Jean-Francois Millet The Young Shepherdess 1870-73
Vaccines and Related Biological Products Advisory Committee October 26, 2021
No data. 5 Years of Study Needed.
Full title: “The SARS-CoV-2 Spike protein disrupts human cardiac pericytes function through CD147-receptor-mediated signalling: a potential non-infective mechanism of COVID-19 microvascular disease.”
• SARS-CoV-2 Spike Protein Disrupts Human Cardiac Pericytes Function (CS)
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes a broad range of clinical responses including prominent microvascular damage. The capacity of SARS-CoV-2 to infect vascular cells is still debated. Additionally, the SARS-CoV-2 Spike (S) protein may act as a ligand to induce non-infective cellular stress. We tested this hypothesis in pericytes (PCs), which are reportedly reduced in the heart of patients with severe coronavirus disease-2019 (COVID-19). Here we newly show that the in vitro exposure of primary human cardiac PCs to the SARS-CoV-2 wild type strain or the Alpha and Delta variants caused rare infection events.
Exposure to the recombinant S protein alone elicited signalling and functional alterations, including: (1) increased migration, (2) reduced ability to support endothelial cell (EC) network formation on Matrigel, (3) secretion of pro-inflammatory molecules typically involved in the cytokine storm, and (4) production of pro-apoptotic factors causing EC death. Next, adopting a blocking strategy against the S protein receptors angiotensin-converting enzyme 2 (ACE2) and CD147, we discovered that the S protein stimulates the phosphorylation/activation of the extracellular signal-regulated kinase 1/2 (ERK1/2) through the CD147 receptor, but not ACE2, in PCs.
The neutralisation of CD147, either using a blocking antibody or mRNA silencing, reduced ERK1/2 activation, and rescued PC function in the presence of the S protein. Immunoreactive S protein was detected in the peripheral blood of infected patients. In conclusion, our findings suggest that the S protein may prompt PC dysfunction, potentially contributing to microvascular injury. This mechanism may have clinical and therapeutic implications.
55 years till you know if the vaccine is safe enough to take. Till the, you’re on your own.
• Vaccine Data Transparency at the FDA (Kheriaty)
In September I organized 30 distinguished academic physicians and scientist colleagues to form Public Health and Medical Professionals for Transparency. This group included, among other luminaries, my friends Harvey Risch of Yale, Andrew Bostom of Brown, Joseph Ladapo of UCLA (who has since been appointed Surgeon General of Florida), Paul Alexander, formerly of HHS and WHO, Aditi Bhargava of UCSF, and other scientists from the U.S., Canada, Denmark, Australia, Germany, and the University of Oxford in the U.K. With the help of my lawyers, Aaron Siri and Elizabeth Brehm, we submitted a FOIA request to the FDA for all the data relied upon to authorize Pfizer’s Covid vaccine. While this information was not available while the vaccine was only approved under Emergency Use Authorization (EUA), under federal law, the FDA was required to make this data publicly available once it received full approval, which happened in August.
The law is crystal clear on this point: our FOIA request was not at all legally complicated, and the FDA’s lawyers at the Department of Justice are well aware of this. As we describe on our website: “The organization takes no position on the data other than that it should be made publicly available to allow independent experts to conduct their own review and analyses. Any data received will be made public.” This is likewise uncontroversial, since transparency is widely regarded as a core ethical principle of all public health initiatives. It is one of the central ethical principles articulated, for example, in the University of California’s “Allocation of Scarce Critical Resources under Crisis Standards of Care,” the ventilator triage policy that I helped draft for the UC’s hospitals last year (see 3.f below):
[..] I look forward to seeing the DOJ lawyers in court, and will keep you updated on this story as the legal proceedings unfold.
As long as he’s useful for Pfizer.
• Fauci Speaks Of ‘Unfinished Business’ Before He Can Retire (RT)
Top White House Covid adviser Anthony Fauci insisted his long career as a federal bureaucrat is far from over, saying retirement is simply out of the question as he looks to wrap up “unfinished business” in the world of medicine. Asked whether he is thinking of leaving his long-held leadership post at the National Institute of Allergy and Infectious Diseases (NIAID), the 80-year-old health official said he’s “not even remotely contemplating that right now.” “There’s a lot of unfinished business right now, so I’m not even thinking about walking away,” Fauci told Reuters in an interview on Tuesday, adding that he would like to see the end of the coronavirus pandemic, and even further progress on eradicating HIV and AIDS, before he steps away from his work.
The White House adviser also reiterated calls for the “overwhelming majority” of fully-vaccinated American adults to receive booster shots, noting that the additional dose could eventually become standard in defining what it means to be ‘fully’ immunized. “Right now, officially, fully vaccinated equals two shots of the mRNA and one shot of the J&J, but without a doubt that could change. That’s on the table for discussion,” he said, referring to Pfizer and Moderna’s vaccines which use messenger-RNA, and Johnson & Johnson’s one-dose formulation.
While an FDA advisory panel initially voted overwhelmingly against booster doses for all healthy Americans – instead greenlighting additional shots only for the elderly and certain at-risk groups – the FDA itself decided to cut the panel out of the process entirely and authorized boosters on its own last week. A similar panel with the Centers for Disease Control and Prevention (CDC), however, did give its blessing, with CDC Director Rochelle Walensky quickly signing off on the decision.
“..the hospital system filed notice that it would appeal the order that had already been carried out. It did this even though Sun Ng seemed to have benefited greatly.”
• Judge Tells Hospital: “Step Aside”, Give a Dying Man Ivermectin (Pfeiffer)
Sun Ng, a retired contractor from Hong Kong, traveled to Illinois to celebrate his only granddaughter’s first birthday. He got covid and was near death in a Chicago-area hospital. All other options were exhausted, but the hospital refused to give Mr. Ng a generic, FDA-approved drug with an extraordinary safety record that a doctor believed could safe his life. Finally, a judge asked the right question about ivermectin. “What’s the downside?” Put another way: If a man is dying of covid in an ICU and all else has been tried, why not order a hospital to give a safe, last-ditch drug? Edward Hospital, located near Chicago, offered three arguments as to why Sun Ng, seventy-one, should not be given ivermectin: There could be side effects. Ordering ivermectin would violate its policies. Forcing the issue would be “extraordinary” judicial overreach.
On each argument, DuPage County Circuit Court Judge Paul Fullerton firmly disagreed. “I can’t think of a more extraordinary situation than when we are talking about a man’s life,” he said in a November 5 decision that is a model of rational decision-making in an irrational era. “I am not forcing this hospital to do anything other than to step aside,” he continued in a Zoom hearing. “I am just asking—or not asking—I am ordering through the Court’s power to allow Dr. Bain to have the emergency privileges and administer this medicine.” The hospital ultimately stepped aside. Dr. Alan Bain, an internist, administered a five-day course of 24 milligrams of ivermectin, from November 8 through November 12. Ng, who with his wife, Ying, had come from Hong Kong to celebrate their granddaughter’s birthday, was able to breathe without a ventilator within five days—he, in fact, removed the endotracheal himself.
He left the ICU Tuesday, November 16, and, although confused and weak, was breathing Sunday without supplemental oxygen on a regular hospital floor. “Every day after ivermectin, there was accelerated and stable improvement,” said Dr. Bain, who administered the drug in two previous court cases after hospitals refused. “Three times we’ve shown something,” he told me. “There’s a signal of benefit for ventilator patients.” Ng’s remarkable progress stands in sharp relief to the repeated attempts by Edward-Elmhurst Health, the hospital’s managing system, to thwart the use of ivermectin. It succeeded in having the court’s initial November 1 order dismissed by claiming Ng was in better health than his lawsuit contended (he wasn’t). It then defied the November 5 order, saying Dr. Bain was not vaccinated (a negative test resolved the issue).
Moreover, after Ng’s treatment was complete, the hospital system filed notice that it would appeal the order that had already been carried out. It did this even though Sun Ng seemed to have benefited greatly. The patient’s improvement, or condition generally, did not seem to matter.
And she’s a Democrat.
• Kansas Governor to Allow Broad Exemptions to COVID-19 Vaccine Requirements (ET)
The governor of Kansas has said she intends to sign a measure that will force businesses that require COVID-19 vaccination to give broad exceptions to workers who don’t want to get the vaccine. Kansas Gov. Laura Kelly, a Democrat, said in a one-sentence Nov. 22 statement that she will sign the legislation “when it reaches my desk.” Derek Schmidt, Kansas attorney general and a Republican, also said he would sign it if he were governor. Schmidt is challenging Kelly in the Kansas gubernatorial race. The Republican-controlled state House of Representatives and state Senate approved House Bill 2001 earlier on Nov. 22 during a special session. The Senate vote was 24–11 and the House vote was 78–41.
The legislation states that any employer who imposes a COVID-19 vaccine requirement must exempt workers if they submit a written waiver request stating that complying with the requirement would endanger the life or health of the waiver applicant or somebody they live with or if receiving the vaccine violates a sincerely held religious belief. Any workers punished or terminated due to violation of the law would be able to file a complaint with state officials, who would be mandated to investigate each complaint and issue an order on each case within 60 calendar days.
An employer who is found to have violated the law would face civil action in a bid to fine them up to $10,000 per violation if they have fewer than 100 employees or up to $50,000 per violation if they have 100 or more employees. The employer would avoid legal action if they reinstate the worker. Another major component of the legislation requires that workers who get laid off due to vaccination requirements be eligible for unemployment benefits. Kansas Senate President Ty Masterson, a Republican, said the measure will “protect the rights of Kansans who are facing impending deadlines from the Biden administration that would force them to choose between their livelihood and their religious freedom or their livelihood and advice from their own physician.”
Like a lab experiment.
• New Zealand To Stay Closed To Foreigners For Another Five Months (MSN)
New Zealand said Wednesday it will not reopen to foreign travellers for at least another five months, as it slowly relaxes some of the world’s toughest pandemic border restrictions. The Pacific nation’s Covid-19 Response Minister Chris Hipkins said New Zealanders stranded in Australia could return home from mid-January and Kiwis travelling from elsewhere would be allowed in a month later. But foreign nationals must wait until the end of April under the blueprint for a phased reopening unveiled Wednesday. “We acknowledge it’s been tough, but the end of heavily restricted travel is now in sight,” Hipkins told reporters. New Zealand closed its borders in March last year, requiring all international arrivals to undergo two weeks of hotel quarantine, a period that was recently cut to seven days.
Hipkins said under the new regime, travellers would self isolate for seven days provided they were fully vaccinated and passed a series of Covid-19 tests. The move comes amid mounting pressure from overseas-based New Zealanders frustrated at being unable to book spots in the overstretched hotel quarantine system. Local media regularly carry reports of Kiwis unable to return home to see visit dying relatives because there are no available quarantine rooms. The border announcement comes as New Zealand prepares to revamp its domestic Covid-19 response to scrap lockdowns in recognition that the highly contagious Delta variant is now firmly embedded in the community.
And why not….
• Scottish Govt Vax Passport Sends People’s Private Data To Amazon, Microsoft (S)
As if the liberty erasing connotations of vaccine passports were not enough on their own, it has been revealed that the Scottish government has allowed data from the scheme to be shared with private companies including Amazon. The Daily Record reports, “We have learned the NHS mobile phone app which presents the personal medical information in the form of a QR Code shares data with companies including Amazon, Microsoft, ServiceNow, Royal Mail and an AI facial recognition firm.” Users of the vaccine passport app were not informed their data would be shared, according to the report.
Commenting on the findings, Sam Grant of privacy advocate group Liberty warned “Vaccine passports create a two-tier society and already many people in Scotland have been coerced into getting a vaccine passport in order to attend events and access certain parts of society.” Grant added, “It’s extremely concerning that, in doing so, data has been shared with third parties without people having the option to opt out or without even being made aware that this is happening. This only furthers the wide concerns people already have around vaccine passports.”
The leader of the Scottish Liberal Democrat party, Alex Cole-Hamilton, also stated that his party “have repeatedly warned the Government that data protection is virtually non-existent – a simple screenshot was enough to bypass whatever ‘security measures’ the system had in place.” “The launch was a shambles and the IT system struggled to cope,” Cole-Hamilton explained, adding “Everyone has the right to medical privacy; nobody should ever have to provide part of their medical history to a bouncer or a series of private companies. That is just simply absurd.”
The WHO itself is the cause.
• Covid Deaths In Europe To Top 2 Million By March, Says WHO (G.)
Total deaths across Europe from Covid-19 are likely to exceed 2 million by March next year, the World Health Organization (WHO) has said, adding that the pandemic had become the number one cause of death in the region. Reported deaths have risen to nearly 4,200 a day, double the number being recorded in September, the agency said, while cumulative reported deaths in the region, which includes the UK, have already surpassed 1.5 million. Describing the situation as “very serious”, the WHO said it expected “high or extreme stress” on hospital beds in 25 of the region’s 53 countries, with intensive care units in 49 countries set to come under similar strain. On current trends, the region’s cumulative death toll would surpass 2.2 million by 1 March, it said.
As Europe again becomes the centre of the pandemic, with tighter controls mainly on the unvaccinated and heated debate in several countries about making vaccination obligatory, Austria this week became the first west European country to re-enter lockdown since inoculation began earlier this year. The increase in cases was being driven by the highly transmissible Delta variant which is now dominant across the region, the WHO said, fuelled by a widespread relaxation of preventive measures, such as mask wearing and physical distancing, since the summer. With more and more people gathering indoors in the colder late-autumn weather, a large number still not vaccinated, and vaccine efficacy against severe forms of the disease waning, “many people are left vulnerable to the virus”.
Dr Hans Kluge, the WHO’s regional director for Europe, said it was essential that countries adopted a “vaccine plus” approach. “This means getting the standard doses of vaccine and taking a booster if offered,” he said, “but also incorporating preventive measures into our normal routines.”
Published: 23 November 2021. Daily intake: 400 IU of vitamin D. Not in good faith. There was a UK report in early 2020 that did the same thing.
• The Health Effects Of Vitamin D Supplementation (Nature)
There is consensus that daily intake of 400 IU of vitamin D can prevent nutritional rickets in infants and children1. However, the skeletal effects of vitamin D deficiency in adults and older adults (aged >65 years), and the potential extra-skeletal effects of vitamin D are more controversial. Some people consider that vitamin D supplementation is futile2. By contrast, others have suggested that the vitamin D intake requirement is much higher than currently achieved by the general population and that people should aim to achieve 25-hydroxyvitamin D (25OHD, the major marker of vitamin D status) concentrations similar to those found in certain tribes in equatorial Africa with a sun exposure lifestyle that might be similar to that of early humans.
The potential extra-skeletal effects of the vitamin D endocrine system (which refers to vitamin D in its active form, its precursors and metabolites, and vitamin D receptor) are based on several arguments. For example, the vitamin D receptor (VDR) and CYP27B1 (the enzyme primarily responsible for producing the active form of vitamin D, 1,25-dihydroxyvitamin D or 1,25(OH)2D3) are widely expressed, including in tissues that are not involved in calcium or phosphate transport (Fig. 1). In addition, ~3% of the human and mouse genomes are under the direct or indirect control of 1,25(OH)2D3 (refs8,9). Finally, many diseases and illnesses in humans are associated with a poor vitamin D status, as measured by low serum levels of 25OHD. Therefore, one of the major clinical questions in the field is whether poor vitamin D status plays a causal role in the diseases and conditions associated with low 25OHD levels, such as cancer, impaired muscle strength and falls, and immune, metabolic or cardiovascular diseases. Furthermore, if the link is causal, the threshold serum level of 25OHD below which the risk of these diseases is increased must be identified.
There’ll be no truckers left.
• US to Require Vaccines for All Border Crossers in January (AP)
President Joe Biden will require essential, nonresident travelers crossing U.S. land borders, such as truck drivers, government and emergency response officials, to be fully vaccinated beginning on Jan. 22, the administration planned to announce Tuesday. A senior administration official said the requirement, which the White House previewed in October, brings the rules for essential travelers in line with those that took effect earlier this month for leisure travelers, when the U.S. reopened its borders to fully vaccinated individuals. Essential travelers entering by ferry will also be required to be fully vaccinated by the same date, the official said. The official spoke to The Associated Press on the condition of anonymity to preview the announcement.
The rules pertain to non-U.S. nationals. American citizens and permanent residents may still enter the U.S. regardless of their vaccination status, but face additional testing hurdles because officials believe they more easily contract and spread COVID-19 and in order to encourage them to get a shot. The Biden administration pushed back the requirement for essential travelers by more than two months from when it went into effect on Nov. 8 for non-essential visitors to prevent disruptions, particularly among truck drivers who are vital to North American trade. While most cross-border traffic was shut down in the earliest days of the pandemic, essential travelers have been able to transit unimpeded.
Even with the delay, though, Norita Taylor, spokeswoman for the trucking group Owner-Operator Independent Drivers Association, criticized the vaccination requirement, calling it an example of “how unnecessary government mandates can force experienced owner-operators and independent truckers out of business.” “These requirements are another example of how impractical regulations will send safe drivers off the road,” she said.
Does he believe it? Quite possible.
• Americans Got Richer Thanks To Vaccines & Covid Policies, Biden Claims (RT)
US citizens are wealthier 20 months after the Covid-19 pandemic than they were before, President Joe Biden has insisted, as many in the country check their pockets and find them still empty. The president praised his economic leadership during a press conference on Tuesday, declaring the US was the only country whose residents could count themselves richer than they had been before the pandemic. However, while the Federal Reserve may have printed up a (digital) storm of new money to keep the economy afloat, ordinary Americans haven’t seen much of it. “America’s the only major economy, the only one in the world, where the economy is bigger today, and families have more money in their pockets today, than before the pandemic hit,” Biden boasted during a Monday press conference, adding that his calculations already took inflation into account.
Not only could “none of our competitors internationally […] say that,” the president continued, but it was a “testament to the effectiveness of the vaccines and our vaccination effort,” as well as “a testament to the economic policies we’ve fought so hard to pass.” While government responses to the Covid-19 pandemic have indeed sent some people’s wealth soaring skyward, much of that growth – a whopping $2.1 trillion – has gone to the billionaires. Tesla tycoon and world’s richest man Elon Musk alone made $209 billion as of October. However, some 89 million ordinary Americans have lost their jobs.
Meanwhile, income inequality continues to swell to preposterous levels – anything but closing the massive gap that already yawned between rich and poor in 2019. Data shows the poor have stayed poor, and the middle-class are rapidly joining them at the bottom of the income ladder. While Biden might have tried to appear sanguine regarding inflation, that monetary force continues to send the price of consumer goods skyward, and most of the federal unemployment benefits that kept out-of-work Americans comfortable during the first year of the pandemic have evaporated, meaning Americans now need to find a job and pay their rent or find themselves out in the cold.
“..coming the same day CNN reported the Biden administration is now mulling additional weapons and military trainers for Ukraine.”
• US, Russia Military Chiefs Hold Urgent “Deconfliction” Call On Ukraine (ZH)
The heads of the Russian and United States militaries held a rare and urgent phone call on Tuesday in efforts to deescalate soaring tensions in eastern Europe, with both sides cryptically confirming it was to discuss “current” international security issues. Russia’s most senior military general, Valery Gerasimov, held the call with US Chairman of the Joint Chiefs of Staff Mark Milley, in which the two top generals talked about “pressing issues of international security”. The past days have witnessed heightening rhetoric and threats being exchanged between Moscow and Washington over tensions in Ukraine and Belarus, especially given recent reports from US media over a Russian force build-up and planned “invasion” of eastern Ukraine, reports which the Kremlin has vehemently denied.
The US side’s readout of the call acknowledged it was for the purpose of rapid “de-confliction” between the two superpowers, also coming the same day CNN reported the Biden administration is now mulling additional weapons and military trainers for Ukraine. No additional details or specifics of the military-to-military call were revealed; however, it was without doubt related to a building new Ukraine crisis, following the US allegations of a massive Russian troop build-up near Ukraine for a potential imminent invasion. At the start of this week it was revealed that the Biden administration was reported to have briefed the European partners that Russia on the supposed planned invasion of eastern Ukraine. The Kremlin has been fierce in its response rejecting the accusations, with some thinly-sourced Western reports suggesting as many as 100,000 active duty Russian troops and reservists were being mustered for a major offensive operation.
A report in US News and World Report that tensions are fast approaching a breaking point, leading to the potential for a ‘Ukraine crisis 2.0’ amid the tit-for-tat accusations: “Through a series of public statements and posts through its state news services, leaders in Russia on Monday presented the unified case that Ukraine was needlessly deploying its military forces to challenge Russia’s sovereignty and its nearby interests, that rising concern in the West of military action by Moscow represents only an attempt by Kyiv to mask its own intentions to do so, that the Western-backed peace process for the conflict in Ukraine is broken and that Kyiv’s allies in Europe and North America are not prepared to back up their pledges of support.”
Melbourne, formerly in every ranking of "most livable city", now just a sad, muted & dull place… because of the selfish unvaxxed that don't want to do their little part of taking regular samples of free miracles of science. pic.twitter.com/M1aeM6cAC8
— Wake Up From COVID (@wakeupfromcovid) November 24, 2021
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