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Fri, 28 Jan 2022
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Australia's TGA evaluation report of the Pfizer vaccine

"The shortcoming of the repeat dose toxicity study design should not preclude approval of the vaccine." Really?

UPDATE: Thank you to this person on Twitter.
Twitter post Screen Shot
© Twitter
Well, well, well. This document that I will talk about today is not new, but it is hot. Where to start? Considering I'm not even sure what the quote that became the title of this article means, let's start with the title of the Report:
Nonclinical Evaluation Report

BNT162b2 [mRNA] COVID-19 vaccine (COMIRNATY™)

Submission No: PM-2020-05461-1-2

Sponsor: Pfizer Australia Pty Ltd

January 2021

Eval Rpt by TGA
The document begins with a summary of what they found in their own assessment of the safety of the COMIRNATY product made by Pfizer. The first thing that you should probably pay attention to is the comment about pharmacology and toxicity in the summary. But wait one second. Let's set the stage here.


Covid-19 exacerbates kidney problems for those with multiple comorbidities

times square covid test
© Reuters / Andrew Kelly
People queue for a Covid-19 test in Times Square as the Omicron variant continues to spread, New York City, US, December 26, 2021.
Covid-19 directly infects cells and can cause severe damage to the kidneys, according to a scientific study connecting serious infection with organ failure.

In a paper published in the scientific journal Cell Stem Cell on Friday, a group of researchers report that Covid-19 can cause serious complications affecting a patient's kidneys.

"SARS-CoV-2 directly infects kidney cells and is associated with increased tubule-interstitial kidney fibrosis in patient autopsy samples," the study says, acknowledging that, while kidney failure "is frequently observed during and after Covid-19," it had previously been inconclusive as to "whether this [was] a direct effect of the virus."

Comment: Covid for the vast majority is relatively harmless, similar to the flu, a great many don't even know they have it without a test, and so kidney failure is not a common occurrence at all. Those who do suffer more severe issues with Covid also have multiple comorbidities, which means that their physiology may already be seriously compromised. In fact, as noted below in red, this seems to be exactly what's happening.

Comment: See also: More than half of people with long Covid might NOT have 'long Covid' after all


Omicron Variant Sends Vaccine Makers' Stocks Soaring, as VAERS Data Show 913,000 Reported Adverse Events After COVID Vaccines

Covid Vaccine
VAERS data released Monday by the Centers for Disease Control and Prevention included a total of 913,268 reports of adverse events from all age groups following COVID vaccines, including 19,249 deaths and 143,395 serious injuries between Dec. 14, 2020, and Nov. 19, 2021.

The Centers for Disease Control and Prevention released new data late Monday showing a total of 913,268 adverse events following COVID vaccines were reported between Dec. 14, 2020, and Nov. 19, 2021, to the Vaccine Adverse Event Reporting System (VAERS). VAERS is the primary government-funded system for reporting adverse vaccine reactions in the U.S.

The data included a total of 19,249 reports of deaths — an increase of 396 over the previous week — and 143,395 reports of serious injuries, including deaths, during the same time period — up 4,269 compared with the previous week.

Excluding "foreign reports" to VAERS, 664,745 adverse events, including 8,898 deaths and 56,297 serious injuries, were reported in the U.S. between Dec. 14, 2020, and Nov. 19, 2021.

Foreign reports are reports received by U.S. manufacturers from their foreign subsidiaries. Under U.S. Food and Drug Administration regulations, if a manufacturer is notified of a foreign case report that describes an event that is both serious and does not appear on the product's labeling, the manufacturer is required to submit the report to VAERS.

Of the 8,898 U.S. deaths reported as of Nov. 19, 20% occurred within 24 hours of vaccination, 26% occurred within 48 hours of vaccination and 56% occurred in people who experienced an onset of symptoms within 48 hours of being vaccinated.

In the U.S., 447.7 million COVID vaccine doses had been administered as of Nov. 19. This includes: 260 million doses of Pfizer, 171 million doses of Moderna and 16 million doses of Johnson & Johnson (J&J).

Comment: See also:

Star of David

Massive new bird flu outbreak could be 2022's deadly pandemic

Wild Cranes
© Sky News
Wild Cranes in Israel
Israel's National Security Council has assumed control of a massive bird flu outbreak in the Galilee, which scientists warn could become a "mass disaster" for humans.

Over half a billion migrating birds pass through the area every year, heading for warm African winters or balmy European summers, making this a catastrophic location for a major bird flu outbreak — right at the nexus of global avian travel.

The virus can be deadly if it infects people. The World Health Organization says more than half of the confirmed 863 human cases it has tracked since 2003 proved fatal. Most strains or variants of avian flu, H5N1, are relatively difficult to transmit to people.

Yossi Leshem, one of Israel's most renowned ornithologists, told The Daily Beast, however, that it is the ability of these viruses to mutate into new strains that poses such a threat, as we have seen with the coronavirus. "There could be a mutation that also infects people and turns into a mass disaster," said Leshem, a zoologist at Tel Aviv University and director of the International Center for the Study of Bird Migration at Latrun.

Comment: The heralds of this disaster are equating it with Coronavirus, ramping up a new bogeyman as the variants peter out. Reality: Another food source is dwindling.

See also:

Cupcake Pink

High-sucrose diet during adolescence may contribute to pathogenesis of psychiatric disorders, including schizophrenia

sucrose psychiatric
© Tokyo Metropolitan Institute of Medical Science.
Hirai et al. demonstrated that a high-sucrose diet during adolescence induces psychosis-related behavioral endophenotypes, including hyperactivity, poor working memory, impaired sensory gating, and disrupted interneuron function in mice deficient for GLO1, an enzyme involved in detoxification of sucrose metabolites. I
Using a mouse model, a team of researchers at the Tokyo Metropolitan Institute of Medical Science demonstrated that high-dietary sucrose consumption during adolescence is a potential risk factor for the development of behavioral phenotypes associated with psychiatric illnesses, such as schizophrenia and bipolar disorder.

Considering the global increase in consumption of simple sugars, the World Health Organization published guidelines that addressed concerns regarding body weight gain and dental caries development in 1995.

High sugar intake alone increases the risks of numerous chronic diseases, including diabetes, hypertension, and kidney disease.

Comment: Interestingly, there's increasing evidence that sufferers of schizophrenia may be extra sensitive to a variety of foods, and that some alleviation of symptoms can be found in eating a more wholefood diet, lower in carbohydrates (simple sugars) and higher in animal fats. Anecdotally, some researchers have highlighted this point by showing that in more primitive societies, these kinds of mental disorders appear to be much less common:

Stock Down

As three more studies show NEGATIVE vaccine effectiveness, when will health authorities face up to what the data is telling us?

vaccine efficacy graph covid
The last two weeks have brought three new studies finding negative efficacy for two vaccine doses, meaning the vaccinated are more likely to be infected than the unvaccinated. These are study findings, not raw data, so have been adjusted for various biases and confounders, making it harder to dismiss them as anomalous or skewed.

The first is a pre-print study from Denmark, published on December 23rd, which looked at nearly all PCR-positive SARS-CoV-2 infections in Denmark from November 20th to December 12th and investigated them to see if they were likely to be the Omicron variant.

By comparing the vaccination status of those infected, the researchers found a vaccine effectiveness against the Omicron variant of minus-76.5% for Pfizer and minus-39.3% for Moderna three months after double vaccination (see chart above), meaning the double-vaccinated were considerably more likely to be infected than the unvaccinated.

They found the vaccine effectiveness against Omicron was significantly lower than against Delta, with Pfizer vaccine effectiveness at 53.8% and Moderna at 65% against Delta after three months. They reported that a third dose of Pfizer got vaccine effectiveness against Omicron back up to 54.6%, at least for a month. The full results are in the table below:

Life Preserver

Stop panicking: You are a third less likely to catch Covid this Christmas than last Christmas and 80% less likely to die from it

children playing
We're republishing the latest analysis by James Ferguson, a financial analyst, which argues - quite convincingly - that not only is Omicron considerably milder than Delta but also less transmissible.

Almost a year ago to the day, I noted that the reasons given for closing down Christmas celebrations in the U.K. last year had owed more to a basic mathematical error than the supposed increased transmissibility and virulence of the new alpha (Medway) variant.

This year, a similar threat from omicron appears to be scaring the politicos, but this again seems more a figment of the scare-mongers' hysteria than scientifically-grounded evidence.

The willful damage that certain so-called scientists have serially inflicted on the economy needs to be queried. However, the propaganda machine likens any healthy skepticism to flat-earth advocacy.

Consequently, this note takes a leaf out of Steven Koonin's excellent book on the climate debate Unsettled, and only interprets the Government's own official data.


Omicron variant could boost immunity against Delta and eventually displace it: study

covid testing
Infection with the Omicron coronavirus variant may provide increased immunity against Delta, according to a new South African study. Here, a passenger of a flight from South Africa is tested for the virus at Amsterdam Schiphol airport on December 2 in Amsterdam, Netherlands.
Omicron coronavirus infections may provide individuals with increased protection against the Delta variant and pave the way for Delta to eventually become displaced, according to a new study published in South Africa.

Researchers from the Africa Health Research Institute (AHRI) conducted a small study and found that people who are infected with Omicron, especially those who are vaccinated, gain stronger immunity against Delta.

The research involved 13 Omicron patients, seven of which were vaccinated and one who had received a booster shot. To conduct the study, the scientists measured how well participants were able to neutralize Omicron and Delta upon enrollment, and 14 days later. During that time-frame, they found that neutralization of Omicron generally increased 14-fold, while Delta neutralization increased 4.4-fold.

According to the paper, vaccinated participants "were able to mount a better neutralizing response against Delta" while those who were unvaccinated had "more variable" responses.


Scientists discover new muscle layer in the human jaw

xray skull
© Peter Dazeley/Getty Images
It turns out there are still exciting new discoveries to be made in a field as well-studied as human anatomy: researchers have confirmed the existence of a layer of muscle in the human jaw that has until now eluded anatomists.

This new muscle is a deeper, third section of the masseter muscle. It's the most prominent jaw muscle: press your hand against the back of your jaw while you chew and you'll feel it moving.

Typically represented as having just two layers, there has been suspicions based on animal studies that there is more to its structure. However until now, attempts to describe it have been contradictory and confusing.

Comment: These discoveries reveal how much we've still to learn about our own bodies, never mind the wider world: Also check out SOTT radio's: Objective:Health #25 - Fascia - The Body's "Fiber Optic" Crystalline Matrix


'Tis the Season to be Tested?

PCR for Christmas
© Unknown
Officials in many jurisdictions are reporting skyrocketing case rates, stoking ever greater fear of the Mighty Omicron.

Yet the breathless, wall-to-wall, MSM coverage doesn't mention that the jump in cases is very likely simply due to the testing rate shooting through the roof.

Instead the MSM is having a field day, thanks to most people's gullibility. And that includes promoting mass testing, early and often.

The media report that new studies are showing people infected with Omicron are far less likely to have severe disease or to be hospitalized than those detected to have Delta, and also usually are vaxxed or have had Covid.

Yet media quote researchers, politicians and public-health officials as warning that the high Omicron case numbers suggest health-care-system capacity could soon be pushed past the limit.

Comment: Er, Omicron (anagram 7 letter word) = Moronic