[Part II] Dr Melissa McCann on Pfizer, TGA, FDA, LongCovid/VAED & Excess Deaths

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(Darn it, my host couldn’t handle the size of the post so I split into two Parts. See also—Part I, which has the video)

THIS IS OUTRAGEOUS. This is a must-listen-to important speech by QLD GP Dr. Melissa McCann. UNBELIEVABLY TRAGIC & CRIMINAL. (Video + Transcript + Screenshots + REFS)

Pfizer denies any warning needed for the frail

And we see an email requesting some editing of the draft media release by none other than the sponsor themselves, Pfizer, which perhaps explains why doctors and the public were not advised of these risks to elderly people. (01) (02)

Pfizer-Says-Pfizer-Safe

19 January 2023

FOI 4073
Notification and subsequent investigation conducted as part of the TGA review of reports of deaths in nursing home residents in Norway after Pfizer BioNTech vaccination.
FOI 4073 document 1 (pdf,321kb)
FOI 4073 document 2 (pdf,308kb)wow, read this one! Suggests that someone at health.gov.au wanted to put a safety signal to precaution vaccinating the frail elderly—but Pfizer said “nah” ~ Penny
FOI 4073 document 3 (pdf,424kb)
FOI 4073 document 4 (pdf,220kb)
FOI 4073 document 5 (pdf,220kb)
FOI 4073 document 6 (pdf,259kb)
FOI 4073 document 7 (pdf,221kb)
FOI 4073 document 8 (pdf,150kb)
FOI 4073 document 9 (pdf,104kb)

This is completely unacceptable.

These official communications are not advertising claims or publicity stunts. These are serious matters relating to public safety, regarding reports of deaths in a vulnerable population.

Inconsistencies are also seen in the review of the clinical trials for the Pfizer product. (See also: BMJ 2022;379:o2628) (03)

For example, these FDA review documents found multiple cases of cardiac arrest, cardiac death and metastatic cancers (p.71) in the first clinical trial for the vaccine, but the FDA assessed these deaths as unlikely to be related to vaccination. (04)

However, no patient level data to support this conclusion has been provided or made public, and in one example, blood clots are reported (p.65), which are attributed to diabetes and an ankle fracture, but no further information provided on these cases. (05)

One patient had pain and paraesthesia that the clinical trial investigator considered was related. (06) However, Pfizer disagreed with the investigator, (p.73) stating there was not enough evidence to support a causal relationship, and thus, the FDA considered the side effect unrelated to the vaccine. (07) (08) (09)

In another event, the trial investigator considered a heart attack in a young person to be related to the vaccine (p.75), but again, the company and the FDA disagreed with this investigator.

And the TGA accepted all of these conclusions despite having no patient level data on these events to review themselves. (FOI 2289, the TGA acknowledges to have not obtained individual patient level data) (10) (11) (12) (13) (14) (15)

A recent independent analysis of the original trial came to different conclusions, finding an excess of severe adverse events compared to placebo, which would point to the need for a formal harm-benefit analysis. (16) (17)

Brought to you by… Pfizer

How could such different conclusions be drawn by independent bio-status tissues reviewing the same trial data when the authors of the original study had concluded that the incidents of severe events was low and similar in the vaccine and placebo groups and that safety over a median of two months was similar to that of other viral vaccines? (18) (19)

The answers to such puzzles are sometimes found in the conflict of interest disclosure documents. For example, the original Pfizer trial publication, we find that almost all of the study authors were employees and shareholders of Pfizer. (20) (“Well, well, well… brought to you by… Pfizer” ~ Penny) (21) (22)

  1. Dr. Absalon reports personal fees from Pfizer Inc, outside the submitted work (Pfizer employee and holds stock)
  2. Dr. Bailey reports personal fees and other from Pfizer Inc, outside the submitted work (Pfizer employee and holds stock)
  3. Dr. Cooper reports personal fees and other from Pfizer Inc, outside the submitted work (Pfizer employee and holds stock)
  4. Dr. Dormitzer reports personal fees and other from Pfizer Inc, outside the submitted work (Pfizer employee and holds stock)
  5. Dr. Gruber reports personal fees and other from Pfizer Inc, outside the submitted work (Pfizer employee, stock, stock options)
  6. Dr. Gurtman reports personal fees and other from Pfizer Inc, outside the submitted work (Pfizer employee and holds stock)
  7. Dr. Hammitt reports grants from Pfizer, during the conduct of the study; grants from Merck, grants from Novavax, outside the submitted work; (Pfizer Research grant to my institution)
  8. Dr. Jansen reports personal fees and other from Pfizer Inc, outside the submitted work (Pfizer employee and holds stock)
  9. Dr. Kalina reports personal fees and other from Pfizer Inc, outside the submitted work (Pfizer employee and holds stock)
  10. Dr. Kitchin reports personal fees and other from Pfizer Inc, outside the submitted work (Pfizer employee and holds stock)
  11. Dr. Koury reports personal fees and other from Pfizer Inc, outside the submitted work (Pfizer employee and holds stock)
  12. Dr. Li reports other (employment compensation) from Pfizer Inc, outside the submitted work (former Pfizer employee and holds stock)
  13. Dr. Lockhart reports personal fees and other from Pfizer Inc, outside the submitted work (Pfizer employee and holds stock)
  14. Dr. Mather reports personal fees from Pfizer, Inc, outside the submitted work (Pfizer employee)
  15. Dr. John Perez reports personal fees and other from Pfizer Inc, outside the submitted work (Pfizer employee and holds stock)
  16. Dr. Pérez Marc reports personal fees from Pfizer, during the conduct of the study; personal fees from Pfizer, outside the submitted work; (Pfizer fees per sub-investigator, Argentina, professional fees for PI in studies of RSV in pregnant women and pneumococcal vaccine in children, Argentina)
  17. Dr. Polack reports personal fees from JANSSEN, grants from NOVAVAX, INC, personal fees from BAVARIAN NORDIC A/S, personal fees from PFIZER, personal fees from SANOFI, personal fees from REGENERON, personal fees from MERCK, personal fees from MEDIMMUNE, personal fees from VIRBIO, personal fees from ARKBIO, personal fees from DAIICHI SANKYO, outside the submitted work. (Pfizer Investigator, site management organization co-owner)
  18. Dr. Roychoudhury reports personal fees and other from Pfizer Inc, outside the submitted work (Pfizer employee and holds stock)
  19. Dr. Swanson reports personal fees and other from Pfizer Inc, outside the submitted work (Pfizer employee and holds stock)
  20. Dr. Thomas reports other from Pfizer, during the conduct of the study; personal fees from Merck, personal fees from Sanofi, personal fees from Takeda, personal fees from Themisbio, personal fees from Janssen, outside the submitted work (My University is receiving resources for the conduct of the COVID vaccine trial being reported in this manuscript. I am the PI at my University.)
  21. Dr. Tresnan reports personal fees from Pfizer, Inc, outside the submitted work (Pfizer employee)
  22. Dr. Tureci has nothing to disclose.
  23. Dr. Frenck has nothing to disclose.
  24. Dr. Moreira has nothing to disclose.
  25. Dr. Nell has nothing to disclose.
  26. Dr. Sahin has nothing to disclose.
  27. Dr. Schaefer has nothing to disclose.
  28. Dr. Unal has nothing to disclose.
  29. Dr. Zerbini has nothing to disclose.

Long Covid / VAED

And now we have the issue of Long COVID, and a recent Senate Inquiry has commenced into repeat COVID infections and Long COVID, and anyone who’s been following that inquiry (23), or read many of the submissions, (24) will have read the harrowing stories of patients who mostly reported being fully vaccinated and therefore expected mild disease or not to catch it at all, but who have been left with a range of medical conditions, severe disabling fatigue, brain fog, pots, heart conditions, and autonomic dysregulation.

These patients were often young, fit and healthy and are now unable to work and are otherwise disabled by Long COVID.

I wrote a submission to this inquiry and drew attention to the issue of Vaccine-associated enhanced disease (VAED), and this is extremely important because if vaccination actually increases the risk of a severe complication from COVID infection, then we need to be protecting the public by looking at things like air filtration and research and treatment of Long COVID and other measures. We should not be recommending further vaccines if it is likely or even possible that this strategy has in fact made the COVID pandemic worse, or may drive more severe disease. (25) (26) (27)

This possibility of Vaccine-associated enhanced disease (VAED) was reviewed by experts in March of 2020 when the COVID-19 enhanced-disease consensus meeting of experts (CEPI, etc.) in partnership with the Brighton collaboration, convened to discuss the risk of Vaccine-associated enhanced disease, and evidence for this phenomena was presented, including the cellular mechanisms and caution around various types of vaccine platforms and adjuvants was discussed. (28) (29) (30) (31) (32) (33) (34)

In October of 2020, a Brighton collaboration case definition and guideline for Vaccine-associated enhanced disease (VAED) was published. (35)

This expert case definition states that “VAED is an illness that occurs in persons who receive a vaccine and who are subsequently infected with the pathogen that the vaccine is meant to protect against,” and stated that “All cases of vaccine failure should be evaluated for VAED.”

In Australia, we had the unique situation of large numbers of people vaccinated who then “caught COVID” and therefore by definition experienced vaccine failure, and by this expert definition, each case of this should have been evaluated for VAED.

The manifestations of VAED are not just respiratory but as this table describes includes acute cardiac injury, bleeding or clotting events, kidney injury, abdominal pain, altered mental states, convulsion, seizures, fatigue, arthritis, multi-organ failure and death.

Organ systemClinical parametersLaboratory parameters
Respiratory system●Cough ●Tachypnea ●Dyspnea ●Lower respiratory tract disease ●Respiratory failure ●Pulmonary hemorrhage ●Radiographic abnormalities●Oxygen requirement ●Hypoxemia ●PaO2 ●PaO2/FiO2 ratio ●Aa gradient
Cardiovascular system●Tachycardia ●Hypotension/ Hypertension ●Acute cardiac injury ●Vasculitis/ Vasculopathy ●Myocarditis ●Heart failure ●Cardiogenic shock●Abnormal ECG ●Abnormal Echocardiogram ●Troponin ●B-Natriuretic Peptide (BNP)
Hematopoietic and Immune system●Coagulopathy ●Disseminated intravascular coagulation ●Bleeding/ Thrombotic events●Leukopenia, lymphopenia ●Thrombocytopenia ●B and T cell function assays ●Altered coagulation parameters (PT, PTT, D-Dimer, INR)
Inflammatory markers●Pro-inflammatory state●Elevated inflammatory markers (CRP, procalcitonin) ●Elevated Ferritin, LDH ●Elevated cytokines
Renal system●Renal dysfunction ●Acute kidney injury ●Renal replacement therapy●Decreased urine output ●Serum creatinine ●Glomerular filtration rate
Gastrointestinal and hepatic system●Emesis/Diarrhea ●Abdominal pain ●Hematochezia/Melena ●Hepatitis ●Liver dysfunction ●Acute liver failure●Electrolyte abnormalities ●Elevation of liver enzymes ●Elevated bilirubin
Central Nervous System●Altered mental status ●Convulsions/seizures ●Cranial nerve involvement ●Unconsciousness●Elevated intracranial pressure ●Abnormal CSF parameters
Other●Fatigue ●Myalgia/myositis/myonecrosis ●Arthralgia/arthritis ●Multiorgan failure ●Death●Viral load (PCR Ct value) ●Antibody titers ●Histopathology

It is basically an abnormal immune response and an exuberant immune inflammatory response following vaccination that is triggered by later contact with the virus, and the clinical outcomes described by this expert definition are:

The following outcomes would be concerning for VAED or VAERD in a person with confirmed infection:

  1. Death. This would be particularly concerning if death occurs in person without other risk factors for mortality (note phase I-II trials with selected healthy population) or if it occurs at higher rates than expected.
  2. Hospitalization, including hospitalization above expected rates.
  3. Worsening or clinical deterioration over time, particularly, although not exclusively, if differing from the anticipated natural course of the disease.
  4. Prolonged clinical course compared to natural disease. (by definition, this is long COVID)
  5. Complications of acute disease, new morbidities or new diagnoses subsequent to natural infection post-vaccination (for example higher rate of MIS-C or MIS-A)

In Summary:

Every positive case in a vaccinated person should have been carefully evaluated for enhanced disease, and all deaths in vaccinated individuals should have been evaluated for VAED as a cause, according to this expert guideline.

Excess Deaths

If we look at the excess death figures, the public health experts tell us that it’s “definitely not the vaccines,” but it might be “delayed impact of COVID”. Well, I think we’ve demonstrated that is a lie, but even if it was, that would also be evidence of VAED and therefore the vaccines would still be the cause of the excess deaths in that circumstance also. (36) (37) (38)

So when we ask, “Was this healthy person or that healthy person who’s just died suddenly and unexpectedly; were they vaccinated?”, this is not some wild conspiracy theory, this is what these expert guidelines instructed before the vaccine roll out stating that, “A control group is helpful to compare the frequency of cases and the severity of illness in vaccinees vs. controls,” [..] “Including the occurrence of specific events of concern such as hospitalisation and mortality,”

Instead, from our public health officials, we were told that, “Breakthrough infections are expected amongst people who are fully vaccinated, but this does not mean the vaccines are not working,” and there has been no mention of the expert consensus summary or the Brighton collaboration definitions of VAED. (39)

So we are left to presume that the officials making these important public health decisions have not familiarised themselves with the available scientific evidence.

Class Action for Vaccine-Injured & Bereaved

So having lost faith in the ability of public health officials, and seeing the devastating impacts on patients who had been left with disabling injuries after vaccines who were not able to access work cover or the compensation scheme because their adverse event was not on the product information, who had been mocked and ostracised and belittled by everyone from their doctors to their workplaces to their family and friends. I took on a role as a patient advocate to assist these patients to explore their options for legal recourse, and this has culminated in a proposed class action for compensation for vaccine injured patients and the bereaved that is to propose to be filed in the federal court in the coming weeks.

Over 350 people have expressed an interest to join this action, and of this group of people I have been continually amazed at their resilience, their strength and their ability to care for each other.

These patients have a range of injuries, horrific injuries from paralysis to seizure disorders, deafness, blindness, strokes, myocarditis, stillbirths, cardiac arrest, blood clots, and aggressive cancers.

I have seen members of this group support each other with ideas for referrals and treatment protocols to help each other crowdfund for MRIs and to ask for nothing more than to be heard and acknowledged and treated with dignity—not to be mocked or ignored.

The proposed action is being funded entirely by donations and will be representing everyone in Australia with a vaccine injury and God-willing we will bring justice and compensation for all the injured.

Among the group is Raelene, a remarkable strong woman representing Caitlin Gotze, her beautiful, vibrant and healthy daughter. (Page 79 | Video) Caitlin became unwell immediately after her second mRNA vaccine and then died suddenly and unexpectedly just weeks later, and yesterday should have been Caitlin’s 25th birthday, instead her mother and her brothers spent yesterday grieving the loss of her life taken too soon. (40) (41) (42) (43) (44)

These people are not just excess death numbers or TGA case report statistics. This is someone’s mother, someone’s daughter, someone’s son, and I have seen Raelene extend the arm of comfort, friendship and a listening ear to the bereaved around the world, who have reached out to her after hearing her story and who just needed to talk to another person who would understand what it is like to lose a child and particularly to lose a healthy child following vaccination, when almost everyone would turn their back and say, “it was coincidence,” or, if it was caused by the vaccine at all, that the “loss of their child was somehow for the greater good.”

It is my greatest hope that in 2023 doctors will turn back to our Code of Conduct remembering that we each have a “responsibility to behave ethically to justify the trust the community has or perhaps had in the medical profession.” (45)

But the care of our patients is our primary concern, and good care involves taking into account the patient views, and respecting and recognising the patient’s rights to make their own healthcare decisions.

  • 3.2.7 Only recommending treatments when there is an identified therapeutic need and/or a clinically recognised treatment, and a reasonable expectation of clinical efficacy and benefit for the patient. (46)
  • 3.2.9 Taking steps to alleviate patient symptoms and distress, whether or not a cure is possible.
  • 3.2.13 Encouraging patients to take interest in, and responsibility for, the management of their health and supporting them in this.
  • 3.2.14 Ensuring your personal views do not adversely affect the care of your patient or the referrals you make.

And to take steps to alleviate patient symptoms and distress whether or not a cure is possible as doctors we are not only allowed but required to ask patients when they had a vaccine and if it might have caused their symptoms and to discuss this with our colleagues and to work together to find treatments for our patients who are suffering and to demand that our government and political leaders provide financial support for these patients to access the care they need. Thank you.

References[+]

Penny... on Health
Penny... on Health

Truth-seeker, ever-questioning, ever-learning, ever-researching, ever delving further and deeper, ever trying to 'figure it out'. This site is a legacy of sorts, a place to collect thoughts, notes, book summaries, & random points of interests.

DISCLAIMER: The information on this website is not medical science or medical advice. I do not have any medical training aside from my own research and interest in this area. The information I publish is not intended to diagnose, treat, cure or prevent any disease, disorder, pain, injury, deformity, or physical or mental condition. I just report my own results, understanding & research.