What Made COVID-19 Vaccines 'Safe and Effective?

By Clare Pain

I am an Australian medical journalist with over a decade’s experience, who is also a UK citizen.

In September and October 2022 I tried to pitch this story raising concerns about the level of information given to the public when the COVID vaccines were rolled out in December 2020 and early 2021.

I submitted it sequentially to the conservative Sunday papers: The Sunday Telegraph, the Sunday Times, the Sunday Express, and the Sunday Mail.

Obviously, I did not expect that these world-famous newspapers would automatically publish anything I write! However, as a seasoned journalist, I do expect an acknowledgement and polite rejection of my pitch.

For all four newspapers there was no acknowledgement of my email, despite follow up. It was as if I had never sent it.

The aim of the story at that time was to inform people that, even at the beginning of the rollout, a reading of the UK Public Assessment Reports should have raised serious concerns about these new genetic vaccines. But it seems people were not ready for this information then.

But now the mood is changing. Many people know someone who has been injured by the vaccines, and we all know they do not stop transmission. Maybe they will be open to reading this story now?

Here's What I Wrote in 2022

The COVID-19 vaccines have been part of our lives for over 21 months, yet few people realise how different they are from vaccines we have used before.

During the first two years of the pandemic, I was a medical journalist writing for GPs and specialist doctors. I had not come across an mRNA vaccine and I had not heard of a DNA viral vector vaccine.

Nevertheless, like most of us, I was very relieved when the vaccines arrived in December 2020, because my dad was 87 and vulnerable.

Now, almost two years later, I think that the government should have been more transparent about the technology they were rolling out.

Some of us had Pfizer or Moderna injections, for instance, not knowing that a vaccine using mRNA (messenger ribonucleic acid) technology had never been approved for use in humans before COVID.

AstraZeneca (AZ) used a different technology, based on DNA (deoxyribonucleic acid). Only two similar vaccines for humans had been approved in the world prior to the AZ vaccine. These were in 2019 and 2020 for the rare and deadly disease, Ebola.

The three COVID injections differ from conventional vaccines because they use gene technology. A small piece of genetic code—in either mRNA or DNA form—is packaged and injected into our arms.

That genetic code tells our bodies to make the spike protein that protrudes from the virus particle. This protein is then recognised as foreign, and our bodies learn how to mount an immune response to it.

That should make us better prepared if we encounter a coronavirus bristling with spike proteins later in our lives.

So, why take this roundabout route of getting our bodies to make the spike protein instead of simply injecting a small amount of the protein as you might with a conventional vaccine?

It’s all about the ease and cost of vaccine production.

First, making DNA and mRNA is relatively easy and can be done quickly. It’s much simpler to do than making a conventional vaccine—that is normally done either by making an inactivated form of the virus or by isolating a protein from it.

Both viruses and proteins are delicate things that must be kept in a precise shape to be useful, so manipulating them to make a conventional vaccine can be tricky.

Unknown Unknowns?

It’s clear that genetic vaccines may be attractive to pharmaceutical companies because they provide a cheaper and more rapid route to market. And making vaccines to tackle new threats more quickly has obvious advantages for us all.
But, of course, we must be sure genetic vaccines are as safe and effective as conventional ones.

With any new technology, there may be new risks, some of which might be “unknown unknowns.”

The biochemistry of the human body is complicated, and a wise medical researcher expects surprises.

What’s more, people differ, so a drug or vaccine that has no side effects for most people may seriously harm a few. This is the reason safety trials include large numbers of participants.

Science is all about asking questions and then doing experiments to answer them. Here are just five of many questions about the genetic vaccines now being raised by people around the world.

First, how much spike protein do people make after a shot? And do different people make different amounts?

Second, how long is the DNA or mRNA active in our bodies? One thing we do know is that both Pfizer and Moderna use a synthetic mRNA that contains N1-methylpseudouridine. This makes the synthetic version last longer than normal mRNA.

Third, it would be nice to be sure that the genetic vaccine stays in the arm muscle and doesn’t reach other parts of the body. There could, for instance, be some organs in the body where making spike proteins would not be a good idea.

Fourth, could this new type of vaccine be harmful in ways that a normal vaccine would not be?

And fifth, when they were rolled out, did we have evidence that the vaccines stopped people from transmitting the virus to others? This is important because we were encouraged to get the injections so that we wouldn’t put other (vulnerable) people at risk.

Is the Devil in the Details?

To try to answer these questions I turned to the public assessment reports (PARs)—a weighty 352 pages in all!
These reports are produced by the UK's Medical and Healthcare Products Regulatory Agency (MHRA) when it approves a drug or vaccine, and they give the evidence behind the approval decision (the PAR for the Moderna vaccine was produced by the European Medicines Agency).

All three PARs have been publicly available on the UK government’s website since early in the rollout. Pfizer's was first published on Dec. 15, 2020, AstraZeneca's on Jan. 5, 2021, and Moderna's on Feb. 19, 2021.

None of the PARs show how much spike protein is made in a person's body or how long the DNA/mRNA remains active, so, unfortunately, we draw a blank in answering questions one and two.

The PARs did provide some information from animal “biodistribution” studies that suggest the vaccines may not just stay in the arm muscle.

We are told, for instance, that “low levels” of DNA from the AZ vaccine “were detectable in bone marrow, liver, lung and spleen” of laboratory mice (pdf).

For Moderna (pdf), no biodistribution studies were reported with the COVID vaccine itself, but a study of a similar vaccine was reported.

This showed that in rats, “low levels of mRNA could be detected in all examined tissues except the kidney.” We are told this included the liver, heart, lungs, testes, and brain and that higher levels were seen in the spleen and eye. We don’t know about ovaries because no female rats were tested.

A mouse study for the Pfizer vaccine suggested it reached the liver (pdf). We are told that information on “potential distribution” to other sites had been submitted to the MHRA, but it was not reported.

On the fourth question, whether the vaccines could do harm, we must remember that safety monitoring of people who were injected in the trials was carried out for just two months after the second dose. No long-term safety data was available.

No animal studies were done to see whether the mRNA/DNA in the vaccines could damage our genes (genotoxicity), according to the Pfizer and AZ documents.

For Moderna, a standard genotoxicity test of a similar mRNA vaccine in rats was done that showed raised levels of micronucleated red blood cells. This can be a signal of genotoxicity,but it can also be caused by other things. It was mentioned that genotoxicity data had been submitted for the COVID vaccine itself, but that did not seem to be reported.

Meanwhile, none of the genetic vaccines were tested to see whether they might increase the risk of cancer (carcinogenicity).

Indeed, for our latest approved “Autumn booster” vaccine, the Moderna bivalent Spikevax, the information leaflet for healthcare professionals (pdf) says “Carcinogenicity studies were not performed.”

By the way, the regulators mentioned a “theoretical risk” of Vaccine Associated Enhanced Disease (VAED) for all three vaccines. In other words, the MHRA and EMA were alert to the possibility that vaccination might make people get COVID more severely.

There was no evidence from the trials that this was occurring, but all three PARs say that the vaccine makers were instructed to keep monitoring for VAED.

Moving on to efficacy.

It’s important to be clear about what the word “effective” meant when the vaccines were rolled out.

Strictly, a vaccine can only be described as effective if it works in a real-world situation.

The original trial data could not show that the vaccines would be “effective” at promoting immunity in people such as the very sick and frail, people with immunodeficiencies, pregnant women, and young children, because people like this were not included.

Furthermore, the trials told us only that the vaccine was effective for two months against the strains of the virus that people encountered during 2020 (the year in which the trials were done). Anything else was a hope.

So when the government said they were effective, what exactly were the vaccines effective at doing? Stopping transmission of the virus; preventing people from getting COVID; or preventing severe disease and death?

Here’s what the trials showed.

If we amalgamate the data across the three vaccines, nearly 41,000 people in total were given two doses of a vaccine, while the same number received a placebo.

In the two groups—those vaccinated and those given a placebo—the number of people who developed symptomatic confirmed COVID was measured over a defined period. This window began one or two weeks after the person had received their second dose and ended two months after that dose.

While about 600 people in the placebo groups got COVID, only 100 did so in the vaccinated groups.

Symptomatic or confirmed COVID was defined slightly differently for each vaccine but boiled down to having one or two COVID symptoms (such as a temperature above a stated level, a new cough, loss of smell, etc.) plus a positive PCR test.

The Moderna trial data also indicated protection against severe COVID, with 30 of the 185 cases in the placebo group being classed as severe versus none of the 11 cases in the vaccinated group.

Could We Pass COVID on to Granny?

Turning now to the question of transmission, none of the trials were designed to test whether the vaccines could reduce the passing of the virus from one person to another. Indeed, the Pfizer PAR makes no mention of transmission.

The AstraZeneca PAR describes how rhesus macaque monkeys were vaccinated and then exposed to the virus. The vaccinated monkeys had a reduced viral load in their lungs but were still shedding the same amount of virus from their noses.

“These data support an interpretation that [the AZ vaccine] may not prevent infection nor transmission of SARS-CoV-2, but it may reduce illness,” the PAR authors wrote.

Later in the AZ document, it is said that data looking at the broadest definition of COVID infections in the human trials “suggests” a possible effect of the vaccine on transmission. However, the reasoning behind this statement is unclear, and more data was requested by the regulator.

Meanwhile, the Moderna PAR states that the effect of the vaccine on viral transmission cannot yet be determined, and “therefore the possibility for achieving herd immunity has not been demonstrated at the present time.”

So, it seems fair to say that when the vaccine rollout began and we bared our shoulders to protect granny, evidence that we would indeed protect her was scant.

A Trojan Horse?

Looking back to December 2020, when many of us rejoiced at the arrival of former Prime Minister Boris Johnson’s “scientific cavalry” that would rescue us from COVID-19, was it made clear to us and our doctors that we were rolling out a new genetic approach to vaccination? Or was that perhaps—keeping the equestrian theme—a Trojan horse?

To ask about this, I emailed the UK Health Security and Protection Agency. There has been no response to date, so I turned to the information currently provided on www.gov.uk .

In the government’s guidance for health professionals (pdf), I have been unable to find mention that the mRNA vaccines were a world first.

And for the rest of us, assuming the current consent forms (pdf) for adults have not been materially changed, there was no explanation of how the injections worked, nor was there an alert that a completely new approach to vaccination was being rolled out.

I wonder, now, whether our doctors and nurses knew enough to properly inform their patients about these genetic vaccines. And I wonder, too, how many people’s informed consent consisted of knowledge of just three words: “safe and effective.”

https://www.theepochtimes.com/opinion/what-made-covid-19-vaccines-safe-and-effective-5520808

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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Should vaccines be adjuvenated with alum?

For a long time vaccines were adjuvenated (made more effective) by adding aluminium salts to them. Eventually, however, sufficient concerns about the practice emerged for the practice to be dropped and Covid vaccines did not contain such adjuvants.

But was something lost by that? Might the Covid vaccines have worked better with adjuvants? The study below used mice to suggest an answer to that. They found that breakthrough infections were much worse with adjuvants.

While COVID-19 vaccines have generally remained effective in stopping more severe illness associated with SARS-CoV-2, the virus behind COVID-19, significant concerns emerge regarding vaccine-associated enhanced respiratory diseases (VAERD) post breakthrough infections. This means even though people get vaccinated, because the COVID-19 vaccines are not of the sterilizing type, they fail to protect against infection, especially over time, less intermittent boosters to bolster protection. Importantly, this recent animal study reveals spike protein subunit vaccines for SARS-CoV-2 induce VAERD in hamsters, where aluminum adjuvants promote a Th2-biased immune response, leading to increased type 2 pulmonary inflammation in animals with breakthrough infections.

Other research such as a study funded by China’s Beijing Science and Technology Plan and Emergency Key Program of Guangzhou Laboratory, found that both novel low-dose and high-dose adjuvanted inactivated SARS-CoV-2 vaccine with CpG and Alum induced high levels of specific IgG antibodies as well as neutralizing antibodies against SARS-CoV-2, and the continuous stability of high-level neutralizing antibody titers over time demonstrates long-lasting immunity.

The prominent study team was represented by Weishan Huang, Ph.D. Department of Pathobiological Sciences, School of Veterinary Medicine, Louisiana State University, as well as Cornell University’s Department of Microbiology and Immunology, College of Veterinary Medicine.

With a focus on virology and immunology, Huang’s lab studies the development and functions ­­of regulatory immunity and immune memory during vaccination, infections, and cancers.

With this infrastructure and expertise in place, plus support in the form of grants by the National Institutes of Health, and a “Big Idea Research Grant” from the Provost’s Fund at Louisiana State University, Huang and colleagues from Louisiana State University sought to gain a more comprehensive understanding of possible risks and the underlying mechanisms of VAERD designed a study involving the immunization of ACE2-humanized mice with SARS-CoV-2 Spike protein adjuvanted with aluminum and CpG-ODN.

After the immunization, the scientists challenged (intentionally infected) the mice with SARS-CoV-2 to establish the breakthrough condition.

What were the findings?

In this case, the authors report that their experimental vaccine A) elicited robust neutralizing antibody responses, B) reduced viral titers and C) enhanced host survival. Yet upon breakthrough infection, the vaccinated animals presented “severe pulmonary immunopathology, characterized by a significant perivascular infiltration of eosinophils and CD4+ T cells, along with increased expression of Th2/Th17 cytokines.”

Th2/Th17 cytokines are groups of signaling molecules produced by specific subsets of T-helped cells (Th cells) that play an important role in the immune system. These cytokines are involved in regulating responses and inflammation, and they are often associated with various immune reactions.

The study team conducted intracellular flow cytometric analysis (a technique used to identify cell types plus analyze signaling and functional responses within cell lines and heterogenous cell samples), revealing a systemic Th17 inflammatory response, especially intense in the subjects’ lungs.

The study authors report in the uploaded preprint server manuscript that the generated data demonstrate that aluminum/CpG adjuvants induce strong antibody and Th1-associated immunity against COVID-19 but also prime a robust Th2/Th17 inflammatory response, which may contribute to the rapid onset of T cell-mediated pulmonary immunopathology post breakthrough infection.

Food for Thought

There are no easy vaccine fixes for SARS-CoV-2, the virus behind COVID-19. These authors reaffirm that especially important principle. They declare in this yet-to-be peer-reviewed paper, “In conclusion, this research underscores the complexity of COVID-19 vaccination and the need for a comprehensive understanding of vaccine-induced immune responses. While vaccines remain a vital tool in combating pandemics, the potential for VAERD highlights the importance of ongoing research, surveillance, and careful vaccine development to achieve broad protection and maximal safety.”

Next Steps

Do these findings underscore the necessity for further research to unravel the complexities of VAERD in COVID-19? Does the study output point to the necessity to enhance vaccine formulations for broad protection and maximum safety? The study authors believe so.

https://www.trialsitenews.com/a/spike-protein-subunit-vaccine-adjuvanted-with-alum-and-cpg-elicits-t-cell-mediated-pulmonary-immunopathology-upon-breakthrough-infection-a8919e13

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DeSantis: Overhaul National Childhood Vaccine Injury Act of 1986 & Impose More Oversight over FDA Staff

In a recent podcast interview, Florida Governor Ron DeSantis went on the record that he supports changing the current vaccine liability laws promulgated by the Reagan administration back in 1986. Those laws have helped spawn a robust vaccine sector targeting more diseases in the name of public health. Or, that’s what the public is told by a wealth-generating vaccine industry. What were at first, pragmatic measures meant to incentivize vaccine manufacturers, according to DeSantis, have turned into a vaccine development free-for-all, a race to generate the next blockbuster not as concerned with safety and quality but for economic return. The Food and Drug Administration (FDA) represents the world’s apex of drug and vaccine regulators. Yet about half of the agency’s budget now derives from Prescription Drug User Fees. This means that the FDA is highly dependent on the very industry it is tasked with regulating. Of the $5.9 billion budget, 45% derives from user fees, and 65% of the funding for human drug regulatory activity comes from user fees.

The National Childhood Vaccine Injury Act. of 1986, or “the Vaccine Act,” offers vaccine manufacturers a form of universal liability providing “no vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death: (1) resulting from unavoidable side effects; or (2) solely due to the manufacturer's failure to provide direct warnings.”

While DeSantis acknowledges at the time the intention was needed to ensure the pharmaceutical companies needed incentives to invest in public health-related vaccines, the politician said on the Shannon Joy podcast, “I think what has happened now it is has shifted incentives actually away from safety.” He takes a controversial stance, markedly opposed to general sentiment from Washington that emphasizes the comprehensive rigor that goes into regulatory approvals.

The Florida Governor continued, “The incentives are now to produce anything you can get to the market and then make money off it because you aren’t going to be held accountable for the safety. So yes, I would support legislation to fix that because I think we want incentives that are going to be positive for the ultimate health outcome.”

While it’s most certainly true that the number of vaccines has exploded since the 1986 Act, it’s likely, not clear if the standards in regulatory oversight have declined generally, and if that is the case, that it’s due to this legislation.

Vaccine opponents believe regulators are “captured” by industry. But that’s a more complex, nuanced issue that DeSantis at least acknowledges.

On the problem of the intertwined nature of the pharmaceutical industry and the regulatory body in the U.S., DeSantis chimed in, “Of course, a lot of the people who work for the FDA end up going to work for Big Pharma after, so we are going to end the revolving door. We are going to put a grace period in there: five to ten years, whatever would be appropriate so that you can't just keep bouncing back and forth.”

Should the revolving door end? This doesn’t sound very pragmatic, given the real-world circumstances—constraints and realities on the ground. After all, an ongoing shortage of the talent needed to run regulatory bodies, industry, academic, and the growing nonprofit research machine, not to mention the private equity firms now investing in drug development, means that placing further constraints on this limited pool of labor likely would lead to a series of other more severe problems. Much legislation, while well-intentioned, often leads to other even worse problems.

Plus, this sounds like substantial federal regulatory oversight of the type that goes well above and beyond what standard Republican and Democrat politicians would be willing to back. Would that truly be a Republican priority should DeSantis be the winner? Or more political talking points to exploit animosity, fear, and anger due to COVID-19-related pandemic government overreach?

Perhaps what’s needed first is solid research into the problem. Have the regulatory standards declined since the 1986 Act? How could evidence be generated to prove that point? Some of the answers may lie in the real-world data.

https://www.trialsitenews.com/a/desantis-overhaul-national-childhood-vaccine-injury-act-of-1986-impose-more-oversight-over-fda-staff-476a9264

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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The Need for Uncensored Data and Debate on COVID

“Ithink we would have done everything differently,” California Governor Gavin Newsom recently told NBC, conceding that strong criticisms of his state’s strict COVID-19 lockdown policies were “legitimate” in hindsight.

Looking in the rear-view mirror, the strict COVID-19 lockdowns, pursued in California and other states, were indeed a disaster. But it was a collective public policy failure, as Newsom observed. Public officials have a responsibility to look back and revisit what they knew—or should have known—before they proposed or implemented the various lockdown policies recommended by federal officials. The often draconian social and economic measures that many state officials imposed, including extended school closures and business shutdowns, resulted in multiple costly consequences that will plague Americans for a long time.

That’s why congressional investigators should take a deeper dive into the rationale behind federal officials’ guidance on COVID-19 lockdowns. States, especially where the toughest restrictions were implemented, should follow suit. Such reviews could help lawmakers avoid ill-advised government overreach when the next pandemic comes along.

COVID Lockdown Data. Peer-reviewed work of an international team of researchers led by Dr. Steve Hanke, professor of economics at Johns Hopkins University, Did Lockdowns Work? The Verdict on COVID Restrictions, offers some good insight. A comprehensive literature review, the first study of its kind over a broad range of countries, by Hanke, Dr. Lars Jonung of Sweden’s Lund University, and Dr. Jonas Herby of the Center for Political Studies in Denmark, examined over 19,000 studies but focused on 22 relevant studies with actual mortality data. Their “meta-analysis” examined the specific relationship of mortality to various lockdown restrictions, including mandatory stay-at-home orders, business and school closures, and mask mandates, especially in the workplace.

Hanke and his colleagues examined the specific impact of certain government mandates exclusively on mortality. Among other findings, they concluded that stay-at-home orders reduced COVID mortality between 1.4 and 4.1 percent; business closures by 7.5 percent; school closures between 2.5 percent and 6.2 percent; and mask mandates, particularly in the workplace, by 18.7 percent.

Looking at the aggregate impact of these restrictions across Europe and the United States, Hanke and colleagues found that “...lockdowns in the Spring of 2020 in Europe resulted in 6000 to 23,000 deaths avoided. To put those numbers in to context, during an average flu season, approximately 72,000 are recorded in Europe. Our results made clear that lockdowns had negligible public health effects when measured by mortality.”

COVID Masking Data. In a 2023 study, a team of researchers publishing in the Cochrane Review conducted the most comprehensive literature review (78 studies) on masking to date and concluded: “There is uncertainty about the effects of face masks. The low to moderate certainty of evidence means our confidence in the effect estimate is limited and the true effect may be different from the observed estimate of the effect. The pooled results of RCTs (Random Controlled Trials) did not show a clear reduction in respiratory viral infection with the with the use of medical /surgical masks.” Random controlled trials are the “gold standard” of academic research.

The Cochrane researchers did note that there is a further need for “large, well -designed” studies in multiple setting and populations, as well as levels of “adherence,” to get a better understanding of the effectiveness of masking. Hanke and his colleagues agree with the need for future research in this specific area.

The Swedish Experience. It is particularly noteworthy that officials in Sweden followed far less restrictive policies than European and American officials. They emphasized public information and voluntary compliance with public health recommendations, notably social distancing. Writing in The Frontiers of Public Health (2023), researchers recently reported: “Existing official statistics at both the European and global levels regarding total COVID-19 associated and excess overall mortality rates suggest that Sweden was less affected than most comparable countries that implemented stricter lockdown measures.”

Put into broader context, Hanke and colleagues observe, “Social distancing works. If you keep distance from others, your risk of being infected with a communicable disease is reduced. However, that fact that social distancing works does not imply that compulsory non-pharmaceutical interventions (NPIs), commonly known as ‘lockdowns—policies that restrict internal movement, close schools and businesses, ban international travel and/or other activities—work.”

Censorship of Science. An academic consensus on the impact of lockdowns does not, however, exist. For example, the British Royal Society published a 2023 study that concludes that the lockdowns did indeed contain the viral contagion and reduce mortality. Hanke and colleagues dispute the Royal Society conclusions because of its methodological flaws, specifically lumping together the effects of government mandates and voluntary compliance.

Previously, Hanke and colleagues published the methodological protocol for their research project in July 2021 in the Social Science Research Network(SSRN), a prominent academic platform for research papers. On March 2022, the SSRN published a critique of the paper, but in August 2023 refused to publish a reply by Hanke and his colleagues.

Because academic freedom is essential to the advancement of science, censoring or “deplatforming” academic debate is obviously unacceptable, especially in public health, where the safety of the public is so often dependent on the quality of academic research. Congress has a broad agenda for COVID-19 oversight. It should not overlook the consequences of censorship or suppression of scientific dissent.

There is rarely a binary choice between protecting public health and preserving some semblance of social and economic normalcy. Public health is not only threatened by viral contagion, but also by draconian social and economic lockdowns.

As Dr. Daniel Johnson, former president of the American Medical Association, counseled at the inception of the pandemic: The tough policy job is to protect lives and livelihoods, a prudential balancing that can preserve public health in a holistic fashion.

Too often that has not happened. In his book The Contagion Next Time, Dr. Sandro Galea, Dean of the Boston University School of Public Health, recounts his own research work on the effect of lockdowns on public health: “We found that lockdowns and socially restrictive policies can undermine health in both the short and long terms, creating particular challenges for vulnerable populations. Our work suggested that the harmful consequences of such policies should be considered in decision-making about pandemic response.”

Today, few dispute the negative consequences of the COVID-19 lockdown policies: major economic disruption and massive unemployment; the closure of hundreds of thousands of businesses and the loss of small businesses, including minority businesses; unprecedented increases in federal deficit spending and debt; severe damage to childhood education; aggravated economic and educational inequality; social isolation and increased mental health problems; and, of course, loss of personal freedom.

Personally, Dr. Galea leans Left, but as a research scientist he rightly emphasizes that sound public health policy is not, and should not be, an ideological issue. Progress is dependent upon competent assessment of the evidence, open scientific debate and sound data—all of it. Uncensored.

https://www.heritage.org/public-health/commentary/the-need-uncensored-data-and-debate-covid-restrictions

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More Than Nine in 10 Americans Say ‘No Thanks’ to Latest COVID-19 Booster Shot

In mid-September, the Centers for Disease Control and Prevention (CDC) issued a press release recommending “everyone 6 months and older get an updated COVID-19 vaccine to protect against the potentially serious outcomes of COVID-19 illness this fall and winter.”

Suffice to say, the CDC’s recommendation has fallen on deaf ears. To date, only 7 percent of U.S. adults and 2 percent of children have followed the CDC’s suggestion. In fact, the rate of Americans receiving the latest COVID-19 booster is so low that Dr. Camille Kotton of Harvard Medical School said the situation is “abysmal.”

Nevertheless, CDC Director Mandy Cohen remains unphased, recently telling Politico, “I think we’re on track. Would I love to see more? Of course, that’s my job as CDC director is to want more.”

Actually, Cohen’s job is to protect the health and wellness of the American people; not the bottom line of Pfizer and Moderna.

The American people are obviously skeptical about receiving yet another COVID-19 booster, which makes sense given the doublespeak, disturbing side effects, and lack of efficacy regarding the vaccine and boosters over the past few years.

To begin with, the CDC lost credibility when it changed the definition of “vaccine” and “vaccination” on its website a few months after the initial rollout.

Before September 1, 2021, the CDC defined “vaccine” as: “A product that stimulates a person’s immune system to produce immunity to a specific disease, protecting the person from that disease.” However, the CDC now defines “vaccine” as: “A preparation that is used to stimulate the body’s immune response against diseases.”

The CDC played semantics with the definition of “vaccination” as well, changing the definition from, “The act of introducing a vaccine into the body to produce immunity to a specific disease” to, “The act of introducing a vaccine into the body to produce protection from a specific disease.”

“Immunity” and “protection” are not synonyms; they have different meanings.

It is also more than likely that most Americans have trepidation regarding the latest booster shot based on the fact that there have been several side effects linked to the initial round of shots and subsequent boosters.

In 2022, the University of Arizona Mel and Enid Zuckerman College of Public Health released a study titled “Understanding low bivalent COVID-19 booster uptake among US adults,” which found that 31.5 percent of respondents said they chose not to receive a booster due to concerns about vaccine side effects and 23.4 percent cited concern about booster safety.

These concerns are warranted, considering the CDC acknowledges that myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) have been linked to “adolescents and young adult males within several days after mRNA COVID-19 vaccination.”

In early 2023, the National Institutes of Health (NIH) released a study that found, “Various cases of thrombosis have been reported as adverse reactions after vaccination with COVID-19 vaccines.” The NIH study also found “a significant increase in the incidence rate” of “pulmonary embolism following vaccination.”

Worse yet, the Vaccine Adverse Effect Reporting System (VAERS) reported 4,812 deaths, 4,996 permanent disabilities, and 21,440 hospitalizations from COVID-19 vaccines as of June 25, 2021.

As most Americans are well aware, the federal government even went so far as to grant a blanket liability shield for the makers of the COVID-19 vaccines under the Public Readiness and Emergency Preparedness Act of 2020.

What’s more, why would Americans take an experimental vaccine that has been shown to produce adverse side effects when the so-called vaccines do not prevent them from getting or transmitting COVID-19?

There are countless examples of high-ranking government officials, such as Dr. Anthony Fauci, who have received numerous boosters yet still became infected with COVID-19. Moreover, studies show that the original COVID-19 shot and the multiple boosters that have been rolled out over the past three years “decline in effectiveness” shortly after they are administered.

And, considering the fact that COVID-19 poses little to no threat among the young and healthy, why in the world would the CDC promote an experimental vaccine for infants?

The good news is that Americans are continuing to get vaccines for diseases such as measles, mumps, the flu, and other preventable illnesses. This shows that there is not a general distaste for vaccines as a whole among the American population. However, given the shoddy track record of a set of vaccines that do not meet the classical definition of vaccine, produce dire side effects, and do not even work as intended, it makes perfect sense that only a sliver of the population is willing to keep getting boosted.

https://townhall.com/columnists/christalgo/2023/11/03/more-than-nine-in-10-americans-say-no-thanks-to-latest-covid-19-booster-shot-n2630710

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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New Covid variant HV.1 variant becomes dominant as America's booster vaccine program lags

A new coronavirus variant is spreading across the United States, but experts have urged people not to be alarmed.

The mutant strain — dubbed HV.1 — is a mutation on the EG.5 variant which sparked concern earlier this year.

It is now dominant in the US behind 25 percent of cases, with experts saying it is more transmissible than other variants. There is no sign it is more likely to cause severe disease.

Experts are not raising the alarm over the mutant strain, however, saying there will 'always be new variants' as Covid continues to spread and mutate.

Concerns are being raised over America's slow booster program, however, with uptake branded 'abysmal' this weekend with less than three percent of Americans having come forward a month into the rollout.

Covid cases and hospitalizations are currently trending downward and deaths are flatlining, although experts warn cold weather leading people to spend more time indoors could lead to an uptick in cases.

Dr Amesh Adalja, an infectious diseases expert at Johns Hopkins University, told WION: 'It is important to recognize that there will always be new variants of SARS-CoV-2.

'[This is] just as there are with any other endemic respiratory virus and most will not be of concern to anyone.'

Dr Ross Kedl, an immunologist at the University of Colorado Anschutz School of Medicine, added: 'All that people know at this point is that it's increasing in representation.

Doctors urge elderly adults to get Covid, flu and RSV vaccines this winter

Doctors have urged older adults to roll up their sleeves for three different vaccines this fall.

'There's no evidence that it's more severe.'

And Dr William Schaffner, an infectious diseases expert at Vanderbilt University School of Medicine in Tennessee, told Prevention: 'I don't think people should be very concerned about this.

'Some of the symptoms recorded have been cough, fatigue, congestion and a runny nose. That sounds pretty much like the common cold.'

Scientists say Covid will continue to mutate and create new variants as new cases arise.

But they add that there is little need to fixate on each new strain that comes along because most will not raise the risk of serious disease.

HV.1 was first detected in late July in Costa Rica, according to Covid variant tracking website outbreak.info.

It has now spread to more than 41 countries — including the UK, Canada and Israel — and a total of 4,397 cases have been detected, mostly in the United States.

This is likely to be a massive underestimate, however, because many cases are not checked for variants.

The mutant strain was spotted in the US back in July and has been accounting for an ever higher proportion of cases since.

By the end of August it was behind three percent of cases, according to figures from the Centers for Disease Control and Prevention (CDC).

By the final week of September, however, it was behind 12 percent of all Covid cases with latest estimates for this month estimating it is now behind one in four infections.

California — America's most populous state — has the most cases at 115 recorded, followed by New York — a 'bellwether' state — at 70 cases.

The mutant strain has several mutations on its spike protein which experts say may make it better able to dodge immunity and infect cells.

There is no sign that it is causing different symptoms at present either, with doctors likening its symptoms — including a cough and runny nose — to the common cold.

The US is currently rolling out an updated Covid booster vaccine which has been made available to everyone over the age of six months. Top advisers say, however, that only those over 65 years old need to get inoculated.

The vaccine is based on the XBB.1.5 Covid variant — which was dominant this summer — with experts saying HV.1 is a 'grandchild' of this strain.

They suggest that the vaccine will still work well against severe disease caused by HV.1 because it only has a few further mutations.

It comes as Covid cases and hospitalizations continue to trend downward nationwide.

Latest CDC data showed the positivity rate — proportion of tests that detected the virus — was down to 8.7 percent in the week to October 21, compared to 9.4 percent in the prior week.

There were also 13,036 Covid patients hospitalized in the week to October 21, the latest available, down 4.6 percent on the 13,652 at the same time last week.

For comparison, at the peak over the last two years there were 145,636 Covid patients in hospitals on January 8, 2022.

Covid deaths are currently flatlining at 1,347 being recorded every week, with preliminary data suggesting they may soon start to fall.

Some experts warn, however, indicators will start to trend upward in the coming weeks because cooler weather will lead to more people staying indoors.

There are also gatherings for the holidays upcoming, including Thanksgiving and Christmas, which will lead to different generations coming together — potentially fueling the spread of Covid.

Dr Kelly Oakeson, chief scientist at the Utah Department of Health, told Deseret News: 'If this was happening in the summertime, it might have less of an impact on everything.

'But now that it's happening in the fall/winter, people are indoors, it's getting colder outside, there's more holidays.

'You're probably going to see an increase in cases for sure. Is that driven by HV.1? Is that driven solely by the seasonality, what time of year it is?

'No, it's probably a combination of all of those things... we've seen this now, year after year.'

Concerns have also been raised over the Covid variant JN.1, which is a mutated version of the strain BA.2.86, or 'Pirola', that scientists warned could spark a new wave of infections.

There have been 51 cases reported worldwide to date across 11 countries including the United States, the UK and Germany.

Some scientists fear this strain is more transmissible than others and could spark a new wave of infections.

Dr Oakeson described this mutant strain as 'alarming'.

'We're definitely watching it,' she said.

'I'm not sure I'm at the same level fo concern I was with BA.2.86 just because this one is a descendent of those and we didn't see that take off in the US like it did in other parts of the world.'

https://www.dailymail.co.uk/health/article-12693085/HV1-new-covid-variant-covid19-know.html

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Government’s Overreach During COVID-19 Is a Likely Contributor to Waning Confidence in Vaccination

The University of Pennsylvania Annenberg Public Policy Center conducted a survey October 5-12, collecting answers from 1,500+ adults across America, and the results in some ways, are not surprising. For example, the number of Americans who believe that generally, Food and Drug Administration (FDA) approved vaccines are safe declined to 71% from the last survey number of 77% done April 2021. Are the numbers of American adults that don’t trust the FDA’s judgment growing? You bet. Now, 16% up from 9% in 2021, don’t believe approved vaccines are safe.

What’s behind this growing distrust of government, particularly in the realm of biomedical and health-related research?

The survey also asked questions about the antiparasitic and quite controversial drug ivermectin. Approved as a parasitic drug in the U.S., the FDA went into an information war against doctors that were prescribing the drug off-label for COVID-19. The agency emphasizes its use primarily for animals, but that’s not really true. It's used as much for humans when looking at programs such as the now 35-year Mectizan program where literally over a billion courses have been administered in tropical Africa to help humans fight off parasite-borne disease.

This media found evidence of improper behavior and of course, in a lawsuit a judicial decision concurred.

The number that believes it's safer to get the vaccines versus succumbing to COVID-19 infection has dropped to lower than two-thirds, down from 77% in November 2021.

But the government, in this case the nation’s public health agency, the Centers for Disease Control and Prevention (CDC), tells us the best way to prevent the disease from causing hospitalizations and deaths is to get the COVID-19 vaccine. But does the government legitimately address many concerns we have about safety signals, for example? Do they help us come up with the individual risk-benefit analysis we need?

So, it's a confusing time. In this case, to have any legitimacy from a broader corporate/government ecosystem, a news outlet must declare exactly what government authorities declare as the exact truth: There can be no deviation. That’s why all trade press following the world of pharmaceutical research such as STAT followed this party line, not daring to question any underlying elements of the formal promulgated narratives.

For example, a news platform seeking full credibility must declare, therefore, that the FDA approved antiparasitic ivermectin is not a safe and effective way for treating COVID-19. Of course, when looked at from a narrow lens of the established narrative, this is of course, true--under the regulatory apparatus empowered for making such calls in the United States.

But during the pandemic, especially earlier in the crisis, ivermectin was used extensively in dozens of nations, often as part of a combination regimen including doxycycline and zinc. C19ivm.org has tracked the number of ivermectin studies involving COVID-19 during the pandemic. While the administrators remain anonymous, which TrialSite suggests was a mistake (they likely did so to keep their employment in academic medical centers or industry), the data is accurate in every case we have checked.

To date, the website reports over 99 studies involving 1,089 scientists, 137,255 patients in 28 counties that generated quite a bit of data showing that the regimen can statistically lower risk for mortality, ventilation, ICU, hospitalization, recovery cases and viral clearance. See the link.

And we can emphatically declare this media, TrialSite, was the first one to systematically track the study output of this drug in the context of the novel coronavirus, plus real-world usage during the pandemic. We have had prominent advocates for use of this drug such as Dr. Pierre Kory, co-founder of the Front Line COVID Critical Care (FLCCC) Alliance, tell us directly that we changed the course of the pandemic for the better. He and many others first learned about its use around the world on TrialSite News.

Of course, a handful of high-profile studies failed to show efficacy, and not surprisingly, those outcomes were fully embraced by mainstream media big time. We have had academic medical researchers look into those studies, and in a few of them raise serious questions which have not been answered.

We certainly sensed an agenda during the pandemic. The government exhibited a clear bias toward waiting for the vaccines and any branded pharmaceutical options. But from March 2020, to essentially the end of the year, there was nothing else. Doctors had to do something on the front lines.

While we cannot declare that across-the-board ivermectin represents a safe and effective treatment for COVID-19, we also cannot just make blanket statements that this would be false and misleading because of government agency or industry pressure.

The way the survey folks will understand it, even discussing ivermectin in the positive would be considered misinformation. But this is not true because there is some level of evidence that it has helped (Remember Uttar Pradesh as a prominent one). Real world scenarios were not documented in study form, and many of the ivermectin studies done around the world were not that well designed. So, we cannot be certain. But we remain open, like true scientists, to the unfolding stream of data. That’s how science is supposed to work.

We reported other glaring examples of industry bias during the pandemic such as with the ICAM protocol at a major Florida-based health system.

What appeared to be a lifesaving protocol involving blood thinners and steroids was quickly discarded after TrialSite reported the topic, gaining hundreds of thousands of views at that time. But due to an apparent contract Pfizer had the health system sign, the health system was forbidden from coming up with a repurposed regimen for COVID-19. It doesn’t matter if lives are saved or not. That policy was enforced by an industry adhesion-like contract, in a pandemic, designed to maximize profits in the worst emergency.

This is absolutely disgusting behavior, and another reason why trust is waning in our health-focused governing institutions. And frankly, while biased on this topic, I think it makes a case for the importance of TrialSite, a unique media and information service platform committed to translating complex biomedical and health research for broader audiences.

https://www.trialsitenews.com/a/governments-overreach-during-covid-19-is-a-likely-contributor-to-waning-confidence-in-vaccination-f221c9b6

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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Some Scientists, Journals Pose 'Potential Threats to Vaccine Confidence', says CDC

Scientists and journals that conduct and publish certain research pose a problem for the federal government's vaccination campaigns that should be addressed, U.S. Centers for Disease Control and Prevention (CDC) officials wrote in newly reviewed emails.

Colin Bernatzky, a public health analyst with the CDC's Immunization Services Division, in one of the missives flagged a paper from scientists in the United States and several other countries that analyzed the effects of repeated COVID-19 vaccination.

Vladimir Uversky, a molecular medicine expert in Florida, and his co-authors noted that experiments have found multiple doses of the Pfizer and Moderna COVID-19 vaccines lead to higher levels of antibodies called IgG4, making the immune system more susceptible.

"COVID-19 epidemiological studies cited in our work plus the failure of HIV, Malaria, and Pertussis vaccines constitute irrefutable evidence demonstrating that an increase in IgG4 levels impairs immune responses," Alberto Rubio Casillas, one of the co-authors, told The Epoch Times.

The paper was published following peer-review by Vaccines.

Mr. Bernatzky took issue with the paper and The Epoch Times' coverage of it despite acknowledging he wasn't sure about its veracity.

"At the very least, it seems like there's some editorial recklessness going on, especially since the net result is that this research is being viewed as legitimate and is circulating widely. (And if the research is in fact legitimate, it should be on CDC's radar)," he wrote.

About a week later, on July 7, Mr. Bernatzky provided colleagues with more information on what he described as "potential threats to vaccine confidence posed by select scientific journals and publishers."

The paper from Mr. Uversky and Mr. Casillas "has been accumulating a massive amount of attention," Mr. Bernatzky said, with a high attention score that was "undoubtedly driven" mostly by The Epoch Times article.

"Unfortunately, the Uversky paper is part of a wider pattern of academic journals conferring legitimacy to anti-vaccine claims through their willingness to publish low-quality work (e.g., reviews with lots of conjecture rather than original research) as well as their apparant reluctance to issue retractions or disclaimers when these issues are called to their attention," he added.

The CDC official noted that the paper was cited by Massachusetts Institute of Technology research scientist Stephanie Seneff and her co-authors in response to criticism of a paper they wrote that outlined concerns with how the vaccines impact the immune system.

The author list of that paper "turns out to be ... a squad of vaccine skeptics that includes Peter McCullough," Mr. Bernatzky said, referring to a U.S.-based cardiologist that has expressed concerns about the safety of the COVID-19 vaccines, "with a track record for promoting ideas about autism, vaccines, Roundup, etc."

Mr. Bernatzky suggested the "systemic issues" with certain scientists and publishers should be addressed, describing the matter as "complicated." He pointed out that a new paper by Dr. McCullough was published as a preprint by The Lancet but quickly removed, spurring criticism.

The email was circulated widely within the CDC, according to other missives obtained by The Epoch Times, with officials focusing on the paper by Mr. Uversky and Mr. Casillas and its conclusions.

"Apparently it's gone viral," Sarah Meyer, another CDC official, said while sharing the email with a colleague. She said she also sent the concerns to the CDC's Coronavirus and Other Respiratory Viruses Division.

Karen Broder, the colleague, forwarded the email to Drs. Tom Shimabukuro and John Su, two top CDC vaccine safety officials.
None of the CDC officials, including Mr. Bernatzky, responded to inquiries. A CDC spokesman declined to comment.

Mr. Bernatzky has sociology degrees and has written that the "anti-vaccine movement is arguably one of the more concerning social movements to have surfaced during the first two decades of the current century." He has also alleged that support for former President Donald Trump is linked to "hate material."

The CDC regularly publishes and promotes papers that have not been peer-reviewed in its quasi-journal, Morbidity and Mortality Weekly Report. In the full set of emails, which were obtained through the Freedom of Information Act, officials on multiple occasions used those papers to craft guidance to the public on COVID-19 vaccine safety.+

The journals Vaccines and Food and Chemical Toxicology, which the CDC singled out for criticism, did not return requests for comment.

Mr. Casillas, a doctor at Autlan Regional Hospital in Mexico, told The Epoch Times in an email that the CDC never contacted him and said the paper he helped put together "must be read and interpreted for what it is: a hypothesis."

"In our work, we developed a series of hypotheses about the possible consequences of a high concentration of IgG4 antibodies induced by repeated mRNA vaccination. It is important that health experts and the general public understand that we never categorically stated that, for example, such antibodies induce cancer. If you read our work, you will notice that throughout the article we used words that denote the nature of a hypothesis," he said.
Mr. Casillas said the CDC's criticism was unwarranted.

"Each of our proposals is based on previous research. They must be evaluated experimentally to be confirmed or refuted. It is the only way science can advance to obtain safer vaccines. We are aware that we may be wrong, but we do not accept that our work is criticized based solely on opinions," he wrote.

Ms. Seneff said that the paper from Mr. Casillas and his co-authors was "a very thorough review that reveals the complexity in the immune system's reaction to antigenic exposures, and examines the potential adverse consequences of the experimentally observed high levels of IgG4 antibodies induced by repeated vaccination with the SARS-CoV-2 mRNA vaccines."

She said that her view on the research into the IgG4 antibodies is that the antibodies are not protective and block other, protective antibodies. She also sees the elevated levels of IgG4 antibodies as linked to serious problems, including severe autoimmune disease.

"This paper is seminal, and it is not surprising that it has gone viral, due to its deep analysis of the significance of elevated IgG4 following mRNA booster shots," Ms. Seneff told The Epoch Times in an email. "I doubt that the mainstream position that these vaccines are safe and effective can survive much longer, even as they continue with aggressive efforts to retract the comprehensive review papers that reveal the true colors of these experimental therapies."

Dr. McCullough told The Epoch Times via email that the CDC and other health agencies would be better served holding open meetings "instead of emailing gossip between each other."

If they held the meetings, he said, officials "can hear directly from the nation's experts who learned how to treat acute ambulatory COVID-19 and who are now handling the tsunami of patients with COVID-19 vaccine injuries, disabilities, and deaths."

https://www.theepochtimes.com/health/exclusive-some-scientists-journals-pose-potential-threats-to-vaccine-confidence-cdc-5520947

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Lack of Informed Consent and Disabling Stroke after Pfizer mRNA Vaccination

It has been difficult for COVID-19 vaccinated Americans to process what has happened to their bodies. Public testimony by mRNA vaccine victims has been a relatable way of try to understand what has happened to our citizenry with a mass, indiscriminate COVID-19 vaccination campaign that failed on the informed consent process as reports of side effects poured into vaccine data systems.

On October 20, 2023, The Novel Coronavirus Southwestern Intergovernmental Committee convened a hearing to review new developments on the COVID-19 vaccine safety debacle and broader issues of informed consent which was highlighted by these words from Committee Chair, Senator Janae Shamp, who is a registered nurse. Be sure to listen to her opening remarks and play to through to heartwrenching story of media executive Ms Calli Varner.

Calli Varner, age 37, with Pfizer mRNA stroke with left face and body paralyzed. She was airlifted to a tertiary center and treated with thrombolytics in 2021

The 37 year-old woman gave her vignette of suffering a stroke after Pfizer, mRNA COVID-19 vaccination. This stroke was so serious she had to be airlifted to a tertiary center and receive thrombolytics (clot-busting drugs). Because the mRNA installed the genetic code for the Wuhan Spike protein, she then had the development of premature menopause, auto-immunity, and a rapidly growing thyroid nodule.

I told the committee and the audience in attendance, this could not have all been attributed to 15 years of oral contraceptive use as Calli’s doctors claimed. I cited medical literature that clearly demonstrate the COVID-19 vaccines cause stroke and doctors are willfully blind to the damaging effects of the vaccines.

LTC Dr. Pete Chambers stated that disabling vaccine injuries are happening to our soldiers. He implored people to have courage, speak out, and “stand in the gap” to warn others. That will be the only way to prevent more causalities.

https://www.trialsitenews.com/a/lack-of-informed-consent-and-disabling-stroke-after-pfizer-mrna-vaccination-3b0d0040

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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European Regulator Confirms Pfizer Did Not Highlight DNA Sequence in COVID-19 Vaccine

Pfizer did not highlight a DNA sequence in its COVID-19 vaccine, a European regulator has confirmed.

"While the full DNA sequence of the plasmid starting material was provided in the initial marketing authorization application for Comirnaty, the applicant did not specifically highlight the SV40 sequence," the European Medicines Agency (EMA) told The Epoch Times in an email.

The email came after Health Canada told The Epoch Times it expects sponsors to identify sequences such as the Simian Virus 40 (SV40) DNA enhancer but that Pfizer did not.

Pfizer and its partner, BioNTech, have not responded to requests for comment.

Pfizer did not highlight the inclusion of the enhancer in its vaccine because "it was considered to be a non-functional part of the plasmid," EMA said. "They have since clarified this information in response to questions raised by EMA."

The EMA said parts of the SV40 sequence are "commonly present in plasmids used for manufacturing of biological active substances," but neither authorities nor Pfizer have been able to say why the sequence was made part of the Pfizer shot.

Dr. Robert Malone, a vaccine expert whose work has been cited by Pfizer, told The Epoch Times "there is no reason" to include the sequence. He has urged U.S. regulators to recall the vaccine, but the regulators have declined.

Contested Claims

According to the EMA, the DNA sequences, including the SV40 sequence, are "broken down and removed" during the manufacturing process. "Fragments of the SV40 sequence may only be present as residual impurities at very low levels that are routinely controlled," the EMA claimed.

The agency did not provide any evidence to support the claim.

"The best independent estimates are 100-200B fragments of the plasmid exist in each dose," Kevin McKernan a microbiologist who first identified the sequence in the vaccine, told The Epoch Times in an email. "The EMA has offered no scientific evidence to make such a claim other than 'Trust our non-peer reviewed heavily redacted failure in transparency.'"

An EMA spokesperson said earlier this year that there was "no evidence to indicate the presence of SV40 ... in the formulation of COVID-19 vaccines."

The EMA is now acknowledging that statement was not correct.

But the regulator said it "has seen no evidence of an association between mRNA vaccines and adverse events that could be linked to the presence of DNA material, nor are we aware of any scientific evidence showing that the very small amounts of residual DNA that may be present in vaccine batches could integrate into the DNA of vaccinated individuals."

It also said, "we have not seen any reliable evidence of residual DNA exceeding approved/safe levels for" the Pfizer vaccine.

Dr. Malone said that the standards they're citing were not designed for the Pfizer and Moderna vaccines, which use modified messenger ribonucleic acid (RNA) technology.

"The safe threshold in the presence of these delivery complexes is something that must be established experimentally by performing genotoxicity studies," Dr. Malone said. "To say that just because we haven't detected it, or it's below the level that we normally accept with, say a flu vaccine, is completely irrelevant."

Fragments Act as Mutagens?

Some scientists say they're concerned because the DNA fragments could act as mutagens, or change the DNA sequence in a gene, even when taking into account how the SV40 sequence in the vaccine is not the cancer-causing large T antigen.
"The thing is that the smaller pieces actually could be very significant," David Wiseman, a former Johnson & Johnson scientist, told The Epoch Times. "They could actually get into your genome, potentially."

Mr. Wiseman was part of a team that recently detected levels of residual DNA in Pfizer's vaccine, as well as in Moderna's vaccine.

Patrick Provost, a professor in the Department of Microbiology, Infectious Diseases, and Immunology at the Faculty of Medicine at Laval University, told The Epoch Times that the danger of the SV40 enhancer being present in the vaccine is its possible integration into a cell's DNA genome.

"All it takes is a single integration at the wrong place in a single cell to initiate a cancerous process and kill a person," he said.

Responding to those concerns, the EMA said that "there is no scientific evidence that any of these SV40 fragments can act as insertional mutagens."

Dr. Malone said that was not true.

"Short DNA fragments and oligonucleotides are specifically used in modern biomedical research to experimentally alter the genomes of cells and embryos," he wrote in an email. "Such DNA fragments are well known to those skilled in the art to be useful for altering genomic information and genome integrity via both recombination and insertional mutagenesis."

Mr. McKernan, a former researcher and team leader for the Massachusetts Institute of Technology Human Genome Project, noted that scientists have found that SV40 sequences are optimal for gene therapy and that one paper described a rate of insertional mutagenesis with transfection being as high as 7 percent of the modified cells.

"Given the EMA waived all genotoxicity studies, their statement is nothing more than complicit wishful thinking," Mr. McKernan said.

https://www.theepochtimes.com/health/european-regulator-confirms-pfizer-did-not-highlight-dna-sequence-in-covid-19-vaccine-5519668?ea_src=au-frontpage&ea_med=top-news-editors-picks-0

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FDA Medicare SafeRx Study—Elevated Risks of Stroke Detected from conjuction of COVID-19 & Influenza Vaccines

Thanks to funding from the SafeRx Project, a joint initiative of the Centers for Medicare & Medicaid Services and the Food and Drug Administration (FDA), a group of authors employed at the FDA (the Agency) and a government contractor called Acumen LLC recently completed a self-control case series (SCCS) study tapping into a vast Medicare database (SafeRx). The mission is to investigate any risks of ischemic stroke associated with the COVID-19 vaccine.

This study was prompted by a concern expressed January 2023, by both the FDA itself and the Centers for Disease Control and Prevention (CDC) for an increased risk of ischemic strokes in adults aged 65 years and up after receiving the COVID-19 vaccine (bivalent targeting BA.4/BA.5); plus, the prospect of such a possibility involving the COVID-19 vaccine and concomitant high-dose/adjuvanted influenza vaccine.

This presented analysis tapped into and analyzed data from the Medicare fee-for-service (FFS) population aged ≥65 years. The agency-sponsored study team sought to estimate the risk of incident stroke following COVID-19 bivalent vaccines among Medicare beneficiaries. The study team evaluated stroke risk among age groups, following influenza vaccines, and following concomitant influenza and COVID-19 bivalent vaccine administration from August 31 to November 6, 2022.

While the primary analysis found no elevated risk, specific subgroup analyses identified elevated risk including A) increased risk for persons age 85 years and up for both non-hemorrhagic stroke (NHS)—another term for ischemic stroke, and transient ischemic attack (TIA) with the Pfizer bivalent COVID-19 bivalent vaccine as well as B) an increased risk for both NHS and TIA for those Medicare beneficiaries who received a concomitant COVID-19 bivalent vaccine and a high-dose/adjuvanted influenza vaccine (NHS with Pfizer and TIA Moderna).

Finally, C) the authors found upon completion of secondary analysis a small increased risk of NHS linked to the high-dose or adjuvanted influenza vaccines. While the FDA-sponsored investigation detected such elevated levels of risk, the authors remain steadfast as to the substantial benefits of vaccination, mindful of the risks associated with viral infection leading to an overall reaffirmation as to the safety of these medical products.

What’s the Concern?

The study authors herein address endpoints including the linking of the COVID-19 vaccine as well as influenza vaccine and ischemic stroke. Specifically identified are both the non-hemorrhagic stroke (NHS) and the transient ischemic attack (TIA).

An NHS or ischemic stroke is a type of stroke that occurs when blood flow to a part of the brain is blocked. This blockage can be caused by a blood clot or atherosclerosis, which is the narrowing and hardening of the arteries. Importantly, Ischemic or NHS are the most common type of stroke, accounting for over 80%.

A TIA is often called a “mini-stroke” and represents a medical condition that mimics the symptoms of a stroke but is temporary and does not cause permanent brain damage. These occur due to a brief interruption of blood flow to the brain.

A Robust Study

Led by agency veterans including Stephen Johnson, Ph.D., Director, Office of Biostatistics and Epidemiology, and Richard Forshee, Ph.D. Deputy Director Office of Biostatistics and Pharmacovigilance, the study team included vaccinated individuals’ data only, leaving them not subject to bias due to underreporting of vaccination status in the claims data. Also, Johnson, Forshee and colleagues claim they mitigated any misclassification bias by conducting medical record reviews of the claims-based NHS definition.

The study authors here report on numerous study strengths, such as a robust, large, representative Medicare database, with minimal beneficiary attrition, ensuring highly generalizable findings to the elderly U.S. population.

They also point to the ability of this self-controlled study design to adjust for time-invariant confounders such as health conditions, socio-economic status, and health-seeking behavior. Such factors can inherently bias a study, drawing from between-individual comparisons.

Results Summary

As reported in the preprint server medRxiv, a primary analysis failed to detect elevated stroke risk post-COVID-19 bivalent vaccination.

However, while slicing and dicing the data, including analyses involving subgroups, the study authors report that the cohort of ≥85 year associated with a risk of non-hemorrhagic stroke “(NHS) (Incident Rate Ratio (IRR)=1.36, 95% CI 1.09 – 1.69 [1-21 days]) and NHS/ transient ischemic attack (TIA) (IRR=1.28, 95% CI 1.08 – 1.52 [1-21 days]) with BNT162b2 Bivalent WT/OMI BA.4/BA.5.”

When analyzing the data associated with the Medicare beneficiaries “that received a concomitant COVID-19 bivalent vaccine and a high-dose/adjuvanted influenza vaccine, an increased risk was observed for NHS (IRR=1.20, 95% CI 1.01 – 1.42 [22-42 days]) with BNT162b2 Bivalent WT/OMI BA.4/BA.5 and for TIA (IRR=1.35, 95% CI 1.06 – 1.74 [1-21 days]) with mRNA-1273.222.”

The authors summarized that once completing their secondary analyses, they detected “a small increased risk of NHS following high-dose or adjuvanted influenza vaccines (IRR=1.09, 95% CI 1.02 – 1.17 [22-42 days]).”

https://www.trialsitenews.com/a/fda-medicare-saferx-studyelevated-risks-of-stroke-detected-linked-to-covid-19-influenza-vaccines-39e3ef01

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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Disastrous Covid vaccination campaign in Poland

Poland’s National Audit Office known as “NIK” has identified a substantial surplus of COVID -19 vaccines due to lack of demand. The nation had contracted for a full vaccination rate multiple times over, yet the national office reports vaccination rate decline. Consequently, 13.1 million doses were allowed to expire and then exposed by the end of 2022, representing PLN 1 billion (US$237.7 million). In total, Poland spent 13.9 billion PLN (US$3.3 billion) for this nation of only 37.7 million people. TrialSite reminds that this was one of the few media to cover Poland’s attempt to renegotiate the COVID-19 vaccine contract with Pfizer due to the impact of the Russian invasion of Ukraine. Pfizer refused to budge. What follows is what in reality is a damning report from the NIK as to what appears to be an unfolding scandal in the aftermath of the COVID-19 response.

The NIK reports the effort to sell, transfer or donate the COVID-19 vaccines to mitigate the effects of the excess. By 31 December 2022, the Governmental Strategic Reserves Agency (RARS) provided to other countries over PLN 27.6 million vaccine doses with an estimated value of PLN 1.4 billion or (US$333.3 million).

A Great & Deadly ‘Health Debt’ Caused by COVID-19 Response
The NIK has gone on record that the COVID-19 response caused significant disruptions in the healthcare provision. Above all, a great part of the healthcare system resources was “relocated” to control the epidemic. That resulted in shrinking access to treatment for a broad group of patients, diagnosed with diseases other than COVID-19. Hence, the so-called health debt was growing (that was a situation where the failure to provide a medical service may lead to a disease development or its worsening).

Excess Deaths during the Pandemic—Despite the Vaccine
In 2020-2021, an increased number of deaths was reported, as compared with the average of 2015?2019. In 2020, there were over 85 thousand more of them, including about 56.5 thousand deaths for reasons other than COVID-19. And in the first half of 2021, excess deaths against the number of deaths reported a year before totaled nearly 61 thousand. But what about the COVID-19 mass vaccination response?

In fact, the COVID-19 universal vaccination countermeasure was supposed to help prevent those negative phenomena. The vaccination did not succeed despite many claims that the vaccines saved millions of lives. TrialSite has reviewed dozens of observational studies suggesting that the vaccines have reduced morbidity and mortality but the nature of these studies are such that this does not prove causation.

NIK points out in line with the assumptions the vaccines should have ensured a “return to normal.” While also serving to “unblock” the healthcare system, particularly for patients with diseases other than COVID-19. As NIK declares in a recent media entry a direct objective in the COVID-19 National Vaccination System was:

to reduce the number of deaths and complications caused by the SARS-CoV-2, particularly in elderly persons,

to reduce the population “health debt” growth.

In 2021-2023, NIK conducted a range of ad hoc audits to establish if the objectives of the COVID-10 National Vaccination Programme were achieved and how. NIK carried out five audits to look into the Programme execution which cost about PLN 17 billion (US$4.05 billion).

The NIK audit revealed that:

The Minister of Health improperly estimated needs related to the purchase of an adequate number of COVID-19 vaccine doses (meaning that the Ministry ordered more doses than they needed to, which of course meant more taxpayer dollars to the pharmaceutical companies).

Poland did not have to enter into agreements - questioned by NIK - to purchase COVID-19 vaccines. The Minister of Health did not use that right.

Estimating demand

It needs to be underlined that no documents were presented showing how the number of vaccine doses, needed to satisfy the demand of Polish citizens, were estimated. There was no basis, no rationalization used to justify the large spend.

From May 2021, subsequent vaccine doses were contracted for, although Poland was bound with contracts enabling the vaccination of the entire population several times (109 million doses were contracted for at the end of April 2021).

Even assuming that every adult person in Poland, i.e., about 31 million individuals, received the third vaccine dose, the demand would be at the level of 93 million doses, i.e., lower than the number of doses contracted for before May 2021.

What did the Health Ministry Know?

Interestingly, what did the Polish Ministry of Health know about the COVID-19 pandemic that informed them to estimate such demand?

NIK reports that the Minister of Health formulated a thesis that prior to the execution of agreements indicated as improper, there were signals that vaccine boosters every 6 months are necessary to maintain the immunological response at an adequately high level. The thesis is not only unconfirmed by the evidence gathered in the audit but also it does not reflect the opinions of specialized EU institutions taking efforts to control the COVID-19 epidemic.

On 31 May 2021, the Minister of Health addressed the EU Health Commissioner concerning the vaccines purchased, pointing to the hazard of huge vaccine surplus in Europe and the need for coordinated cooperation to start talks with individual manufacturers to reduce the volumes of vaccine orders.

NIK emphasizes that the Health Ministry could have been culpable in questionably intentioned pursuits.

“It needs to be stressed that the Minister stated that the epidemiological situation is about to stabilise and pointed to the “hazard” of significant surpluses of the COVID-19 vaccines, only 11 days after signing the third agreement with Pfizer/BioNTech. It points to complete inconsistency of the Minister’s actions. According to NIK those measures were unreliable and wasteful.”

Poland’s COVID-19 Vax Contracts

As reported by the NIK, the Republic of Poland acquired the COVID-19 vaccines as part of the Agreement on the joint mechanism for the COVID-19 vaccine purchase.

The Agreement authorized the European Commission to negotiate and conclude vaccine purchase contracts, on behalf of the EU Member States. Remember, TrialSite reported on how at least part of the EC negotiation was done via private personal text between Pfizer’s CEO Albert Bourla and Commission President Ursula von der Leyen. The situation is so egregious that even the New York Times has sued the EC to get to the bottom of this possible scandal.

NIK reports that the EC as an entity took responsibility for the contracts’ content, including the principles of sharing vaccines among the EU Member States, the pool of vaccines covered by the contract, their prices and delivery dates.

The EC notified the EU member states of the former’s intention to sign the deal, and the reality that the latter had no rights to modify. NIK does inform that member states were notified that they did have the option to withdraw from the vaccine purchase contract. It was a take it or leave it deal.

NIK informs the world now that in the vaccine purchasing process two types of contracts were used: 1) contracts defining the right to purchase vaccine doses and 2) contracts defining the obligation to purchase them.

First, NIK notes that participating EU Member States were not obliged to sign that contract. With the second contractual model, the EC was obliged to inform the EU Member States about the intention to sign the contract with an obligation to purchase the vaccine doses, also defining its signing conditions. Again, Member States had not input.

NIK cites the problems with the contractual scheme as devised:

“All the contracts negatively evaluated by NIK were contracts defining the obligation to purchase COVID-19 vaccines. The states that did not agree to sign that contract or its conditions had 5 days to withdraw from the contract or declare a number of vaccines other than set out in the contract (the so-called “opt-out clause”).

NIK points out in their media entry “The opt-out clause required consent of partner states, in cooperation with the EC, to accept extra doses or to give away appurtenant doses.”

Outrageous: 117.6K Hazardous COVID-19 Vax Doses Administered to Polish Population

TrialSite also learned about this scandal in the recent NIK media piece, under the section “Supervision of the Chief Pharmaceutical Inspectorate (GIF) over the COVID-19 National Vaccination Programme.”

NIK added in its report the state’s negative evaluation supervision exercised by the Chief Pharmaceutical Inspector over the vaccine storage and distribution. The body responsible for pharmaceutical safety of the state, obliged with “special supervision”, did not know in which warehouses the vaccines were stored. This NIK reports, “The relevant information was taken from the media,” meaning the nation state had no control over the pharmaceutical product within its borders.

The Polish government found defects, yet as the government itself via the NIK reports, “GIF failed to take efforts to withdraw part of vaccines, in which some quality defects were found, also the ones posing a threat to health and life. In consequence, 117.6 thousand hazardous vaccine doses were administered to patients.”

Distribution and storage of vaccines

According to the NIK audits, 17 pharmaceutical warehouses were involved in the process of the COVID-19 vaccine distribution and storage. In the audited period, GIF carried out only two inspections in one of pharmaceutical warehouses taking part in the COVID-19 vaccine distribution.

“A lot of critical irregularities were identified, e.g., the vaccine storage conditions in special rooms or the vaccine transport from the Governmental Strategic Reserves Agency (RARS) were not registered. Also, the product safety was not provided during vaccine storage in that warehouse.”

NIK reports an alternative inspection targeting the same supply pointed to a scandalous takeaway: the “distribution process does not guarantee the safety of vaccines in terms of their quality maintenance.”

While European GIF inspectors were in fact, cognizant of the discovered irregularities adversely impacting COVID-19 vaccine safety and effectiveness, they carried out no inspections in the remaining 16 warehouses.

Consequently, Poland’s national auditor points out how the Minister of Health was culpable in an unfolding scheme:

“The Minister of Health had a significant, adverse impact on the effectiveness of actions taken by GIF. He made the following statement which was contrary to the applicable law:

the distribution of COVID-19 vaccines is not the trade in medicinal products, in the light of the Pharmaceutical Law Act, and hence,

the trade in vaccines may not be monitored via the Integrated System for Monitoring the Trade in Medicinal Products (ZSMOPL).”

Poland’s Minister of Health essentially blocked and tackled on behalf of what appears to be some kind of cabal consisting of EC bureaucrats, industry and perhaps other high placed persons. After all, thanks to the Minister’s efforts “pharmaceutical warehouses were freed from the obligation to report vaccine stock availability on a daily basis. Hence, GIF could not monitor the trade in those vaccines. The Inspectorate drew its knowledge about the COVID-19 vaccine warehouses from the media.” This unfolding scenario could only be considered an utter and complete scandal.

Risking Patient Safety

TrialSite reminds all that national health authorities exist to ensure the safety and welfare of the population, not to further endanger them.

Yet Poland’s own auditors report that “The decision of the Minister of Health not to use the monitoring system also had a negative impact on the safety of patients.”

The NIK informs the world:

“In two cases, GIF did not decide to withdraw from the market a series of vaccines, although the Inspectorate was aware of their quality defects. GIF could not withdraw the vaccines, because their distribution was not subject to the Pharmaceutical Law Act – in line with the interpretation of the Minister of Health, and so GIF had no legal grounds to withdraw them from the market. Besides, the Inspectorate did not know in which warehouses the defective vaccines were found.”

Vaccine quality defects

GIF received eight reports of actual or alleged quality defects of the COVID-19 vaccines, of which two were of significant importance, reports the NIK media entry.

Additional Notes

On 23 April 2021, the Chief Pharmaceutical Inspectorate received information in the Rapid Alert system from the European Medicines Agency, about a possible quality defect in one of the COVID-19 vaccine series, already used in Polish patients. The report dealt with the suspicion of a 2nd class defect, that is the one that could cause an illness or improper effects. GIF failed to issue a decision to withhold or withdraw that vaccine series from the market.

Meanwhile, in April 2022 the Federal Agency for Medicinal and Health Products in Belgium informed GIF about withdrawing that series from the market. Having received the report, GIF provided the relevant information to RARS, requesting the Agency to take action to identify distribution channels and inform recipients about the situation. The efforts were pointless, though, because the entire vaccine series was already administered to patients

the quality defect of the vaccine series was reported on 7 April 2022 by the Spanish Agency of Medicines and Medical Products (AEMPS).

In the second case The vaccine quality defect could pose a threat to patients’ health and life (1st class defect), which obliged GIF to withdraw the defective product from the market.

Summary of Breaches Risking Patient Health

Summarizing this scandal, NIK reports that “In both cases, GIF not only failed to withdraw the vaccine series from the market but also did not know where they can be found.”

Having received the report, information was passed on to RARS with a request to identify distribution channels and notify recipients about the situation. The Chief Pharmaceutical Inspector explained that in the light of the Minister of Health’s interpretation, the decision to withdraw the vaccine could not be issued for the product that is not in the market. That information was also provided to RARS.

The government's vaccination commissioner

The Chancellery of the Prime Minister and the Government Commissioner for the National Vaccination Programme dealt mainly with conducting campaigns encouraging Polish people to vaccinate. Over PLN 155 million (US$36.9 million) was spent in pursuit of that aim.

In parallel, no definitions were established to determine the effects of this initiative. How could they know what success is?

While the Commissioner according to the NIK had an obligation to analyze the relevant activated legislation as well as existing solutions as they relate to prophylactic vaccinations, the office failed to do so whatsoever. The Commissioner simply deferred to analyses promulgated by the Minister of Health. This is truly problematic.

The Commissioner was also obliged to prepare proposals of new legal solutions and initiatives in terms of the COVID-10 National Vaccination Programme.

“In view of the above, according to NIK, it was unjustified to appoint a vaccination commissioner, whose tasks could be discharged by the existing state bodies.”

In performing his tasks, particularly in drafting changes to resolutions on the National Vaccination Programme, the vaccination commissioner drew on the information and knowledge of the Government Analysis Centre, the Ministry of Health, the National Health Fund, the e-Health Centre, the Government Security Centre or the Chief Sanitary Inspector.

After the vaccination commissioner’s office was lifted, the Programme supervision was entrusted to the Minister of Health, meaning a complete takeover, clearing the pathway for the exact COVID-19 countermeasure execution NIK founds so many troubles with.

https://www.trialsitenews.com/a/polands-national-auditor-condemning-covid-19-report-ec-response-a-scandal-quality-chucked-vax-injury-a-certainty-e9ae0c03

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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