https://mobile.twitter.com/VigilantFox/status/1622434385290006530
The Vigilant Fox 🦊
@VigilantFox
Japanese Professor Sues the Government for Hiding Inconvenient Truths About the Jab
Prof. Fukushima: "This is a historically serious problem that threatens the very existence of the nation of Japan."
"As a medical doctor … I had no choice but to dare to take legal action."
https://mobile.twitter.com/EnemyInAState/status/1622028604807725062
Chris Turnbull
@EnemyInAState
Dramatic near 2x higher deaths in area of Australia has new variant: very high deaths BUT very low cases???
Something strange going on??
h/t
@Mike_Honey_
https://mobile.twitter.com/DrLoupis/status/1622025274769510400
Dr. Anastasia Maria Loupis
@DrLoupis
“Sterile” face mask, anyone?
https://mobile.twitter.com/Jikkyleaks/status/1622062038246912000
Jikkyleaks 🐭
@Jikkyleaks
BREAKING CHEESE 🧀🧀🧀
#spraygate
Who is Dr Kirsty Ainslie
@ainslielab
and why is she included in the Ecohealth DEFUSE proposal yet doesn't have her Ecohealth affiliation listed in papers?
And what has she been spraying, exactly?
Jikkyleaks 🐭
@Jikkyleaks
·
Feb 4
Replying to
@Jikkyleaks
No mention of Ecohealth anywhere yet she is mentioned 3 times in the DEFUSE proposal.
Aerosol is mentioned 12 times
@CharlesRixey
@chrismartenson
#spraygate #letusspray
Jikkyleaks 🐭
@Jikkyleaks
·
Feb 4
No mention of Ecohealth
@AinslieLab
?
Why so shy?
Please can you tell us more about your microparticle delivery systems for aerosol release in the DEFUSE protocol?
Jikkyleaks 🐭
@Jikkyleaks
·
Feb 4
Where were you planning to use this vaccine delivery system?
And what vectors did you have in mind?
sciencedirect.com
Electrospray for generation of drug delivery and vaccine particles applied in vitro and in vivo
Also known as electrospray, electrohydrodynamic atomization has been used extensively in the last 15 years to develop polymer-based particles for
Jikkyleaks 🐭
@Jikkyleaks
·
Feb 4
And if the coronavirus is not stable enough, I guess we can just make a poxvirus chimera and spray that around the "bat cave" eh?
#spraygate
@daoyu15
@chrismartenson
@SenRonJohnson
@jjcouey
Jikkyleaks 🐭
@Jikkyleaks
·
Feb 4
#spraygate #DEFUSE
@WarClandestine
Jikkyleaks 🐭
@Jikkyleaks
·
Feb 4
Or maybe use the Baric measles chimera?
Is this what happened in #Samoa?
arkmedic.substack.com
The Killing Fields of Samoa
What happened in Samoa in 2019 and why is it so important now?
Jikkyleaks 🐭
@Jikkyleaks
·
Feb 4
Dr Tonie Rocke is involved with making aerosolised pox vector "vaccines" but despite the references in the DEFUSE document, hasn't published it.
"aerosolized application to roost sites in caves… remains to be tested."
ncbi.nlm.nih.gov
Protection of bats (Eptesicus fuscus) against rabies following topical or oronasal exposure to a…
Rabies is an ancient neglected tropical disease that causes tens of thousands of human deaths and millions of cattle deaths annually. In order to develop a new vaccine for potential use in bats, a…
Jikkyleaks 🐭
@Jikkyleaks
·
Feb 4
I think Dr Ainslie (spray), Dr Rocke (Poxvirus) and Dr Unidad (spray) need to make a statement urgently as to whether they have collaborated with Ecohealth at any point and release their documents.
Otherwise they may need to answer questions in a more formal environment.
Jikkyleaks 🐭
@Jikkyleaks
·
Feb 4
Either
(1) Ecohealth were planning to use these aerosol sprayers to distribute gene therapy vaccines (dangerous and unethical)
or
(2) these methods were already used to distribute "vaccines" that resulted in "COVID"
Or both.
This crap needs to stop.
#spraygate #shutitdown
Jikkyleaks 🐭
@Jikkyleaks
·
Feb 4
Source document (DEFUSE protocol)
https://files.catbox.moe/plzt68.pdf
Jikkyleaks 🐭
@Jikkyleaks
·
Feb 4
Related thread - how did #COVID19 spread in such a discontiguous yet synchronous manner around the world?
Quote Tweet
Jikkyleaks 🐭
@Jikkyleaks
·
Feb 3
Can anyone explain how all-cause mortality in the UK in April 2020 spiked at exactly the same time in every region when travel routes into the UK are overwhelmingly via the South East?
[If it was from an imported virus]
@boriquagato @EthicalSkeptic https://ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/deaths/datasets/weeklyprovisionalfiguresondeathsregisteredinenglandandwales
Show this thread
Jikkyleaks 🐭
@Jikkyleaks
·
19h
WHOA!
For the EVALI link…
What if Wisconsin was the testing ground for Rocke's delivery system?
Quote Tweet
Προμηθεύς
@Prometeusz
·
23h
NWHC (Rocke) has a captive bat colony located in Madison, Wisconsin. ( https://researchgate.net/publication/363729325_DRASTIC_-_An_Analysis_of_Project_DEFUSE ; https://drasticresearch.files.wordpress.com/2021/09/main-document-preempt-volume-1-no-ess-hr00118s0017-ecohealth-alliance.pdf ; https://ncbi.nlm.nih.gov/pmc/articles/PMC5543807/ )
Show this thread
Startling Evidence Suggests BioNTech and Pfizer Falsified Key Data: Part 1
https://www.trialsitenews.com/a/startling-evidence-suggests-biontech-and-pfizer-falsified-key-data-part-1-e2595e7f
Evidence has emerged casting serious doubt over the authenticity of tests carried out by BioNTech (Marketing Authorisation Holder) and Pfizer to prove the fidelity of their product by demonstrating that only the spike protein of SARS-CoV-2 is expressed in cells by the nucleoside-modified mRNA Pfizer-BioNTech Covid-19 vaccine (BNT162b2).
Several Western Blot tests were conducted to evaluate the protein expression of the mRNA in HEK cells transfected with the vaccine taken from different lots. Using this technique, the expressed proteins showed up as highly unusual looking ‘bands.’
Certain independent scientific experts have described these Western blots as the “smoking gun” evidence (particularly the “duplication” of the results) which suggest that BioNTech and Pfizer falsified key data as part of their submissions to the European Medicines Agency and the Federal Drugs Agency for securing emergency use authorisation (conditional) and later marketing authorisation approval of their product.
The bombshell evidence was dropped without so much as a ripple in the sea of brewing scandals washing up on the shores of the behemoth pharmaceutical company and its partner, BioNTech. However, some in the scientific community have taken notice and written about this scandal, known on social media as #Blotgate.
The fact there could be actual evidence to prove that Pfizer and BioNTech engaged in fraud by fabricating critical data would have major ramifications. For instance, their indemnity status (protection from any legal liability resulting from deaths or injuries caused by their product) which was written into their purchasing contracts and signed by many countries, would cease to apply.
cont…
https://ehden.substack.com/p/pfizer-and-the-royal-thai-family
PFIZER AND THE ROYAL THAI FAMILY
There's been a lot of talk in the last few days about the possibility that the Royal Thai family will nullify the Pfizer contracts. Let's make things clear.
By Ehden Biber
Since the news of the collapse of the Thai princess came, and the revelations that the Thai royal family are furious because it seems her condition is a result of the Pfizer shot, there has been lot of chatter about the possibility that Thailand will nullify their contract with Pfizer. The purpose of this post is to help people understand the legal framework which will govern such attempt.
Sense of Awareness is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.
First, I invite everyone who has been talking about the idea that the Thai royal family will simply nullify the agreement they signed with Pfizer to read what I've written in July 2021, after discovering THE ONLY PFIZER MANUFACTURING AND SUPPLY AGREEMENT that we can discuss in certainly as authentic, which is the Brazilian one (as part of my #PfizerLeak revelations on twitter, a day after I shared the Albanian contact).
If you want to understand the Pfizer negotiation process that led to the signing of the manufacturing and supply agreement by Thailand, read my post entitled “The Negotiations”. The highlights from Carlos Murillo's testimony are truly pivotal!
The important point is: Thailand cannot risk nullifying the contract because they put as collateral against this contract ALL OF THE COUNTRY ASSETS, including currency reserves and embassies!
If Thailand will want to dispute the contract, the need to go to an arbitration process, govern by the International Chamber of Commerce (ICC) arbitration process. Each side will nominate an arbitrator, and the ICC court will nominate the chair, who will make the decision.
Image
The problem is that since a court case against Pfizer/BioNTech regarding their product will take place in NY, it will be govern by the PREP act, conducted in an where willful misconduct requires a proof or 3 things (below). While we have evidence on #3, how exactly will anyone clearly prove #1 & #2?
Image
Practically, the ONLY WAY anyone can nullify the contracts is if they can prove that BioNTech who developed the "vaccine" knowingly planned to kill people. Why do you think the creators of this deadly shot got involved in writing a book about it? They were trying to frame their narrative.
Image
HOWEVER!!!
In my honest opinion, countries MIGHT have ONE get-out-of-jail-ticket from these draconian contracts, as the executive branch (government) signed a SECRET commitment that the contract cannot and will not be overruled by legislative & judiciary branches. But… it’s not going to be that easy. After all, will claims of unconstitutional contract work in this court? I cannot tell. Also, as the chair decides, it's a high risk.
To understand the complexity of the international arbitration process, I STRONGLY RECOMMEND reading "What's law got to do with it? The role of governing law in international commercial arbitration" by Jennifer L. Permesly (@SkaddenArps), from 2018.
Here are some important quotes from the article:
“An arbitrator who decides according to some other law, whether a national or otherwise, presumes to rewrite the bargain”
“an arbitrator’s primary duty is to interpret the terms of the parties’ contract in accord with their expectations.”
“In the arbitrator’s decision-making process, his "reason and logic", rather than the statutory rulebook of interpretation, are considered the guiding light for his interpretation of the disputing parties’ contract.”
“arbitrators are free to consider sources of transnational and international law in addition to the national law rules chosen to govern the contract.”
“some arbitrators have resorted to a hybrid method, mixing the concepts of trade usages, general international principles, and lex mercatoria into a sort of interpretative stew”
“Most legal systems provide that that arbitrators’ determinations on the substance of the dispute are not subject to judicial review. On this premise, some have suggested that arbitrators are free to disregard certain principles of governing law, and even to replace the law chosen by the parties in favor of a different domestic law or transnational principles, without fear of repercussion.”
p1
“One of the most contentious features of United States arbitral law is the doctrine that permits vacatur of an arbitral award based on a "manifest disregard of the law" by the arbitrators”
“most commentators concede that arbitral awards may be reviewed where the decision would violate national or international public policy, which could encompass situations where an arbitrator’s decision not to apply "mandatory rules" of national law is considered to violate a public policy of the enforcing state.”
“the privacy of the arbitral process and the absence of full scrutiny of arbitrators’ substantive decisions may incentivize some international arbitrators to depart from legal decisional norms”
“the incorporation of international arbitration in the parties’ contract may be more meaningful than their choice of governing law.”
“At its most basic, governing law can offer predictability of result, or at least a meaningful and experience rich body of law and precedent to guide the substantive result.”
“Perhaps the very lack of judicial review of arbitrators’ substantive decision-making has contributed to a lacuna in this area; we have developed clear and nearly universally accepted standards to address various procedural issues in arbitration, but leave the scope and nature of legal decision making distinctly to the individual arbitrator.
“Nearly all arbitral institutions, as well as the UNCITRAL Model Law and UNCITRAL Arbitration Rules, provide that arbitrators "shall" or "will" apply the law or rules of law designated by the parties in their agreement.”
“The ICC Rules similarly envision the application of the law chosen by the parties, stating that the "parties shall be free to agree upon the rules of law to be applied by the arbitral tribunal to the merits"”
“While it is not clear that these directives go so far as to preclude reference to principles falling outside of national law, there is no reason that they should be considered any less indicative of party intent than, for example, the "clear and unmistakable evidence" to allow arbitrators to decide their own jurisdiction that is commonly found by U.S. courts when parties refer their dispute to arbitral rules containing provisions regarding competence-competence.”
“the prevailing view is that arbitrators should not resort to lex mercatoria where not expressly authorized to do so by the parties in their contract.”
“Modern arbitral procedure tends to focus on facts and procedure over the application of legal standards; counsel and arbitrators share responsibility for this trend.”
“There are myriad ways in which these issues can be addressed, all of which first and foremost rely on attention, rigor, and care from arbitrators and counsel alike. A few specific proposals for ways in which legal decision-making might be elevated and prioritized include:
Reference to burdens/standard of proof and evidentiary standards in order to place emphasis on those facts relevant to the legal dispute at hand.
Consideration of early dismissal of claims without legal merit.
Constitution of a tribunal familiar with the law and/or reliance on legal experts, where necessary.”
“Increased attention to the governing law chosen by the parties, including by insisting that a party’s claims and defenses be framed within the applicable legal construct and by providing clear and consistent reasoning as to when and how transnational principles will be applied, are small steps that could go a long way in re-elevating the role of "law" in arbitral decision-making.”
Again - I HIGHLY RECOMMEND anyone who want to try to understand the process of challenging the Pfizer contracts to read this article !!! It’s A MUST!
Finally, if you’re interested, I’ve written a lot about the contracts multiple posts in the past, which you can find here, on Substack.
Sending love and healing to everyone who got injured by the jabs.
Ehden Biber
2 of 2
https://mobile.twitter.com/ShortShort_News/status/1622224704064098304
ShortShort News
@ShortShort_News
The Japanese Government concealed data that was inconvenient for the promotion of vaccination
Professor Fukushima filed a lawsuit against Japanese government.
https://mobile.twitter.com/LionAdvocacy/status/1622049638688718848
Lion Advocacy
@LionAdvocacy
Pfizer has been found guilty of violating three sections of the British Pharmaceuticals Code of Practice?
This seems rather newsworthy.
I’m surprised it got so little media attention, especially given the recent concerns about misinformation.
https://www.pmcpa.org.uk/cases/completed-cases/auth35911221-a-complaint-on-behalf-of-usforthem-v-pfizer/#:~:text=COMPLAINANT%20v%20PFIZER
AUTH/3591/12/21 - A complaint on behalf of UsForThem v Pfizer
Case Summary
A complaint on behalf of UsForThem, a parent-led campaign group calling for children’s needs to be prioritised during the Covid pandemic response, was received about an article and video posted on the BBC news website.
The item at issue, entitled ‘Pfizer boss: Annual Covid jabs for years to come’ consisted of an interview conducted by a BBC medical editor with Pfizer’s Chief Executive Officer (CEO) and appeared in the ‘Health’ section of the BBC website on 2 December 2021.
COMPLAINT
The complainant stated that the tone, content and means of dissemination of this article and the associated video were extremely promotional in nature. The complainant strongly believed that it was not appropriate for Pfizer to promote its product in this way. The complainant referred to three earlier cases against Pfizer for promoting its Covid-19 vaccine illegitimately online (Cases AUTH/3422/11/20, AUTH/3438/12/20 and AUTH/3437/12/20). In these cases the Panel decided that Pfizer’s Covid-19 vaccine regulatory status was that of a temporary approval for emergency use only and stated that the vaccine was not a licensed medicine, and that Pfizer was guilty of promoting an unlicensed medicine in breach of the Code. The complainant was not aware that the UK regulatory status of Pfizer’s Covid-19 vaccine had changed since these cases and therefore alleged Pfizer was, with the material at issue, once again in breach of the Code. Furthermore, in view of the fact that Pfizer had had several findings of a similar nature in the past 6 months, the complainant alleged that Pfizer was also in breach of the Code for failing to comply with its undertaking.
The complainant made specific allegations about statements and claims made in the promotional piece relating to children:
p1
1 ‘Immunising that age group [children under the age of 11] in the UK and Europe would be a very good idea.’
The complainant alleged that by recommending vaccinating healthy British children under the age of 11 against Covid-19, the Pfizer CEO was making a claim for the clinical efficacy and safety of Pfizer’s product and its risk/benefit balance, even though the vaccine had not yet been included in the emergency use temporary approval for use in children this young in the UK.
2 ‘Covid in schools was thriving’. ‘This was disturbing significantly the educational system and there were kids that would have severe symptoms.’
The complainant stated that severe Covid-19 was rare amongst children and school age in the UK and while the virus did circulate in schools, schools had typically reflected community transmission throughout the pandemic. Neither had Covid-19 itself had a significant impact on disturbing children’s education in the UK. The ‘disturbance’ to the UK educational system had resulted from political decisions made by governments, not the virus. Indeed, the complainant knew that the UK had the second highest rates of school closures in Europe, except for Italy – a result of political decisions.
The complainant stated that there was simply no evidence that healthy school children in the UK were at significant risk from the SARS COV-2 virus and to imply that they were was disgracefully misleading.
3 ‘So, there was no doubt in my mind that the benefits completely were in favour of doing it.’
The complainant alleged that this was probably the most egregiously false and misleading of the Pfizer’s CEO’s statements. It completely neglected to consider that there were potential risks to healthy children associated with administration of the Covid-19 vaccine. The complainant referred to a number of documents including a Pfizer leaflet listing side-effects; Latest government advice regarding myocarditis to healthcare workers detailing rates of myocarditis in hospitalised children; and Latest adverse events reported for Pfizer.
The complainant stated that the conclusion of the Joint Committee on Vaccination and Immunisation earlier in 2021 when asked to give an opinion on this very subject in relation to the older cohort of children between 12 and 15 hardly seemed to be consistent with the opinion of Pfizer’s CEO that there was ‘no doubt’ or that ‘the benefits completely were in favour’. The complainant alleged that the failure to promote the rational use of the medicine, the misleading presentation of the risk/benefit profile and the use of exaggerated, all-embracing claims (‘no doubt’ and ‘completely in favour’) was in breach of the Code.
p2
The complainant stated whether Pfizer, or indeed the BBC, liked it or not, opinion about the benefits and risks of vaccinating healthy children against an infection which posed little risk to them, and the ethical considerations of exposing healthy children to the risks of vaccination (no matter how rare those effects might be) in order to protect adults or vulnerable members of society, was not settled. For a pharmaceutical company to be behaving on a public platform as if it was, was wrong. The complainant alleged that the material was in breach of the Code in that ‘emerging clinical and scientific opinions which had not been resolved in favour of one generally accepted viewpoint must be referred to in a balanced manner’.
The complainant understood that Pfizer’s Covid-19 vaccine fell within the clause of the Code relating to temporary authorisation for sale or supply without a marketing authorisation. The complainant stated such was the poor quality of this activity and the materials which were the subject of this complaint in terms of their lack of compliance with the Code that the complainant found it difficult to believe that Pfizer had undergone the required prior scrutiny and approval by the MHRA on behalf of the ministers as set out in Clause 11.3 of the Code.
The complainant alleged a breach of the Code as no information, whatsoever, was provided about reporting of side-effects, or indeed the side-effects themselves.
The complainant had no way of knowing whether the interview was or was not solicited by Pfizer. Similarly, the complainant had no way of knowing whether Pfizer’s CEO was formulating his answers based on briefing notes prepared by the Pfizer communications department or, indeed, whether the journalist prepared his written article with the aid of written briefing notes or press releases provided by Pfizer. This information would no doubt inform and guide judgements about this case.
In summary, the complainant alleged that the article, and associated video constituted promotion by Pfizer of its unlicensed medicine which fell within the scope of the Code. The complainant further alleged that Pfizer had failed to maintain high standards and brought discredit upon the industry. Furthermore, bearing in mind that Pfizer was found guilty of illegitimately promoting its Covid-19 vaccine using the internet less than six months ago, a breach of undertaking was alleged.
The detailed response from Pfizer is given below.
p3
PANEL RULING
The Panel noted Pfizer’s submission that it had been approached by the BBC for an interview with its CEO which was held on 22 November 2021. The news article and associated video interview, referred to by the complainant, were produced and published by the BBC on 2 December 2021. The Panel noted Pfizer’s submission that the 45-minute interview was intended to cover news topics identified by the BBC about Pfizer’s commitment to the global Covid-19 vaccine rollout and ongoing innovation to fight the pandemic.
The Panel noted that complaints about third party articles in the press etc were judged upon the acceptability of the information provided to that third party by the pharmaceutical company, such as any press release, unedited interview etc rather than the final published article. The Panel noted Pfizer’s submission that it had no editorial control or right to review the excerpts of the interview chosen by the BBC for inclusion in their news articles and no Pfizer press briefing was issued to the BBC in association with the interview. The Panel also noted Pfizer’s submission that it had not been able to obtain a full transcript of the interview from the BBC as the BBC’s own policies did not allow this; it had, however, obtained some limited expanded excerpts from the interview. The Panel noted that it was obliged to make its rulings based on what Pfizer’s CEO had actually stated rather than the edited published article and video. The Panel noted, therefore, that in relation to the quotations cited by the complainant, these could only be considered within the context of the overall interview based on the limited BBC transcript provided by Pfizer as part of its response.
The Panel did not have the full unedited transcript of the interview or the video. Whilst the complainant referred to the published video, it appeared that the substantive allegations related to the published article.
The Panel noted Pfizer’s submission that prior to the interview, Pfizer UK had briefed the CEO who was based in the USA about the interview, the regulatory status of Covid-19 vaccines in the UK and the requirements of the ABPI Code.
p4
The Panel noted the comments that had been included in the article which were attributable to Pfizer’s CEO within the context of the limited interview excerpt provided by Pfizer particularly ‘Immunising that age group [children under the age of 11] in the UK and Europe would be a very good idea’ and ‘So, there is no doubt in my mind that the benefits, completely, are in favour of doing it [vaccinating children against Covid-19]’ and considered that the strong unqualified nature of the comments were such that they promoted Covid-19 vaccines including the Pfizer-BioNTech Covid-19 vaccine.
The Panel noted, that at the time the CEO’s comments were made, and subsequently published, the Pfizer-BioNTech Covid-19 vaccine did not have a temporary supply authorisation, it was the subject of a conditional marketing authorisation. In the Panel’s view, the medicine therefore had not been promoted prior to the grant of its marketing authorisation and no breach of the Code was ruled.
In relation to the alleged breach of undertaking, the Panel noted that the current case (Case AUTH/3591/12/21) concerned excerpts from an interview with Pfizer’s CEO which were subsequently published in an article by the BBC and referred to Pfizer-BioNTech Covid-19 vaccine which had a conditional marketing authorisation at the time. In the Panel’s view, the current case, Case AUTH/3591/12/21, was sufficiently different to the previous cases which involved promotion prior to the grant of the market authorisation as a result of individual employee’s personal use of social media which did not follow company policy such that there had been no breach of the undertakings given in Cases AUTH/3422/11/20, AUTH/3437/12/20 and AUTH/3438/12/20 as alleged. The Panel therefore ruled no breach of the Code.
In relation to the quotation ‘Immunising that age group [children under the age of 11] in the UK and Europe would be a very good idea’ the Panel noted Pfizer’s submission that at the time the article at issue, including excerpts from the Pfizer CEO’s interview, was published, the Pfizer-BioNTech Covid-19 vaccine was approved for use in individuals 12 years and older; no Covid-19 vaccines were approved by the MHRA for use in children under the age of 12 years.
p5
Whilst the Panel noted that the Pfizer-BioNTech Covid-19 vaccine was not licensed for use in under 12 year olds at the time the CEO’s comments were made, and subsequently published within the BBC article, it did have a conditional marketing authorisation for use in those aged 12 and over. The Panel did not consider, therefore, that the clause which required that a medicine must not be promoted prior to the grant of its marketing authorisation which permits its sale or supply was relevant and no breach of the Code was ruled in relation to the quotation in question.
The Panel noted, however, that the Pfizer-BioNTech vaccine was not approved by the MHRA for use in children aged 5 to 11 years until 22 December 2021. At the time the CEO’s comments were made and subsequently published within the BBC article, the Pfizer-BioNTech vaccine was not approved for use in children aged 5-11 years. In the Panel’s view, the statements attributable to the Pfizer CEO promoted the Pfizer-BioNTech vaccine in this age group and a breach of the Code was ruled. This ruling was appealed by Pfizer.
The Panel noted that with regard to the quotations ‘Covid in schools was thriving’ and ‘This was disturbing significantly the educational system and there were kids which would have severe symptoms’, Pfizer provided a BBC transcript of this part of the interview. The quotations in question were slightly different in the transcript: ‘I think that Covid in schools was thriving’ and ‘I believe that this is disturbing, significantly the educational system’. They appeared as part of a response to a question about whether immunising 5 to 11 year olds was likely to happen in the UK and Europe. The Panel noted Pfizer’s submission that the evidence showed rising levels of Covid-19 infection seen in UK school age children in autumn 2021 potentially representing a pool of infection and risk of transmission to peers, staff and families. An opinion piece published in the British Medical Journal (BMJ) December 2021 highlighted the key issues. Further, in the UK, the pandemic had resulted in two significant periods of school closures causing notable disturbance to the education system. The Panel noted Pfizer’s submission that numerous reports documented the detrimental impact of the disruption on children’s wellbeing and learning. This included The Office of Qualifications and Examinations Regulation (OFQUAL) review published in July 2021, which stated that the nature of learning loss varied depending on the phase of education. Primary leaders were most likely to report significant learning loss, with the youngest pupils apparently most negatively affected by the pandemic. The Panel further noted Pfizer’s submission that whilst data concerning long Covid-19 were limited in young children, there was documented evidence of the occurrence of long Covid-19 in children aged 11 to 17 years; the BMJ reported that one in seven children in the UK might still have symptoms 15 weeks after infection. The Panel did not consider that the complainant had established that the cited quotations were misleading or incapable of substantiation on the basis that there was no evidence that healthy school children in the UK were at risk from the SARS COV-2 virus as alleged. Based on the very narrow allegation, no breaches of the Code were ruled.
p6
With regard to the allegations about the statement ‘So, there is no doubt in my mind that the benefits completely are in favour of doing it [vaccinating children against Covid-19]’ the Panel noted that a transcript of this part of the interview was provided to Pfizer by the BBC. The Panel noted Pfizer’s submission that it showed that its CEO was asked a specific question about vaccinating 5 to 11-year-old children against SARS-CoV-2 infection. The interviewer asked ‘In October the FDA, the American regulator approved your vaccine for 5-to 11-year-olds after successful trials. Do you think immunising that age group is likely to happen in the UK and Europe? And if so, why is it a good idea?’. The CEO responded ‘I think it will happen. I don't want to speak about specific candidates I don't want to speak about for the health authorities or the regulatory authorities of UK. It’s up to them to approve it and use it or not. I believe it's a very good idea. I think that COVID in schools is thriving. I believe that this is disturbing, significantly, the educational system. I think is becoming the pool of infection for the adults. It is becoming a pool of infection for a pool of where the virus keeps replicating and that creates variants. At the end of the day, although the symptoms are not very severe, there is the long COVID. That is very worrisome. And there are kids that will have severe symptoms. So there is no doubt in my mind about the benefits completely are in favour of doing it’.
The Panel noted Pfizer’s submission that the CEO made it clear that the decision on whether to authorize the vaccines in the 5 to 11 year age group was the responsibility of the MHRA and he was not speaking on its behalf. He also explained that he was answering the question in the context of Covid-19 vaccination in general rather than specifically the Pfizer-BioNTech vaccine. Pfizer’s CEO then went onto express his opinion that the wider benefits of vaccinating the 5 to 11 year age group were in favour of vaccination. The Panel noted from the transcript that there was a clear inference that a risk/benefit analysis would be undertaken by the regulator. On balance, however, the Panel considered that the subsequent strong opinion statements, including ‘So, there was no doubt in my mind that the benefits completely were in favour of doing it [vaccinating children against Covid-19]’ and ‘I believe it’s a very good idea’ might infer to the ultimate audience, including members of the public, that there was no need to be concerned about potential side-effects which was not so. The Panel considered that this implication was incapable of substantiation and through phrases such as ‘no doubt’ and ‘completely in favour’, Pfizer’s CEO did not encourage the rational use of a medicine. Breaches of the Code were ruled. These rulings were appealed by Pfizer.
The Panel noted that at the time the CEO’s comments were made and subsequently published within the BBC article, there appeared to be differing opinion on the benefit of vaccinating children under 12. Whilst the Panel noted the CEO’s statement that he/she ‘did not want to speak for the health authorities or the regulatory authorities of UK, it was up to them to approve it and use it or not’, the Panel considered that the CEO’s opinion statements, including ‘So there is no doubt in my mind about the benefits completely are in favour of doing it’ might infer to the ultimate audience, including members of the public, that the benefits outweighed the risks when the regulatory authorities had not yet made any conclusions in relation to the vaccination of 5 to 11 year olds; the Pfizer-BioNTech Covid-19 vaccine was not licensed in the UK in that age group when the article at issue was published and the Panel therefore ruled breaches of the Code. These rulings were appealed by Pfizer.
p7
The Panel noted that, at the relevant time, the Pfizer/BioTech vaccine had a conditional marketing authorisation. The clause of the Code which applied to medicines with a temporary supply authorisation, was therefore not applicable and no breach was ruled.
The Panel did not consider that the complainant had established that the interview with the CEO, excerpts of which were subsequently included in the BBC article, was a campaign approved by health ministers and thereby required a reference to reporting of side-effects. No breach of the Code was ruled.
The Panel did not consider that the complainant had established that the interview in question was intended for patients taking the Pfizer-BioNTech Covid-19 vaccine and therefore the requirements of the Code which related to material related to a medicine intended for patients taking that medicine were not relevant. No breach of the Code was ruled.
The Panel noted its comments and ruling above and considered that Pfizer had failed to maintain high standards and a breach of the Code was ruled. This ruling was appealed by Pfizer.
The Panel noted its comments and rulings above, including that the statements made by the Pfizer CEO did not encourage the rational use of the medicine, and considered that the briefing document by Pfizer UK did not sufficiently brief the CEO on how to address questions on children aged 5 to 11, despite this being described as a hot topic; the briefing was limited to stating that there were no current plans to authorise the vaccine for ages 5 to 11 and that Pfizer would submit data on the 5 to 11 population to the UK regulator in the coming weeks. [See post Panel consideration note]. Further, whilst the briefing instructed the CEO not to promote nor state messages which could appear to encourage individuals to specifically ask their doctors for a prescription based on the information provided, it provided key messages, contradictory to this instruction such as ‘I encourage anyone who is on the fence about receiving a vaccine to think again and to look at the science’ and ‘This is a decision that will not only affect your life but those you spend the most time with including your family and loved ones’. The Panel noted its comments and rulings above and considered that Pfizer had brought discredit upon, and reduced confidence in, the industry in this regard and a breach of Clause 2 was ruled. This ruling was appealed by Pfizer.
[Post Panel consideration note: Following notification of the Panel’s rulings, Pfizer pointed out that the briefing stated ‘No current plans to authorize the vaccine for ages 5-11 but this is hot topic behind closed doors within Government (not publicly in media)’].
p8
Pfizer considered the briefing document to be confidential and initially did not want it to be shared with the complainant. The briefing document was not provided to the complainant when notified of the outcome of the Panel’s consideration of the case as it was not considered relevant to enable him/her to decide whether or not to appeal the Panel’s rulings of no breach of the Code. Upon Pfizer’s appeal the issue of confidentiality of the enclosure which Pfizer re-submitted as part of its appeal was reviewed. A redacted version of the briefing document was settled by the Director as set out in Paragraph 7.5 of the PMCPA Constitution and Procedure. The terms of its disclosure to the complainant, however, could not be settled with the parties. The complainant declined to receive the redacted Enclosure based on the terms of confidentiality and was originally sent Pfizer’s appeal papers without it. The Chair of the Appeal Board was asked to decide how to proceed and decided that relevant sections, quoted directly from the Enclosure, were to be included in one document titled ‘Relevant extracts from Enclosure 22, a briefing document from Pfizer for an interview with the BBC on November 22, 2021.’ and that this was shared with the complainant, Pfizer and the Appeal Board.
The appeal from Pfizer and the complainant’s detailed comments upon it are given below.
APPEAL BOARD RULING
The Appeal Board noted Pfizer’s submission that the 45-minute interview was intended to cover news topics identified by the BBC about Pfizer’s commitment to the global Covid-19 vaccine rollout and ongoing innovation to fight the pandemic. Pfizer’s objective for the interview was to reiterate its continued commitment to delivering equitable access to its COVID-19 vaccine across low- and middle-income countries which was a topic of particular media interest at the time. Pfizer submitted that it had reasonably considered that the topic of childhood vaccination would not be a specific focus of the interview. At the appeal Pfizer stated that its CEO who was based in the USA had been given the briefing document and verbally briefed by an experienced media relations team and senior staff. Pfizer UK had briefed the CEO about the regulatory status of Covid-19 vaccines in the UK and the requirements of the ABPI Code. In response to a question at the appeal, Pfizer acknowledged that perhaps additional wording could have been added to the briefing to help the CEO navigate the more complicated areas.
The Appeal Board noted Pfizer’s submission that it had no editorial control or right to review the excerpts of the interview chosen by the BBC for inclusion in its news articles and no press briefing was issued to the BBC in association with the interview. The Appeal Board also noted Pfizer’s submission that it had not been able to obtain a full transcript of the interview from the BBC as the BBC’s own policies did not allow this; it had, however, obtained some limited expanded excerpts. Pfizer stated at the appeal that whilst the topic of vaccination in children appeared to be a focus in the online article, it formed only a small part of the complete 45 minute interview. The Appeal Board agreed with the Panel that it was obliged to make its rulings based on what Pfizer’s CEO had actually stated rather than the edited published article and video. The Appeal Board noted that whilst it did not have the full unedited transcript of the interview, it had before it two questions and answers in relation to vaccination in children. One was not included within the online article and was not the subject of the complaint. The other was:
BBC medical editor: ‘In October the FDA, the American regulator approved your vaccine for 5 to 11-year-olds after successful trials. Do you think immunising that age group is likely to happen in the UK and Europe? And if so, why is it a good idea?
p9
Pfizer CEO: ‘I think it will happen. I don't want to speak about specific candidates I don't want to speak [about] for the health authorities or the regulatory authorities of UK. It's up to them to approve it and use it or not. I believe it's a very good idea. I think that COVID in schools is thriving. I believe that this is disturbing, significantly, the educational system. I think is becoming the pool of infection for the adults. It is becoming a pool of infection for a pool of where the virus keeps replicating and that creates variants. At the end of the day, although the symptoms are not very severe, there is the long COVID. That is very worrisome. And there are kids that will have severe symptoms. So there is no doubt in my mind about the benefits completely [completely] are in favour of doing it.’
The Pfizer-BioNTech vaccine was not approved by the MHRA for use in children aged 5 to 11 years until 22 December 2021, after this interview.
The Appeal Board noted Pfizer’s submission that its CEO was asked a specific question about vaccinating 5 to 11-year-old children against SARS-CoV-2 infection. At the appeal Pfizer submitted that it was not unreasonable to talk about the principles of vaccination in this age group in general and that at the time, there were two other vaccine candidates being investigated in children under 12.
The Appeal Board considered the comments by Pfizer’s CEO particularly ‘Immunising that age group [children under the age of 11] in the UK and Europe would be a very good idea’ and ‘So, there is no doubt in my mind that the benefits, completely [completely], are in favour of doing it [vaccinating children against Covid-19]’. The Appeal Board determined that the strong unqualified nature of the comments were such that they promoted the use of Covid-19 vaccines in the 5-11 age group in general, but in the context of the whole answer the Appeal Board considered that those comments did not promote the Pfizer-BioNTech Covid-19 vaccine in isolation.
The relevant clause which stated that the promotion of a medicine must be in accordance with the terms of its marketing authorisation and must not be inconsistent with the particulars listed in its summary of product characteristics (SPC) had not been raised in relation to the allegation that the Pfizer-BioNTech vaccine had been promoted for use in 5 to 11 year olds for which it was not approved at the time of the interview and so the Panel had considered the matter under the clause relating to maintaining high standards. The Appeal Board, noting its comments above, did not consider that Pfizer’s CEO had specifically promoted Pfizer’s Covid-19 vaccine for use in the 5-11 age group and no breach of the Code was ruled in this regard. The appeal on this point was successful.
p10
The Appeal Board noted Pfizer’s submission that its CEO made it clear that the decision on whether to authorize the vaccines in the 5 to 11 year group was the responsibility of the MHRA and that he was not speaking on its behalf. He also explained that he was answering the question in the context of Covid-19 vaccination in general rather than specifically in relation to the Pfizer-BioNTech vaccine. Pfizer’s CEO then went on to express his opinion that the wider benefits of vaccinating the 5 to 11 year age group were in favour of vaccination.
In the Appeal Board’s view the alleged clauses of the Code would apply if classes of medicines were referred to and not only a specific medicine.
The Appeal Board considered that the subsequent strong opinion statements, including ‘So, there was no doubt in my mind that the benefits completely [completely] were in favour of doing it [vaccinating children against Covid-19]’ and ‘I believe it’s a very good idea’ might infer to the ultimate audience, including members of the public, that there was no need to be concerned about potential side-effects of vaccination in healthy children aged 5-11 which was not so. The Appeal Board considered that this implication was misleading and incapable of substantiation. The Appeal Board therefore upheld the Panel’s rulings of breaches of the Code. The appeal on this point was unsuccessful.
The Appeal Board, however, did not consider the claim failed to ‘encourage the rational use’ of a particular medicine and it therefore ruled no breach of the Code. The appeal on this point was successful.
Whilst the Appeal Board noted the CEO’s statement that he/she ‘did not want to speak for the health authorities or the regulatory authorities of UK, it was up to them to approve it and use it or not’, the Appeal Board considered that the CEO’s opinion statements, including ‘So there is no doubt in my mind about the benefits completely are in favour of doing it’ might infer to the ultimate audience, including members of the public, that the benefits outweighed the risks when the UK regulatory authorities had not yet made any conclusions in relation to the vaccination of 5 to 11 year olds; no Covid-19 vaccine was licensed in the UK in that age group when the article at issue was published and the Appeal Board therefore upheld the Panel’s rulings of breaches of the Code. The appeal on this point was unsuccessful.
The Appeal Board noting the unique circumstances of the Covid-19 pandemic and its comments above including that Pfizer UK had briefed the CEO about the regulatory status of Covid-19 vaccines in the UK and the requirements of the ABPI Code, considered that in the particular circumstances of this case its concerns were covered by its rulings above, and further rulings of breaches of the Code in relation to high standards and Clause 2 were not warranted. The Appeal Board ruled no breach including of Clause 2. The appeal on these points was successful.
11 of 11
‘Wouldn’t Do Anything Different’: Dr. Peter McCullough Unbowed After Winning Legal Case
https://www.dailywire.com/news/wouldnt-do-anything-different-dr-peter-mccullough-unbowed-after-winning-legal-case
A district judge vindicated Texas cardiologist and outspoken COVID vaccine critic Dr. Peter McCullough on Wednesday, dismissing a lawsuit filed against him approximately two years ago by his former employer Baylor Scott and White Health system.
McCullough, dubbed a prominent purveyor of COVID misinformation by his detractors, was sued by the health system two years ago for allegedly violating a separation agreement and bringing the Baylor Scott and White Health name into the media. Associate Judge Tahira Khan Merritt of the Judicial District Court Dallas County dismissed the suit with prejudice.
“This is a strong victory for freedom of speech and fair balanced publication and media presentation of clinical data as it has emerged over the course of the pandemic crisis,” McCullough told The Daily Wire. “My analyses and conclusions have been accurate, consistent, and have always been my own, not those of any institution.”
Baylor accused McCullough in the $1 million lawsuit of “reputational harm,” stating that McCullough gave several media interviews and was published in journals that mentioned Baylor as an affiliate even though he had parted ways with the employer.
Baylor Scott & White Health told The Dallas Morning News in a written statement at the time of the filings that McCullough’s views don’t represent those of the health care provider.
“The lawsuit was filed to enforce this separation and avoid public confusion,” the statement said. “We take very seriously our responsibility to be a trusted source of medical information in the communities we serve.”
Yet, representatives for the cardiologist asserted McCullough never stated he was employed by the health system and that it was third parties who referenced the relationship.
“The lawsuit, in a sense, represented a form of intimidation and professional reprisal, and I feel vindicated by the dismissal,” McCullough said.
A spokesperson from Baylor Scott and White Health told The Daily Wire in an emailed statement that the health system takes “very seriously our responsibility to be a trusted source of information in the communities we serve.”
“Dr. McCullough is not an employee and has agreed to not represent himself as such,” the spokesperson said. “As a result, both parties mutually agreed in late January to dismiss all actions.”
McCullough participated in health system task forces, led research activities on COVID for the health system, and teamed with government officials throughout the early days of the pandemic in 2020. Prominent medical journals published peer-reviewed studies of McCullough’s early treatment and response to the COVID health crisis.
In response to his work, McCullough claims the health system decided not to renew his contract, which was “tantamount to termination” without reason or due process. Following the non-renewal, McCullough said he negotiated a settlement agreement that made way for the lawsuit.
“I’m glad it’s behind us,” he said. “The process was draining,” he continued, adding that he believes the lawsuit was designed to injure his professional career.
“Moreover, it was a message to other doctors to follow a narrative,” he said. “And that narrative is becoming increasingly uncomfortable for physicians in terms of a narrative that directs doctors not to treat patients early for COVID-19 and to continue to support and recommend emergency use authorized COVID-19 vaccination, despite mounting data that the vaccines have a very unfavorable safety profile.”
p1
McCullough became a controversial figure in the medical field amid the global pandemic, which prompted medical associations and legacy media to discredit his promotion of hydroxychloroquine and other early treatments.
In December 2021, the cardiologist appeared on “The Joe Rogan Experience” podcast where he made a number of claims about information surrounding treatments for the coronavirus, including questioning the efficacy and safety of the vaccines and how the pandemic started.
“When I graduated from medical school, I took the Hippocratic Oath, which said that, above all, I would do no harm to any patient, and I would do everything in my power to help each and every patient,” McCullough said. “I’ve done that throughout the pandemic — not only with my personal patients — but through my public statements in my work as a public figure to help as many people in the world as possible, helping them avoid hospitalization and death with COVID-19 illness and helping them avoid injury, disability and death with COVID-19 vaccination.”
“I think this is a very important stance — I wouldn’t do anything any differently,” he said. “Whether there was a lawsuit or no lawsuit — this is very important. The question on the table is, ‘Why can’t all doctors in America in the world say that?’”
2 of 2
>AUTH/3591/12/21 - A complaint on behalf of UsForThem v Pfizer
bun for baker
5G Mold Possesses Building in Archive 81 Series & It's Happening Now Again
EntertheStars
1 hr ago
watch at 2x speed if you have issues w/ attention/length