Want to know what’s inside the vaccine vials?
These results could depend on the methods used and more thorough testing may be needed. Nevertheless, I was able to confirm that the apparent “blank” vials from at least one researcher came from batches of Pfizer and Moderna that had almost no adverse events reports in VAERS: two batch numbers had 1 report each and one batch number had no reports. This should be contrasted with some batch numbers of Pfizer and Moderna associated with 5000+ adverse event reports in VAERS, and an average of ~1500 adverse event reports including ~700 serious reports and deaths across all CDC verified batch numbers.
Almost all vials examined contain high contamination levels of various metals that are toxic to human body. This finding is consistent across all groups and methodologies, and therefore should be deemed more conclusive. There is no explanation of the origin or purpose of these materials according to the known manufacturing processes. Additional findings include various forms of carbon, including, potentially graphene oxide which is a known toxin. Finally, almost all vials examined contain a variety nano- and micro-particulate contaminants – another conclusive finding with plenty of photo and video documentation. These appear under microscope examinations as shapes and structures of various sizes and include characteristic ribbons, fibers, and crystals. Several published reports by qualified and credentialed microscopy experts have excluded the possibility of environmental dirt on the microscope slides. Sometimes a process of movement and what can be described as “self-assembly” is visible and has been documented in a single take video. The researchers also take steps to maintain the chain of custody, examine unexpired product and keep the vials frozen per manufacturer’s instructions.
Below are some representative images from various manufacturers’ injection vials from many studies:
Dr. David Nixon – Australia, Pfizer
Another Dr. from Australia, Pfizer:
The images above are startling and remain unexplained to date. Some scientists insist these are all “salt and cholesterol”, and nothing to see here folks! I disagree. Images of salt and cholesterol under microscope may match some of these structures, but by far do not explain all of them, and seem especially poor explanations for assembly-disassembly processes that have been observed and video recorded. Sizes of these structures alone are problematic. Dismissing them as “manufacturing junk” is not a great way to instill confidence in anyone.
These contaminants and bizarre objects are not rare, in fact as the last image shows, at least some of the vials are teeming with them. While many speculations can be made, one overwhelming conclusion from all the vial tests by independent investigations is that the products are extremely “dirty”, do not conform to their labels and should thus be deemed adulterated. This is a clear indicator that the manufacture of these products is not compliant with the current Good Manufacturing Practices (cGMP).
Sloppy manufacturing process may result from numerous factors, including lack of accountability, negligence, incompetence and possibly fraud. Review of the contracts with the manufacturers made by the U.S. Department of Defense, BARDA and HHS shows that the main driver were the gigantic sums of money made available with no real accountability for quality or safety – all resulting from the forced extreme speed (“warp speed”) of the scale up of manufacturing. The U.S. DOD contracted Pfizer in May of 2020 for production of at least 100 million doses by October 31, 2020, and up to 500 million doses later. Pfizer’s initial contract award was for $10 billion, with many additional incentives for delivering more doses faster. Similar contracts were made with numerous other “vaccine” manufacturers, and hundreds of other suppliers, all under the guise of panic buying for covid countermeasures. No real accountability for product quality or consistency or safety was built into those contracts, in fact the manufacturers were explicitly exempt from all possible liability under the PREP Act, which is specified in a separate contract clause. The purchaser is the DOD, the distributor is the DOD (and not the licensed and accountable pharmaceutical distributors), and furthermore, the product is not serialized and hence open to both adulteration and falsification or mislabeling.
To meet the contract obligations, Pfizer’s manufacturing batch size has increased from microgram scale for lab and animal study volumes to commercial batches of ~140 liters at the end of 2020 and ~300 liters by late 2021. In my experience commercializing biotechnologies from academia, failure to scale is one of the leading causes of failures of all new technology ventures. Showering this problem with money rarely accelerates the solution, and very often accelerates the demise of the whole venture. This is common sense. For example, placing an order today for 1,000,000 of a new type of vehicles with Ford Motor Company to be delivered in 6 months will likely fail no matter the dollars spent, since even obtaining the raw materials in time will be problematic. Complex manufacturing requires materials, systems, capacity, experienced staff, established processes, suppliers, and most importantly control systems at the correct scale to be successful and produce high quality consistent product. Now imagine simultaneously asking several direct competitors – Ford, GM and Toyota to produce 1,000,000 new cars each in the next 6 months.
Based on review of available literature on mRNA manufacturing and my discussions with experts who have made mRNA in the lab, it is not clear that mRNA can be manufactured at the scale that is estimated for these injections from known shipment numbers and disclosed manufacturing documentation: 200-300 liters of drug product per average batch, 700+ batches a year in the US alone. This is particularly unlikely if strict cGMP rules are applied to the manufacturing requirements, and we know that cGMP is not followed for production of these injections. Recently FDA found Catalent non-cGMP compliant. Catalent handles large volumes of fill-finish for Moderna, therefore batches processed through Catalent are non-cGMP compliant.
The generation of mRNA by in-vitro transcription (IVT) at large scale and under current good manufacturing practice conditions is challenging. For example, the specialized components of the in-vitro transcription IVT reaction must be acquired from certified suppliers that guarantee that all the material is animal component-free and GMP-grade. Furthermore, the availability of large amounts of these materials is limited and purchasing costs are high. This is true, for example, in the case of the enzymes used for translation and capping. Even the glass vials themselves were reported as a shortage. Additionally, the low yields and batch failure are a known problem. Conceptual process flow of making mRNA drug substance contains several steps:
The process is composed of a 2-step enzymatic reaction in continuous form, followed by enzyme recycling using tangential flow filtration strategies and two multimodal chromatography steps, one in bind-elute mode for the intermediate purification, and a second in flowthrough mode for polishing. Formulation is achieved using a third tangential flow filtration module. This means the mRNA needs to be made by chemical reaction, and then purified, and then capped and purified again. There are many variations of this process, and no standards exist. At the “formulation” step (last box in the picture), there are further multiple steps to create lipid nanoparticles, and get the mRNA encapsulated. Further, there are fill and finish steps that likewise are not problem free and decrease the yield. Finally, transportation and manual dose preparation add an extra variability layer.
Here is a simple heuristic to understand any manufacturing process flow and not get confused by the jargon: each arrow in the flowchart points to places where errors accumulate Each output-input point in a complex manufacturing flow is where the errors can be checked for and rectified or, if unsolved, will amplify and destroy the product quality and consistency. This is especially dangerous at the extreme speed and scale.
In science papers mRNA manufacturing is described with problem-free cartoons, it all works beautifully regardless of whether it is microgram or kilogram output, and not a single paper on this topic dwells much on low yields or process failures. This is because the academia never has to confront reality. However, the pesky reality of manufacturing mRNA (or anything else) at large scale is highly error prone. Each step has a yield of anywhere between 50% and 80%, and sometimes the whole batch fails, and that is especially true at the large scale of production. mRNA reaction fidelity is less than 100%, the caps and tails fall off, mRNA breaks into fragments, lipid nanoparticles do not form perfectly and PEGylation can be inhomogeneous leading to their breakage and subsequent escape and breakage of mRNA. Large mRNA breaks into smaller fragments, and these remain in the substance. At large scale of reaction, the enzymatic process for making mRNA was reported seizing at 37.5 liters of mRNA substance (before encapsulation into LNP and making drug product) according to the European Medicines Agency (EMA) documents. It is not clear how this was resolved and transitioned to 100’s of liters scale in a matter of few months, and for all suppliers. mRNA fragments were deemed process related impurities by the EMA who raised a significant concern, but they were dismissed by the FDA as a “theoretical problem” – as leaked emails from EMA have shown. mRNA “fragments” may or may not code for proteins, however micro-RNAs (miRNA) can interfere with endogenous cellular processes to detrimental health effects which is described in many scientific papers and even in a textbook on biological weapons published by the NIH in 2018. Chapter 6 of the book describes gene therapy as a class of biological weapons. Coincidentally, the DOD-pharma contracts for covid-19 shots also explicitly state that the product is being developed for both civilian and military applications.
Returning to mRNA manufacturing, multiplying even an optimistic 80% yield by, for example, 7 process steps results in 20% final yield, and if the in-process failures are larger, final yield is single digit percentage or a failure has occurred. Each step generates large amounts of impurities, which are never fully removed as aggressive purification will break the fragile product. Furthermore, the mRNA substance is never equally distributed in the batch volume as thorough mixing of the product is not possible due to its fragility, and lipids tend to float to the top of the vat as well as stick and congregate together. Dangerous possibly cytotoxic aggregates of broken LNPs and mRNA (mRNA adducts) can result and were reported by Moderna a full year after large scale deployment of their product. As a result, the larger the volume of the batch, the more inhomogeneity at the vial level. These conditions can create over-concentrated, toxic vials and the ones that could be “blanks”, or anything in between. The larger the batch volume the more duds it will produce, which in case of this product is largely good news for the injectees. Avoidance of specifying any product conformity tests at the vial level by the manufacturers seems to be intentional in this context.
Data from Pfizer’s own CMC documentation submitted to EMA at the end of November 2020 shows “failure to scale” beginning at approximately 25% of the current commercial scale of the batch (current scale = 600,000 vials = 3-4 million doses per batch). The graphs below were generated using exact sizes in vials and doses for each Pfizer batch manufactured between August and November 2020 (Figure 1) and all Pfizer shipped doses in the US up to end of April 2022 (Figure 2). I used reported deaths and adverse events in VAERS database associated with those batches as a measure of batch variability. This does not address vial variability but provides directional information especially for the scale of manufacturing. The batches in Figure 1 were the first ones to ship commercially and were likely all used close to 100% since at that time the demand for these injections was insatiable. As the “scale-up” of manufacturing proceeded in 2020, the batches were manufactured in a variety of sizes from 50,000 and up to 300,000 vials (~140 liters of drug product). During this time, several major changes were made to the manufacturing, for example, transition from the pilot facility at Polymun Scientific to Pfizer’s own plants and changing major manufacturing steps to new processes.
Figure 1.
First, the overall data indicate a statistical trend toward increased number of reported deaths with the increase in the batch size – the more this product is used, the more deaths are reported. This is not news for anyone who has been paying attention to the injection related adverse events and deaths. However, the variability batch-to-batch demonstrated by the vertical dispersion of the death reports associated with batches of the same size is already apparent at approximately 150,000 vial batch size (25% of the full commercial scale). Batches of the same size are 4-5 times different from each other in the number of reported deaths.
The “failure to scale” story gets larger at scale, no pun. Recently, the exact sizes of Pfizer lots shipped in the United States became known via a FOIA data release, including all doses with associated lot numbers shipped as of end of April 2022 to various vaccination centers. Figure 2 is the plot of all batches from Pfizer, by their reported size in doses on the x-axis and serious adverse events including deaths reported for those lot numbers on the y-axis. Data from VAERS was downloaded on September 24, 2022.
Figure 2.
This graph includes the “early” scale up batches from Figure 1, as well as what appears smaller shipments possibly for batches that were largely distributed overseas. What is immediately apparent from the data – the staggering inconsistency of the product batch-to-batch and the rapid decline of apparent toxicity measured by the adverse events with increase in batch size. The latter trend is the opposite of what was observed with the early batches. The product is causing fewer adverse events per dose when there are more doses available. This does not make sense, except if these doses are simply sitting on the shelves. Of note is batch FM0173 (only 26,700 doses shipped in the US) that generated the highest rate of serious adverse events (3.3/1000 doses), upper left dot.
The scale of manufacturing strains the credulity. A batch of 12 million doses translates to approximately 900+ liters of mRNA! Given the manufacturing steps involved, impurities generates and the amount of raw materials, and the scale of manufacturing equipment and disposables needed, it should be questioned whether this truly was a single production run.
Figure 3 is the same data as in Figure 2, with outlier batches removed for clarity (includes batch sizes from 100K to 4M doses):
Figure 3:
It is evident that the variability batch-to-batch is highly significant and remains unexplained. It is also strangely declining as the size of the batch is becoming larger. The only reasonable explanation to this is that the usage of this product per batch has plummeted. Most of what is produced later in the time period is sitting on the shelves. At the end of the time period in this graph (end of April 2022), an estimated 100M doses were manufactured but not administered in the United States. At the beginning of this graph, nearly all manufactured doses were administered. That is the only reasonable explanation – and it proves that these injections cause the injuries and deaths reported to VAERS!
Table below lists all batches >4 million doses, including their date of manufacture and the number of serious adverse events and deaths reported for them in VAERS:
Table 1:
The “mega” batches are not entirely benign. They are simply a larger lottery pool. The single death reported for batch FL0007 is for an 8-year-old girl who died in Texas from a multi-system organ failure (VAERS ID 2327226-1) – see Figure 4. While the first batch listed in her report RL0007 appears to be a typo (RL series do not exist for Pfizer), it is evident that she received both doses from the same FL0007 batch and passed away 3 months later.
Figure 4:
Here is my educated guess on what is going on with the batch variability: Pfizer’s (and other manufacturers’) contracts were for delivery of DOSES. Millions of them and fast. Contract scope is simply a “demonstration of large-scale manufacturing” and billion-dollar bonuses attached for shipping millions of doses by certain dates. No accountability, no checks, no liability, just ship the doses on time! The batches of 5 million+ doses should be questioned in this context. These appear largely benign from the adverse event perspective but, since the demand for these shots has plummeted coinciding with production of mega-batches, it is hard to say what the real driver of “safety” is – over-dilution of the product or refusal of the customers to be injected. I hope it is the latter.
Here is as close as I can get to answering the question “why aren’t MORE people dying?”: Too many people have died and have been injured by these injections, and plenty more will ultimately have their lives cut short. The manufacturers are making both – lethal shots and highly diluted “blanks” in a sloppy, uncontrolled, unaccountable, and ultimately fraudulent manner.
To know the truth, these products must be tested at the vial and dose levels, in a random sampling by independent 3rd party laboratories. In the meantime, the products must be recalled, and a proper investigation initiated.
December 25, 2022
Posted by aletho |
Corruption, Deception | CDC, COVID-19 Vaccine, DoD, Pfizer, PREP Act |
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