Wed Sep 14, 2022 2:23 pm
EU stonewalls over von der Leyen’s role in multibillion-euro Pfizer vaccine deal
With every passing day, the negotiations held between the European Commission and Pfizer over the EU’s largest COVID-19 vaccine contract look less like business as usual and more like a whodunnit.
The plot thickened further after the European Court of Auditors published a report today, accusing the Commission of refusing to disclose any details of Commission President Ursula von der Leyen's personal role in the talks.
The budget watchdog found that the EU chief threw out the existing rulebook to hash out a preliminary deal with the U.S. multinational, paving the way for a contract for up to 1.8 billion coronavirus vaccine doses to be signed in May 2021. For all the other vaccine deals struck by the EU between 2020 and 2021, a joint team comprising officials from the Commission and seven member countries conducted exploratory talks. The outcome was then taken to a Vaccine Steering Board made up of representatives from all 27 EU member states who signed off on it.
But this established procedure was not followed in the case of the EU’s biggest contract, the Court of Auditors says. Instead, von der Leyen herself conducted preliminary negotiations for the contract in March, and presented the results to the steering board in April. Meanwhile, a planned meeting of scientific advisers, organized to discuss the EU’s vaccine strategy for 2022, never took place, the court writes.
Unlike with the other contract negotiations, the Commission refused to provide records of the discussions with Pfizer, either in the form of minutes, names of experts consulted, agreed terms, or other evidence. "We asked the Commission to provide us with information on the preliminary negotiations for this agreement," the report's authors write. "However, none was forthcoming."
A senior auditor who helped lead the investigation told POLITICO that the Commission's refusal to divulge information was highly unusual. “This comes up almost never. It’s not a situation that we at the court normally face," said the auditor, who requested anonymity.
The audit report raises further concerns about von der Leyen's actions, just two days before she is due to deliver her annual State of the Union address.
Already in April 2021, the New York Times reported that the EU leader had exchanged text messages with Albert Bourla, the chief executive officer of Pfizer, in the run-up to the deal. The seemingly cozy relationship between top political and business leaders raised eyebrows at the time.
And, as the report notes, the European ombudsman's investigation into the matter met a wall of silence. At the time, the Commission claimed that it no longer had the text messages on record. In response, ombudsman Emily O'Reilly determined that maladministration had taken place.
Read more: https://www.politico.eu/article/eu-ston ... -jab-deal/
Wed Sep 14, 2022 2:29 pm
US criticised for rolling out Covid boosters without human trials
Health experts have warned that the US decision to roll out new coronavirus boosters without clinical testing on humans risks denting public trust and increasing hesitancy about vaccines.
The Joe Biden administration is using the bivalent boosters, which contain the original Covid-19 strain and the genetic code of the Omicron sub-variants BA.4 and BA.5, to vaccinate more Americans against the virus.
It has bought 171mn doses of the BioNTech/Pfizer and Moderna boosters for $5bn and fast-tracked their authorisation before human trials are complete, hoping that they provide better protection against the dominant variants than existing Covid vaccines.
As doses began arriving at pharmacists for distribution this week, US officials said the rollout marked an “important milestone”. In future people would probably only require annual boosters just as they take a yearly influenza jab, they said.
But several health experts said that the boosters have yielded only limited data from a small number of tests on mice. They said there is no evidence that they provide better protection against infection or severe disease than existing jabs.
“Without the data and getting a human response in at least a limited number of people, you just set it up for the anti-vaxxers, anti-science [people],” said Eric Topol, founder and director of the Scripps Research Translational Institute.
“There are already groups calling it the mouse vaccine . . . We already have a trust problem in this country and we don’t need to make it worse,” he said.
“People have booster fatigue. They feel by this stage they are mostly protected and the pandemic is largely behind them: so I think there will be less interest in these boosters,” said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.
Offit was one of two members of a US Food and Drug Administration advisory panel to vote against asking Pfizer and Moderna to develop the bivalent vaccine without clinical data showing it performed better than the existing Covid jab.
“What bothers me in this is that we’re willing to move forward with a vaccine with no human data? I just think that’s a lot to ask people,” he told the Financial Times.
Wed Sep 14, 2022 8:21 pm
Thu Sep 22, 2022 2:28 pm
Vaccine damage is a matter of health, not politics
PANDEMIC policy is slowly changing in response to health data. Is it changing fast enough and is it changing in the right direction?
From the beginning, there were concerns about the long-term outcomes following both Covid infection and vaccination. At this point these are becoming more clearly appreciated.
Neither the dire predictions of widespread Covid severity nor the protection of Covid vaccination have come to pass as initially promised.
Health authorities remain heavily committed to a Covid strategy which relies upon mRNA vaccination. Is it working?
All-cause mortality has reached record levels. Our health system is reportedly overwhelmed. The mRNA vaccination does not prevent Covid infection. Why?
The reasons for these effects are technical, but were not unexpected. There has always been a fear that mRNA vaccination might depress immune function.
Vaccine-induced antibody-dependent enhancement (ADE) occurs when our immune antibodies generated as a result of vaccination combine with a pathogen to facilitate its entry into cells and thereby enhance infection. In one sense we could say this occurs because our immune system becomes so familiar with a pathogen that it learns to accept it. The result can be repeated infections.
A ground-breaking paper from Japan published on September 16 titled ‘Re-evaluation of antibody-dependent enhancement of infection in anti-SARS-CoV-2 therapeutic antibodies and mRNA-vaccine antisera using FcR- and ACE2-positive cells’ explores this possibility and concludes that both therapeutic antibody Covid treatments and mRNA vaccination can result in ADE.
Does this mean that mRNA Covid vaccination programmes should be halted? At this point, policy makers are beginning to entertain divergent opinions. Denmark has halted Covid vaccination for the under-50s. The UK has halted vaccination for the under-12s.
Amid growing concerns, the most worrying trend is for authorities and employers to double down on vaccine requirements or dismiss questioning voices out of hand in a manner that is detached from the evolving scientific findings. Incredibly, the Netherlands is discussing the reintroduction of vaccine passes.
It is important to understand that vaccination in general is the mainstay of medical policy everywhere. From the outset, policy makers accepted that mRNA vaccination would be effective and safe. Now significant doubts have arisen, but like a poker player who has gone all in on a bet, changing strategies does not look possible to many in the medical profession. They are hoping that more of the same – more boosters – will pull everyone through.
Conversely a number of formerly strong vaccine advocates are expressing doubts and wavering. Dr Paul Offit, a paediatrician specialising in infectious diseases and a world expert on vaccines, immunology and virology, who is a contributing editor of the authoritative New England Journal of Medicine, does not himself intend to get Omicron-specific boosters and doesn’t advise it for others. He says the research is insufficient. He also worries that mRNA vaccination has been inappropriately offered to young people.
Offit is by no means the only one speaking up. Discussions about mRNA vaccine safety are being widely aired. See this article in SSRN, ‘COVID-19 Vaccine Boosters for Young Adults: A Risk-Benefit Assessment and Five Ethical Arguments against Mandates at Universities’.
There is still a lot that we don’t know. I have written extensively about this over the last few weeks at the Hatchard Report.com and referenced the issue to recent journal publications.
With all-cause mortality rising, the real concern here is that governments have been very cagey about releasing data on cause of death paired with vaccination status – a prerequisite for definitive research. Where data is available, such as from Britain’s ONS, it strongly points to a concerning relationship between all-cause death and Covid vaccination. The MSM is reluctant to cover these issues, especially ADE.
New Zealand PM Jacinda Ardern has flown to New York in a private jet with Emmanuel Macron and Justin Trudeau for a week of intense diplomacy with world leaders. Her focus is expected to be on controlling mis- and disinformation, and online extremism.
Just remember that last September NZ health officials and advisers dismissed as disinformation claims by GP Dr Peter Canaday that mRNA vaccination can result in ADE. It never was disinformation; Canaday was simply seeking to initiate a scientific discussion based on published research and theoretical inference. Now ADE is a scientifically recognised result of mRNA vaccination, so he was right to probe the issues.
This wasn’t Dr Canaday’s only claim. He also suggested mRNA vaccines are not very effective at preventing transmission – a claim which was also dismissed as disinformation at the time and we now know to be true.
My suggestion is that we are being left partially in the dark. This is partly because mRNA vaccination safety has become a hot potato that no one wants to hold and partly the result of vaccine extremism. Public safety should have been paramount. New research is raising concerning issues.
We are talking human health here, not political allegiance. This is fundamentally a scientific matter. Therefore you might consider joining those who are asking hard questions and expecting answers. Otherwise research findings could be swept under the carpet and deliberately withheld from the public.
Tue Sep 27, 2022 4:33 am
Tue Sep 27, 2022 11:58 am
Wed Oct 12, 2022 2:23 pm
Pfizer Exec Concedes COVID-19 Vaccine Was Not Tested on Preventing Transmission Before Release
A Pfizer executive said Monday that neither she nor other Pfizer officials knew whether its COVID-19 vaccine would stop transmission before entering the market last year.
Member of the European Parliament, Rob Roos, asked during a session: “Was the Pfizer COVID vaccine tested on stopping the transmission of the virus before it entered the market? Did we know about stopping immunization before it entered the market?”
Pfizer’s Janine Small, president of international developed markets, said in response: “No … You know, we had to … really move at the speed of science to know what is taking place in the market.”
Roos, of the Netherlands, argued in a Twitter video Monday that following Small’s comments to him, millions of people around the world were duped by pharmaceutical companies and governments.
“Millions of people worldwide felt forced to get vaccinated because of the myth that ‘you do it for others,'” Roos said. “Now, this turned out to be a cheap lie” and “should be exposed,” he added.
The Epoch Times has contacted Pfizer for comment.
What Was Said
The Food and Drug Administration wrote in late 2020 that there was no data available to determine whether the vaccine would prevent transmission and for how long it would protect against transmission of the SARS-CoV-2 virus that causes COVID-19.
“At this time, data are not available to make a determination about how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person,” the agency specifically noted.
Meanwhile, Pfizer CEO Albert Bourla, around the same time, said his firm was “not certain” if those who receive its mRNA vaccine will be able to transmit COVID-19 to other people.
”I think this is something that needs to be examined. We are not certain about that right now,” Bourla told NBC News in December 2020 in response to a question about transmissibility.
Former White House medical adviser Dr. Deborah Birx in June revealed that there was evidence in December 2020 that individuals who received COVID-19 vaccines, including Pfizer’s, could still transmit the virus.
“We knew early on in January of 2021, in late December of 2020, that reinfection was occurring after natural infection,” Birx, the White House COVID-19 response coordinator during the Trump administration, told members of Congress this year.
‘Not Going to Get COVID’
A number of officials in the United States and around the world had claimed COVID-19 vaccines could prevent transmission. Among them, President Joe Biden in July 2021 remarked that “you’re not going to get COVID if you have these vaccinations.”
Chief Biden administration medical adviser Anthony Fauci in May 2021 said in a CBS interview that vaccinated people are “dead ends” for COVID-19, suggesting they cannot transmit the virus. “When you get vaccinated, you not only protect your own health and that of the family but also you contribute to the community health by preventing the spread of the virus throughout the community,” Fauci said.
Two months later, in late July of that year, Fauci said that vaccinated people are capable of transmitting the virus.
In the coming months, Fauci, Biden, CDC Director Dr. Rochelle Walensky, and others pivoted to say the vaccine prevents severe disease, hospitalization, and death from COVID-19.
Thu Oct 13, 2022 9:30 am
EXCLUSIVE: CDC Won’t Release Review of Post-Vaccination Heart Inflammation
The U.S. Centers for Disease Control and Prevention (CDC) will not release its review of post-COVID-19-vaccination heart inflammation.
The CDC has been performing abstractions on reports of post-vaccination myocarditis, a form of heart inflammation, submitted to the Vaccine Adverse Event Reporting System.
But the agency is saying that federal law prevents it from releasing the results.
The abstractions “are considered medical records which are withheld in full from disclosure,” the CDC told The Epoch Times in a recent letter, responding to a Freedom of Information Act request.
One of the exemptions in the act says that agencies can withhold materials that are “specifically exempted from disclosure by statute, if that statute (i) requires that the matters be withheld from the public in such a manner as to leave no discretion on the issue; or (ii) establishes particular criteria for withholding or refers to particular types of matters to be withheld; and (B) if enacted after the date of enactment of the OPEN FOIA Act of 2009, specifically cites to this paragraph.”
The CDC pointed to the Public Health Service Act, which was enacted in 1944, and says that vaccine injury reports and other information that may identify a person shall not be made available to any person except the person who received the vaccine or a legal representative for that person.
The information sought is available through the CDC website without details that would identify patients, the agency also said.
The CDC said that it does not have a formal definition of “abstraction” but that it means the process of reviewing medical records, including autopsy reports and death certificates, and recording data in a database. “Please note that this definition means that any abstracted data, because they originate from medical records, is also considered medical records,” a CDC records officer told The Epoch Times in an email.
Refusing to release the data raises concerns about transparency, according to Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center.
“The stubborn refusal of officials heading up federal health agencies responsible for protecting the public health to come clean with Americans about what they know about COVID vaccine risks is stunning,” Fisher told The Epoch Times in an email.
Fisher noted that the CDC has funded electronic medical record systems that collect personal health information and that the agency shares the data with a number of third parties, such as contractors and researchers.
“Yet, CDC officials are claiming they cannot release de-identified abstraction information curated from the medical records of individuals, who have suffered myocarditis or died after COVID shots? This looks and feels like a coverup of the true risks of COVID vaccines,” Fisher said.
Fisher called for a congressional probe into what she described as “the disturbing lack of transparency on the part of federal agency officials, who granted COVID vaccine manufacturers an Emergency Use Authorization (EUA) to widely distribute the vaccines in December 2020 and have recommended and aggressively promoted the vaccines for mandated use ever since.”
In response to a separate Freedom of Information Act request, the CDC initially said that it did not perform any abstractions or produce any reports on post-vaccination myocarditis. That request was for reports between April 2, 2021, and Oct. 2, 2021.
The agency also falsely said that a link between myocarditis and the messenger RNA COVID-19 vaccines was not known during that time.
A possible link between those vaccines, made by Pfizer and Moderna, became known in early 2021. Many experts now acknowledge the link is likely or definitely causal.
The CDC later issued a correction on the false claim, as well as the claim that the agency started performing a type of data mining on VAERS data as early as February 2021.
The CDC said in its correction that myocarditis abstractions began being performed in May 2021.
Notified that its response was false and asked to do a fresh search, the records office did not respond.
Appeals have been lodged in that case and after the more recent response withholding the records.
Dr. Rochelle Walensky, the CDC’s director, said in a press conference in April 2021 that the agency had not detected a link between the vaccines and myocarditis. The basis for that statement remains unclear.
Part of Pattern
The refusal to provide the myocarditis abstractions is part of a pattern with the CDC and its partner, the Food and Drug Administration (FDA).
The CDC still hasn’t released the results of the data mining, to The Epoch Times, Sen. Ron Johnson (R-Wis.), or a nonprofit called Children’s Health Defense. The agency also declined to provide results from a different monitoring system, V-safe, to a nonprofit called Informed Consent Action Network, which then sued the agency and just recently received the first tranche of data.
The FDA, meanwhile, has refused to release the results of a different type of analysis on the VAERS data, claiming it cannot separate the results from protected internal communications. The agency is also withholding autopsies conducted on people who died after getting COVID-19 vaccines, pointing to exceptions laid out in the Freedom of Information Act.
Along with Johnson, several other lawmakers are pressing at least one of the agencies to release the data, asserting that not doing so is illegal.
Sat Oct 22, 2022 4:41 pm
95 Percent of Corpses Had Received COVID Vaccination Within 2 Weeks of Death: Funeral Director
A funeral director from New Zealand says that 95 percent of the corpses he has been seeing had received a COVID-19 vaccine within two weeks of their passing away.
“Ninety-five percent of the people who have passed away through the work that I’ve done have been vaccinated within two weeks,” Brenton Faithfull said.
Faithfull has been working as a funeral director for the last 41 years and has been running his own mortuary business for the last 26 years. He recently spoke out about the apparent relationship between the COVID-19 vaccines and the deaths he has been observing.
“It’s very obvious, they die within two weeks of receiving the vaccination, a lot of them … almost appear to have died from anaphylaxis, almost a reaction straight away to the booster.”
Anaphylaxis is an acute reaction of the body to an antigen, such as that of a bee sting, or an injection.
“They die the same day, the following day after receiving the COVID-19 vaccination. This isn’t a one-off case, this is the majority of cases that have come through our facility,” Faithfull said in an interview.
UK Funeral Director
Similar data has been discussed by funeral director John O’Looney in the UK and Richard Hirschman from Alabama, previously reported by The Epoch Times.
“From the very moment these injections went into arms, the death rate soared beyond belief. They labeled them all as COVID deaths, but the reality is they were almost exclusively the people who were vaccinated,” O’Looney told The Epoch Times.
“We now see record numbers of deaths in the vaccinated and in record numbers of young people. They die from a mixture of sudden very aggressive cancers or blood clots, which cause heart attack and stroke,” he added.
Dr. Sherri Tenpenny, who has been informing the public on the dangers of vaccines for over two decades, weighed in on Faithfull’s testimony:
“On Dec. 2, 2020, UK regulators granted emergency-use authorization (EUA) to Pfizer’s COVID-19 shot. Within a week, MHRA [Medicines and Healthcare products Regulatory Agency] Chief Executive Officer June Raine said in a statement that ‘Any person with a history of anaphylaxis to a vaccine, medicine or food should not receive the Pfizer BioNTech vaccine.’ She went on to say that ‘allergic reactions had not been a feature of Pfizer’s clinical trials,'” Dr. Tenpenny told The Epoch Times.
However, Tenpenny further noted that anaphylaxis was the “first identified risk.”
“Pfizer was forced to release their findings by a Texas federal judge in January 2022. Within that first tranche of documents, you will find Table 3–Safety Concerns–on page 10 of this document [pdf]. The first identified risk is anaphylaxis. In a risk survey … conducted between Dec. 1, 2020, and Feb. 28, 2021, a mere three months, 1,833 cases of anaphylaxis had been observed and four individuals died from anaphylaxis on the same,” she said.
The Epoch Times reached out to Pfizer for comment.
In certain cases, Faithfull and his staff try to get the coroner involved.
Faithfull shared one instance where a man insisted that his father should not get the vaccine, but his sister pressured their father. When the father conceded and took the shot, he died four days later.
“When I started counting in August of last year, it was one after the other, after the other, after the other, and when I got to 20, it was 19 who had died within two weeks [of getting the vaccine],” Faithfull said.
“So the first 20 days, I counted 19 of them—that’s 95 percent,” the funeral director explained. “The next number was 100 percent of the people who died had been vaccinated within two weeks.”
Dr. Sanjay Verma is a cardiologist practicing in California who has been seeing a dramatic increase in heart problems since the rollout of the vaccines.
“Previous work by Dr. Gundry demonstrated an increase in cardiac inflammatory markers after COVID-19 vaccination. Interestingly, from Dec 2021 thru Jun 2022, 100 percent of the patients needing urgent cardiac catheterization for heart attack had been vaccinated, many of them with booster doses. More than half had been recently vaccinated (within a few weeks). In a county where 60 percent of the population is vaccinated, this trend was worrisome,” Verma told The Epoch Times.
“There have been 31,470 deaths after COVID-19 vaccination reported in VAERS. The vast majority of them are clustered within seven days after vaccination. Additionally, there are some other worrisome trends. Data from CDC indicate there were 60,000 deaths in Sept 2019 and Sept 2020. However, in Sept 2021 that number surged to 90,000. We also have numerous social media posts on people, especially athletes, who ‘died suddenly’ with no apparent cause,” Verma said.
Verma believes that any unexplained death within a few weeks or even months after vaccination should be “investigated with a thorough autopsy,” specifically evaluated for spike protein in the brain, major blood vessels, and heart.
“We know the spike protein is toxic to blood vessels, causing endothelial dysfunction. The spike protein is also toxic to heart muscle, causing myocardial injury. There are also case reports of autopsy proven vaccine-mediated encephalitis (inflammation of the brain), myocarditis, and vasculitis, all of which can cause death,” Verma added.
Thu Nov 24, 2022 6:46 pm