Was the COVID Vaccine Safe for Pregnant Women?

MARTY MAKARY

In December 2020, just before the vaccines for COVID-19 were first released to the public, Dr. Mandy Cohen, the Secretary of the Department of Health and Human Resources in North Carolina, urged everyone to get vaccinated as soon as they were able. “Corners were not cut,” Cohen said with confidence.

Then as now, pregnant women asked if COVID vaccines were safe for them. Public health officials said “yes” when the correct answer should have been “we don’t know yet,” given that pregnant and breastfeeding women were excluded from the original COVID vaccine trials. With Cohen set to replace Dr. Rochelle Walensky as director of the Center for Disease Control at the end of June, it is a good time to consider how Walensky performed on COVID—and in particular, on Women’s health issues—and ask whether Cohen will be any different.

In February 2021, to settle the controversy over whether the COVID vaccines should be used during pregnancy, Pfizer launched a randomized controlled trial of 4,000 pregnant women. But five months into the study, after enrolling 349 women, the study mysteriously stopped recruiting. Pfizer never offered a reason. Most concerning, the pregnancy outcomes of those who participated in the trial, and their babies, are still not public today, nearly two years later.

But the CDC did not wait for good data to make a decisive recommendation. In April 2021, just four months after the COVID vaccine was first granted an emergency use authorization and two months into the then ongoing Pfizer pregnancy trial, Walensky decided not to wait for the trial results, and instead recommended that all “pregnant people” get the vaccine. Three months later, the American College of Obstetricians and Gynecologists (ACOG) followed the CDC and “enthusiastically” recommended it as well.

Concerned by the zealousness and absolutism of this recommendation in the absence of evidence, a group of scientists and I petitioned the FDA to add a disclaimer to the vaccine label stating that no randomized trial data is available on the vaccine in pregnant women.

A few months ago, the FDA’s Dr. Peter Marks wrote back to us, denying our request. “The Petition fails to explain how including the fact of no results being reported would be relevant information that would contribute to the safe and effective use of the vaccine,” he claimed.

In other words, women don’t need to know. Just get vaccinated.

Not having any good data didn’t seem to bother the CDC.

Can a vaccine have a different safety profile in pregnant women than in the general population? There’s actually a precedent. The CDC advises that pregnant women not receive the HPV, MMR, or chickenpox vaccines, and instead recommends taking them before or after pregnancy, when indicated.

Remarkably, as the now outgoing CDC director—along with the ACOG—was pushing COVID vaccine absolutism for all pregnant women (regardless of preexisting natural immunity), a June 2021 New England Journal of Medicine editorial on COVID vaccines warned readers of “the dearth of safety information about pregnancy.” The article added the importance of waiting for Pfizer’s pregnancy trial to shed light on the matter, but alas, the early results are still locked up.

Pharma companies actually have a track record of halting trials that aren’t going their way and hiding results they don’t like. It allows them to control the narrative and manipulate markets. In many cases where data is hidden, Pharma companies play doctors like a fiddle.

A 2021 study by Yale, Stanford, and the University of Pennsylvania published in The BMJ found that out of 58 new drugs that the FDA approved in a two-year period, 33% did not make their trial results public, according to the researchers’ review of the data six months after the drugs’ approval. In 2004, Merck famously withheld clinical trial findings that Vioxx, their newly approved drug that was being used by 80 million Americans, increased heart attack risks. Vioxx was eventually pulled off the market.

In the case of the COVID vaccine trial in pregnant women, the trial may have been terminated not because the results were unfavorable, but because no data was needed. The medical and public health establishments had already made up their minds, declaring it safe and effective regardless of what the data was going to show. Why evaluate a product if the CDC and ACOG are already sold on the product?

Using the same groupthink science, the CDC and ACOG are now blindly recommending boosters and the new bivalent vaccine for healthy pregnant women, and once again ignoring the role of natural immunity. The ACOG website does not cite any clinical trials to back their recommendation, of course. Not only does the new bivalent vaccine lack any randomized trial data in pregnant women, it lacks any randomized trial data in humans (it was authorized based on data from eight mice).

Recently, public health officials went a step further and proposed the idea that people will need an annual COVID shot. That would mean that the average 5-year-old girl would need 77 mRNA COVID vaccine shots in her lifetime. Given the known risks of myocarditis and blood clots with each shot, such a sweeping recommendation should be based on trial data, not dogma. A recent study authored by Dr. Joseph Fraiman in the journal Vaccine identified the rate of “serious adverse events” after the COVID vaccine to be 1 in 662 doses.

To their credit, ACOG’s website does acknowledge COVID vaccination could delay menstruation. A large COVID vaccine study published last July found that “periods were late by less than 1 day on average.” When asked about this, Dr. Anthony Fauci told Fox News’ Bret Baier, “The menstrual thing is something that seems to be quite transient and temporary. We need to study it more.” But saying for two years that we don’t have enough studies is ironic when Fauci himself commanded an annual research budget of $6 billion. A Swedish study published last month in The BMJ found that an adjusted 26% increased risk of menstrual disturbance after the COVID vaccine in women age 12-49.

Since early 2021 women were reporting changes to their periods and unexpected vaginal bleeding, calling for proper study. Last October, the European Union’s regulator advised that “heavy menstrual bleeding” be added as a side effect on Pfizer and Moderna vaccine labels. Here in the U.S. there’s been no such update to product labeling.

This lack of humility was also evident when healthy young women were told with incredible absolutism that the COVID vaccine cannot affect fertility. The right answer should have been: We don’t think it will affect fertility but we don’t have any good data on the question. A Journal of the American Medical Association (JAMA) study published last fall concluded that, “Findings of this study suggest that receipt of the first inactivated COVID-19 vaccine dose 60 days or less before fertilization treatment is associated with a reduced rate of pregnancy.”

The medical establishment has also blindly pushed for universal COVID vaccination and boosters in lactating mothers. This recommendation came before a study in JAMA Pediatrics discovered vaccine mRNA particles in breast milk. The finding was so unexpected that it became the journal’s No. 1 most discussed study of 2022, according to the JAMA website. Coming in second was a study reporting myocarditis after COVID vaccination, and third was a study I authored with my teams at Johns Hopkins on durability of natural immunity. It’s telling that the most discussed JAMA studies of 2022 were all on topics that public health officials have consistently downplayed.

In the absence of good data, organized medicine chose the path of stern paternalism. But in my experience as a physician, it’s far better to properly inform a patient rather than steamroll their questions. It may be that Pfizer’s pregnancy trial would have been favorable to the vaccine, showing that the benefits outweigh harms, but Pfizer has not released the data. Perhaps the data was not favorable, or perhaps Pfizer realized they had convinced the medical establishment without data, so why run the risk of sharing what a placebo-controlled trial shows?

In the absence of good data, organized medicine chose the path of stern paternalism.

Perhaps the most famous example of hidden trial data is the 1989 Minnesota study that found there were more deaths in the group that ate a low-fat diet than in the control group that did not. The study was completed in 1973, 16 years before it was released to the public. When asked about the delay, the lead investigator, Dr. Ivan Frantz, famously said “we were just so disappointed in the way they turned out.”

The FDA recently authorized a second round of COVID bivalent vaccines for people over the age of 65, with no supporting clinical data. The authorization came a month after the FDA leaked to the press their intention to do so. This is the Biden administration’s new way of running the FDA. Leak something to the media, gauge public backlash, and fast track authorization of the drug without the supporting data typically required.

Is the COVID vaccine safe in pregnancy? Probably. But cutting corners on research and pushing vaccines without data is dangerous. It’s probably why 58% of women under age 50 say they do not trust public health officials when they say that the COVID vaccine is safe and effective in pregnancy, according to a University of Pennsylvania study published last month. Overall trust in the CDC is down from 69% pre-pandemic to 44% today. Dishonesty has consequences.

Even if the vaccine’s benefit outweighs the risks in healthy pregnant women, a review of 65 studies published in The Lancet in February concluded that natural immunity is at least as effective as vaccinated immunity, and probably more effective. So why is the medical establishment blowing through so much political capital on a blanket campaign to immunize those already immune?

For those who think the boondoggle of COVID policy has ended, consider the fact that just two months ago, public health officials beclowned themselves by insisting Novak Djokovic could not enter the U.S. to play tennis outdoors because he’s not vaccinated. This position, known as Biden’s “Djokovic doctrine,” embodies persistent errors in public health groupthink today, from ignoring natural immunity to downplaying vaccine induced myocarditis in young males to overlooking data on how extremely low risk the virus is for healthy young people to segregating people by vaccine status.

And just this week, the Biden White House required college athletes who won national championships visiting the White House to mask and stay six-feet apart if they are not vaccinated. Even if they have natural immunity. What does Mandy Cohen have to say about this standing policy still in place today?

To rebuild trust, the medical establishment—including physician associations and academic leaders—should be honest about what is known and unknown, rather than lock arms and broadcast its dogmas as science. For every subgroup in the population, medical science has long held high the principle of requiring data before making strong recommendations. Women should not be treated any differently.

https://www.tabletmag.com/sections/news/articles/was-covid-vaccine-safe-pregnant-women

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All-Cause Mortality Up after Mass COVID-19 Vaccination

Data from Japan and Germany display disturbing trend

Governments around the globe put a huge amount of faith in COVID-19 vaccines as their only intervention to reduce mortality. Yet, no prospective randomized, double-blind placebo-controlled trial has demonstrated a reduction in death with COVID-19 vaccines. On the contrary, every single data system around the globe has reported increased mortality coinciding with the roll-out of the vaccines.

Scherb and Hayashi used Japan and Germany for study of temporal trends in mortality. Both countries have excellent reporting systems. For Japan (125.7 M) and Germany (83.2 M), the WHO indicates as of 18, June 2023, and 14 May 2023, a total of 392,346,325 and 193,232,623 vaccine doses, respectively have been administered. This equates to 2-3 doses per person.

The authors found a disturbing jump in mortality coinciding with the start of mass vaccination. At the end of a pandemic, since the frail and elderly have suffered disproportionate casualties, there is usually a culling effect and mortality should go down. If the vaccines were effective, then certainly they should have dropped the death rate even more. The figures from Japan and Germany tell a different story.

https://www.trialsitenews.com/a/all-cause-mortality-up-after-mass-covid-19-vaccination-c5aaa4f2

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Also see my other blogs. Main ones below:

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

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

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

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

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

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

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

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

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Illness

I came down with a nasty cold on Friday and am still at the tailend of it. I will not be blogging today but hope to be recovered and back on deck tomorrow. I was tested for Covid but did not have it. It is just a seasonal virus

SARS-CoV-2 Mass Vaccination Likely Accelerates Viral Mutation—Time to Upgrade COVID-19 Vaccines?

The lead scientist at Sechenov Institute of Evolutionary Physiology and Biochemistry, Russian Academy of Sciences, Saint-Petersburg, Russia, and an expert infectious disease modeler at University Medical Center, Utrecht, Julius Center, Epidemiology & Health Economics in the Netherlands combined their intellectual prowess to investigate SARS-CoV-2 immune selection pressures, ultimately producing an important, published analysis titled “Evolutionary implications of SARS-COV-2 vaccination for the future design of vaccination strategies.” Mass vaccination was the “pillar of the public health response to the COVID-19 pandemic.”

But critics such as Geert Vanden Bossche, a TrialSite contributor, warned that mass vaccination might trigger mass evolutionary pressures, thus accelerating pathogen mutations. The Belgian virologist was summarily dismissed by mainstream science and its media channels as an overreacting crank. However, here, an intellectually gifted duo based in Russia and Holland raise the specter that based on their modeling “mass vaccination might accelerate SARS-CoV-2 evolution in antibody-binding regions compared to natural infection at the population level.”

In what should be a must read for decision makers in vaccination, the authors both review the most important factors shaping vaccination strategies during the COVID-19 crisis, while also probing the implications of SARS-CoV-2 vaccination on virus evolution in light of accumulated knowledge and in the context of viral evolutionary theory.

Their analysis raises the specter of a reality involving the evolution of rapidly mutating antibody-binding regions. Finally, the pair acknowledge the need for their own assumptions to be validated, while also pointing to the need for the research necessary to design potential future advancements in both vaccination and broader vaccination strategy.

The basis for mass vaccination

The formidable pair introduce the reader to vaccination strategies in the context of COVID-19, educating that primary tools employed during the pandemic were predictions based on robust epidemiological models tailored to the available data. Called “dynamic transmission models” or “infectious disease models”, they were used to simulate the transmission of a virus across a specific population, introducing and evaluating potential software simulated control measures.

It was, after all, transmission models for the virus, including mutation and how vaccination would respond, that were used to develop vaccination schemes during COVID-19: many national strategies were based on these models.

Key assumptions

Embracing material evidence of robust genetic variation in antibody-binding regions of SARS-CoV-2, the authors both capitalize on the similarity involving both the envelope proteins of SARS-CoV-2 as well as influenza, the pair make a key assumption: “That immune selection pressure acting on these regions” of both COVID-19 and the flu are comparable.

The authors, hardening their data including assumptions, analyze and discuss implications for SARS-CoV-2 evolution based on a mathematical model developed initially for influenza. The duo, if their analyses are accurate, most certainly impacts the future design of SARS-CoV-2 vaccination strategies.

While mass vaccination helped reduce morbidity and mortality, in many cases, that was a temporal public health gain, due to the combination of both an evolving pathogen and what TrialSite has argued are limitations with the initial vaccination products (e.g., durability, breadth challenges, lack of sterilizing powers, etc.).

Chinks in the mass vaccination armor?

Both Rouzine and Ganna raise the specter of limitation to the current mass vaccination approach. They raise the critical concern that “vaccination can also have implications for SARS-CoV-2 evolution in antibody-binding regions, located in the spike protein that is targeted by the available vaccines. SARS-CoV-2 perpetually evolves due to its escape from the immune response in individuals induced by both natural infection and vaccination.”

In fact, the authors remind the reader that irrespective of vaccination, when it comes to a pathogen like SARS-Cov-2 accumulating mutations in T-cell epitopes and antibody-binding regions powers selection pressure to escape natural immunity.

The authors demonstrate via modeling that mass vaccination can in fact, increase this inherent pressure, thus accelerating SARS-CoV-2 evolution in spike epitopes when compared to natural infection. The authors model this, thus conveying the distinct possibility that the arguments of Vanden Bossche have some merit.

Future research

The authors’ time and effort into this investigation evidence ongoing concern. “If SARS-CoV-2 continues to cause the substantial burden of severe disease in vulnerable individuals, we should either design a type of vaccine that does not carry any potential danger of accelerating virus evolution in epitopes but is still effective against severe disease or find other methods of reducing virus circulation.”

Rouzine and Ganna introduce several research pathways to consider for ongoing investigation into better options. Will apex research institutes, national public health agencies and major centers of biomedical research be receptive?

Summary

While the authors contribute their customary kudos to the current response to COVID-19 mass vaccination scheme, completely bypassing the topic of serious safety signals, they acknowledge that the pathogen that caused the COVID-19 pandemic continues to evolve, escaping in many cases from both natural and vaccine-induced immunity.

Demonstrating the distinct possibility that mass vaccination schemes in the context of the SARS-CoV-2 pathogen may serve to accelerate its evolution in rapidly mutating antibody-binding regions when comparing to natural infection, Rouzine and Ganna point out that their conclusion rests upon fundamental assumptions, including A) that the immune selection pressure exerted on antibody-binding regions of SARS-CoV-2 are in fact similar to those of influenza and B) on existing multi-locus models of influenza evolution.

Capitalizing on similarities between the envelope proteins of both SARS-CoV-2 and influenza in antibody epitopes, they further acknowledge that their model’s assumptions must be tested and potentially hardened. But in these author’s favor—they’ve proven to be correct with influenza—they have a serious track record.

Emphasizing what are limitations with the current COVID-19 mass vaccination approach, the authors carefully warn public health leaders that the role of mass vaccination on SARS-CoV-2 evolution “should be acknowledged for future vaccination strategies that target most at-risk populations, especially if vaccination campaigns will cover a substantial part of the population.”

Key considerations in the next round of COVID-19 vaccine development: “Mutations in immunologically relevant genomic regions, viral recombination, virulence and fitness evolution.”

The authors conclude by validating the current approach as likely the best considering all the factors involved (emergency pandemic, etc.).

https://www.trialsitenews.com/a/sars-cov-2-mass-vaccination-likely-accelerates-viral-mutationtime-to-upgrade-covid-19-vaccines-b6e80ab0

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Covid heartburn on Twitter

It’s incredible how soft some people are on social media. And I’m not even talking about overly political people right now. A mass exodus of scientists and medical professionals appears to be leaving Twitter because they can’t handle the trolls. Do they know of these fantastic features called the “mute” and “block” buttons that drown out the clowns? Some are annoying, but if they’re asking questions and looking for a debate, you can choose to or not to engage with them. Those with too much time on their hands focusing only on ad hominem attacks should be blocked. It’s not complicated.

Conservative women, especially, have been subjected to heinous harassment by progressives, who are, at their core—just miserable people. Incapable of accepting differing views and the people who hold them for some reason. They have an addiction to harassing people to cower to their political opinions. While not religious, left-wingers do carry the same evangelist zeal, stunningly intolerant that some people think differently than they do. We’re supposedly on the "wrong side of history"—how often have you heard that phrase— and they can’t sleep at night knowing everyone doesn’t think alike under the authoritarian ethos of progressivism.

And yet, scientists decide to leave the battlefield because some no-name trolls decide to call out these people about vaccines. Galileo was tortured and didn’t bend. Eppur si muove has lost its meaning. The fireworks began when Dr. Peter Hotez appeared on Joe Rogan’s podcast (via Axios):

A feud broke out on Twitter over the weekend between popular podcaster Joe Rogan and prominent vaccine researcher Peter Hotez, with the podcaster challenging the scientist to a debate about vaccines in an online skirmish that drew fire from a few billionaires.

Why it matters: The incident — which ultimately resulted in individuals approaching the scientist outside his home — highlighted the potential risks for researchers and medical professionals using the platform, which saw a rise in hate speech after its acquisition by billionaire Elon Musk.

[…]

The Twitter battle over the weekend started after Rogan hosted Democratic presidential candidate Robert F. Kennedy Jr. on his show for three hours, spending much of the time talking about anti-vaccine views.

In response, Hotez, part of a Nobel Prize-nominated team that created an affordable, patent-free COVID vaccine for use in poorer countries, retweeted a Vice article with the headline "Spotify Has Stopped Even Sort of Trying to Stem Joe Rogan's Vaccine Misinformation."

The show spread "nonsense," Hotez tweeted.

That prompted a challenge from Rogan to Hotez: "Peter, if you claim what RFKjr is saying is 'misinformation' I am offering you $100,000.00 to the charity of your choice if you're willing to debate him on my show with no time limit."

What happened next: Rogan's challenge sparked an internet pile-on against Hotez, accusing him of being a "pharma shill," as well as a back-and-forth between some of Twitter's most influential, including Musk and billionaire investor Mark Cuban.

[…]

What they're saying: Twitter is "no longer a tool that's accelerating science. On the contrary," said Michael Mina, chief science officer at eMed and a pediatric immunologist who regularly used Twitter during the pandemic to talk about COVID. He still uses Twitter, but sparingly, and expects he'll leave completely within the next six months, he said.

"It allowed me to effectively and efficiently sift through the noise of this massive explosion of new publishers and journals and papers that were published," Mina told Axios.

[…]

In comments to Axios as well as online, scientists and medical researchers have said they're increasingly finding it difficult to find relevant information on Twitter. A recent study found Twitter's new algorithms are amplifying anger more since Musk took over the platform.

Hotez told Axios he's seen a clear shift in anti-vaccine views as part of a well-organized, well-financed anti-science movement, and that's playing out on the platform.

Of course, Axios finds a way to thread a swipe at Elon Musk’s takeover of Twitter. There are ways to moderate your communities, as mentioned above. The publications added that scientists are posting elsewhere, like Substack. Still, the fires of outrage over vaccines could be addressed if the medical community owned up to the misinformation about the COVID vaccine and the pandemic. We were told to get the shot, take off the mask. The efficacy rates were touted as the main selling points. And then the vaccinated got COVID during the Omicron wave.

There have been shiploads of people dying from cardiovascular episodes, many under 44. And now, we’ve learned that those who have contracted and survived infection had an antibody response that was just as good as those vaccinated with two doses of the mRNA vaccine. The reality of the vaccine is that it might prevent death, but there’s no protection against infection. It’s very much like the flu shot, which has an efficacy of less than 60 percent, but it does increase the odds of you not dying from the virus that kills tens of thousands of Americans every winter.

But that fact dilutes the panic and fear the COVID regime sold to us for months over a virus with a 99-plus percent survival rate. People got vaccinated and still contracted COVID, with some dying from infection, especially older Americans. And now, with boosters, we’re learning that it weakens the immune system. Until these philosopher kings admit they blew it on COVID, expect more angry folks to confront them.

The online shenanigans still pale compared to what Galileo and other scientists of his era endured when presenting their scientific findings. Imagine being tortured for suggesting the Earth revolves around the sun. He stood firm while today’s Dr. Hotez mulls leaving because it’s too heated on Twitter. Yikes.

https://townhall.com/tipsheet/mattvespa/2023/06/21/galileo-would-be-spinning-in-his-grave-if-he-found-out-scientists-were-doing-this-n2624769?utm_source=thdailyvip&utm_medium=email&utm_campaign=nl&recip=6139244

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Also see my other blogs. Main ones below:

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

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

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

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

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

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

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

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

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Analysing a vaccine critic's claims

Should there be a Royal Commission conducted as part of the Australian government’s COVID-19 emergency response? That’s the opening question media personality professor David Flint David asks Malcolm Roberts, an Australian politician on the “Save the Nation” show.

Roberts, a member of right-leaning populist One Nation and a Queensland senator since 2019, replied “Absolutely.” In an interview on the “malfeasance” associated with the Australian government’s response to COVID-19, Malcolm Roberts speaks some truth, but at some points in the conversation conveys points that aren’t necessarily true or conclusively proven as fact.

COVID-19 shines a spotlight on the politicization of medicine across the board, from right to left, from so-called “old” industry to so-called new green industry advocates—they all are using the unfolding science to make their convenient point. But some of what Roberts has to say cannot be ignored. Of the more controversial stances, it’s proven that the 30,000 excess deaths in Australia in 2022 were caused by the mass COVID-19 vaccination countermeasure response to the SARS-COV-2 pandemic.

Roberts told Professor David Flint that in March 2021, as the mass COVID-19 vaccination campaign got underway, he asked both the Chief Medical Officer (CMO) of Australia and the head of the Therapeutic Goods Administration (TGA), the nation’s drug regulator, if the vaccines were 100% safe.

The Australian senator shared, “The immediate answer was, no they are not.” TrialSite reminds all that no vaccines are 100% safe. There are no perfect solutions to public health. There are instead tradeoffs where hopefully smart, objective biomedical scientists, physicians, regulators and other relevant experts in their respective fields determine the risk-benefit analysis—do the benefits of such vaccines markedly outweigh risks at a population/societal level? But that’s the reality of how vaccination works. Thus, Robert’s first question to the heads of Australia’s vaccine response was just not based on a notion of reality.

But Roberts' second question to the CMO and head of TGA was more on point, a question grounded in real-world reality. He asked, “Will they stop someone from getting the virus?" He told the interviewer that these top medical and regulatory heads in Australia declared, “No they will not.”

So, this was an honest answer. By March 2021, TrialSite was already learning of breakthrough infections due to the Delta variant, meaning that these COVID-19 vaccines were not of the sterilizing type. They could not stop all infectious transmission meaning that they could not be counted on to control the pandemic.

Nearly all developed nations produced public health data showing how the jabs did help reduce the incidence of morbidity and mortality associated with COVID-19 and although critics don’t believe those numbers, they don’t take time either to prove why they are incorrect.

However, the durability of the mRNA products became a serious question early on—by the spring of 2021. A significant issue was mRNA vaccine durability, so ultimately, three boosters were necessary in a period of just over a dozen months after the first primary series. While the RNA virus was mutating, this was a well-known topic. But it remained politically incorrect to even critique the vaccines for fear of creating vaccine hesitancy---something was terribly wrong.

Back to the interview, Roberts told the Save the Nation host he then asked the top medical and regulatory brass of Australia, “What dosage will you be administering the vaccines, the injections?" The Senator told Professor Flint that these powerful overseers of COVID-19 vaccine response declared, “We don’t know.”

The Australian senator summarized, “So they don’t know the dose, they know that it's not effective, they know that it won’t stop transmission, and they know that it's not 100% safe.” He paused and continued, “There is no benefit from these things, none whatsoever.”

Roberts then said, “In fact, efficacy goes into the negative after some time with people who have had these injections because it destroys the immune system.”

Mandates down under?

What about injection mandates in Australia? The Senator told the Save the Nation host that the head of the county at the time, Scott Morrison, would go on television and repeatedly lie to the Australian public that there were no such mandates.

According to Roberts, “Scott Morrison bought the injections, he gave them to the states, he then indemnified the states for their use, he then gave them access to the National Health Data, which enabled the injection to be mandated, because otherwise, the states couldn’t have enforced the mandate.”

Roberts continued, “Then we had the state premiers at the same time telling us that the reason they wanted mandates was to comply with the national cabinet.” He continued, “Well, the head of the national cabinet, which is a bogus entity as you know, was Scott Morrison.”

His point—“Scott Morrison drove the whole thing in this country.”

As part of the national Australian emergency Roberts emphasized that Morrison "redistributed taxpayer money to states for COVID-19 lockdowns (Australia was notorious in the Western world for these) and other inhuman restrictions, ineffective, damaging restrictions that weren’t effective in managing COVID.”

A correction, as TrialSite reported during the pandemic, Australia to some extent embraced the Chinese zero-tolerance COVID policy which meant strict enforcement of rules and regulations to prevent the spread of the virus. It implies that any violation of these rules would not be tolerated, and appropriate action will be taken to enforce compliance.

The specifics of zero tolerance policy for COVID-19 vary depending on the nation, context of jurisdiction, and the like. But some common elements were embraced by the Australian national and state government. This in fact, did stop the spread of COVID-19 (Australia wasn’t hit early on nearly as hard as places like America), but the policy in reality only delays the eventual spread of the pathogen, at great cost to human psychology, cultural vitality and economy we might add.

What’s Senator Roberts’ takeaway on the Australian gov response to COVID-19?

The pandemic response was “completely mismanaged, deceitful, it killed thousands of people…” Roberts intensifies his criticism of the government introducing the phenomenon of excess deaths.

Declaring that there are now 30,000 excess deaths in Australia for the year 2022 alone, this elicited an immediate response from host Professor David Flint who interrupted the Senator, “Could you explain to viewers what an excess death is?”

The Senator responded, “Every year in Australia there are an expected number of deaths, and they vary slightly but because no two years are identification, there is slight variation… and there is a range above and below the mean [number] so it varies,” and the senator demonstrated how a certain number of deaths are expected with some variation above or below the mean number.

So, the point is that the number typically occurs within an expected range, but since COVID-19 and the mass vaccination program the expected death numbers have skyrocketed across much of the developed world.

TrialSite has reported on this number. In fact, this media chronicled in early 2022, that the death rates surged just as the nation’s population became heavily vaccinated which defied expectations.

For example, TrialSite reported in late April 2022 in “Heavily Vaxxed Australia: First 3.5 Months of 2022 has Doubled the COVID-19 Deaths from 2020-2021 Combined.”

Back to the interview, Roberts said, “What we know is that provisional death data shows an excess of 30,000 or more in 2022.”

On the interest of these deaths among the leadership of Australia? Roberts said these people who head TGA, the CMO the secretary of the federal health department “don’t give a damn, there is no inquiry going on as to what is causing these excess deaths. We know, we know from overseas experts, from peer-reviewed scientific papers that it is the injections causing these [excess] deaths. And an alarming level of deaths.”

Why don’t they care? Roberts declared, “I think they are worried about being found culpable for the injections that they have pushed on people and killed people with.”

But contrary to Roberts’ claim there has not been one peer review, scientific study published in a mainstream journal that connects the mounting excess deaths crisis and the mass vaccination program.

Speculation has included COVID-19 itself, and all the problems that come after lockdowns, tight access to healthcare, and the like. But the vaccines are suspect, and Roberts is correct in his assessment that generally, governments are avoiding the topic. That avoidance most certainly signals a set of priorities and values.

https://www.trialsitenews.com/a/australian-senator-claim-30k-excess-deaths-caused-by-the-mrna-vax-b93a05a8

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Pfizer mRNA Vaccine Appeared to Trigger Stroke-like symptoms in one patient

Physicians from multiple health centers in Paris, France including Percy Army Training Hospital in Clamart, France in the southwestern suburbs of Paris report on a case series involving a case of subacute lumbosacral NA after the patient received the Pfizer-BioNTech COVID-19 vaccine, called Comirnaty (BNT162b2).

After a thorough diagnosis the French providers concluded that there was no “triggering factor” injuring the 48-year-old patient other than the mRNA-based COVID-19 vaccine—the doctors could not confirm the suspected causation however exhibiting a common trend. Does this reflect a real hesitancy to identify when the vaccine causes harm? Luckily, the patient went into full recovery after treatment with intravenous immunoglobulin.

The French doctor’s report in the journal Revue Neurologique that the individual patient has a recorded history of obstructive sleep apnea syndrome which had been treated with mandibular advancement orthotic with no history of diabetes and no medication.

Summary

The patient was infected by SARS-CoV-2 by March 2020, and later received his first jab of the Comirnaty vaccine on January 20, 2021. Just six days later on January 26, 2021, the authors report:

“The patient experienced a sudden onset of paresthesia in the anterior part of his lower right limb. The symptoms rapidly worsened throughout the day, with anesthesia starting at mid-thigh and extending to the right ankle. These deficits were then followed by neuropathic pain of the right lower limb, for which the patient was put on Pregabalin therapy by his general practitioner and a hospitalization in neurology was programmed. The patient had difficulty walking with weakness of the right lower limb.

On February 11, 2021, the patient received a second dose of Comirnaty© vaccine.”

By April 13, the patient was hospitalized in the hospital’s neurology department. Doctors reported he had “sensory symptoms” plus had difficulty walking which persisted since the jab.

A series of diagnostic measures were taken, along with tests discovering neurogenic aspect when assessing the right vastus medialis and vastus lateralis muscle with electromyography.

Considering multiple conditions including Guillain Barre syndrome, the eventual diagnosis was subacute lumbosacral NA, following a Pfizer SARS-Cov-2 vaccine in a 48-year-old patient.

The diagnosed condition is an issue related to the lower back and sacral region that has a subacute course. Lumbosacral is the region in the lower back where the lumbar spine meets the sacrum whereas subacute means a condition that is intermediate in nature—falling between acute (sudden onset, severe) and chronic (long-lasting) conditions.

The authors report that this 48-year-old patient fully recovered after receiving a regimen of intravenous immunoglobulins. While it would appear that the vaccine is the cause, the authors cannot conclusively state so.

https://www.trialsitenews.com/a/pfizer-mrna-vaccine-appears-to-trigger-subacute-lumbosacral-na-264ced0d

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Also see my other blogs. Main ones below:

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

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

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

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

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

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

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

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

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Time to Launch Government-funded Investigations Into the COVID-19 Vaccines

While the COVID-19 vaccines, particularly the mRNA base product developed by both Pfizer-BioNTech and Moderna, became vital tools and countermeasures as part of a global emergency response to the SARS-CoV-2 (COVID-19) pandemic, a lot of problems have been suppressed by a confluence of government, industry and health establishments.

Yes, the Phase 3 mRNA studies showed a remarkable benefit as measured in efficacy, and documents accessed via the Freedom of Information Act (FOIA) suggest a significant surge in vaccine-related side effects. We must remember the COVID-19 vaccines were non-sterilizing and possess questionable durability and breadth. The vaccines were helpful tools during COVID variant surges and overall, the safety record has been decent for most people. The vast majority of these side effects are mild and go away within a few hours to a few days.

However, life is rarely so simple and convenient, and COVID-19 is no exception. A significant number of rare, but real adverse events (AEs) have led to vaccine injury. In fact, TrialSite has tracked enough studies pointing to some connection of the mRNA vaccines to inflammatory actions possibly associated with lipid nanoparticles, used to help deliver the mRNA (payload).

The other culprit for vaccine-related AEs comes as a consequence of the production of the spike (S) protein as well as related subunits and peptide fragments manufacturing across human tissue or organ(s). Much research to date focused on lab tests at the cell or model organism level.

A growing body of evidence points to AEs associated with the COVID-19 vaccines linked to the spike protein, likely associated with molecular mimicry with human proteins or via ACE2 ligand according to some researchers. It's perfectly OK and in fact, part of the scientific tradition to be open, critical and upfront with concerns.

The official medical establishment narrative is as follows: the mRNA vaccines are safe and effective, and that’s the end of the story. Like any vaccine or medication they can have side effects, but these are mostly mild and temporary. But the reality is that no medicine or vaccine is perfect, and in fact, there are no solutions but only tradeoffs, based on multiple considerations such as overall public health.

Serious side effects, however, associated with the mRNA jabs can and do occur. They have been associated with myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining around the heart) and recently validated in a Korean national cohort study, sudden death in a few extremely rare cases. The most at-risk cohort for these cardiovascular-related risks is young men, typically from the teens up to 30.

Other side effects associated with the mRNA vaccines, although rare, can and do occur and include the presentation of acute myocardial infarction, Bell’s palsy, cerebral venous sinus thrombosis, Guillain–Barré syndrome, myocarditis/pericarditis (mostly in younger ages), pulmonary embolism, stroke, thrombosis with thrombocytopenia syndrome, lymphadenopathy, appendicitis, herpes zoster reactivation, neurological complications and autoimmunity (e.g., autoimmune hepatitis and autoimmune peripheral neuropathies.

Anti-Vaccine activists point to the exponential increase in reported cases of AEs in the Vaccine Adverse Event Reporting System (VAERS), however, the logging of these reports doesn’t automatically prove that the AEs are vaccine-related. Historically, VAERS counts, which are managed by the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration, are undercounted. This means that the actual number of serious adverse events associated with the mass COVID-19 vaccine response in America (270 million primary series in just a couple years) could be far higher than represented in VAERS. But we cannot be sure. As of March 1, 2023, 19,476 deaths are logged in VAERS. Again, this doesn't mean that these deaths are linked to the COVID-19 vaccines (again the vast majority were vaccinated with mRNA-based products).

However, some anti-vaccine activists point out that over 50% are reported within a week or so of the jab, meaning a likely temporal connection. Regardless, over 19,000 deaths represent a lot of deaths possibly linked to vaccines logged in the very system that’s supposed to track incidences. Moreover, VAERS is historically undercounted. But again, as fact-checkers point out in VAERS, correlation does not imply causation — just because an adverse event is reported as having occurred does not mean that a vaccine was the cause.

But based on our ongoing tracking of research around the globe we believe sufficient safety signals are sufficiently present for government investment in specific research to identify the true risks associated with these novel products.

I say novel here because the mRNA vaccines were accelerated due to the declared emergency and completed in 10 months. Importantly, while mRNA research has been going on for a couple of decades, actual commercialization efforts are far newer. For example, Moderna’s own investor disclosures as recent as the end of 2019 acknowledge that these products have never been commercialized and significant risk is consequently attached to the entire research, development and manufacturing initiative. See the link.

TrialSite secured evidence from leaked European Medicines Agency (EMA) emails that at least some prominent employees there were bothered by the pressure to rush the products. Sonia Elijah has reported on this in detail.

We also reported on the avoidance of all required pre-IND enabled studies; biodistribution data accessed via a Japanese FOIA which was given to use by Canadian researchers early in the pandemic.

Additionally, variation in lot quality reported in TrialSite by Sasha Latypova points to potential quality issues in the production of the mRNA vaccines. Sonia Elijah tracked multiple packages of documents released as a result of FOIA. Potential issues are identified.

We are aware of problems directly in the Pfizer clinical trials based on the Brook Jackson lawsuit. While that lawsuit has been tossed by the judge, this author reviewed internal documentation directly involved with that litigation which points to severe quality problems at the Texas-based trial site network (Ventavia).

Any normal study would have been put on hold based on what we reviewed. Multiple media point to grossly inadequate FDA oversight of the mRNA vaccine trials.

While pregnant women were told to get the vaccine by the summer of 2021, they were done so before any regulatory edict. This was seemingly orchestrated between CDC observational data and physician societies focusing on women’s health. Both were concerned with a risk-benefit equation favoring vaccination, but adequate safety data was never produced.

While female rats are a start, it's absolutely outrageous that this class of data was used as evidence to justify the injection of a novel product into a highly vulnerable class of humans. To this day, the FDA package inserts for both Pfizer and Moderna are troubling to say the least. For example, the FDA package inserts for Pfizer’s mRNA Comirnaty as of this writing explicitly declare a lack of data to know whether it's safe or not. See the link. The FDA declares:

“Available data on COMIRNATY administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.”

For studies involving vaccination of pregnant women follow the link to the following TrialSite piece “ACIP Vote Unanimously to Add mRNA-based COVID-19 Vaccine Shots for Children Program.”

We have delineated a timeline of exactly what group recommended vaccination for pregnant women and when. We don’t argue for a conspiracy, but we do argue that herd mentality was at play. Now only investigational products (boosters) are recommended by the FDA. Although, there is an argument that the Pfizer and Moderna mRNA platforms are validated.

Access to other documentation via FOIA such as the CDC’s V-Safe database (thanks to attorney Aaron Siri) pointed to up to 7% of the population receiving the COVID-19 vaccines experiencing an adverse event requiring medical attention. We have acknowledged that the data source can’t prove anything but we don’t summarily discount the data either. While anti-vaccination activists point to the 7% figure as a proxy for vaccine-injured numbers, TrialSite doesn’t agree with this assessment. Our estimation of COVID-19 vaccine injured is far less than anti-vaccine activists. While the latter argues for tens of millions, our estimates at TrialSite suggest anywhere from half a million to 2 million people have been impacted by adverse events which in some way impact quality of life.

Those actually permanently debilitated by the COVID-19 vaccines we believe are a number under 50,000. But this would still be an unacceptable number, demanding not only a government-funded investigation but also a change in vaccine injury compensation policy. Currently, only a handful of people have even been compensated under the government’s Countermeasures Injury Compensation Program (CICP). The average award is under $2,000 dollars and the whole affair is a national disgrace in this author’s opinion. How can there be a mandated policy for a novel medical product (countermeasure in emergency terms) and no viable mechanism to care for people hurt by such a product? What kind of society accepts this? Governments in places like Taiwan and Singapore do a far better job than the United States on this front.

While the majority of investigators in academic medicine line up and report overwhelming safety and efficacy data there are exceptions. We at TrialSite track National Institutes of Health (NIH) awards and record research payments over the past couple of years are allocated to major academic medical centers.

In one study looking at the problem more critically Peter Doshi, and colleagues, all serious physician-scientists, demonstrate based on an extensive review of clinical trials that the mRNA vaccines are “associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI −0.4 to 20.6 and −3.6 to 33.8), respectively.

Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95 % CI 2.1 to 22.9); risk ratio 1.43 (95 % CI 1.07 to 1.92). The Pfizer trial exhibited a 36 % higher risk of serious adverse events in the vaccine group; risk difference 18.0 per 10,000 vaccinated (95 % CI 1.2 to 34.9); risk ratio 1.36 (95 % CI 1.02 to 1.83). The Moderna trial exhibited a 6 % higher risk of serious adverse events in the vaccine group: risk difference 7.1 per 10,000 (95 % CI –23.2 to 37.4); risk ratio 1.06 (95 % CI 0.84 to 1.33). Combined, there was a 16 % higher risk of serious adverse events in mRNA vaccine recipients: risk difference 13.2 (95 % CI −3.2 to 29.6); risk ratio 1.16 (95 % CI 0.97 to 1.39).”

Does the mRNA spike protein stay in the body or is it expeditiously flushed out of the human body?

According to conventional medical establishment, the mRNA vaccines do not cause the spike protein to say in the body indefinitely. This is generally the case as the mRNA vaccine provides instructions to cells in the body to produce a harmless piece of the spike protein found on the surface of the SARS-CoV-2 virus. This spike protein is then displayed on the surface of the cells temporarily.

The wisdom tells us that the immune system recognizes the spike protein as foreign and mounts an immune response to it. This response includes the production of antibodies and the activation of immune cells. Once the immune response is triggered and the spike protein is recognized, it is broken down and eliminated from the body.

As the logic goes mRNA is a transient molecule that is rapidly degraded within cells. After the spike protein is produced and the immune response is activated, the mRNA from the vaccine is also broken down and eliminated.

Although mRNA is considered a gene therapy, it's not of the type, according to the medical establishment, that alters a person’s DNA or integrates into the genome. The mRNA is supposed to remain in the cytoplasm of the cell, as there it is used as a template to generate the spike protein. Key to the medical establishment’s declaration that the vaccine is not a traditional gene therapy: it doesn’t breach the nucleus of the cell where DNA is based. But make no mistake, TrialSite has verified it's classified as gene therapy by the manufacturers themselves in investor disclosures, directly from the proverbial “horse's mouth.”

While the standard medical establishment understanding means that the spike protein only remains in the body for a temporary period of time, and the mRNA associated with the jabs is rapidly degraded and eliminated, there are plenty of exceptions that are frankly suppressed by the media.

TrialSite supports vaccine injured group React19 to organize the largest data repository of post-COVID-19 vaccine serious adverse event case series, observational and randomized studies. Follow the link for the repository. This is something the federal government should have financed. See the link to access over 3,400 studies.

We have studied enough to know better. There was enormous pressure to not spook consumer markets during the COVID-19 pandemic across local, state and national governments in the U.S, and across other nations around the world. That pressure started in the Trump admin—the POTUS at the time admitted in the Woodward interview that he downplayed the seriousness of SARS-CoV-2, likely for political purposes. Among other problems, this created a cult of COVID-19 denial.

On the other hand, Biden declared a COVID-19 mandate when the science was absolutely clear that the mRNA COVID-19 vaccines were not of the sterilizing variety—meaning they could not reliably stop viral transmission, even though at least in surges of 3 to 12 months they could reduce the probability of morbidity and mortality.

The mandate was clearly unethical, representing some form of power play, and a clear example of executive overreach that the courts recognized in part. We at TrialSite suggest that both Republicans and Democrats politicized the pandemic for their own aims and that the American people are the pawns in a bigger socio-political and economic game. This is one reason for ever more intensive divisive politics—they want us divided and at each other’s throats.

So as long as we have enough readers/subscribers that demand actual objective, unbiased (or as unbiased as possible) news and analysis, we at TrialSite will continue to bring as much transparency and clarity to biomedical and health-related research as possible—our original and only mission, started when we founded and launched the site in late 2018, focused on the translation of complex biomedical research for busy professionals and other consumers interested in research. That mission continues on.

And based on all of the data and analyses we have accumulated over the past two-and-a-half years, not to mention extensive discourse with intelligent experts around the world, we do believe formal investigations must be launched to better understand the true risks associated with the COVID-19 vaccines.

https://www.trialsitenews.com/a/time-to-launch-government-funded-investigations-into-the-covid-19-vaccines-5d9147a0

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Also see my other blogs. Main ones below:

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

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

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

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

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

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

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

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

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COVID-Vaccinated MORE Likely to Be Hospitalized: CDC Data

There are some problems with inferences here but a complete reversal of the expected result is extreme and seems unlikely to be explained by confounds etc. We may have to allow that the vaccines are more harmful than helpful in the medium term

COVID-19 vaccine effectiveness against hospitalization turned negative over time, according to U.S. Centers for Disease Control and Prevention (CDC) data presented on June 15.

The effectiveness against hospitalization plummeted to negative 8 percent for people who received one of the old COVID-19 vaccines, according to data from a CDC-run hospital network.

A dose of one of the updated bivalent vaccines moved the protection above zero, to 29 percent, but the protection fell back to negative 8 percent beyond 89 days, the data show.

The protection estimates were for adults without a compromised immune system from Jan. 23 to May 24, when the XBB strain was dominant in the United States. The data came from people hospitalized at one of 25 hospitals across 20 states that are part of the Investigating Respiratory Viruses in the Acutely Ill network. Both cases and controls were hospitalized with COVID-like illness but the cases tested positive for COVID-19 and the controls tested negative for COVID-19.

“We see a pattern of waning against hospitalization,” Dr. Ruth Link-Gelles of the CDC said while presenting the data to a U.S. Food and Drug Administration (FDA) panel as they consider updating the composition of the vaccines.

Link-Gelles didn’t specifically comment on how the effectiveness turned negative but noted the wide confidence intervals for some of the effectiveness estimates.

The bivalent vaccines, made by Moderna and Pfizer, were introduced in the fall of 2022 with the hopes of improving protection against hospitalization and death after the old vaccines proved increasingly incapable of providing sustained shielding.

Dr. Robert Malone, who helped invent the messenger RNA technology utilized by the vaccine companies in their vaccines, said that the negative effectiveness is consistent with prior data such as a study from the Cleveland Clinic that found each successive vaccine dose increased the risk of infection.

Other papers have also estimated that protection against infection turns negative over time. Some datasets have indicated that vaccinated people were at higher risk of hospitalization, long seen as a surrogate for severe disease.

Researchers in one recent paper said that repeated vaccination—some Americans have received a half-dozen COVID-19 shots in under three years—weakens immune systems, potentially making people susceptible to life-threatening conditions such as cancer.

The estimates were negative even after CDC officials made adjustments for factors such as age, sex, and ethnicity. The median time since the last dose for the people who only received one or more doses of an old vaccine was 464 days. For the group who received a bivalent vaccine but saw effectiveness turn negative, the median time was 137 days.

Other Data

Data from another network found that protection neared zero over time.

Among adults deemed immunocompetent after XBB became dominant, the protection from the old vaccines against hospitalization was measured at 9 percent in the CDC’s VISION network. A shot of a bivalent vaccine increased protection to 51 percent, but the shielding plunged to 20 percent 90 to 179 days after the shot.

From September 2022 to May 2023, immunocompromised adults in the same network who only received an old vaccine had just 3 percent protection against hospitalization.

A bivalent shot increased the protection to 39 percent, although the shielding was reduced to 11 percent beyond 119 days.

VISION includes sites across 11 states, including Kaiser Permanente Northern California and Columbia University in New York.

Under half of each age group in the United States has received a bivalent dose, including 43 percent of those age 65 and older and 0.6 percent of 2- to 4-year-olds.

The CDC didn’t present data on the effectiveness against infection.

XBB became dominant in the United States in January, displacing BA.5 and its subvariants. The bivalents contain a BA.4/BA.5 component in addition to the Wuhan component. The FDA plans to update the vaccines to target XBB and its sublineages for a renewed vaccine campaign in late 2023 and early 2024.

“We’re concerned that we may have another wave of COVID-19 during the time when the virus has further evolved, immunity of the population has waned further, and we move indoors for wintertime,” Dr. Peter Marks, an FDA official, said during the meeting.

Turn to ‘Critical Illness’

Officials have increasingly been focusing on protection against so-called critical illness, or intensive care unit admission or death, as protection against hospitalization drops lower and lower.

Protection against critical illness from a bivalent was 58 percent initially and only dropped to 48 percent, according to data from VISION during XBB’s predominance.

There weren’t enough critical cases in the Investigating Respiratory Viruses in the Acutely Ill network to provide estimates of protection against critical illness, Link-Gelles said.

She said that patterns of waning with the bivalent vaccines “have been very similar to what we knew from the monovalent vaccine” and that U.S. officials don’t make vaccine policy decisions “based solely on vaccine effectiveness data.”

Limitations of the data include the high levels of prior infection, or natural immunity, and potential differences between unvaccinated and vaccinated people, officials said.

https://www.theepochtimes.com/health/covid-vaccinated-more-likely-to-be-hospitalized-cdc-data_5335428.html

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Chinese Researchers Demonstrate in Lab D-glucosamine Inhibits SARS-CoV-2 and other Coronaviruses

Researchers from the Beijing Institute of Microbiology and Epidemiology, China report in the peer-reviewed journal Nature on the urgent need for the development of broad-spectrum antiviral therapies targeting not only SARS-CoV-2 but also all other coronaviruses, which may either reemerge or emerge for the first time, not to mention mutant variants that can cause so much trouble as humanity discovered during the COVID-19 pandemic.

For example, in China, directed by top-down command and control ethos, this led to extremely costly (both in terms of human health and economy) societal lockdowns, finally changing the so-called “zero tolerance COVID policy” toward the end of the pandemic. In this study involving both infected cells and mice, a dietary supplement with 50 years of use as a regimen against osteoarthritis could possibly, as a supplement administered at daily doses help reduce the impacts of SARS-CoV-2. Of course, more research, including human trials, is needed to investigate the potential of D-glucosamine (GlcN) as a regimen against COVID-19, but the output from this study demonstrates promise.

This research, represented by corresponding authors Chengfeng Qin and Xiaotao Daun, both employed at the Beijing Institute of Microbiology and Epidemiology identified a possible target for broad-spectrum antiviral therapy centering on O-GlcNAcylation, a posttranslational modification derived from hexosamine biosynthetic pathway (HBP), and essential for virus-induced MAVS activation and IFN signaling.

In the lab, the team from the People’s Republic of China identified that a common dietary supplement known as D-glucosamine (GlcN), “enhanced MAVS-mediated IFN signaling, meaning that this low-cost accessible supplement exhibits a broad-spectrum antiviral activity.”

What about applied coronaviruses, however? Before answering that question, a brief overview of D-glucosamine.

What is D-glucosamine?

A naturally occurring amino sugar, D-glucosamine is a building block for various important molecules in the body. It’s a derivative of glucose and is commonly found in the exoskeletons of shellfish, as well as in the tissues of some fungi and microorganisms.

It’s often used as a dietary supplement in support of joint health.

Any studies in humans to date?

Yes. These authors point to a recent clinical study (ClinicalTrials.gov: NCT04706416) reporting that orally administrated N-acetyl glucosamine (NAG), a downstream metabolite of GlcN, decreases the mortality rate and improves clinical outcomes of SARS-CoV-2 infected patients. That was a phase 1 study sponsored by Quantinosis.ai LLC. See the link.

A total of five studies involving D-glucosamine are registered in Clincialtials.gov. They include three complete studies and two active studies. The two active studies include the use of a drug sulodexide which is a mixture of glycosaminoglycans (GAGs) composed of dermatan sulfate (DS) and fast-moving heparin.

The study

The investigational team set up a model for infection based on human lung epithelial cells like Calu-3 and human liver cancer cell line Huh7. The study team used GlcN ultimately at 20mM for 3 h on the Calu-3 or Huh7 cells infected with SARS-CoV-2 at a multiplicity of infection (MOI) of 1.

At 24 hours of infection, the team “observed that SARS-CoV-2 infected cells showed a significantly enhanced intensity of cellular O-GlcNAcylation compared to the non-infected group.”

According to Qin, Duan and their colleagues as conveyed in Nature this observation indicated that SARS-CoV-2 does promote HBP metabolism and protein O-GlcNAcylation in host cells.

Similar to other observations in RSV virus-based infections (e.g., IAV and VSV) they report, “As expected, we found that GlcN significantly increased the cellular level of O-GlcNAcylation and substantially suppressed SARS-CoV-2 replication in infected lung epithelial cells as measured by SARS-CoV-2 spike protein expression.”

The authors further report, “Virus titers in the supernatant were significantly reduced (P < 0.01) in GlcN treatment group.” Additionally, Qin, Duan and colleagues write in their study, “Time course measurements (6 to 24 h post-infection) further confirmed our observation, GlcN treatment significantly inhibited replication of SARS-CoV-2, consistent with titer reduction.”

Moving on, the authors further report the median effective concentration (EC50) value of GlcN against SARS-CoV-2: “GlcN inhibited SARS-CoV-2 infection in Calu-3 cells with a EC50 value of 11.82 mM.”

The authors also conducted an investigation to better understand the viral mechanism of GlcN against the novel coronavirus showcasing intriguing observations that the supplement led to “a considerable increase of both phosphorylated IRF3 and phosphorylated TBK1 and thereby promoted IFN signaling in response to SARS-CoV-2. This in turn decreased the expression of SARS-CoV-2 spike protein in the GlcN treatment group.”

What about the antiviral effect of GlcN against SARS-CoV-2 in vivo? The authors used mice that were infected and treated with the targeted regimen. While the body weight of the orally GlcN-based treatment of mice remained normal, a review of the impact of GlcN against samples of the mice lungs, spleens and livers showed no inducement of systemic IFN response.

The regimen demonstrated potential against at least a couple of other coronaviruses suggesting the potential for application against a broad spectrum of coronaviruses as well.

Overall, the authors report:

“Taken together, this study demonstrated that GlcN enhances SARS-CoV-2 induced IFNs signaling and restricts SARS-CoV-2 replication in multiple human cell lines. In the SARS-CoV-2 infected mouse model, prophylactic administration of GlcN at a clinical-relevant dose significantly reduces the viral load in lung and trachea, and considerably alleviates lung inflammation.”

Summary

This lab study in China demonstrates that GlcN shows potential efficacy against multiple coronaviruses including SARS-CoV-2 in both cell-based and mouse infection models.

The authors remind us:

“GlcN has been clinically applied for the treatment of osteoarthritis for more than 50 years. As a nutrient supplement, orally administered GlcN at daily doses ranging from 750 to 3500 mg is well tolerated in human subjects. Given the safety profile and its broad-spectrum anti-HCoVs activity, GlcN may serve as a promising drug for preventing the spread of SARS-CoV-2 and its emerging variants in healthy populations.”

https://www.trialsitenews.com/a/chinese-researchers-demonstrate-in-lab-d-glucosamine-inhibits-sars-cov-2-and-other-coronaviruses-fbcf472c

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Also see my other blogs. Main ones below:

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

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

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

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

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

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

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

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

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The Nail in the COVID Coffin

We can now say definitively that the virus came from the Wuhan lab because three named workers were the earliest to become infected.

Granted, the American people have mostly moved beyond COVID-19, both literally and figuratively. But there are still some vital housekeeping matters to take care of — and as of this week, one less of them: We now know definitively, not speculatively, from whence it came. As independent journalists Michael Shellenberger, Matt Taibbi, and Alex Gutentag write on Substack:

After years of official pronouncements to the contrary, significant new evidence has emerged that strengthens the case that the SARS-CoV-2 virus accidentally escaped from the Wuhan Institute of Virology.

According to multiple U.S. government officials interviewed as part of a lengthy investigation by Public and Racket, the first people infected by the virus, “patients zero,” included Ben Hu, a researcher who led the WIV’s “gain-of-function” research on SARS-like coronaviruses, which increases the infectiousness of viruses.

“Strengthens the case”? These gents are being too modest. This closes the case and puts a nail in its coffin, to mix our metaphors. It’s one thing to identify the Wuhan lab as the source of the deadly scourge, but it’s another thing entirely to name individual names, which is what this new report does: the aforementioned Ben Hu, and Yu Ping, and Yan Zhu. These are three of the earliest people to become infected with SARS-CoV-2, and they all worked at the Wuhan Institute of Virology.

B-b-b-but, but, they could’ve all been shopping for some fresh dog or pangolin at that nearby wet market!

Yeah, right.

This, of course, isn’t the first time that anyone has claimed COVID-19 came from a lab. Heck, this humble correspondent has been claiming it for years. And doubling down on it.

As for those apologies, we aren’t holding our breath. Still, it’s instructive to remember just how wrong these people have been proven to be. Even lefty Jon Stewart, who came out of retirement to address his people’s Krazy Glue adherence to the theory that a bat flew into the cloaca of a turkey and resulted in the deaths of — depending on who’s counting — more than 1.1 million deaths in the U.S. and nearly seven million deaths worldwide.

It’s also worth remembering the evolution of the blame. As first, everyone was calling it “the Wuhan coronavirus.” But then the ChiComs put the arm on their leftist fellow travelers here in the U.S., and pretty soon it became racist to imply that the Wuhan coronavirus was in fact the Wuhan coronavirus. Take a look.

But merely identifying the Wuhan lab and its earliest victims isn’t the end of it. There’s also the matter of the Chinese military’s involvement. As Shellenberger writes elsewhere on Substack: “You may recall that The New York Times called Robert F. Kennedy a ‘conspiracy theorist’ for saying Covid resulted from a bio-weapons program. And yet one of the State Department cables [which were recently obtained via a FOIA request] shows a connection between China’s biotechnology sector and the Chinese military (People’s Liberation Army), which included its construction of the Wuhan lab.”

The ChiComs’ military involvement in COVID-19 gained momentum earlier this week, when the UK’s Sunday Times published a bombshell report about it. As our Nate Jackson wrote:

Researchers “were combining the world’s most deadly coronaviruses to create a new mutant virus,” the Times says. This gain-of-function research using viruses collected from bats was funded in part with U.S. taxpayer money funneled from the National Institutes of Health (NIH) through EcoHealth Alliance, which almost certainly lied to keep the funding coming, and conducted by “researchers from the Chinese military” who were “pursuing bioweapons.”

We wonder: Will the commie apologists affix the “RACIST!” label to those of us who are now suggesting, with ever-increasing evidence, that the Red Chinese military is behind all this? Time will tell. And time will tell whether the ChiComs will pay any real price for what they’ve done. (By the way: How is it racist to think that the Chinese are both intelligent enough to develop a deadly virus and stupid enough to accidentally leak it, but it’s not racist to accuse them of shopping at these weird wet markets and eating dogs and bats and pangolins and hedgehogs?)

National Review’s Jim Geraghty reminds us what happened to an honest Chinese doctor who tried to alert the rest of the world to what was happening back when it could’ve saved millions of lives:

The problem was that when those doctors tried to pull the alarm, the local, regional, and national Chinese government authorities above them kept shutting down their efforts until it was too late. Dr. Li Wenliang got dragged into a police station and was berated for “rumormongering” and for “publishing untrue statements,” and threatened with prosecution. A little more than a month later, the virus that he had desperately tried to warn his countrymen and the world about killed him.

Earlier in the week, Geraghty noted an exhaustive Times of London piece which leads folks to a single inevitable conclusion — or one of two conclusions, if you’re a dead-ender who can’t agree with Donald Trump under any circumstances: “Either Covid-19 plagued the globe because of an accident at the Wuhan Institute of Virology in late 2019, or an absolutely remarkable series of coincidences, against overwhelming odds, led to a virus that has never been found in nature infecting a human being just down the road where the WIV was doing gain-of-function research on the virus in nature that is most similar to SARS-CoV-2.”

The question now is: What are we going to do about it — not only with respect to the Chinese, who have yet to atone for it, but also regarding those here in the U.S. who went to such extraordinary lengths to defend the purveyors, to hide the truth, and to rewrite history?

As blogger and public health expert Michael Hanna writes, “The most troubling part for me is knowing that this will likely happen again, and again — unless some very nasty consequences are brought to bear for those who knowingly or unknowingly enabled this unmitigated disaster in funding and oversight of biohazardous research.”

https://patriotpost.us/articles/98113

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US presidency through the Covid lens

We stand at a Covid cross-roads. On one side, there is by now a wealth of studies demonstrating the negligible benefits of the key pandemic interventions. In May the US finally ended its ban on unvaccinated foreigners’ entry into the country. A study by Kevin Bardosch looked at 600 publications using a ‘harm framework’ to conclude that ‘the collateral damage of the pandemic response was substantial, wide-ranging and will leave behind a legacy of harm for hundreds of millions of people in the years ahead’, exactly as many of us warned from the beginning. In June a major peer-reviewed meta-analysis of 20,000 studies from the Institute of Economic Affairs by US, Swedish and Danish researchers concluded that, regarding stringent lockdowns, in the words of co-author Steve Hanke, ‘the lives saved were a drop in the bucket compared to the staggering collateral costs imposed’.

On the other hand, there remain many disquieting indicators of the continuing hold that the failed and discredited narratives have on policymakers and publics to suggest that the insanity could be repeated at short notice. For example, Biden’s pick as the new CDC director, Mandy Cohen, is a lockdown, mask and vaccine fanatic. On 14 August 2020 she tweeted a photo of herself wearing a mask imprinted with a portrait of the execrable Anthony Fauci. Many of the worst offenders on lockdown, masks and vaccines have been honoured with gongs while the likes of Oxford University’s Carl Heneghan and Stanford’s Jay Bhattacharya were monitored by the government’s Counter-Disinformation Unit and heavily censored on social media. Governments remain stubbornly resistant to investigating the concerning phenomenon of excess deaths. The WHO and the European Commission have launched a digital health initiative for creating global vaccine passports. The WHO effort at expanded powers to rule over the world through a new treaty and/or amended international health regulations remains on track.

President Dwight Eisenhower’s warning, in his farewell address of 17 January 1961, of ‘the military-industrial complex’ is one of the most quoted phrases of any US president. In the same speech, he also warned of another danger: ‘The prospect of domination of the nation’s scholars by Federal employment, project allocations, and the power of money’ such that ‘public policy could… become the captive of a scientific-technological elite’. The lens of how various leaders managed the pandemic therefore helps us to frame the contest in terms of their respective culpability in enabling and facilitating the grave attacks on freedoms, versus their capacity and willingness to resist and reverse the blanket of authoritarianism that has suffocated liberal democracies since 2020.

Because of the dominant influence of America on the rest of the democratic world, the US presidential contest has unique global resonance. Lord Sumption, the former UK Supreme Court justice, said in May 2020 that ‘the lockdown is without doubt the greatest interference with personal liberty in our history’. On 18 May US Supreme Court Justice Neil Gorsuch echoed Sumption: ‘Since March 2020, we may have experienced the greatest intrusions on civil liberties in the peacetime history of this country’.

In this perspective, the ideal Republican and Democratic champions would be Ron DeSantis and Robert F. Kennedy Jr. No one else comes close in the two parties to their record in forceful opposition to lockdowns, masks and vaccines. For them to triumph in the primaries would mean the campaign will be a referendum on Covid, the resistance heroes win the public debate, and the new president has a clear mandate to revert to pre-Covid normality. At present both are miles behind the two front-runners Trump and Biden in the RealClearPolitics poll of polls and betting averages. However, both DeSantis and Kennedy are well clear of other candidates. Considering both have only recently declared, this is an impressive solid base on which to build.

Democrats have been unsettled by the high profile and surging support for Kennedy. On many character and judgment attributes, voters rate Kennedy higher than Biden. In the Echelon poll in May Kennedy scored a massive 40 per cent net favourability advantage over Biden. Little wonder Republican political consultant Douglas MacKinnon believes that Kennedy will be the Democratic nominee. Of course, the media continues to smear Kennedy for kooky conspiracy theories even as many have come true. But he has name recognition, speaks with passion and gravitas and as an experienced trial lawyer, has good debating skills.

In DeSantis, Trump faces the most successful, best funded and best prepared intra-party opponent of his political career. DeSantis gained national profile for turning a marginal victory in 2018 into a landslide in 2022, colouring America’s biggest swing state from rosé to ruby red. Many Americans applaud DeSantis for the fightback against the metastasising woke ideology. He famously declared ‘Florida is where woke goes to die’. Good leaders pick highly capable aides and work well with them over many years. Trump is notable for the rapid churn of most of his hand-picked senior aides. He demands total loyalty but gives none in return. For most of this year, the focus of Trump’s ire and schoolyard insults has been DeSantis. The Republican base loves DeSantis, if less than Trump, and reviles former New York governor Andrew Cuomo. In his desperation to wound DeSantis on Covid management, Trump has gone full-on Cuomosexual, besties with benefits. Because Cuomo is toxic among diehard Republicans, Trump risks damaging his own standing with them.

In a one-minute video rant, Trump accused Florida of having the third-worst Covid death rate in the US. ‘Even [former New York governor Andrew] Cuomo did better, he was number 4’. Put aside the fact that Trump himself moved to Florida. On the raw figures, the US national average is 352.5 Covid deaths per 100,000 people. Florida is tenth-worst with 412.1 deaths/100k and New York ranks 16 with 399.1 deaths/100k. But the CDC’s state-by-state analysis of age-adjusted Covid mortality (a more accurate mortality metric) gives the national average as 282.9. Florida ranks a lowly 36 among the 50 mainland states with 245.2 compared to New York’s 311.7 that put it at number 17. Trump’s instincts may have been libertarian but he allowed himself to be manipulated into policies that have produced disastrous consequences. DeSantis attacked Trump for turning over the country to Fauci in Match 2020 that ‘destroyed millions of peoples’ lives’.

Trump’s federal indictment on 9 June for holding classified documents throws a wrench into all calculations: will it derail his candidacy or solidify support in anger at the Democrats’ weaponisation of the criminal justice system?

https://www.spectator.com.au/2023/06/us-presidency-through-the-covid-lens/

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Also see my other blogs. Main ones below:

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

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

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

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

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

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

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

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

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mRNA vaccines fast-tracked for Australian agriculture

After the spectacular failure of mRNA vaccines in human trials, the agricultural industry is pushing ahead with mRNA vaccines for livestock engaged in the food industry.

Whispers of stock ‘dying suddenly’ will no doubt become a complaint of farmers in the future, summarily ignored by government in the same way officials refuse to listen to serious concerns about dam-building restrictions, price hikes on Ag products, ridiculous fees and charges, incomprehensible red and green tape, biosecurity regulations that do nothing, and – fresh out of Western Australia – expensive negotiations with Indigenous groups who have never set foot on the land they claim to ‘own’.

In one example that mRNA is on its way Down Under, on May 2, 2023, Meat and Livestock Australia (MLA) announced funding for a project to ‘test mRNA vaccines that can be rapidly mass-produced in Australia in the event of a lumpy skin disease or other exotic disease outbreak’.

The Manager for Animal Wellbeing, released a statement saying:

‘This project will develop a mRNA vaccine pipeline initially for LSD, but potentially for other emergency diseases. This will enable capacity for rapid mass production of a vaccine for LSD in the event of an outbreak. No LSD vaccines are registered for use in Australia yet. While some vaccines exist overseas, the path to registration in Australia for traditionally-produced [vaccines] is longer than that of an mRNA vaccine.’

Why are traditional vaccines, which have safety records that outstrip mRNA vaccines, subject to longer approval periods than mRNA vaccines? That sounds like a significant structural failure within Australia’s health body that, instead of being fixed, has the potential to be exploited by manufacturers looking to cash in on mRNA.

mRNA vaccines are quick to produce and ‘nimble’, which is why pharmaceutical companies like them – but that doesn’t mean that they are safe, effective, or suitable for consumers whether those are humans or livestock.

A 2022 article in PubMed Central notes: ‘Recently, the successful application of mRNA vaccines against Covid has further validated the platform and opened the floodgates to mRNA vaccine’s potential in infectious disease prevention, especially in the veterinary field.’

No doubt this is why we keep hearing bleatings of ‘emergency’ and ‘outbreak’ in the same breath as mRNA, as if to remind us of the mantra used during the Covid era to embark on what the former Health Minister referred to as the ‘largest clinical trial – the largest global vaccine trial ever’. Look how that turned out.

The fall-out of Covid mRNA vaccines is likely to continue for the best part of a century as a percentage of vaccinated individuals ‘die suddenly’ or suffer from long-term debilitating illnesses. These are quickly becoming a burden for the health industry and state finances after vaccine manufacturers hand-waved responsibility because it was an ‘emergency’. Most nations are setting up compensation pools of cash to cope with the growing list of individuals who claim to have been harmed.

Another excuse used to feather the nest of mRNA vaccines is that they are thought to provide the solution for influenza-style viruses which traditional vaccines have proven ineffective against. Everyone wants to see an effective vaccine against respiratory viruses, but it’s almost as if the doe-eyed vaccine industry has put on a blindfold for the last three years. mRNA Covid vaccines did next to nothing to combat or control the influenza-style Covid and do not, based on what we have seen, offer any advantage to traditional vaccines for this problem beyond the feel-good marketing headlines. There is a strong argument that for the majority of the population, they did more harm than good.

Instead of suspending all mRNA vaccines until we understand what went wrong, they are being given priority treatment by regulators and championed by manufacturers who love the competitive edge of speed their production offers. Governments, particularly the (broke?) Victorian state government, are funnelling tens of millions into mRNA development to keep capitalising on the political popularity they enjoyed during the Covid era.

MLA note that mRNA vaccines should be ready for use within two years and while everyone is busy stressing that this will be a ‘voluntary’ option for the farming community, vaccines inside the agricultural industry rarely are if a producer wishes to sell their product into domestic and international markets. If we go down the mRNA vaccine production line, it is extremely likely that Australians will be eating mRNA-vaccinated livestock within a couple of years with very little understanding of what this will mean health-wise.

Anyone who criticises mRNA vaccines or their potential future within the agricultural industry are paraded through the press as ‘conspiracy theorists’ with publications quick to send out the fact-checkers to insist that it’s pure fear-mongering to suggest fragments of these vaccines will end up in the food chain.

Except, it was a ‘conspiracy theory’ to suggest that the human body would continue making Covid mRNA vaccines long after the injection, or to raise concerns that it would leave the site of the injection. Not only did the fears described as ‘conspiracy’ prove to be true, the behaviour and side effects of Covid mRNA vaccines are reaching well beyond what anyone predicted.

How sure are we that in the rush to saturate the market with mRNA vaccines, that proper long-term testing will be conducted, particularly when it comes to lingering in meat and milk? Will it impact high-risk activities such as calving, given there is a strong suspicion that Covid vaccines are responsible for a spike in human miscarriages?

Keep in mind that we are still being told Covid vaccines are ‘safe and effective’. The Australian government, sitting on a pile of unwanted vaccines, is spending public money on marketing campaigns, encouraging Australians to go and get their booster shots at the same time other countries have removed Covid vaccines.

At least some States in the US are taking note, rushing to pass legislation to ban the use of mRNA vaccines for animals involved in the food industry whose meat or milk is produced for human consumption. Idaho is one example where it will be a misdemeanour to use mRNA vaccines – and that includes the Covid vaccines.

Australians need to be aware that mRNA vaccines are coming for the agricultural industry and they will likely be compulsory. America is having a serious conversation about whether this should be allowed, and Australia needs to do the same thing. It is perfectly reasonable to require extensive long-term safety data before we revolutionise agriculture.

This conversation will not happen on its own. Australia’s agricultural elite resemble a body of yes-men nodding furiously toward mRNA. Family farmers – disempowered, constrained, and demoralised – have no voice in this matter. Their wishes will be bulldozed by a small collection of billion-dollar farming entities, several of which are foreign-owned.

If Australians care about what they eat, it’s time to start making a racket.

https://www.spectator.com.au/2023/06/mrna-vaccines-fast-tracked-for-australian-agriculture

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Vaccine advisory group to meet, including vaccine critics

Current vaccines of little use

TrialSite has reported that this week, the Food and Drug Administration (FDA) Vaccines and Biological Products Advisory Committee (VRBPAC), a group of independent experts in the fields of virology and vaccinology, will meet tomorrow, Thursday June 15 from 8:30AM to 5:00PM ET, accessible via YouTube.

Among other presenters and speakers will be David Wiseman, Ph.D., a frequent TrialSite contributor and critique as to how government agencies such as the FDA have conducted its affairs during the pandemic. TrialSite has reported how both the World Health Organization (WHO) and the European Medicines Agency (EMA) and the European Centers for Disease Prevention and Control (ECDC) have made the call to accelerate the move away from the current COVID-19 vaccine formulations to more relevant Omicron strains such as those associated with XBB lineages.

TrialSite wrote and warned frequently during the early parts of the mass countermeasure roll out that it would be difficult to impossible to control SARS-CoV-2 with vaccines. A dynamic, mutating RNA virus, the pathogen drastically changed over the last couple years, emerging as not only more transmissible but also less severe. The pathogen increasingly evaded the defensive powers of the COVID-19 vaccines.

The FDA’s briefing artifacts point to a comparable direction for the American vaccine regulator. TrialSite reviewed the artifacts, finding that Pfizer, Moderna and Novavax need to advance formulations, becoming monovalent again, targeting the Omicron XBB sublineages with an emphasis on XBB.1.5, XBB.1.6 or XBB.2.3. The FDA now embraces a process comparable to how the specific annual influenza vaccine is selected.

The current COVID-19 vaccine in use in America, the bivalent booster (index strain plus Omicron BA.4/BA.5), has emerged as the only vaccine product recommended by the FDA. But there is just one problem: The strains that this vaccine targets are basically extinct. The quality of this product as measured by durability and breadth of effectiveness is questionable---at least this is the case according to TrialSite. Also as TrialSite’s founder recently argues for in an opinion piece, the government should invest in more detailed safety reviews.

So, expected at tomorrow’s meeting is that a strain will be selected, and then the pharmaceutical companies of Pfizer-BioNTech, Moderna and Novavax will be expected to update their platforms with the targeted updated strains. Importantly, as is the case with WHO, EMA and CDC, the pharmaceutical vaccine makers will not have to revalidate their platforms. This means that human clinical trials data will likely not be required assuming a sufficient collection of prespecified data meeting key targets are provided by the vaccine makers before authorization by the agency. However, this process has detractors, such as Dr. David Wiseman, who argues changes to formulation have included material modifications to the vaccines necessitating validation—meaning extensive clinical trials to verify efficacy and safety.

The current bivalent BA.4/BA.5 vaccine now streamlined as the only option in America based on a handful of studies affords only nominal to slightly improved neutralizing antibody protection against current predominant SARS-CoV-2 Omicron strains such as XBB and XBB.1 than compared to three doses of the original monovalent jab.

Moreover, the bivalent jabs met significant hesitance among the American healthcare market, COVID-19 or not. Americans were increasingly hesitant due to a confluence of factors including concerns about vaccine quality and safety. Under 20% of the eligible population opted to even receive the jab.

By February of 2023, the CDC reported that the XBB 1.5, an Omicron lineage, emerged as the predominant SARS-CoV-2 pathogen in circulation. First detected in October 2022, by May 2023, the University of Nebraska reported XBB.1.5 emerged with 53.8% of all cases, followed by XBB.1.16 with 15.1% of cases, and XBB.1.8.1 with 11.8 of cases. According to Dr. Mark Rupp, “The original omicron variant is gone now.”

The FDA has noted in the past that “intrinsic viral factors” such as rate of mutation and recombination potential suggest greater transmissibility and adaptation to the human host while host immune response and a confluence of other forces may contribute to selection of variants. An outspoken critic, Belgium vaccine specialist Geert vanden Bossche has gone on the record that it was a mistake to conduct a mass vaccination in the middle of a pandemic. While the conventional wisdom of medical and scientific establishments, often unduly influenced by industry, points to the vaccines saving millions of lives.

https://www.trialsitenews.com/a/covid-vax-critic-to-speak-at-tomorrows-fda-vrbpac-meetingexperts-likely-to-select-xbb.1.5-as-target-for-monovalent-formulation-784df42a

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Also see my other blogs. Main ones below:

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

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

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

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

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

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

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

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

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