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FDA Refuses To Provide Key COVID-19 Vaccine Safety Analyses

FDA Refuses To Provide Key COVID-19 Vaccine Safety Analyses

Authored by Zachary Steiber via The Epoch Times (emphasis ours),

U.S. drug regulators…

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FDA Refuses To Provide Key COVID-19 Vaccine Safety Analyses

Authored by Zachary Steiber via The Epoch Times (emphasis ours),

U.S. drug regulators are refusing to provide key analyses of a COVID-19 vaccine safety database, claiming that the factual findings cannot be separated by internal discussions protected by law.

A sign for the Food And Drug Administration outside of the headquarters in White Oak, Md., on July 20, 2020. (Sarah Silbiger/Getty Images)

The Epoch Times asked the Food and Drug Administration (FDA) in July for all analyses performed by the agency for the COVID-19 vaccines using a method called Empirical Bayesian data mining, which involves comparing the adverse events recorded after a specific COVID-19 vaccine with those recorded after vaccination with non-COVID-19 vaccines.

According to operating procedures laid out by the agency and its partner in January 2021 and February 2022, the FDA would perform data mining “at least biweekly” to identify adverse events “reported more frequently than expected following vaccination with COVID-19 vaccines.” The agency would perform the mining on data from the Vaccine Adverse Event Reporting System (VAERS).

In a recent response, the FDA records office told The Epoch Times that it would not provide any of the analyses, even in redacted form.

The agency cited an exemption to the Freedom of Information Act that lets the government withhold inter-agency and intra-agency memorandums and letters “that would not be available by law to a party other than an agency in litigation with the agency.”

The agency also pointed to the Code of Federal Regulations, which says that “all communications within the Executive Branch of the Federal government which are in written form or which are subsequently reduced to writing may be withheld from public disclosure except that factual information which is reasonably segregable in accordance with the rule established in § 20.22 is available for public disclosure.”

It’s not clear why the FDA could not produce copies of the analyses with non-factual information redacted. The Epoch Times has appealed the determination by the records office. The FDA declined to comment, citing the appeal.

‘Unacceptable’

Kim Witczak, co-founder of Woodymatters, a nonprofit that advocates for a stronger FDA and drug safety system, said the agency’s refusal to provide the analyses was not acceptable.

The secrecy is unacceptable for an agency that said it is transparent with the public about vaccine safety,” Witczak, who sits on one of the FDA’s outside advisory panels, told The Epoch Times.

“What’s the point of having VAERS if you’re not releasing it to the public?” she added.

Witczak said her concerns about vaccine safety were heightened by a recent paper from Dr. Joseph Fraiman and others that found a higher incidence of serious adverse events in vaccinated participants in the original Pfizer and Moderna vaccine trials than in placebo recipients. She noted that the FDA’s 2004 warning for antidepressants that the drugs could increase the risk of suicidal thoughts and behavior came over 10 years after the trials on which it was based.

“If this data is available, shame on you for not making it known to the public,” Witczak said. “It’s as if they don’t trust the people to make their own best decision for what’s good for them and their families.”

A healthcare worker prepares a COVID-19 vaccine in Southfield, Mich., in an Aug. 24, 2021, file image. (Emily Elconin/Getty Images)

CDC

The Centers for Disease Control and Prevention (CDC), according to the documents outlining operating procedures, was going to perform a different type of data mining analyses, called Proportional Reporting Ratio (PRR) mining.

The CDC has also refused, so far, to provide the results for those analyses.

It has also twice provided false information when responding to questions.

The agency initially said that no PRR analyses were done and that data mining is “outside of th[e] agency’s purview.” The agency then said that it did perform PRRs, starting in February 2021.

Later, the agency acknowledged that wasn’t true. The agency did not begin performing PRRs until March 2022, a spokesperson told The Epoch Times.

Roger Andoh, a records officer, gave the initial response, citing the CDC’s Immunization and Safety Office. Dr. John Su, a CDC official, gave the second response. It remains unclear with whom the information originated.

The Epoch Times has submitted Freedom of Information Act requests for internal emails that may provide answers.

Data Mining Reports

The Empirical Bayesian (EB) is focused on identifying disproportional numbers of adverse events, CDC scientist Dr. Tom Shimabukuro said in January 2021. It identifies “with a high degree of confidence, adverse event-vaccine pairs reported at least twice as frequently as expected for a COVID-19 vaccine compared to the VAERS database,” he said, or a comparison between the incidence of a specific event such as kidney disease after COVID-19 vaccine compared to the incidence of the same event after all other U.S.-licensed vaccines.

The FDA and CDC have provided periodic updates on the EB data mining effort.

“Importantly, there were no Empirical Bayesian data mining alerts detected for any adverse event COVID-19 vaccine pairs as of the last data mining run that the FDA performed on February 18th,” Shimabukuro told members of the FDA’s vaccine advisory panel on Feb. 26, 2021.

In a review memorandum (pdf) for an expansion of the emergency authorization granted to Pfizer’s vaccine, FDA researchers said that data through April 16, 2021, showed only a possible signal for body temperature.

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Tyler Durden Tue, 09/13/2022 - 11:47

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International

Global Wages Take A Hit As Inflation Eats Into Paychecks

Global Wages Take A Hit As Inflation Eats Into Paychecks

The global inflation crisis paired with lackluster economic growth and an outlook…

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Global Wages Take A Hit As Inflation Eats Into Paychecks

The global inflation crisis paired with lackluster economic growth and an outlook clouded by uncertainties have led to a decline in real wages around the world, a new report published by the International Labour Organization (ILO) has found.

As Statista's Felix Richter reports, according to the 2022-23 Global Wage Report, global real monthly wages fell 0.9 percent this year on average, marking the first decline in real earnings at a global scale in the 21st century.

You will find more infographics at Statista

The multiple global crises we are facing have led to a decline in real wages.

"It has placed tens of millions of workers in a dire situation as they face increasing uncertainties,” ILO Director-General Gilbert F. Houngbo said in a statement, adding that “income inequality and poverty will rise if the purchasing power of the lowest paid is not maintained.”

While inflation rose faster in high-income countries, leading to above-average real wage declines in North America (minus 3.2 percent) and the European Union (minus 2.4 percent), the ILO finds that low-income earners are disproportionately affected by rising inflation. As lower-wage earners spend a larger share of their disposable income on essential goods and services, which generally see greater price increases than non-essential items, those who can least afford it suffer the biggest cost-of-living impact of rising prices.

“We must place particular attention to workers at the middle and lower end of the pay scale,” Rosalia Vazquez-Alvarez, one of the report’s authors said.

“Fighting against the deterioration of real wages can help maintain economic growth, which in turn can help to recover the employment levels observed before the pandemic. This can be an effective way to lessen the probability or depth of recessions in all countries and regions,” she said.

Tyler Durden Mon, 12/05/2022 - 20:00

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Unprecedented Liquidations Lead To Historic Collapse In Investors’ Oil Exposure

Unprecedented Liquidations Lead To Historic Collapse In Investors’ Oil Exposure

By John Kemp, senior market analyst

Portfolio investors sold…

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Unprecedented Liquidations Lead To Historic Collapse In Investors' Oil Exposure

By John Kemp, senior market analyst

Portfolio investors sold petroleum heavily for the third week running as fears about disruption to crude oil flows from the price cap on Russia’s exports receded.

Hedge funds and other money managers sold the equivalent of 42 million barrels in the six most important oil-related futures and options contracts over the seven days ending on Nov. 29.

Sales over the three most recent weeks totalled 190 million barrels, more than reversing the 169 million barrels purchased over the previous six weeks in October and early November. As Bloomberg adds, money managers have trimmed positioning in Nymex crude for three weeks in a row. A breakdown of the data show the drop in positions is mostly from money managers cutting long exposure, rather than an abrupt short-covering.

In the latest week, sales were again concentrated in crude (-40 million barrels), especially Brent (-39 million), with only insignificant changes in other contracts.

Brent is the contract with the most direct exposure to the crude exports from Russia subject to the price cap announced by the United States, the European Union and their allies on Dec. 2.

Fund managers cut their net position in Brent to just 99 million barrels (6th percentile for all weeks since 2013) last week from 238 million barrels (50th percentile) on Nov. 8.

Bullish long positions outnumbered bearish short ones in Brent by a ratio of just 2.17:1 (11th percentile), down from 6.74:1 in late October (76th percentile).

The long-short ratio is the lowest for two years since November 2020, before the first successful coronavirus vaccines were announced a few weeks later.

Fears the price cap would reduce global crude supplies appear to have prompted a wave of buying in both physical and paper markets throughout late September and early October.

Precautionary buying drove front-month Brent futures up to a high of almost $99 per barrel on Nov. 4 from just $84 on Sept. 26. It also helped keep the futures market in a steep six-month backwardation.

But as it became clear the cap would be set at a relatively high level, with a relaxed approach to enforcement, this buying has reversed, causing prices and spreads to fall sharply.

With the risk from the price cap removed, for now investors’ attention has returned to the weak outlook for the economy and oil consumption in 2023.

Tyler Durden Mon, 12/05/2022 - 14:21

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The Gall Of Lockdowners Who Support China’s Anti-Lockdown Protests

The Gall Of Lockdowners Who Support China’s Anti-Lockdown Protests

Authored by Michael Senger via ‘The New Normal’ Substack,

If the intent…

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The Gall Of Lockdowners Who Support China's Anti-Lockdown Protests

Authored by Michael Senger via 'The New Normal' Substack,

If the intent was to get western elites to simultaneously support totalitarianism in their own countries while pretending to oppose it in China, then Xi Jinping has certainly made his point...

Across the political spectrum, voices have risen up in support of the Chinese people who’ve launched protests of unprecedented scale against the Chinese Communist Party’s indefinite Covid lockdown measures.

As well they should. Even by Chinese standards, the lockdowns that Xi Jinping pioneered with the onset of Covid are horrific in terms of their scale, their duration, their depravity, and the new totalitarian surveillance measures to which they’ve led. Anyone who participates in a protest in China runs a risk of being subject to cruel and arbitrary punishment. For ordinary Chinese people to brave that risk in defiance of this new form of inhuman medical tyranny is an act of courage worthy of admiration.

There are notable exceptions to the otherwise widespread support the protesters have received. Apple has been silent about the protests, and had the gall to limit the protesters’ use of a communication service called AirDrop in compliance with the CCP’s demands, even as it threatens to remove Twitter from its app store over Elon Musk’s free speech policy. This comes even after Apple has long ignored requests by FCC officials to remove the Chinese-owned app TikTok from its app store over unprecedented national security concerns. So Apple complies with requests by the Chinese government, but not the United States government. Let that sink in…

Apple is, unfortunately, far from alone in its CCP apologism. Anthony Fauci told CNN that China’s totalitarian lockdowns would be fully justified so long as the purpose was to “get all the people vaccinated.”

This kind of apologism for the CCP’s grisly bastardization of “public health” is horrific, especially coming from the man most widely seen as the leader of America’s response to Covid.

But what may be even more galling than this apologism is the widespread support China’s anti-lockdown protesters have received even among those who demonized anti-lockdown protesters in their home countries and wished their lockdowns were more like China’s.

In 2020, the New York Times denounced anti-lockdown protesters as “Anti-Vaxxers, Anticapitalists, Neo-Nazis” and urged the United States to be more like China.

But in 2022, the New York Times admired the bravery of China’s anti-lockdown protesters fighting Xi Jinping’s “unbending approach to the pandemic” that has “hurt businesses and strangled growth.”

In 2020, CNN published an open letter from “over 1,000 health professionals” denouncing anti-lockdown protests as “rooted in white nationalism” while admiring “China’s Covid success compared to Europe.”

But in 2022, CNN admired China’s anti-lockdown protesters as “young people” who “cry for freedom”

In 2020, the Washington Post denounced anti-lockdown protesters as “angry” populists who “deeply distrust elites,” and wished the United States was more like China.

But in 2022, the Washington Post celebrated global “demonstrations of solidarity” with China’s anti-lockdown protests.

In 2020, the New Yorker denounced anti-lockdown protesters as “militias against masks” while marveling at how “China controlled the coronavirus.”

But in 2022, the New Yorker admired the protesters standing up to Xi Jinping.

Earlier this year, Amnesty International issued a statement of concern about Canada’s anti-lockdown Freedom Convoy protests being affiliated with “overtly racist, white supremacist groups,” even as Justin Trudeau invoked the Emergencies Act to crush the protests.

But now, Amnesty International has issued a statement urging the Chinese government not to detain peaceful protesters.

These headlines are, of course, in addition to the hundreds of other commentators, influencers, and health officials, such as NYT journalist Zeynep Tufekci, who used their platforms in 2020 to urge for lockdowns that were even stricter than those their governments imposed, but now join in support for those in China protesting the same policies they were urging their own countries to emulate.

Etymologically, Zeynep’s latter comment makes no sense. Lockdowns had no history in western public health policy and weren’t part of any democratic country’s pandemic plan prior to Xi Jinping’s lockdown of Wuhan in 2020. Though some countries, such as Italy, imposed lockdowns shortly before the United States, their officials too had simply taken the policy from China. Thus, because no other precedent existed, any call for a “real lockdown” or a “full lockdown” in spring 2020 was inherently a call for a Chinese-style lockdown.

Though by “full lockdown” Zeynep may have intended somewhere in between the strictness of lockdowns in the United States and China, there was no way for any reader to know what that medium was; it existed only in her own head. Thus, the reader is left only with a call for a “full lockdown,” and the only example of a “successful” “full lockdown” that then existed was a full Chinese lockdown.

Zeynep’s latter comment further illustrates the efficacy of what was arguably some of the CCP’s most effective lockdown propaganda in early 2020: The ridiculous viral videos of CCP cadres “welding doors shut” so poor Wuhan residents couldn’t escape.

CCP apologists have argued that these videos prove the CCP was not trying to influence the international response to Covid, because they make the CCP look so bad. But on the contrary, the over-the-top inhumanity of the idea of welding residents’ doors shut was precisely the purpose of this propaganda campaign. The idea had to be so absurd that no decent government would ever actually try it. It thus gave the CCP and its apologists an infinite excuse for why lockdowns “worked” in China and nowhere else—because only China had ever had a “real lockdown” in which residents were welded into their homes.

When those with a decent knowledge of geopolitics or a bit of common sense see a graph like this, which looks nothing like that of any other country in the world, from a regime with a long history of faking its data on virtually every topic, the conclusion is obvious: China’s results are fraudulent. But to simple minds, a weld is a strong, durable bond capable of incredible feats, from supporting skyscrapers to spaceships. Surely, if a weld can do all that, then it must be able to stop a ubiquitous respiratory virus?

The entire concept is, of course, utterly asinine. You cannot stop a respiratory virus by indefinitely suspending everyone’s rights. But this idea that lockdowns had worked in China because the CCP had gone so far as to weld people into their homes was invoked over and over again during Covid, creating a limitless “No-True-Scotsman” out for lockdown apologists as to why lockdowns weren’t “working” anywhere except China. Whether COVID-19 cases went up, down, or sideways, the solution would always be the same: “Be more like China.”

The use of this darkly humorous propaganda campaign of welding residents into their homes speaks to two key points as to how Xi Jinping and CCP hawks like him view China’s relationship with the west. The first is that westerners will never respect the CCP; thus, you can make westerners believe anything so long as it confirms westerners’ prior belief that the CCP is barbaric.

Second, Xi Jinping sees the concepts of democracy and human rights as mere propaganda that western elites use to further their own self-interest. So long as they approve of a policy, then it’s not a human rights violation, but if they oppose it, then it is. It remains to be seen whether the response to Covid will, in the long run, ultimately advance Xi’s goal of making the world China. But insofar as the intent was to get western elites to simultaneously support totalitarianism in their own countries while pretending to oppose it in China, then he’s certainly made his point.

*  *  *

Michael P Senger is an attorney and author of Snake Oil: How Xi Jinping Shut Down the World. Want to support my work? Get the book

Tyler Durden Mon, 12/05/2022 - 15:53

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