Oct 142021
 


Pieter Bruegel the Elder Children’s games 1560

 

Pfizer’s COVID-19 Vaccine With Comirnaty Label Still Not Available in US (ET)
Modelling: Covid Cases Could Peak At 5,300 A Week In Auckland Next Year (G.)
Aspirin Not Recommended For Most Adults To Prevent Heart Attacks (Hill)
Unexpected Allies (Ishmael)
Southwest CEO Says No Employees Will Be Fired Over Vaccine Mandate (AmG)
Chicago Police Union Head Urges Cops To Defy Vaccine Mandate (AP)
Vaccine Mandate Challenges Falter, Judges Shrug At Natural Immunity (JTN)
Victoria Nuland Is In Moscow Negotiating The Status Of Ukraine’s Donbass (ZH)
The Hidden $150 Trillion Agenda Behind The Climate Change “Crusade” (ZH)
Wall Street’s Takeover of Nature Advances with Launch of New Asset Class (Webb)

 

 

In England during weeks 36 to 39 in 2020, there were 571 COVID deaths.
In the same period in 2021, there were 3,026 COVID deaths.
2,281 (75%) of these deaths were fully vaccinated, i.e. >= 14 days post dose 2.

 

 

Rogan and Gupta

 

 

“You cannot interchange BioNTech’s Cominarty with Pfizer’s [shot] from a legal standpoint. They are legally distinct.”

What an odd game this has become.

Pfizer’s COVID-19 Vaccine With Comirnaty Label Still Not Available in US (ET)

Officials in 19 states confirmed this week to The Epoch Times they have not received doses of Pfizer’s COVID-19 vaccine labeled Comirnaty. So did pharmacies in New York, California, and Missouri. A Pfizer spokesperson told The Epoch Times in an email that there are no doses of Comirnaty in the United States as of Oct. 12. “The FDA-approved Comirnaty and the EUA-authorized Pfizer-BioNTech COVID-19 vaccine have the same formulation and, according to the FDA labeling, can be used interchangeably to provide the COVID-19 vaccination series,” a Pfizer spokesman told The Epoch Times. However, lawyers representing clients challenging vaccine requirements, say the lack of availability means vaccine mandates based on the Food and Drug Administration (FDA) approval are unlawful.

“Under the emergency use authorization, everyone has an option to accept or refuse the product. And that means every person, military and civilian. So this is critical. All of the mandates, from the military to the civilian population, are violating federal law,” Mathew Staver, chairman of Liberty Counsel, a Christian legal group, told The Epoch Times. The situation would be different if Comirnaty was available, Staver said. “You cannot interchange BioNTech’s Cominarty with Pfizer’s [shot] from a legal standpoint. They are legally distinct.” Contact with state and federal officials and pharmacies revealed widespread confusion regarding the differences between the approved Pfizer-BioNTech vaccine and the version that received emergency use authorization (EUA) in December 2020 and continues to be administered under EUA now.

A number of officials were unaware of any differences and others insisted they were the same for all intents and purposes, including several officials with the Department of Health and Human Services (HHS), which handles distribution of COVID-19 vaccines. “It’s the same thing,” an HHS official told The Epoch Times. That’s a different message than that being sent to states, some of which have been told by federal officials not to expect doses of Comirnaty for a while. “The CDC anticipates that Comirnaty will begin to ship some time in November at the earliest,” a spokesman for the Arizona Department of Health told The Epoch Times in an email, referring to the Centers for Disease Control and Prevention. “The Maryland Department of Health has been told by the CDC that Comirnaty will not ship until the end of October/beginning of November,” a spokesman with the Maryland Department of Health told The Epoch Times in an email.

Read more …

What a success story!

Modelling: Covid Cases Could Peak At 5,300 A Week In Auckland Next Year (G.)

New Zealand is preparing to face up to 5,300 cases of Covid-19 a week in Auckland and the neighbouring region of Northland alone next year, even with a vaccination rate of 90%, according to modelling from the Ministry of Health. The minister of health, Andrew Little revealed the plan for how the health system could manage a surge in cases after the current vaccination drive, as the country recorded 71 new cases on Thursday. It includes upping intensive care (ICU) beds, preparing to relocate health staff to smaller regions if an outbreak emerges, giving nurses preemptive ICU training and preparing to support people recovering at home.


The number of people in ICU and high dependency units (HDU) is currently at roughly two-thirds of capacity and 16% of available ventilators are being utilised. The capacity ICU and HDU beds nationwide can be surged to 550 beds from its current capacity of 320-340 beds. Ministry of Health chief medical officer Andrew Connolly said the system is well prepared, but any system would be overwhelmed if the numbers became too great. Between 0.2 and 0.4% of Delta patients will require ICU care, while the others may need a “short, sharp burst” of hospital-level care, Connolly said. Providing vaccination levels are high, the vast number of cases would be able to recover at home in the future, with about 5% needing hospital care, Little said.

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Mere days after it was recommended for Covid. Next week: vitamin D.

Aspirin Not Recommended For Most Adults To Prevent Heart Attacks (Hill)

An influential U.S. panel of experts changed its recommendations for people who take low dosages of aspirin in order to prevent first heart attacks or strokes. The U.S. Preventative Services Task Force in a draft proposal released Tuesday recommended that adults ages 40 to 59 should only be taking low dosages of the blood thinner if their physician determines that they are at high risk for cardiovascular disease. Aspirin acts as an anticoagulant, which means it aids in preventing blood clots from forming, which is how heart attacks and strokes typically develop. Taking daily doses of aspirin was thought to lower the risk of these clots, and therefore lower the risk of heart disease and stokes.

In addition, the new guidance detailed in the draft recommends that people over the age of 60 not take aspirin to prevent first heart attacks or strokes. Previously, guidance had recommended a daily regimen of low-dose aspirin for people over the age of 50 who were at higher risk for heart attacks or strokes in the next decade, as long as they were not at a higher risk of bleeding. This move marks the first time that a U.S. health task force has recommended that adults in their 40s speak with their doctors about aspirin for heart health. This draft recommendation does not apply to people who have already suffered a heart attack or stroke. The task force still recommends that those people take aspirin preventatively.

“The latest evidence is clear: starting a daily aspirin regimen in people who are 60 or older to prevent a first heart attack or stroke is not recommended,” Tseng said in a statement. “However, this Task Force recommendation is not for people already taking aspirin for a previous heart attack or stroke; they should continue to do so unless told otherwise by their clinician.”

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Ishmael is Karl Denninger’s alter ego.

Unexpected Allies (Ishmael)

Strikes and quitting jobs are the last peaceful means left before the guns and gasoline come out. If the right 10% of Americans quit, the ones who move people and freight around the country, clown world would disappear in a week. Even idiots in D.C. will understand when their grocery store shelves are bare. When planes and trains don’t move, they’ll get it. Those folks have the ability to end it the quickest, but what about everyone who doesn’t work in transportation? Same thing, strikes and walkouts work. Twenty percent of the workers at any job do 80% of the work. If you’re in the 20%, you leaving throws things into chaos. Oh, the company might not realize it for a while since many have a lot of vacation and sick leave to burn before slamming the door. Companies who pontificated how replaceable everyone is are going to find out the hard way they’re wrong.

Oops. When 80% of the money and productivity walk out the door they can’t import an H1B or hire a recent college grad. Training? Forget it. The company is stuck with a huge, gaping knowledge hole and the only one capable of training the replacement walked out the door! Don’t have one of those sexy jobs? You might be part of the 20% and not realize it. This could be as simple as being the only person who knows how to order supplies in a timely manner or does all the little things everyone takes for granted but no one knows exactly who does it. The secretary throws sand into the gears on her way out because a design engineer has to figure out how to order post-its. And God help you if the person who walks is in payroll. Whoever you are, you have the ability to bankrupt the company.

Who are your allies? What pool of people out there are most likely to act along with you (striked and quitting)? Some allies are obvious: folks in the “ain’t no way, no how, no body jabbing me,” crowd are natural allies. Their actions perfectly align. Jab mandate? Good-bye, and the door will not hit them on the way out. Some people got the first round of clot shots, but don’t believe in mandates. If they strike or walk, they’re allies. Some will, some won’t. If they are supportive, they aren’t enemies, which counts for something. Some want you to take the jab because they did. These are not allies. They range from idiots to true believers. Don’t engage with idiots. Don’t explain how to pour water out of a boot, they’ll never acknowledge the boot or water exist. Save your energy for the enemy: the true believer. There’s the pool of potential allies.

Looks pretty shallow: purebloods with ****-you money and maybe a few sympathizers. Remember the 20% rule and don’t lose hope. But wait purebloods, there is another group of natural allies: Those who got ****ed by the vax and survived (so far). People whose loved ones face expensive health problems are going to sit this one out. The parent who was “so proud” of their kid for getting the clot shot only to have him end up in the ICU with a heart attack? They are going to do whatever it takes to pay for the best treatments possible, including ****ing themselves up the ass to keep their insurance. These are not the allies. The working adults who got screwed by the vax are. Screwed. Hospitalizations, cancer, autoimmune disorders, permanent disabilities. Not sick for three days, screwed by life altering side effects. Why are they allies? ALLIES ACT. The act is “not working.”

Read more …

Mixed messages at best.

Southwest CEO Says No Employees Will Be Fired Over Vaccine Mandate (AmG)

During an interview with ABC News Tuesday, Gary Kelly, the CEO of Southwest Airlines, stated that no employees will be fired over the company’s vaccine mandate. However, the airline announced on October 4 that all 56,000 U.S. Southwest employees needed to get vaccinated against COVID-19 by November 24, or face termination. The CEO also told ABC’s George Stephanopoulos that there was “no evidence” that any type of demonstration against the mandate had contributed to the massive service disruptions over the holiday weekend. Over 2,000 Southwest flights were cancelled, leaving tens of thousands of passengers stranded. “There’s just no evidence of that,” Kelly said. “Our people are working very hard, they’re doing a great job, I’m very proud of them.”

He did acknowledge that the vaccine mandate is “very controversial,” and not something he wanted for his company. “This is a government mandate, it’s a presidential order, and we’re doing our best to comply with that according to the deadlines that have been set,” Kelly said. The CEO told employees last week that the airline had no choice but to comply with the regime’s vaccine mandate. “Southwest Airlines is a federal contractor and we have no viable choice but to comply with the U.S. government mandate for employees to be vaccinated, and — like other airlines — we’re taking steps to comply,” Kelly said. An executive order was issued last month requiring all federal employees to get vaccinated, but no executive order, or federal regulation has yet been issued for private companies.

Joe Biden on September 9 unveiled his draconian plan to force all private businesses with more than 100 employees to make their workers get inoculated with the experimental COVID vaccines, or face weekly testing. A month later, no official guidance on the alleged mandate has been issued by the White House, the Occupational Safety and Health Administration (OSHA), or the Department of Labor. During his interview on ABC Tuesday, Kelly stated that Southwest would not be terminating any employees who refuse the injections. “We’re not going to fire any employees over this. We’re urging all of our employees to get vaccinated. If they can’t get vaccinated, we’re urging them to seek an accommodation, so we’ll do everything we can to support our people here,” he said. The guidance below went out to all Southwest employees on October 4:

Read more …

“I do not believe the city has the authority to mandate that to anybody, let alone that information about your medical history.”

Chicago Police Union Head Urges Cops To Defy Vaccine Mandate (AP)

The head of the Chicago police officers union has called on its members to defy the city’s requirement to report their COVID-19 vaccination status by Friday or be placed on unpaid leave. In the video posted online Tuesday and first reported by the Chicago Sun-Times, Fraternal Order of Police President John Catanzara vowed to take Mayor Lori Lightfoot’s administration to court if it tries to enforce the mandate, which requires city workers to report their vaccine status by the end of the work week. After Friday, unvaccinated workers who won’t submit to semiweekly coronavirus testing will be placed on unpaid leave.

Catanzara suggested that if the city does enforce its requirement and many union members refuse to comply with it, “It’s safe to say that the city of Chicago will have a police force at 50% or less for this weekend coming up.” In the video, Catanzara instructs officers to file for exemptions to receiving the vaccine but to not enter that information into the city’s vaccine portal. He said that although he has made clear his vaccine status, “I do not believe the city has the authority to mandate that to anybody, let alone that information about your medical history.”

During a news conference Wednesday, Lightfoot accused Catanzara of spreading false information and dismissed most of his statements as “untrue or patently false.” She said COVID-19 vaccines are proven to be effective and that getting vaccinated would protect city workers and their families. “What we’re focused on is making sure that we maximize the opportunity to create a very safe workplace,” Lightfoot said. “The data is very clear. It is unfortunate that the FOP leadership has chosen to put out a counter narrative. But the fact of the matter is, if you are not vaccinated, you are playing with your life, the life of your family, the life of your colleagues and members of the public.”

Read more …

Hot potatoes.

Vaccine Mandate Challenges Falter, Judges Shrug At Natural Immunity (JTN)

Legal challenges to COVID-19 vaccine mandates on the basis of natural immunity are faltering, even as more research shows the comparable durability of the protection that natural antibodies afford against infection. U.S. District Judge Paul Maloney denied a preliminary injunction Friday against Michigan State University’s mandate, citing an order last month that left in place the University of California’s mandate as litigation proceeds. The course of litigation seems to be substantiating a warning by University of Notre Dame Law Professor Gerard Bradley, a vocal critic of mandates, that judges would be “very wary” of lawsuits that are “very heavily dependent upon medical facts and statistics.”

Religious challenges are faring better. A federal judge Tuesday blocked New York Gov. Kathy Hochul from removing religious exemptions from a vaccine mandate for healthcare workers originally imposed by her predecessor, the disgraced Andrew Cuomo. Illinois Gov. J.B. Pritzker is also seeking to “clarify” a state law that bans discrimination by public or private institutions based on a person’s “conscientious refusal to receive” healthcare services. Pritzker’s spokesperson told ABC 7 the Health Care Right of Conscience Act is at risk of being “misinterpreted by fringe elements.” The Fraternal Order of Police said it’s considering invoking the law against Chicago Mayor Lori Lightfoot’s COVID vaccine mandate for city employees.

As noted by the New Civil Liberties Alliance (NCLA), which is representing MSU employee Jeanna Morris, Judge Maloney previously issued an injunction against a vaccine mandate that violated the religious beliefs of student athletes, who “had no immunity whatsoever.” The public interest law firm didn’t answer a query from Just the News on whether it plans to revisit its litigation strategy in the wake of these setbacks. Its first natural immunity challenge prompted George Mason University to issue a medical exemption to law professor Todd Zywicki, but the vaccine mandate remains in force. The latest study to verify the protective power of natural immunity was published this week in the Journal of the American Medical Association Internal Medicine.

In a study of more than 800,000 Swedish families, Scandinavian university researchers found that family members without “immunity” — prior infection or vaccination — had a 45-97% lower risk of COVID infection “as the number of immune family members increased.” “The results were similar for the outcome of COVID-19 infection that was severe enough to warrant a hospital stay,” they wrote. Notably, the researchers weren’t able to perform a sensitivity analysis in fully vaccinated individuals because too few participated in the study. Vaccination is also proving insufficient to protect older people, according to U.K. government figures published last week that showed fully vaccinated older age groups now had higher infection rates than unvaccinated younger age groups.

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In what context do you send someone that you know the other side absolutely despises?

Victoria Nuland Is In Moscow Negotiating The Status Of Ukraine’s Donbass (ZH)

Look who’s back in Eastern Europe – this time forced to deal directly with the Kremlin after a half-decade of military and political stalemate in war-torn eastern Ukraine. Victoria “F*ck The EU” Nuland is currently in Moscow for high-level talks with top Russian officials. Among multiple tense issues, there’s reportedly been progress on the situation in eastern Ukraine, related to working out a potential lasting political settlement leading to the cessation of violence there. As Biden’s Under Secretary for Political Affairs, Nuland kicked off three days of talks Tuesday and into Wednesday with Yury Ushakov, the top foreign policy aide to Putin. Interestingly the Kremlin agreed to a temporary lifting of travel sanctions against her just to enter the country for the meeting.

After initial meetings, Nuland hailed “the frank, productive review” of US-Russia relations, noting that the two sides are “committed to a stable, predictable relationship,” according to a US Embassy statement. On Tuesday after her arrival she had met with Deputy Foreign Minister Sergey Ryabkov, reportedly for more than an hour-and-a-half. The US side has indicated “no breakthroughs” in US-Russia relations as of yet, which comes after a year of sanctions and counter-sanctions targeting diplomats and mutual restrictions on media entities. It’s among the highest level meetings since Putin and Biden’s June summit in Geneva where the two leaders pledged better, frank and open communication – given Nuland is the number three highest official at the State Department.

While the American delegation hasn’t commented to this level of specifics, Russian media is citing Kremlin deputy chief of staff Dmitry Kozak as saying after Wednesday meetings that “A thorough and constructive dialogue took place regarding the settlement of the conflict in south-east Ukraine.” Kozak told the top daily newspaper Kommersant that there’s general agreement over mutual recognition of special autonomy for Donbass – where the Russia-backed, self-proclaimed Donetsk People’s Republic and Lugansk People’s Republic have been in a military stalemate with Ukrainian national forces for the past six years: “It was confirmed that the Minsk agreements remain the only basis for a settlement,” he continued. “During the talks, the US confirmed its position… that significant progress towards the settlement of the conflict is unlikely without any agreement on future parameters of Donbass autonomy. In other words, giving the region a special status within Ukraine.”

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You’ll own nothing and you’ll be happy.

The Hidden $150 Trillion Agenda Behind The Climate Change “Crusade” (ZH)

Responding rhetorically to the key question, “how much will it cost?”, BofA cuts to the case and writes $150 trillion over 30 years – some $5 trillion in annual investments – amounting to twice current global GDP! At this point the report gets good because since it has to be taken seriously, it has to also be at least superficially objective. And here, the details behind the numbers, do we finally learn why the net zero lobby is so intent on pushing this green utopia – simple answer: because it provides an endless stream of taxpayer and debt-funded “investments” which in turn need a just as constant degree of debt monetization by central banks.

Consider this: the covid pandemic has so far led to roughly $30 trillion in fiscal and monetary stimulus across the developed world. And yet, not even two years later, the effect of this $30 trillion is wearing off, yet despite the Biden’s admin to keep the Covid Crisis at bay, threatening to lock down society at a moment’s notice with the help of the complicit press, the population has made it clear that it will no longer comply with what is clear tyranny of the minority. And so, the establishment needs a new perpetual source (and use) of funding, a crisis of sorts, but one wrapped in a virtuous, noble facade. This is where the crusade against climate change comes in.

Much digital ink has been spilled on the philosophy and debate behind the green movement, and we won’t bore you with the details, but we will instead focus on the very clear, and very tangible financial consequences of a world where the establishment agrees, whether with democratic support or not, to allocate $5 trillion in new capital toward some nebulous cause of “fighting global warming.” Here are the highlights from Bank of America:

• Will it be inflationary? Yes, expect 1-3% pa shock. This is for the next 30 years… over and on top of any already present inflation!
• What are the bottlenecks? Geopolitics, climate wars and EM.
• Do we have the resources? Nickel and Lithium are just two that could be in deficit as soon as 2024.
• Is green technology really green? Not really (see below).

Drilling down on the absolutely staggering costs, at an estimated $150 trillion over 30 years, boosting funding sources to $5tn a year is equivalent to the entire US tax base, or 3x the COVID-19 stimulus this decade. Here are the details: The energy transition to a net zero greenhouse gas (GHG) economy by 2050 will be a very expensive exercise, estimated by the IEA at $150tn of total investment, over a period of 30 year. At $5tn p.a, the IEA see it costing as much as the entire US tax base every year for 30 years. Not high enough for you? Hang on then because… BNEF has a higher estimate that the total investment needed for energy supply and infrastructure could be as high as $173tn through 2050, or up to $5.8tn annually, which is nearly three times the amount invested on an annual basis today.

Read more …

Nature exists to be exploited.

Wall Street’s Takeover of Nature Advances with Launch of New Asset Class (Webb)

Last month, the New York Stock Exchange (NYSE) announced it had developed a new asset class and accompanying listing vehicle meant “to preserve and restore the natural assets that ultimately underpin the ability for there to be life on Earth.” Called a natural asset company, or NAC, the vehicle will allow for the formation of specialized corporations “that hold the rights to the ecosystem services produced on a given chunk of land, services like carbon sequestration or clean water.” These NACs will then maintain, manage and grow the natural assets they commodify, with the end of goal of maximizing the aspects of that natural asset that are deemed by the company to be profitable.

Though described as acting like “any other entity” on the NYSE, it is alleged that NACs “will use the funds to help preserve a rain forest or undertake other conservation efforts, like changing a farm’s conventional agricultural production practices.” Yet, as explained towards the end of this article, even the creators of NACs admit that the ultimate goal is to extract near-infinite profits from the natural processes they seek to quantify and then monetize. NYSE COO Michael Blaugrund alluded to this when he said the following regarding the launch of NACs: “Our hope is that owning a natural asset company is going to be a way that an increasingly broad range of investors have the ability to invest in something that’s intrinsically valuable, but, up to this point, was really excluded from the financial markets.”

Framed with the lofty talk of “sustainability” and “conservation”, media reports on the move in outlets like Fortune couldn’t avoid noting that NACs open the doors to “a new form of sustainable investment” which “has enthralled the likes of BlackRock CEO Larry Fink over the past several years even though there remain big, unanswered questions about it.” Fink, one of the world’s most powerful financial oligarchs, is and has long been a corporate raider, not an environmentalist, and his excitement about NACs should give even its most enthusiastic proponents pause if this endeavor was really about advancing conservation, as is being claimed.

The creation and launch of NACs has been two years in the making and saw the NYSE team up with the Intrinsic Exchange Group (IEG), in which the NYSE itself holds a minority stake. IEG’s three investors are the Inter-American Development Bank, the Latin America-focused branch of the multilateral development banking system that imposes neoliberal and neo-colonalist agendas through debt entrapment; the Rockefeller Foundation, the foundation of the American oligarch dynasty whose activities have long been tightly enmeshed with Wall Street; and Aberdare Ventures, a venture capital firm chiefly focused on the digital healthcare space. Notably, the IADB and the Rockefeller Foundation are closely tied to the related pushes for Central Bank Digital Currencies (CBDCs) and biometric Digital IDs.

Read more …

 

 

 

 

 

 

 

 

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Aug 252021
 


Vincent van Gogh The red tree house 1890

 

 

The FDA. the U.S. Food and Drug Administration, announced on Monday that it gave full approval to a vaccine. But it didn’t. Or rather, it did, but the approval is for a vaccine that doesn’t exist. Or rather, it exists, but it’s not being produced. Or rather, it’s being produced, but under different names and with different legal statuses.

The FDA is playing a game with Americans, in order to get them to submit to being vaccinated. And this has to stop. No more. The role of the FDA is to protect people, not cajole them into politically desired but illegal actions. Below are 3 -bullet points of- articles about the (non-) approval. One from Peter Doshi, senior editor at The BMJ, and a powerful foe to the FDA, one from Robert Kennedy jr, and one from Jill Malone, wife of Dr. Robert Malone.

But first, yet another lie -BIG, not noble- from Anthony Fauci, as told to Anderson Cooper. There is no approval for “the Pfizer product”, and Fauci knows that very well. Or rather, there is approval for a Pfizer product that is not available to anyone. And that should never have been approved the way it was in the first place, but that’s another story. Still, Fauci said it.

In theory, if he were called on it (but of course he won’t be by any reporter he talks to), he could say that the products are the same anyway. But he won’t say that, because he realizes full well that they have different legal statuses; they are “legally distinct” in the words of the FDA. So Fauci can’t say they are the same. Even if it’s just a matter of a different label on a vial.

Yes, it sounds crazy, but that’s the legal labyrinth the FDA and Pfizer have negotiated themselves into. Why? Kennedy says it best: Pfizer is unlikely to allow any American to take a Comirnaty vaccine until it can somehow arrange immunity for this product..

And: “If it says “Comirnaty,” it’s a licensed product. If it says “Pfizer-BioNTech,” it’s an experimental product, and under 21 U.S. Code 360bbb, you have the right to refuse. If it comes from Moderna or Johnson & Johnson (marketed as Janssen), you have the right to refuse. [..] If it doesn’t say Comirnaty, you have not been offered an approved vaccine.”

Jill Malone: The vaccine that is likely to be supplied for some time, WILL BE THE Pfizer – EUA vaccine. So any mandates based on full approval are meaningless.

 

Fauci Dismisses “Freedom” In Call For Vaccine Mandates: “The Time Has Come. Enough Is Enough.”

“There was some poll that showed about 30% of people who are not anti-vax, they were just waiting to get what they felt was the real final stamp of approval, which we just got today with the Pfizer product.” He continued, “And those 30% are saying when that occurs, they will feel very, very comfortable about getting vaccinated. So right away, you’re talking about 30%. I hope they come through with what the survey said.”

[..] “They’re going to give a lot of incentive and backing for a lot of institutions and organizations and places of employment to mandate, and that could be colleges, university, the military, organizations that employ a lot of people, some of the big corporations are going to say if you want to work for us in person, you’ve got to be there and get vaccinated.”


[..] “I know I respect people’s freedom, but when you’re talking about a public health crisis that we’ve been going through for well over a year and a half, the time has come. Enough is enough. We’ve just got to get people vaccinated.” “If we keep lingering without getting those people vaccinated that should be vaccinated, this thing could linger on, leading to the development of another variant which could complicate things.”

Here’s Peter Doshi, senior editor at The BMJ.

Does The FDA Think These Data Justify The First Full Approval Of A Covid-19 Vaccine?

On 28 July 2021, Pfizer and BioNTech posted updated results for their ongoing phase 3 covid-19 vaccine trial. The preprint came almost a year to the day after the historical trial commenced, and nearly four months since the companies announced vaccine efficacy estimates “up to six months.” But you won’t find 10 month follow-up data here.

While the preprint is new, the results it contains aren’t particularly up to date. In fact, the paper is based on the same data cut-off date (13 March 2021) as the 1 April press release, and its topline efficacy result is identical: 91.3% (95% CI 89.0 to 93.2) vaccine efficacy against symptomatic covid-19 through “up to six months of follow-up.”

[..] the recent reports from Israel’s Ministry of Health caught my eye. In early July, they reported that efficacy against infection and symptomatic disease “fell to 64%.” By late July it had fallen to 39% where Delta is the dominant strain. This is very low. For context, the FDA’s expectation is of “at least 50%” efficacy for any approvable vaccine.

[..] evidence of waning immunity was already visible in the data by the 13 March 2021 data cut-off… And it’s hard to imagine how the Delta variant could play a real role here, for 77% of trial participants were from the United States, where Delta was not established until months after data cut-off.

[..] Despite the reference to “six month safety and efficacy” in the preprint’s title, the paper only reports on vaccine efficacy “up to six months,” but not from six months. This is not semantics, as it turns out only 7% of trial participants actually reached six months of blinded follow-up (“8% of BNT162b2 recipients and 6% of placebo recipients had ≥6 months follow-up post-dose 2.”) So despite this preprint appearing a year after the trial began, it provides no data on vaccine efficacy past six months, which is the period Israel says vaccine efficacy has dropped to 39%.

[..] —a total of three covid-19 related deaths (one on vaccine, two on placebo). There were 29 total deaths during blinded follow-up (15 in the vaccine arm; 14 in placebo). The crucial question, however, is whether the waning efficacy seen in the primary endpoint data also applies to the vaccine’s efficacy against severe disease.

[..] here we are, with FDA reportedly on the verge of granting a marketing license 13 months into the still ongoing, two year pivotal trial, with no reported data past 13 March 2021, unclear efficacy after six months due to unblinding, evidence of waning protection irrespective of the Delta variant, and limited reporting of safety data.

Robert F. Kennedy, Jr. and Meryl Nass, M.D. at childrenshealthdefense.org.

2 Things Mainstream Media Didn’t Tell You About FDA’s Approval of Pfizer Vaccine

Monday, the U.S. Food and Drug Administration (FDA) approved a biologics license application for the Pfizer Comirnaty vaccine. The press reported that vaccine mandates are now legal for military, healthcare workers, college students and employees in many industries. New York City Mayor Bill de Blasio has now required the vaccine for all teachers and school staff. The Pentagon is proceeding with its mandate for all military service members.

[..] First, the FDA acknowledges that while Pfizer has “insufficient stocks” of the newly licensed Comirnaty vaccine available, there is “a significant amount” of the Pfizer-BioNTech COVID vaccine — produced under Emergency Use Authorization (EUA) — still available for use. The FDA decrees that the Pfizer-BioNTech vaccine under the EUA should remain unlicensed but can be used “interchangeably” (page 2, footnote 8) with the newly licensed Comirnaty product. Second, the FDA pointed out that the licensed Pfizer Comirnaty vaccine and the existing, EUA Pfizer vaccine are “legally distinct,” but proclaims that their differences do not “impact safety or effectiveness.”

[..] EUA products are experimental under U.S. law. Both the Nuremberg Code and federal regulations provide that no one can force a human being to participate in this experiment. Under 21 U.S. Code Sec.360bbb-3(e)(1)(A)(ii)(III), “authorization for medical products for use in emergencies,” it is unlawful to deny someone a job or an education because they refuse to be an experimental subject. Instead, potential recipients have an absolute right to refuse EUA vaccines.

U.S. laws, however, permit employers and schools to require students and workers to take licensed vaccines. EUA-approved COVID vaccines have an extraordinary liability shield under the 2005 Public Readiness and Preparedness Act. [..] At least for the moment, the Pfizer Comirnaty vaccine has no liability shield. Vials of the branded product, which say “Comirnaty” on the label, are subject to the same product liability laws as other U.S. products.

When the Centers for Disease Control and Prevention’s (CDC) Advisory Committee for Immunization Practices places a vaccine on the mandatory schedule, a childhood vaccine benefits from a generous retinue of liability protections. But licensed adult vaccines, including the new Comirnaty, do not enjoy any liability shield. Just as with Ford’s exploding Pinto, or Monsanto’s herbicide Roundup, people injured by the Comirnaty vaccine could potentially sue for damages. And because adults injured by the vaccine will be able to show that the manufacturer knew of the problems with the product, jury awards could be astronomical.

Pfizer is therefore unlikely to allow any American to take a Comirnaty vaccine until it can somehow arrange immunity for this product.

[..] the FDA’s acknowledgement in its approval letter that there are insufficient stocks of the licensed Comirnaty, but an abundant supply of the EUA Pfizer BioNTech jab, exposes the “approval” as a cynical scheme to encourage businesses and schools to impose illegal jab mandates. The FDA’s clear motivation is to enable Pfizer to quickly unload inventories of a vaccine that science and the Vaccine Adverse Events Reporting System have exposed as unreasonably dangerous, and that the Delta variant has rendered obsolete.

Americans, told that the Pfizer COVID vaccine is now licensed, will understandably assume COVID vaccine mandates are lawful. But only EUA-authorized vaccines, for which no one has any real liability, will be available during the next few weeks when many school mandate deadlines occur. [..] While the media has trumpeted that the FDA has approved COVID vaccines, the FDA has not approved the Pfizer BioNTech vaccines, nor any COVID vaccines for the 12- to 15-year age group, nor any booster doses for anyone.

And the FDA has not licensed any Moderna vaccine, nor any vaccine from Johnson & Johnson — so the vast majority, if not all, of vaccines available in the U.S. remain unlicensed EUA products.

Here’s what you need to know when somebody orders you to get the vaccine: Ask to see the vial. If it says “Comirnaty,” it’s a licensed product. If it says “Pfizer-BioNTech,” it’s an experimental product, and under 21 U.S. Code 360bbb, you have the right to refuse. If it comes from Moderna or Johnson & Johnson (marketed as Janssen), you have the right to refuse. The FDA is playing bait and switch with the American public — but we don’t have to play along. If it doesn’t say Comirnaty, you have not been offered an approved vaccine..

And Jill Malone.

FDA Pfizer Authorization (Comirnaty): Key Points To Consider And Discuss

FDA Pfizer authorization (Comirnaty): Key points to consider and discuss.
These points are an aggregate of many minds, including Dr. Robert Malone. 23 Aug 2021
General talking points
• Why mandates if herd immunity isn’t possible?
• What happens 8 months after boosters?
• What’s the plan for the next variant?
• Why we’re messing with vaccine injury liability if the vaccines are safe and effective?

There are now TWO LEGALLY distinct (Pfizer vs. BionTech), but otherwise identical products, based on two FDA letters, as well as a press release. The analysis of these FDA products below is preliminary and subject to change.

Letter to Pfizer
https://www.fda.gov/media/150386/download
DOES NOT GIVE FULL APPROVAL
• Extends EUA to allow supply of current Pfizer under EUA because limited supply of BioNTech version.
• “The products are legally distinct with certain differences that do not impact safety or effectiveness. (page 2, Pfizer letter) [..] here FDA quietly admits that the licensed Pfizer vaccine and the authorized Pfizer vaccine are identical with regard to safety/efficacy, but they are “legally distinct.” That’s code for one has manufacturer liability, while the other doesn’t. It is also code for “we don’t want to impose a mandate on the EUA product cause it is illegal, but we can probably get away with a mandate on the licensed product.”

[..] yes, we licensed the vaccine, but…there is a lot of the old vaccine out there, actually “a significant amount” and this amount will be considered an EUA and will continue to be used. Now, why would they do that? Why specify that identical versions of the product will be legally different? Because they need the license to impose the mandates. But they need the EUA to evade liability.

Along with the license comes liability for the manufacturer. (While all EUA products were given a liability shield.) the feds want us to THINK the vaccine we are receiving is licensed, which will make people submit because they think it can now be mandated , but instead we are almost certain to receive the EUA vials instead, to save Pfizer’s behind.

Press release
https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

“On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.” The efficacy claims are based on outdated data. The press release indicates that the basis of the efficacy claims was as quoted below. However, those data are outdated, and captured with strains of virus (Alpha, Beta) that are no longer predominant. The efficacy claims are therefore invalid – it is quite clear that the vaccine is much less effective in preventing infection by the currently circulating strain (Delta)

In its letter to BioNTech, the FDA states “” We have determined that an analysis of spontaneous postmarketing adverse events reported under section 505(k)(1) of the FDCA will not be sufficient to assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis. Furthermore, the pharmacovigilance system that FDA is required to maintain under section 505(k)(3) of the FDCA is not sufficient to assess these serious risks.” The first sentence says that VAERS will be incapable of assessing known serious risk The second sentence says that the other pharmacovigilance systems that by law FDA employs (supposedly about 20 different databases when they were bragging about them last October) are similarly incapable of assessing known serious risk.

• The risks in pregnancy remain unknown. “although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.” The prescribing info says: “There is a pregnancy exposure registry for COMIRNATY. Encourage individuals exposed to COMIRNATY around the time of conception or during pregnancy to register by visiting https://mothertobaby.org/ongoingstudy/covid19-vaccines/ .” WHY ARE THEY DOING A PREGNANCY STUDY?

FDA has licensed the BioNTech vaccine for 16 and up
• All of the authorized vaccine on shelves and in freezers will remain only authorized, until the new product with Cominaty labelling arrives.
• 3d or booster doses and vaccine for 12-15 year olds remains under EUA
• Why not also approve the Pfizer version? Why leave it under EUA?
• When the press says the “Pfizer vaccine is fully approved.” It is not. The vaccine that is likely to be supplied for some time, WILL BE THE Pfizer – EUA vaccine. So any mandates based on full approval are meaningless.

THE BLA acknowledges LONG term myocardial issues with a 5 year follow up consistent with the lower range for LTFU for Gene Therapy Products. Is FDA quietly acknowledging the Gene Therapy classification? These products have been classified by FDA as Gene Therapy Products which require UP to 15 years long term follow up in studies. This was acknowledged by Moderna in their 2Q 2020 filing.

Using superior CDC published methods, normalizing for people vaccinated, Children’s Health Defense estimates 176x reports of VAERS deaths associated with C19 vaccines compared with flu vaccines. 35x the number for H1N1 (where stimulated reporting is speculated) Using CDC published methods we estimate under-reporting of VAERS deaths to be 5- 15x. for a total of 30,000-90,000 deaths, mostly non-C19. Underreporting for lifethreatening events may be 24-64x. IN ADDITION – (Israel MOH, combined with Dagan study), we have estimated between 35-86,000 EXCESS USA deaths due to Covid in those vaccinated (>=1 dose)

 

 

 

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