https://mobile.twitter.com/GBNEWS/status/1538967854896320513
GB News
@GBNEWS
Mark Steyn speaks to Vikki Spit whose fiancé died after having the AstraZeneca Covid vaccine.
Vikki will become the first person in the UK to receive a Covid vaccine damage payment of £120,000, GB News can exclusively reveal.
https://www.researchgate.net/publication/356756711_Latest_statistics_on_England_mortality_data_suggest_systematic_mis-categorisation_of_vaccine_status_and_uncertain_effectiveness_of_Covid-19_vaccination
Latest statistics on England mortality data suggest systematic mis-categorisation of vaccine status and uncertain effectiveness of Covid-19 vaccination
Abstract and Figures
This paper has been updated and the new version can be found here: Official mortality data for England suggest systematic miscategorisation of vaccine status and uncertain effectiveness of Covid-19 vaccination UPDATED WITH ONS DECEMBER DATA RELEASE & HEALTHY VACCINEE/MORIBUND ANALYSIS http://dx.doi.org/10.13140/RG.2.2.28055.09124 https://www.researchgate.net/publication/357778435_Official_mortality_data_for_England_suggest_systematic_miscategorisation_of_vaccine_status_and_uncertain_effectiveness_of_Covid-19_vaccination -– The risk/benefit of Covid vaccines is arguably most accurately measured by an all-cause mortality rate comparison of vaccinated against unvaccinated, since it not only avoids most confounders relating to case definition but also fulfils the WHO/CDC definition of "vaccine effectiveness" for mortality. We examine the latest UK ONS vaccine mortality surveillance report which provides the necessary information to monitor this crucial comparison over time. At first glance the ONS data suggest that, in each of the older age groups, all-cause mortality is lower in the vaccinated than the unvaccinated. Despite this apparent evidence to support vaccine effectiveness-at least for the older age groups-on closer inspection of this data, this conclusion is cast into doubt because of a range of fundamental inconsistencies and anomalies in the data. Whatever the explanations for the observed data, it is clear that it is both unreliable and misleading. While socio-demographical and behavioural differences between vaccinated and unvaccinated have been proposed as possible explanations, there is no evidence to support any of these.By Occam's razor we believe the most likely explanations are systemic miscategorisation of deaths between the different categories of unvaccinated and vaccinated; delayed or non-reporting of vaccinations; systemic underestimation of the proportion of unvaccinated; and/or incorrect population selection for Covid deaths.
https://www.techradar.com/features/this-is-how-new-indian-privacy-law-will-have-negative-impact-on-peoples-privacy
This is how new Indian privacy law will have 'negative impact on people's privacy'
In April, the Indian government dropped a hard pill to swallow for VPN services and their users.
According to India's new data retention law,security software firms will be forced to keep users' data for up to five years. What's more, providers will need to be ready to hand over this information to authorities upon request, too.
The news sparked a chasm of discontent across the VPN industry, privacy advocates groups and internet users.
"One way or another, it will have a negative impact on people’s privacy and digital security," Laura Tyrell, Head of PR at Nord Security - the company behind the popular NordVPN - told us.
While, in a tweet (opens in new tab), digital rights NGO Access Now wrote: "VPNs are necessary in a country with rampant shutdowns and surveillance, and no data protection law. Authorities must stop what they’re doing, and consult with security researchers, civil society, and cybersecurity experts on what to do instead."
So, what's at stake for Indian internet users' privacy?
VPNs forced to keep users logs
On April 28, the Indian Computer Emergency Response Team (CERT-In) announced that - among other directives, like the obligation to report a cyber attack within six hours - virtual private network (VPN) providers will soon be required to retain users' logs for at least five years. Companies will be also forced to hand over this data to authorities upon request.
And it's not just VPNs that are the subject of the new data retention law (opens in new tab) which will come into effect from late June.Virtual private servers (VPS), cloud service providers, data centers and crypto exchanges all will have to follow the new directive.
Specifically, the pieces of information that will need to be collected and stored are:
Validated names of subscribers/customers hiring the services
Period of hire including dates
IPs allotted to/being used by the members
Email address and IP address and time stamp used at the time of registration/on-boarding
Purpose for hiring services
Validated address and contact numbers
Ownership pattern of the subscribers/customers hiring services
Statement: We call on @IndianCERT to recall Directions on Information Security Practices issued on April 28 that go into effect on June 27. These directions are vague. They undermine user privacy and information security, contrary to CERT's mandate. 1/n pic.twitter.com/okzMhgIG0yMay 4, 2022
While cybersecurity experts are lamenting its vagueness, lack of feasibility and worrying privacy implications, the CERT-in justifies the decision as needed to better police cybercrime.
With a total of 86.63 million data breaches in 2021, Surfshark found India to be the third most affected nation worldwide (opens in new tab). "Most of the frauds were happening through VPNs," an Indian government official said to The Economic Times (opens in new tab).
At the same time,India also gained the gold medal for the number of internet shutdowns executed. Digital rights campaigner group Access Now found the country to be responsible for 106 out of the 182 incidents documented in 2021 (opens in new tab). Not to mention the allegations thatthe Indian government used Pegasus technology to spy on activists, politicians and lawyers.
With such a track record, it's no great surprise that many are worried that authorities might abuse this data grab to implement mass surveillance.
pt 1
VPN companies respond
The news fueled anger across the tech world as these requests run roughshod over the principles and policies upon which virtual private networks and other security software are based.
VPNs are technology aimed to protect users' internet privacy and secure their data inside an encrypted tunnel. They aim to prevent third parties from tracking users' activities as well as accessing their sensitive information.
It might not only affect people’s privacy, but also freedom of speech.
Laura Tyrell, Head of PR, Nord Security
A strict no-logging policy - meaning that, beside some functional logs, the service doesn't retain any information about you and your activities - is, therefore, a guarantee that most private VPN services offer to their subscribers. Something that providers are not eager to negotiate.
"It is premature to say if we will launch a legal challenge, but Proton has taken measures like that in the past and routinely appeals invasive law enforcement requests. Regardless, we remain absolutely committed to our no-logs policy and preserving our users’ privacy,” a spokesperson from ProtonVPN told TechRadar.
Commenting on this point, Laura Tyrell at NordVPN said: "In the past, similar regulations were mostly introduced by authoritarian governments in order to gain more control over their citizens. If democracies are going to follow the same path, it might not only affect people’s privacy, but also freedom of speech."
The new Indian VPN regulations are an assault on #privacy and threaten to put citizens under a microscope of surveillance. We remain committed to our no-logs policy and recommend everyone using our servers in India to follow these guidelines: https://t.co/85WTkUJ5Z6. (1/2)May 5, 2022
See more
First steps towards a VPN ban?
With most VPN providers vocally defending their no-logs policies and some others even threatening to pull their servers out of the country (opens in new tab), the government might decide to go further and ban all the services that don't comply with its demands.
On the other hand, it was less than a year ago when the Parliamentary Standing Committee on Home Affairs proposed the banning of VPN service in India to counter cybersecurity threats.
Although, Tyrell thinks that there is still a concrete possibility that the directive would change: "It is difficult to imagine a scenario in which all local companies are able to adjust their infrastructure and operations in time, therefore there is still a chance that the proposed wording and timeline of the regulation may not be final."
What's at stake for users' privacy?
According to the latest statistics from AtlasVPN, India has more than 270 million (opens in new tab) active VPN users who enjoy a better network security, online anonymity and geo-restricted content.
Furthermore, ProtonVPN told TechRadar: "The rules would not only make it harder for people to protect their data online but also give the government more tools to monitor people’s locations and identities while eroding civil liberties more generally."
That's especially worrying in a country where many journalists using this software to cope with a media freedom under attack - India just dropped to 150th out of 180 countries (opens in new tab) in the 2022 Reporters Without Borders’ Press Freedom Index.
And it's not just privacy that's a concern, as the change could also mean higher fees for India VPN users.
As Tyrell from NordVPN explains: "From what it seems, the new law will definitely create additional difficulties for the internet infrastructure providers and their operations. Overhead in operation costs may translate into increased costs to end users which for some people might complicate internet access in general."
pt 2 of 2
not just UK LYING…
Swedish Public Health Agency reporting has distorted mortality rates for the unvaccinated and the vaccinated
https://lakaruppropet.se/public-health-agency-reporting-has-distorted-mortality-rates-for-the-unvaccinated-and-vaccinated/
The Swedish Public Health Agency has misled the public about the benefits of vaccination against Covid-19 by recording Covid-19 deaths amongst the vaccinated as unvaccinated. Over 900 deaths with Covid-19 have been misrepresented as occurring in the unvaccinated, thereby greatly distorting the effectiveness of the vaccination programme, for which the Swedish Public Health Agency is responsible. We demand that the original data relating to this case be reported in full. We also demand that independent and fully transparent evaluation is conducted for mortality rates among the fully unvaccinated versus different subgroups of the vaccinated.
The Swedish Public Health Agency’s weekly report counts people as unvaccinated up to 14 days after receiving a second dose. This introduces a bias into the reporting of deaths with Covid-19, according to vaccination status. What this shift means is not reported by the Agency and a false picture is presented to the media and to the Swedish public. For some reason, this does not seem to concern the Agency. For example, when journalist Per Shapiro asked the following pertinent question to the Swedish Public Health Agency’s press conference on 27th January 2022: ”So why are you blurring the real control group and when are you going to report on how the unvaccinated have actually fared compared to the others?” Britta Björkholm replied, ”I don’t know what to say. We have a lot of data, we have a lot of figures, we follow up in many different ways. I think we are transparent and report what is relevant”1.
We have requested data from the Swedish Public Health Agency on the number of deaths from Covid-19 infection in 2021, when vaccination was implemented. For four groups: 1) completely unvaccinated, 2) partially vaccinated: those who had received dose 1 and less than 21 days had passed, 3) partially vaccinated: either at least 21 days had passed after dose 1 but dose 2 has not been administrated or dose 2 had been given but less than 14 days had passed and 4) fully vaccinated: dose 2 or 3 had been given, and at least 14 days had passed after dose 2.
The results are shown in the following table. In its weekly reporting, the Swedish Public Health Agency transferred deaths in the partially vaccinated (group 2 = 666 and group 3 = 253) to the unvaccinated group. This skewed the number of deaths in the unvaccinated group by 919 persons, or 32%. Instead, these deaths should have been counted in vaccinated group, which thus increases by 919 persons or 135%.
pt 1
Footnote: The weekly report figure for January 2021 is different, because it includes people who had a confirmed Covid-19-infection before 1st January 2021. Therefore, we have used the total number of people who died in January 2021 and who were confirmed to have Covid-19 infection from 1st January of that year, i.e. the data we received from the Swedish Public Health Agency. According to the weekly report, no vaccinated person died in January 2021 (which means that no fully vaccinated person died).
A reanalysis statistics according to the categories defined above, raise the possibility of an increased mortality rate (deaths per 100,000) from Covid-19-infection in the first 21 days after dose 1, compared to the unvaccinated. Hence, during 2021, a total of 666 people have died in this 21-day period. This high mortality following the administration of the Covid-19 vaccines may have several causes. The vaccination program was carried out in the midst of a major outbreak, which does not normally happen. For example, the seasonal influenza vaccine is given before the infection enters a country. There is also evidence in preprint studies that Covid-19 vaccines may increase mortality from Covid-19 in the first period after injection., Several explanations for susceptibility to infection after Covid-19 vaccination have been proposed, including a decline in lymphocytes in the days following administration of both Pfizer’ and AstraZeneca’ vaccines 5. The ensuing immunosuppression could result in the resources of the immune system being ”stretched” and insufficient to deal with another infection.
We propose that in order to properly evaluate the effects of Covid-19 vaccination, all injected persons must be considered as vaccinated, though not necessarily immune. Although significant antibody-mediated immunity does not occur until 21 days after dose 1 or 14 days after dose 2, when evaluating vaccine efficacy, mortality rates during these time intervals must also be considered. If the mortality rate is higher during periods before the vaccine has had time to generate immunity, compared to the mortality rate for unvaccinated persons, then the protective effect is negative rather then positive.3 4.
In order for individuals to make an informed decision about the risks and benefits of Covid-19 vaccination, we request that the Swedish Public Health Agency reports publicly on the raw data on mortality rates for completely unvaccinated persons as well as those vaccinated from the day they received dose 1. Mortality for these groups and specific subgroups of the vaccinated group should also be calculated for those who have received: 1) dose 1 and less than 21 days had elapsed, 2) dose 1 and at least 21 days had elapsed but dose 2 had not yet been given, 3) dose 2 and less than 14 days had elapsed, 4) those who have received dose 2 and at least 14 days had elapsed, 5) dose 3 and less than 14 days had elapsed, and 6) dose 3 and at least 14 days had elapsed.
Nils Littorin, MD, Senior House Officer in Psychiatry, PhD in Clinical Microbiology
Anette Stahel, MSc in Biomedicine
Ann-Cathrin Engwall, Immunologist and Virologist, PhD in Molecular Cell Biology with an Immunological Focus
Ragnar Hultborn, MD, Specialist in Oncology, Professor Emeritus
Sture Blomberg, MD, Specialist in Gynaecology and Anaesthesia and Intensive Care Unit, Associate Professor
Lilian Weiss, MD, Specialist in General Surgery, Associate Professor
Niklas Lundström, Associate Professor in Mathematics
Boris Klanger, MD, Specialist in General Medicine, Director of Operations
Dinu Dusceac, MD, Specialist in Cardiology, PhD
Susanna Hartmann-Petersen, MD, Specialist in Dermatology, PhD
Bo Jonsson, MD, Specialist in General Psychiatry, PhD
Anna Maria Wiedemann, MD, specialist in general medicine, PhD
Roger Nilson, MD, specialist in orthopaedics and addiction medicine
Anne Liljedahl, MD, Specialist in General Medicine and Emergency Medicine
Ludwig Hellmundt, MD, Specialist in Anaesthesia, Pain Physician
Nina Yderberg, MD, Specialist in Child and Adolescent Psychiatry
Hanna Åsberg, MD, Specialist in General Medicine
Constanze Pilgram, MD, Specialist in Orthopaedics
Carina Ljungfelt, MD, Specialist in General Medicine
Ute Krüger, MD, Specialist in Pathology
Karin Olsson Vallander, MD, Specialist in Ophthalmology
Ida Höglund, MD, Specialist in Surgery
Lisa Palmlöf, MD, Specialist in Rehabilitation Medicine
Delia Slotte, MD, Specialist in Psychiatry
Margareta Andersson, MD, Specialist in General Medicine
Magnus Burling, MD, Specialist in General Medicine
Sara Mattson, MD, Specialist in General Medicine
Arnaldo Kaminer, MD, Senior House Officer in Psychiatry
Johan Wadenbäck, PhD in Biology with Specialisation in Biotechnology & Genetics
2 of 2
>not just UK AND SWEDEN LYING…
>not just UK LYING…
Israel TOO…
https://mobile.twitter.com/PECC_eng/status/1523280868751642625
The Israeli PECC
@PECC_eng
Data-skewing mechanisms to inflate numbers of positive COVID cases among unvaccinated individuals in relation to vaccinated individuals upon arrival at the hospital.
A memo from the Israeli Ministry of Health (IMOH) to hospital directors indicates how this works.
___
The memo, from the Director of the Medical System, IMOH ordered Israeli hospital directors to perform PCR tests only on the unvaccinated. This bias contributed to the narrative that the unvaccinated are more likely to be hospitalized or die because of COVID.
Translation:
>>>
____
https://www.trialsitenews.com/a/what-the-leaked-ema-emails-docs-reveal-major-concerns-with-pfizer-c-19-vaccine-batch-integrity-and-the-race-to-authorise-cdda0ba2
What the Leaked EMA Emails & Docs Reveal: Major Concerns with Pfizer C-19 Vaccine Batch Integrity and The Race to Authorise
Trial Site News recently were able to review leaked internal emails from the European Medicines Agency (EMA) and meeting report between the agency and Pfizer. The EMA oversees the evaluation and supervision of medicinal products for the European Union. Like other regulatory health bodies, its main responsibility is to protect and promote public health. Snapshots of internal EMA email correspondence; a November 26, 2020, PowerPoint presentation from a pivotal meeting between Pfizer and the agency, as well as a confidential 43-page Pfizer report were provided by an anonymous source because of their trust in Trial Site’s commitment to transparency, accessibility, and accountability in furtherance of a highly ethical, quality-focused and public health-centric biomedical research industry.
Regulatory agencies, like the EMA, the Food and Drug Administration (FDA) in the U.S. and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) are chartered to make decisions based to better the public. External influences such as political or media pressure are not meant to be a driving factor in their decision-making, however, when it came to pandemic conditions and the fast-tracked conditional marketing authorization of the Covid-19 vaccines (particularly for the mRNA-based vaccines produced by Pfizer-BioNTech and Moderna), it appears the latter won the day.
The time period of the email correspondence in question stretches from November 10 – 25, 2020, just weeks before the EMA granted CMA (conditional marketing authorization) for the Pfizer-BioNTech Covdid-19 vaccine on December 21, 2020. The FDA granted EUA (emergency use authorization) for this vaccine on December 11 with the MHRA making it first to the finish line on December 2. Here this author uses the term ‘finish line,’ as the emails do reveal an intense, almost competitive-like rush to authorize the Covid-19 vaccines, as quickly as possible. Understandably, the world was gripped by a pandemic at the time, where there was immense impetus to authorize a vaccine to protect people from the novel coronavirus.
The Rush into EUA
In an email from Marco Cavaleri, at the time the EMA’s Head of Biological Health Threats and Vaccines Strategy, communicated with urgency how the U.S. FDA “are going to rush into EUA.”
1
Cavaleri refers to this ‘rush’ being ‘pushed hard by Azar and US GOV.’ Under the Trump administration, Alex Azar, former pharmaceutical executive was the United States Secretary of Health and Human Services (HHS) from 2018-2021. The FDA is an agency that falls directly under the HHS.
It’s worth noting that when Azar was former president of Lilly USA LLC, a division of Eli Lilly, drug prices skyrocketed under his leadership. The pharmaceutical company was also embroiled in a class-action lawsuit under his tenure where it was accused of exploiting the drug pricing system to increase profits for its insulin drug. Of course, this doesn’t necessarily mean this executive was complicit in any way, but the timing is noteworthy.
Cavaleri’s email speaks to the extent of how politics (and the US government) was driving the FDA’s regulatory process, making sure it was going at ‘warp speed’. And of course, on that note Trump’s Operation Warp Speed was to ensure all vaccine development records would be shattered. The intentions were undoubtedly good given the outbreak of the worst pandemic in a century.
However, across the Atlantic in Europe’s regulatory agency tension mounted as the pressure to accelerate deadlines made the air and general mood tense—the pressure and anxiety was palpable in the reviewed email exchanges.
Persons of high integrity and clarity as to their roles and commitments as stewards of public health emerged. For example, one individual demonstrated palpable concern over accelerated timelines to ensure they would meet the ‘deadline’ for vaccine authorization at the expense of a robust assessment. He was Noel Wathion, at the time the EMA’s deputy executive director, but who has since retired. This EMA official importantly pointed out, ‘We are speeding up as much as possible, but we also need to make sure that our scientific assessment is as robust as possible. Let’s not forget the responsibility/accountability attached to the recommendation to the EC to grant a CMA.’
2
Wathion assumes the FDA (and the MHRA’s) EUA would be issued before the EMA granted its own CMA, which turned out to be correct. What’s interesting is his concern to address the ‘damage limitation’ resulting from the probable outcome of the EMA finishing last in this regulatory race and his fear that this would result in public opinion and the media turning against the agency. Speed seemingly superseded concerns of quality based on a careful review of these emails.
In a November 19 email, Wathion reveals a ‘rather tense’ TC (teleconference call) with the European Commissioner (Ursula von der Leyen) which was ‘at times even a bit unpleasant.’ This reflects the mounting pressure which the EMA staff were under to issue CMA quickly following an EUA granted by the FDA/MHRA for the Pfizer-BioNTech vaccine. Von der Leyen is implicated in potentially being responsible for this tense environment with ‘a delay of several weeks…not easily acceptable for the EC [European Commission].’
In early 2022, Trial Sites News reported how von der Leyen was embroiled in scandal when a group of independent MEPs demanded her immediate resignation and full disclosure of a series of private text messages between her and Pfizer’s CEO, Albert Bourla. Only a small portion of these texts were ever disclosed. Of the ones that were, they revealed her negotiating portions of a European-wide vaccine deal, unilaterally with Bourla via a series of texts! Clearly standard protocols in Europe were thrown out the window in favor of expediency and this seemingly was tied to a unified competitive pressure on all three regulatory agencies.
Wathion lays bare his reflections after this particular TC, and shockingly writes how ‘the political fall-out seems to be too high even if the “technical” level at the MSs [Member States] could defend such a delay in order to make the outcome of the scientific review as robust as possible.’ Put another way the continuous broadcast of science first appeared as a cover for politics first.
3
Wathion points out that a potential delay of several weeks to secure ‘robust assurance in particular as regards CMC and safety’ will be met with ‘criticism from various parties,’ including media, EC (European Commission) and EP (European Parliament). Wathion speaks of his fear that if the deadline ‘to align as much as possible with the “approval” timing by FDA/MHRA’ cannot be met- ‘we will be overwhelmed from all fronts and be in the middle of the storm.’ However, this potential delay appeared to be necessary ‘in order to make the outcome of the scientific review as robust as possible.’ This implies that speed at the expense of safety was the order of the day to avoid ‘political fallout.’ Clearly, politics was dictating Covid-19 vaccine authorisation protocol, not the science.
In the above email from Marco, the EMA official reveals that Pfizer’s CEO Albert Bourla ‘lobbied’ Peter Marks, and this could be interpreted as highly controversial, given Marks is the director of the Center for Biologics Evaluation and Research (CBER) at the FDA. Pfizer’s apparent access into the federal watchdog raises significant questions at the least, if not introduces the possibility for disturbing entanglements between industry and a purportedly independent, scientific federal agency.
Major concerns with the integrity between vaccine batches
An email from Cavaleri (see below) reveals at that time the FDA knew of ‘some issues’ associated with the CMC which needed to be sorted out and may ‘end up being the difficult bit.’ CMC refers to the Chemistry, Manufacturing and Controls, also referred to as pharmaceutical quality, which covers various procedures used to assess and ensure the safety and consistency between pharmaceutical product batches.
An email from Evdokia Korakianiti (an EMA scientific administrator) explains in more detail what these “issues” were and how they were in fact major concerns to do with the Pfizer- BioNTech vaccine.
Alarmingly, significant differences in the levels of mRNA integrity between Pfizer-BioNTech’s commercial (large scale) and clinical vaccine batches (small scale) were observed. ‘~78% mRNA integrity’ in the clinical ones and ‘~ 55% in the proposed commercial batches’ with the ‘root cause’ not yet identified. Safety and efficacy implications due to this concern were also noted in the email ‘as yet to be defined.’
In a confidential Pfizer report, which was also leaked along with the EMA emails, the company states that according to Acuitas Therapeutics’ (the biotech company who developed the lipid nanoparticle platform for the Pfizer and Moderna vaccine) own general experience, ‘a minimum threshold is approximately 70%.’ (See screenshot below)
Then on page 30 it states: ‘The efficacy of the product is dependent on expression of the delivered RNA, which requires a sufficiently intact RNA molecule.’ (See screenshot below)
4
This exact phrase ‘requires a sufficiently intact RNA molecule’ was used in the email from EMA staffer, Evdokia Korakianiti, which I included above, sent on November 23, 2020- now we likely know where Korakianiti referenced it from.
For the commercial batches (which were going to be rolled out across the globe) to have such a significantly lower level of mRNA integrity (intact RNA molecule) is greatly concerning given its intrinsic tie to the efficacy and potential safety of the product.
The next day Veronika Jekerle, Head of Pharmacy Quality Office, writes to Evdokia (see below).
The difference in the level of mRNA integrity was again noted as a major concern ‘shared by most member states’ and its ‘potential impact on safety.’ Jekerle highlights in bold, “An approval by the end of the year could potentially be possible, if these concerns + GMP will be resolved.”
This gives rise to the critical question- how were all these concerns resolved when CMA was granted only a few weeks later, on December 21? A possible way it was resolved is explained later in this report.
In contrast to the concerns of some of the other EMA officials, Marco Cavaleri writes around the same time in the following email (see below) that the mRNA content is not a major concern, according to the FDA- ‘the issue on the mRNA content not perceived as major.’ He also shockingly states, ‘unclear if GCP inspections ever done.’ This revelation is highly concerning given that GCP refers to Good Clinical Practise, which is ‘an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.’
What’s even more alarming is his following statement- ‘no major interest from FDA.’ This looks to reveal the regulatory agency’s apparent lack of concern or even interest on whether GCP inspections were completed, in the context of Pfizer’s clinical trials, which was relied on by the FDA to grant EUA for the Pfizer-BioNTech vaccine. In one of this author’s previous investigative reports for Trial Site News, we noted that the FDA only inspected 1% of Pfizer’s trial sites.
Further damming information is revealed (see screenshot below) when multiple regulatory agencies: Health Canada (HC), EMA, MHRA and FDA are all aware of the issue with % mRNA integrity, yet FDA and Health Canada make an unsubstantiated claim that ‘safety concerns associated. Are more of a theoretical concern.’
Health Canada then appears to contradict itself because its later described as showing particular concern about one region receiving ‘all the suboptimal material.’ Obviously, it didn’t want to be that region.
Shockingly, the end of the email reveals the ‘Applicant [Pfizer] has shared with FDA and us [EMA]/MHRA only today and issue with visible particles in the DP [drug product] appears to be lipid nanoparticle components.)’
This is highly concerning due to this significant issue being made known to the three key regulatory agencies on November 25, only a few weeks away before the EMA granted CMA and the FDA granted EUA for the Pfizer vaccine. Alarmingly, it was just days before the MHRA granted authorization in the UK on December 2, 2020. Veronika’s assumption that the ‘visible particles’ could be LNPs (lipid nanoparticles) is hard to accept given nanoparticles are not visible to the naked eye. Other anomalies were apparent, yet this was probably still a historical effort in terms of speed of vaccine development. It seems clear however some more time was needed.
5
How % mRNA integrity was apparently resolved
The discrepancy between batches appears to have may been resolved when it’s mentioned that the ‘latest lots [received by the FDA] indicate the % intact RNA are back around 70-75%.’
However, in a leaked report of a meeting with Pfizer and the EMA on November 26, 2020, a day after Veronika’s email, it shockingly reveals that the RNA integrity specification was revised down to >=50% for drug product shelf life, significantly lower than the minimum threshold of 70% that Acuitas Therapeutics had stipulated and the average 78% of the clinical batches. Was this the EMA’s (and potentially FDA/MHRA/HC) way of ‘resolving’ the issue to ensure ‘an approval by the end of the year’?
Mention is made of ‘uncertainties about consistency of product quality and hence uncertainty as regards product safety and efficacy of the commercial product.’ Yet, it’s baffling how lowering the RNA integrity specification would remedy that major objection.
In another slide the artifact states, ‘Truncated [shortened] and modified RNA species should be regarded as product- related impurities.’ This confirms that these shortened mRNA species which lowered the level of %mRNA integrity were classed as impurities. Another alarming concern arising from these impurities is flagged ‘the possibility of translated proteins other than intended spike protein (S1 S2) resulted from truncated and/or modified mRNA species should be addressed.’ (See screenshot below)
The evidence in this report confirms that regulatory bodies like the FDA, MHRA, EMA and Health Canada knew of the differences in batches, regarding % mRNA integrity and because of that the effect on ‘safety and efficacy’ was unknown. The leaked Pfizer/EMA meeting report raises material concerns assuming the issue was resolved by simply lowering the RNA integrity specification. In other words, perhaps it was never resolved.
A particular website that has drawn a lot of attention recently, which speaks to the difference between batches is howbadismybatch.com. It’s a comprehensive database with analysis on ‘batch codes and associated deaths, disabilities and illnesses for Covid 19 Vaccines.’ By entering a batch number of any of the Covid-19 vaccines, it tells you the frequency of adverse events reported associated with that batch.
I spoke with Sasha Latypova, who has run clinical trials for over 25 years and owns her own biotech company, to ask her expert opinion on the leaked documents. She said, “The lack of mRNA integrity and presence of uncharacterized fragments of RNA in batches of Pfizer's product was identified as a "Major Objection" - a formal regulatory red flag, deemed a product impurity and would have been a showstopper in any normal drug approval process. At a minimum, it required an additional "bridging" clinical trial to evaluate the clinical effects which would have taken months to design and conduct properly. Panic overruled scientific integrity, and an arbitrarily lowered batch acceptance standard was adopted for the sake of meeting a politically motivated deadline. To date, this issue remains unresolved and could be the underlying cause for the enormous variation in the rates of adverse events and deaths observed for different manufacturing batch numbers in the CDC VAERS and other databases.’
Latypova made an apt reference to the fate of the Titanic, by drawing a comparison in the way regulatory bodies conducted their ‘warp speed’ process of authorising the Covid-19 vaccines. The Titanic's captain, Edward J. Smith, was aiming to better the crossing time of another vessel, which meant the ship was travelling way too fast, in waters known to have ice. This set it on a fatal collision with an iceberg and the rest is history.
In light of the evidence included in this report and the fact that the Pfizer-BioNTech Covid-19 vaccine is one of the most lucrative products in history (last year Pfizer made $37 billion in sales with predictions for 2022 being $32 billion), this author strives to open a discussion with some vital questions which must be addressed by the regulatory agencies involved, Pfizer and those in the scientific/medical community:
What are the safety and efficacy implications of a significantly lowered mRNA integrity (arising from truncated and modified mRNA) in the commercial batches of this vaccine?
Exactly what are the visible particles observed in the DP (drug product) that Pfizer shared last minute with the EMA, FDA and MHRA and what are its safety and efficacy implications?
Answers to these questions are of major public importance.
6 of 6
https://www.trialsitenews.com/a/what-the-leaked-ema-emails-docs-reveal-major-concerns-with-pfizer-c-19-vaccine-batch-integrity-and-the-race-to-authorise-cdda0ba2
https://archive.ph/sQYoE
https://www.breitbart.com/entertainment/2022/06/20/report-netflix-preparing-for-more-layoffs-as-stock-languishes/
Report: Netflix Preparing for More Layoffs as Stock Languishes
Netflix is reportedly preparing for another bloodbath in the form of a new round of layoffs this week — the latest austerity measure as the far-left-wing streamer’s stock continues to languish at depressed levels.
Pink slips are expected to go out by Friday and could impact a similar number of people who were laid off last month when Netflix axed 150 employees and dozens of contractors and part-timers, according to a report from Variety.
That round of layoffs wiped out 2 percent of Netflix’s global workforce, which stands at about 11,000 staffers.
The once-invincible Netflix is now cutting spending in response to a disastrous subscriber forecast predicting that the streamer could lose a stunning 2 million customers in the months ahead. As a result, Netflix shares have plummeted in recent weeks, causing the company to lose close to 70 percent of its market capitalization so far this year.
As part of its cost-cutting, Netflix has axed a number of woke series, including a planned animated adaptation of Ibram X. Kendi’s Anti-Racist Baby. But the woke streamer is still doing business with former President Barack Obama and Michelle Obama, who have a production deal with the company.
The Obamas’ just announced their first scripted series with Netflix — Bodkin, a comedic thriller starring Saturday Night Live alum Will Forte.
https://www.the-sun.com/tech/5599222/mark-zuckerberg-has-been-designing-clothes-for-metaverse/
ZUCK SUIT Mark Zuckerberg has been designing clothes for you to wear in the metaverse – including a formal grey suit
https://www.thegatewaypundit.com/2022/06/vax-2-0-go-moderna-announces-human-trials-new-hybrid-flu-covid-vaccine-officially-underway-future-triple-threat-vaccine-works/
Vax 2.0, Here We Go: Moderna Announces “Human Trials” ofNew Hybrid Flu-Covid VaccineAre Officially Underway – Future “Triple-Threat” Vaccine “in the Works”
On Sunday, Moderna’s Chief Medical Officer Dr. Paul Burton announced the vaccine maker had officially kicked off phase 1 “human trials” for its new two-in-one Flu-Covid jab.
According to Burton, who spoke exclusively with 9News Australia, phase one clinical trials for the hybrid vaccine are currently underway and progressing on schedule, with the new treatment expected to be rolled out between late 2023 and early 2024.
From 9News:
“A phase one trial of a combination flu and Covid vaccine is currently underway. Moderna plans to have that vaccine ready by next year or by early 2024.”
Moderna’s CMO also announced that the company is currently working on a “triple-threat” vaccine that will be made available sometime in 2024 or 2025, following the rollout of the hybrid ‘Flu-Rona’ vaccine. The third-generation treatment will also target a lung infection called respiratory syncytial virus (RSV), which is a common, contagious virus that causes infections of the respiratory tract, according to the CDC.
Just like with Covid, RSV has an extremely low mortality rate for the vast majority of people. But, the sCiEnCe says we need another experimental vaccine – and you must take it.
Initial “human trials” for this triple vaccine are also expected to begin by the end of this year.
Burton explained:
“We have a three-in-one, which is Covid, Flu, and something called RSV. These are all respiratory pathogens that kill people young and old every year.”
Despite the undeniable failure of the vaccine’s effectiveness, Burton described the experimental hybrid treatment as necessary, especially in the face of the new Omicron subvariants that are spreading across the west. He promoted Moderna’s latest iteration of the mRNA vaccine – the also-failed, Omicron-specific boosters – as the temporary solution until the new version is rolled out next year.
From Burton:
“I think BA.4 and 5 are concerning, they’re more transmissible, they have more immune escape, this is something we have to take very seriously. I don’t think it’s as severe and dangerous as delta…
…Spikevax was a good vaccine two years ago, it’s still a very good vaccine today, but we need a variant adapted booster and that’s what we have generated now.”
Watch Burton’s interview on 9News Australia:
Human trials of combo vaccine for COVID-19 and flu | 9 News Australia
9 News Australia pic.twitter.com/fTskuYG72w
— Wittgenstein (@backtolife_2022) June 20, 2022
Considering all of the issues with the singular experimental vaccine – myocarditis, pulmonary embolism, strokes, facial paralysis, Sudden Adult Death Syndrome (they think we’re stupid), just to name a few – only God knows what complications will come from adding in additional mRNA to combat these other two viruses.
Here we go.
Mexican President To Meet with Joe Biden and Propose Western Hemisphere Union Just Like the EU
https://www.thegatewaypundit.com/2022/06/mexican-president-meet-joe-biden-propose-western-hemisphere-union-just-like-eu/
Earlier this month President Andres Manuel Lopez Obrador of Mexico confirmed he would skip the Summit of the Americas conference in Los Angeles.
The Summit was hosted by President Biden and focused on the ongoing migration crisis at the US Southern border.
According to Reuters, Lopez Obrador previously threatened to boycott the event if the Biden administration excluded failed socialist regimes, Cuba, Venezuela, and Nicaragua.
After the administration confirmed that Cuba, Venezuela, and Nicaragua would not be on the invite list, Lopez Obrador announced his plans to skip the event.
But Lopez Obrador is meeting with Joe Biden in Washington DC in July.
According to reports, Lopez Obrador will push the White House about a plan to integrate all of the Western Hemisphere into one community similar to the European Union.
That way all citizens will be able to freely travel between the failed states, the sh*tholes, the developing nations and the United States and Canada.
You know that since this further weakens the US, Joe Biden and his handlers will be all over this.
VDare reported:
July Visit Plan
So AMLO didn’t come to the U.S. for the Summit. But don’t worry, he plans to visit Biden in July. And guess what he’s going to propose:
In July I’m going to see him [Biden] in the White House and I want to talk to him about the integration of all América [the Western Hemisphere]. My proposal is that, as the European Community was created and later became the European Union, we need to do the same in América. But this means a change in policy, leaving behind confrontation, hate, threats, embargoes, meddling and instead choose brotherhood, for the Good Neighbor Policy.
[Versión estenográfica. Conferencia de prensa del presidente Andrés Manuel López Obrador del 6 de junio de 2022 (“Stenographic Version. Press Conference of President Andres Manuel Lopez Obrador of June 6, 2022”), Mexican Presidential Website, June 6, 2022]
Submerging the U.S. in a hemispheric superstate—that sounds like the sort of plan Biden and company will like!
Once again, what a change from the Trump Era. What a difference American leadership makes!
some anons have been pointing out that EVs with L-ION batteries are remote-capable weapons, like city busses, scooters, ebikes, AND iphones and teslas, etc.
China be knowin' too. It ain't just about the cameras.
https://www.asiaone.com/china/tesla-cars-barred-2-months-beidaihe-site-china-leadership-meeting
Tesla cars barred for 2 months in Beidaihe, site of China leadership meeting
SHANGHAI - Tesla cars will be prohibited from entering the Chinese coastal district of Beidaihe, the site of a secretive annual summer party leadership conclave, for at least two months, starting on July 1, a local traffic police official told Reuters on Monday (June 20).
The decision by the Beidaihe authorities comes just weeks after Tesla cars were also barred from driving onto some roads in the central city of Chengdu in early June, which coincided with a visit by Chinese President Xi Jinping to the city.
More from AsiaOne
Read the condensed version of this story, and other top stories with NewsLite.
The official from the Beidaihe Traffic Police Brigade, who declined to give his name, did not provide a reason for the move but said it concerned "national affairs".
An announcement will be made soon, the official said.
Tesla did not immediately respond to a request for comment.
Beidaihe, a beach resort east of Beijing, traditionally hosts a summer conclave of China's senior leaders where they discuss personnel moves and policy ideas behind closed doors.
China does not typically formally announce the dates for the meeting.
The Chengdu restrictions on Tesla cars, which were not officially announced, came to light earlier this month after videos were posted on social media of Tesla cars being diverted away from certain areas by the police.
Last year, the Chinese military banned Tesla cars from entering its complexes, citing security concerns over cameras installed on the vehicles, according to Reuters reports at the time citing sources who had seen the directive.
Tesla chief executive officer Elon Musk said at the time that Tesla's cars did not spy in China or anywhere else, and that the company would be shut down if it did so.
Months later, Tesla said that all data generated by cars it sells in China would be stored in the country.
Automakers have been increasingly equipping vehicles with cameras and sensors that capture images of a car's surroundings.
Control of how those images are used and where they are sent and stored is a fast-emerging challenge for the industry and regulators around the world.
Tesla cars have several external cameras to assist drivers with parking, changing lanes and other features.
China is one of Tesla's largest markets as well as production sites, where it makes Model 3 and Model Y vehicles for domestic sale and export from its factory in the country's economic hub of Shanghai.
Tesla's Shanghai plant made about half of the 936,000 vehicles the US automaker delivered globally last year.
However, the factory has this year been hobbled by Shanghai's Covid-19-induced lockdown, which forced the plant to shut for a record 22 days.
>>16482521 is mislabeled as
"BREAKING: Twatter board unanimously recommends shareholders approve Elon Musk's $44 billion takeover"
aladdin will own everything
https://www.newsweek.com/sunspot-surface-sun-doubles-size-solar-flare-earth-1717343
Giant Sunspot Has Doubled in Size in 24 Hours and It's Pointed at Earth
blood and gore. not a joke.
https://www.swfinstitute.org/news/89109/al-gore-and-david-blood-to-create-fund-manager-just-climate
doesn't make it false does it. gays are everywhere, so it fits, eh?
only thing stopping the quantum ai, sky net, etc is the sun/'son'. recognize, clown.