Friday, February 03, 2023

Immune Exhaustion Emerges After 3rd Vaccine Dose: Current Findings

Vaccines have been upheld as the best strategy for dealing with infectious diseases, but that’s largely because of a limited understanding of the immune system and how to best complement and support its function. Our bodies are normally able to separate the wheat from the chaff when it comes to invading pathogens or when a vaccine stimulates an immune reaction, but there are factors that can compromise that.

A study published in Science Immunology in January 2023 (but first submitted in August 2022) shows that incremental doses of the mRNA COVID-19 vaccine boosters may be one such factor, based on how they train our immune systems. In this case, the immune system seemed to gain a false sense of security from dealing with the booster version of the vaccine, which is supposed to teach the immune system how to deal with the virus. Unfortunately, in this case, it seemed that the immune system has learned that it doesn’t need to mount a strong counterattack. Worse, the vaccine boosters might not even induce any effect in people at high risk of severe infection.

IgG Subtype Composition Changed After Vaccination
According to the study, the third dose of the mRNA vaccines seems to be linked with a class switch in subtypes of immunoglobulin G (IgG), the dominating serum antibody in our immune system, which raises the question of immune exhaustion. Class switching is when B cells redirect their efforts toward producing IgG. To start, they produce generic immunoglobulin cells such as IgM. But once they find that the invading pathogen is tougher than they thought, they switch to producing the more effective IgG to ward off the infection.

IgG is an important serum antibody that makes up roughly 80 percent of all antibodies in our immune system. After class switching occurs, B cells release different types of IgG instead of other less-effective immunoglobulin cells. Depending on the severity of the infection, the ratio of IgG may also vary.

IgG is the more effective fighter in our immune system, as it has the ability to opsonize and fixate complements, meaning that it attaches to infected cells or pathogens and instructs killer cells to swallow intruders up through phagocytosis. It’s also the only antibody that crosses into the placenta, playing a critical role in protecting the unborn fetus.

However, IgG is split up into four major subtypes—denoted IgG1 through IgG4—and each has its own strengths and limitations.

Out of all four, IgG1 makes up most of serum IgG, as it has the best immune properties. Along with IgG3, these two are the most potent members of the IgG family.

IgG4 is considered one of the weakest types, as it doesn’t do as well in attracting immune cells responsible for eliminating invaders.

Research shows that IgG4 composition usually hovers at about 4 percent, a number matched by the aforementioned study for patients after five months of receiving the second dose of vaccine.

Right after the second dose, IgG4 levels were at 0.04 percent while IgG1 and IgG3—the most potent members in the IgG family—made up 96.55 percent of all IgG, according to the aforementioned Science Immunology paper.

This change in IgG levels indicates that the body interprets the second dose as a serious infection and produces the more effective IgG to tackle the simulated infection. However, things look a little different after the vaccine booster shot.

In the study, the percentage of IgG4 in the blood serum rose to unexpectedly high levels after the third dose. Ten days after the third vaccination, IgG4 levels rose to 13.91 percent and jumped to 19.27 percent five months after. At the same time, IgG1 and IgG3 levels both dropped, showing a significant change in blood serum antibody composition.

This isn’t good, as higher levels of IgG4, without the ability to stimulate immune cells, could indicate immune exhaustion. It’s also an indication that the immune system intentionally dampened the response starting with the third dose of the vaccination.

On the other hand, although IgG3 and IgG1 contribute the most to immune mechanisms, the downside is that they’re costly to produce and can quickly wear out the body. In contrast, IgG4 isn’t as effective but it’s more economical to produce.

The immune system will always place warding off outside intruders at the top of its to-do list while keeping efficiency in mind. This is why the amount of each IgG subtype produced varies with each infection.

In the Science Immunology study, high IgG4 levels after the third dose, even a long time after it, indicate that the immune system is being worn out through the repeated vaccination course. The body treats the third dose with more indifference and deploys the less effective IgG4 in response.

This development of more IgG4 than usual is unhealthy and riskier for people if they encounter the real virus later, as COVID-19 can develop into a rather severe disease, especially for people with chronic conditions. If the body begins to treat the SARS-CoV-2 vaccine like a boy crying wolf, then what if the real virus comes knocking at the door?

The vaccine is meant to train the immune system’s memory cells so that the next time something similar comes along, they know how to quickly defend the immune system. This process is also called antibody acquisition. The aforementioned study demonstrates that the body stops regarding COVID-19 as a serious viral infection after the vaccine booster shot. However, in some people, the boosters actually have no effect at all.

One group of people who might gain the least from vaccination seems to include those who are immunocompromised, such as organ transplant recipients—people who regularly take immunosuppressants as a part of post-operational procedures.

A study published in Nature shows that antibody acquisition rates against COVID-19 were “extremely low” in kidney transplant patients. This finding contradicts the purpose of the vaccine, as it’s meant to induce antibody acquisition.

Similar reports have also surfaced elsewhere, especially in regard to newer variants of COVID-19. An observational study claiming to be the largest when analyzing four-dose vaccinated organ transplant recipients shows that the mRNA vaccine booster demonstrates a “lack of formal neutralization” against “variants of concern including Omicron.”

Data published by Elsevier also shows that antibody neutralization against the Omicron coronavirus variant has seen a 15- to 20-fold reduction when compared with the wild-type virus in transplant recipients. These findings are of grave concern.

The U.S. Centers for Disease Control and Prevention still recommends that immunocompromised people receive a COVID-19 vaccine, as well as get their vaccine boosters.

According to data published in the medical journal Transplantation, during the recent Omicron wave, although COVID-19 cases have increased for organ transplant recipients, the death rate of this population has dropped fivefold.

However, is this reduction due to repeated vaccination or to the reduced pathogenicity of Omicron variants? Is it really effective to drive vaccination campaigns for the immunocompromised, based on the trifling level of antibody acquisition? Can the benefits of repetitive boosting outweigh the increased risk of side effects?

It’s really time to reconsider what place the COVID-19 vaccines should take. Are we underestimating the wisdom of our immune system? This stance is similar to that taken in a previous article that mentions how “negative efficacy” should have stopped vaccine recommendations in their tracks.

Now, researchers are saying that vaccines, especially boosters, fail to have a significant effect on the immunocompromised—the very group of people especially susceptible to severe disease and death. We need to stop placing the mRNA shots on a pedestal and consider all options in response to SARS-CoV-2, such as focusing on bolstering our natural immune system and holistic well-being.


Countries with the longest life expectancies revealed in interactive map... and neither Britain or the US are in the top 30

Given its nickname of the 'billionaire's playground', chances are you'll know about the lavish luxury on offer in Monaco.

But did you know the principality, famously so wealthy it doesn't bother tracking poverty rates, also has the world's highest life expectancy? Babies born today in the 40,000-strong nation, sandwiched on the south coast of France, have a life expectancy of 85.9 years, data suggests.

In contrast, the Republic of Chad, a country at the crossroads of north and central Africa, ranks bottom of the world's league table.

The 10 countries with the LONGEST life expectancy

Monaco - 85.9 years
Hong Kong - 85.5 years
Macao - 85.4 years
Japan - 84.8 years
Australia - 84.5 years
Switzerland - 84 years
Malta - 83.8 years
South Korea - 83.7 years
Liechtenstein - 83.3 years
Norway - 83.2 years

The African country, one of the world's poorest countries, has a life expectancy of just 52.5 years.

In fact, all 10 countries with the shortest life expectancy are in Africa, with Chad followed by Nigeria, Lesotho, Central African Republic, South Sudan, Somalia, Eswatini, Cote d'Ivoire, Guinea and Mali. None are above 60.

Neither the UK or the US made it into the top 30, according to the league table.

The UK has a life expectancy of 80.7 years, putting it in 34th place. And the US comes in far lower at 69th, with a life expectancy of just 77.2 years.

Life expectancies have extended drastically across the world over the past few decades thanks to medical advances.




Thursday, February 02, 2023

The Deceptive Campaign for Bivalent Covid Boosters

You might have heard a radio advertisement warning that if you’ve had Covid, you could get it again and experience even worse symptoms. The message, sponsored by the Health and Human Services Department, claims that updated bivalent vaccines will improve your protection.

This is deceptive advertising. But the public-health establishment’s praise for the bivalent shots shouldn’t come as a surprise. Federal agencies took the unprecedented step of ordering vaccine makers to produce them and recommending them without data supporting their safety or efficacy.

The idea of updating mRNA Covid shots every season originally held promise. One advantage of mRNA technology is that manufacturers can tweak the genetic sequence and rapidly produce new vaccines targeting new variants. Hence the bivalent boosters targeting the BA.4 and BA.5 Omicron variants along with the original Wuhan strain.

But three scientific problems have arisen. First, the virus is evolving much faster than the vaccines can be updated. Second, vaccines have hardwired our immune systems to respond to the original Wuhan strain, so we churn out fewer antibodies that neutralise variants targeted by updated vaccines. Third, antibodies rapidly wane after a few months.

Two studies in the New England Journal of Medicine this month showed that bivalent boosters increase neutralising antibodies against the BA.4 and BA.5 variants, but not significantly more than the original boosters. In one study, antibody levels after the bivalent boosters were 11 times as high against the Wuhan variant as BA.5.

The authors posit that immune imprinting “may pose a greater challenge than is currently appreciated for inducing robust immunity against SARS-CoV-2 variants.” This isn’t unique to Covid or mRNA vaccines, though boosters may amplify the effect. Our first exposure as children to the flu — whether by infection or vaccination — affects our future response to different strains.

The original Covid vaccines and boosters trained our memory B-cells to produce antibodies against the Wuhan variant. As the University of Pennsylvania’s Paul Offit explains in a New England Journal of Medicine article, previously vaccinated people who received the bivalent booster were “primed” to respond to the Wuhan strain and mounted an inferior antibody response to other variants.

The studies’ findings contradict November press releases from Pfizer and Moderna asserting that their bivalents produced a response to the BA.4 and BA.5 variants four to six times that of the original boosters. These claims are misleading. Neither vaccine maker conducted a randomised trial. They tested the original boosters last winter, long before the BA. 5 surge and 4½ to months after trial participants had received their third shots. The bivalents, by contrast, were tested after BA.5 began to surge, 9½ to 11 months after recipients had received their third shots.

A longer interval between shots would increase the antibody boost to the BA. 5 variant. So would a prior infection with the BA.5 variant. In other words, people who received the bivalent boosters in August would have been primed to produce more antibodies in response to BA.5.

The vaccine makers designed their studies to get the results they wanted. Public-health authorities didn’t raise an eyebrow, but why would they? They have a vested interest in promoting the bivalents.

The Food and Drug Administration ordered the vaccine makers in June to update the boosters against BA.4 and BA.5 and rushed in late August to authorise the bivalents before clinical data were available. The Centers for Disease Control and Prevention recommended the bivalents for all adults without any evidence that they were effective or needed.

Vaccine makers could have performed small randomised trials last summer and early fall that tested the bivalents against the original boosters and a placebo group. Results could have been available by the end of September. But the public-health authorities didn’t want to wait — and now we know why.

The CDC published a study in November that estimated the bivalents were only 22% to 43% effective against infection during the BA.5 wave — their peak efficacy. As antibodies waned and new variants took over later in the fall, their protection against infection probably dropped to zero.

Another CDC study, in December, reported that seniors who received bivalents were 84% less likely to be hospitalised than the unvaccinated, and 73% less likely than those who had received two or more doses of the original vaccine. But neither study controlled for important confounding factors — for one, that the small minority who got bivalents were probably also more likely than those who hadn’t to follow other Covid precautions or seek out treatments such as Paxlovid.

FDA Commissioner Robert Califf tweeted on Jan. 11 that “COVID-19 vaccines have been associated with a significant reduction in hospitalisation and death” (my emphasis). He should know that correlation doesn’t prove causation. A study found the unvaccinated were significantly more likely to get into car accidents, but that doesn’t mean vaccines prevent crashes.

Many of the same experts who trashed observational studies supporting hydroxychloroquine and ivermectin now flog intrinsically flawed studies on bivalent boosters. After zealously promoting the bivalents, they may be seeking vindication. But science isn’t about vindication.

Covid vaccines mitigated severe illness while most Americans gained immunity through natural infection, which substantially boosts protection. There’s a growing consensus that we need better vaccines and treatments to protect those still at risk. But we also need honest public health leaders.


California's Medical Misinformation Law Struck Down

So far, California has shown to be turning an even deeper corner in 2023. On January 1, several far-left laws went into effect. The state also made headlines last week, as Matt covered, for its new tax policies. There has, however, been some relief. Perhaps one of those most worrisome laws mentioned above included a law that punished physicians for so-called medical misinformation about COVID-19, which was blocked late last week.

According to a report from Reuters' Brendan Pierson:

Senior U.S. District Judge William Shubb in Sacramento ruled on Wednesday that Assembly Bill 2098, which was signed last October by California Governor Gavin Newsom, a Democrat, was too vague for doctors to know what kind of statements might put them at risk of being penalized."COVID-19 is a quickly evolving area of science that in many aspects eludes consensus," he wrote.

The preliminary order means that the law cannot be enforced while Shubb hears two lawsuits brought against the law shortly after its passage last year - one by a group of five doctors, and another by a doctor and two advocacy groups including Robert F. Kennedy Jr's Children's Health Defense, which has long promoted false information about standard childhood vaccines.

The law, known as Assembly Bill 2098, which was signed into law last October, required medical licensing boards in the state to take disciplinary action against physicians who were involved in so-called "dissemination or misinformation or disinformation" related to COVID-19.

Doctors found violating the law wouldn't just be faced with a slap on the wrist. A report from The New York Time's Steven Lee Myers noted that expanding medical licensing boards in such a way "could lead to a suspension or revocation of a doctor’s license to practice in the state."

As Pierson's report mentioned, that misinformation was defined as "false information that is contradicted by contemporary scientific consensus contrary to the standard of care."

The law certainly had chilling effects on free speech, as Jacob Sullum highlighted in a column from last November, but it also did not provide enough clarity as to what could get doctors into trouble.

Pierson’s report also added statements from those blasting this aspect of the law:

"This Act is a blatant attempt to silence doctors whose views, though based on thorough scientific research, deviate from the government-approved 'party line,'" said Greg Dolin of the New Civil Liberties Alliance, a lawyer for the doctors, in a statement. "At no point has the State of California been able to articulate the line between permissible and impermissible speech."

The doctors said in their lawsuit that the law gave them no way to know what was "contemporary scientific consensus," and violated their right to free speech under the First Amendment of the U.S. Constitution.

The American Civil Liberties Union filed briefs supporting the plaintiffs in both cases, saying that while the state did have the power to punish doctors for spreading harmful false information, AB 2098 was a "blunt instrument" that went too far.

Senior U.S. District Judge William Shubb granted a preliminary junction on the law, which is blocked while he considers lawsuits challenging it on free speech grounds




Wednesday, February 01, 2023

Growing Number of Doctors Say They Won’t Get COVID-19 Booster Shots

A growing number of doctors say that they will not get COVID-19 vaccine boosters, citing a lack of clinical trial evidence.

“I have taken my last COVID vaccine without RCT level evidence it will reduce my risk of severe disease,” Dr. Todd Lee, an infectious disease expert at McGill University, wrote on Twitter.

Lee was pointing to the lack of randomized clinical trial (RCT) results for the updated boosters, which were cleared in the United States and Canada in the fall of 2022 primarily based on data from experiments with mice.

Lee, who has received three vaccine doses, noted that he was infected with the Omicron virus variant—the vaccines provide little protection against infection—and described himself as a healthy male in his 40s.

Dr. Vinay Prasad, a professor of epidemiology and biostatics at the University of California, San Francisco, also said he wouldn’t take any additional shots until clinical trial data become available.

“I took at least 1 dose against my will. It was unethical and scientifically bankrupt,” he said.

Allison Krug, an epidemiologist who co-authored a study that found teenage boys were more likely to suffer heart inflammation after COVID-19 vaccination than COVID-19 infection, recounted explaining to her doctor why she was refusing a booster and said her doctor agreed with her position.

She called on people to “join the movement to demand appropriate evidence,” pointing to a blog post from Prasad.

“Pay close attention to note this isn’t anti-vaccine sentiment. This is ‘provide [hard] evidence of benefit to justify ongoing use’ which is very different. It is only fair for a 30 billion dollar a year product given to hundreds of millions,” Lee said.

Dr. Mark Silverberg, who founded the Toronto Immune and Digestive Health Institute; Kevin Bass, a medical student; and Dr. Tracy Høeg, an epidemiologist at the University of California, San Francisco, joined Lee and Prasad in stating their opposition to more boosters, at least for now.

Høeg said she did not need clinical trials to know she’s not getting any boosters after receiving a two-dose primary series, adding that she took the second dose “against my will.”

“I also had an adverse reaction to dose 1 moderna and, if I could do it again, I would not have had any covid vaccines,” she said on Twitter. “I was glad my parents in their 70s could get covid vaccinated but have yet to see non-confounded data to advise them about the bivalent booster. I would have liked to see an RCT for the bivalent for people their age and for adults with health conditions that put them at risk.”

The U.S. Food and Drug Administration (FDA) granted emergency use authorization to updated boosters, or bivalent shots, from Pfizer and Moderna in August 2022 despite there being no human data.

Observational data suggests the boosters provide little protection against infection and solid shielding against severe illness, at least initially.

Five months after the authorization was granted, no clinical trial data has been made available for the bivalents, which target the Wuhan strain as well as the BA.4 and BA.5 subvariants of Omicron. Moderna presented efficacy estimates for a different bivalent, which has never been used in the United States, during a recent meeting. The company estimated the booster increased protection against infection by just 10 percent.

The FDA is preparing to order all Pfizer and Moderna COVID-19 vaccines be replaced with the bivalents. The U.S. Centers for Disease Control and Prevention, which issues recommendations on vaccines, continues advising virtually all Americans to get a primary series and multiple boosters.

Professor Calls for Halt to Messenger RNA Vaccines
A professor, meanwhile, became the latest to call for a halt to the Pfizer and Moderna vaccines, which are both based on messenger RNA technology.

“At this point in time, all COVID mRNA vaccination program[s] should stop immediately,” Retsef Levi, a professor of operations management at the Massachusetts Institute of Technology, said in a video statement. “They should stop because they completely failed to fulfill any of their advertised promise[s] regarding efficacy. And more importantly, they should stop because of the mounting and indisputable evidence that they cause unprecedented level of harm, including the death of young people and children.”

Levi was referring to post-vaccination heart inflammation, or myocarditis. The condition is one of the few that authorities have acknowledged is caused by the messenger RNA vaccines.

Pfizer and Moderna have not responded to requests for comment.


CDC Acknowledges Overcounting COVID-19 Hospitalizations

Which makes Covid sound worse than it is

The U.S. government overcounts COVID-19 hospitalizations, according to officials with the Centers for Disease Control and Prevention (CDC), but the agency suggested that it doesn’t overcount deaths.

COVID-19 hospitalizations listed on the CDC’s data tracker webpage, which is utilized by a wide variety of health officials, journalists, and others, include three types of hospitalizations, the CDC said in a Jan. 27 statement.

The types are hospitalization because of COVID-19, because of a non-COVID condition “that was likely made worse” by COVID-19, and because of non-COVID reasons after testing positive for COVID-19. The latter is known as an incidental hospitalization.

Experts are increasingly warning against putting forth numbers that include incidental hospitalizations, or hospitalization “with” COVID-19 as opposed to “for” COVID-19. They say that separating the incidental hospitalizations will improve the accuracy of numbers and help the public better understand the current state of the COVID-19 pandemic.

“I think that’s becoming increasingly important as we move into an era where these variants are clearly more infectious and cause more asymptomatic disease,” Dr. Cody Meissner, professor of pediatrics and medicine at Dartmouth College’s Geisel School of Medicine, said during a recent meeting.

Multiple states and jurisdictions, including Massachusetts and King County, Washington, don’t include incidental hospitalizations in their COVID-19 reporting.

The CDC does make the distinction in some of its studies, including papers analyzing data from COVID-NET, a CDC surveillance system that includes hospitals in 98 counties across 13 states.

“It’s not broken out in the surveillance data that’s reported online, but they do use a reasonable case definition, which is essentially that people who’ve tested positive in a reasonable amount of time before admission, or within several days after admission, are basically called a COVID associated case,” Heater Scobie, a CDC researcher, said during the meeting, which featured experts advising the U.S. government on the future of the COVID-19 vaccination program.

Neither Scobie nor the CDC explained why the agency isn’t separating out incidental hospitalizations.

Death Data

While the hospitalization data is an overcount, the CDC is insisting that its COVID-19 death count is largely accurate.

“COVID-19 death data are tracked differently—they include only the deaths in which COVID-19 played a meaningful role,” the CDC said in its statement.

The agency claimed that most COVID-19 deaths were people who had COVID-19 listed as the primary or secondary cause on their death certificates, noting that “people who happen to have COVID-19 at the time of their death but it is unrelated to their death—for example, someone who dies in a car accident—should not have COVID-19 listed on their death certificates.”

However, the CDC has previously acknowledged that a percentage of deaths involved factors such as poisoning or car accidents, and federal officials have said that any patients who definitely have or are suspected to have COVID-19 would be counted as a COVID-19 death, even if the cause of death was unrelated to the disease.

The Council of State and Territorial Epidemiologists stated in late 2021 (pdf) that deaths should be counted as COVID-19 deaths if the death occurred within 30 days of a confirmed laboratory test and was defined as due to any natural cause.

In an update in late 2022 (pdf), the council, which develops its guidance in partnership with the CDC, stated that even in some cases in which COVID-19 wasn’t confirmed, they should count as deaths if the certificates indicated COVID-19 “or an equivalent term” was listed as a cause of or contributor to the deaths.

“The reason for this difference is the recognition of the importance of counting all COVID-19-associated deaths, including deaths that may occur after an at-home over the counter antigen SARS-CoV-2 result, if COVID-19 is felt to be a cause of or contributor to death by the healthcare provider certifying the death,” the council stated. “Current applied public health data suggest that these numbers of deaths identified through death certificates only, without accompanying confirmatory or presumptive laboratory evidence, are a low percentage of the total.”

Margery Smelkinson, an infectious diseases expert with the U.S. National Institute of Allergy and Infectious Diseases, was among those questioning the CDC’s statement.

“CDC concedes that their hosp data may be a mess but is emphatic that their deaths are totally accurate. Can you really have one without the other? If you incentivize testing, it’ll get on death certificates,” she wrote on Twitter.

Smelkinson noted that families often push to have COVID-19 included on a certificate because they’ll be eligible for benefits from the Federal Emergency Management Agency, including funeral assistance.




Tuesday, January 31, 2023

Pfizer admits 'engineering' Covid mutants in lab studies to ensure its antiviral drug works on new variants — but pharma giant insists tests were not 'gain of function’ and did not pose risk to public

I am not too critical of this. The more we know about what the virus can do, the better. But they should probably have sought some form of approval for the work

Pfizer has admitted it ‘engineered’ mutated Covid viruses in lab tests to ensure its vaccine and drugs remained effective against new variants – but the company denies the experiments posed a risk to the public.

In a press release sneaked out on Friday night, the pharma giant finally responded to an undercover video that went viral last week in which a supposed director at the firm claimed the company was exploring 'directed evolution' research on monkeys to make the virus 'more potent'.

Jordon Trishton Walker, who appears to have been a senior staffer in Pfizer's research and development division, was caught making the explosive claim in a sting by the right-wing activist group Project Veritas.

Pfizer flatly denied conducting gain of function or directed evolution research on monkeys but admitted that ‘in a limited number of cases’ it altered the virus and tested new mutations against its Covid antiviral drug Paxlovid in Petri dishes.

The New York-based firm claims the experiments are essential to get ahead of drug-resistant strains and says similar tests are carried out by 'many companies and academic institutions in the US and around the world'.

But spoke to several independent virologists and epidemiologists who were split about whether Pfizer's experiments posed a risk to the public.

Professor Richard Ebright, a molecular biologist at Rutgers University in New Jersey, has been an outspoken advocate of the lab leak theory, the idea Covid escaped from the Wuhan Institute of Virology in China.

He told that Pfizer's press release 'unequivocally' indicates that 'Pfizer and its collaborators performed... high-risk gain-of-function research and enhanced potential pandemic pathogens research'.

But Professor Ian Jones, a virologist at the University of Reading in the UK, told this website: 'I don't find it [Pfizer's statement] alarming for a number of reasons.'

Paxlovid works by blocking the virus from releasing an enzyme crucial for Covid to replicate when it enters the body, known as the 3CL protease, explained Professor Jones.

He said Pfizer's experiments involve looking at 'what changes to the sequence of the protease gene would be necessary to make the virus no longer sensitive to the drug'.

'So they make a range of mutations in the virus, led by computational predictions, and then culture that mutated virus in the drug to see if indeed it is no longer sensitive and if so by what degree,' he added.

150 experts call for gain-of-function research to CONTINUE

The group - mainly virologists and biologists from the US and the UK - argue the experiments are necessary to stop future outbreaks.

'Many of the mutants they make will not do anything, but some could make a Paxlovid-resistant virus. The risk would be that this could escape and spread, making the drug useless.

'My point is that such a virus remains unaltered in every other way, so the overall risk [of the virus being able to infect people and leaking from the lab] is very small.'

Professor Jones said this tiny risk is outweighed by the benefit of 'being ahead' of the virus' evolution in nature.

Professor Paul Hunter, an infectious disease expert at the University of East Anglia in the UK, also told 'The press release doesn’t cause me too much concern. 'To me, it doesn’t look like Pfizer is doing anything that isn’t being done by many other groups.'

His comments were echoed by Dr Simon Clarke, a microbiologist at the University of Reading. Dr Clarke told 'These are not experiments which might risk the generation of a new variant that transmits more readily between people.

'What Pfizer are doing is to look at how Covid becomes resistant to nirmatrelvir, a component of their PAXLOVID antiviral medicine. 'They are looking to see what mutations to the molecule that nirmatrelvir’s targets can make it resistant to the drug.

'This is important because scientists don’t fully understand how viruses might become resistant to nirmatrelvir.

'These sorts of experiments are routine in the development of new anti-infective drugs and are required by regulators around the world. 'Without this level of understanding, we could end up relying too heavily on drugs that rapidly become useless.'

Pfizer's response was released at 8pm on Friday, three days after the Project Veritas video was released, unleashing a frenzy on social media.

The post was also based out of the Pfizer Pearl River R&D facility, a research lab around 20 miles from New York.

It is the company's only biosafety level three (BSL-3) lab out of its nine major research and development sites in the US and UK.

BSL-3 labs are authorized to handle dangerous pathogens. Experiments at these labs often involve tinkering with animal viruses to advance treatments and vaccines that could be used in a future outbreak.

In BSL-3 labs, researchers do all experiments in a ‘biosafety cabinet’ — an enclosed, ventilated workspace for handling materials contaminated with pathogens.

Work on the live virus that causes Covid must be carried out at a BSL-3 or BSL-4 lab.

Pfizer denied that its work qualifies as gain of function, a loaded term that has become synonymous with questions about Covid's origin.

This type of research involves tinkering with viruses to make them more lethal or infectious - hoping to get ahead of a future outbreak and develop treatments.

The authors of two United Nations reports into the pandemic's origins say a laboratory leak was the most likely cause of Covid.

The Wuhan Institute of Virology - located just 8miles from where the first cluster of cases were detected - was carrying out similar research on bat coronaviruses in the years predating the pandemic using US taxpayer money.

The WIV received government grants through a subcontractor known as the EcoHealth Alliance.

Gain of function was largely restricted in the US until 2017 when the National Institutes of Health began to allow it to take place using government funds.

Research teams wanting to do gain of function research in the US using government grants must have their work approved by an independent review panel that decides whether the benefits outweigh the risks.

But Congress admits privately funded research by pharmaceutical companies are not subject to the same oversight.

Pfizer also claimed that its lab work was not 'directed evolution'. This research is intended to imitate the process of natural selection and push a virus' mutations down a certain path. It can be performed in living organisms - such as monkeys - or in vitro (in cells).

Pfizer did admit that it modified the original Covid virus to produce the spike protein of new variants to test them against its vaccine.

Most scientists agree this does not count as gain of function because the variants already exist in nature and infect people.

The grey area appears to be Pfizer's admission that it conducted 'in vitro resistance selection experiments' on its antiviral drug Paxlovid. In vitro resistance selection experiments involve predicting how a virus will mutate as it develops resistance to treatments.

Their purpose was to test which mutations would need to occur to the piece of the virus that Paxlovid targets to render it ineffective. But exactly what these experiments involve is unclear and Pfizer refused to comment again when approached by today.

Pfizer's official release does not refer to Project Veritas or the alleged employee Mr Walker.

Instead, the statement opens with: 'Allegations have recently been made related to gain of function and directed evolution research at Pfizer and the company would like to set the record straight.'

It adds: 'In the ongoing development of the Pfizer-BioNTech Covid-19 vaccine, Pfizer has not conducted gain of function or directed evolution research.'

But the company does admit to using the original Covid strain to express the spike protein of new variants of concern to test its vaccine.

'This work is undertaken once a new variant of concern has been identified by public health authorities.'

Most scientists endorsed this research because it helped governments assess how effective their vaccine rollouts would hold up against new variants like Omicron and Delta when those variants took off.




Monday, January 30, 2023

Prestigious medical journal probes study that claimed Covid vaccines have killed up to 280,000 people in the US

I have read the journal article and can compare its methods with my own very extensive experience of survey research.

I was long of the view that online sampling is crap but it is so extensively used these days that I have to give it some credence. And this survey did employ extensive precautions to ensure that something like a true sample was obtained.

So the reported doubts about the conclusions would seem to be driven by their unpalatibility rather than any methodological problems. Prof Skidmore did carry out a careful survey by current standards.

His conclusions are probably on the whole at the better end of the available research. If his work is discredited an awful lot of other survey research would also go down in flames

And an alternative way of assessing the numbers was badly needed now we know -- largely courtesy of Elon Musk -- how much the official figures were "edited". American official figures for anything these days are about as trustworthy as the old Soviet production figures

The publisher of some of the world's most prestigious scientific journals is investigating a study which claimed Covid vaccines have killed up to 280,000 people across the US.

The bombshell estimate has since been peddled by anti-vaxx groups across the planet, who used 'the truth' as ammunition to push for roll-outs across the world to be urgently suspended.

It was also shared by the likes of Jordan Peterson, a Canadian psychologist who has shared discredited views online.

Springer Nature told MailOnline it had now launched an investigation into the study, which was published in one of its underling journals.

'Once the journal's investigation has concluded and we have the necessary information to make an informed decision, we will follow up with the response that is most appropriate and that provides clarity for our readers,' it said. 'This may include potentially taking editorial action.'

The study, published this week in the journal BMC Infectious Diseases, was authored by an economist at Michigan State University.

Professor Mark Skidmore, who has posted a number of articles critical of Covid jabs on his personal blog, used an online survey of 2,840 people taken in December 2021 to make his estimate of Covid vaccine-related deaths in the US.

Funding for the survey was provided by Catherine Austin Fitts.

A woman of the same name - the former assistant secretary of Housing and Urban Development under President George H.W. Bush - recorded a lengthy interview as part of the 2021 documentary film 'Planet Lockdown'. The 90-minute video makes a number of unsubstantiated claims about the Covid vaccine programme and cause of the pandemic.

Respondents of the survey were asked if they knew of someone who had suffered a severe health reaction from getting a Covid vaccine.

Of the total 612 people (22 per cent) who claimed they had, 57 people (2 per cent) said that they knew someone who had died as a result. These included deaths from heart attacks, strokes or blood clots.

Professor Skidmore then used the data to create a vaccine fatality ratio and extrapolated that data to the entirety of the US population that received Covid vaccines in the first year they were deployed.

Writing in the journal, Professor Skidmore said: 'The total number of fatalities due to Covid inoculation may be as high as 278,000.' He claimed, however, that the actual death toll could be closer to the 330,000 mark, according to his calculations.

And Professor Skidmore, who is listed by his university as an expert on finances and the economics of natural disasters, stated the figure was 'after fatalities that may have occurred regardless of inoculation are removed'.

Experts raised concerns over the study's methodology.

Dr Simon Clarke, an associate professor in cellular microbiology at the University of Reading, told MailOnline: 'Any study on a self-selecting cohort of participants, like this one, automatically has a flaw in its methodology.

'They can never be said to be sampling a random selection of people, nor one that uses dispassionate participants. Put simply, people can lie to skew the findings.

'There's nothing wrong with a scientific journal publishing the work of an economist, but we should always be mindful of the limitations any study and just because it's been accepted by a scientific journal does not automatically mean it's right. Editors can make mistakes too.'

'For me, the biggest problem with this paper is that fails to sufficiently highlight its own potential shortcomings and it was the job of the Editors to insist that they be included before they authorised publication.'

US health agencies have said they have received 18,769 reports of death related to a Covid vaccination, about 0.0028 per cent of the 667 million doses administered.

These reports were made via the US's Vaccine Adverse Event Reporting System (VAERS), and doesn't conclusively mean a death is actually linked to a vaccine, as it could be a coincidence.

All Americans are urged to report any health problem they notice post-vaccination, even if they aren't certain the jab was to blame.

US health authorities have verified nine deaths reported via VAERs that are 'causally associated' to Covid vaccines after reviewing the information like death certificates, and autopsy and medical records.

The UK has a similar reporting mechanism in place, called the Yellow Card Scheme, where around 475,000 adverse events to Covid vaccines have been recorded.

Reports of flatulence, yawning and crying have been logged by vaccine recipients. But it does not mean that the jabs are to blame.

Under the surveillance system in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) has received 19 UK reports of 'suspected adverse drug reactions with a fatal outcome' linked to the bivalent Covid Pfizer/BioNTech vaccine and 32 reports for the bivalent Covid vaccine Moderna.

No fatal outcomes following the Novavax Covid vaccine have been reported.

The MHRA does not publicize the exact number of fatal outcomes linked with the AstraZeneca jab, which does not contain mRNA unlike the Pfizer and Moderna jabs.

Multiple real-world studies have repeatedly shown that Covid vaccines are safe and have saved lives in the pandemic.

Yet, like with every medicine, drug and procedure there are risks. People can have allergic reactions to components of vaccines and can suffer from a rare but dangerous heart inflammation called myocarditis.

Some have even died from blood clots, a rare complication of AstraZeneca's jab that eventually saw it restricted for the over-40s. The side effect was so rare that it wasn't spotted in the initial trials involving tens of thousands of people.

But antivaxxers claim deaths from vaccine have also been underreported by global health authorities and masked as a mysterious rise in excess deaths. Such tolls have seen them call for jab roll-outs to be suspended.

Professor Skidmore himself said that the problems reported by survey respondents, including heart attacks and strokes, 'are consistent with Pfizer documentation about the potential risks of the Covid vaccine'.

Health chiefs have repeatedly dismissed fears that mRNA jabs are behind any rise in heart problems.

Latest official data, published earlier this week, shows the US has suffered nearly 300,000 more deaths than usual since the pandemic began that cannot be attributed to Covid.

Leading experts believe these are mostly made up of surges in deaths from cancer, heart disease, drug overdoses and firearms during the pandemic. However, a full analysis by the CDC is still likely weeks away.

Excess deaths across England have been on the rise since summer but have spiked in recent weeks, running a fifth above expected levels. Almost 3,000 more people died than usual during the first full week of January alone.

Experts have blamed the NHS crisis — which has seen record waits for ambulances and in A&E — as well as a brutal wave of flu and the freezing temperatures logged in December.

Charities, including the British Heart Foundation, have warned that 'significant and widespread disruption to heart care services' is to blame for excess coronary heart disease-related deaths.




Sunday, January 29, 2023

Resisting fallacious arguments

The last three years since the start of the pandemic have done more to undermine trust in the institutions that were supposed to uphold this set of commitments to an objective truth than anyone could ever have imagined.

First off, most everything the doctorly caste in the form of the official organisations told us has turned out to be either wrong or highly questionable. Heck, last week a new study came out suggesting elderly people did better versus Covid if they were near young ones. Our politicians, backed up by the doctorly organisations, kept grandparents away from grandchildren and left many old and elderly to die on their own. We got myriad idiotic rules – sorry, no golf or tennis for you – that made no sense to any questioning being.

Then there were all the lockdown supporters. At the end of 2019 every major democracy had pandemic plans that said ‘do not lockdown’. These were based on a century of data. In six weeks, based on what a thuggish, authoritarian China was doing, most everywhere outside of Sweden and soon Florida swapped over to despotism. What new data was there? None. Now Sweden has the OECD’s lowest cumulative excess deaths – the hardest criterion to game – and excess deaths about one-third of the other Scandinavian countries. Moreover, even that mouthpiece of lockdown mania, the Washington Post, is reporting that during the pandemic Covid deaths were wildly over-reported. You don’t say? Upwards of half, maybe more, were people who died ‘with Covid’ not ‘because of Covid’. Know what? When it comes to the flu, dying ‘with it’ is not counted as a flu death. My kingdom for a sceptical reporter!

Then there were the three years of the establishment suppressing dissenting views and nudging fear. Read what happened to three of the world’s best epidemiologists – Jay Bhattacharya (Stanford), Martin Kulldorff (Harvard) and Sunetra Gupta (Oxford) – who wrote the Great Barrington Declaration. They were censored online. With the Twitter Files dump we now know that the Biden administration was pushing for them and many others to be silenced and pilloried. If anyone thinks that sort of ‘we are the government and the medical establishment and we know best’ type thinking is consistent with Enlightenment values – or with long-term good consequences for society – then he or she is frankly deluded.

We saw similar cravenness from the churches (who disgracefully closed their doors); we saw it from Dr Fauci, with his laughable claim that ‘I represent the science’ (when we now see he was wrong on more than he was right, perhaps starting with the lab-leak origin theory); we saw it with the endless appeals to authority (that’s not a scientific argument), claims about disinformation and misinformation and myriad personal attacks on dissenters; we saw it with the media’s fearmongering and distinct lack of curiosity as regards anything fed to it by Big Government and Big Tech. Meanwhile almost no media is reporting Germany’s all-cause deaths are now higher than at any time during the last three years and it’s not Covid.

Here’s something else that needs pointing out. One can believe all the long-established vaccines are virtually medical miracles and those who refuse them basically stupid. That’s my belief. And that same person can have real questions about this mRNA vaccine governments indirectly forced many to take. Having questions about one particular pharmaceutical injection (which was given the label ‘vaccine’) does not mean you have questions about them all. Nor does it make one an ‘anti-vaxxer’. If Jeremy Clarkson dislikes one particular brand of car that does not make him ‘anti-cars’, right? This ‘anti-vaxxer’ label is being thrown around now solely as a rhetorical tool. Look, I got the first two shots but no more. The data coming out is making it pretty clear that no young person needed to get any of these mRNA shots. Firstly, the young were 1,000 times less at risk from Covid deaths than the elderly. Their risk was basically zero. So if this new mRNA shot has any risk to them, and it is plain it does, it makes no sense for them to get it. Well, unless perhaps they’re being forced to take it for others, the old. But now we know these shots do not do anything to slow Covid’s spread or the chances you, the taker, will get it. There is data now that suggests the boosters make it more likely you’ll get it. Explain to me the ethics of forcing the young, or any dissenter, to take it, please.

In fact, there are all sorts of questions out there. In the past we would have had a back-and-forth debate that appealed to studies and empirical evidence. The last three years we’ve had only the cancelling of dissenting views. Such behaviour only makes doubters like me more likely to doubt. You see, the science is never settled. I spent a few years teaching the philosophy of science way back when living in Hong Kong. Anyone who tells you the science is settled simply doesn’t understand how science works. You never know when an Einstein will show that two centuries of Newtonian physics turns out to be wrong at some level. For these experimental vaccines just remember they were not tested nearly as rigorously as standard practice requires and that Pfizer and Moderna got government indemnities. If that’s such a great process then why not make it standard practice for all medicines? And if it really was just a case of ‘we’ll take a lot of collateral damage in the hope this is better than nothing’ then you can see why no government will now say so. Ever.


FDA Quietly Changes End Date for Study of Heart Inflammation After Pfizer COVID Vaccination

The U.S. Food and Drug Administration (FDA) has changed the end date for a key study on post-vaccination heart inflammation without notifying the public.

Pfizer was supposed to complete a study on the occurrence of subclinical myocarditis, or heart inflammation, after receipt of its COVID-19 vaccine. The completion date was listed by the FDA in 2021 as June 20, 2022. Pfizer was also supposed to submit the results of the study to the FDA by the end of 2022 as part of a list of requirements the FDA imposed as a condition of approving Pfizer’s jab.

But after the deadline passed, the FDA quietly changed the date.

Under a list of postmarketing requirements for the Pfizer-BioNTech vaccine, the FDA now says the same study has an “original projected completion date” of June 30, 2023. The current status of the study is listed as “pending.”

Jessica Adams, a former regulatory review officer at the FDA, said the wording amounts to misinformation. “By definition, ‘original’ dates can’t change,” she wrote on Twitter, tagging the agency. “Please correct this ‘misinformation.'”

Dr. Vinay Prasad, who has increasingly criticized the FDA over its decisions during the pandemic, said the new timeline “is so slow it will be entirely moot.” “Another FDA failure,” he said on Twitter.


The study is one of nine Pfizer was to complete to examine post-vaccination adverse events. The study is designed to “prospectively assess the incidence of subclinical myocarditis” after receipt of a third dose, or a booster, in people aged 16 to 30.

Pfizer submitted a timetable to the FDA stating the company would submit a final protocol by Nov. 30, 2021, and complete the study by June 30, 2022, according to the FDA’s approval letter for the company’s vaccine. The final report was due to the FDA by the end of 2022.

The study was one of several examining myocarditis and pericarditis, a related condition. Both are caused by the Pfizer and Moderna vaccines, according to U.S. officials and other experts.

Some of the vaccine-caused myocarditis cases have led to death.

FDA officials expressed concern about the post-vaccination heart inflammation when considering whether to approve Pfizer’s vaccine.

Signal for Myocarditis After New Booster

The bivalent Pfizer vaccine triggered a safety signal for adults aged 18 to 35, Richard Forshee, an FDA official, told the agency’s vaccine advisory committee on Jan. 26.

Regulators cleared that bivalent and one from Moderna in the fall of 2022 despite there being no clinical data for either shot.

The adverse event happened at a concerning rate after a Pfizer bivalent in recent months, according to analyses of data from the FDA’s Biologics Effectiveness and Safety initiative, which pulls from systems such as one managed by CVS Health.

“The only signal we have detected so far is for myocarditis/pericarditis following the Pfizer bivalent vaccine among adults 18 to 35 years old,” Forshee told the panel.

Safety signals indicate a vaccine may cause events but don’t establish causality. But officials have stressed that the bivalents are similar to the original vaccines in defending the authorization without clinical data, and have acknowledged a causal link between the original messenger RNA vaccines and the heart inflammation.

Most of the meeting presentations that went over adverse events focused on ischemic stroke, which triggered the threshold for a safety signal following Pfizer’s bivalent booster in the elderly and following receipt the original Pfizer and Moderna vaccines in all adults.

Officials said that the stroke has happened in many people who received a flu vaccine on the same day as a COVID-19 vaccine. They’re studying whether there’s a connection, though they noted there was no signal for the stroke after a flu shot alone.

Dr. Nicola Klein, a Kaiser Permanente researcher who helps the CDC monitor vaccine safety, said that the signal for stroke wasn’t as strong as that for myocarditis.

“This is a cluster but … it doesn’t stand out as extremely striking, unlike some other signals which we have seen,” Klein said. “For example, myocarditis, it’s an extremely strong signal that you can see without doing statistics.”