Aug 212021
 


Salvador Dali Swans reflecting elephants 1937

 

FDA Aiming To Give Full Approval To Pfizer Covid-19 Vaccine Next Week (RT)
FDA To Grant Full Approval To Pfizer Vaccine Without Public Discussion (BMJ)
Development Of Safe And Effective Covid-19 Vaccines (Nature)
Vaccinated Man Dies In Florida, Daughters Urge People To Get Vaccinated (Hill)
World First Plasmid DNA Covid-19 Vaccine Gets Emergency Approval In India (RT)
Director Of Yale University Research Center About Ivermectin (CdS)
French Businesses Are Refusing to Enforce Vaccine Passport (SN)
Almost 9 In 10 Britons Likely Or Very Likely To Go For Covid Booster Shot (RT)
The Heebie-Jeebies of August (Kunstler)
2020: A Propaganda Masterpiece 2: Divide and Conquer (Perspectives on the Pandemic)
Dr. Peter McCullough (1 of 2) | Episode #19 (Perspectives on the Pandemic)

 

 

Quite the paradox. That not even everybody recognizes.

 

 

 

 

In Canada, 15 people <19 have died with Covid. So 10 million must be jabbed.

And remember what Yeadon said:

 

 

 

 

How little managers become mass murderers.

FDA Aiming To Give Full Approval To Pfizer Covid-19 Vaccine Next Week (RT)

The FDA will give full authorization to Pfizer’s Covid jab sometime next week, according to multiple reports, putting it on track to be the first in the US to get approval and likely paving the way for additional vaccine mandates. The US regulator is expected to give the greenlight for Pfizer’s immunization in the coming days, the New York Times and Politico reported on Friday, citing several “people familiar” with the agency’s planning. Though the FDA still has a “substantial amount of paperwork and negotiation with the company” to get through, it could give full approval as soon as Monday, the Times added. It was previously reported that the FDA hoped to grant authorization before Labor Day on September 6, and now appears set to meet that informal deadline.

With a number of hospital systems and universities around the US signaling plans to mandate vaccinations against Covid-19 upon full approval, the move is likely to trigger a spate of new requirements around the country. The US military, moreover, has also said it would compel immunizations for its 1.3 million active-duty troops by the middle of next month, but could do so sooner should the FDA give its blessing to Pfizer. While the Joe Biden administration previously suggested the president would issue a waiver to allow vaccine mandates for soldiers, it decided to hold off until regulators signed off.

Reports of the FDA’s plans come soon after the White House began promoting booster shots for all fully vaccinated adults, citing US health agencies, which noted the immunizations are losing effectiveness over time, particularly against more infectious Delta mutation. While the FDA hasn’t yet approved third doses for all healthy Americans, the agency did give the go-ahead for those with compromised immune systems, while Pfizer recently submitted its initial trial data for universal boosters. Health officials have voiced hopes that full approval for the Covid jabs could improve vaccination numbers in the US, which have been losing pace since hitting a peak in April. Recent polling by the Kaiser Family Foundation showed that more than 30% of respondents would be “more likely” to be vaccinated if the FDA authorized the shots, suggesting the move could indeed spur immunizations.

On August 5 (last update), this was still up on clinicaltrials.gov for the Pfizer trials:

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They don’t want anyone to see the paperwork.

FDA To Grant Full Approval To Pfizer Vaccine Without Public Discussion (BMJ)

Transparency advocates have criticised the US Food and Drug Administration’s (FDA) decision not to hold a formal advisory committee meeting to discuss Pfizer’s application for full approval of its covid-19 vaccine. Last year the FDA said it was “committed to use an advisory committee composed of independent experts to ensure deliberations about authorisation or licensure are transparent for the public.”1 But in a statement, the FDA told The BMJ that it did not believe a meeting was necessary ahead of the expected granting of full approval. “The FDA has held numerous meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) related to covid-19 vaccines, including a 22 October 2020 meeting to discuss, in general, the development, authorisation, and licensure of covid-19 vaccines,” an FDA spokesperson said.

“The FDA also has held meetings of the VRBPAC on all three covid-19 vaccines authorised for emergency use and does not believe a meeting is needed related to this biologics license application.” The spokesperson added, “The Pfizer BioNTech covid-19 vaccine was discussed at the VRBPAC meeting on 10 December 2020.3 If the agency had any questions or concerns that required input from the advisory committee members we would have scheduled a meeting to discuss.” The vaccine has already been rolled out to millions of Americans through an emergency use authorisation. Companies typically apply for full approval after a longer period has elapsed so that more data are available for review.

But with the US government indicating this week that it plans to start making booster shots widely available next month, experts said the decision not to meet to discuss the data was politically driven. Kim Witczak, a drug safety advocate who serves as a consumer representative on the FDA’s Psychopharmacologic Drugs Advisory Committee,4 said the decision removed an important mechanism for scrutinising the data. “These public meetings are imperative in building trust and confidence especially when the vaccines came to market at lightning speed under emergency use authorisation,” she said. “The public deserves a transparent process, especially as the call for boosters and mandates are rapidly increasing. These meetings offer a platform where questions can be raised, problems tackled, and data scrutinised in advance of an approval.”

Witczak is one of the more than 30 signatories of a citizen petition5 calling on the FDA to refrain from fully approving any covid-19 vaccine this year to gather more data. She warned that without a meeting “we have no idea what the data looks like.” “It is already concerning that full approval is being based on 6 months’ worth of data despite the clinical trials designed for two years,” she said. “There is no control group after Pfizer offered the product to placebo participants before the trials were completed. “Full approval of covid-19 vaccines must be done in an open public forum for all to see. It could set a precedent of lowered standards for future vaccine approvals.”

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October 2020.

Development Of Safe And Effective Covid-19 Vaccines (Nature)

In the 1960s, scientists found that antiviral antisera might result in an exceptional increase in viral infectivity of animal viruses. This phenomenon that viral infection can be enhanced by internalization associated with antibody Fc receptors (FcRs), denoted as ‘antibody-dependent enhancement’ (ADE; Box 1), was then widely reported in infections with flaviviruses and other viruses. Later, more antibody FcR-mediated effects, such as complement activation and release of inflammatory cytokines, were reported to be involved in severer disease. ADE has also been observed in vaccinated animals after viral challenge with the corresponding virus.

For example, cats immunized with a vaccine expressing the feline infectious peritonitis virus (FIPV) S protein on a recombinant pox virus vector died earlier than control animals when challenged with FIPV25. Given that passive immunization with feline serum containing high-titre antibodies reactive with feline FIPV also resulted in a more rapid disease after FIPV challenge, the vaccine-induced disease exacerbation may be attributed to ADE. Apart from ADE, type 2 T helper cell (TH2 cell)-based immunopathologic responses induced by homologous viral challenge after vaccination could also result in disease exacerbation.

In this Perspective, we use the term ‘vaccine-associated disease enhancement’ (VADE; Box 1) to describe both antibody-dependent and TH2 cell-dependent disease exacerbation (Fig. 1). We summarize examples of VADE in the history of the development of vaccines against respiratory syncytial virus (RSV), dengue virus (DENV), SARS-CoV and Middle East respiratory syndrome coronavirus (MERS-CoV), each of which provides clues for safe COVID-19 vaccine development and highlights the need for rigorous preclinical and clinical safety testing.

There have been warnings that ADE should be fully evaluated for coronavirus vaccines to avoid repeating the tragic failure of the RSV vaccine. The first RSV vaccine, based on formalin-inactivated RSV (FI-RSV), entered a clinical trial in 1965, a time when several other inactivated or attenuated virus-based vaccines had already been successfully developed, such as vaccines against smallpox and polio. The FI-RSV vaccine was well tolerated and appeared to be moderately immunogenic at first. However, instead of protecting study participants, the FI-RSV vaccine exhibited a paradoxical disease-strengthening effect (enhanced respiratory disease (ERD); Box 1) during subsequent natural RSV infection. Among the 20 infants who received the FI-RSV vaccine, 16 required hospitalization, including two who subsequently died, whereas only one of the 21 participants in the control group was hospitalized. The FDA then urgently suspended all clinical studies of RSV vaccines.

Vaccination induces humoral and cellular immune response in immunized individuals. In the normal condition, when the homologous virus enters an immunized body, it will be neutralized or cleared by vaccine-induced neutralizing antibodies (Abs) or specific T cells, respectively. In the context of vaccine-associated disease enhancement, vaccines mainly induce non-neutralizing Abs or low titres of neutralizing Abs (suboptimal concentration) or type 2 T helper cell (TH2 cell)-biased T cell responses. When these vaccinated individuals are challenged by homotypic or heterotypic serotype viruses, the antibodies will immediately recognize the viruses and mediate antibody-dependent disease exacerbation in two ways. First, virus–antibody complexes might enter Fc receptor (FcR)-bearing cells, such as dendritic cells and monocytes, by FcR-mediated internalization, which is termed ‘antibody-dependent enhancement’ (ADE). For viruses with innate tropism for FcR-bearing cells, such as dengue virus, ADE will result in higher viral loads than in conditions without antibodies.

a | After entry, the virus, no matter whether it replicates or does not replicate, may activate a harmful immune response, resulting in the release of proinflammatory cytokines. b | Aside from ADE, antibody–antigen complexes can stimulate the complement pathway through activation of the C1q pathway, thus further strengthening the inflammatory responses c | Vaccine-associated disease enhancement can also involve a TH2 cell-biased immune response. The activated TH2 cells contribute to the activation of antibody production. However, they release interleukin-4 (IL-4), IL-13 and IL-5, as well as eosinophil chemoattractant, thus resulting in eosinophil infiltration and proinflammatory cytokine production in the lung. d | Natural killer (NK) cells and CD8+ cytotoxic T lymphocytes (CTLs) are poorly stimulated in TH2 cell-skewed immune responses. The exaggerated cytokine release (part b), activation of the complement pathway (part c) and the excessive mobilization of eosinophils all contribute to the infiltration of the lung by eosinophils, neutrophils and lymphocytes, and production of inflammatory cytokines (part d), leading to acute lung injury or acute respiratory distress syndrome.

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Tragic, of course it is. But:

Blame unvaccinated people, blame Florida all you want. The vaccine still didn’t work. How do you not reach that conclusion?

And his doctor is a doofus who says there’s a “one-in-a-million” chance of a “breaktrough” infection. He should get informed. There’s an every hour, if not more.

Vaccinated Man Dies In Florida, Daughters Urge People To Get Vaccinated (Hill)

A fully vaccinated man who resided in a Florida retirement home died from COVID-19. His daughters wrote an obituary urging people to get vaccinated and blame the state for his life ending. Clark Allen died on July 22 after contracting a breakthrough case of COVID-19, a “one-in-a-million” chance, according to the man’s doctor. The surviving daughters of Clark Allen, Danielle and Nicole Allen-Gentile, expressed their anger in an obituary about how their father could have been infected and said his death was preventable, The Washington Post reported. America is changing faster than ever! Add Changing America to your Facebook or Twitter feed to stay on top of the news.

“He was infected by someone who chose to not get vaccinated and his death was preventable,” the obituary reads. “It is the wish of his family that everyone get vaccinated in order to prevent further death, sickness and heartbreak.” The daughters also told The Washington Post that if their father were in a different state, they believe he wouldn’t have died. During the pandemic, Clark Allen’s two daughters — along with their five siblings — debated whether their father should be in an assisted living home in Florida or Connecticut. The daughters received a blunt message from a Connecticut home: “You need to get him out of Florida. He will die in Florida,” The Washington Post reports. The daughters speculate that he contracted the virus from an unvaccinated person at Carlisle Palm Beach, an assisted living facility in Lantana, Fla.

Allen reportedly took the virus very seriously, paying close attention to public health measures as he had chronic obstructive pulmonary disease that could make a possible infection more severe, according to the Tampa Bay Times, which first shared the story. “It was a relief when he got vaccinated, but the reality was he was around a lot of unvaccinated people,” Danielle Allen, who lives in Portland, Ore., told The Post. “I’m attempting to not be very angry at unvaccinated people and it’s become extremely difficult. We’re all really angry and struggling.” In response to the claim, a spokesperson for Senior Lifestyle, the company that operates Carlisle Palm Beach, told The Post that its facility implements safety measures provided by Centers for Disease Control and Prevention (CDC) and “other expert sources and health authorities.”

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“The system delivers medicine to intramuscular and subcutaneous tissue depths without needles, which may prove particularly useful in a world competing for needles and syringes.”

World First Plasmid DNA Covid-19 Vaccine Gets Emergency Approval In India (RT)

India’s drug regulator has approved a three-dose Covid-19 vaccine which uses plasmid DNA technology developed by indigenous drugmaker Zydus Cadila, after trials indicated it was 66.6% effective. On Friday, the Drug Controller General of India gave the green light to Zydus Cadila’s Covid-19 vaccine. The inoculation, now the sixth such to be approved in India, has received Emergency Use Authorization (EUA) for use in adults and children aged 12 and above. The generic drugmaker, which applied for authorization of its three-dose vaccine in July, enlisted 28,000 volunteers into its trial. Data from the late-stage trial suggested the jab was 66.6% effective at preventing symptomatic Covid-19.

The vaccine, known as ZyCoV-D, is the world’s first vaccine against Covid-19 that uses plasmid DNA technology. It works by injecting genetically-engineered plasmid containing the DNA sequence of the pathogen. Cadila’s vaccine was developed in partnership with India’s Department of Biotechnology and is the second home-grown shot to be approved for use against Covid-19; the first being Bharat Biotech’s Covaxin jab. Instead of traditional syringes, the vaccine is administered using a needle-free applicator. The system delivers medicine to intramuscular and subcutaneous tissue depths without needles, which may prove particularly useful in a world competing for needles and syringes.

Cadila has already started stockpiling its vaccine and hopes to make 100 million to 120 million doses every year, enough for 40 million people, the company’s managing director told Reuters in April. Despite being one of the world’s largest vaccine manufacturers, India’s Covid-19 inoculation program has fallen flat amid a shortage of shots. Delhi has been pushing for ‘Atmanirbhar Bharat’, a Hindi phrase roughly translating as ‘self-reliant India’, in a number of fields, including defense technology and medical products. The vaccination program was meant to reflect India’s self-reliance and burgeoning manufacturing capacity in the medical and pharmaceutical industry.

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Google translate. Like his description of the “mechanisms” of both the virus and IVM.

Director Of Yale University Research Center About Ivermectin (CdS)

Ivermectin has more than one potentially effective mechanism of action against Covid 19. A major one is its ability to adhere to the Coronavirus Spike1 protein at various strategic points used by the virus to bind and enter our cells. For this reason, unlike monoclonal antibodies, it can act against all variants. By doing so, you prevent the virus from attaching itself to ACE2, which is the main gateway for the virus to enter our cells, and this allows it to reduce the virus’s ability to enter our body. If Covid stays outside of our cells, it becomes easy prey for our immune system, which can get rid of it much more easily. It is important to note that the protein docking region of the virus, the spike spikes, binds not only to our ACE2 receptors, but also to other docking receptors that are very important to the virus, those that depend on sialic acid, Receptor CD147 and on a cholinergic receptor called a7nAChr. I don’t want to get into technicalities, but this premise helps us understand how Covid attacks our body.

Once it has entered our lungs and damaged them, the virus enters the blood and travels through our body carried by red blood cells and platelets that are found in large quantities in our blood. Today we know that the virus attaches itself to red blood cells and platelets because both are coated with sialic acid receptors and CD147 and thanks to this it invades all blood vessels until it is “released” into the endothelium (the inner part of our blood vessels ). ) and then causes systemic vasculitis, which is why most of us are ultimately unable to overcome the infection. When the virus replicates within the endothelial cells of the vessels, it inflames them and creates sticky aggregates of red blood cells and platelets – dense masses,Small clots that initially hamper cause circulation in small vessels (capillaries), but then progressively swell and block larger and larger vessels. When this happens in the lungs, it causes a lack of oxygen that therefore damages all our organs such as the brain, liver, kidneys and heart, especially in the elderly, diabetics and people with previous diseases.

The mechanism by which the virus moves in the blood also explains why Covid is more lethal in people with high glucose levels, such as diabetics and prediabetics. The reason is because the receptors made of sialic acid and CD147 are basically zuccheri. In a diabetic, these sialic acids are richer in sugar (glucose) and the virus sticks better and its systemic spread is even easier. This selectivity of the virus for the characteristics of some subjects is also given by blood groups, for example those with blood group A or B have red blood cells with a greater presence of sialic acid / sugars on the surface, while those with a Type 0 blood group, on the other hand, is less susceptible to the virus as it has less sialic acid / receptor that lines red blood cells and,therefore, the virus sticks less. Patients with diabetes or those with these blood groups (A and B) have a statistically more severe course of the disease.

One of the fundamental mechanisms by which ivermectin acts in patients is because it “puts a wall” (a shield) between our body (red blood cells, platelets and vessels) and the virus, and therefore no longer allows it to latch on in our cells. thus facilitating the flow of red blood cells that carry oxygen in the blood vessels. Ivermectin appears to be able to quickly break the link between the virus (Spike’s key) and its receptors (the ACE2 gate, sialic acids, the CD147 receptor, and a7nAChr), so patients miraculously begin to breathe and oxygenate properly again normally within 24- 48 hours. This is also what happens in the rest of the microcirculation of the whole body and leads to the rapid improvement of the functionality of the various organs.

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The protests will now grow fast. In many countries.

French Businesses Are Refusing to Enforce Vaccine Passport (SN)

Anecdotal evidence detailed by former Google software engineer Mike Hearn strongly suggests that most restaurants, cafes and other businesses in France are not enforcing the country’s controversial vaccine passport system. As we highlighted last week, on the first day the new program was in place, police were visibly patrolling bars and cafes demanding customers show proof they’ve had the jab. However, this seems to have largely been a bluff as just days later, businesses and venues have become very lax at checking people’s papers despite the threat of large fines. “I decided to do a simple experiment to find out: always present an expired test even though I had a valid negative one, and see what happens,” writes Hearn.

“Over a four day stay I was required to show a valid pass exactly zero times; that includes at the airports in both directions. Compliance is absolutely min viable and often lower.” “At small businesses enforcement was non-existent: sometimes the pass requirement was ignored entirely, other times we were asked “do you have a pass” and our answer wasn’t checked. One restaurant had come up with a clever way to detect police stings without requiring customers to actually present a pass. As expected, enforcement was stricter by larger firms, however even there we saw the following:

– Test certificates being checked once and then swapped for a token that doesn’t expire.
– Expired tests being accepted.
– People accepting paper test certificates without scanning them.
– Scanning tests and then not looking at the screen to see the results.
– Accepting QR codes that failed to scan.”

Hearn also reveals how mask mandates in theme parks and other venues are also not being followed, despite signs everywhere ordering people to cover their faces, while social distancing is also a “forgotten memory.” Images showing empty cafes and bars on the first day the system was introduced may have spooked venues into taking a hands off approach. In passing the law but failing to ensure that it is enforced, France is following the same model as Israel, where the point of introducing the system wasn’t really to enforce it, but merely as a means of bullying young people into getting the vaccine. As we highlighted last week, despite the odious and draconian nature of the vaccine passport system, President Macron asserted that the it was actually introduced to protect people’s “freedom,” which is like saying putting you in prison is for your own safety.


French Health Pass has space for 8 shots

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A country inhabited by spike protein reservoirs.

Almost 9 In 10 Britons Likely Or Very Likely To Go For Covid Booster Shot (RT)

Nearly 90% of people across the UK are “likely or very likely” to accept a third Covid-19 jab if offered, a new survey released by the Office for National Statistics (ONS) has revealed. On Friday, the ONS released the latest data from its ongoing Opinions and Lifestyle Survey project, which found that a whopping 87% of respondents would be in favour of receiving a Covid booster shot. Older members of the population expressed more enthusiasm at the prospect of a third jab, with almost 96% of those aged 70 or over saying they would be “likely or very likely” to do so. The survey figure was lower for younger Britons in the 16 to 29 age-bracket, standing at 78%. Speaking to reporters on Thursday, Britain’s Health Secretary Sajid Javid said that the proposed booster scheme will likely start in September. Javid, however, did not pinpoint an exact date, citing that the government first needs final advice on the matter from the Joint Committee on Vaccination and Inoculation (JCVI).


A handful of countries have already introduced a booster dose as part of their vaccination regimens. Serbia and Hungary began offering its citizens a third Covid shot earlier this month, while Israel continues to lower the eligible age for its booster jabs after rolling out the scheme at the end of July. The head of the WHO Tedros Adhanom Ghebreyesus urged nations to pause or delay issuing third shots in a bid to alleviate vaccine inequity between high and low income states. “WHO is calling for a moratorium on boosters until at least the end of September, to enable at least 10% of the population of every country to be vaccinated,” he implored the governments of richer nations. The JCVI last month recommended that all adults in the UK aged 50 and over, pensioners living in care homes, frontline workers, and anyone aged 16 and higher who is clinically vulnerable or immunocompromised should be offered a vaccine top-up this autumn.

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“Nobody is at the controls of this outfit as we sail into the fog.”

The Heebie-Jeebies of August (Kunstler)

Jimmy Carter was undone by a mere fifty-two hostages in Iran, 1979, but this fiasco is orders of magnitude greater. The Taliban could easily put an end to the whole question of extracting the thousands of Americans stuck in Af-stan just by firing a few RPG rounds onto the runway of Hamid Karzai International Airport. After that, would they go about the grisly business of beheading any Afghani who so much as took a stick of gum from an American?

“Graveyard of Empires,” indeed. Rome waited a few centuries to collapse but America seems to be demonstrating we can git’er done in just a couple of years. And, beyond these questions of global hegemony, there is the matter of what happens here in the so-called Homeland. The Covid-19 vaccine-and-masking hysteria is coming to a head. The school boards are getting an earful about race-based everything in the curriculum. Certain state governors and mayors seem determined to destroy what remains of small business. A mutiny is brewing against Bill de Blasio’s new semi-lockdown in New York City. Gavin Newsom is about to be tossed into the North Pacific Gyre.

Any moment, the Arizona election audit will issue a preliminary report, said to be shocking. Financial markets are in the wobble-zone. Supply lines are down for many parts of things needed to run daily life in this land. And millions are wondering anxiously now: what really are the latent effects of those jabs? Things are shaking loose all over the place. As Bob Dylan once said, the order is rapidly fading (and he’s even older than “Joe Biden.”) Everyone I know has got the heebie-jeebies. Nobody is at the controls of this outfit as we sail into the fog.

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Part 1 of this interview is in the August 4 Debt Rattle. Interesting voice.

2020: A Propaganda Masterpiece 2: Divide and Conquer (Perspectives on the Pandemic)

Mark Crispin Miller is Professor of Media, Culture and Communication at New York University. His research interests include modern propaganda, history and tactics of advertising, American film, and media ownership. He is the author of Boxed In: The Culture of TV; Seeing Through Movies; Mad Scientists: The Secret History of Modern Propaganda; Spectacle: Operation Desert Storm and the Triumph of Illusion; and The Bush Dyslexicon.

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And since we’re with Perspectives on the Pandemic, here’s part 1 of their piece with Peter McCullough.

Dr. Peter McCullough (1 of 2) | Episode #19 (Perspectives on the Pandemic)

Renowned physician and professor of medicine Dr. Peter McCullough describes early treatment protocols for COVID-19 that have saved countless lives… and the forces that have aligned themselves against their widespread adoption.

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