CDC chief overrules advisory panel, okays boosters for people based on job risk – HotAir

For reasons I don’t understand apart from the partisan impulse to ding her with a gotcha, Rochelle Walensky is taking heat this morning for allegedly not “following the science” in deciding to overrule the CDC’s advisory panel. The panel okayed boosters yesterday for senior citizens and people 50-64 with health problems, and advised those aged 18-49 with medical conditions to at least consider a third dose. But they rejected boosters for those who stand a high risk of being exposed to COVID on the job, like doctors, nurses, teachers, and other frontline workers. That proposal went down on a 9-6 vote.

Which was foolish.

So Walensky exercised her authority and ignored them, making those high-risk workers eligible for shots after all. Good for her.

Dr. Walensky’s decision to go against her own agency’s advisers came as a surprise to at least some of her staff members: The C.D.C. director’s endorsement of the advisory committee’s recommendations is typically just a formality. Hours before her statement, agency insiders predicted she would stick with the usual protocol because doing otherwise would undermine the process and upset the advisers as well as her own staff.

But experts outside the C.D.C. said Dr. Walensky may have had no choice but to align herself with the F.D.A.’s decision. “There’s a complexity here, because Dr. Walensky was part of the White House announcement” on boosters, noted Dr. Ashish Jha, dean of the Brown University School of Public Health…

Dr. Walensky’s decision revealed the continuing divisions and confusion among federal regulators and outside advisers about how to contain the virus nearly two years into the pandemic.

It’s true that Walensky has been erratic in the great booster debate, initially supporting Biden’s decision to roll out third doses on September 20, then backing off to give the CDC and FDA more time to crunch the data, and now opposing her own advisory panel on boosting people due to professional hazards. Does that prove that her decision to overrule them was based on politics rather than science? Well, no. The FDA’s own advisory panel “specified that health care workers, emergency responders and others whose jobs put them at special risk should also be eligible for the booster shots,” a recommendation which the agency later formalized.

Walensky ended up agreeing with them and the six members of the CDC panel that supported boosting people at special risk on the job. So who failed to “follow the science” here? All of them, or the nine CDC advisors who opted against boosters based on occupational hazards?

How about the fact that various well-known doctors criticized the advisory panel’s decision to omit job-based boosters and cheered Walensky this morning for overruling them?

All seem to think that “the science” in this case broke in favor authorizing boosters based on job risk. So did Anthony Fauci, who told Politico, “Dr. Walensky made a good judgment and showed good leadership in making that decision. I totally agree and support that decision she made.” Bear in mind too that the advisory panel refused to support Pfizer shots for people who have already received Moderna or Johnson & Johnson even though it means tens of millions of Americans — including frontline workers — are locked out of a booster at the moment even though their immunity may be starting to wane. (That’s especially risky for J&J people, who’ve had only one dose.) That illustrates how cautious, even overly cautious, the panel was about endorsing boosters. Why let that degree of over-caution deprive frontline workers of a needed extra dose?

It’d be one thing if the panel thought there was a safety risk to giving out third doses based on job risk, or if they reasoned that medical professionals, teachers, cashiers, and others who have likely been face to face with infected people for months are already naturally immune and don’t need a boost. (Although in that case, why not authorize boosters for them and let them decide with their doctors whether to get one? Not every frontline worker has already been infected.) But that’s not why the panel voted against third doses for people with high-risk jobs. They did it because they were practicing pop psychology, trying to anticipate how the public — especially the unvaccinated segment of the public — would react to a broad-based booster authorization based on employment.

Privately, administration officials had hoped the booster recommendations would be as expansive as possible and include workplace exposure, Lena and Laurie write. But some on the CDC’s advisory panel were afraid to allow workers to get the booster, worried it would essentially open the door too wide.

“We might as well just say give it to anyone 18 and over,” Pablo J. Sanchez, a professor of pediatrics at Ohio State University, said at yesterday’s meeting. “We have a really effective vaccine, and it is like saying that it is not working, and it is working.”

They’re afraid of “underselling” the vaccine to the unvaccinated. If they authorize a third dose for people who are at risk while at work, the unvaxxed may conclude that two doses aren’t sufficient to keep people out of the hospital despite the fact that they are. But (a) the hardline anti-vaxxers will always find an excuse not to get their shots (authorizing boosters for any segment of the population will give them a pretext to claim that first two doses don’t work as advertised) and (b) a third dose for people in high-risk jobs may be beneficial to the public at large by keeping the recipients from having to miss work if they’re infected. A nurse or a teacher with two doses probably won’t end up in the ER but they may need a week or two off to recuperate, which would mean hospitals and schools going understaffed. A third dose might mean a much quicker recovery. The more critical workers can be kept on the job this winter, the more others will get the services they need and the faster the economy will revive.

And remember, the jury remains out on whether a third dose might actually provide durable protection against COVID and future variants to an extent that two doses don’t. The worst-case scenario for boosters is that they increase one’s antibodies for a few weeks or months and then fade, a fleeting temporary benefit. The best-case scenario, which Fauci has mused about, is that they’ll elicit a more mature immune response to future encounters with the virus, reducing the severity of infections for years. There could be a big payoff to being more liberal with boosters now, in other words, producing more durable immunity throughout the population.

Here’s Walensky defending her decision.





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COVID-19 vaccines do not increase risk of miscarriage, birth defects, CDC

Vaccinating against COVID-19 does not increase the risk of miscarriage or birth defects, the Centers for Disease Control and Prevention said Thursday.

The government agency tracked 1,613 pregnant women who received a COVID shot during either their second or third trimester of pregnancy (30% second, 70% third.) The women in the study gave birth to 1,634 live-born infants, a figure that includes 42 twins – there were no infant fatalities in the  group.

CDC medical officer Dr. Christine Olson told the agency’s Advisory Committee on Immunization Practices that her team “reviewed the currently available registry data and found no evidence of an increase in spontaneous abortion rates, and no evidence of any disproportionate negative infant birth outcomes.”

By demographic, 79.4% of the women whose pregnancies were monitored were white, 8.4% were Asian, 8.1% were Hispanic, and 1.4% were black. Close to 65% were between the ages of 25-34, while 33% were between 35-44 years old. 

The government health agency has previously determined that pregnant women face a higher risk for severe COVID cases than members of the non-pregnant population. The virus also raised the likelihood of a premature birth.



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IG: Pentagon Reliance on Chinese Pharmaceuticals Creates National Security Risk

Report calls for moving supply chains away from China

U.S. general Mark Milley and Chinese general Li Zuocheng in 2016 (Mark Schiefelbein/AFP via Getty Images)

Jack Beyrer • September 22, 2021 12:10 pm

The Defense Department’s reliance on Chinese supply chains for pharmaceuticals poses a severe national security risk, a Pentagon inspector general’s report warns.

The U.S. military’s ability to treat soldiers and personnel worldwide relies on products made and shipped in foreign countries. The Pentagon does not produce its own pharmaceuticals, so it relies on the American commercial sector to procure vital medicines for the armed forces. As the commercial sector increases its reliance on foreign countries the department follows suit, the report, which was released Wednesday, found.

“Pharmaceutical supply disruptions could compromise the standard of care to [Defense Department] beneficiaries,” the report concludes. “A disruption of the supply of foreign-made [active pharmaceutical ingredients] to domestic manufacturers could cause a drug shortage that affects every level of the U.S. health care system.”

Some 72 percent of commercial pharmaceuticals are procured from foreign countries, and 13 percent come from China, according to a 2019 Food and Drug Administration study. During the early stages of the coronavirus pandemic, China threatened to withhold life-saving drugs from American citizens over the growing rift between Washington and Beijing.

China’s ability to weaponize public health does not end with pharmaceuticals or the coronavirus. A national intelligence assessment found that the Chinese Communist Party uses American medical data to collect the DNA of U.S. citizens, the Washington Free Beacon reported in February. China may aim to use the data to target Americans for surveillance or manipulation purposes.

The inspector general’s report calls for lawmakers to pursue remedies for the Pentagon’s reliance on Chinese goods.

“We recommend that the Under Secretary of Defense for Acquisition and Sustainment develop and issue implementing guidance for [Department of Defense] supply chain risk management for [Defense] materiel, which includes pharmaceuticals, [and] pursue Federal legislation requiring pharmaceutical manufacturers to include [active pharmaceutical ingredients] and final drug product country of origin information of the pharmaceuticals’ lot on the pharmaceuticals’ packaging,” the report says.





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American Investors Are At Risk When Congress Gives Chinese Companies A Pass

Concern this week about the possible collapse of China’s Evergrande, which has a massive debt burden of $305 billion, highlights one more reason Congress needs to act to protect U.S. investors from Chinese companies.

The Sarbanes-Oxley Act of 2002 mandates the Public Company Accounting Oversight Board (PCAOB) and the U.S. Securities and Exchange Commission (SEC) inspect audit paperwork of all companies that issue securities in the U.S. The goal is to “protect investors and further the public interest in the preparation of informative, accurate, and independent audit reports.” More than 50 foreign jurisdictions comply with this U.S. law. But in the name of national security concerns, the Chinese government has prevented both domestic and foreign auditors of Chinese companies listed on U.S. exchanges from submitting audit reports to PCAOB and the SEC for inspection.

SEC Chairman Gary Gensler issued a warning to Chinese companies listed on U.S. stock exchanges recently: comply with our audit rules or be delisted. But Gensler’s threat came with a caveat: Chinese companies will have a three-year grace period before they may have to face any consequences. Given all the known risks of investing in Chinese companies, Kyle Bass, Hayman Capital founder and a vocal critic of China, said the SEC’s delayed enforcement would allow Chinese companies to have an “open season on U.S. investors” for three more years.

For decades, Chinese companies have successfully tapped into the U.S. capital market and U.S. investors have helped fund China’s astonishing economic growth. As of May 2021, there are 248 Chinese companies listed on U.S. stock exchanges, with a market capitalization of $2.1 trillion.

Past Fraud at Chinese Companies Listed on U.S. Stock Exchanges

U.S. regulators have good reasons to be concerned about investors’ risk exposure because corporate fraud in China is a well-known epidemic. In 2018, auditors in China declined to endorse 219 annual reports prepared by Chinese companies because the auditors either found problems with these companies’ financial statements or had expressed concern about the companies’ likelihood of survival.

Last year, Luckin Coffee, a Chinese startup that went public on NASDAQ in May 2019, disclosed that several of its employees, including its chief operating officer, had fabricated the majority of the company’s 2019 sales. Two months later, NASDAQ delisted Luckin stock. At the time, Luckin’s share price was only $1.48, a stunning 97 percent decline from its all-time high of $51 per share less than a year ago. Investors of Luckin stock suffered massive losses.

Shortly after Luckin’s financial fraud was exposed, another U.S.-listed Chinese company, TAL Education Group, one of the largest education providers in China that offer K-12 after-school tutoring services, revealed that one of its employees had inflated the company’s sales by “forging contracts and other documentation.” The share price of TAL dropped 23 percent in one day. The accounting scandals of Luckin and TAL renewed the concern that Beijing’s refusal to comply with the U.S. law while continuing to access U.S. capital markets has subjected U.S. investors to significant investment risk.

A succession of U.S. administrations has engaged many rounds of diplomatic negotiations with Beijing, hoping that China would comply with U.S. law and let PCAOB and SEC inspect audit reports for Chinese companies listed on U.S. exchanges. Beijing never budged. In 2012, a frustrated SEC filed administrative proceedings against five Chinese accounting firms (all of them global firms’ Chinese subsidiaries), for failing to hand over audit records of the Chinese companies under SEC investigation. The five firms claimed that if they followed SEC’s order, they would violate Chinese laws.

Even if PCAOB or SEC were granted access to Chinese companies’ auditors, another ongoing concern is that some of China’s homegrown accounting and auditing firms are just as unreliable as their corporate clients. Rather than acting as gatekeepers, these firms have turned a blind eye to their clients’ fabricated financial statements to maintain lucrative business relationships. For example, Chinese regulators launched investigations of China’s accounting firms Ruihua and GP in 2019. The regulator found that one of GP’s corporate clients inflated its cash holding by $4 billion, and one of Ruihua’s corporate clients overstated its profit for four years by $1.7 billion.

Shell Companies Are Another Risk

Widespread corporate fraud of Chinese companies and lax oversight from Chinese auditors are only some of the many known problems investors and U.S. regulators have to deal with. Another significant problem is Chinese companies’ circuitous corporate structure.

Since Beijing bars foreigners from taking ownership in what it deems strategic sectors of the Chinese economy, many large Chinese companies created offshore holding companies or variable-interest entities (VIEs) to raise capital outside of China. Since these VIE shares do not represent ownership, they offer foreign investors minimal legal rights or protections. According to Paul Gillis, an economics professor at Peking University, in the event of any dispute between foreign investors and VIEs, foreign investors “risk finding themselves owning shares in a shell company with no assets and no business if the contracts fall apart.”

Chinese Communist Party Influence on Chinese Companies

While foreign investors do not have ownership of Chinese companies they invested in, the Chinese Communist Party (CCP) has vast influence over Chinese companies and their management. For example, between 2016 and 2017, more than 30 Hong Kong-traded Chinese companies required their boards to consult Communist Party committees before making major business decisions.

Yet, Chinese companies listed on U.S. exchanges have yet to disclose either the CCP’s ownership stake or its power to influence their business operations. Without such disclosure, foreign investors in these Chinese companies are in the dark regarding the magnitude of risks they are exposed to.

Congress Must Authorize the SEC to Act Now

U.S. lawmakers sought to protect U.S. investors and address China’s decades-long refusal to comply with the Sarbanes-Oxley Act by passing the Holding Foreign Companies Accountable Act (HFCAA) in 2020. President Trump signed it into law. HFCAA stipulates auditors of foreign public companies must allow PCAOB to inspect their audit reports of non-U.S. operations, and if “a company’s auditors fail to comply for three consecutive years, then the company’s shares would be prohibited from trading in the United States.”

The lawmakers clearly aimed at China when they drafted HFCAA, but a three-year grace period is too long to address problems we have known of for decades. While the SEC is still drafting new rules to implement HFCAA, new challenges from China have emerged.

Less than two months ago, foreign investors who have funded China’s economic growth by investing in Chinese companies had suffered their most significant loss since the 2008 financial crisis. The CCP launched a crackdown on China’s largest technology firms, private education businesses, video game makers, and food-delivery companies. Bloomberg estimates that the Chinese government’s action has wiped out $1.5 trillion in value of these companies. Even investors who do not own these stocks directly suffer losses because many mutual funds hold these Chinese stocks in their investment portfolios.

There are indications the CCP hasn’t finished its crackdown yet, as its leader Xi Jinping is determined to reshape China’s economy by will and consolidate power and control in his own hands. Xi announced in early September that China would launch a new stock exchange in Beijing to help small to medium-sized companies raise capital. China already has three stock exchanges: Shanghai, Shenzen, and Hong Kong. The establishment of the Beijing stock exchange is the latest indication that China intends to develop its own capital market further and reduce Chinese businesses’ reliance on foreign capital markets. The SEC would have very little leverage left if it waited three years to delist Chinese companies that don’t comply with U.S. law. By 2024, China’s capital market will be mature enough that these Chinese companies probably will be more than happy to take their businesses back to China and re-list on Chinese stock exchanges.

The U.S. Senate passed the Accelerating Holding Foreign Companies Accountable Act this summer, which, if enacted, would reduce the three-year grace period to two. But even two years in the investment world is still a long time. American investors continue to face the risk of enormous financial losses as Beijing stonewalls U.S. laws. To truly protect American investors, the U.S. Congress needs to authorize the SEC to take action now, not two or three years from now.

 





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Nancy Pelosi, Chuck Schumer risk government shutdown to avoid Democrat-only hike in debt ceiling

Congressional Democratic leaders on Monday set themselves on the road to a potential government shutdown and a default on U.S. debt by the end of the month.

House Speaker Nancy Pelosi of California and Senate Majority Leader Charles E. Schumer of New York announced they would seek to suspend the debt ceiling until the end of December 2022. They also said they will link the move to a broader stopgap funding bill meant to keep the government afloat until at least the end of this year.

“Both Republicans and Democrats have priorities they want to see addressed … and an extension of government funding through December will provide an appropriate amount of time for that bipartisan, bicameral process to come to completion,” they said in a joint statement. “The legislation to avoid a government shutdown will also include a suspension of the debt limit through December 2022 to once again meet our obligations and protect the full faith and credit of the United States.”

Mrs. Pelosi has already pledged to secure House passage of the measure later this week. But within the evenly split Senate, any measure to hike the debt ceiling faces long odds.

Republicans say Democrats should unilaterally suspend the cap on the debt ceiling, a limit on how much the government can borrow to pay for federal expenditures. Many in the GOP say that if Democrats are content to pass President Biden’s $3.5 trillion expansion of the federal safety net along party lines, they should then be responsible for its impact on the debt.

“Democrats are intent on going on a reckless spending spree — spending money we don’t have on things we can’t afford, which will fuel runaway inflation and harm American families,” Sen. Ted Cruz, Texas Republican, told The Washington Times. “Despite the fact Democrats have total control of Washington and can raise the debt ceiling on their own, they are playing political games with the debt ceiling.”

Mrs. Pelosi and Mr. Schumer claim the stance taken by Republicans is reckless, arguing that current U.S. debts were accumulated under prior administrations, including that of former President Donald Trump.

“Addressing the debt limit is about meeting obligations the government has already made, like the bipartisan emergency COVID relief legislation from December as well as vital payments to Social Security recipients and our veterans,” they said.

Senate Minority Leader Mitch McConnell, Kentucky Republican, disagrees. He said on Monday that Democrats could deal with the debt ceiling using budget reconciliation. 

The process, which Democrats are using to pass Mr. Biden’s $3.5 trillion social welfare package, allows some spending and tax measures to avoid a filibuster and pass with a simple majority of 51 votes.

“We do not have divided government. Democrats do not need our help,” Mr. McConnell said. “They have every tool to address the debt limit on their own, the same party-line process they used to ram through inflationary spending in March and already plan to use once again this fall.”

Mr. McConnell, who has already pledged that no Republican will vote to hike the debt ceiling, said bipartisan support existed for a “standalone” bill to keep the government running.

“Senate Republicans would support a clean continuing resolution that included appropriate disaster relief and targeted Afghan assistance,” he said. “We will not support legislation that raises the debt limit.”

Democrats are unwilling to entertain the idea, as it would remove any leverage they have to get out of raising the debt ceiling unilaterally via budget reconciliation.

Raising the debt ceiling along party lines would require congressional Democrats to specify a dollar amount. Many lawmakers, especially vulnerable Democrats facing tough reelection battles, don’t want to be on record for hiking the federal debt above the current limit of $28.5 trillion.

“We can do it through reconciliation. Leadership has said they don’t want to do that,” said House Budget Committee Chairman John Yarmuth, Kentucky Democrat, on MSNBC. “The reason is if we do that through reconciliation, we actually have to specify a number.”

With Mr. McConnell vowing that no Republicans will back a vote to hike the debt ceiling and Democrats unwilling to do it unilaterally and tying it to the stopgap measure, Congress faces a potential government shutdown on Sept. 30.

At the moment, neither side appears willing to compromise. Mrs. Pelosi and Mr. Schumer are warning lawmakers to prepare for a series of long nights over the next month.

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Central bank group BIS warns of green asset bubble risk

FILE PHOTO: The tower of the headquarters of the Bank for International Settlements (BIS) is seen in Basel, Switzerland January 30, 2020. REUTERS/Arnd Wiegmann

September 20, 2021

By Marc Jones

LONDON (Reuters) – The central bank to the world’s central banks, the Bank for International Settlements, has warned of the growing risk of a price bubble in environmentally friendly-focused asset markets.

Increasing urgency to limit global warming and tackle other issues such as racial and social inequality has seen Environmental, Social and Governance (ESG) investing explode in popularity in recent years.

Some estimates indicate ESG-focused assets have soared to a value of $35 trillion and now account for more than a third of all assets professionally managed by banks and investment funds.

A narrower definition including only exchange-traded funds (ETFs) and mutual funds with ESG or socially responsible investment (SRI) mandates points to even faster, tenfold growth, to approximately $2 trillion. This is evidenced in assets such as clean energy and electric car stocks and green bonds, which have soared in recent years.

“There are signs that ESG assets’ valuations may be stretched,” the BIS, which holds regular meetings for the world’s central banks, said as part of its latest quarterly report.

Claudio Borio, head of its monetary and economic department, referred to it as the “green bubble” risk, highlighting how the surge in ETFs and mutual funds was comparable to parts of the mortgage backed security market in the runup to the global financial crisis.

“You could have too much, too quickly of a good thing,” Borio said. “We know valuations are rather rich”.

Prices have eased somewhat this year but markets are awash with examples of the moves. Electric car doyen Tesla for example raced up 750% in last year’s frenzy and is up 16,000% over the last decade.

Borio said authorities needed to be aware of the risk such huge shifts in investor demand can have, also drawing comparisons to the internet stock boom of the early 2000s and the railroad boom in the 1800s.

For the moment, regulators’ concerns should be eased by the fact that most of the exposure is to equity markets which tend to have less of systemic relevance.

Current holdings of ESG linked bonds are only estimated to account for about 1% of total bond portfolios for both U.S. insurance companies and European banks.

Borio did also warn of “definitional risk” and of so-called “greenwashing”, where the environmental benefits of certain assets were potentially being over-exaggerated. If those exaggerations are exposed, values could then plunge.

The BIS’ report also focused on the current surge in global inflation, which is being fuelled by rising energy and labour costs as the world’s economies reopen after COVID-19 enforced shut downs.

Borio said the BIS’ view remained that the rise in inflation would be temporary although he acknowledged it wasn’t as clear cut as initially expected.

“It may indeed be possible as we see in terms of supply side constraints and some of the pressures, could be somewhat longer lasting than we had originally anticipated, but the view has not fundamentally changed,” Borio said.

For a graphic on Green asset markets showing similarities to other financial bubbles:

https://fingfx.thomsonreuters.com/gfx/mkt/klpykgnlkpg/Pasted%20image%201632134499455.png

(Reporting by Marc Jones; Editing by Bernadette Baum)





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FDA Panel Rejects Pfizer Booster Shot for Ages 16-65 Over Increased Risk of Heart Inflammation

On Friday, Biden’s vaccination plan hit a major roadblock after an FDA advisory panel declined to endorse authorization the Pfizer-BioNTech Covid booster shot for people aged 16 or older.

The 18 member group of influential experts was tasked with deciding if Pfizer’s latest clinical trials had provided adequate results that demonstrate the safety and effectiveness of their booster shot.

Unsurprisingly, the results did not make the cut, not even close.

The panel voted 16-2 to reject extra doses of experimental vaccine, citing insufficient data from incomplete clinical trials and the potential risk of heart inflammation – especially among young men. 

TRENDING: Crossing the Line: Nicki Minaj Exposes the Media Mafia; Posts Private Messages From Reporters Threatening Her Family Members

The panel did, however, vote unanimously to endorse the booster for people aged 65 or older and “high-risk” individuals

According to Fox News:

“[The FDA Panel] endorsed emergency approval for the Pfizer-BioNTech COVID-19 vaccine booster shot at least six months following the second dose among people ages 65 and older and those at high risk of occupational exposure and severe COVID-19.

The meeting included members of the FDA’s Vaccines and Related Biological Products Advisory Committee, (VRBPAC), as well as officials from the Centers for Disease Control and Prevention (CDC), lsrael’s Health Ministry, vaccine experts and Pfizer representatives.”

The panel’s vote will now be weighed by the FDA to make a final decision on who will be eligible for the Pfizer booster. 

The additional doses are being pushed because the original vaccine effectiveness has been fading quickly over time. Several studies have shown that people who have gotten the virus and then recovered – leaving them with natural immunity – are much better protected than those who are relying on the Pfizer jab.

In fact, one study that was conducted on 800,000 individuals showed that people who have taken both doses of the Pfizer jab are 13 TIMES more likely to have a breakthrough infection, and are at a “greater risk for Covid-19 hospitalizations.”

New Israeli Study Finds Fully Vaccinated People are at “Greater Risk of Hospitalization” and 13 TIMES MORE LIKELY to Catch Covid-19 Than Those Who Have Recovered and Have Natural Immunity

So much for the ‘pandemic of the unvaccinated’..

The US health regime and Big Pharma have cleverly used the poor vaccine results to push another round of experimental shots. They have begun to acknowledge the decline in protection against infection, but refuse to mention anything about natural immunity and downplay the adverse reactions that have been well documented.

Fox News: Dr. William Gruber, senior vice president of vaccine clinical research and development at Pfizer, noted Phase 3 trial data indicating waning protection over time, from 96% vaccine efficacy within two months after the second dose to about 84% by six months and amid the dominant delta variant.

Additional data suggested a third Pfizer dose would ramp up protection on par or better than the second dose, however concerns were raised over the potential increased risk of myocarditis. The FDA panel’s review included Pfizer’s trial results with some 300 participants ages 18-55 who received a booster dose about six months after the second dose.

The FDA will review the committees vote and is expected to issue a final decision on Pfizer’s booster sometime next week. 





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FDA advisory committee recommends Pfizer COVID-19 boosters for people 65+ or at high risk of severe COVID-19

An advisory committee has voted in favor of recommending Pfizer-BioNTech COVID-19 vaccine booster shots for people ages 65 and above as well as for people with high risk of severe COVID-19.

The 18-0 vote came after the Vaccines and Related Biological Products Advisory Committee had already voted 16-2 against recommending Pfizer-BioNTech vaccine booster shots for individuals ages 16 and older.

The U.S. Food and Drug Administration is not bound to follow the committee’s recommendations, though it usually does, according to the New York Times.

In the 16-2 vote, a majority voted against recommending boosters for people 16 and older. The actual question read: “Do the safety and effectiveness data from clinical trial C4591001 support approval of a COMIRNATY booster dose administered at least 6 months after completion of the primary series for use in individuals 16 years of age and older?”

The committee later voted “yes” by 18-0 on the question: “Based on the totality of scientific evidence available, including the safety and effectiveness data from clinical trial C4591001, do the known and potential benefits outweigh the known and potential risks of a Pfizer-BioNTech COVID-19 vaccine booster dose administered at least 6 months after completion of the primary series for use in” people ages 65 and above, and people “at high risk of severe COVID-19.”

The panel also indicated that they believe people working in healthcare and other individuals facing high risk of occupational exposure should be included in the emergency use authorization.

So far 63.6% of the U.S. population ages 12 and above has been fully vaccinated against COVID-19, while 74.4% of that demographic has received at least one dose, according to the Centers for Disease Control and Prevention.

In August the FDA approved the the Pfizer vaccine for use in individuals ages 16 and older, making it the first COVID-19 vaccine to secure full approval from the agency. “The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals,” the FDA noted in announcing the approval last month.


Vaccines and Related Biological Products Advisory Committee – 9/17/2021

www.youtube.com





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Migrants risk lives crossing S. America Darien Gap on trek to US

As thousands of illegal migrants wait along the southern border of Texas to be processed into the United States, hundreds more are risking their lives crossing through the Darien Gap to eventually seek asylum in the US.

A group of roughly 500 migrants are trekking through the jungle for six days in order to cross from Columbia to Panama, according to the Associated Press. Along their journey, they will face bandits, dangerous animals and hazardous rivers.

Photos of the migrants preparing to enter the jungle show dozens carrying food, water, children, blankets and other provisions through waist high rivers and valleys.

For the journey, two migrants are carrying 20 liters of water, which cost them $20.

The migrants crossing through the Darien Gap are mostly Haitian who have been living in South America. Visa requirements and the coronavirus pandemic have made it extremely difficult for them to fly directly to the US, Mexico or Panama, leaving many to rely on trekking through the jungle.

A group of migrants carry gallons of water while hiking north near Acandi, Colombia on September 15, 2021.
AP Photo/Fernando Vergara
Migrants cross the Acandi River on a horse cart in Acandi, Colombia, Tuesday, Sept. 14, 2021.
A group of migrants with children cross the Acandi River on a horse cart in Acandi, Colombia on September 14, 2021.
AP Photo/Fernando Vergara

“The jungle is very tough, we just walk without a precise idea of where we’re headed,” Davidson Lafleur, a 24-year-old Haitian, told the Associated Press.

Lafleur is just one of hundreds of migrants looking to travel to the US with his family after living in South America the past three years. As he is traveling with his wife and 11-month old daughter, Lafleur reportedly paid someone $120 to carry his bags to the Panama border.

While trekking through the jungle, the migrants are faced with the decision to leave behind belongings to carry less weight throughout the strenuous journey. Some groups have had to turn back after migrants suffering from different ailments faint or run out of their medication.

Migrants have reported getting foot funguses, gastrointestinal problems and respiratory infections throughout the journey. Women have allegedly given birth while on the trek and children have reportedly died.

Migrants rest at a camp in Acandi, Colombia, Tuesday, Sept. 14, 2021.
Migrants on their journey through the Darien Gap’s jungles rest at a camp in Acandi, Colombia on September, 14, 2021.
AP Photo/Fernando Vergara
Migrants continue on their trek north, near Acandi, Colombia, Wednesday, Sept. 15, 2021.
The majority of trekking migrants dump their belongings during their journey through the Darien Gap.
AP Photo/Fernando Vergara

Other humans pose an extremely dangerous threat to the migrants. Earlier this year, nearly 100 women were sexually assaulted by bandits while trekking through the jungle. The trails, which are often used to traffic drugs, are also controlled by armed groups.

“Fear is always with us,” Lafleur said. “But we have no choice but to keep on going.”

Local guides helping migrants through the jungle face additional dangers, as some who spoke with the Associated Press decline to give their names to avoid being prosecuted for human trafficking.

Immigration officials in Panama have reported record numbers of migrants crossing the Darien Gap, saying at least 70,000 people have made the trek in 2021. To curb the growing numbers, Colombia and Panama agreed to limit the number of people crossing through the jungle each day. The limit however has created a bottleneck for immigrants looking to get to the jungle from Colombia in the first place.

A migrant carries two children across a river as they continue their trek north, near Acandi, Colombia, Wednesday, Sept. 15, 2021.
A migrant carries two children across a river near Acandi, Colombia.
AP Photo/Fernando Vergara

If the hundreds of traveling migrants can make it to the US, they face the problem of processing with the US border patrol.

As of Thursday, over 10,000 migrants were waiting underneath the Del Rio International Bridge to be processed into the United States, while 2,000 to 3,000 are in detention “at any given moment,” according to Del Rio Mayor Bruno Lozano



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Canadian Charter architect says democracy is at risk of failure

(LifeSiteNews) – The last surviving architect of the Canadian Charter of Rights and Freedoms has sounded the alarm at the state of democracy in Canada in an interview released earlier this month. Brian Peckford is the former premier of Newfoundland and Labrador, and was part of the group of lawmakers and politicians who formulated the Canadian Charter of Rights and Freedoms.

The Charter, as it is commonly called, is a bill of rights entrenched in the Constitution of Canada, which formed the first part of the Constitution Act of 1982. The intent of the Charter is to guarantee certain fundamental rights to Canadians. It was designed to unite Canadians around a certain set of values that best embody the Canadian way of life. It was signed into law by Queen Elizabeth II.

The forerunner to the Charter was the Canadian Bill of Rights, which was not a constitutional document, but rather a federal statute. A federal statute could be amended by the normative legislative process and does not have the same weight regarding direct application to provincial laws. The aim of the lawmakers behind the Charter was to standardize the values therein, while at the same time giving the courts the power to enforce the laws as part of the constitutional framework of Canada.

The Charter has been applauded by proponents, but opponents of the document and its use have voiced their concerns about the abuse of powers of the courts as a result of the document. The Charter only applies to government laws, but not to private activity.

It is the opinion of Peckford that the intent of the Charter and the spirit of the Charter has been lost in Canada, and is being abused under the tyranny that has arisen since the advent of the COVID narrative.

Peckford is alarmed at the apparent disregard for the Charter by the government, and by the courts. He explained that at the time the Charter was formulated, that he doesn’t think “anybody thought at that time that it was possible for a government or governments of this country to do anything to infringe upon these rights and freedoms.”

Over the past 19 months, Canada has seen a sweeping change in the way governments respect various constitutional freedoms, such as freedom to assemble or to gather for matters of religion. There is a provision in the Charter that allows governments to suspend Charter rights for what are considered reasonable and justifiable concerns to the public.

The first section of the Charter says: “The Canadian Charter of Rights and Freedoms guarantees the rights and freedoms set out in it subject only to such reasonable limits prescribed by law as can be demonstrably justified in a free and democratic society.”

Peckford explained in the interview how this clause is supposed to be understood: “There may be situations … where governments are going to have to take certain actions which may infringe upon what we set below [in the Charter], however, in order for them to do that they have to demonstrably justify what it is they are proposing to do.”

It is his opinion that “none of the governments, the federal government in Canada, or any of the provinces, have even made an attempt to justify what they’re doing.” Peckford also believes that the governments “know that the data is not on their side,” referring to the justifications given to use the coronavirus as an excuse to suspend the rights of Canadians.

Patriotic lawyers and organizations have taken on cases to advocate for Canadians and the fight for their rights, but it is a slow-going affair. Peckford believes this is the case because the process is being abused or ignored on behalf of the provinces. “Unfortunately in our legal process it takes so long to get through the procedures … that all of these things can be done and the harm can be done … before any judgement is rendered about the constitutionality of what they’re doing.”

He added, “If we had a province which had any intestinal fortitude, they would do a reference themselves, which would go directly to their appeal court and then could get into the supreme court quicker … it could be done faster, but because all the provinces have capitulated into this fearmongering … then we have no way of expediting that court process.”

When asked why he thinks Canadian governments and officials have fallen into such a state of fear and unwillingness to advocate for the rights of Canadians, Peckford explained that he believes there has been a decline in the ethical standards of Canadian society. “There is no question … there has been a gradual degradation by the ethical standards by which we operate.”

He said this even calls into the question the legitimacy of the courts of Canada, and he hopes that as constitutional lawyers get through the system, judges are forced to take a clear look at the data. He explained that a lawyer from Alberta who works with Peckford told him that he was taking the courts in Alberta to task, because the courts themselves had already “implemented all the lockdown measures in their court.”

The lawyer told the former premier that this was a reason to believe that court did not have legitimacy on any matter pertaining to lockdowns, as they would have a clear bias, since they were already operating under the auspices that the data was in favor of implementing the unconstitutional public health measures.

Peckford said Canadians are at a “turning point,” adding that he had for years been a part of the Conservative Party of Canada and various provincial conservative parties, but that he now supports the People’s Party of Canada. He characterized it as only party standing for the Charter rights of Canadians.

Peckford said Canada needs a complete reform, and this will have to happen with massive participation of individual citizens. Regarding vaccine mandates, Peckford said that it is important to serve employers with notices of liability, as even if employers choose to fight them, it will be documented at each level of participation that the employer was documented as acting illegally. He also advised against seeking religious exemptions, if possible, because that can add legitimacy to the claims of the organizations acting in contravention of the Charter.

Peckford also spoke strongly about the role that health officers are supposed to have in provincial government. He expressed emphatically that they are not elected officials, and that their role is to advise, not govern. In his opinion, premiers are being lazy and not learning the information they should, and therefore relying on the health officers to make all the decisions. He explained that public health officials have no legal authority to govern, and should not be telling the public what to do legally, as it is not their jurisdiction.

At the end of the interview, Peckford offered hope and encouragement to Canadians about what they can do to right the ship. “They can make a difference, if enough of them get out and do it … everyone matters … We have got to resist this business of not mattering, we do matter. The more and more people that get out to these rallies partake in active participation in public policy through the election, the better.”

The Canadian federal election will take place Monday.



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