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Pfizer Classified Almost All Severe Adverse Events During COVID Vaccine Trials ‘Not Related to Shots’

By Michael Nevradakis, Ph.D. | The Defender | June 22, 2022

The latest release by the U.S. Food and Drug Administration (FDA) of Pfizer-BioNTech COVID-19 vaccine documents reveals numerous instances of participants who sustained severe adverse events during Phase 3 trials. Some of these participants withdrew from the trials, some were dropped and some died.

The 80,000-page document cache includes an extensive set of Case Report Forms (CRFs) from Pfizer Phase 3 trials conducted at various locations in the U.S., in addition to other documentation pertaining to participants in Pfizer-BioNTech vaccine trials in the U.S. and worldwide.

The FDA on June 1 released the documents, which pertain to the Emergency Use Authorization (EUA) of the vaccine, as part of a court-ordered disclosure schedule stemming from an expedited Freedom of Information Act (FOIA) request filed in August 2021.

Public Health and Medical Professionals for Transparency (PHMPT), a group of doctors and public health professionals, submitted the FOIA request.

CRFs show deaths, severe reactions to the vaccines during Phase 3 trials

The CRFs included in this month’s documents contain often vague explanations of the specific symptoms experienced by the trial participants.

They also reveal a trend of classifying almost all adverse events — and in particular severe adverse events (SAEs) — as being “not related” to the vaccine.

For example:

  • A female in her early 50s (randomization number 86545) who participated in the trial at the Sterling Research Group in Cincinnati, Ohio, died of an apparent myocardial infarction on Nov. 4, 2020. She had received two doses of the vaccine, on Sept. 10 and Sept. 29, 2020.

The patient had a medical history of chronic obstructive pulmonary disease, hypertension, hypothyroidism, osteoarthritis of the knees and attention deficit disorder. Her death was listed as “not related” to the vaccine, and was instead attributed to “hypertensive cardiovascular disease.”

  • A female in her late 50s (randomization number 220496), who participated in the trial at Cincinnati Children’s Hospital Medical Center, died of cardiac arrest on Oct. 21, 2020. Her death, however, was indicated as “not related” to her vaccinations (which occurred on July 30, 2020, and Aug. 20, 2020) as it “occurred 2 months after last receipt of study agent,” according to her CRF.

The participant’s medical history included obesity, placement of a gastric sleeve, gastroesophageal reflux, sleep apnea, supraventricular tachycardia, hypothyroidism, depression and asthma.

  • A male in his mid-60s (randomization number 221076) who participated in the trial operated by the Texas-based Ventavia Research Group died of an apparent myocardial infarction on Nov. 28, 2020. He had received the two doses of the vaccine on July 31, 2020, and Aug. 19, 2020.

The participant had a medical history that included a previous myocardial infarction, high blood pressure, high cholesterol, anxiety, bilateral hip pain, type 2 diabetes, fluid retention, angina (intermittent), restless leg syndrome, Vitamin D deficiency, tobacco dependency and the placement of a coronary arterial stent in 2017.

According to the CRF, he sustained the myocardial infarction on Oct. 27, 2020, and was diagnosed with pneumonia the following day. While both diagnoses were classified as “serious” in his CRF, they were both listed as “not related” to the vaccination, with his myocardial infection attributed to a “failed cardiac stent” and the pneumonia simply attributed to “infection.”

  • A female in her teens (randomization number 104650) was diagnosed with right lower extremity deep vein thrombosis on Nov. 15, 2020, which was still ongoing as of Mar. 29, 2021, the date of the CRF. She was hospitalized and her condition was classified as “serious,” but it was indicated as “not related” to the vaccine, instead attributed to a “fracture” occurring prior to her vaccination on Sept. 11, 2020.

The patient had a medical history including asthma, attention deficit hyperactivity disorder, Charcot-Marie-Tooth disease and obesity.

  • A male in his mid-70s (randomization number 227629) participating in the trial at Clinical Neuroscience Solutions Inc. (operating in Florida and Tennessee) sustained a series of adverse events following his vaccinations on Aug. 13 and Oct. 7, 2020.

He was diagnosed with COVID-19 on Aug. 30, 2020, which coincided with several other diagnoses classified as “serious,” including abdominal adhesions (Aug. 29, 2020), altered mental status (Aug. 29, 2020, lasting through Sept. 16, 2020), and acute hypoxic respiratory failure (Aug. 30, 2020). These diagnoses required his hospitalization.

He was also listed as having suffered from congestive heart failure on Aug. 30, 2020, but this diagnosis was listed as “not serious” and as “not related” to the vaccine, but to “prior surgery,” with no further details given. Similarly, his other serious adverse events were listed as being related to “prior” or “previous” surgery, or to “concomitant non-drug treatment.”

Other “non-serious” adverse events listed in this patient’s CRF include hypokalemia, anemia, acute renal failure, sepsis, hyponatremia, leukopenia, small bowel obstruction, aspiration pneumonia, mild concentric left ventricular hypertrophy (symptoms of which were still ongoing as of the CRF date of Mar. 29, 2021) and urinary tract infection.

The patient had a medical history encompassing ongoing hypertension, hypercholesterolemia, gastroesophageal reflux disease, constipation, hiatal hernia and previous diagnoses of small bowel resection, small bowel perforation, inguinal hernia, osteoarthritis in both knees and knee replacement (both knees).

  • A male in his mid-70s (randomization number 266982) participating in the trial at Boston Medical Center suffered a series of adverse events following vaccination, including pneumonia and peripheral edema. He had received two doses of the vaccine, on Oct. 2, 2020, and Oct. 27, 2020.

The patient was hospitalized for pneumonia on Jan. 20, 2021, in an event classified as “serious” but also as “not related” to the vaccine. However, the cause of his pneumonia was listed in the CRF simply as “un-related to vaccine,” while his peripheral edema diagnosis was attributed to “existing neuropathy.”

During his hospitalization with pneumonia, his blood pressure was measured as high as 179/72, with a heart rate reaching 105 beats per minute and an oxygen saturation level that fell to 92.0. In total, he had three emergency room visits during the observation period.

The patient had a medical history that included type 2 diabetes, alcoholic cirrhosis, hypothyroidism, asthma, sleep apnea, hypertension, diabetic neuropathy, congestive heart failure, generalized anxiety disorder, depression, insomnia, excessive urination, chronic obstructive pulmonary disease and HIV-positive status.

A protocol deviation also occurred involving this patient, as his diary was not activated following administration of the first dose of the vaccine.

  • A male in his early 40s (randomization number 68489) who participated in the trial at Cincinnati Children’s Hospital Medical Center sustained chronic myelogenous leukemia on Sept. 24, 2020, with the condition ongoing as of the date of the CRF on Mar. 29, 2021.

This was classified as a “serious” and “life-threatening” adverse event, albeit one that did not require hospitalization, but it was listed as “not related” to the vaccination but instead to a “genetic change in stem cells.”

The patient had been vaccinated on Aug. 26, 2020, and Sept. 17, 2020, and had a medical history of asthma and seasonal allergies. Other “non-serious” adverse events he sustained included leukocytosis and thrombocytosis.

  • A female in her mid-40s (randomization number 49018) who participated in the trial at Clinical Neuroscience Solutions Inc. was diagnosed with kidney stones on Jan. 4, 2021.

This was classified as a “serious” adverse event that required hospitalization, but was listed as “not related” to the vaccine, instead being related, again, to “kidney stone” (sic). She had received the two doses of the vaccine on Aug. 17, 2020, and Sept. 8, 2020.

The patient was diagnosed with COVID-19 on Jan. 27, 2021. Her prior medical history included migraine headaches, hypercholesterolemia and a Tarlov cyst.

  • A female approximately 30 years old (randomization number 53307) participating in the trial at Boston Medical Center, with nothing to report in her medical history, sustained a shoulder injury related to vaccine administration (SIRVA) on Sept. 9, 2020, with symptoms continuing until Feb. 8, 2021.

This injury was listed as being related to the second dose of the vaccine, which she received on Sept. 9, 2020 (she had previously received her first dose on Aug. 17, 2020).

  • A female in her late 50s (randomization number 260125) participating in the trial at Clinical Neuroscience Solutions Inc., suffered from acute exacerbation of asthma. The symptoms appeared in mid-December 2020, following her vaccination on Sept. 16, 2020, and Oct. 5, 2020.

Her symptoms were classified as serious but not life-threatening, and she was hospitalized. However, her asthma symptoms were listed as “not related” to the vaccine, instead being related to “asthma” with no further explanation provided. On Jan. 12, 2021, her blood pressure was recorded as 183/130, with a heart rate of 98 beats per minute.

Other less serious adverse events sustained by the patient included injection site pain, body pain, chills and a low-grade fever.

Her medical history included cholecystitis (and a cholecystectomy), herniated disc, total abdominal hysterectomy, bilateral oophorectomy, bilateral salpingectomy, endometriosis, hypertension, hypercholesterolemia, rheumatoid arthritis in remission, asthma, seasonal allergies, irritable bowel syndrome and obesity.

  • A male in his late 20s (randomization number 48413) who participated in the trial at Clinical Neuroscience Solutions Inc., sustained a bilateral pulmonary embolism on Dec. 14, 2020, with symptoms still ongoing as of the CRF date of Mar. 29, 2021.

This was listed as a “serious” adverse event that required hospitalization, but was attributed to the patient’s habit of vaping and his “sedentary lifestyle.” He had received the two doses of the vaccine on Aug. 13, 2020, and Sept. 2, 2020.

Other post-vaccination symptoms listed for the patient included fever, fatigue, headache, chills, vomiting, diarrhea, new/worsened muscle pain, new/worsened joint pain and swelling.

The patient had a medical history that included elevated triglycerides, genital herpes and seasonal allergies, in addition to a vaping habit.

The many serious adverse events – and several deaths – recorded during the Phase 3 trials are also apparent in a separate, massive document, exceeding 2,500 pages, cataloging such adverse events.

This document lists a wide range of adverse events suffered by trial participants classified as toxicity level 4 — the highest and most serious such level.

However, not one of the level 4 (most severe) adverse events listed in this particular document is classified as being related to the vaccination.

Level 4 adverse events listed in the document include but are not limited to the following, many of which occurred in multiple patients:

  • Acute cholecystitis
  • Acute respiratory failure
  • Adrenal carcinoma
  • Anaphylactic shock
  • Aortic valve incompetence
  • Appendicitis
  • Arrhythmia, supraventricular
  • Arteriosclerosis
  • Brain abscess
  • Cardiac arrest
  • Chronic myeloid leukemia
  • Complicated appendicitis/acute appendicitis with necrosis
  • Congenital heart disease/heart anomaly
  • Coronary artery occlusion
  • COVID-19 illness
  • Deep vein thrombosis
  • Diverticulitis
  • Hemiplegic migraine
  • Hemorrhagic stroke
  • Interstitial lung disease
  • Myocardial infarction
  • Orthostatic hypotension/possible postural hypotension
  • Osteoarthritis
  • Pericolic abscess
  • Peritoneal abscess
  • Renal colic
  • Ruptured diverticulum
  • Small bowel obstruction/small intestinal obstruction
  • Spontaneous coronary artery dissection
  • Subarachnoid hemorrhage
  • Suicidal ideation (and suicidal ideation with attempt)
  • Syncope
  • Type 2 diabetes
  • Worsening of abdominal pain
  • An “unevaluable event/“unknown of unknown origin”

Similarly, only a small number of toxicity level 3 adverse events were indicated as having been “related” to vaccination. Such adverse events included but are not limited to the following, some of which occurred in multiple trial participants:

  • Arthralgia
  • Blood glucose increase/glucose spike
  • Deafness/hearing loss
  • Dyspepsia
  • Hypotension
  • Lymph node pain
  • Lymphadenopathy/lymph node swelling
  • Musculoskeletal chest pain (non-cardiac)
  • Neutropenia
  • Pain in fingers/bilateral hands
  • Pruritus
  • Pyrexia/febrile syndrome
  • Severe headache
  • Shoulder injury related to vaccine administration
  • Sleep disorder/sleep disturbance
  • Tachycardia
  • Urticaria
  • Ventricular arrhythmia
  • Vertigo

Page 2,525 of the document in question also lists six trial participant deaths, with causes of death including arteriosclerosis, cardiac arrest, hemorrhagic stroke and myocardial infarction.

The small number of adverse events listed as being connected to the vaccine follows a trend noted in the previous tranche of Pfizer-BioNTech documents, released in May.

An additional document released in this month’s tranche catalogs patients who discontinued their participation in the Phase 3 trial, or whose participation was discontinued by physicians or other medical professionals.

While many patients were discontinued because they could not be located, because of a physician’s orders, because they moved to another region or for other personal reasons, numerous patients ended their participation due to adverse events, including but not limited to the following symptoms:

  • Acute myocardial infarction
  • Amnesia
  • Anorexia
  • Atrial fibrillation
  • Cerebral infarction
  • Congestive cardiac failure
  • Coronary artery disease
  • Deafness (unilateral)
  • Depression
  • Diabetic foot
  • Diverticular perforation
  • Exposure during pregnancy
  • Eye pain
  • Gait instability
  • Gastric adenocarcinoma
  • Gastrointestinal hemorrhage
  • Hypertension
  • Irregular heart rate
  • Loss of taste and smell
  • Myalgia
  • Paraparesis
  • Parkinsonism
  • Presyncope
  • Pulmonary embolism
  • Pyrexia
  • Swelling face
  • Tachycardia
  • Transient ischaemic attack
  • Urticaria
  • Vaccine allergy
  • Vertigo

In other instances, subjects withdrew because of fears connected to safety concerns related to the vaccine, or discomfort in receiving the second dose.

Clinical review document glosses over adverse events during trials

Also included in June’s FDA document dump was a 334-page “clinical review” document, which appears to have been approved by the FDA on Apr. 30, 2021, and which presents “pivotal data” from Phase 1/2/3 Study C4591001, conducted in the U.S., along with “supporting” Phase 1/2 data from Study BNT162-01, performed in Germany.

This document refers to both Pfizer-BioNTech vaccine, which received an EUA from the FDA, and the Pfizer Comirnaty vaccine, which received full FDA approval but is reportedly almost impossible to find at vaccination locations in the U.S.

As previously reported by The Defender, a federal judge found the Pfizer-BioNTech and Pfizer Comirnaty vaccines are legally distinct.

The clinical review document states:

“BNT162b2 has received temporary authorizations for emergency supply in 28 countries and conditional marketing authorizations in 39 countries globally.

“The name of the product supplied under emergency/temporary use authorization for all applicable regions is Pfizer-BioNTech COVID-19 Vaccine.

“The name of the product supplied under conditional marketing authorization for all applicable regions is COMIRNATY [COVID-19 mRNA Vaccine (nucleoside modified)].”

The document states that trial participants were administered one of two candidate vaccines, labeled BNT162b1 and BNT162b2 (the latter of which ultimately received an EUA from the FDA), or a placebo. A variety of dosage levels were also tested, ranging from 10 μg to 100 μg for BNT162b1, and 10 μg to 30 μg for BNT162b2.

In Phase 1 of Study BNT162-01, the clinical review reports that “40% to 45% of participants who received BNT162b1 and BNT162b2 across age groups and across dose levels reported one or more AEs [adverse events] from Dose 1 through 28 days (i.e., 1 month) after Dose 2.”

In what will turn out to be a general pattern throughout the clinical review, we are told that “most AEs were considered by the investigator as not related to study intervention and mild to moderate in severity, and all AEs were reported as resolved.”

Some specific adverse events highlighted in this part of the clinical review include:

“Among BNT162b1 recipients, 1 younger participant in the 10 μg group discontinued the study due to a moderate AE of malaise (considered as not related to study intervention) after Dose 1 and 1 younger participant in the 60 μg group discontinued due to a dose-limiting toxicity of pyrexia after Dose 1.

“One older participant in the 20 μg group had an SAE of severe syncope (considered as not related to study intervention) after Dose 1 and study treatment was withdrawn.

“Among BNT162b2 recipients, 1 younger participant in the 10 μg group discontinued the study due to a moderate AE of nasopharyngitis (considered as not related to study intervention) after Dose 1.

“One older participant in the 20 μg group had an SAE of ankle fracture (considered as not related to study intervention) after receiving both doses, was listed as recovering, and remains in follow-up.”

The clinical review also states “no deaths occurred in the Phase 1 part of Study BNT162-01.”

The review adds that “from Dose 1 of BNT162b2 30 μg to the unblinding date, 6 (50.0%) participants in the younger age group and 3 (25.0%) participants in the older age group reported at least 1 AE.”

Specifically, in this portion of the study, “two (16.7%) participants in the BNT162b2 30 μg younger age group and 1 (8.3%) participant in the BNT162b2 30 μg older age group reported at least 1 severe AE,” and “in the BNT162b2 30 μg younger age group, 3 (25.0%) participants reported at least 1 related AE and 1 (8.3%) participant reported 1 severe SAE.”

These specific adverse events, according to the review, were reported in “the system organ class (SOC) of nervous system disorders (3 [25.0%] participants in the younger age group and 1 [8.3%] participant in the older age group), followed by musculoskeletal and connective tissue disorders (1 [8.3%] participant in each age group). All AEs by preferred term (PT) were reported by no more than 1 participant.”

The review adds, “from Dose 1 to the unblinding date, 1 participant in the BNT162b2 30 μg younger age group reported a severe SAE (neuritis) that was assessed by the investigator as not related to study intervention,” and “there were no Phase 1 participants randomized to BNT162b2 30 μg or corresponding placebo who died through the data cutoff date of 13 March 2021.”

Review of results from Study C4591001

While “incidences in the BNT162b2 and placebo were similar within the age groups for younger (9.1% vs 11.1%) and older (4.3% vs 8.9%) participants, among those who received BNT162b2 instead of the placebo, “two severe events of myalgia and gastric adenocarcinoma (which was also an SAE) were reported for 2 participants in the … younger age group, both assessed by the investigator as not related to study intervention.”

It is further mentioned that “the only discontinuation due to an AE during this time was the participant in the BNT162b2 younger age group who reported an SAE of gastric adenocarcinoma (discontinued from the study on Day 23 after Dose 1 of BNT162b2).”

Ultimately, from dose 1 to 1 month after dose 2 for participants during the blinded safety follow-up of study C4591001, “the numbers of overall participants who reported at least 1 AE and at least 1 related AE were higher in the BNT162b2 group (30.2% and 23.9%, respectively) as compared with the placebo group (13.9% and 6.0%, respectively).”

Specifically, “severe AEs were reported by 1.2% and 0.7% in in the BNT162b2 and placebo groups respectively, and life-threatening AEs were similar (0.1% in both groups),” and “SAEs and “AEs leading to withdrawal were reported by ≤0.6% and ≤0.2%, respectively, in both groups,” while “discontinuations due to related AEs were reported in 13 participants in the BNT162b2 group and 11 participants in the placebo group (0.1% in both groups).”

Overall, as reported for this part of the study, “in the younger age group, the number of participants who reported at least 1 AE from Dose 1 to 1 month after Dose 2 was 4233 (32.6%) and 1871 (14.4%) in the BNT162b2 and placebo groups, respectively. In the older age group, the number of participants who reported at least 1 AE from Dose 1 to 1 month after Dose 2 was 2384 (26.7%) and 1177 (13.2%) in the BNT162b2 and placebo groups, respectively.”

The review specifies that “the most frequently reported AEs in the BNT162b2 group … were injection site pain (2915 [13.3%]), pyrexia (1517 [6.9%]), fatigue (1463 [6.7%]), chills (1365 [6.2%]), headache (1339 [6.1%]), and myalgia (1239 [5.7%]),” however, some more serious adverse events that were reported during this stage of the trial included facial paralysis, cardiac disorders, hepatic cirrhosis, cholecystitis/cholecystitis acute, biliary colic, bile duct stone, biliary dyskinesia, lymphadenopathy, appendicitis, optic neuritis and hypersensitivity/anaphylaxis.

Overall, according to the review, “from Dose 1 to 1 month after Dose 2, severe AEs reported during the blinded follow-up period were low in frequency, reported in 1.2% of BNT162b2 recipients and 0.7% of placebo recipients.”

During the “open-label follow-up period,” referring to the period when the initial trial has been completed but participants are invited to continue taking the study drug for an additional period, the review states “three participants originally randomized to BNT162b2 died during open-label follow-up.”

While one of these deaths was reportedly due to a road accident, the other two were attributed to lung metastases and myocardial infarction. However, none of these deaths “were assessed by the investigator as related to study intervention.”

Furthermore, according to the report, during this period “there were 12,006 participants who had at least 6 months of follow-up. Among these, 3,454 participants (28.8%) reported at least 1 AE and 2245 participants (18.7%) reported at least 1 related AE. Severe AEs and SAEs were reported by 2.1% and 1.6%, respectively.”

The review provides data for participants from dose 3 (first dose of BNT162b2) to the data cutoff date. The severe adverse event incidence rate (IR) was 6.0 per 100 PY (patient-years), with specific conditions reported including pulmonary embolisms, thrombosis, urticaria, a cerebrovascular accident and COVID-19 pneumonia.

Here, the review adds that the IR for original placebo participants who had at least 1 life-threatening AE from Dose 3 to the data cutoff date was 0.5 per 100 PY. Only one such life-threatening event, an instance of anaphylactoid reaction, was considered to be related to the vaccination. Other life-threatening, serious adverse events included cardio-respiratory arrest, gastrointestinal necrosis, deep vein thrombosis and pulmonary embolism.

The report also notes, “There were 15 deaths in the BNT162b2 group and 14 deaths in the placebo group from Dose 1 to the unblinding date during the blinded placebo-controlled follow-up period.”

However, the report does not appear to go into detail about the causes of death for either group, other than to state, “None of these deaths were assessed by the investigator as related to study intervention.”

In the “Blinded Follow-Up Period from Dose 1 Through 1 Month After Dose 2,” in the BNT162b2 group, “SAE [serious adverse events] was similar in the BNT162b2 group (0.6%) and in the placebo group (0.5%),” with three SAEs in the non-placebo group deemed to be related to the vaccine. These included ventricular arrhythmia, lymphadenopathy and SIRVA.

During the “open-label follow-up period” for “original BNT162b2 participants,” the report states “one younger participant with no past medical history had a life-threatening SAE of myocardial infarction 71 days after Dose 2 that was assessed by the investigator as related to study intervention.”

However, despite its life-threatening nature, this condition “lasted 1 day and resolved the same day.”

Overall, “from Dose 1 to 6 months after Dose 2, during the blinded and open-label follow-up periods, 190 (1.6%) participants in the BNT162b2 group reported at least 1 SAE,” and “the number of participants who reported at least 1 SAE was 73 (1.1%) and 117 (2.2%) in the younger and older age groups, respectively.”

These SAEs were categorized as neoplasms, infections and infestations, gastrointestinal disorders, hepatobiliary disorders, respiratory/thoracic/mediastinal disorders and injury/poisoning/procedural complications.

An original placebo participant who received BNT162b2 for Dose 3 experienced a severe adverse event that “was assessed by the investigator as related to study intervention; specifically, “an anaphylactoid reaction 2 days post Dose 3” leading to the participant’s withdrawal from the study, despite a reported resolution.

A separate subsection in the report specifically addressed cases of Bell’s palsy and facial paralysis among trial participants. Specifically, “during the blinded placebo-controlled follow-up period, 6 participants developed one-sided facial paralysis (Bell’s palsy): 4 were randomized to BNT162b2 (all male) and 2 were randomized to placebo (1 male; 1 female),” according to the review.

Regarding the four vaccinated trial participants, their ages ranged from 40 to 70, with symptoms appearing three to 48 days after their last dose. Their symptoms were recorded as “mild to moderate in severity,” with duration ranging “from 3 to 68 days,” and with two of these cases “considered by the investigator to be related to study intervention.”

Moreover, “during the open-label follow-up period, 3 participants who received BNT162b2 as Dose 3 or Dose 4 (after originally being randomized to placebo) experienced facial paralysis,” according to the review. These patients were all female, with an age range between 19 and 34. Events were recorded as beginning two to eight days after administration of the third dose, and “were mild to severe.” One case had a duration of 12 days, while the other two cases were ongoing as of the cutoff date of the trial.

Notably, according to the review, “all these events of facial paralysis were considered by the investigator as related to study intervention.”

The review adds, “during the open-label follow-up period for participants originally randomized to BNT162b2, a male participant 51 years of age developed Bell’s Palsy 154 days after receiving Dose 2.” No indication is given as to whether this was deemed to be related to the vaccination or not.

From dose 1 to the unblinding date, heart-related adverse events included “6 acute myocardial infarctions, 4 myocardial infarctions group, and 1 acute coronary syndrome” in the BNT162b2 group.

According to the review, “most of these events had onset distant (ie, >30 days following) to receipt of vaccine or placebo. None of these events were assessed by the investigator as related to study intervention.”

Moreover, “there was 1 participant in the older BNT162b2 age group with pericarditis. The event had an onset of 28 days after Dose 2, was ongoing at the data cutoff date, and was assessed by the investigator as not related to the study intervention.”

Additionally, “there were 8 cases of pulmonary embolism in the BNT162b2 group,” in addition to four hemorrhagic strokes and “2 ischemic strokes, 4 cerebral vascular accidents, 2 transient ischemic attacks” in this group, plus “1 case of thrombocytopenia and 1 case of platelet count decreased.”

Furthermore, “there were 9 thrombotic events in the BNT162b2 group,” including seven instances of deep vein thrombosis, one case of coagulopathy and one case of ophthalmic vein thrombosis.

Regarding autoimmune issues in the BNT162b2 group, the review states “there were 10 autoimmune disease cases identified,” with one case each of “autoimmune thyroiditis, ulcerative colitis, Crohn’s disease, reactive arthritis, fibromyalgia, systemic lupus erythematosus, alopecia areata, psoriasis,” and two cases of psoriatic arthropathy.

Pregnancies were largely glossed over in the review, which states:

“At the time of the data cutoff date (13 March 2021), a total of 50 participants who had received BNT162b2 had reported pregnancies, including 42 participants originally randomized to the BNT162b2 group and 8 participants originally randomized to the placebo group who then received BNT162b2.”

“In total, 12 participants (n=6 each in the randomized BNT162b2 and placebo groups) withdrew from the blinded placebo-controlled vaccination period of the study due to pregnancy, and 4 participants originally randomized to placebo who then received BNT162b2 withdrew from the open-label vaccination period due to pregnancy.

“These participants continue to be followed for pregnancy outcomes. No births have been reported from individuals who have become pregnant in Study C4591001 as of the time of this submission.

“All pregnancies have a risk of birth defect, loss, or other adverse outcomes. Available data on BNT162b2 administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.”

Pfizer concludes vaccines are ‘safe and well-tolerated’

Overall, despite the incidence of severe adverse events — some of which were admitted to be related to the vaccine — and deaths, as well as an admitted lack of data regarding outcomes for pregnant women who participated in the trial, the “safety conclusions” of the review indicate the following:

“Based on Phase 1 data from the FIH Study BNT162-01, BNT162b1 and BNT162b2 were safe and well-tolerated in healthy adults 18 to 55 years of age, with no unanticipated safety findings … and the AE profile and clinical laboratory results did not suggest any safety concerns.

“Based on Phase 1 data from Study C4591001 and Study BNT162-01, BNT162b1 and BNT162b2 were safe and well-tolerated in younger healthy adults 18 to 85 years of age, with no unanticipated safety findings … and the AE profile did not suggest any safety concerns, including up to approximately 6 months after Dose 2 for BNT162b2 30 μg groups.

“Based on Phase 2/3 data from approximately 44,000 participants ≥16 years of age with up to at least 6 months of follow-up after Dose 2 in Study C4591001, BNT162b2 at 30 μg was safe and well-tolerated across age groups … and the AE profile did not suggest any serious safety concerns. The incidence of SAEs and deaths were low in the context of the number of participants enrolled and comparable in BNT162b2 and placebo. The incidence of discontinuations due to AEs was also generally low and similar between BNT162b2 and placebo groups.

“Cumulative safety follow-up to at least 6 months after Dose 2 for approximately 12,000 Phase 2/3 participants originally randomized to BNT162b2, comprising the combined blinded and open-label periods, showed no new safety signals or suggested [any] new safety concerns arising from this period of follow-up.

“Similarly, open-label follow-up of participants originally randomized to placebo from the time of unblinding to receive BNT162b2 until the data cutoff date showed no new safety signals or concerns.

“The AE profile among approximately 44,000 participants ≥16 years of age enrolled to date as of the most recent safety cutoff date (13 March 2021), was mostly reflective of reactogenicity events with low incidences of severe and/or related events. The incidence of SAEs was low and similar in the vaccine and placebo groups. Few participants withdrew from the study due to AEs. Few deaths occurred overall in both the vaccine and placebo groups with no imbalance.

“For participants randomized to placebo and then unblinded to receive BNT162b2 vaccination, open-label data from the time of unblinding to the data cutoff date (13 March 2021) showed no new safety findings or signals.

“Taken together, efficacy and immunogenicity data suggest the BNT162b2 (30 μg) 2-dose regimen induces a strong immune response and provides durable protection from COVID-19 across a spectrum of individuals representative of the population at large for individuals ≥16 years of age: those with or without prior exposure to SARS-CoV-2 and those in higher-risk categories based on age, race, ethnicity, and/or comorbidity.”

As a result, and based on the above data, the review makes a case for the approval of BNT162b2:

“A vaccine program must be implemented expediently and rapidly expanded to have a significant impact on the pandemic course. Licensure of BNT162b2 is likely to enhance vaccine uptake by facilitating supply of vaccine from Pfizer/BioNTech directly to pharmacies and healthcare providers/facilities.

“The greatest impact of BNT162b2 licensure may be direct supply to healthcare providers who serve vulnerable populations such as elderly patients and those who live in rural and underserved communities (i.e., individuals who might be unable to navigate the challenges of securing vaccine access using the systems in place for EUA).

“Expansion of vaccine via licensure would ultimately improve the prospect of achieving population herd immunity to bring the pandemic under control.

“Overall, the potential risks and benefits, as assessed by the safety profile and the efficacy and immunogenicity of BNT162b2 (30 μg), are balanced in favor of the potential benefits to prevent COVID-19 in immunized individuals.

“Likewise, the BNT162b2 30 μg benefit and risk profile support further development in pediatric, maternal, and other at-risk populations.”


Michael Nevradakis, Ph.D., is an independent journalist and researcher based in Athens, Greece.

© 2022 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.

June 23, 2022 Posted by | Deception, Science and Pseudo-Science | , , , | 3 Comments

They Attempt to Justify Approval for Use in Infants and Toddlers

They want the COVID-19 vaccine approval for children so bad, Peter Marks himself and his cronies published the very study he has to use to evaluate for approval.

By James Lyons-Weiler | Popular Rationalism | June 11, 2022

As promised, the FDA has ginned up a report that ostensibly will be used to try to justify “approval” (whatever they mean by that now) of COVID-19 vaccines for infants and toddlers (children < 5 years old). Here’s the report for your reference.

This report comes after a torrent of massive reports from Moderna and Pfizer that claim to review studies of the safety and efficacy of COVID-19 vaccines in children. It is not hard to see what shenanigans the FDA has been up to to try to bolster a vaccine that fewer and fewer adults want. It’s more of the same: exaggerate the apparent risk of the virus and minimizing the perception of risk. In other words, lies.

  1. There is no evidence of clinical urgency. Infants and toddlers (and children in general) do not get COVID-19; they do not (yet) die from COVID-19. All that can change when antibody dependent enhancement kicks in for the vaccinated. FDA’s own reports cites 1,086 deaths “from COVID-19” and 10,700,000 “cases” of COVID-19 in children aged 0-17. There have been 832 days since April 1, 2020 when diagnoses started for COVID-19. For the entire population of children in the US (73,000,000), the risk of COVID-19 infection since the onset of COVID is 10,700,000/73,000,000 = 0.14657. The risk of a child dying if they have a diagnosis is 1,086/10,700,00 or 1086/10700000 = 0.00010149532. The risk of any child dying of COVID-19 over this time period is 1,086/73000000 = 0.00001487671. The per-day risk is on the order of 1.78806611e-8 (0.000000001788). There is no real unmet clinical need and the FDA needs to go back to college to understand how to use RT-PCR correctly. Children do not get COVID-19, and they do not die.
  2. Inconsistent use of the idea “vaccinated”. This has been the pattern from the very first study. FDA, CDC, Moderna, Pfizer, and others pull out whatever definition of “vaccinated” they want. Examples: “Vaccinated” is defined in the original trials as people who received both doses and who did not develop COVID-19 before two weeks passed after the second exposure to the vaccine. In fact, that means that people who developed COVID-19 due to disease enhancement were dropped from the study calculations. First, this is the first time people were dropped from a vaccine trial for getting infected with the pathogen targeted by the vaccine up to 13 or 14 days after being vaccinated. Second, it’s actually five entire weeks – one month and one week – 44 days – after the first exposure. ALL of the vaccine efficacy being cited by FDA is suspect. Moderna’s and Pfizer’s vaccines never achieved >90% true vaccine efficacy; the best estimate is more like 75%.
  3. Inconsistent use of the idea “vaccine efficacy”. Over the time period since the first COVID-19 vaccine trials, various definitions of “vaccine efficacy” have been used. Decreased transmission. Reduction in infection rates. Reduced hospitalization. Presence of neutralizing antibodies. Presence of antibodies. All are used and cited in FDA’s report whenever convenient, all in an ad-hoc manner. It’s more than irritating. It’s moving the goal post and represents reckless (and ineffective) attempts to manipulate public perception. This practice continues in the reports and studies that are cited by FDA. I do not trust the efficacy data FDA cites in their report (why would we given Point 1?).Further evidence of the futility of the evidence used to claim efficacy comes from Moderna’s Sponsor Briefing report to the FDA:“3.3 Regulatory Considerations for Clinical Development of COVID-19 Vaccines in Children

    Effectiveness

    Regulatory precedent with other preventive vaccines provides a basis for inference of vaccine effectiveness in pediatric populations based on immunobridging to a young adult population in which clinical disease endpoint vaccine efficacy has been demonstrated for the same prototype vaccine. The immune marker(s) used for immunobridging do not need to be scientifically established to predict protection but should be clinically relevant to the disease. Based on available data in humans and animal models, FDA considers neutralizing antibody titers (a functional measure of the vaccine immune response against SARS-CoV-2) to be clinically relevant for immunobridging to infer effectiveness of COVID-19 vaccines in pediatric age groups. Because no specific neutralizing antibody titer has been established to predict protection against COVID-19, two immunogenicity endpoints (GMT and SRR) are considered appropriate for comparing the range of neutralizing antibody responses elicited by the vaccine in pediatric versus young adult populations.

    Also embedded in this piece of work is the fact that FDA does not need evidence of long-term immunity; they are settling for something called “immunobridging” – guessing at the efficacy of a vaccine in one clinical population from measurements made from other clinical populaton.

    They also are making people dependent on vaccines… expecting patients to have antibodies from one vaccine to the next. This makes no sense immunologically. We don’t need continuously high antibody levels against any pathogen. We have memory B-cells and T-cells. In accepting this paradigm, FDA is completely off its rocker and will cause immune exhaustion with constant vaccinations every 3-4 months.

  4. Incomplete consideration of the scientific data (Barnstable County, Israel, Ontario). We know that months after vaccination, those who are vaccinated are at higher risk of infection and now of hospitalizations. Data actually show negative vaccine efficacy in children (per Jeremy Hammond). See: “Evidence for Negative COVID-19 Vaccine Effectiveness in Children”. From that article:“vaccine effectiveness (VE) in children becomes(sic) negative within several months since receipt of the second dose.Researchers from the New York State Department of Health published a study on the preprint server medRxiv on February 28 noting that the evidence for vaccine effectiveness in children, particularly those aged five to eleven, was “limited”. So, they aimed to provide data to inform policymaking.“During Omicraon variant predominance,” the authors concluded, “VE against infection declined rapidly” for young children in the state of New York, “with low protection by one month following full-vaccination.”Comparing COVID-19 cases during January between unvaccinated and vaccinated children, they estimated initial vaccine effectiveness for children aged twelve to seventeen to be 76 percent, but this dropped to below 50 percent after just five weeks since receipt of the second dose.Moreover, for young children (aged five to eleven), they observed a drop from 65 percent to just 12 percent after only one month.Thereafter, their estimate indicated significantly negative effectiveness for this age group, as shown in Figure 2 of their paper: by 35 to 41 days, VE reached negative 10 percent, and by 42 to 48 days, it reached negative 41 percent.

    Jeremy goes on to report (correctly) that the authors of the article misinterpreted their own data. History will remember Jeremy as a reporter with great integrity.

  5. Moderna and Pfizer reports fail to study long-term risks. Like I said, more of the same shenanigans. In this report, for example, Moderna offers data on myocarditis only up to Day 28 after the vaccine. Why Day 28? Why not “since the vaccine has been administered” to more accurately reflect the real-world clinical situation? They also state that myocarditis in a large concern in people infected with SARS-CoV-2 – but the comparison is to the uninfected, not the vaccinated, and we know that the spike protein is the cause (syncytia among heart muscles caused by the spike protein). The spike protein, of course, is the basis of their mRNA vaccines.
  6. Incestuous COIs/Unjustified Influence by Regulators. Peter Marks is charged with setting the decisions at FDA whether to consider vaccines for specific populations. Why the hell is he involved in a study conducted to bolster the vaccines he is going to have to decide upon? See “Benefit-risk assessment of COVID-19 vaccine, mRNA (Comirnaty) for age 16–29 years”. That “study” is also guilty of all of the same loose logic as above; it is noteworthy that the study assumes as “worst case scenario” of zero deaths from myocarditis following COVID-19 vaccination (Credit: Toby McDonald, who wrote this to me:“I’m reading the Moderna “Sponsor Briefing Document” and they built their benefit-risk assessment off of Funk et al. (2022). So I looked up Funk and it’s a recent paper by six staffers at the FDA including Peter Marks, Richard Forshee, and Hong Yang (who wrote the dreadful benefit-risk assessment for kids 5 to 11 back in October). Quite literally in their “worst-case scenario” they predict 0 deaths from myocarditis in the vaccine group. It’s a stunning work of fiction.”
  7. I’m on an email thread with Steve Kirsch (he considers me part of his “debate team”. Last week, Steve challenged Peter Marks to a debate:“Hi Peter,You are right about the vaccine uptake problem. According to independent survey we just commissioned, only 33% of Americans opted to go further than the first 2 doses.You were quoted in that CNN article:“We do have a problem with vaccine uptake that is very serious in the United States and anything we can do to get people more comfortable to be able to accept these potentially life-saving medical products is something that we feel we are compelled to do,” said Dr. Peter Marks, director of the Center for Biologics Evaluation and Research.Isn’t it time for you to end the misinformation problem by debating us in a public forum?My colleagues and I look forward to hearing from you.

    The only way to end the misinformation is to debate the top misinformation spreaders. You will never win by trying to censor us.

    We would be HAPPY to debate to you to end the misinformation problem. As you can see from this slide deck, all the evidence we’ve been able to find shows there was clinical trial fraud and that the vaccines are very dangerous. We would love to know how we got it wrong

    I look forward to hearing from you.

    -steve

    To my knowledge, Marks has not replied. I replied to Steve and the entire email thread, including Marks, though:

    “Steve,

    History is going to remember one person on this email thread in a manner in which I would not ever care to be seen associating with.

    I would therefore decline to participate in such a debate.

    Sincerely,

    James Lyons-Weiler, PhD

I could continue and debate dozens more points in the report dump by the FDA. I don’t have to. Marks himself provides evidence of being way off-target immunologically and lying about the “need” for COVID-19 vaccines for children.

Here’s an old video of Prevaricating Peter lying about the need for “high antibody titres” for immunity, and that children’s immune response is “not enough for some of these variants” (no data on that, just words):

The comments in that video have not aged well. Call your Senator and Congressional Reps and demand that Peter Marks resign. Email them this article. Marks and the FDA are NOT basing their considerations on independent fact, science and logic. He and his cronies are either incompetent or working for the industry. Either way, he and his cronies have to go.

June 14, 2022 Posted by | Deception, Science and Pseudo-Science, War Crimes | , , , , , | Leave a comment

Ghost Shot: Pfizer quietly admits it will never manufacture original FDA approved COVID vaccines

Company claims it is manufacturing Comirnaty product with new formula

By Jordan Schachtel | The Dossier | June 3, 2022

The August 23, 2021 FDA approval of Pfizer’s Comirnaty vaccine was a cause for celebration. Marked as a turning point in the battle against COVID19, the announcement was highly publicized by the Biden Administration with the clear intention to extinguish “vaccine hesitancy” and boost uptake.

It was celebrated as a cause for national relief, and many Americans arrived at their local pharmacies under the impression, via government and pharmaceutical propaganda, that they were receiving an FDA-approved COVID vaccine. Yet that legally distinct product, as we know it, never existed. And now we know, via Pfizer, that it will never exist.

For the uninitiated:

Comirnaty is a legally distinct product from the emergency use authorization (EUA) shots, and It has never made its way to market. For months on end, no such vaccine has ever become available. Those who received the “Pfizer shot(s)” have been injected with the emergency use authorization (EUA) version of the shots. See my piece in The Dossier for more info:

Shell Game? There remains no FDA approved COVID vaccine in the United States

The information operation succeeded. There was indeed an FDA approved vaccine, at least on paper, but you couldn’t get it.

When originally confronted with this ordeal, Pfizer labeled this issue an inventory question that had nothing to do with the legal distinction between an experimental EUA product and an FDA-approved vaccine. Up until just weeks ago, this was the statement up on the CDC website via Pfizer:

“Pfizer received FDA BLA license on 8/23/2021 for its COVID-19 vaccine for use in individuals 16 and older (COMIRNATY).  At that time, the FDA published a BLA package insert that included the approved new COVID-19 vaccine tradename COMIRNATY and listed 2 new NDCs (0069-1000-03, 0069-1000-02) and images of labels with the new tradename.

At present, Pfizer does not plan to produce any product with these new NDCs and labels over the next few months while EUA authorized product is still available and being made available for U.S. distribution.  As such, the CDC, AMA, and drug compendia may not publish these new codes until Pfizer has determined when the product will be produced with the BLA labels.”

In May, Pfizer updated its statement to mention a December 2021 licensed Comirnaty product, which was granted a license four months after the highly-publicized August FDA press release.

And just last week, Pfizer finally acknowledged that its original licensed product will never be distributed. In an unreported update on the CDC website, Pfizer told the agency:

“Pfizer received initial FDA BLA license on 8/23/2021 for its COVID-19 vaccine for use in individuals 16 and older (COMIRNATY). At that time, the FDA published a BLA package insert that included the approved new COVID-19 vaccine tradename COMIRNATY and listed 2 new NDCs (0069-1000-03, 0069-1000-02) and images of labels with the new tradename. These NDCs will not be manufacturedOnly NDCs for the subsequently BLA approved tris-sucrose formulation will be produced.”

The key distinction between the originally approved formulation and the tris-sucrose formulation is that — according to manufacturers — the latter can be held for a much longer period of time outside of an ultra cold freezer. These freezers cost over $10,000 a piece and each unit uses as much energy per day as an average American household. Improper storage can render the mRNA unstable.

Notably, the clinical trials for the Pfizer shot were conducted without the modified tris-sucrose ingredient. Given the partisan nature of Pfizer, the corporate media, government health bureaucracies, and your correspondent’s lack of expertise in this area, it is unclear whether this is significant.

Another notable thing to look out for in the coming days and weeks is the possibility that the subsequently FDA approved product finally becomes available in the United States. In recent days, the CDC removed the language of “not orderable at this time” above the description of both Comirnaty and Moderna’s Spikevax.

Additionally, as reported by Uncover DC, the Defense Department appears to be in the early stages of ordering what it has interpreted as a legally required minimum of Comirnaty in order to continue its mRNA mandate of American service members.

June 7, 2022 Posted by | Deception | , , , | Leave a comment

Concerns of Fraud in Pfizer Vaccine Trial as Participant’s Hospitalisation with Heart Inflammation is Swept Under Carpet

By Will Jones | The Daily Sceptic | May 23, 2022

You may have heard the disturbing story of Maddie de Garay, who in July 2020, aged 12, participated in Pfizer’s Covid vaccine trial of adolescents aged 12-15. Within 24 hours of receiving the second dose in early January 2021, Maddie experienced “zapping pain up and down her spine with severe abdominal pain… her toes and fingers turned white and were ice cold”. She now can barely see, suffers from tinnitus, mobility issues, vomiting, blood in her urine, numbness in her body and has at least 10-20 seizures a day. Yet her injury was recorded in the vaccine trial data as “abdominal pain” and it was asserted without investigation to be not related to the vaccine.

Another case, similarly disturbing, has now emerged of an adverse reaction during a Pfizer trial that was not recorded in the trial data, raising concerns about the integrity of the trial data and the possibility of fraud.

Augusto Roux is a 35-year old lawyer from Buenos Aires, Argentina who volunteered for Pfizer’s Covid vaccine phase 3 trial. He did so to protect his mother, who has emphysema.

On the way home after his second dose on September 9th 2020, he began feeling unwell, developed a high fever and felt very ill. He fainted on September 11th and went to the hospital on September 12th. The hospital ran tests, including a CAT scan of his chest, which showed an abnormal collection of fluid around the outside of the heart, indicating pericarditis (a form of heart inflammation).

On September 14th he was discharged, with the doctor writing in his discharge note that he had suffered an adverse reaction to the vaccine. Augusto was also told by hospital staff that there had been a considerable number of people from the clinical trial coming to the hospital – one nurse estimated staff had seen around 300 people – so his experience was not new to them. Around 3,000 trial participants had been enrolled before Augusto, so, if the nurse’s estimate is accurate, this would be a hospitalisation rate of 10%.

Following his adverse reaction, Augusto asked to see his trial clinical records, but those running the trial refused. Being a lawyer, Augusto went to law to get access to his records, which took over a year. Once he saw them, he could well imagine why someone might not want them to be released.

In hospital, Augusto had tested negative for Covid, and the doctor at the hospital had written that his condition was due to the vaccine. However, when Augusto contacted the trial site on September 14th to notify the investigators he had been in hospital, they wrote down in his clinical trial record that he had been admitted for a “bilateral pneumonia” that had nothing to do with the “investigational product” – the vaccine – even though that was not what he told them or what the doctor who examined him had stated.

For obvious reasons, Augusto was keen to know whether he’d had the vaccine or not. However, the principal investigator for the trial, Fernando Polack (pictured below), had inaccurately claimed that he could only be unblinded if his life were in danger. Augusto appealed to ANMAT, the Argentinian equivalent of the FDA, and following a formal hearing on October 9th 2020 it forced the trial investigators to tell Augusto that he had, indeed, received the vaccine.

The clinical trial notes reveal that two days prior to this hearing, on October 7th, “at the request of the sponsor” (Pfizer), the adverse event code was updated from pneumonia to “COVID-19 disease”. This is despite Augusto testing negative at the time of his admission. (Conveniently for Pfizer, the COVID-19 ‘diagnosis’ would not be included in the trial vaccine efficacy calculations due to the negative test.)

Even more disturbing, on October 8th, Polack wrote in Augusto’s clinical trial records that he had had an attack of “severe anxiety” starting on September 23rd (not caused by the vaccine, naturally). Polack added that Augusto suspected a conspiracy between the two hospitals, described his anxiety as “constitutional”, and noted that it was ongoing, evidenced by his pursuing his appeal to ANMAT. On October 11th, Polack had this mental health diagnosis added to his actual medical records.

Dr. David Healy, who has interviewed Augusto and seen the medical records in question, comments that “there is nothing in any record that indicates that Dr. Polack or any other doctor attempted on September 23rd to establish whether Augusto had a mental disorder”. He adds:

Augusto points to the notes of October 8th and 11th as evidence that this idea was invented just around the time the ANMAT hearing was about to happen. He states that it is in breach of Argentinian law for Dr. Polack to have diagnosed someone with a medical condition that the person does not have – and to have entered it into his medical record.

Note that Polack is a paediatrician so lacks the qualification to make mental health diagnoses, especially without any formal assessment.

Polack is a key player in the Pfizer Covid vaccine trials. He was the lead author on the December 2020 NEJM paper on the safety and efficacy of the vaccine. Israeli academic Josh Guetzkow notes that he is also one of the directors of i-trials, the site management organisation “paid handsomely by Pfizer to run the trial in Argentina (the largest site of the trial by far)”. Guetzkow adds:

If he raised an alarm about the vaccine safety, his company would have lost a ton of money and would be an unlikely choice by any company to run any trials in the future. So to say that he had an interest in achieving a positive trial outcome would be quite an understatement. There may be other conflicts we’re not aware of.

The evidence of malpractice and possible fraud in the Pfizer Covid vaccine trials is certainly stacking up now. But very few people are aware of it as it is mostly only being reported in alternative media. When will mainstream outlets start following up properly on this potentially massive story?

May 23, 2022 Posted by | Deception, Science and Pseudo-Science, Timeless or most popular, War Crimes | | 2 Comments

FDA Dumps More Pfizer Documents: Why Were So Many Adverse Events Reported as ‘Unrelated’ to Vaccine?

By Michael Nevradakis, Ph.D. | The Defender | May 17, 2022

The latest release of Pfizer-BioNTech COVID-19 vaccine documents raises questions about how frequently adverse events experienced by clinical trial participants were reported as “unrelated” to the vaccine.

The 80,000-page document cache released May 2 by the U.S. Food and Drug Administration (FDA) includes an extensive set of Case Report Forms (CRFs) from Pfizer trials conducted at various locations in the U.S.

The documents also include the “third interim report” from BioNTech’s trials conducted in Germany (accompanied by a synopsis of this report and a database of adverse events from this particular set of trials).

The FDA released the documents, which pertain to the Emergency Use Authorization (EUA) of the vaccine, as part of a court-ordered disclosure schedule stemming from an expedited Freedom of Information Act (FOIA) request filed in August 2021.

Public Health and Medical Professionals for Transparency, a group of doctors and public health professionals, submitted the FOIA request.

Adverse events during Pfizer vaccine trials in the U.S. usually reported as ‘unrelated’ to vaccination

Pfizer conducted a series of vaccine trials at various locations in the U.S., including the New York University Langone Health Center, Rochester Clinical Research and Rochester General Hospital (Rochester, New York) and the J. Lewis Research, Inc. Foothill Family Clinic (Salt Lake City, Utah).

The Pfizer documents released this month by the FDA included a series of CRFs for patients who suffered some type of adverse event during their participation in the COVID-19 vaccine trials.

As the documents reveal, despite the occurrence of a wide range of symptoms, including serious cardiovascular events, almost none were identified as being “related” to the vaccine.

Such serious yet “unrelated” adverse events included:

Of the CRFs found in the documents released this month, only one adverse event is clearly specified as being related to the vaccination: a participant who suffered from psoriatic arthritis, with no prior history of the condition.

In addition, several CRFs indicated exposure during pregnancy (see here and here), or during a partner’s pregnancy (see here and here). However, the documents provided do not appear to have provided any follow-ups regarding any outcomes or potential adverse events for the participants, their partners or their newborn babies once born.

In some instances, while the CRFs claimed the adverse events suffered by patients were not related to the vaccine, their cause was unspecified, simply indicated as “other,” while in another case, a participant’s “unplanned” small bowel obstruction and panic attacks were listed as being unrelated to the vaccination despite no relevant medical history pertaining to the SAEs (severe adverse events) in question.

Did Pfizer hide critical information from regulators?

It is difficult to draw concrete conclusions about any specific case from the data provided by CRFs and vaccine trial summaries.

However, what raises eyebrows is the very large number of adverse events — often serious and often requiring the hospitalization of the patients involved — that were determined to be “unrelated” to the administration of the COVID vaccine.

Previously released Pfizer documents also included discrepancies in the recording of adverse events.

According to investigative journalist Sonia Elijah, these discrepancies include:

  • Trial participants were entered into the “healthy population” but were, in actuality, far from healthy.
  • SAE numbers were left blank.
  • Barcodes were missing from samples collected from trial participants.
  • The second vaccine dose was administered outside the three-week protocol window.
  • New health problems were dismissed as “unrelated” to the vaccination.
  • A remarkable number of patients with an observation period of exactly the same duration — 30 minutes, with very little variety in observation times and raising questions as to whether patients were adequately observed or were put at risk.
  • Oddities pertaining to the start and end dates of SAEs – for instance, a “healthy” diabetic suffered a “serious” heart attack on October 27, 2020, but the “end” date for this SAE is listed as the very next day, even though the patient was diagnosed with pneumonia that same day.
  • Impossible dating: in the aforementioned example of the patient who sustained a heart attack and pneumonia, the individual in question later died, but the date of death is indicated as the day before the patient was recorded as having gone to a “COVID ill” visit.
  • Unblinded teams, who were aware of which patients received the actual vaccine or a placebo, were responsible for reviewing adverse event reports, potentially leading to pressure to downplay COVID-related events in the vaccinated, or to indicate that adverse events were related to the vaccine.
  • Other adverse events were indicated as “not serious” despite extensive hospital stays, of up to at least 26 days in the case of one patient who suffered a fall which was classified as “not serious,” yet facial lacerations sustained as a result of the fall were attributed to hypotension (low blood pressure).

Many of these practices seem to appear in the trial-related documents released this month.

Medical and scientific experts who spoke to The Defender expressed similar concerns about what this month’s tranche of documents reveals, and addressed cases of “disappearing” adverse events.

Brian Hooker, chief scientific officer for Children’s Health Defense, remarked:

“I’m most concerned about ‘disappearing’ patients. One cannot conduct a valid trial and simply omit the results that they don’t like!

“With the stories about Maddie de Garay and Augusto Roux surfacing, I have to wonder how many other participants were dropped in order to hide vaccine adverse events/effects.

“If you look at the data in VAERS [Vaccine Adverse Event Reporting System], COVID-19 vaccines are the most dangerous ever introduced into the population.”

Dr. Madhava Setty, a board-certified anesthesiologist and senior science editor for The Defender, said:

“The ‘unrelated’ label the investigators use to divert attention from AEs [adverse events] is a powerful point that stands on its own. We haven’t pushed back on this enough.

“Equivalently, we can say that the meager and short-lived benefit of these shots is also ‘unrelated’ using their ‘standards.’ On what grounds can they say that their product is preventing infection (which it isn’t anymore), or death (marginally)?

“They cannot have it both ways. They cannot claim a benefit through short-term outcomes while denying that side effects of any kind are related to their product.

“That’s the whole point of doing a trial. You cannot prove causation, only statistically significant correlation.”

Setty provided further context for his remarks in an April 2022 article for The Defender and in a March 2022 presentation, in which he discussed the number of these adverse events and how Pfizer swept them away (timestamp 24:00).

In Setty‘s view:

“There’s a high likelihood of malfeasance going on. [Pfizer whistleblower] Brook Jackson says the PIs [principal investigators] were unblinded. If true, it would make it very easy for the investigators to bump up the AEs in the placebo group while ignoring some of the AEs in the vaccine group.

“Pfizer claims that 0.5% of placebo recipients suffered a serious adverse event compared to 0.6% in the vaccine group. This is how these events were obscured.”

The extant body of evidence indicates Pfizer “is hiding critical information from regulators,” Setty said:

“The clincher is in the memorandum to the VRBPAC [Vaccines and Related Biological Products Advisory Committee] (Table 2, efficacy populations), where they show us that five times more people in the vaccine group were pulled out of the trial than the placebo within seven days of their second shot for ‘important protocol deviations.’

“In a trial that big the chances that could have happened coincidentally is infinitesimally small (less than 1 in 100,000).

“Moreover, months later, the same thing happened in the pediatric trial (Table 12). This time, six times more children were pulled from the trial after their second dose.

“There are, of course, procedural differences when administering a placebo versus the mRNA vaccine, but why didn’t it happen after the first dose as well?

“Mathematically, that is about as close as you can get to eliminating any ‘shadow of doubt.’ With a formal allegation by a trial coordinator that states the same thing [referring to whistleblower Brook Jackson], we can be assured Pfizer is hiding critical information from regulators.”

BioNTech trials in Germany claim few adverse events ‘related’ to vaccine

The BioNTech trial in Germany tested various dosages of two COVID-19 vaccine formulas, labeled BNT162b1 and BNT162b2 — the latter granted EUA by the FDA.

The latest cache of Pfizer documents suggests a pattern, similar to the one in the U.S. trials, of not reporting adverse events as related to the vaccine.

According to the third interim report, dated March 20, 2021, among trial participants who were administered the BNT162b2 candidate vaccine granted EUA in the U.S.:

  • 87% of younger participants reported solicited local reactions, and 88% reported solicited systemic reactions, with 10% reporting solicited systemic reactions of Grade 3 or higher.
  • 87% of younger participants experienced “mild” solicited local reactions, and 35% experienced “moderate” solicited local reactions.
  • 88% of younger participants experienced “mild” solicited systemic reactions, and 38% experienced “moderate” solicited systemic reactions. As stated in the report:

“The most frequently reported solicited systemic reactions of any severity were fatigue (n=40, 67%), followed by headache (n=32, 53%), malaise (n=24, 40%), and myalgia (n=23, 38%). The remaining symptom terms were less frequent.

“For nausea, headache, fatigue, myalgia, chills, arthralgia and malaise each symptom was assessed as severe in <10% of participants.”

  • 43% of younger participants reported a total of 51 unsolicited TEAEs (treatment-emergent adverse events, referring to conditions not present prior to treatment or that worsened in intensity after treatment) within 28 days of the first or second dose, nine of which were deemed to be “related” to the vaccination. One participant in this category sustained a TEAE assessed as Grade 3 or higher, but “which was assessed as not related by the investigator.”
  • TEAEs among younger participants included hypoaesthesia, lymphadenopathy, heart palpitations, external ear inflammation, blepharitis, toothache, non-cardiac chest pain, cestode infection, oral herpes, tonsillitis, neck pain, insomnia, anosmia and dysmenorrhea.
  • No unsolicited treatment-emergent serious adverse events (TESAEs) or deaths were reported among younger participants, but one discontinued participation due to moderate nasopharyngitis.
  • One younger participant “discontinued due to a moderate AE (nasopharyngitis).”
  • 86% of older participants reported solicited local reactions, with 6% reporting solicited local reactions of Grade 3 or higher, 78% reporting “mild” solicited local reactions and 36% reporting “moderate” solicited local reactions.
  • 72% of older participants reported solicited systemic reactions, with 11% of these participants sustaining solicited systemic reactions of Grade 3 or higher, 69% sustaining “mild” solicited reactions and 36% sustaining “moderate” solicited reactions.
  • 33% of older participants reported a total of 20 unsolicited TEAEs, four of which were determined to be “related” to the vaccination. Among older participants, 8% reported a TESAE of Grade 3 or higher, with “one event assessed as related by the investigator.”
  • One older participant was reported to have sustained a “not related TESAE” (an ankle fracture).
  • TESAEs among older participants included back pain, chest pain, facial injury, increased lipase, increased amylase, muscle spasms, musculoskeletal pain, tendon pain, orthostatic intolerance, renal colic, seborrhoeic dermatitis and “painful respiration.”

Among trial participants who received the BNT162b1 candidate vaccine (not granted EUA):

  • 86% of “younger participants” reported solicited (expected) localized reactions (remaining in one part of the body), with 18% reporting Grade 3 or higher solicited local reactions, 86% of younger participants reporting “mild” solicited local reactions and 54% reporting “moderate” solicited local reactions.
  • 92% of younger participants reported solicited systemic reactions (spreading to other parts of the body), with 44% reporting Grade 3 or higher solicited systemic reactions, 90% reporting “mild” solicited systemic reactions and 74% experiencing “moderate” solicited systemic reactions.

The report states:

“The most frequently reported solicited systemic reactions of any severity were fatigue (n=68, 81%), headache (n=66, 79%), myalgia (n=51, 61%), malaise (n=50, 60%), and chills (n=47, 56%). The remaining symptom terms were less frequent.

“For nausea, vomiting, diarrhea, myalgia, arthralgia and fever each symptom was assessed as severe in ≤10% of participants.”

  • 45% of younger participants reported a total of 83 unsolicited (unexpected) TEAEs within 28 days of receiving the first or second dose.

A total of 51 of these unsolicited TEAEs were reported as “related” to the vaccination, while 2% of participants sustained Grade 3 or higher TEAEs (four in total), “of which three events were assessed as related by the investigator.”

No unsolicited TESAEs or deaths were reported in this category.

  • According to the report, among younger participants, TEAEs included:

“‘General disorders and administration site conditions’ reported by 9 participants (11%),” including influenza-like illness and injection site hematoma.

“‘Nervous system disorders’ reported by 10 participants (12%),” including presyncope, hyperaesthesia, paraesthesia, and headache.

“‘Respiratory, thoracic and mediastinal disorders’ reported by 9 participants (11%),” including cough and oropharyngeal pain.”

Other symptoms included back pain, musculoskeletal chest pain, cervicobrachial syndrome, taste disorder, sleep disorder, depression, hallucination, dysmenorrhoea, pruritus and pityriasis rosea, while one participant required the excision (removal) of a papilloma.

  • One younger participant discontinued participation in the trial, “due to a moderate AE (malaise),” while another participant discontinued participation “due to dose-limiting toxicity.”
  • 83% of “older participants” reported solicited local reactions, but none were reported as Grade 3 or higher, while 83% of solicited local reactions were “mild” and 42% were “moderate.”
  • 92% of older participants reported solicited systemic reactions, with 28% of participants experiencing Grade 3 or higher solicited systemic reactions, 89% experiencing “mild” solicited systemic reactions, and 61% experiencing “moderate” solicited systemic reactions.

According to the report:

“The most frequently reported solicited systemic reactions of any severity were headache (n=29, 81%), fatigue (n=27, 75%), myalgia (n=18, 50%), and malaise (n=18, 50%). The remaining symptom terms were less frequent.”

  • 36% of participants reported a total of 24 unsolicited TEAEs within 28 days of the first or second dose, nine of which were assessed as “related” to the vaccination.

Of the participants in this category, 11% reported TEAEs of Grade 3 or higher (four events in total), with one of these events assessed as “related” to the vaccination.

  • TEAEs reported by older participants included oropharyngeal pain, nasopharyngitis, bladder dysfunction, sleep disorder, musculoskeletal pain and musculoskeletal chest pain, pollakiuria, migraine, syncope and alopecia.
  • One older participant receiving the BNT162b1 candidate sustained a TESAE (syncope), and there were no deaths in this category.

Of note, none of the participants for either vaccine candidate were pregnant, which raises questions about recommending and administering the vaccine to pregnant women despite the absence of any clinical trial data.

As the documents show, a wide range of adverse effects were reported, including cardiovascular and nervous system conditions, most of which were determined to be unrelated to the vaccination itself.


Michael Nevradakis, Ph.D., is an independent journalist and researcher based in Athens, Greece.

© 2022 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.

May 22, 2022 Posted by | Deception, Science and Pseudo-Science | , , , | 3 Comments

Pfizer Document Dump Shows Doctor With Ties to Gates Foundation Deleted Trial Participant’s Vaccine Injury

By Michael Nevradakis, Ph.D. | The Defender | May 18, 2022

An 80,000-page cache of Pfizer-BioNTech COVID-19 vaccine documents released by the U.S. Food and Drug Administration (FDA) sheds light on Pfizer’s extensive vaccine trials in Argentina, including the unusually large size of the trials and the story of a trial participant whose vaccine reaction was “disappeared.”

The case of Augusto Roux in Argentina suggests that in at least one instance, a trial participant whose symptoms were determined to be connected to the COVID-19 vaccine was later listed, in official records, as having experienced adverse events that were not related to the vaccination.

Vaccine trials in Argentina also appear to have glossed over adverse events suffered by other trial participants, and the potential connection between the adverse events and the vaccine.

The FDA on May 2 released the latest cache of documents, which pertain to the Emergency Use Authorization of Pfizer’s vaccine, as part of a court-ordered disclosure schedule stemming from an expedited Freedom of Information Act request filed in August 2021.

As previously reported by The Defender, the documents included Case Report Forms from Pfizer COVID vaccine trials in the U.S., and the “third interim report” from BioNTech’s trials conducted in Germany, both of which listed adverse events sustained by participants in the U.S. and German trials.

Many of these adverse events were indicated as being “unrelated” to the vaccines — even in instances where the patients were healthy or otherwise had no prior medical history related to the injuries they sustained.

Story of ‘disappeared patient’ goes public

Several bloggers and online investigators called into question various aspects of the Argentine vaccine trials, pointing out the number of participants in the Argentine trials dwarfed that of other, typically smaller trials at other locations in different countries.

They also pointed out the large number of participants appeared to have been recruited to the trial in a remarkably short time, and questioned the connections between one of the key figures of the Argentine trial to vaccine manufacturers, Big Pharma and the Bill & Melinda Gates Foundation.

The large number of trial participants in Argentina may be related to the fact that the trial appears to have been held simultaneously in 26 hospitals.

The large number of participants is revealed in another of the documents released this month, where on page 2,245, the list of randomized participants at trial site 1231 begins, while on page 4,329, the list of participants at trial site 4444 begins.

Site 1231 refers to the main trial site location and 4444 (page 24) most likely refers to the disparate hospitals participating in the trial outside the main location.

Commenting on the revelation, blogger David Healy wrote:

“About 5,800 volunteers were enrolled, half getting the active vaccine. This is almost 4 times more than the next largest centre in this trial.

“Amazingly 467 doctors were almost instantly signed up and trained as assistant investigators in the study.”

In all, 4,501 patients participated in the Argentine trials, representing 10% of all Pfizer trial participants worldwide.

Complete information about adverse events during this extensive trial in Argentina does not appear to have been released as of this writing.

However, Roux’s experience has since become public.

Roux, often referred to as the “disappeared” patient, volunteered for the trial (volunteer number 12312982) and received his first dose of the Pfizer vaccine on Aug. 21, 2020.

According to Healy, Roux “felt pain and swelling in his arm right after the injection. Later that day he had nausea, difficulty swallowing, and felt hungover.”

After a series of symptoms, Roux — during a clinical trial visit on Aug. 23, 2020 — was classified as experiencing a “toxicity grade 1 adverse effect.”

He nevertheless received his second dose on Sept. 9, 2020.

According to Healy:

“On the way home by taxi, he started feeling unwell. At 19:30, he was short of breath, had a burning pain in his chest and was extremely fatigued. He lay on his bed and fell asleep. He woke up at 21:00 with nausea and fever (38-39 C) and was unable to get out of bed due to the fatigue.

“Over the next two days, he reports a high fever (41 C) and feeling delirious.

“On September 11, he was able to get out of bed and go to the bathroom when he observed his urine to be dark (like Coca-Cola). He felt as if his heart expanded, had a sudden lack of breath and fell unconscious on the floor for approximately 3 hours.

“Once he recovered, he felt tired, was uncomfortable, had a high heart rate on minor movement, was dizzy when changing posture. He had a chest pain which radiated to his left arm and back.”

On Sept. 12, 2020, Roux was admitted to the Hospital Alemán, where he stayed for two days. It was initially believed he had COVID-19, but he tested negative for the virus. His symptoms also were found to not correspond with viral pneumonia.

After a series of X-rays, CT scans and urine tests, Roux was discharged Sept. 14, 2020, after being diagnosed with an adverse reaction — specifically, an unequivocal pericardial effusion — to the coronavirus vaccine (high probability), according to his discharge summary.

Doctor who altered Roux’s record had ties to Gates, NIH, Big Pharma

However, on Sept. 17, Dr. Fernando Polack, Pfizer’s lead investigator for the Argentine trials according to a Pfizer document released in December 2021, reported in Roux’s record that his “hospitalization was not related to the vaccine.”

Even after Roux’s discharge, his health difficulties continued. As reported by Healy:

“On November 13 [2020], he had negative IgG and IgM SARS COV-2 (QML technique), which is unusual post vaccine.

“On February 24, 2021, a liver scan showed a minor degree of abnormality. In March 2021 and February 2022, his liver enzymes remained abnormal.”

Ultimately, Roux lost 14 kilograms (30.8 pounds) in a period of three to four months, and continued to suffer from fever and bouts of breathlessness for several months afterward.

Polack, who reported Roux’s hospitalization as unrelated to the vaccination, is known for his close ties with various vaccine manufacturers, pharmaceutical companies and the Bill & Melinda Gates Foundation.

For instance, he is listed as the lead author in a Dec. 31, 2020, New England Journal of Medicine (NEJM) article on the purported efficacy of the Pfizer COVID-19 vaccine.

According to Healy, Polack also appears to be the founder of iTRIALS, a trial site management company, and another organization located at the same physical headquarters, the Fundación INFANT.

Healy wrote:

“When COVID struck Argentina, [Polack] and his Fundación became involved in a trial of immune plasma, taken from patients who had recovered from COVID, given to patients who had recently acquired the disease.

“In May 2020 he speculated that this would make COVID like an ordinary cold, and the Gates Foundation would offer financial support. He used high-profile press conferences to disseminate his exciting message.”

The conclusion of the study published in the NEJM following the plasma study reads:

“Funded by the Bill and Melinda Gates Foundation and the Fundación INFANT Pandemic Fund; Dirección de Sangre y Medicina Transfusional del Ministerio de Salud number, PAEPCC19, Plataforma de Registro Informatizado de Investigaciones en Salud number, 1421, and ClinicalTrials.gov number, NCT04479163.”

According to Healy, “[a] subsequent systematic review and meta-analysis failed to confirm these findings, noting ‘very serious imprecision concerns.’”

Healy pointed out that Polack, in his NEJM disclosure statement, did not indicate any conflict of interest or financial interest in the COVID-19 vaccine trials in Argentina, but:

“Polack reported grants from Novavax and personal fees from Janssen, Bavarian Nordic A/S, Pfizer, Sanofi, Regeneron, Merck, Medimmune, Vir Bio[technology], Ark Bio, Daiichi Sankyo outside the submitted work.

“At least eight of these companies are engaged in RSV vaccine research in babies and pregnant women. Fernando has mentioned a combined RSV, flu and COVID vaccine.”

And, in relation to Polack’s relationship with the Bill & Melinda Gates Foundation, Healy reported:

“[Polack] also doesn’t mention his extensive financial involvement with the Bill & Melinda Gates Foundation. This organization supports industry vaccine trials including Covid and RSV. Fernando is heavily involved through his Gates-sponsored Fundación INFANT in Buenos Aires in RSV trials and research.

“Gates sunk $82,553,834 into Novavax’s RSV vaccine ResVax which was shown to be ineffective in clinical trials in pregnant women.”

Polack’s own bio from a 2017 medical conference states “[h]is work is funded by the Bill & Melinda Gates Foundation, the National Institutes of Health [NIH], the Thrasher Research Fund, the Optimus Foundation and other international organizations.”

That same year, Polack testified at an FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting, where he “acknowledged having financial interests in or professional relationships with some of the affected firms identified for this meeting, namely Janssen [producer of the Johnson & Johnson COVID vaccine], Novavax, and Bavarian Nordic.”

According to Dr. Joseph Mercola, Polack “also happens to be a consultant for the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee (VRBPAC),” and “a current adjunct professor at Vanderbilt University in Tennessee.”

Michael Nevradakis, Ph.D., is an independent journalist and researcher based in Athens, Greece.

May 20, 2022 Posted by | Corruption, Deception, Science and Pseudo-Science | , , , , , , , | 1 Comment

Putting Big Bad Pharma Back on Trial in the COVID-19 Era

They keep telling us to “trust the science.” But who paid for it?

Photo credit: Massimo Giachetti
By Rebecca Strong – February 16, 2022

After graduating from Columbia University with a chemical engineering degree, my grandfather went on to work for Pfizer for almost two decades, culminating his career as the company’s Global Director of New Products. I was rather proud of this fact growing up — it felt as if this father figure, who raised me for several years during my childhood, had somehow played a role in saving lives. But in recent years, my perspective on Pfizer — and other companies in its class — has shifted. Blame it on the insidious big pharma corruption laid bare by whistleblowers in recent years. Blame it on the endless string of big pharma lawsuits revealing fraud, deception, and cover-ups. Blame it on the fact that I witnessed some of their most profitable drugs ruin the lives of those I love most. All I know is, that pride I once felt has been overshadowed by a sticky skepticism I just can’t seem to shake.

In 1973, my grandpa and his colleagues celebrated as Pfizer crossed a milestone: the one-billion-dollar sales mark. These days, Pfizer rakes in $81 billion a year, making it the 28th most valuable company in the world. Johnson & Johnson ranks 15th, with $93.77 billion. To put things into perspective, that makes said companies wealthier than most countries in the world. And thanks to those astronomical profit margins, the Pharmaceuticals and Health Products industry is able to spend more on lobbying than any other industry in America.

While big pharma lobbying can take several different forms, these companies tend to target their contributions to senior legislators in Congress — you know, the ones they need to keep in their corner, because they have the power to draft healthcare laws. Pfizer has outspent its peers in six of the last eight election cycles, coughing up almost $9.7 million. During the 2016 election, pharmaceutical companies gave more than $7 million to 97 senators at an average of $75,000 per member. They also contributed $6.3 million to president Joe Biden’s 2020 campaign. The question is: what did big pharma get in return?

ALEC’s Off-the-Record Sway

To truly grasp big pharma’s power, you need to understand how The American Legislative Exchange Council (ALEC) works. ALEC, which was founded in 1973 by conservative activists working on Ronald Reagan’s campaign, is a super secretive pay-to-play operation where corporate lobbyists — including in the pharma sector — hold confidential meetings about “model” bills. A large portionof these bills is eventually approved and become law.

A rundown of ALEC’s greatest hits will tell you everything you need to know about the council’s motives and priorities. In 1995, ALEC promoted a bill that restricts consumers’ rights to sue for damages resulting from taking a particular medication. They also endorsed the Statute of Limitation Reduction Act, which put a time limit on when someone could sue after a medication-induced injury or death. Over the years, ALEC has promoted many other pharma-friendly bills that would: weaken FDA oversight of new drugs and therapies, limit FDA authority over drug advertising, and oppose regulations on financial incentives for doctors to prescribe specific drugs. But what makes these ALEC collaborations feel particularly problematic is that there’s little transparency — all of this happens behind closed doors. Congressional leaders and other committee members involved in ALEC aren’t required to publish any records of their meetings and other communications with pharma lobbyists, and the roster of ALEC members is completely confidential. All we know is that in 2020, more than two-thirds of Congress — 72 senators and 302 House of Representatives members — cashed a campaign check from a pharma company.

Big Pharma Funding Research

The public typically relies on an endorsement from government agencies to help them decide whether or not a new drug, vaccine, or medical device is safe and effective. And those agencies, like the FDA, count on clinical research. As already established, big pharma is notorious for getting its hooks into influential government officials. Here’s another sobering truth: The majority of scientific research is paid for by — wait for it — the pharmaceutical companies.

When the New England Journal of Medicine (NEJM) published 73 studies of new drugs over the course of a single year, they found that a staggering 82% of them had been funded by the pharmaceutical company selling the product, 68% had authors who were employees of that company, and 50% had lead researchers who accepted money from a drug company. According to 2013 research conducted at the University of Arizona College of Law, even when pharma companies aren’t directly funding the research, company stockholders, consultants, directors, and officers are almost always involved in conducting them. A 2017 report by the peer-reviewed journal The BMJ also showed that about half of medical journal editors receive payments from drug companies, with the average payment per editor hovering around $28,000. But these statistics are only accurate if researchers and editors are transparent about payments from pharma. And a 2022 investigative analysis of two of the most influential medical journals found that 81% of study authors failed to disclose millions in payments from drug companies, as they’re required to do.

Unfortunately, this trend shows no sign of slowing down. The number of clinical trials funded by the pharmaceutical industry has been climbing every year since 2006, according to a John Hopkins University report, while independent studies have been harder to find. And there are some serious consequences to these conflicts of interest. Take Avandia, for instance, a diabetes drug produced by GlaxoSmithCline (GSK). Avandia was eventually linked to a dramatically increased risk of heart attacks and heart failure. And a BMJ report revealed that almost 90% of scientists who initially wrote glowing articles about Avandia had financial ties to GSK.

But here’s the unnerving part: if the pharmaceutical industry is successfully biasing the science, then that means the physicians who rely on the science are biased in their prescribing decisions.

Where the lines get really blurry is with “ghostwriting.” Big pharma execs know citizens are way more likely to trust a report written by a board-certified doctor than one of their representatives. That’s why they pay physicians to list their names as authors — even though the MDs had little to no involvement in the research, and the report was actually written by the drug company. This practice started in the ’50s and ’60s when tobacco execs were clamoring to prove that cigarettes didn’t cause cancer (spoiler alert: they do!), so they commissioned doctors to slap their name on papers undermining the risks of smoking.

It’s still a pretty common tactic today: more than one in 10 articles published in the NEJM was co-written by a ghostwriter. While a very small percentage of medical journals have clear policies against ghostwriting, it’s still technically legal —despite the fact that the consequences can be deadly.

Case in point: in the late ’90s and early 2000s, Merck paid for 73 ghostwritten articles to play up the benefits of its arthritis drug Vioxx. It was later revealed that Merck failed to report all of the heart attacks experienced by trial participants. In fact, a study published in the NEJM revealed that an estimated 160,000 Americans experienced heart attacks or strokes from taking Vioxx. That research was conducted by Dr. David Graham, Associate Director of the FDA’s Office of Drug Safety, who understandably concluded the drug was not safe. But the FDA’s Office of New Drugs, which not only was responsible for initially approving Vioxx but also regulating it, tried to sweep his findings under the rug.

“I was pressured to change my conclusions and recommendations, and basically threatened that if I did not change them, I would not be permitted to present the paper at the conference,” he wrote in his 2004 U.S. Senate testimony on Vioxx. “One Drug Safety manager recommended that I should be barred from presenting the poster at the meeting.”

Eventually, the FDA issued a public health advisory about Vioxx and Merck withdrew this product. But it was a little late for repercussions — 38,000 of those Vioxx-takers who suffered heart attacks had already died. Graham called this a “profound regulatory failure,” adding that scientific standards the FDA apply to drug safety “guarantee that unsafe and deadly drugs will remain on the U.S. market.”

This should come as no surprise, but research has also repeatedly shown that a paper written by a pharmaceutical company is more likely to emphasize the benefits of a drug, vaccine, or device while downplaying the dangers. (If you want to understand more about this practice, a former ghostwriter outlines all the ethical reasons why she quit this job in a PLOS Medicine report.) While adverse drug effects appear in 95% of clinical research, only 46% of published reports disclose them. Of course, all of this often ends up misleading doctors into thinking a drug is safer than it actually is.

Big Pharma Influence On Doctors

Pharmaceutical companies aren’t just paying medical journal editors and authors to make their products look good, either. There’s a long, sordid history of pharmaceutical companies incentivizing doctors to prescribe their products through financial rewards. For instance, Pfizer and AstraZeneca doled out a combined $100 million to doctors in 2018, with some earning anywhere from $6 million to $29 million in a year. And research has shown this strategy works: when doctors accept these gifts and payments, they’re significantly more likely to prescribe those companies’ drugs. Novartis comes to mind — the company famously spent over $100 million paying for doctors’ extravagant meals, golf outings, and more, all while also providing a generous kickback program that made them richer every time they prescribed certain blood pressure and diabetes meds.

Side note: the Open Payments portal contains a nifty little database where you can find out if any of your own doctors received money from drug companies. Knowing that my mother was put on a laundry list of meds after a near-fatal car accident, I was curious — so I did a quick search for her providers. While her PCP only banked a modest amount from Pfizer and AstraZeneca, her previous psychiatrist — who prescribed a cocktail of contraindicated medications without treating her in person — collected quadruple-digit payments from pharmaceutical companies. And her pain care specialist, who prescribed her jaw-dropping doses of opioid pain medication for more than 20 years (far longer than the 5-day safety guideline), was raking in thousands from Purdue Pharma, AKA the opioid crisis’ kingpin.

Purdue is now infamous for its wildly aggressive OxyContin campaign in the ’90s. At the time, the company billed it as a non-addictive wonder drug for pain sufferers. Internal emails show Pursue sales representatives were instructed to “sell, sell, sell” OxyContin, and the more they were able to push, the more they were rewarded with promotions and bonuses. With the stakes so high, these reps stopped at nothing to get doctors on board — even going so far as to send boxes of doughnuts spelling out “OxyContin” to unconvinced physicians. Purdue had stumbled upon the perfect system for generating tons of profit — off of other people’s pain.

Documentation later proved that not only was Purdue aware it was highly addictive and that many people were abusing it, but that they also encouraged doctors to continue prescribing increasingly higher doses of it (and sent them on lavish luxury vacations for some motivation). In testimony to Congress, Purdue exec Paul Goldenheim played dumb about OxyContin addiction and overdose rates, but emails that were later exposed showed that he requested his colleagues remove all mentions of addiction from their correspondence about the drug. Even after it was proven in court that Purdue fraudulently marketed OxyContin while concealing its addictive nature, no one from the company spent a single day behind bars. Instead, the company got a slap on the wrist and a $600 million fine for a misdemeanor, the equivalent of a speeding ticket compared to the $9 billion they made off OxyContin up until 2006. Meanwhile, thanks to Purdue’s recklessness, more than 247,000 people died from prescription opioid overdoses between 1999 and 2009. And that’s not even factoring in all the people who died of heroin overdoses once OxyContin was no longer attainable to them. The NIH reports that 80% of people who use heroin started by misusing prescription opioids.

Former sales rep Carol Panara told me in an interview that when she looks back on her time at Purdue, it all feels like a “bad dream.” Panara started working for Purdue in 2008, one year after the company pled guilty to “misbranding” charges for OxyContin. At this point, Purdue was “regrouping and expanding,” says Panara, and to that end, had developed a clever new approach for making money off OxyContin: sales reps were now targeting general practitioners and family doctors, rather than just pain management specialists. On top of that, Purdue soon introduced three new strengths for OxyContin: 15, 30, and 60 milligrams, creating smaller increments Panara believes were aimed at making doctors feel more comfortable increasing their patients’ dosages. According to Panara, there were internal company rankings for sales reps based on the number of prescriptions for each OxyContin dosing strength in their territory.

“They were sneaky about it,” she said. “Their plan was to go in and sell these doctors on the idea of starting with 10 milligrams, which is very low, knowing full well that once they get started down that path — that’s all they need. Because eventually, they’re going to build a tolerance and need a higher dose.”

Occasionally, doctors expressed concerns about a patient becoming addicted, but Purdue had already developed a way around that. Sales reps like Panara were taught to reassure those doctors that someone in pain might experience addiction-like symptoms called “pseudoaddiction,” but that didn’t mean they were truly addicted. There is no scientific evidence whatsoever to support that this concept is legit, of course. But the most disturbing part? Reps were trained to tell doctors that “pseudoaddiction” signaled the patient’s pain wasn’t being managed well enough, and the solution was simply to prescribe a higher dose of OxyContin.

Panara finally quit Purdue in 2013. One of the breaking points was when two pharmacies in her territory were robbed at gunpoint specifically for OxyContin. In 2020, Purdue pled guilty to three criminal charges in an $8.3 billion deal, but the company is now under court protection after filing for bankruptcy. Despite all the damage that’s been done, the FDA’s policies for approving opioids remain essentially unchanged.

Purdue probably wouldn’t have been able to pull this off if it weren’t for an FDA examiner named Curtis Wright, and his assistant Douglas Kramer. While Purdue was pursuing Wright’s stamp of approval on OxyContin, Wright took an outright sketchy approach to their application, instructing the company to mail documents to his home office rather than the FDA, and enlisting Purdue employees to help him review trials about the safety of the drug. The Food, Drug, and Cosmetic Act requires that the FDA have access to at least two randomized controlled trials before deeming a drug as safe and effective, but in the case of OxyContin, it got approved with data from just one measly two-week study — in osteoarthritis patients, no less.

When both Wright and Kramer left the FDA, they went on to work for none other than (drumroll, please) Purdue, with Wright earning three times his FDA salary. By the way — this is just one example of the FDA’s notoriously incestuous relationship with big pharma, often referred to as “the revolving door”. In fact, a 2018 Science report revealed that 11 out of 16 FDA reviewers ended up at the same companies they had been regulating products for.

While doing an independent investigation, “Empire of Pain” author and New Yorker columnist Patrick Radden Keefe tried to gain access to documentation of Wright’s communications with Purdue during the OxyContin approval process.

“The FDA came back and said, ‘Oh, it’s the weirdest thing, but we don’t have anything. It’s all either been lost or destroyed,’” Keefe told Fortune in an interview. “But it’s not just the FDA. It’s Congress, it’s the Department of Justice, it’s big parts of the medical establishment … the sheer amount of money involved, I think, has meant that a lot of the checks that should be in place in society to not just achieve justice, but also to protect us as consumers, were not there because they had been co-opted.”

Big pharma may be to blame for creating the opioids that caused this public health catastrophe, but the FDA deserves just as much scrutiny — because its countless failures also played a part in enabling it. And many of those more recent fails happened under the supervision of Dr. Janet Woodcock. Woodcock was named FDA’s acting commissioner mere hours after Joe Biden was inaugurated as president. She would have been a logical choice, being an FDA vet of 35 years, but then again it’s impossible to forget that she played a starring role in the FDA’s perpetuating the opioid epidemic. She’s also known for overruling her own scientific advisors when they vote against approving a drug. Not only did Woodcock approve OxyContin for children as young as 11 years old, but she also gave the green light to several other highly controversial extended-release opioid pain drugs without sufficient evidence of safety or efficacy. One of those was Zohydro: in 2011, the FDA’s advisory committee voted 11:2 against approving it due to safety concerns about inappropriate use, but Woodcock went ahead and pushed it through, anyway. Under Woodcock’s supervision, the FDA also approved Opana, which is twice as powerful as OxyContin — only to then beg the drug maker to take it off the market 10 years later due to “abuse and manipulation.” And then there was Dsuvia, a potent painkiller 1,000 times stronger than morphine and 10 times more powerful than fentanyl. According to a head of one of the FDA’s advisory committees, the U.S. military had helped to develop this particular drug, and Woodcock said there was “pressure from the Pentagon” to push it through approvals. The FBI, members of congress, public health advocates, and patient safety experts alike called this decision into question, pointing out that with hundreds of opioids already on the market there’s no need for another — particularly one that comes with such high risks.

Most recently, Woodcock served as the therapeutics lead for Operation Warp Speed, overseeing COVID-19 vaccine development.

To be continued…

Rebecca Strong is a Boston-based freelance health and wellness writer currently contributing to Insider, Health magazine, Healthline, Eat This Not That, and more.

April 7, 2022 Posted by | Corruption, Deception, Science and Pseudo-Science, Timeless or most popular | , , | Leave a comment

Australian Senators raise serious Vaccine Issues in Parliament

The Naked Emperor’s Newsletter | March 31, 2022

Two Australian Senators raised some serious vaccine issues during a recent debate in their parliament. As has been the case with questions raised by other parliamentarians from around the world, these speeches were made to an empty room. Fortunately, they are recorded for the world to listen too.

The first speech is by Malcolm Roberts, Senator for Queensland. He raised the issue of documented evidence and victim testimony of vaccine injuries which are hidden behind anonymous government data. The Senator says that the very least we can do for the victims is to say their names and he precedes to recall accounts of various individuals who have died after being vaccinated.

Senator Roberts says the Australian regulators have been bullying medical practitioners not to report or talk about vaccine harms. Furthermore, he claims 98% of the 800 vaccine deaths, reported by physicians, have been erased without autopsy or consideration of medical data.

He says data recently revealed in US court papers shows vaccine harm was apparent in the Pfizer clinical trials. This information should have resulted in the refusal of the application for provisional use. No data was provided on individuals in the trials and no independent analysis of the fundamental issues surrounding novel mRNA vaccines was conducted in Australia. Instead, the Secretary just took Pfizer, AstraZeneca and Moderna’s word for it.

The Senator goes on to list the fines that these same pharmaceutical companies have been issued with (for criminal behaviour) over the years. AstraZeneca had a US $355 million fine for fraud and US $550 million fine for making unfounded efficacy claims. Pfizer had a US $430 million fine for unfounded claims about efficacy and a US $2.3 billion fine for unfounded claims about efficacy and for paying kickbacks.

Indemnities have been made against any damage caused by the vaccines which he calls deceit and criminal incompetence. Some of the Australian political parties have accepted $1 million each from the pharmaceutical companies in this election cycle alone. Billions more are being set aside in the Australian budget to continue the pharmaceutical companies’ COVID-19 gravy train.

Senator Roberts says mention should be made to the decision to ban safe, fully approved and widely accepted alternatives to COVID-19 vaccines, including hydroxychloroquine, Ivermectin, vitamins, minerals, natural antivirals, healthy eating and lifestyles. This ban was taken to ensure the fastest and widest-possible adoption of the vaccines and the vaccines approval was funded by the same pharmaceutical companies that produce them.

He thinks the Australian Bureau of Statistics is culpable in this scandal and cover-up. It’s annual budget is $400 million but the most recent mortality data is from November 2021. The most recent breakdown of mortality by cause and age is from 2020 as is the most recent data on live births. Birth data used to be available six weeks after so he asks are they hiding miscarriages?

The Senator says peer reviewed and soon to be published data is to be released from outside the government which must require the secretary to cancel the provisional approval of the vaccines.

He recaps the extent to which we have been misled:

  1. Freedom of information documents show there has been a failure to assess the reproductive toxicology of the vaccines;
  2. Documents indicate a failure to assess the impact of micro RNA sequences and related molecular genetic issues on the human body;
  3. Peer-reviewed and published in-vitro research shows gene based vaccine generated spike proteins can migrate into human cell nuclei to disrupt DNA repair mechanisms;
  4. Vaccine derived RNA can be reverse transcribed leading to possible integration into the human genome, which is denied based on what the pharmaceutical companies say.
  5. Internal Pfizer data indicate they accepted 1,272 different adverse vaccine events, including paralysis and death. German and US insurance actuarial data suggests the Australian database of adverse events notifications is under reporting by nine fold. Documents show there are two databases, an official one and one for the public meaning vaccine injury is likely to be significantly higher than reported.

He reports on German pathologists describing pathological aggregates of spike proteins and lymphocyte infiltrations in inflamed organs in autopsies related to deaths post vaccination. Whistle-blowers to the British Medical Journal provide reports on inadequacies, irregularities and possible fraudulent practises in the Pfizer vaccine trials.

Too frequent vaccines for respiratory viruses runs the risk of desensitising the immune response to the virus and lead to hypo immunity, a worse illness than without the immunisation. He says repeated vaccination is doing more harm than good.

The Senator concluded by asking a question to all those who have gone along with the deceit, “how the hell do you expect to get away with it? We’re not going to let you get away with it, we won’t let you get away with it. We’re coming for you. We have the stamina to hound you down and we damn well will.”

The next speech was by Senator Gerard Rennick, another representative from Queensland.

He says, to date, government figures show there have been over 116,000 reported, suspected adverse events to the vaccines in Australia. This is more than all other drugs put together since 1971 and the number is still climbing. Is it any wonder the Australian health system is struggling?

Most of these cases are prepared by medical professionals and almost every one has ticked the box indicating that they suspect the injury was caused by the vaccine. Anyone who has failed to speak up is destroying the lives of so many Australian people.

March 31, 2022 Posted by | Science and Pseudo-Science, Timeless or most popular, Video, War Crimes | , , , , | 4 Comments

Pfizer CEO says 4th shot needed, while EMA says doing so risks damaging your immune system

By Meryl Nass, MD | March 14, 2022

Pfizer’s Bourla says we need a 4th shot. Pfizer sold $36.8 billion dollars’ worth of COVID vaccines in 2021, making its vaccine the top-selling pharmaceutical product in history.  Pfizer has estimated its COVID vaccine sales for 2022 at $32 billion.

Albert Bourla says we need a 4th dose of his magic money-making elixir, but his company is also working on a universal coronavirus vaccine (a 2nd magic elixir), which we will only need once a year.

Albert Bourla, PhD, CEO of Pfizer, said a second booster shot of the COVID-19 vaccine is necessary for protection against infection, according to a March 13 interview with CBS News.

Dr. Bourla said the third dose of the COVID-19 vaccine provides protection from hospitalization and death, but “it’s not that good against infections” and the protection is relatively short-lived. Pfizer is preparing data for the FDA about the need for a fourth dose.

“Many variants are coming,” Dr. Bourla told CBS. “And omicron was the first one that was able to evade in a skillful way the immune protection that we were giving. But also, in all that the duration of the protection, it doesn’t last very long.”

… In February, the CDC published a study showing the efficacy of booster shots of Pfizer-BioNTech and Moderna vaccines waned after about four months, but still provided significant protection from hospitalizations during the omicron surge.

Dr. Bourla also told CNBC that Pfizer is developing a vaccine that will protect against all COVID-19 variants, including omicron, for at least a year. He expects to review data from trials on the long-term vaccine by the end of the month.

But Dr. Marco Cavaleri, a top regulator at Europe’s FDA, called the European Medicines’ Agency (EMA), says this may weaken the immune response. According to Reuters :

The European Union’s drug regulator on Tuesday expressed doubts about the need for a fourth booster dose of COVID-19 vaccine and said there is currently no data to support this approach as it seeks more data on the fast-spreading Omicron variant.

“While use of additional boosters can be part of contingency plans, repeated vaccinations within short intervals would not represent a sustainable long-term strategy,” the European Medicines Agency’s Head of Vaccines Strategy, Marco Cavaleri, told a media briefing.

The EMA official raised concerns that a strategy of giving boosters every four months hypothetically poses the risk of overloading people’s immune systems and leading to fatigue in the population.

Cavaleri also said more data on the impact of the new variant on vaccines and a better understanding of the evolution of the current wave were needed to decide whether an Omicron-specific vaccine was needed.

“It is important that there is a good discussion around the choice of the composition of the vaccine to make sure that we have a strategy that is not just reactive … and try to come up with an approach that will be suitable in order to prevent a future variant,” he said.

The EMA said it was currently in conversation with vaccine developers in case there is a need for an updated vaccine but added that any such change would need to be coordinated globally.

March 14, 2022 Posted by | Deception, Science and Pseudo-Science | , | 1 Comment

Data Show FDA Process for Emergency Authorization of Pfizer, Merck COVID Pills Not Based on Science

By John Droz, Jr., M.S. | The Defender | March 7, 2022

The U.S. Food and Drug Administration (FDA) in December 2021 granted Emergency Use Authorization (EUA) to two COVID-19 early treatment oral drugs: Pfizer’s Paxlovid and Merck’s molnupiravir.

This was a major milestone, as until then, there were no FDA-endorsed pharmaceutical pill options for people diagnosed with COVID-19.

The standard medical therapy for a newly diagnosed person was: Go home, rest, drink water and go to the hospital if things get dire.

Now, after almost two years, people diagnosed with early stages of COVID-19 can be prescribed a pill!

As background, there are three stipulations a drug must meet in order to obtain EUA from the FDA:

  • There must be an emergency.
  • The treatment in consideration must be safe and offer 50% efficacy.
  • There must not be an alternative available treatment that is safe and effective.

Pfizer and Merck oversaw clinical trials that attempted to prove their products were safe and effective. In the letters of authorization issued to Pfizer and Merck, the FDA outlined what tests were done, what the results were, what some of the limitations and concerns are, etc.

The FDA then generated more detailed advisories to healthcare providers (doctors) for Paxlovid and molnupiravir. These documents give more specifics about use restrictions (e.g., not to children), potentially adverse effects of each drug (e.g., not to be used by pregnant women, etc.), potential conflicts with other drugs (quite a few), etc.

Here are four key points to consider regarding the Paxlovid and molnupiravir data:

  • The tests were conducted by the pharmaceutical companies themselves (not an unbiased entity).
  • No long-term testing was done on either of these drugs (the trials lasted a few months).
  • The effects on patients with many other diseases (e.g., Parkinson’s) were not evaluated and remain unknown.
  • The reported effectiveness of each drug (hospitalization or death: 88% and 30%) are relative not absolute. (See this explanation about this important point.)

OK, kudos to the FDA for giving consumers some early treatment options for dealing with COVID-19. It’s especially good that they are non-hospital, take-at-home therapies.

However, the question remains: How do these FDA-endorsed drugs compare to other over-the-counter (OTC) and non-patented drugs — especially ivermectin (IVM) and hydroxychloroquine (HCQ) — that are reported to have some early treatment effectiveness against COVID-19?

As a scientist (physicist) I try to be careful in analyzing data, to not only be accurate but to present it objectively and understandably.

In that light, see this table where I juxtapose Paxlovid and molnupiravir to IVM, HCQ and three OTC drugs: curcumin, Vitamin D and zinc. The comparisons made are based on about 20 COVID-19 factors (effectiveness, safety, cost, etc.).

Comparison of Major COVID-19 Early Treatment Oral Pharmaceuticals

Click here to increase the size of the chart and access the hyperlinks.

COVID chart

6 takeaways from comparison of Paxlovid and molnupiravir to IVM, HCQ, and OTCs

  • Pfizer’s Paxlovid is reported to have very high effectiveness.
  • HCQ and the curcumin have effectiveness comparable to Paxlovid.
  • Merck’s molnupiravir has very low effectiveness.
  • IVM, Vitamin D and Zinc have effectiveness far superior to molnupiravir.
  • Paxlovid and molnupiravir have more serious side effects than the others.
  • Paxlovid and molnupiravir cost considerably more than the non-patented options.

Are Pfizer and Merck oral treatment EUAs legal? 

Remember, federal law stipulates that an EUA can not be granted unless: “There is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the disease or condition.”

The data in this analysis indicate there are “adequate and available alternatives for treating” COVID-19. If the data are accurate, then these EUAs have questionable legality.

Adequate and available alternatives for treating COVID-19 do, in fact, exist — the FDA has no scientific justification for ignoring IVM, HCQ, Vitamin D and zinc.

Further, if these FDA-issued EUAs for Paxlovid and molnupiravir violate federal statutes, a closer examination of the FDA’s COVID-19 vaccine EUAs seems warranted.

If the Pfizer and Merck EUAs are legal, then why haven’t HCQ and IVM also been given EUAs?

Considering the six takeaways listed above — plus the fact, as noted in the above table, that there have been successful HCQ and IVM studies much larger (~10x) than those done for Paxlovid and molnupiravir — exactly why has the FDA not issued EUAs for IVM and HCQ?

The comparative in Table 1 adequately demonstrates there is no justification for the FDA’s refusal to grant EUAs to IVM and HCQ.

If the FDA had granted EUAs for HCQ and IVM a year ago, hundreds of thousands of COVID-19 deaths would have been prevented.

What FDA policy, procedure or precedent took priority over preventing hundreds of thousands of American deaths?

What about monoclonal antibody therapies?

Let us now expand our comparisons to include current monoclonal antibody therapies:

Comparison of Major COVID-19 Early Treatment Pharmaceuticals

Click here to increase the size of the chart and access the hyperlinks.

Early treatment chart

Note that the four key points identified above, regarding the Paxlovid and molnupiravir data, all apply here.

Some of the main takeaways from this comparison are:

  • Sotrovimab has the highest effectiveness — but the least amount of data.
  • HCQ and curcumin have effectiveness comparable to the bamlanivimab+ and casirivimab+ combinations.
  • The first FDA EUA given to bamlanivimab turned out to be a mistake (as health issues were discovered).
  • All the monoclonals have more serious side effects than the non-EUA options.
  • All the monoclonals cost considerably more than the non-EUA options.
  • All the monoclonals have much less safety data than the non-EUA options.

Again, this comparison shows that IVM, HCQ, curcumin, vitamin D and zinc compare very favorably to all of the early treatments that received EUA from the FDA.


John Droz, Jr. is an independent North Carolina physicist.

© 2022 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.

March 8, 2022 Posted by | Corruption, Deception, Science and Pseudo-Science, Timeless or most popular | , , , , , , | Leave a comment

CHD Says Pfizer and FDA Dropped Data Bombshell on COVID Vaccine Consumers

Children’s Health Defense | March 03, 2022

Washington, DC, — In a 55,000-page set of documents released on Tuesday, the U.S. Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER) is for the first time allowing the public to access data Pfizer submitted to FDA from its clinical trials in support of a COVID-19 vaccine license. This follows U.S. District Judge Mark T. Pittman’s decision on January 6 to deny the request from the FDA to suppress the data for the next 75 years which the agency claimed was necessary, in part, because of its “limited resources.”

A 38-page report included in the documents features an Appendix, “LIST OF ADVERSE EVENTS OF SPECIAL INTEREST,” that lists 1,291 different adverse events following vaccination. The list includes acute kidney injury, acute flaccid myelitis, anti-sperm antibody positive, brain stem embolism, brain stem thrombosis, cardiac arrest, cardiac failure, cardiac ventricular thrombosis, cardiogenic shock, central nervous system vasculitis, death neonatal, deep vein thrombosis, encephalitis brain stem, encephalitis hemorrhagic, frontal lobe epilepsy, foaming at mouth, epileptic psychosis, facial paralysis, fetal distress syndrome, gastrointestinal amyloidosis, generalized tonic-clonic seizure, Hashimoto’s encephalopathy, hepatic vascular thrombosis, herpes zoster reactivation, immune-mediated hepatitis, interstitial lung disease, jugular vein embolism, juvenile myoclonic epilepsy, liver injury, low birth weight, multisystem inflammatory syndrome in children, myocarditis, neonatal seizure, pancreatitis, pneumonia, stillbirth, tachycardia, temporal lobe epilepsy, testicular autoimmunity, thrombotic cerebral infarction, Type 1 diabetes mellitus, venous thrombosis neonatal, and vertebral artery thrombosis among 1,246 other medical conditions following vaccination.

“This is a bombshell,” said Children’s Health Defense (CHD) president and general counsel Mary Holland. “At least now we know why the FDA and Pfizer wanted to keep this data under wraps for 75 years. These findings should put an immediate end to the Pfizer COVID vaccines. The potential for serious harm is very clear, and those injured by the vaccines are prohibited from suing Pfizer for damages.”

The U.S. government has already purchased 50 million doses of the Pfizer vaccine intended for children under five years of age to be delivered by April 30, 2022 although the FDA has yet to grant an Emergency Use Authorization (EUA) for this age group. The risk of serious injury or death from COVID to healthy children is practically nil and so far, the vaccine is not effective when used in young children.

According to The Guardian, “Pfizer made nearly $37bn (£27bn) in sales from its Covid-19 vaccine last year – making it one of the most lucrative products in history – and has forecast another bumper year in 2022, with a big boost coming from its Covid-19 pill Paxlovid.” President Biden advertised Paxlovid in his State of the Union address on Tuesday, the same day the Pfizer data was released to the public. “We’re launching the ‘Test to Treat’ initiative so people can get tested at a pharmacy, and if they’re positive, receive antiviral pills on the spot at no cost,” Biden said during his speech.

From mid-December, 2020 through February 18, 2022, the U.S. government’s database, the Vaccine Adverse Events Reporting System (VAERS), has received 1,134,984 reports of adverse events, including 24,402 deaths, following COVID vaccination. Additionally, there have been 4,021 cases of myocarditis and pericarditis in the U.S. with 2,475 cases associated with Pfizer, 1,364 cases with Moderna and 171 cases with J&J’s COVID vaccine. These include 643 reports of myocarditis and pericarditis in children aged 12 to 17.

“It would be criminal to expose infants and young children to this extremely risky product,” said Holland. “VAERS data show the catastrophic health impacts the vaccine is having on millions of people, yet Pfizer and other vaccine makers are raking in billions of dollars with no fear of being held accountable for injuries and deaths from their vaccines.”

The FDA’s attempt to suppress these data in support of the pharmaceutical industry’s bottom line isn’t a new phenomenon in this country’s public health system. For more information on pharmaceutical corruption and the tight relationship the industry has with government regulatory agencies, read The Real Anthony Fauci: Bill Gates, Big Pharma and the Global War on Democracy and Public Health by CHD Chair and lead counsel Robert F. Kennedy, Jr.

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Children’s Health Defense is a 501(c)(3) non-profit organization. Its mission is to end childhood health epidemics by working aggressively to eliminate harmful exposures, hold those responsible accountable, and establish safeguards to prevent future harm. For more information, visit ChildrensHealthDefense.org.

March 4, 2022 Posted by | Deception | , , | 2 Comments

Pfizer Steps Up Advertising for Its ‘Blockbuster’ Drug to Treat Heart Conditions…

… Including Those Caused by COVID Vaccines

By Michael Nevradakis, Ph.D. | The Defender | February 24, 2022

Two major pharmaceutical companies chose February, the month of love — or hearts — to launch an advertising campaign urging people experiencing heart issues for the first time to visit their doctors.

Pfizer and Bristol Myers Squibb (BMS) this month revived the “No Time to Wait” ad campaign, spending $1.28 million on TV ads alone.

The campaign warns anyone experiencing palpitations and shortness of breath that they may be at increased risk of developing atrial fibrillation (AF), deep vein thrombosis (DVT), other types of blood clots and strokes — the same types of cardiovascular ailments found among people who have received COVID-19 vaccines.

The campaign urges viewers to seek early medical attention in order to reduce the risk of these serious complications.

“Early medical attention” could include prescription drugs — including Eliquis, developed and marketed by none other than Pfizer and BMS.

According to industry publication Fierce Pharma :

“The aim is to get patients back into their doctors’ offices — and of course, if needed, be diagnosed with any relevant condition that may require them to take a blood thinner, such as Eliquis.”

Eliquis, described as a “blockbuster blood thinner and atrial fibrillation (AF) drug,” is a major revenue generator for the Pfizer-BMS alliance, delivering more than $9 billion in annual revenue — far more than competing drugs such as Xarelto (produced by Bayer in conjunction with Johnson & Johnson), and Pradaxa, produced by Boehringer Ingelheim.

Pfizer and BMS relaunched the “No Time to Wait” campaign in conjunction with several advocacy organizations and medical societies, including World Thrombosis Day, which expressed support for the Pfizer-BMS initiative as a means of “educating” the public.

Characterized as a “surround-sound campaign,” Pfizer-BMS use television, radio and social media to deliver the “No Time to Wait” message to the public.

As part of the campaign, a DVT and pulmonary embolism (PE) television advertisement debuted on Valentine’s Day, Feb. 14. The ad showed two patients describing how they “didn’t wait” to speak to their doctors about the AF, DVT and PE symptoms they had begun to experience while performing everyday activities.

Speaking to the camera, the two actors describe symptoms, such as shortness of breath and a racing heart, which are potential indicators of AF, DVT and PE.

Official campaign literature urges the public to take action:

“Right now, people may be weighing a decision to visit a healthcare provider. However, symptoms like swelling, pain, tenderness or redness in the leg, thigh or pelvis can possibly be related to a potentially serious condition such as deep vein thrombosis (DVT). It’s critical to not brush off these symptoms.”

BMS, via its spokesperson, described the reasons for relaunching the campaign:

“We received so much positive feedback from patients and advocates on the impact this campaign had on patients, we knew it was our responsibility to continue to evolve the program and further get the message out.

“In the middle of 2021, we decided to evolve the campaign, with new insight that symptomatic people at risk for AFib or DVT/PE can often dismiss their symptoms or misattribute [emphasis added] them to other health and lifestyle factors.”

Could “misattribute,” in this instance, actually refer to cases where those who had recently received a COVID vaccine experienced the onset of heart-related conditions, in some cases leading to their deaths?

Is Pfizer benefitting from vaccine-induced ailments?

Could the relaunching of the “No Time to Wait” campaign represent an effort by Pfizer to engage in damage control from the increase in vaccine-induced heart conditions — while benefiting from the sale of a drug used to address those same ailments?

There are several objectives Pfizer and BMS could accomplish with the campaign.

First, by launching an advertising campaign warning people they may be at risk of certain heart conditions, Pfizer and BMS are in a sense “naturalizing” heart ailments in young and/or healthy individuals.

Second, by “naturalizing” the prevalence and likelihood of such heart conditions, these companies may deflect blame for these conditions from COVID vaccines, including the Pfizer-BioNTech vaccine.

Third, by referring patients to their doctors, the Pfizer-BMS alliance may directly benefit financially from the increased prevalence of heart ailments and conditions in the vaccinated public — as doctors prescribe more Eliquis, the top-selling blood thinner and AF drug, to treat their symptoms.

‘Normalizing’ heart conditions in young and healthy

According to Pfizer and the Centers for Disease Control and Prevention (CDC), even “the healthiest athletes” are now at risk for blood clots, as stated in an urgent warning issued this month.

The media and health authorities in recent months have proffered multiple explanations for why healthy people are developing blood clotting and heart conditions, blaming everything from weather and energy bills to cannabis use — but not COVID vaccines.

Here are some examples:

  • September 2021: The Times of India ran a story on a “doctors’ reminder” that “nobody is too young for a heart attack.”
  • September 2021: A study indicated that cannabis use doubled the risk of heart attacks in young adults.
  • October 2021: The New York Posreported on “[t]he little-known heart attack that’s striking ‘fit and healthy’ women as young as 22.”
  • November 2021: British tabloid The Sun reported on “[t]he ways cold weather can affect your body — from winter vagina to blood clots.”
  • November 2021: A Times of India report asked why heart attacks are “becoming common in ‘seemingly’ fit people.”
  • November 2021: Healthline reported e-cigarettes can raise the risk of heart disease and stroke.
  • December 2021: Another British tabloid, Expresswarned about the “healthy” diet that “may ‘increase’ your risk of having a heart attack.”
  • January 2022: Norton Health informed us that “[p]reventing heart disease in children is becoming more urgent as more kids develop heart disease.”
  • January 2022: A report is published warning that “sports can break your heart in more ways than one.”
  • January 2022: A report by CT (Connecticut) Insider indicated more people were suffering from heart disease and strokes “after COVID.”
  • January 2022: The Daily Mail warned the “[r]isk of heart problems could be increased even if you drink less than NHS weekly units,” referring to recommendations made by the UK’s National Health Service.
  • January 2022: The Sun ran a report claiming weather can “harm” one’s health, leading to heart attacks, stroke or gout.
  • January 2022: Another report by The Sun warned 300,000 Brits were “living with [a] stealth disease that could kill within 5 years.” The “stealth disease” in question is aortic valve stenosis, a condition where the heart’s aortic valve narrows.
  • February 2022: Nature magazine reported the risk of heart disease “soars after COVID — even with a mild case.”
  • February 2022: A doctor interviewed on the UK’s ITV warned an increase in energy bill amounts may cause heart attacks and strokes.

Mark Crispin Miller, professor of media, culture and communication at New York University and founder of News from Underground compiled a list of reports like those listed above.

In looking at incidents and reports during the week of Feb. 8-14 alone, Crispin told readers:

“Before we note all those whose ‘sudden deaths’ made news just this past week — ‘unexpected deaths’ with no reported cause, or due to heart attacks, strokes, blood clots, cardiac arrest or swift, aggressive cancers (all known to be ‘adverse events’ post-‘vaccination’) — let’s review how this unprecedented global spike in sudden death has been deliberately obscured by ‘our free press.’”

Miller highlighted an ABC News report, “‘Broken heart’ cases surge during COVID, especially among women.”

In another example, Science magazine reported geneticists found the answer to “sudden unexplained child deaths.”

Downplaying of the connection between the COVID vaccines and serious heart conditions often has involved high-profile athletes.

For instance, 33-year-old soccer star Sergio Aguero of FC Barcelona was forced to announce his retirement in December 2021, after suffering chest pains and dizziness during a match in October 2021. He never played again.

According to Aguero’s cardiologist, the vaccine was not the reason for his ailment and retirement.

However, Aguero himself, in a Twitter question-and-answer session earlier this month, did not reject this possibility, stating: “I don’t know if Covid or [the] vaccine caused my retirement.”

Media, however, continue to promote the narrative that vaccines have nothing to do with the surge in sudden illnesses or deaths among athletes.

For example, Miller cited a Feb. 1 Washington Post article describing stories of athletes dying due to COVID vaccination as a “falsehood.”

Miller then compared what he described as the “disgraceful” Washington Post report with a documented timeline of athletes who suffered from heart failure between March 2021 and January 2022.

This string of incidents is further illustrated and detailed by the Real Science blog, which found 707 such incidents as of this writing and demonstrated in graphical form the sharp increase in heart failure incidents involving athletes over the course of 2021 and into 2022, as COVID vaccination uptake increased.

Nevertheless, Politifact, in December 2021, assured the public “[t]here’s no proof athletes collapsed with heart issues because of COVID-19 vaccination,” while in November 2021, U.S. News & World Report warned “COVID may trigger [a] heart condition in young athletes.”

As reports of vaccine-induced heart ailments rise, studies confirm link

Multiple studies and reports have confirmed a link between COVID vaccines and heart ailments.

These reports include:

  • September 2021: A report found adolescent boys are at higher risk of hospitalization from the Pfizer vaccine than from COVID.
  • November 2021: Renowned cardiologist Dr. Steven Gundry warned the Pfizer and Moderna COVID vaccines “dramatically increase” the risk of heart attacks.
  • January 2022: Data from the Vaccine Adverse Event Reporting System (VAERS) indicates myocarditis tops the list of COVID vaccine injuries for 12- to 17-year olds.

Meanwhile, reports continue to grow of previously healthy people who develop heart conditions following COVID vaccines.

Here are just a few examples:

  • June 2021: A 13-year-old Michigan boy died three days after receiving the second dose of the Pfizer COVID-19 vaccine.
  • June 2021: An athlete who received the second dose of the Pfizer vaccine developed myocarditis, triggered by the vaccine.
  • August 2021: A 14-year-old boy developed myocarditis after receiving the Pfizer vaccine.
  • October 2021: A 17-year-old developed multisystem inflammatory syndrome and myocarditis after receiving the Pfizer vaccine.
  • December 2021: A 26-year-old’s death from heart inflammation was found to have “probably” been caused by the Pfizer vaccine.
  • January 2022: An autopsy found the death of another 26-year-old from myocarditis was the direct result of receiving the Pfizer vaccine.
  • February 2022: A six-year-old developed vaccine-induced myocarditis, leaving him unable to walk.
  • February 2022: Autopsies showed that the deaths of two teenage boys who died soon after receiving the Pfizer vaccine were directly caused by the vaccine.

Reports and studies like those listed above have led to increasing calls for the vaccination of minors to be reassessed or outright halted, including:

  • January 2022: More than 30 experts called on UK regulators to reassess COVID vaccination for 12- to 15-year olds.
  • January 2022: Data revealed reports of heart disease following COVID vaccines had increased 15,600% in young people under the age of 30, compared to the previous 31 years of heart injuries reported following receipt of FDA-approved vaccines.

They’ve also triggered calls for further scrutiny on the part of health authorities, which appear to have had some effect, at least in certain instances.

For example:

  • October 2021: The U.S. Food and Drug Administration delayed a decision on green-lighting the administration of the Moderna vaccine to adolescents, citing heart problems (however, the Pfizer vaccine was nevertheless approved for the same age group).
  • October 2021: Health authorities in Denmark and Sweden paused administration of the COVID vaccine to younger age groups, citing reports of myocarditis.
  • December 2021: The CDC was monitoring eight cases of heart inflammation reported in 5- to 11-year-olds who received the Pfizer vaccine.

Nevertheless, in January 2022, the Centers for Disease Control and Prevention (CDC)  refused to investigate the case of a 13-year-old who died of myocarditis days after receiving the Pfizer vaccine, while in August 2021, doctors “downplayed” the connection between the onset of myocarditis in a 25-year-old, and receipt of the Moderna vaccine.

‘No Time to Wait’ campaign spending indicative of broader Big Pharma marketing expenditures

Big-dollar ad spending is par for the course for Big Pharma companies such as Pfizer, as previously reported by The Defender.

For instance, a 2019 Forbes article reported Pfizer spent twice as much on marketing/selling as it spent on research.

Pfizer’s heavy advertising is also evident in its most recent quarterly report, for the fourth quarter of 2021. The report indicates a 10% increase — a total of $12.7 billion — in 2021 “SI&A expenses,” which include marketing and advertising, as compared to 2020, when there was no COVID vaccine available.

The report also projects Pfizer’s SI&A expenses will range between $12.5 and $13.5 billion in 2022.

BMS, in turn, spent $990 million in advertising and marketing in both 2020 and 2021 — after spending $633 million in 2019.

In sum, pharmaceutical ad spending totaled $6.58 billion in 2020, and was expected to surpass $11 billion by the end of 2021 — including $3.9 billion in spending on television advertisements alone.

In addition to “traditional” advertising and marketing campaigns, pharmaceutical companies adopted some more creative ways to promote their products — and perhaps purchase further goodwill on the part of media outlets.

In an October 2021 article, The Defender highlighted several examples of Pfizer sponsoring television news programs and segments, ranging from “Good Morning America” to “Anderson Cooper 360°” to “CBS HealthWatch.”

For example, an Oct. 4, 2021 tweet posted on CNBC’s official Twitter account portrayed Pfizer in glowing terms, accompanied by the text: “paid post for Pfizer.”

And a March 15, 2021 tweet by Pfizer expressed pride in the release of a National Geographic documentary, “Mission Possible: The Race for a Vaccine.”


Michael Nevradakis, Ph.D., is an independent journalist and researcher based in Athens, Greece.

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February 25, 2022 Posted by | Deception, Mainstream Media, Warmongering | , , | 3 Comments