This post is by our South American correspondent.
A Water into Wine miracle occurred in Buenos Aires in October 2020. A 66 year old volunteer, number 12315632 in Pfizer’s Comirnaty vaccine trial, had received his second vaccination of BNT162b2 (30 μg) on the nineteenth of September in the city’s Hospital Militar.
Twenty-nine days later he was admitted to hospital with chest pain.
According to the Adverse Events file released by FDA to PHMPT, this man had a serious adverse event of “Pericarditis” grade 2, which clearly someone in the trial process deemed not related to the vaccine. It apparently did not resolve.
Then a miracle occurred.
Somehow the diagnosis of pericarditis at least, maybe not the underlying condition, became “suspected covid-19”. The Suspected Covid-19 diagnosis survived three negative covid swab tests. Pfizer concurred with this view of the investigator or the treating doctor or someone who was involved in assembling the ‘facts’ that Suspected Covid-19 – Suspected is the key word – was the diagnosis.
(DSM could be doubled in size if we add Suspected to everything and perhaps doubled again for Suspected Martian disorder or whatever related entities we can conjure up. The link to DSM here is very deliberate as readers are about to find out).
The Narrative for this is reproduced below. It comes from a Narrative (Sensitive) file – a different file to the Adverse Events file – that says:
Subject C4591001 1231 12315632, a 66-year-old white male with no reported medical history, received Dose 1 on 31 Aug 2020 and Dose 2 on 19 Sep 2020 (Day 20). The subject reported suspected (but not confirmed) COVID-19 on 17 Oct 2020, 28 days after receiving Dose 2.
On 17 Oct 2020 (Day 48) the subject experienced left shoulder and arm pain. On 18 Oct 2020 (Day 49), at 01:00 AM the subject experienced chest pain and dyspnea and called the emergency system. He was taken to the emergency room by ambulance where they performed: electrocardiogram with no ischemic changes, chest x-ray with unknown results, chest computerized tomogram that showed pneumonia of unknown localization. At the time of reporting the subject had presented with a temperature of 38°C. Blood/laboratory tests were done but results were unreported.
In accordance with the hospital COVID-19 pandemic protocol the subject had a SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) swab. The date of discharge from hospital is unknown, however, the site received a discharge summary on 20 Oct 2020 (Day 51) stating the result of the SARS-CoV2 RT-PCR swab was negative. The swab taken for the purposes of the study and analyzed at the central laboratory was also negative. An additional SARS-CoV-2 test performed locally on 28 Oct 2020 was also negative. The cause of the potential COVID-19 illness remains unknown as no other microbiological studies were performed. The suspected (but not confirmed) COVID-19 illness was ongoing at the time of the last available report. In the opinion of the investigator, there was no reasonable possibility that the suspected COVID-19 was related to the study intervention or clinical trial procedures. Pfizer concurred with the investigator’s causality assessment.
As we have reported, Augusto Roux was on the receiving end of a similar miracle, a short while before. His hospital-confirmed vaccine-induced adverse reaction of pericarditis similarly disappeared into “suspected covid” and then “severe anxiety”. At the moment it looks like iTRIALS team led by Fernando Polack were responsible for this transformation.
We have written to Drs Polack and Thomas, lead investigators for this trial.
Dear Drs Polack and Thomas]
The writing of papers like the ones in the NEJM on which you are first authors is a well-oiled business. I realise that you did not have access to the trial data, and likely may not know the answer to the following, or if you do know the answer you may not be in a position to help me.
I am copying FDA and ANMAT into this email for this reason, without any expectation regulatory bureaucrats are likely to do anything soon.
My query concerns a second instance of a BNT162b2 vaccinated patient from Argentina who is recorded as developing an adverse event of pericarditis 28 days after receiving his second dose.
The volunteer’s trial number is 12315632.
Page 996 of the narrative account of this event states that he had “probable covid-19 illness” (despite three negative swab tests) with no mention of pericarditis.
The pericarditis is documented in page 286 of the Clinical Safety Report. It is also documented in an Adverse Events document. The mention on p 286 of the Clinical Safety report tells us that:
Pericarditis 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. A narrative for this event is provided (see Section 22.214.171.124.4.4 [Subject C4591001 1231 12315632]).
This reference to a narrative takes us back to the account noted above, which has no mention of pericarditis.
I imagine most people reading these entries would view pericarditis as a more likely diagnosis than probable Covid-19 illness in this case. It is also difficult to see a basis for not making a possible linkage to the vaccine in an event that is coded as Severe, toxicity grade 2.
The clinical information in the narrative summary about this volunteer’s hospital admission seems inadequate. It looks possible that the data for #12315632 might have been altered.
This case seems a replay of what happened to volunteer 12312982, Augusto Roux, whose clinically confirmed adverse event of illness with pericarditis has disappeared.
Mr Roux seems to have had a raw deal from his participation in this trial, as perhaps this other volunteer has also. The consent form for the trial indicates that Mr Roux and this latest volunteer would get clinical support from Pfizer in the event of anything going wrong. This didn’t happen in Mr Roux’s case.
One plausible explanation for the disappearance of injuries to these two volunteers is that keeping them in place would jeopardise the rapid approval of this vaccine – this seems to be direct conflict with Pfizer and i-Trials obligations in this trial.
Quite aside from the injury to this volunteer, as with Mr Roux, the conflicting documents cause their own problem. Knowing the sequence in which they were assembled and who they were written by might help. I realise there were a range of ‘fact’ checkers from Pfizer and iTrials and Icon and perhaps others involved.
Can you send me the back and forth between these parties or otherwise help to reconcile these incompatible trial documents? If this can be done for this volunteer, I would appreciate a similar sequence of documents and back and forth with dates and times in the case of Augusto Roux.
I realise this trial appears to have been governed by military secrecy needs in both Argentina and the United States. I imagine you might both be under orders to say nothing. The regulators may be similarly constrained.
I have no idea whether Data Safety Monitoring Boards are also constrained in this respect and for this reason I have included the DSMB for this trial in this correspondence also.
At the end of the day, in military speak, there is an obligation to troops who have volunteered in this War, whose contracts essentially say they will be given the best possible treatment, who were provided with Dr Polack’s day and night time phone numbers in the contract they signed, but who, in this case, cannot get the right treatment, never mind the best treatment, if it is not possible to acknowledge the source and nature of their injuries.
These volunteers are being treated as soldiers were in the days before the American Civil War.
This email will be posted publicly. I will happily also post any responses I receive from any party copied in here.
On August 18, 1996 in the Church of Santa María in Almagro, Buenos Aires, Argentina, the start of a miracle occurred. A consecrated Host (bread) had been desecrated on a candle holder in the back of the Church. Unable to consume the Host, the priest, Fr. Pezet put it into a glass of water into the tabernacle so that it would dissolve.
When he opened the tabernacle on August 26, he saw that the Host had been transformed into a piece of bloody tissue which was much larger than the original Host. When Fr. Pezet informed Archbishop Bergoglio of the occurrence, the archbishop asked him to have the Host professionally photographed.
After three years, the bloody tissue had not decomposed. Archbishop Bergoglio asked that the bloody tissue be scientifically examined. The analyzed material has been shown to be a fragment of the heart muscle found in the wall of the left ventricle close to the valves.
This was reported widely in Catholic Communities as Eucharistic Miracle of Buenos Aires. The official documentary is here. The version we have has an opening additional paragraph.
According to Fr. Robert Spitzer, a Jesuit priest and doctor of astrophysics, a recent Jesuit survey has revealed that, far and away, the greatest cause today for people losing their faith and becoming either agnostic or atheistic in our country (The US) is the perceived conflict between faith and science. In fact 93% of those who lose their faith say the claims of religion do not hold up to the scrutiny of what we know through modern science. Put another way, these individuals have simply shifted their faith in God to faith in science as the definitive way of knowing truth.
The Church position is that faith and reason are simply different ways of coming to know truth, either through divine revelation or through careful observation of the created universe. They can never truly be in conflict because God, who is The Truth, is both the creator of the ordered, observable universe and the very author of science. However, to try to reach those who have lost their faith in this way and who perhaps do not share the Church’s view on truth, Spitzer has suggested featuring miracles of the Church that have undergone intense scientific scrutiny, where “the finger of God” has stumped all scientific explanation. One definition of “miracle” is “an event that is not explicable by natural or scientific laws and is therefore considered to be the work of divine agency”. Understood in this way, the existence of miracles should lead one to faith.
The first point to note of course is that Robert Spitzer was the architect of the modern DSM system.
Second, what gets called science these days is a ghost-written literature, a great deal of which is essentially fraudulent, one of whose functions like all organized religions is to keep the people moving together as a herd.
Third, the Bible that Bergoglio claims to adhere to gives a very different message. The Kingdom of God is in everyone you meet. Your job is not to tell them to get vaccinated – Bergoglio was later the first to mandate vaccines. Your job, like a Good Samaritan, is to recognize them when they are injured.
The people who get harmed on a drug or vaccine are the Crack through which the Science gets in. As Spitzer would have been better placed saying – they deserve careful observation of the created universe. They are increasingly, however, as the bible put it, the Stone that the Builders have rejected.
And there are new ‘sciences’ like Harmatology conjured into being to make them disappear,
If Bergoglio wants to reconcile religion and science, rather than meeting up with the Global Elite to plan a post Covid World he should pay more heed to Augusto Roux, Brianne Dressen, volunteer 12315632 and the hundreds of others in this and other vaccine trials that have gone missing – see The Disappeared.
Spitzer seems to be struggling to say science and religion need truth not myth. When it comes to treatment induced injuries, these days both science and religion lean toward myths rather than truth. Bergoglio seems all too keen to reconcile ‘science’ with ‘religion’.Share this:
Copyright © Data Based Medicine Americas Ltd.
If there are two or more unrecognized pericarditis cases in Buenos Aires which was probably a very well run site compared to many others in this trial, then there may have been 15 – 20 or more overall
According to FDA, TGA, EMA and other documents
8.3.2. Method of Detecting AEs and SAEs
The method of recording, evaluating, and assessing causality of AEs and SAEs and the procedures for completing and transmitting SAE reports are provided in Appendix 3.
Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and nonleading verbal questioning of the participant is the preferred method to inquire about AE occurrences.
8.3.3. Follow-up of AEs and SAEs
After the initial AE/SAE report, the investigator is required to proactively follow each participant at subsequent visits/contacts. For each event, the investigator must pursue and obtain adequate information until resolution, stabilization, the event is otherwise explained,
or the participant is lost to follow-up (as defined in Section 7.3).
In general, follow-up information will include a description of the event in sufficient detail to allow for a complete medical assessment of the case and independent determination of possible causality. Any information relevant to the event, such as concomitant medications
and illnesses, must be provided
8.3.4. Regulatory Reporting Requirements for SAEs
Prompt notification by the investigator to the sponsor of an SAE is essential so that legal obligations and ethical responsibilities towards the safety of participants and the safety of a study intervention under clinical investigation are met.
The sponsor has a legal responsibility to notify both the local regulatory authority and other regulatory agencies about the safety of a study intervention under clinical investigation.
The sponsor will comply with country-specific regulatory requirements relating to safety reporting to the regulatory authority, IRBs/ECs, and investigators.
Investigator safety reports must be prepared for SUSARs according to local regulatory requirements and sponsor policy and forwarded to investigators as necessary.
“Lord! It’s a miracle! Man up and vanished like a fart in the wind!” ~ Warden Samuel Norton, Shawshank Prison Governor
Fascinating bit of research done here.
Do we know if the patient with “suspected Covid19” was told to have an imagined self-isolation period?
If, indeed, he had suspected Covid19, were others in the trial that had been in close proximity to him, including investigators and staff, given PCR tests and told to self-isolate, even if those tests were negative?
Suspected definition: To form an opinion from little or no evidence. (No science)
Faith definition: Complete trust or confidence in someone or something (No science)
They may as well have written, “It is thought” or “It’s widely believed” to cover all bases.
With such a study protocol/design, it would be a miracle if any adverse event actually showed that it was vaccine related.
Allowed on twitter
Booted off and locked out of twitter
The back story on Robert Spitzer
James Davies’ speech is very interesting, especially for us on the ‘recieving end’ of DSM.
How can the whole of western psychiatry be boiled down to a handful of professors having a meeting behind closed doors, some of which wasn’t even vocal enough to be called participants?
In a ‘box-ticking’ and ‘questionaire’ world, such DSM origin makes sense. But on the other hand, they are all willing to admit that the human brain is far more complex, they just refuse to mention both in the same sentense.
From birth to death and everything in between we can be sure corruption of truth as is known even provisionally is rife . How many ‘scientists’ are willingly involved would be worth discovering. Can ‘science’ itself be corrupted is a conundrum . The project of discovery in certain fields especially has become an obscenity and a sadness It leaves many who honour a spiritual dimension to life which can be coupled to the hope in ‘science’ with a massive loss ., like a constant heartache ,or drug induced pericarditis. Compensation will help ( eg people killed and harmed by the cover up regarding contaminated blood ) but not heal the injury being done to humanity which seems is unstoppable . The world has never been a place of innocence but now corruption is possible on such a scale maybe deaths from medical harms will outweigh any number of callous deaths caused by warmongering.
Johnson and Johnson will discontinue talc based baby powder worldwide
BMJ 2022; 378 doi: https://doi.org/10.1136/bmj.o2046 (Published 17 August 2022)
Cite this as: BMJ 2022;378:o2046
The company is facing over 40 000 lawsuits in the US alleging that baby powder contaminated with asbestos caused ovarian cancer or mesothelioma. But Johnson & Johnson did not attribute the switch to that controversy,
Our position on the safety of our cosmetic talc remains unchanged,” the statement continued. “We stand firmly behind the decades of independent scientific analysis by medical experts around the world……
A landmark 2006 article in the journal Nature that sent Alzheimer’s research down new paths may have used manipulated images to support its conclusions, says an independent researcher whose findings prompted the journal to publish an expression of concern last month.
The article, A Specific Amyloid-β Protein Assembly in the Brain Impairs Memory,1 has been cited 2300 times in other papers, making it the fifth most cited article on Alzheimer’s disease since it was published in 2006.
On December 10th a few weeks after the Comirnaty trial concluded, there was an FDA meeting that concluded with an Emergency Use Authorization for the Pfizer vaccine. Various parties, primarily Pfizer submitted materials to meeting for consideration by FDA and assembled experts.
One document from Pfizer was a 53 page briefing document, which in page 43 states:
Pfizer-BioNTech COVID-19 Vaccine VRBPAC Briefing Document
Suspected COVID-19 Cases
As specified in the protocol, suspected cases of symptomatic COVID-19 that were not PCR confirmed were not recorded as adverse events unless they met regulatory criteria for seriousness. Two serious cases of suspected but unconfirmed COVID-19 were reported, both in the vaccine group, and narratives were reviewed. In one case, a 36-year-old male with no medical comorbidities experienced fever, malaise, nausea, headache and myalgias beginning on the day of Dose 2 and was hospitalized 3 days later for further evaluation of apparent infiltrates on chest radiograph and treatment of dehydration. A nasopharyngeal PCR test for SARS-CoV-2 was negative on the day of admission, and a chest CT was reported as normal. The participant was discharged from the hospital 2 days after admission. With chest imaging findings that are difficult to reconcile, it is possible that this event represented reactogenicity following the second vaccination, a COVID-19 case with false negative test that occurred less than 7 days after completion of the vaccination series, or an unrelated infectious process.
In the other case, a 66-year-old male with no medical comorbidities experienced fever, myalgias, and shortness of breath beginning 28 days post-Dose 2 and was hospitalized one day later with abnormal chest CT showing a small left-sided consolidation. He was discharged from the hospital 2 days later, and multiple nasopharyngeal PCR tests collected over a 10-day period beginning 2 days after symptom onset were negative. It is possible, though highly unlikely, that this event represents a COVID-19 case with multiple false negative tests that occurred more than 7 days after completion of the vaccination regimen, and more likely that it represents an unrelated infectious process.
Among 3410 total cases of suspected but unconfirmed COVID-19 in the overall study population, 1594 occurred in the vaccine group vs. 1816 in the placebo group. Suspected COVID-19 cases that occurred within 7 days after any vaccination were 409 in the vaccine group vs. 287 in the placebo group. It is possible that the imbalance in suspected COVID-19 cases occurring in the 7 days postvaccination represents vaccine reactogenicity with symptoms that overlap with those of COVID-19. Overall though, these data do not raise a concern that protocol-specified reporting of suspected, but unconfirmed COVID-19 cases could have masked clinically significant adverse events that would not have otherwise been detected.
Readers will have to make up their own mind about how many bureaucrats (FDA) or experts will have read through much if any of the voluminous material then assembled on a trial that had only finished somewhere around 4-6 weeks earlier with ongoing algorithmic assembly of documents purporting to represent the data in the intervening period.
Some may have looked over – literally over rather than at – it is quite possible that almost no-one had looked at and that everyone was dependent on this Pfizer summary.
There are things to chase here. How many suspected Covid 19 cases ended up in hospital in either group. How many if any suspected Covid 19 cases in either group were used as evidence for efficacy or otherwise of the vaccine. Alternately, how many in each group became evidence for efficacy or lack of efficacy – rather than adverse events.
Calling them adverse events, when the primary outcome measure was Covid is strange.
Investigators didn’t have to do PCR tests if they thought this was a probably Covid reaction. If Pfizer’s view that at least some of these cases might be Covid with a false negative test than how are we to know there was efficacy at all for the vaccine in this trial
‘efficacy at all’
Argentina invented The Tango…
Robert Spitzer: The most influential psychiatrist of of his time
Bob had his limitations and inevitably they are also part of the DSM legacy. Because his career didn’t include much patient contact, I felt that he tended to imagine mental disorders as pure Platonic ideal types, conforming to the packages contained in the criteria sets he was so skillful in writing. In day to day clinical life, patients are much more heterogeneous in their presentation, and the boundaries between disorders are rather fuzzy. Bob seemed to have a naive belief that he was describing illnesses that actually existed in nature, rather than merely creating convenient, but necessarily arbitrary, constructs. Bob was too optimistic about the potential benefits of new diagnoses and relatively blind to their risks. The addition in DSM of many new diagnostic categories and loose definitions of old ones has led to diagnostic inflation and the misuse of medication. Bob’s lifelong grudge against psychoanalysis trapped him in the box of descriptive and biological reductionism, paying too little attention to the psychological, interpersonal, social, and cultural factors that affect psychiatric presentations and their treatment. Moreover, Bob had little knowledge of, or concern about, the historical traditions and philosophical complexities that caution against the unintended consequences of radical change. But Bob’s limitations were also keys to his great strength. More a doer than a theoretician, unencumbered by the doubts and scepticism of others, not chained by tradition, he was a confident and undaunted innovator pulling a reluctant field forward.
Francis of A-SEE-SEE
The Miracle: Reason to Believe
“More than a WOW moment. It was a traumatic day for Science.” – Mike Willesee, Journalist.
“Pope Francis, like many other leaders, has stressed that this situation demands a new beginning…
osh Guetzkow Retweeted
Kids randomized to Moderna had more total upper respiratory infections than kids randomized to placebo, but FDA agrees with Moderna that it is “unrelated to the vaccine,” thereby eliminating the whole point of a randomized controlled trial.
The first ‘persuasive’ litany for the FDA
About Our Landmark Trial
The development of an RNA-based vaccine encoding a viral antigen, which is then expressed by the vaccine recipient as a protein capable of eliciting protective immune responses, provides significant advantages over more traditional vaccine approaches. Unlike live attenuated vaccines, RNA vaccines do not carry the risks associated with infection and may be given to people who cannot be administered live virus (eg, pregnant women and immunocompromised persons). RNA-based vaccines are manufactured via a cell-free in vitro transcription process, which allows an easy and rapid production and the prospect of producing high numbers of vaccination doses within a shorter time period than achieved with traditional vaccine approaches. This capability is pivotal to enable the most effective response in outbreak scenarios
2.3. Benefit/Risk Assessment There is an ongoing global pandemic of COVID-19 with no preventative or therapeutic options available. While there were no data available from clinical trials on the use of BNT162 vaccines in humans at the outset of this study, available nonclinical data with these vaccines, and data from nonclinical studies and clinical trials with the same or related RNA components, or antigens, supported a favorable risk/benefit profile. Anticipated AEs after vaccination were expected to be manageable using routine symptom-driven standard of care as determined by the investigators and, as a result, the profile of these vaccine candidates supported initiation of this Phase 1/2/3 clinical study
Growing evidence suggests Pfizer committed widespread fraud in its COVID jab trials
If fraud did take place, Pfizer can (and likely will) be held liable for the more than one million injuries its injection has caused in the U.S. alone, and we all look forward to that reckoning.
Site 4444 (the second enrollment session for site 1231) supposedly enrolled 1,275 patients in a single week, from September 22 through 27, 2020, and the suspicious thing about that — aside from the speed — is the fact that this was the last week that recruitment could take place to meet the data cutoff for the FDA meeting in December 2020. Jikkyleads writes:
“My guess: they needed enough numbers of ‘positive PCR tests’ in the placebo group to show a difference between groups for that VRBPAC meeting on the 10th Dec, and they didn’t have them. So, site 4444 appeared and gave them their ‘perfect’ result.
The BBC propaganda machine has started churning out simplistic publicity to get ‘jabs’ (who invented that disrespectful term?) Claims to be using Moderna are a bit confusing as other vaccines are to be used as back ups/ Moderna changed the name of the vaccine to Spikevax so bit odd it’s not being used in official announcements.
Focus on Omicron when booster jab campaign launches on 5 September
18 August 2022
GPs have been told to start delivering the autumn Covid booster campaign from 5 September, with patients set to receive Moderna’s new Omicron booster jab.
It set out that:
PCN groupings and other sites should start vaccinating residents and staff in care homes and arrange visits to the housebound from the week commencing 5 September
Over-75s and ‘self-declaring’ health and social care workers will be able to book appointments via the national booking service (NBS) from the week commencing 5 September, for appointments starting the following week
Bookings will later extend to over-65s and self-declaring pregnant women, carers, household contacts of immunosuppressed people and at-risk groups, with ‘further announcements made in due course’
Immunosuppressed people ‘will be able to continue to self-declare or attend walk-ins for their vaccination in line with existing guidance’
The letter said that NHS England ‘will be engaging with professional bodies on options to support providers in prioritising the completion of vaccinations in care homes as early as possible’.
It added: ‘The Secretary of State has also asked the NHS to put plans in place to accelerate the programme should it be necessary (especially to anticipate and mitigate broader pressures on the NHS as a whole as we get closer to winter) and bring forward the end date if clinically advised and operationally viable.’
The letter also set out that the NHS ‘will deploy a single type of vaccine’ – Moderna’s newly-approved Omicron-targeting bivalent vaccine – for adult booster doses ‘in line with’ a recommendation from the JCVI.
‘The JCVI and MHRA have stressed that the original vaccines also continue to provide great protection and people should come forward regardless of vaccine offered.’
This week, the JCVI issued advice on which Covid vaccines should be used in the booster campaign – which included the new Omicron Moderna vaccine and the original Moderna and Pfizer jabs, as well as the Novavax vaccine ‘in exceptional circumstances’.
Around 26 million people across England will be eligible for an autumn booster in line with guidance set out by the JCVI on which cohorts should receive the vaccine.
Amongst the adverse effects is this – even with 3200 cases documented there seems to be a throwing of doubt that even some may be caused by vaccines.
https://www.ema.europa.eu/en/documents/covid-19-vaccine-safety-update/covicasesd-19-vaccines-safety-update-14-july-2022_en.pdfSpikevax (Moderna Biotech Spain, S.L.)
Extensive swelling of the vaccinated limb
Update to the product information
Following PRAC’s assessment, extensive swelling of the vaccinated limb will
be included in the EU product information as a side effect of Spikevax. The
frequency category will be ‘not known’, as it is generally difficult to robustly
estimate side effect frequencies from spontaneously reported cases of
suspected side effects.
Cases of extensive swelling of the vaccinated limb have been reported
spontaneously with use of Spikevax (more than 3,200 EU/EEA cases
reported to EudraVigilance (see section 2) by 2 May 2022). Generally, cases
reported spontaneously by a patient or healthcare professional concern
suspected side effects, i.e. medical events that have been observed after
vaccination, but which are not necessarily related to or caused by the
In general, extensive swelling of the vaccinated limb is a condition that
does not require treatment and resolves after some days. (Eh!!
The Epidemic of Sudden Deaths
in 2021 & 2022
Edward Dowd Discusses 20% Increase In Excess Deaths In Working Age Adults After Vaccine Mandates
SMOKING GUN: Insurance Company Data Points Towards Huge Amounts of Excess Deaths Following Covid Vaccine Mandates
Sideline Sanity – Michelle Tafoya w/guest speaker, Kim Witczak @woodymatters
Imagine hearing your husband, wife or partner hung him-or-herself from the rafters of your garage. Imagine tracing that event back to a prescribed medication. Find out how Kim Witczak went from that horrifying experience to advocating for people with Covid-19 vaccine injuries.
Yes, they are real.
Effects of lockdown could be causing more deaths than Covid: Fears rise over silent health crisis as ONS records nearly 10,000 more deaths than the five-year average – none of which are linked to the virus – in the last two months
Noting a ‘disturbing’ number of mental health conditions, undetected cancers and cardiac problems, chief executive of private GP service Doctorcall Dr Charles Levinson said: ‘Hundreds and hundreds of people dying every week, what’s going on?
Dr Malone goes on the offensive with The Washington Post. Should be very interesting
“WaPo’s President even got in on the calumny and insulting words.”
(“You really can’t make this
stuff up. Idiocoracy1 [sic] is here. A vaccine scientist’s discredited claims have bolstered
a movement of misinformation”)].
“Idiocracy” is a society or group that is controlled by or consists of people
of low intelligence a/k/a idiots.”
Bravo Dr Malone !
Banned, Sues, Awarded – all in one go…
Robert Kennedy Jr’s anti-vaccine group banned from Facebook and Instagram
Facebook and Instagram Simultaneously Deplatform Children’s Health Defense Accounts Denying More Than Half a Million Followers Access to Truthful Information
Medical Journalists’ Association
The “incredible honesty” of this piece from
on taking antidepressants impressed our judges and is a worthy #MJAawards finalist in the mental health category
DR ELLIE CANNON: Antidepressants ARE worth the risk – and I should know, I’ve been on them for 15 years
So many similarities between what is happening in the world today and what we are learning about the “chemical imbalance”and antidepressants.
How We Have Been Misled About Antidepressants
BY JOANNA MONCRIEFF AUGUST 18, 2022
Our umbrella review that revealed no links between serotonin and depression has caused shock waves among the general public, but has been dismissed as old news by psychiatric opinion leaders. This disjunction begs the questions of why the public has been fed this narrative for so long, and what antidepressants are actually doing if they are not reversing a chemical imbalance.
Edward Dowd Reposted
Lawsuit filed: RW Malone vs. WP Company, LLC
Sometimes, you have to do what is right – no matter the personal cost
Substack @ RWMaloneMD
Please share with all of your social media outlets
On of the most egregious offenders has been the Washington Post.
Malone has also threatened to sue other media outlets, including the New York Times, but decided to start with the Post because the case “is really straightforward,” he said.
“We encourage free expression, but don’t allow false information about COVID-19 that could contribute to physical harm,” the Facebook notification read, noting that the page would now be unsearchable on the platform and the user would be unable to access it.”
Robert F. Kennedy, Jr. said, “Facebook is acting here as a surrogate for the Federal government’s crusade to silence all criticism of draconian government policies –
They understood that a government that can silence its critics has license for every atrocity.”
will we be having a bonfire of the books one day soon ?)
Covid-19 Origins author Paolo Barnard
Review and interviews with the authors by Claire Robinson for GBNews blog
Covid-19 Origins – Origin of the virus front A new book has been published on the origin of SARS-CoV-2, the virus that causes COVID-19. As you’ll gather from my review, it doesn’t pull its punches. That’s both refreshing and important because the origins issue has been bedevilled by censorship, including self-censorship. I explored this problem of censorship with two of the books’ authors when I interviewed them recently to discuss their book. I wanted to know whether they’d had direct experiences of censorship – and if so, what were the motivations behind it, in their view. I give the answers that emerged at the end of this review. They’re eye-opening.
Titled The Origin of the Virus: The hidden truths behind the microbe that killed millions of people, the book is authored by the Italian investigative journalist Paolo Barnard, in collaboration with two distinguished scientific co-authors, Prof Angus Dalgleish and Dr Steven Quay, in a year-long investigation.
Covid-19 Origins author Angus DalgleishProf Dalgleish is a cancer specialist who is best known for his contributions to HIV/AIDS research and who has helped develop a potential vaccine for COVID-19. It was in the course of his vaccine research that his co-researcher Birger Sørensen hit upon the idea that the virus did not appear natural and was likely an engineered lab creation – a conclusion that Prof Dalgleish came to share.
Dr Quay is the founder, chair and CEO of the biopharmaceutical company Atossa Therapeutics.
* Shi Zhengli, the “batwoman” who led gain-of-function research at the Wuhan Institute of Virology (WIV) that made bat viruses more infectious and virulent to humans, and who was under the yoke of the ever-present Chinese People’s Liberation Army medical staff, who, the book claims, have long been the supervisors of her labs;
* The US scientists and institutions that collaborated with the WIV researchers;
* Peter Daszak, the “batman” who via his nonprofit, the EcoHealth Alliance, funnelled millions of dollars of US taxpayer money into funding the dangerous research at the WIV, and who manipulated scientists into publicly denying the lab origin theory even though they privately believed it to be plausible;
* Francis Collins, director of the National Institutes of Health (NIH), and Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID). These institutes gave the taxpayer dollars to EcoHealth to give to the WIV;
* The World Health Organisation, which embarrassed itself by arranging a “farcical” investigation into the virus’s origins, with none other than Daszak on its team. The team studiously avoided looking at any evidence that could lead to the conclusion there had been a lab escape and then, unsurprisingly, claimed that there was no evidence of one;
* The scientific journals which, hobbled by their fear of upsetting their major sponsor, China, refused to publish any paper that cast doubt on the zoonosis theory ……..
Barnard writes with passion – even controlled fury – about these people. He describes Daszak, in his role in the WHO investigation, as having a conflict of interest “visible from the moon” and quotes a world renowned virologist who spoke on condition of anonymity as calling Fauci “a narcissistic megalomaniac and far too powerful”, due to his ability to “sign off large multi-million dollar grants” without the usual independent scrutiny. And all three authors are united in exposing how this web of political deceit and shady scientific practices coalesced across the two major superpowers to conceal from the world the vital warnings of the impending COVID-19 pandemic.
……..Then my medical school (St George’s, part of the University of London) issued advice that no one was to enter discussion on the origins. When this news reached Sir Richard Dearlove, the former head of the British Secret Intelligence Service, he went ballistic. He is chair of the Board of Trustees of the University of London and he said no scientist was going to be silenced on his watch.
Reluctance, censorship and mute responses have plagued this book since before it was even written. My search for scientific co-authors fished, predictably, into the pool of eminent researchers that had somehow expressed doubts about a SARS-CoV-2 spillover from bats to animal hosts to humans. How many did I find? Quite a few willing to blast (to different degrees) the zoonotic theory on social media, but when it came to them committing to an actual written investigation into the theory, their tenacious engagement invariably went the way of a flat tyre in seconds.
“Why agitating on Twitter and not writing a ground breaking book to expose this?” flatly replied, “Writing is formal… thus dissent in writing is career-threatening”.
His stunningly honest response speaks volumes about what I went through to find reputable scientists who were willing to speak up on SARS-CoV-2’s origin.
So much for the latter statement, given the latest revelations. But what is of interest here is that this was a veto that I received from an internationally renowned scientist and a critic of zoonosis who had actually accepted full authorship of this book back in 2020 and who had sent me a particularly pugnacious list of topics he promised to cover in this investigation. Then he got cold feet. I had to jettison him shortly afterwards. Again, it speaks volumes.
In the United Kingdom the book was submitted to a number of so called “courageous indie publishers”, who all turned it down with, at times, spurious replies (a great one was “An important unsettling book, but we sense the British public is tired of reading about COVID”). This despite all of them having been told that in Italy a major publishing house called Chiarelettere Ltd had accepted the challenge of publication. It was subsequently printed in the UK by Clinical Press, a small and dignified medical publisher in Bristol.
But then even in Italy, the moment the book was out on bookshelves, its promotion hit a brick wall. Fortunately, in spite of this, it’s selling well.
The Italian publisher’s international rights manager pitched the book to no less than 86 EU publishing houses and it was turned down by all of them. The Brazilian LAYLA had at first agreed to publish it but then vanished into thin air.
In the US, the PR firm that manages Dr Steven Quay’s media relations has been facing an unexpected uphill struggle to pitch the book ;;;;;
The reasons for this sorry state of affairs can be summed up as follows:
* NIH research grants – the fear of losing them, since Fauci is up to his neck in this scandal and desperately wants it to go away;
* Academic careers (impossible without said research grants in most Western countries);
* Chinese funding of Western universities and scientific journals (hugely expanding);
* The hypertrophic reach of political correctness into mainstream media (anyone pointing to China in the COVID story must be by default a racist xenophobic conspiracist and a Trumpist);
* Colossal business interests in not triggering an unprecedented commercial/legal confrontation with China;
* Biotech interests – don’t alert the public to the insane biotech experiments like gain-of-function, which gave rise to the worst crime against global health in a century.
Taken together, these are more than enough for the truth about the preventable death of almost 5 million humans never to come out.
JC on a bike spoke about all this on his bike going to work a few years ago. A sad irony – he lost his job over his increasing focus on working out what had happened and making it public while he rode his bike to work talking about this nerdhaspower blog. Don’t know if his videos are still up on YouTube – insightful chap.
Here’s a video of the interview with two Israeli academics who presented damning evidence that
manipulated and hid key results of a study it funded on COVID-19 vaccine adverse events after being warned that the results could lead to lawsuits:
Major truth bombs to be dropped on the @IsraelMOH on Neil Oliver’s show tonight on GB News. Starts 8pm Israel time, 6pm London time, 1pm Eastern. Not to be missed.
Ministry of Health Caught Manipulating Results of Study on COVID-19 Adverse Events
joshg99 Published August 21, 2022
“this is something we have observed in other countries”
“the consequences are really harmful”
Prof Levi on the possible side effects of the Pfizer jab and Israeli politicians’ response – YouTube
“The Coronavirus vaccines (Covid-19) are safe and effective. They give you the best protection against Covid-19.”
The Rio Times
RIO DE JANEIRO, BRAZIL – Peter Doshi, editor-in-chief of the British Medical Journal (BMJ), and Retsef Levi, a professor at the Massachusetts Institute of Technology, told an expert panel that data from the COVID vaccine trial do not support the claim that the vaccines are “safe and effective.”
Xavier Azalbert: Suing Bill Gates for Disparagement
“Asking for an open, scientific debate over experimental medical interventions is not a “conspiracy theory.” Questioning the efficacy of Covid vaccines that, in fact, are ineffective against the infection is not “jeopardizing the lives of others.” It is unacceptable in a free society to ruin people’s careers and reputations because they ask for medical transparency and legal accountability. This is why Xavier Azalbert, the founder of the French civilian alliance BonSens and the publisher of the online newspaper FranceSoir, is taking Bill Gates to court. “
So impressed with this interview, Chris, one of the most lucid, factual, actual, clever, I have ever seen – so well done for finding it…
Xavier Azalbert, compte personnel
Une démission qui ne passera pas inaperçue et qui ne manquera pas de faire couler de l’encre. Cependant qui pour le remplacer?
JUST IN – Dr. Fauci announces resignation as NIAID director and chief medical advisor to Biden.
NHS leaders prepare to give out millions of Covid booster vaccines in September: ‘We’ll be ready’
“Vaccines offer the best defence against the virus and will help relieve pressure on the NHS at its most difficult time of year, so I encourage all those eligible to come forward as soon as they are contacted by the NHS.”
Chalk and Cheese…
Another important video from Amy Kelly
“In this video, Project Director Amy Kelly delves into findings so far on male fertility post-mRNA vaccine. As well as effecting sperm count and quality, reproductive toxicity in men was not tested. “Anti-sperm antibodies” from the mRNA is an adverse event following vaccination that treats sperm as “invaders,” and attacks them, leading to male infertility.”
“Pfizer, FDA, CDC Hid Proven Harms to Male Sperm Quality, Testes Function, from mRNA Vaccine Ingredients”
Attorney Robert Barns discusses the Dr Robert Malone vs The Washington Post law suit
‘Dr. Fauci Doesn’t Work for Us’: Dr. Naomi Wolf on Fauci’s Betrayal of the American People
“The institutions need to be held accountable – this is what democracy is all about”
“A state within a state ignoring the chain of command, ignoring The White House, ignoring President Obama saying this is now unlawful – you can’t do this.”
“This is a circle of traitors on a massive scale”
A Spectator – Australia gives a Send-Off…
“Democrats, meanwhile, write mad children’s books about him.” …
“RFK Jr.’s story of Fauci’s failure as the government’s AIDS coordinator is a highly disturbing prologue to his COVID mandate as head of NIAID. So, who is Dr. Fauci in the end? Has American medicine truly become a ‘racket,’ as corrupt as a mafia organization? Does everything in our country turn on the size of the money involved? How can we begin to solve this? The Real Anthony Fauci is a fascinating starting point. RFK Jr. has written a strong, strong book.”
—Oliver Stone, award-winning director, producer, and screenwriter
The Real Anthony Fauci: Bill Gates, Big Pharma, and the Global War on Democracy and Public Health (Children’s Health Defense) Hardcover – 28 April 2022
by Robert F. Kennedy Jr. (Author)
Robert F. Kennedy Jr
Check out my recent podcast about leaked Moderna files with Sasha Latypova.
Sasha Latypova discusses leaked Moderna files showing FDA colluded with Moderna
Farewell, St Anthony Fauci
During the Covid pandemic, however, Fauci made the mistake a lot of experts made: he equated himself with the entire concept of science as a way of giving his pronouncements an aura of infallibility. ‘Irepresent science,’ he said, as a response to criticism after he repeatedly said his institute didn’t fund ‘gain of function’ virology research in Wuhan, when in fact it did.
He appeared on the cover of Time magazine twice. He also appeared on the cover of magazines such People, InStyle and others. But, like health experts almost everywhere else, Fauci simply pinballed from one official narrative to another. Often there was little to no change in the actual science, just a war-time sense that the public must be scared or reassured for their own good.
Angry right-wingers now babble about arresting Fauci or suggest that his retirement is an attempt to dodge Congressional testimony after the midterms. Democrats, meanwhile, write mad children’s books about him. His fans and his enemies give him too much credit. In the end, Fauci didn’t actually create mask guidelines or impose lockdowns. He wasn’t doing any substantial work on creating or testing a vaccine. He just became the mascot for a kind of Covid mania. And he loved every second.
‘a wider zeitgeist’ – Spirit of the Time…
Re: Sixty seconds on . . . medical gaslighting Jacqui Wise. 378:doi 10.1136/bmj.o1974
Astonishing reading this little article  that two years on the Cumberlege Review is not mentioned and is evidently completely forgotten .
Meanwhile, I read 
“As of 27 July 2022, for the UK, 172,476 Yellow Cards have been reported for the COVID-19 Vaccine Pfizer/BioNTech, 245,996 have been reported for the COVID-19 Vaccine AstraZeneca, 40,270 for the COVID-19 Vaccine Moderna and 1,791 have been reported where the brand of the vaccine was not specified.”
“The MHRA has received 815 UK reports of suspected ADRs to the COVID-19 Pfizer/BioNTech Vaccine in which the patient died after vaccination, 1,297 reports for the COVID-19 Vaccine AstraZeneca, 65 reports for the COVID-19 Vaccine Moderna and 49 reports where the brand of vaccine was unspecified.”
It has also been stated elsewhere by the government:
“It is estimated that only 10% of serious reactions and between 2 and 4% of non-serious reactions are reported.” 
And yet we hear little about these poor people – we are too adept at making little things big and big things little. Another name for it perhaps is news management. After two years, and especially these two years we perhaps need to apply ourselves for more than a minute to what could possibly go wrong.
 Jacqui Wise, ‘ Sixty seconds on . . . medical gaslighting’, BMJ 2022; 378 doi: https://doi.org/10.1136/bmj.o1974 (Published 09 August 2022)
Competing interests: AgeofAutism.com, an on-line daily journal, concerns itself with the potential environmental sources for the proliferation of autism, neurological impairment, immune dysfunction and chronic disease. I receive no payment as UK Editor. I also moderate comments for the on-line journal ‘The Defender’ for which I am paid. I am also a member of the UK Medical Freedom Alliance
22 August 2022
The Nuremberg Code: 75th Annual Commemoration
Vera Sharav 29.34
Tess Lawrie 5:15:40
It’s very difficult for people who have anxiety to present to an audience, also for videos, so very well done to those who have over come this.
The role of psychiatry
The “Euthanasia “ Program in Nazi-Psychiatry:
Prof Frank Schneider discusses the Nazi era and its impact on psychiatry:
Ex-Twitter exec blows the whistle, alleging reckless and negligent cybersecurity policies
Busy day for Vaccines, pity about the kiddies’ uptake – but Albert ploughs on (with his babies) …
PLUS the utter shambles at the CDC who seem to have completely lost-the-plot, reinforced by John B…
Pfizer COVID-19 vaccine 73 percent effective in children under 5
BY PETER SULLIVAN – 08/23/22
Pfizer’s COVID-19 vaccine was 73.2 percent effective against the disease in children under 5, the company said Tuesday.
The company touted the data as reinforcing the importance of the vaccine, which was authorized in June, after months of waiting for a vaccine for the youngest children.
The effectiveness is for after three shots of the vaccine. The Pfizer vaccine’s authorization was delayed earlier this year to allow time to study a third shot, with the idea that two shots was not enough.
The results, based on 34 cases, came when the strain of the virus circulating was primarily the omicron subvariant BA.2, slightly different than the BA.5 omicron subvariant that is largely circulating now.
Pfizer said Tuesday that it is working on a vaccine for children under 12 specifically targeting BA.5, matching its approach for adults 12 and over.
“Building on the strong safety and immunogenicity data that led to FDA authorization of our COVID-19 vaccine for children 6 months through 4 years, we are pleased to share confirmatory evidence that a full course of vaccination helps protect against symptomatic disease, particularly during a time when the Omicron BA.2 strain was predominant,” Pfizer CEO Albert Bourla said.
Getting parents to vaccinate their young children is an ongoing challenge. Only about 5 percent of children under 5 have been vaccinated so far, ABC News reported last week.
Vast majority of the youngest Americans remain unvaccinated against COVID
CDC admits failure in COVID-19 response after scathing report
Epidemiologist Dr. John Brownstein discusses the report on the CDC’s failures responding to the COVID-19 pandemic as the CDC director vows to implement major changes.
Just 4.8% of the 19.5 million U.S. children under 5 have been vaccinated.
It has now been two months since the start of the COVID-19 vaccine rollout for the youngest Americans, and despite some initial enthusiasm from a select group of parents, the vast majority of children under the age of 5 remain completely unvaccinated.
About 941,000 children, under the age of five have now received their first shot of a COVID-19 vaccine, newly updated federal data shows. The overall total represents approximately 4.8% of the 19.5 million U.S. children in that age group.
Just 182,000 of those children, or less than 1%, have been fully vaccinated.
When broken down by age group, data shows …..
Pfizer said the EMA and International Coalition of Medicines Regulatory Authorities (ICMRA) had given guidance to file for approval of a BA.1-based vaccine.
I’m thrilled to share updated #COVID19 vaccine data for children aged 6 mos to <5yrs: https://on.pfizer.com/3R22f3U
Anthony Fauci has been the voice of health and hope throughout his distinguished career advising seven US presidents through HIV/AIDS, West Nile, Ebola, Zika, #COVID19, monkeypox, and more. Thank you Dr. Fauci for your immeasurable service and best wishes for your retirement!
In June, we shared that we are developing a bivalent Omicron BA.4/BA.5-adapted vaccine. I’m excited to update that we completed our EUA submission to @US_FDA today, and plan to complete our EMA submission in the coming days: https://on.pfizer.com/3QXMg6T
Emergency uses of the vaccine have not been approved or licensed by US FDA but have been authorized to prevent COVID-19 in ages 6mos+. See Fact Sheets: http://cvdvaccine-us.com
To have or not to have – more parents have become more cynical about yet more vaccines but the coercion in various countries perhaps more varies If MHRA in UK jumps on it parents may be more manipulated into agreeing – and perhaps likely to accept something shoved up their childrens’ noses eventually- unless they get access to this kind of information rather than the simplistic info. pumped out in UK Now whole cohorts have resigned from government positions along with the prime minister – Whitty and co are gone -who is even running the show here?
What do we know about covid-19 vaccines in under 5s?
BMJ 2022; 378 doi: https://doi.org/10.1136/bmj.o1892 (Published 23 August 2022)
David Cox, freelance journalist
It took a year for covid-19 vaccines to be tested and approved for use in children. As countries now reach out to the youngest age group, David Cox reports on the evidence for their effectiveness and deployment
On 18 June 2022, regulators in the US voted to authorise the rollout of Pfizer and Moderna’s covid-19 vaccines to children under the age of 5, meaning that the jabs will now be available to an estimated 20 million babies and toddlers.1 The decision sees the US join Argentina, Bahrain, Chile, China, Cuba, Hong Kong, the United Arab Emirates, and Venezuela in offering covid-19 vaccines to the youngest age category.
Regulators in Europe are predicted to follow in the coming weeks.
But not all scientists are convinced that vaccinating under 5s will make a meaningful difference in tackling the pandemic.
“The risk of severe covid-19 in children is very, very low in terms of hospital admissions, fatalities, and long term problems,” says Shamez Ladhani, a paediatric infectious diseases specialist at St George’s Hospital, London. “You end up having to vaccinate a lot of children to have a little bit of improvement in terms of outcomes at a population level.” According to Office for National Statistics data for the week ending 3 July, hospital admission rates for children under 5 in the UK were just eight per 100 000, compared with 59.33 per 100,000 for 75 to 84 year olds.3
….,” says Ladhani. “The benefits of vaccinating on top of a previous infection, using a strain from two and a half years ago, are not known.”
Clinical trial data
One of the criticisms of both Pfizer and Moderna’s vaccines is that the interim data from clinical trials show they are relatively ineffective in preventing symptomatic infection in young children.
Moderna’s two dose regimen is between 37% and 51% effective at preventing children under 6 from becoming infected.4 Pfizer claim their vaccine, administered in three doses, to be 80% effective at preventing infection in children between 6 months and 4 years old—this figure was, however, based on a sample of 10 children.
“The top line efficacy results from interim analysis are not impressive,” says Hamid Merchant, a researcher in the department of pharmacy at the University of Huddersfield. “Although the vaccines are likely to be approved by the Medicines and Healthcare Products Regulatory Agency, they’ll probably be deemed non-essential for healthy children under 5.”
And it’s not just Pfizer and Moderna. There are limited efficacy data available for the three other covid-19 vaccines currently approved for under 5s in various countries—those produced by Chinese companies Sinopharm and Sinovac, and the Soberana vaccine from Cuba. Earlier this year, a study of Sinovac’s vaccine in 49 694 3-5 year olds in Chile, found that it was just 38% effective at protecting against symptomatic infection.5
Of course, how researchers and public health officials perceive the risk-benefit ratio of rolling out vaccines to under 5s varies around the world and depends on the impact covid-19 has had on that country. Sweden has had just a handful of fatalities in those aged under 18,6 and vaccines are still not available to children aged 5-11 years. But in Brazil the virus has killed an average of two children under the age of 5 each day7—a rate which equates to around one in every five deaths among under 5s worldwide. Understandably, doctors are keen to boost protection levels, fearful of the impact that future variants might have.
Even if vaccines are made available to children, it remains to be seen whether parents will accept them. The Kaiser Family Foundation has already noted that vaccination rates among under 5s in the US have peaked and are now decreasing, just weeks after they became available.8
Data looking at the proportion of 5-11 year olds in the US and UK who have received covid-19 vaccines since they became available to this age group have already provided indications that many parents are not convinced they are necessary.
So far just 36% of 5-11 year olds in the US have had at least one dose of a covid-19 vaccine since they were approved in November 2021.9 Rates are lower in England where only 10% of 5-11 year olds have received a single dose.10 In one survey conducted in March, 41% of parents of UK primary school children said that they would not have their children vaccinated if offered the jab.
This may represent part of a concerning trend.
Others, however, feel it is likely because the UK’s Joint Committee on Vaccination and Immunisation (JCVI) has downplayed the benefits of vaccination in young children. “The advice from JCVI was that vaccines for this age group are non-essential,” says Merchant, “The low uptake is not surprising.”
Vaccine uptake in Australia is much higher with more than half of 5-11 year olds having received one jab, and 40% being double vaccinated.12 This followed a sustained grassroots engagement approach with initiatives such as the Vaccine Champions Program and Building Confidence in Covid-19 Vaccines sessions emphasising the importance of childhood immunisation to communities across the country.
Ladhani feels that the major public health risks which come with making vaccines available to under 5s is not so much safety—all studies so far have reported minimal side effects—but what he calls “opportunity costs.”
Nasal vaccines: game changer?
There are currently a range of nasal covid-19 vaccines in clinical development, including candidates from AstraZeneca, Bharat Biotech, CanSinoBIO, Lancaster University, National Taiwan University Hospital, Sputnik V, and the Université de Tours.
Risk of preterm birth, small for gestational age at birth, and stillbirth after covid-19 vaccination during pregnancy: population based retrospective cohort study
BMJ 2022; 378 doi: https://doi.org/10.1136/bmj-2022-071416 (Published 17 August 2022)
Response on 24 Aug 2022
Re: Risk of preterm birth, small for gestational age at birth, and stillbirth after covid-19 vaccination during pregnancy: population based retrospective cohort study
Covid-19 vaccine safety in pregnancy was one of the many unknowns at the time of conditional marketing authorization in late 2020 because the phase III pivotal trials of mRNA vaccines did not include pregnant women.
Fell et al. report a post-authorisation observational study using the provincial birth registry of Ontario (BORN) to estimate the risk of mRNA covid-19 vaccination on adverse pregnancy outcomes. Of note, only liveborn or stillborn infants 20+ weeks of gestation or with birthweight at least 500 grams are systematically recorded in BORN such that adverse events after vaccination occurring before gestational week 20 are missed in this study.
Each pregnancy contributed gestational time in days between May 1, 2021 and December 31, 2021. Risk estimates of exposure are based on a total of 43,099 women who received at least 1 dose during pregnancy.
Exposure-time to full mRNA vaccination (two doses) during pregnancy was limited to only 29,650 women with median gestational age of 29.1 weeks at dose 1 with only 301 women (1%) receiving dose 1 during their first trimester. The remaining 13,416 women were not fully exposed during pregnancy but received their first dose at a median gestational age of already 34 weeks, and further doses after delivery. In other words, the contribution of each vaccinated woman to the exposure time with two vaccine doses is not identical and generally of short duration, in particular for the outcome very preterm birth (<32 weeks), as well as preterm birth (<37 weeks), while 42,063 women in the unvaccinated comparison group are continuously contributing pregnancy days at risk of adverse pregnancy outcomes due to important other factors such as maternal age, comorbidity, smoking, substance abuse, low socio-economic status, and gestational age.
Marked imbalances between the vaccinated and unvaccinated study groups with respect to characteristics not only linked to the outcome but also to the probability of being vaccinated introduce the potential for strong bias (i.e. healthy user bias). When looking at the subgroup of 422 women who received only 1 dose in total, a statistically significant 9% increase in risk of adverse pregnancy outcomes (95% CI 1.01 to 1.16) is observed. With observational data that raises more questions than provides answers, it is worth reflecting on what may be gained from randomized trial data. While pregnant women were excluded from the pre-authorization trials, a recent independent re-analysis of the phase III Pfizer and Moderna trials found serious adverse events of special interest elevated at 1 event per 800 vaccinated adults. This raises the obvious question of whether such harms are limited to non-pregnant adults, or would also apply to pregnant women. The risk management plan of the Pfizer/BioNTech mRNA vaccine comprises one randomized study (NCT04754594 or C4591015) on safety and immunogenicity in pregnant women.
Starting February 2021, the trial (NCT04754594 or C4591015) originally planned to enroll 4000 women between the 24th and 34th week of their pregnancy. However on November 16, 2021, the manufacturer stopped enrollment at only 348 women because pregnant women in the study countries U.S., Spain, Brazil, and South Africa had allegedly already been vaccinated and were no longer eligible for enrollment. Fell et al. provide evidence that this can hardly be the case . In our eyes, with a study size of only 10% of the originally planned participants, the aims of study NCT04754594 or C4591015 as specified in the risk management plan cannot be achieved. Regulators are responsible for oversight and must inform the public about what went wrong in study NCT04754594 or C4591015. Without access to individual participant data for independent scrutiny of randomized controlled trials we do not have reliable evidence to recommend Covid-19 vaccines for pregnant women.
Angela Spelsberg MD, SM
Comprehensive Cancer Center Aachen, Germany
Ulrich Keil MD, PhD , FRCP
Prof. emeritus, Institute of Epidemiology and Social Medicine, University of Muenster
In support of the Dr Robert Malone vs The Washington Post lawsuit John Allison J.D. wrote this:
Early morning UK BBC R4 reporting serious charges could be about to be put to Donald Trump
This story is storming International News Sites –
Moderna sues Pfizer and BioNTech over coronavirus vaccine
Company is suing pharmaceutical rival and its German partner for patent infringement
Fri 26 Aug 2022 14.08 BST
Moderna is suing its US pharmaceutical rival Pfizer and its German partner BioNTech for patent infringement in the development of the first Covid-19 vaccine approved in the United States, alleging they copied technology that Moderna developed years before the pandemic.
The lawsuit, which seeks undetermined monetary damages, was being filed in US district court in Massachusetts and the regional court of Düsseldorf in Germany, Moderna said in a news release on Friday.
“We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the Covid-19 pandemic,” Moderna’s chief executive, Stéphane Bancel, said in the statement.
Moderna Inc, on its own, and the partnership of Pfizer and BioNTech were two of the first groups to develop a vaccine for the coronavirus.
Just a decade old as a company, Moderna, based in Cambridge, Massachusetts, had been an innovator in the messenger RNA (mRNA) vaccine technology that enabled the unprecedented speed in developing the Covid-19 vaccine after the coronavirus pandemic began in late 2019 and spread around the world.
An approval process that previously took years was completed in months, thanks largely to the breakthrough in mRNA vaccines, which teach human cells how to make a protein that will trigger an immune response.
Germany-based BioNTech had also been working in this field when it partnered with the US pharma giant Pfizer.
The US Food and Drug Administration granted emergency use authorization for the Covid-19 vaccine first to Pfizer/BioNTech in December 2020, then one week later to Moderna.
Moderna alleges Pfizer/BioNTech, without permission, copied mRNA technology that Moderna had patented between 2010 and 2016, well before deadly Covid-19 emerged in 2019 in China and exploded into global consciousness in early 2020.
Early in the pandemic, Moderna said it would not enforce its Covid-19 patents to help others develop their own vaccines, particularly for low- and middle-income countries.
But in March 2022 Moderna said it expected companies such as Pfizer and BioNTech to respect its intellectual property rights. It said it would not seek damages for any activity before 8 March 2022.
Patent litigation is not uncommon in the early stages of new technology.
Pfizer and BioNTech are already facing multiple lawsuits from other companies who say the partnership’s vaccine infringes on their patents. Pfizer/BioNTech have said they will defend their patents vigorously.
Germany’s CureVac, for instance, also filed a lawsuit against BioNTech in Germany in July. BioNTech responded in a statement that its work was original.
Moderna has also been sued for patent infringement in the US and has an ongoing dispute with the US National Institutes of Health over rights to mRNA technology.
In Friday’s statement, Moderna said Pfizer/BioNTech appropriated two types of intellectual property.
One involved an mRNA structure that Moderna says its scientists began developing in 2010 and were the first to validate in human trials in 2015.
“Pfizer and BioNTech took four different vaccine candidates into clinical testing, which included options that would have steered clear of Moderna’s innovative path.
Pfizer and BioNTech, however, ultimately decided to proceed with a vaccine that has the same exact mRNA chemical modification to its vaccine,” Moderna said in its statement.
The second alleged infringement involves the coding of a full-length spike protein that Moderna says its scientists developed while creating a vaccine for the coronavirus that causes Middle East Respiratory Syndrome (Mers).
Although the Mers vaccine never went to market, its development helped Moderna rapidly roll out its Covid-19 vaccine.
Last Updated 2 hours ago
Moderna sues Pfizer/BioNTech for patent infringement over COVID vaccine
By Daniel Trotta
Aug 26 (Reuters) – Moderna sued Pfizer and its German partner BioNTech on Friday for patent infringement in the development of the first COVID-19 vaccine approved in the United States, alleging they copied technology that Moderna developed years before the pandemic.
The lawsuit, which seeks undetermined monetary damages, was filed in U.S. District Court in Massachusetts. In a news release on Friday, Moderna said the lawsuit would be filed also in the Regional Court of Duesseldorf in Germany.
Whatever next? Well in the same week;-
Richie and Truss two contenders for the prime minister’s job in UK have publicly turned against rhe scientists they collectively appointed to to scare the hell out of the population during the covid epidemic. Maybe a few successful lawsuits over the harms and deaths they’ve caused will come next.. Let’s watch them stick together again when that happens
Moderna sues BioNTech/Pfizer?
Bring popcorn and pull up a recliner. Here are the details that corporate media completely missed.
Robert W Malone MD, MS
Based on my experience, all three of these patents can be readily invalidated due to the failure to cite relevant prior art. To repeat, I have no financial interests here. But the work that I did and the relevant patents that I am a co-author on (which Moderna conspicuously fails to cite) are now in the public domain. They belong to everyone, not to Moderna, or to CureVac, or to BioNTech. And this may explain part of why there has been such an effort to write me out of history. Not only because some seek the Nobel Prize, but also because the intellectual property patent positions of some very profitable companies may become at risk if those contributions are acknowledged.
And those contributions are increasingly being recognized, despite the concerted efforts of many to deny them.
Josh Guetzkow Retweeted
Prof Norman Fenton
have disabled likes, retweeting and replies on my tweet about John Campbell’s video being banned by .
Prof Norman Fenton
A video by John Campbell (who has over 2.4 million subscribers) – that ever so lightly touched on the possibility that the vaxx may have caused some UK deaths – has been removed by .
. The video is on .
; link in the article:
‘Does this change the risk benefit analysis for vaccination – clearly’
‘Why is no one talking about this – it’s strange’
‘That’s my appraisal of the situation’
John’s first Rumble video. An introduction to who I am and the content I produce.
“and look out for more”…
Tony, you were an amazing public servant long before COVID-19 struck – and now you are a hero to millions of people, including me.
Indeed, under Fauci’s guidance, scientists at his institute aggressively pursued a vaccine for COVID-19. And, in an astonishing span of less than a year, they brought one into being, in partnership with the drug company Moderna. It was even more effective than Fauci had dared hope, achieving an efficacy of over 90%.
“He was giddy with laughter,” Benjamin recalls. “I remember watching him on TV with the joy of a new parent who has something that’s just precious, and understood just how valuable that vaccine was going to be.”
Bill and Ben, the Pflower-Pot men…
XR – “we need to use our underground sources to get people to actually start repeating the science” RKJr.
Xavier Azalbert, compte personnel
“Résistez, résistez, résistez car une fois qu’ils ont le pouvoir ils ne le rendent jamais” @RobertKennedyJr dans un débriefing exclusif
Durée : 00:40:42
Publiée le : 29/08/2022
Interview in English –
Robert Kennedy Jr: “Resist, resist because once they have power they never give it back!”
Lawyer and founder of Children’s Health Defense, Robert Kennedy Jr. explains on our set what his association is and the fights it leads for the protection of children. He took the opportunity to denounce the corruption of American health agencies and their compromises with the pharmaceutical industry, the complacency of some mainstream media towards them as well as the considerable influence of public figures such as Bill Gates or Anthony Fauci.
His association has been at the forefront of advocating for children’s health for many years. CHD is a non-profit organization (code 501 (c) in the United States) with a European section.
Its mission is to end child epidemics by working hard to eliminate harmful exposures, bring those responsible to justice, and establish protective measures to prevent future harm.
On the website of the association, we can read: “there are too many sick children”, “the culprits are known” with a photo of industrial chimneys, “fake speeches”. In response to this, the association is working on the vaccine safety project to restore children’s health and is proposing a research database.
Robert Kennedy Jr. is also the author of a best-selling book: “Anthony Fauci, Bill Gates and Big Pharma – The Global War on Democracy and Public Health.” This book has been translated into French, German and soon Italian and Spanish. In its French version, Professor Perronne prefaced it explaining that this book would probably serve as a basis for many legal actions.
The book has sold more than a million copies in the United States.
Robert Kennedy Jr. answers our questions about the origin of CHD, how his vision has evolved with the Covid-19 health crisis. It puts into perspective the role of the pharmaceutical industry and the capture of authorities and regulators. His observation is scathing towards Anthony Fauci, who has control over the health system in the United States (National Institutes of Health and the Food Drug Administration) as well as Bill Gates, who finances a large part of the pharmaceutical industry.
It also makes a scathing observation about the media and the lack of freedom of expression that currently reigns there. Thus, he sees in the acquisition of Twitter by Elon Musk a sign of hope, while asking to see if the promises made by the creator of Tesla for more freedom on Twitter will finally be kept.
Finally, he delivers an unequivocal message to the French: “When men have taken power, they never want to let go of it. So you have to resist, resist and resist!”
The Real Anthony Fauci: Bill Gates, Big Pharma, and the Global War on Democracy and Public Health
Kindle £2.99 or $2.99
Where does the Big Friendly Gates https://davidhealy.org/yellow-and-other-virus-and-vaccine-perils/ fit in?
‘finding the immunological sweet spot –
The Bill & Melinda Gates Foundation is supporting work to develop a vaccine that could be given to pregnant mothers who, in turn, produce antibodies and pass them to their fetus before birth to prevent RSV in infancy. But by 6 months of age, that protection would fade, leaving the young child vulnerable again, Peeples said.
ANN ARBOR, Mich. — NanoBio Corporation announced today that it has received a $6M grant from the Bill & Melinda Gates Foundation to support the development of a safe and effective intranasal vaccine for Respiratory Syncytial Virus (RSV).
To read the full press release, visit the NanoBio Corporation web site.
Blue Willow Biologics – PageNotFound
Blue Willow is a realistic children’s fiction book by Doris Gates, published in 1940. Called the “juvenile Grapes of Wrath”,
“Hospital Rooms’ mission to radically transform the face of mental health care in the UK and beyond, and to generate new knowledge around how the arts operate in the mental health sphere.”
Didn’t know about this Hospital Rooms until just recently. Hauser and Wirth is one of the top 5 or 6 fine art dealers in the world, so it caught my attention. Art occupational therapy happens in psych hell holes but it’s just a cover and almost totally blown out of the water by the drugs. Nobody on anti-psychotic drugs gives a flying you know what about art so I think ‘the face of’ is correct.
Until antipsychotic induced AKATHISIA is addressed in psych hell holes, and they are hell hole prisons not ‘hospitals’ no top art dealer will change anything. I could not not begin to express how horrific high dose antipsychotics really are. 80% inside thase places having akathisia is spot on. But then you have to know the horror of akathisia. And some how I don’t think any artist is going to put the truth about the Robert Spitzers DSM, WWII German psychiatry and akathisia on the walls.
Good comment about the Art Work. But am worried about the final line. Spitzer was a social psychiatrist. The German psychiatry program was social – these have nothing to do with biology. The people who fail to recognise akathisia are not biological psychiatrists. The maas use of these drugs in teens has nothing to do with biology. These are social situations that need to be addressed socially.
Akathisia is the main gone wrong thing going on in psych ‘hopsitals’ for sure and it’s really serious. But art goes everywhere, it’s not only about that, that is gone wrong. I’d be willing to bet none of the artists involved have any clue of any of this. They would need to know as much as possible.
“These are social situations that need to be addressed socially.” I do agree with this.
Whilst I agree about the “social situations” and the fact that they need to be addressed socially, I feel it goes deeper than this. the “professional” attitude to akathisia – as with many other states – needs to change. Any mention of akathisia in many medical situations is met with rejection, disbelief and/or ignorance. This is gaslighting at its very worst. it gives the patient the feeling that their word is rubbished, that their entire ‘world’ is self-inflicted and that a lay-person should shut up about matters that they don’t understand.
A young person who I’m supporting at present is, most definitely, now suffering from akathisia. He has shared his thoughts within his present placement and the staff have shown no understanding whatsoever of such a condition. Not being one to go down at the first punch (!), he has described the condition and shared info about it to no avail. He is in a hospital – a medical hospital – surely staff there should know of akathisia. Maybe not having come across it – but surely be ready to learn about it? due to his state of mind and body, he was given MH surveillance over a weekend. He thought for sure this nurse would believe and understand – oh no, her distaste for such a topic was even more pronounced than the other staff’s attitude had been!
If we can’t get the very people who work IN medicine to believe and share concern then when on earth are we likely to get the masses OUTSIDE of medicine to believe us.
The bottom line here, of course, is THAT WHATEVER THE LABEL, THE CARE SHOULD EXIST AT THE SAME STANDARD – that, to my mind, is what is missing within, and outside of, medical institutions and minds.
This is totally correct, they can’t stand it.
The vehemence with which they come down on you for mentioning AKATHISIA and the truth about it in the context of a closed culture of abuse which is what psych ‘hospitals’ are, is sickening and yes I never stopped talking about it so I was threatened with sectioning if I didn’t shut up, followed by being made to take Lorazepam on top of 400mg of quetiapine. I’ve never been psychotic.
What we understand as care is abuse in a psych situation. And it’s an all around situation from the architecture to the staff, the drugs and the CQC. If you make a complaint to the CQC it just goes straight to whom ever abused you. I told them such and such happened but I don’t wish to make a compliant, they replied saying we’re going to put it to them anyway. I told them you are putting people at risk.
Chris I agree with you = this stuff wont change anything,They need activists not ‘outsider art’ dealers
This is one of the hospitals H and W is colaborating with ….
Norfolk and Suffolk NHS Foundation Trust warned by CQC over failures
Chief executive Stuart Richardson said he was “deeply sorry” for not making progress in key areas
More than 100 patients died unexpectedly in a two-year period at England’s worst-performing mental health trust, inspectors say.
Norfolk and Suffolk NHS Foundation Trust (NSFT) has been warned by the Care Quality Commission (CQC) that it must improve.
Norwich South Labour MP Clive Lewis has called on the government to take direct control of NSFT with immediate effect.
NSFT chief executive officer Stuart Richardson said he was “deeply sorry”.
Following the latest inspection, the trust was downgraded from “requires improvement” to “inadequate” and remains the only mental health trust within the NHS’s improvement regime for not meeting standards.
Mr Lewis cites claims from mental health campaigners that there could have been as many “1,000 avoidable mental illness-related deaths” at the trust over the years – a figure the trust says it does not recognise.
Two wards were immediately closed to new patients after a CQC visit in November. The trust, which has a £305m budget and employs 4,227 staff, was threatened with enforcement action if urgent measures were not taken.
Other issues highlighted by the CQC include staffing problems, including an annual nurse vacancy rate of more than 17%, staff not completing regular checks on an adult long-stay ward and a severe deterioration on the Dragonfly Unit in Carlton Colville, Suffolk – an inpatient ward for children and young people.
Services for people with autism and learning difficulties, however, were rated “good”.
Key findings from the CQC
The trust has been given a deadline to improve services or face enforcement action by the CQC
115 “unexpected or potentially avoidable” deaths reported over a two-year period
15 people in contact with trust services were “thought likely” to have taken their own lives in the previous three months
The long stay unit for adults had one consultant psychiatrist working half a day per week when patient reviews took place, and a locum junior doctor was shared between this service and another
A patient’s carer shared concerns about illegal substances on a ward with staff not always taking appropriate action
A huge rise in referrals within children and adolescent community services – from 95 in August 2020 to 2,547 in July 2021
Craig Howarth, CQC head of inspection for mental health and community services, said: “Due to our findings, we have served the trust a warning notice so its leaders are clear about what must be done to improve patient care and safety.
“They have a legal obligation to deliver this.”
The notice requires improvements in a number of areas, including maintaining safe staffing levels.
Activists protested outside the trust headquarters after the report came out, tying hearts to hedges
After the report came out, activists from the Campaign to Save Mental Health Services in Norfolk and Suffolk staged a protest outside the trust’s Norwich headquarters.
They attached paper hearts to hedges with the names of people they claimed had died while in the trust’s care.
‘I tried to make things better’
Sheila Preston said she quit from her role as governor after being frustrated by the culture at the trust
Sheila Preston was a governor at the trust when her son Leo, who had a serious mental illness, died from an suspected accidental overdose.
She was determined to make a difference, but after serving a full term of nine years she had become highly critical at the way the trust had been led.
“They have completely failed in their responsibility to the public,” she said.
“There doesn’t seem to be any accountability when things have been going really wrong.
“I think things have got worse in all respects.
“Unfortunately, I cannot change the fact that I’m angry and I spent a lot of time trying to make things better. I failed.”
Transforming a failing trust can’t be done overnight. But campaigners say while they’re told it’s a marathon not a sprint, many don’t make it to the end of that journey.
But staffing shortages are a nationwide problem, so why is this mental health provider the only one in the NHS’s recovery support programme?
Norfolk has the highest number of referrals for young people in the country and a high elderly population, so demand in those age groups is significant.
But management instability has also meant ineffective leadership, with eight chief executives in 10 years. It’s the oversight to bring in staff with the right skills, join services together and learn from mistakes that appears to be lacking.
NSFT has already had an improvement director and managers seconded from another trust in East London, but some services are getting worse not better.
There isn’t much left to try. Well there’s always Hauser and Wirth They will cover things up with arts and farts collaborations with even more hell holes (See below)
As usual brilliant research Susanne. I was aware of Norfolk and Suffolk but not the terrible details. The CQC are useless and I’ve witnessed it close up and utterly shocking, so I’ve little doubt it’s all very much worse.
I might email your comment to Hauser and Wirth.
Go for it it Chris. Here’s the latest but of course wont be the last re the Care! Quality Commission. By the way I gave evidence to whoever was chair or whatever on the cqc at the time , distinguished, compassionate blah blah, that the tavistock was publishing so called ‘cases histories’ without persons’ consent and which amounted to a travesty of anything called even pseudo science. they were inventing the ‘cases’ to back theories they favoured and publishing in little known journals.. People has given me their accounts of meetings with therapists and agreed to them being provided to care quality commission. Received reply along lines of shocking! never should happen on both betrayal of trust and corruption of the theories promoted for .treatment. That was the end of it although things were changed at other trusts.
Took 3 yrs for this person to get around the corruption – there are some who just wont shut up despite the consequences .
CQC found to have unfairly dismissed whistleblowing doctor
05 September 2022
A doctor and NHS whistleblower has won a case against the CQC over his unfair dismissal from an adviser role.
Consultant orthopaedic surgeon Shyam Kumar was found last week to have been unfairly dismissed from his part-time role as a CQC special adviser on hospital inspections.
In the four years prior to his sacking in 2019, Mr Kumar wrote to senior CQC colleagues with issues such as a hospital inspection during which whistleblowing doctors were not allowed to share their concerns.
Mr Kumar said he raised worries on multiple occasions about a surgeon at his own trust, Morecambe Bay, who had done operations that were ‘inappropriate’ and of an ‘unacceptable quality’.
He warned the CQC that the trust aimed to bury the incidents ‘under the carpet’, but the surgeon later had conditions put on his licence to practise.
The tribunal’s judgement said: ‘It is very clear that the emails and concerns raised by Mr Kumar had a material impact on the decision to disengage him.’
Mr Kumar has been awarded compensation.
BBC News reported Dr Kumar saying: ‘The whole energy of a few individuals in the CQC was spent on gunning me down, rather than focusing on improvement to patient safety and exerting the regulatory duties.’
At a hearing in Manchester last year, Mr Kumar said: ‘I was perceived as a troublemaker within the CQC, or as a thorn in their side.’
BMA council chair Professor Philip Banfield said: ‘It is absolutely paramount that doctors are able to raise safety concerns without fear of recrimination or backlash from employers.
‘This judgment clearly underlines the fundamental need to protect whistleblowers and is a significant legal victory that the BMA is proud to have supported.
‘That such a case happened within the very organisation that is meant to safeguard standards within the NHS and social care is incredibly concerning indeed and the CQC must answer serious questions about its culture and the policies that allowed this to happen.’
A CQC spokesperson said: ‘We accept the tribunal findings and have learnt from this case. We have already improved many of our processes and will continue to review these based on the findings to ensure we make any further necessary changes.’
Again very important information re CQC Susanne
Thought about H&W. They are major fine art dealers meaning very large sums of money and billionaires.
They have taken on a multilingual specialist expert in Asian art, from a major auctioneer. I watched this person selling contemporary single paintings for multi-millions no doubt to billionaires for future profit.
The idea that our knowledge and purpose – to expose the truth about psychiatric and other drugs and concoction injections could inspire art that would make billionaires and millionaires even more profit is not what I’m about. So I kinda regret starting this.
Open letter to the CEOs of Pfizer and Moderna
Re: Covid-19: Researchers face wait for patient level data from Pfizer and Moderna vaccine trials Jennifer Block. 378:doi 10.1136/bmj.o1731
As co-authors of a recent study on the safety of mRNA covid-19 vaccines that called for the full transparency of covid-19 vaccine clinical trial data, we wish to share this open letter to the CEOs of Pfizer and Moderna.
Dear Albert Bourla and Stéphane Bancel,
In the summer of 2020, before results from the trials were announced, vaccine manufacturers were criticized for keeping the trial protocols secret. In response, the protocols were released.[2,3] Yet the same did not happen for the trial data.
To the best of our knowledge, regulators such as the European Medicines Agency, UK MHRA, and Health Canada lack electronic individual participant data (IPD) datasets. As discussed below, these data can answer lingering questions regarding what the trials indicated regarding the balance of benefit to harm in December 2020, questions which are difficult to answer with what has been made public. The effort to prepare these datasets is minimal, and no potentially identifying data is needed. We therefore add our names to the call on Pfizer and Moderna to release the data.
Today (Aug 31), our study of serious adverse events in the Pfizer and Moderna phase 3 covid-19 vaccine trials was published in the peer-reviewed journal Vaccine. The results showed the Pfizer and Moderna both exhibited an absolute risk increase of serious adverse events of special interest (combined, 1 per 800 vaccinated), raising concerns that mRNA vaccines are associated with more harm than initially estimated at the time of emergency authorization.
We acknowledge that our estimates are only approximations because the original data remain sequestered. For example, we could not stratify by age, which would help clarify the populations in which benefits outweigh harms.
A more definitive determination of the actual harms and benefits requires individual participant data (IPD) that remain unavailable to research investigators. Unlike its European counterpart, the US regulator FDA does hold electronic IPD datasets, and in a meeting to discuss our study last March, we requested they repeat our analysis using IPD, but to our knowledge, this has not occurred. With the publication of our study, we have written the FDA again to reiterate our request.
Specifically, to allow assessment of the items of concern, for each and every hospitalization and SAE (including covid-19 and covid-19 sequelae), we need: a unique participant ID number, demographic details (participant’s age, sex, etc.), the type of SAE, some dates (enrollment, dose 1 and 2 administration, date of SAE or hospitalization), and whether or not the participant was included in the “FDA safety” subgroup (participants with median ≥ 2 months followup post dose 2). The above data should be extracted from the dataset at the timepoint that supported emergency use authorization (data cutoff 14 Nov 2020 for Pfizer, 25 Nov 2020 for Moderna). To support a more thorough analysis, manufacturers should also provide datasets with the above information at the timepoint that supported the vaccines’ subsequent approval (BLA).
Covid-19 vaccines are now among the most widely disseminated medicines in the history of the world. Yet, results from the pivotal clinical trials cannot be verified by independent analysts. The public has a legitimate right to an impartial analysis of these data. COVID vaccinations have cost taxpayers tens of billions of dollars, perhaps even rivaling the annual NIH budget for all aspects of biomedical and behavioral research.
Transparency, reproducibility, and replication are cornerstones of high-quality science. The time is overdue for Pfizer and Moderna to allow independent scientists and physicians to see the original data and to replicate the analyses. These small datasets can help answer very important questions and lay to rest widespread concerns over lack of transparency.
Joseph Fraiman, MD
Louisiana State University, Lallie Kemp Regional Medical Center, Independence, LA, U.S.A.
Juan Erviti, PharmD, PhD
Unit of Innovation and Organization, Navarre Health Service, Spain
Mark Jones, PhD
Institute of Evidence-Based Healthcare, Bond University, Gold Coast, QLD, Australia
Sander Greenland, MA, MS, DrPH
Fielding School of Public Health and College of Letters and Science, University of California, Los Angeles, CA, U.S.A.
Patrick Whelan, MD PhD
Geffen School of Medicine, University of California, Los Angeles, CA, U.S.A.
Robert M. Kaplan, PhD
Clinical Excellence Research Center, School of Medicine, Stanford University, CA, U.S.A.
Peter Doshi, PhD
University of Maryland School of Pharmacy, Baltimore, MD, U.S.A.
“We are grateful to the FDA for their decisive leadership.”
FDA authorizes Pfizer and Moderna Covid boosters targeted against Omicron strains
By Matthew Herper Aug. 31, 2022
In a move that mirrors the long-used strategy for influenza vaccines, the new booster shots are being authorized without new human clinical trial data for this exact formulation. Instead, the authorization is based on data in mice and experience so far with the mRNA vaccine platforms used by the drugmakers. Covid vaccines using this technology have been given to millions of people and have proved effective against previous strains of the SARS-CoV-2 virus.
In statements, the CEOs of vaccine manufacturers used the authorization as an opportunity to take a victory lap. Albert Bourla, Pfizer’s CEO, called it “another important milestone in our ongoing efforts to provide protection against this virus.” Ugur Sahin, of BioNTech, said it “further underlines the strength of rapidly adaptable mRNA vaccines against this continuously evolving virus.”
Stéphane Bancel, Moderna’s CEO, called it “an important public health measure that people can take to help protect themselves,” adding: “We are grateful to the FDA for their decisive leadership.”
Booster jabs for all is waste of taxpayer cash, says AstraZeneca boss
The UK is using Pfizer and Moderna vaccines for its booster efforts, rather than AstraZeneca vaccines.
High-ranking FAA Whistleblower went public yesterday. He spoke of his grave concerns of elevated risks of danger to public aviation safety. Vaccines and mandates have shaken the industry, and it needs to be fixed.
@USFreedomFlyers @IamBrookJackson @DrNaomiRWolf @WarRoom
Investigate the Danger
Bombshell Whistleblower Declaration from High-Ranking FAA Official
“Safety is our Passion”. That’s the slogan of the FAA, the institution that was created to ensure that aviation safety in the United States is the best in the world, and to create standards that other nations follow. What’s transpired in the last almost 3 years demonstrates that they no longer deserve to use that as their slogan.
Despite a range of aviation professionals raising safety concerns to the FAA, they took no official position regarding the treatment of Covid, as late as Dec 2021. Instead of advising their pilots and flight crews on how to manage Covid symptoms and treat the virus, they kept quiet until it was time to roll out the EUA Covid-19 shots. Right off the bat that was a red alarm.
According to the FAA’s own regulation guidelines, no pilot may take a drug until it’s been one year since full FDA approval. If they do, they don’t get medical approval to fly. Despite this rule, the government issued a blanket waiver for the Covid-19 shots without any documentary evidence and scientific studies.
Evidence: Medical Danger to Life and Health
Pure dead brilliant…