Thursday, March 21, 2024

New Canadian vaccine works

As SARS-CoV2 evolves into more distant Omicron variants, companies continue to invest in research and development and potentially vie for lucrative government contracts for future COVID-19 vaccine deals. In this context, the Canada based Providence Therapeutics mRNA platform appears to support the acceleration of next-generation COVID-19 vaccine candidates.

Researchers affiliated the clinical-stage mRNA platform company developing vaccines for cancers and infectious disease, report on a study comparing their investigational mRNA vaccine with the Pfizer-BioNTech COVID-19 vaccine BNT162b2 (Comirnaty). When considering this approach to mRNA vaccine development the company touts its “dynamic and adaptable responses, emphasizing the importance of sustained vaccination strategies.”

How did the Canadian company’s experimental vaccine targeting COVID-19 compare against Pfizer-BioNTech BNT162b2 in a Phase 2 clinical trial?

With results of this study (NCT05175742) published in Nature Scientific Reports, the study team based out of Canada reports on the results of the head on comparison study leveraging trial sites in Canada and South Africa.

The Study

In this investigation, the sponsor-funded study looks at their COVID-19 vaccine called PTX-COVID19-B mRNA Humoral Vaccine, developed to prevent COVID-19 in a general population. Importantly, the Pfizer-BioNTech vaccine does not stop viral transmission but reduces the probability of morbidity and mortality.

For comparison of the vaccines, the study’s protocol was designed to produce the data to evaluate the safety, tolerability, and immunogenicity of PTX-COVID19-B compared to Pfizer-BioNTech COVID-19 vaccine in healthy seronegative adults aged 18 to 64.

An observer-blind, double-dummy, randomized immunobridging phase 2 study, the researchers compared the immunogenicity induced by two doses of 40 μg PTX-COVID19-B vaccine candidate administered 28 days apart, with the response induced by two doses of 30 µg Pfizer-BioNTech COVID-19 vaccine (BNT162b2), administered 21 days apart, in Nucleocapsid-protein seronegative adults, again ranging in age from 18–64 years.

The study team reports that both vaccines were administrated via intramuscular injection in the deltoid muscle. Two weeks after the second dose, the neutralizing antibody (NAb) geometric mean titer ratio and seroconversion rate met the non-inferiority criteria, successfully achieving the primary immunogenicity endpoints of the study. PTX-COVID19-B demonstrated similar safety and tolerability profile to BNT162b2 vaccine.

Importantly, a non-inferiority trial is a study that determines if a new treatment is not worse than an active treatment it is being compared to. These trials are used when a placebo (an inactive treatment) cannot be used, or when the incremental benefits of newly developed treatments may be only marginal over existing treatments, which appears to be the case here.

While NAb with lowest response was detected in subjects with low-to-undetectable NAb at baseline or no reported breakthrough infection, the study investigators also found that the study result demonstrates induction of cell-mediated immune (CMI) responses by PTX-COVID19-B.

Cell-mediated immunity (CMI), also known as cell-mediated immune response or cell-mediated immune defense, is a crucial aspect of the immune system's defense mechanism. It involves specialized cells, primarily T lymphocytes (T cells), which directly attack and destroy infected or abnormal cell


According to the entry, the candidate PTX-COVID19-B demonstrated favorable safety profile along with immunogenicity similar to the active comparator BNT162b2 vaccine.


Now That Puberty Blockers Have Been Banned, it’s Time to Ban Covid Vaccines for Children Too

Puberty blockers have finally been banned in the U.K. The decision came after an independent review of services for children under 18 and a sharp rise in referrals to the Gender Identity Development Service run by the Tavistock and Portman NHS Foundation Trust, which is closing at the end of March.

“We have concluded that there is not enough evidence to support the safety or clinical effectiveness of puberty-suppressing hormones” an NHS spokesperson told the Telegraph on March 12th 2024.

MPs and media personalities have come out in support of this move. But in reality, most of them have remained silent on this issue up until now. It has previously been considered too politically sensitive and controversial to comment on, with the threat of being branded a ‘transphobe’ or ‘bigot’ no doubt playing a significant role in their collective silence. Nonetheless, I have yet to meet a single person, outside of social media, who agrees that puberty blockers are either ethical or safe. Thankfully, strong and courageous voices, such as J.K. Rowling, Allison Pearson, Molly Kingsley and Jordan Peterson have been calling out the dangers of this practice from the start. They are now clearly vindicated.

When the issue is stripped back to its essence, puberty blockers have been banned on the basis of long established medical ethics. Specifically, that children should never be given a medical intervention which they do not need and which poses known and serious risks to them – a view which before 2020 would have been the reasonable position to take. Indeed, to argue otherwise would have been regarded as extreme. The factor which changed after 2020 was the rollout of the Covid vaccines to children. Seemingly overnight, medical ethics was suspended and inverted in favour of pushing ahead with the vaccine rollout. However, if we apply the same principles behind the banning of puberty blockers to the Covid vaccines, they would also be banned for children with immediate effect.

The Covid vaccine rollout to children has always been controversial. Consider:

Covid vaccinations were not recommended by the Joint Committee on Vaccination and Immunisation (JCVI) for under-16s, a decision overridden by the Chief Medical Officers in England, Wales, Scotland and Northern Ireland.

When Matt Hancock was Health Secretary, he stated in Parliament that the Covid vaccines were for the adult population only. He said that children would not be offered the vaccine because it had not been tested on children and that they were at low risk from Covid. Despite this, he then supported the rollout to the nation’s children.

There are still no long-term safety data for the Covid vaccines (and at the time of the rollout to children, incomplete short-term and no medium-term safety data).
Covid vaccines pose known and very serious risks (these include potentially fatal myocarditis, pericarditis etc.) Tragically, there have also been coroner confirmed deaths caused by the Covid vaccines.

A child can still catch and spread Covid when vaccinated against the virus.

Healthy children are at extremely low risk of serious illness from Covid, so the risks posed by the vaccines outweigh any possible benefit for a child.

When Sajid Javid was Health Secretary, he stated that 12 to 15 year-old children would have the final say on whether or not to receive the Covid vaccine. Children were told that they were allowed to override their parents’ decision. This remains, in my opinion, the most egregious act of the entire pandemic.

The Government chose Pfizer, the pharmaceutical company with a long history of criminal and medical negligence (and which paid the biggest criminal fine in U.S. history) as the company to provide the Covid vaccine for our children. This really should have been a red flag from the start.

One of the most controversial points was the decision by the U.K. Government to shut down its own Ethics Committee when its members raised serious concerns about the Covid vaccine rollout to children.

Like puberty blockers, the general public appears to have been opposed to the Covid vaccine rollout to children. In the end, 89.4% of five to 11-year-olds did not receive a single Covid vaccine or booster. This is despite a multi-million pound marketing campaign directed at children and their parents. Over 50% of the 12-15 year old cohort did not receive a single dose either.

The evidence keeps stacking up against the Covid vaccines

MPs have said they believe the MHRA were aware of heart and clotting issues caused by the Covid vaccines in February 2021 but did not highlight the problems for several months. The all-party parliamentary group (APPG) on pandemic response and recovery raised “serious patient safety concerns”, claiming that “far from protecting patients” the regulator operates in a way that “puts them at serious risk”. Some 25 MPs across four parties wrote to the Health Select Committee asking for an urgent investigation.

The group also warned that the MHRA Yellow Card reporting system – which encourages patients and doctors to flag-up medicine side effects – “grossly” underestimates complexities, and in some instances picks up just one in 180 cases of harm.

MPs and peers have also accused the Health Secretary of withholding data that could link the Covid vaccine to excess deaths, and criticised a “wall of silence” on the topic. A cross-party group has written to Victoria Atkins to sound alarm about the “growing public and professional concerns” at the U.K.’s rates of excess deaths since 2020.

With the growing evidence that something is seriously amiss with the Covid vaccines, surely we should stop giving them to our children? Currently within the U.K., children who are considered vulnerable (including those with Autistic Spectrum Disorder and ADHD) and those living with clinically vulnerable adults are eligible for the vaccine. It is also possible for parents to privately purchase the Covid vaccine for their children if they are 12 years old or over. In light of the ban on puberty blockers, it makes sense to apply this thinking to the Covid vaccines too.

Things will change when members of the public speak up

Being critical of puberty blockers will become the accepted narrative now that they have been banned. Members of the public, media personalities and politicians will begin to openly express this position (which has always been the majority view). However, we need to get to a point when people begin to express opinions which they genuinely hold but are still considered controversial. Expressing lawful opinions about sensitive topics, particularly when it comes to safeguarding children against harm, should be encouraged and not vilified.

All of the safeguarding training across workplace sectors is easily dismantled and destroyed in the face of moral cowardice. As a former headteacher, with 30 years’ experience within the education sector, I had to attend annual safeguarding training which laid out what an education professional must do when he or she has concerns about a child. The training always highlighted examples in which entire organisations have been complicit in widespread abuse.

We are told that it is not just the perpetrators of the abuse who are accountable. Those who are not directly involved in the abuse, but who remain silent about it, are equally accountable under law. These individuals, woefully lacking in moral courage, place their self-preservation ahead of the needs of the children in their care. It is also a serious breach of their legal duty to safeguard children against harm.

Of course, cancel culture, as well as employers evangelised by whatever the latest thing happens to be, inhibits free speech. If an opinion goes against the current narrative, employees are likely to be attacked for expressing it. Whether that be criticism of puberty blockers, the Covid vaccines, climate alarmism, drag queen storytime or anything else. Expressing lawful opinions about controversial and politically sensitive topics will almost always result in some sort of attack. However, we must draw a line when it comes to safeguarding children against harm.

As the only U.K. headteacher to publicly express concerns about lockdowns, masking kids and the Covid vaccines for children, I have experienced multiple attacks and personal losses. This is why I am now taking my former employer, East Sussex County Council, to court. In the end, expressing my valid concerns in a lawful and moderate manner cost me my career. My employer tried to silence me through the complaints and investigation process, but I continued to express my concerns. I was fulfilling my legal and moral duty in doing so. My philosophical belief in the importance of critical thinking, freedom of speech and safeguarding children underpins my case. It is predicted to set an important legal precedent for free speech in the workplace and has gained the overwhelming support of the public, high-profile free speech advocates and the Daily Telegraph.

But it needn’t result in expensive court cases and conflict if everyone expressed their lawful opinions about the things which matter. The ban on puberty blockers is a fantastic development in the battle to protect our children, but those who were silent about it are partly responsible for the delay. This abhorrent medical intervention should have been banned long ago. The same principles applied to the ban on puberty blockers should now be applied to the Covid vaccines for children. Children do not need this medical intervention, which is ineffective and known to cause harm. The general public is clearly in agreement so the time to speak up about it is now. Silence should never be an option when safeguarding children against harm.




Wednesday, March 20, 2024

Murthy v. Missouri Puts Government Censorship on Trial

On Monday, the Supreme Court will hear arguments in Murthy v. Missouri, formerly Missouri v. Biden, the president whose administration has been accused of strong-arming Big Tech to remove “objectionable posts.” The attorneys general of Missouri and Louisiana, joined by doctors such as Jay Bhattacharya of Stanford, argue that the administration censored dissenting speech on COVID-19 and other policies by pressuring tech platforms to remove or restrict posts.

Consider this account from Martin Kulldorff, former professor of medicine at Harvard and co-author of the Great Barrington Declaration (GBR) with Dr. Bhattacharya and Oxford University’s Sunetra Gupta, a leading infectious-disease epidemiologist. The GBR, signed by thousands of medical scientists, advocated an approach to the pandemic similar to the one taken by Kulldorff’s native Sweden, which declined to shut down schools.

Kulldorff recalls that although Sweden had the lowest excess mortality among major European countries and “despite being a Harvard professor, I was unable to publish my thoughts in American media. Twitter (now X) put me on the platform’s Trends Blacklist.” Twitter did the same to Dr. Bhattacharya.

“Seeking to prop up Anthony Fauci and the lockdown policies he promoted in response to the COVID-19 pandemic,” the plaintiffs explain, “Twitter (and other Big Tech companies) intentionally blacklisted, censored, suppressed, and targeted the GBD and its signers.”

National Institutes of Health (NIH) director Francis Collins smeared the GBD authors as “fringe epidemiologists,” but they were far more qualified than Collins, a “lab scientist with limited public-health experience,” according to Kulldorff. Fauci, longtime boss of the National Institute of Allergy and Infectious Diseases, is a nonpracticing physician whose bio shows no advanced degrees in molecular biology or biochemistry. The government’s white-coat supremacists were causing extensive damage, and the GBD scientists called them out.

“It was also clear that lockdowns would inflict enormous collateral damage,” notes Kulldorff, “not only on education but also on public health, including treatment for cancer, cardiovascular disease, and mental health. We will be dealing with the harm done for decades. Our children, the elderly, the middle class, the working class, and the poor around the world—all will suffer.”

As the ousted Harvard professor explains, “The pursuit of truth requires academic freedom with open, passionate, and civilized scientific discourse, with zero tolerance for slander, bullying, or cancellation.” That sort of activity has been going on at Facebook for some time.

In 2018, in his first public testimony before Congress, CEO Mark Zuckerberg admitted that Facebook was collaborating with the investigation of President Trump by former FBI director Robert Mueller. The FBI had interviewed some Facebook employees, but Zuckerberg would not say who they were “because our work with the special counsel is confidential.”

When Sen. Ted Cruz asked Zuckerberg if Facebook was a “neutral forum,” the CEO seemed puzzled by the concept. Sen. Cory Gardner asked if the government had ever demanded that Facebook remove a page from the site. “Yes, I believe so,” said Zuckerberg. He did not reveal the content of the page or when the removal had taken place.

Joe Biden has accused Facebook of “killing people” with vaccine misinformation. From the ordeals of Kulldorff, Bhattacharya and others, it’s now clear that the Biden administration was peddling misinformation, slandering the GBD scientists, and blocking them from setting forth the truth to the widest possible audience.

“In an environment where just about every decision tech platforms make becomes highly politicized,” one article previewing Murthy v. Missouri explains, “lawmakers on both sides of the aisle have grown accustomed to making pointed—if, often empty—threats at Big Tech. Now, the Supreme Court will decide just how far those threats can go.”

Murthy v. Missouri aside, it’s clear that white-coat supremacy and government censorship are incompatible with a free, safe, and healthy society.


Mandatory lockdowns had almost no benefit—but did significant economic and health-related damage

Four years ago this week Vice President Mike Pence announced the White House’s “15 days to slow the spread” campaign. What followed was the unprecedented use of lockdowns, school closings and other sweeping measures to mitigate Covid-19.

Four years later, we know what many of us suspected then: None of those policies were successful, and many were gravely damaging.

The Covid health benefits of mandatory lockdowns were tiny. Lockdowns in the U.S. prevented between 4,000 and 16,000 Covid deaths. In an average year 37,000 Americans die from the flu, according to the Centers for Disease Control and Prevention. Lockdowns also failed to reduce infections more than a trivial amount, in part because people voluntarily alter their behavior when a bad bug is in the air. Coercive government policies generated few benefits—and massive costs.

Public-health agencies exacerbated the damage by failing to keep their heads and follow standard pandemic-management protocols. Before 2020, it was recognized that communities respond best to pandemics when government measures are only minimally disruptive. During Covid, however, officials junked that practice by green-lighting restrictive practices and intentionally stoking fear. That response overlaid enormous economic, social, educational and health harms on top of those caused by the virus.

Those harms are captured, in part, in excess deaths—the number beyond what would have been expected without a pandemic. Non-Covid excess deaths from lockdowns, the shutdown of non-Covid medical care, and societal panic are estimated at nearly 100,000 between April 2020 and at least the end of 2021. The number of lockdown and societal-disruption deaths since 2020 is likely around 400,000, as much as 100 times the number of Covid deaths the lockdowns prevented.

The best measure of health performance during the pandemic is all-cause excess mortality, which captures the overall number of deaths relative to the expected level, encompassing Covid and lockdown-related deaths. On this measure Sweden—which kept most schools open and avoided strict lockdown orders—outperformed nearly every country in the world.

A recent study published in the Proceedings of the National Academy of Sciences found that the U.S. “would have had 1.60 million fewer deaths if it had the performance of Sweden, 1.07 million fewer deaths if it had the performance of Finland, and 0.91 million fewer deaths if it had the performance of France.” In America, states that imposed prolonged lockdowns had no better health outcomes when measured by all-cause excess mortality than those that stayed open. While no quantifiable relationship between lockdown severity and a reduction in Covid health harms has been found, states with severe lockdowns suffered significantly worse economic outcomes.

Closing hospitals and cutting off access to non-Covid healthcare generated a fear of entering medical facilities. That was a profound mistake, as was encouraging the false belief that hospitals were too busy to treat people who needed care. Healthcare utilization rates were at low levels between 2020 and 2022. In spring 2020, nearly half of the nation’s some 650,000 chemotherapy patients didn’t get treatment, and 85% of living organ transplants weren’t completed. One study found that there were 35.6% fewer calls for cardiac emergencies after March 10, 2020, compared with the year prior. Emergency-room visits were down between 40% and 50%, according to an estimate in May 2020. That doubtless contributed to observed non-Covid excess deaths and may continue to do so, as Americans suffer from undetected cancers and other long-term conditions. Healthcare uptake is still lower than pre-pandemic levels.

The economic costs of lockdowns were also staggering. According to the Bureau of Labor Statistics, as many as 49 million Americans were out of work in May 2020. This shock had health consequences. A National Bureau of Economic Research study found that the lockdown unemployment shock is projected to result in 840,000 to 1.22 million excess deaths over the next 15 to 20 years, disproportionately killing women and minorities.

Perhaps the worst policy error was prolonged school closings. Learning loss for children, especially in poor families, is already showing up in reduced standardized-test scores. These losses will affect earnings for decades. By one estimate today’s children will lose $17 trillion in lifetime earnings owing to school closings. They may also suffer shorter life expectancy, which is linked to income and educational attainment.

While school closings had no offsetting public-health benefits, the attendant isolation led to massive increases in psychiatric illness, self-harm, obesity and substance abuse. Healthy children were always at vanishingly small risk from Covid, and nearly all of them were infected at some point anyway, according to CDC data. Like a regressive tax, these harms were severest for lower-income and minority students.

One result of the government’s Covid response is that Americans have lost faith in public-health institutions. To earn back their confidence, Congress and the states should rewrite their statutes regarding public-health emergencies. Legislatures should place strict limitations on the powers conferred to public-health executives, in addition to implementing sunset clauses that require legislative majorities to extend them. Congress should likewise set term limits for all senior positions in U.S. health agencies.

The CDC, the Food and Drug Administration and the National Institutes for Health should be fully transparent about their deliberations. They should publish transcripts of their formal discussions on digital forums for public consumption. Congress should also restate that the CDC’s guidance is strictly advisory and that the agency doesn’t have power to set laws or issue mandates. The U.S. should halt all binding agreements with the World Health Organization until it also enhances transparency and accountability.

Most important, these institutions must acknowledge that lockdowns, school closings and mandates were egregious errors that won’t be repeated. Until they do, the American people should continue to withhold their trust.




Tuesday, March 19, 2024

Report claims Covid-19 lab leak theory ‘more probable’ than natural occurrence

What was once considered a far-fetched conspiracy theory has now been floated as a “more probable” answer to the million dollar Covid-19 question.

The origins of Covid-19 have been pontificated on by millions around the world after the first wave exploded through Wuhan, China in 2019.

The US National Library of Medicine claimed the virus that turned planet Earth on its head originated from pangolin samples “obtained by anti-smuggling operations in the Guangdong province of China”.

But sceptics have been highly critical of the assumption the virus, which was highly infectious to humans, naturally developed in the wild.

The Lancet, another major medical journal, boldly proclaimed that those suggesting the virus originated from a laboratory were attempting to “manipulate public opinion with political language”.

“Peer-reviewed evidence available to the public points to the hypothesis that SARS-CoV-2 emerged as a result of spillover into humans from a natural origin,” the Lancet published in 2023.

But now, a major scientific paper led by Australian pandemic expert Professor Raina MacIntyre suggests that a lab leak is actually “equally or more probable” than Covid-19 springing from nature.

The paper, featuring scientists from the Kirby Institute at the University of NSW, says that while a lab leak theory is plausible, the true origin of the pandemic may never be confirmed.

The research used the Grunow-Finke tool, an epidemiological risk scoring method, contrasting with the genetic analysis methods more commonly used to investigate the virus’s origins.

“An unnatural origin of SARS-COV-2 is plausible, and our application of the Grunow-Finke tool suggests it is equally or more probable than a natural origin, although both remain possible,” the researches wrote.

“The gathering of intelligence may include open source, signals or satellite intelligence, political factors, as well as other ‘detective work’ to piece together the complex question of the origin of SARS-COV-2.

“This would include full records of viruses housed at the relevant laboratories, of experiments conducted, and records of accidents and illness among staff. The question of origin cannot be answered solely by phylogenetic analysis, as viruses resulting from gain-of-function research using serial passage in an animal model cannot easily be distinguished from naturally emerged ones.”

This analysis is presented against a backdrop of widespread dismissal of the lab leak hypothesis in scientific circles and by the World Health Organisation, which deemed a leak from the Wuhan Institute of Virology “extremely unlikely”.

The study analysed various factors, including the peculiar biological characteristics of SARS-CoV-2, its rapid human-to-human transmission rate, and unusual actions at the Wuhan Institute of Virology prior to the outbreak, such as military control takeover and removal of a large virus database from public access.

The paper’s findings, suggesting a 68 per cent likelihood of an unnatural origin of SARS-CoV-2 based on the modified Grunow-Finke tool, contrast sharply with other scientific opinions and WHO conclusions.

The research has been criticised by some international scientists, including Alice Hughes from the University of Hong Kong, who labelled the analysis method as potentially “dangerous and misleading” due to its subjective nature and reliance on conjecture.

As the world emerges from one of the most destabilising periods in recent history, more and more information about the potential cause of the pandemic has risen to the surface.

In November 2023, a whistleblower came forward to claim CIA analysts who favoured the lab leak theory were bribed to change their position.

The bribe was allegedly made to take the focus off China and the Wuhan Institute of Virology.

The National Intelligence Council’s Director for Global Health Security, Adrienne Keen, worked as an independent consultant for the WHO from 2016.

Former Acting Assistant Secretary of State Thomas DiNanno said that Ms Keene tried to push Covid-19 was a natural occurrence, rather than a lab leak.

“I had found out that apparently she was an outside adviser also to the World Health Agency – they are a political agency, they are a UN agency,” Mr DiNanno said.

“It’s just not appropriate to do work for a foreign power and that would include in the United Nations.”

A few months prior, a report claimed that Covid-19’s “patient zero” was a Wuhan scientist carrying out experiments on souped-up coronaviruses,

According to the report, the scientist, Ben Hu, was conducting risky tests at the Wuhan Institute of Virology with two colleagues, Ping Yu and Yan Zhu.

It’s understood all three fell ill with Covid-like symptoms and needed hospital care weeks before China disclosed the virus outbreak to the world.

A bombshell report by journalists Michael Shellenberger and Matt Taibbi alleged the scientists were experimenting with coronaviruses when they became sick in 2019.

Many experts and intelligence officials have long suspected scientists at the lab accidentally spread Covid-19 during so-called “gain of function” experiments on bat coronaviruses.

The naming of “patient zero” could be the so-called smoking gun – adding to mounting circumstantial evidence of a lab leak.

It’s not clear who in the US government had the intelligence about the sick lab workers, how long they had it, and why it was not shared with the public.

Jamie Metzl, a former member of the World Health Organisation advisory committee on human genome editing, described it as a possible “game changer”.

“It’s a game changer if it can be proven that Hu got sick with Covid before anyone else,” he said.

“That would be the ‘smoking gun’. Hu was the lead hands-on researcher in (virologist Shi Zhengli’s) lab.”


UK: Up to 20,000 prostate cancer diagnoses could have been missed during the pandemic, research suggests

Up to 20,000 diagnoses of prostate cancer could have been missed during the pandemic, research suggests.

Analysis of 24million patient records since 2020 found tens of thousands of men have missed potentially life-saving cancer diagnoses.

The study by the University of Surrey and the University of Oxford said there was 'unprecedented disruption' in the diagnosis of cancer with a drop in urgent referrals from GPs, caused by difficulties accessing care and longer waiting times.

They analysed prostate cancer incidence between January 2015 and July 2023 using data representing 40 per cent of the country. This revealed a 31 per cent drop in diagnoses of prostate cancer in 2020 and 18 per cent in 2021, returning to normal in 2022.

When extrapolated across the country, there were 19,800 fewer cases, according to the findings published in the British Journal of Urology International.

Lead author Dr Agnieszka Lemanska, of the University of Surrey, said: 'Understandably, during the pandemic, resources and attention in healthcare systems shifted towards preventing and managing the virus.

'It is important that we learn the lessons from the pandemic. However, to do this, we need to understand the scale of how diagnosis rates were impacted during this time.'




Monday, March 18, 2024

mRNA Experts acknowledge many faults in mRNA vaccines

But they still seem to believe that the vaccines helped on balance. Most deaths were among the elderly, who probably died WITH rather than FROM Covid. Among the under-65s, most infections were minor. A few lives may have been saved by the vaccines but some were lost from vaccine effects too

A trio of experts from one of the birthplaces of mRNA breakthroughs represented by Drew Weissman, MD, PhD Perelman School of Medicine, University of Pennsylvania, and along with Katalin Kariko, winner of the Nobel Prize in Physiology or Medicine in 2023 for their role in driving mRNA-related discovery directly influencing the development of the Pfizer—BioNTech COVID-19 vaccine (BNT162b2) discuss the need to look at mRNA technology, beyond the COVID-19 vaccines.

In a way, a code word to acknowledge that these products in the form delivered to the world as a mass countermeasure/immunization scheme during a global pandemic are not ready for more refined therapeutic delivery. Put another way the products as represented by the vaccines are by no means ready for prime time! Why? One of the true authorities on the subject of mRNA, Weissman and University of Pennsylvania colleagues, point out in their recent paper published in The Lancet problems, or challenges ongoing with mRNA stability, duration of expression, targetability, and the like, but also introduces scientific advances to harden these products. These products were rushed to market in the pandemic. Key preclinical steps such as pharmacodynamics were all but bypassed due to the exigencies of the time. As a deadly virus spread, government health agencies and industry decided that acceleration of mRNA vaccine delivery for mass immunization was acceptable.

Yet because of the emergency conditions and the medical establishment’s declaration that the vaccines saved millions of lives, any externalities continue to be swept under the carpet of history. And these are externalities that derive from the gaps called out by one of the most notable authorities on the topic of mRNA technology. Advancing this medicinal technology in more refined therapeutics necessitates improvements they discuss in their paper. The good news, industry is quietly capitalizing on advancements in science to stabilize these products. The bad news, any externalities adversely affecting what is likely a relatively small percentage of the masses during the pandemic don’t exist according to the medical establishment. Is human suffering a consequence of advancement?

Declaring that the recent COVID-19-driven advancements ushered in a new era in medicine powered by mRNA-based therapeutics, “the rapid, potent, and transient nature of mRNA-encoded proteins” less any nucleus penetration or risk of genomic integration positions mRNA-based medicine as “desirable tools for treatment of a range of diseases, from infectious diseases to cancer and monogenic disorders (inheritance of a single gene mutations).

Yet this view evades over some fundamental challenges that the medical research establishment will not come out and admit publicly! At least in a minority of cases, for example, the spike protein generated by the mRNA does not just flush out of the system as declared by the boosters. Peer-reviewed study after peer-reviewed study finds evidence of the spike protein distribution sending the potentially toxic protein to various tissues or organs in the human body. This has become fact yet the medical research establishment will not accept this reality, at least not yet.

Or perhaps they have and experts such as Dr. Drew Weissman, the American physician-immunologist known for this contributions to RNA biology, whose work underlies the development of the mRNA vaccines of BioNTech (Pfizer), does perhaps acknowledge the need to advance the technology in this latest piece published in The Lancet.

While he and Penn-based colleagues declare in their recent paper, “The rapid pace and ease of mass-scale manufacturability of mRNA-based therapeutics supported the global response to the COVID-19 pandemic,” they explicitly acknowledge that “challenges remain with regards to mRNA stability, duration of expression, delivery efficiency and targetability.” Acknowledging and overcoming these fundamental challenges, an admission in many ways, are absolutely vital before any broadening of applicability for mRNA therapeutics can happen.

Put in simple terms the trio, rightly considered an authority on the topic, argue in this latest entry that it’s not prime time for mRNA technology!

But hold on, didn’t we just inject hundreds of millions of people worldwide with mRNA vaccines? Yes, of course, and that was an emergency use authorization scenario in an emergency setting. And while the jabs were ultimately approved by the Food and Drug Administration (except now for children 6 months to 11, which are still investigational), driving their logic is the assumption that the benefits given the COVID-19 pandemic outweighed any costs or externalities, which medical authorities and regulators resist any acknowledgment.

Of course, the evidence of these externalities exists in persons that combat ongoing issues, injuries derived from the mass immunization program. TrialSite has amassed more than enough evidence along with partner React19, the largest COVID-19 vaccine injury advocacy group worldwide.

TrialSite’s founder, Daniel O’Connor, shared, “This most recent piece in The Lancet represents yet another admission as to the reality that it’s not prime time yet for the mRNA therapeutic technology.” The TrialSite founder said, “You could not find a better, more authoritative source than Dr. Weissman, who, along with Katalin Kariko, received the Nobel Prize in Physiology or Medicine in 2023 for the discoveries of these two leading to the mRNA technology today as we know it.”

TrialSite has tracked a series of papers and studies now representing authoritative figures in science who come forth via academic papers discussing the gap between the existing platform in use, billions of doses administered, and the needs for better stability, efficient delivery, and targetability, as Weissman and colleagues postulate.

For example, TrialSite recently reported on the ex-Moderna scientists and the Northeastern University professor that recently had a similar paper published.

See the TrialSite piece based on the authored by four ex-Moderna scientists and a Northeastern University professor, the paper calls attention to serious limitations in the existing mRNA technology now on the market. See “Bombshell? Ex-Moderna Preclinical Scientists Acknowledge Serious Safety Concern with Current mRNA Technology..”

Weissman and colleagues acknowledge the ongoing need to learn “rapidly” from the growing number of both preclinical and clinical trials testing mRNA-based therapeutics and vaccines.

The goal: to optimize what essentially in the minds of the authors are a proven medical technology, based on what Weissman and colleagues breakdown as advances in mRNA technology, many overlapping with those discussed by the ex-Moderna scientists and in select other papers published in TrialSite.

How are these advancements being used in Immunotherapeutics, protein replacement therapy, and genomic editing? How is targetability improving in that scientists can, with more predictability, deliver mRNA to “desired specific cell types and organs?”

These breakthroughs, or better, incremental advancements are what is needed to validate the “development of the next generation of targeted mRNA therapeutics.”

Behind The Lancet paywall, we must respect their boundaries, as we have our own for economic sustainability, so for those tracking these trends the Weissman piece most certainly should be studied.

But here at TrialSite, we think it’s fair and important to ask about those gaps, the deficiencies in the mRNA technology that were clearly part of the emergency countermeasure product administered by over a billion people. Considering externalities in what, in essence, was a declared war against a pathogen, why is there such resistance to recognize and accept publicly what one of the true inventors of the technology has acknowledged?




Sunday, March 17, 2024

Catching Covid has made people less intelligent - with severe infections reducing IQ the most, new study suggests

Catching Covid makes people less intelligent, with severe infections reducing IQ the most, a study suggests.

Britons who avoided the disease typically performed best in intelligence tests, while those who ended up in hospital scored worst.

But even those who suffered only mild disease are likely to have had their cognitive abilities decline, it is believed.

Scientists from Imperial College London analysed data on more than 112,000 volunteers who took Covid tests during the pandemic.

Analysis revealed that those who were admitted to intensive care with Covid scored around nine IQ points lower on average in exams than those who avoided infection.

Those who reported having long Covid – persistent symptoms such as 'brain fog' – scored six points lower and those with only mild infection two points lower.

Professor Adam Hampshire, lead author of the study published in The Lancet medical journal, tried to match people as closely as possible when comparing the groups in a bid to account for other factors. 

Further examination found long-lasting cognitive impacts, even in people infected a year or more earlier.

The original Covid strain was associated with a bigger drop in IQ, while there were only marginal differences with Omicron. Vaccination also appeared to have a protective effect.

Professor Hampshire said the implications of the figures are 'quite scary'.

The participants had enrolled on Imperial College's React study. Dr Taquet said the results should be interpreted with caution as the study did not compare the same person before and after infection.

Professor Benedict Michael, director of the University of Liverpool's infection neuroscience laboratory, said there is 'clearly a very severely affected group'. 

But he added: 'I haven't yet seen convincing evidence that the vast majority of the population have been knocked back by X number of IQ points.'

Separate studies analysing brain scans taken before and after the pandemic suggest Covid infection can have an impact, even in those who had not been hospitalised.

Professor Michael said it did not appear to be the virus that was infecting the brain but a secondary consequence of infection elsewhere in the body – potentially acting on blood vessels, reducing oxygen flow. Researchers say it remains unclear if brains of Covid patients will fully recover.


Covid DID come from Wuhan lab, says new analysis of patients, records and virus' makeup: '70% chance'

After being denounced as a conspiracy for years, the Covid lab leak hypothesis is now considered the most likely origin of the virus, according to a new analysis.

Researchers from Australia and Arizona used a risk analysis tool- which they described as the most comprehensive yet - to determine the chances the SARS-CoV-2 virus was of 'unnatural' or 'natural' origin. 

The team compared the characteristics of the virus and the pandemic to 11 criteria that analyzed things like the rarity of a virus, the timing of a pandemic, the population infected, the spread of a virus and the unexpected symptoms of a virus. 

Based on the nature of Covid, researchers assigned a score to each category -  less than 50 percent meant the pandemic would be classified as a natural outbreak, but 50 or more percent would mean the pandemic was an unnatural outbreak. 

Covid received a score of 68 percent. 

The study said: 'The origin of [Covid] is contentious. Most studies have focused on a zoonotic origin, but definitive evidence such as an intermediary animal host is lacking.'

However, just because Covid received a higher score, the researchers said the 'risk assessment cannot prove the origin of [Covid], but shows that the possibility of a laboratory origin cannot be easily dismissed.'

Co-author Dr Raina MacIntyre, a professor of Global Biosecurity at the University of New South Wales, told 'The key point [the findings] make is that the likelihood of [Covid] originating from a lab is non-trivial and cannot be dismissed as a conspiracy theory.'

In the study, the virus and pandemic scored the maximum number of points in three categories. 

The first was the 'existence of a biological risk,' which is considered to be a geopolitical environment from which a biological threat could originate. 

With the pandemic, a biological risk was present in an area where dangerous pathogens were researched and where poor lab security could allow a pathogen to be released. 

Covid scored nine out of nine. 

Researchers said the score was high because WIV was located just 1,000 feet from the wet market believed to have been the site of the first cases of Covid and because Chinese researchers were experimenting with dangerous pathogens under lax protocols.  

In the 'unusual strain' category, Covid also scored a nine out of nine. This class was described as virus strains having atypical, rare, newly emerging or antiquated characteristics, as well as showing signs of gain-of-function or genetic engineering. 

This score was attributed to the virus' unique characteristics that allowed it to evade the immune system and be adept at infecting humans and mutating.  

Lastly, Covid scored the maximum nine-out-of-nine points in the 'special insights' category.

This was defined as 'suspicious circumstances and other insights identified prior to the outbreak, during the period of outbreak or post-outbreak.'

In this area, researchers highlighted the extensive debates around the origin and 'a series of unusual actions at the WIV,' including handing over control of the lab to the military and removing a large virus database containing 20,000 samples from bats and mice.  

Overall, out of a possible maximum 60 points, the Covid virus and the pandemic scored 41 - or 68 percent.  

While controversial, the Covid lab leak theory - that the virus was borne out of gain-of-function research at Wuhan Institute of Virology bankrolled by the US taxpayer through Dr Anthony Fauci's former department - has been endorsed by the FBI and other government agencies. 

Those subscribing to the zoonotic theory believe the virus originated in animals and jumped from host to humans.

A September 2023 study published in the journal Nature found a strain of coronavirus found in the rare animal pangolin - believed to be the zoonotic origin - was nearly identical to the the virus that sparked a worldwide pandemic. 

The discovery led the scientists to theorize that the first cases of SARS-CoV-2 likely jumped from pangolins to immunocompromised people. 

This gave the novel virus ample opportunity to mutate and replicate until it reached its full pandemic potential. 

However, lab leak supporters were recently emboldened after it was revealed that American and Chinese scientists sought to create a Covid-like virus just a year before the pandemic began. 

Records - obtained by FOIA requests in December - laid out a plan to 'engineer spike proteins' to infect human cells that would then be 'inserted into SARS-Covid backbones' at WIV in December 2018.

The proposal was made by the now-notorious EcoHealth Alliance, a New York nonprofit that channels US government grants abroad to fund these types of experiments.

Ultimately, the application was denied by the US Department of Defense, but critics say the plans laid out in the proposal served as a 'blueprint' for how to create Covid.

Talking about the implications of the study, Dr MacIntyre told this website: 'For policy, this [study] matters because we have more control over prevention of unnatural outbreaks, many of which arise from simple human error or inadequate biosafety. 

'Poor biosafety procedures in bat sampling and at the Wuhan Institute of Virology were documented but lab accidents are common all over the world.'