Friday, May 13, 2022



COVID-19 Vaccine Producer Hid Evidence of Problems: Report

Executives at a company that produced millions of COVID-19 vaccine doses attempted to hide evidence that some of the doses were contaminated, according to a congressional report released on May 10.

Emergent BioSolutions “took repeated steps to conceal its quality failures from the federal government and other third parties by limiting access to Bayview, tampering with drug-substance labels to impede FDA oversight, and strategizing to withhold information from HHS following the cross-contamination event in March 2021,” a report from the House Oversight Committee and the Subcommittee on the Coronavirus Crisis concluded.

The Food and Drug Administration (FDA) and its parent agency, the Department of Health and Human Services (HHS), identified deficiencies in the manufacturing process at Emergent’s Baltimore, Maryland facility—known as Bayview—in 2020.

In early 2021, Johnson & Johnson announced that up to 15 million doses of its COVID-19 vaccine at the facility became contaminated.

Documents obtained by the committees showed that Emergent rejected requests from Johnson & Johnson to visit the site around that time ahead of a follow-up FDA inspection.

One email from a consultant hired by Emergent indicated that employees removed quality-assurance tags from containers of Johnson & Johnson’s vaccine drug substance just before inspectors began their tour and put them back into place after inspectors left. The tags alerted employees that portions of the batches were potentially unable to be used.

Several days later, the consultant said that the tags were removed to “avoid drawing attention” to the potential quality issue.

Internal communications obtained by lawmakers show top executives at Emergent were aware of what happened.

Despite the tag removal, the FDA identified problems during the inspection.

In March 2021, another cross-contamination issue was identified by Johnson & Johnson, but Emergent did not alert AstraZeneca—whose vaccines Emergent was also manufacturing—and HHS for three weeks, according to the new report.

When an HHS agency asked for details, an executive said that no details should be shared with the government until its investigation was over.

“Today’s report shows that Emergent profited from the pandemic while violating the public’s trust. Despite major red flags at its vaccine manufacturing facility, Emergent’s executives swept these problems under the rug and continued to rake in taxpayer dollars,” Rep. Carolyn Maloney (D-N.Y.), chairwoman of the House oversight panel, said in a statement.

Approximately 400 million doses of COVID-19 vaccines were destroyed because of the contamination issues.

“These doses were squandered despite repeated warnings from employees, outside consultants, pharmaceutical companies, and FDA regulators that the company’s manufacturing practices were unsafe and that it was unlikely to fulfill the contract recklessly awarded by the Trump administration. Emergent executives prioritized profits over producing vaccines in a responsible manner that complied with FDA requirements,” Rep. Jim Clyburn (D-S.C.), chairman of the subcommittee, said in a statement.

Emergent was operating on a $628 million contract awarded during the Trump administration. The Biden administration canceled the contract in late 2021.

In a statement issued in response to the new report, Emergent said the report contained nothing new. The company also said it did not knowingly mislead the FDA, other government agencies, or private partners.

“During the last few years, the FDA and other international regulatory authorities have visited Emergent facilities dozens of times. On several occasions, Emergent invited FDA personnel to visit Bayview to review our progress, assess our capabilities, and provide feedback on our facilities, processes, and systems when no FDA inspection was required.

Further to that point, the single contaminated batch was brought to the attention of the FDA by Johnson & Johnson and Emergent,” the company said, adding that it has been in “constant communication” with the FDA and its clients as it tried to manufacture the Johnson & Johnson and AstraZeneca vaccines.

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All About the Newest COVID Pills – Should You Take Them?

Pfizer’s new antiviral pill Paxlovid is receiving high-profile attention – the vice president even took it when she contracted COVID. But a strange phenomenon is being reported by some of its users, raising the question if it, too, should be avoided.

Story at-a-glance:

* So far, all of the drugs developed against COVID-19 have been disastrous in one way or another. Remdesivir, which to this day is the primary COVID drug approved for use in U.S. hospitals, routinely causes severe organ damage and, often, death

* Despite that, the U.S. Food and Drug Administration has approved remdesivir for in-hospital and outpatient use in children as young as 1 month old

* Another COVID drug, Paxlovid, will in some cases cause the infection to rebound when the medication is withdrawn

* Molnupiravir (sold under the brand name Lagevrio) also has serious safety concerns. Not only might it contribute to cancer and birth defects, it may also supercharge the rate at which the virus mutates inside the patient, resulting in newer and more resistant variants

* The fact that U.S. health authorities have focused on these drugs to the exclusion of all others, including older drugs with high rates of effectiveness and superior safety profiles, sends a very disturbing message. They’ve basically become extensions of the drug industry, protecting the drug industry’s interests at the cost of public health

So far, all of the drugs developed against COVID-19 have been disastrous in one way or another. Remdesivir, for example, which to this day is the primary COVID drug approved for use in U.S. hospitals,1 routinely causes severe organ damage2,3,4,5 and, often, death.

Despite its horrible track record, the U.S. government actually pays hospitals a 20% upcharge for sticking to the remdesivir protocol, plus an additional bonus.6,7,8 Hospitals must also use remdesivir if they want liability protection.

Incentives like these have turned U.S. hospitals into veritable death traps, as more effective and far safer drugs are not allowed, and hospitals are essentially forced to follow the recommendations of the U.S. Centers for Disease Control and Prevention. As reported by Forbes science reporter JV Chamary back in January 2021, in an article titled, “The Strange Story of Remdesivir, a COVID Drug That Doesn’t Work”:9

“Remdesivir is an experimental drug developed by biotech company Gilead Sciences (under the brand name Veklury) in collaboration with the US Centers for Disease Control and Army Medical Research Institute of Infectious Diseases …

The drug proved ineffective against the Ebola virus … yet was still subsequently repurposed for SARS-CoV-2 coronavirus. News media prematurely reported that patients were responding to treatment.

But the published data10 later showed that ‘remdesivir was not associated with statistically significant clinical benefits [and] the numerical reduction in time to clinical improvement in those treated earlier requires confirmation in larger studies’ …

What’s weird about remdesivir is that it hasn’t been held to the same standards as other drug candidates. Normally, a drug is only approved for use by a regulatory body like the U.S. Food and Drug Administration if it meets the two criteria for safety and efficacy.

Nonetheless, in October 2020, remdesivir was granted approval by FDA based on promising data from relatively small trials with about 1,000 participants. A large-scale analysis11 by the World Health Organization’s Solidarity trial consortium has cleared-up the confusion.

Based on interim results from studying more than 5,000 participants, the international study concluded that remdesivir ‘had little or no effect on hospitalized patients with COVID-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay.’ As a consequence of being mostly ineffective, WHO recommends against the use of remdesivir in COVID-19 patients.”

Shockingly, US Approves Remdesivir for Babies

Curiously, while Big Tech — aided and abetted by the U.S. government — has spent the last two years censoring and banning any information that doesn’t jibe with the opinions of the WHO, the U.S. government has completely ignored the WHO’s recommendation against remdesivir.

In fact, in late April 2022, the FDA approved remdesivir as the first and only COVID-19 treatment for children under 12, including babies as young as 28 days,12 which seems beyond Orwellian and crazy considering it’s the worst of both worlds: It’s ineffective AND has serious side effects.

What’s worse, the drug is also approved for outpatient use in children, which is a first. In an April 30, 2022, blog post,13 Dr. Meryl Nass expressed her concerns about the FDA’s approval of remdesivir for outpatient use in babies, stating:

“Remdesivir received an early EUA (May 1, 2020) and then a very early license (October 22, 2020) despite a paucity of evidence that it actually was helpful in the hospital setting. A variety of problems can arise secondary its use, including liver inflammation, renal insufficiency and renal failure14 …

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Inflation up another 8.3 percent in April as Biden economy teeters on the edge. Has the recession already begun?

By Robert Romano

Consumer inflation increased another 8.3 percent annualized in April, according to the latest data compiled by the Bureau of Labor Statistics (BLS), amid increases in prices for housing, food, airline tickets and new vehicles.

And it is crushing wages, with BLS reporting a 2.6 percent drop in real average hourly earnings, thanks to the inflation.

Inflation has now been north of 5 percent since June 2021, in what is the worst inflation since the late 1970s and early 1980s. It caused recessions then, and it may have already induced another recession now just two years after the 2020 Covid recession.

The U.S. economy already contracted 1.4 percent on an inflation-adjusted basis, according to the Bureau of Economic Analysis. The economy did grow on a nominal basis by almost 6.5 percent annualized, by $382 billion to $24.4 trillion, but because inflation averaged about 8 percent the first quarter, real GDP came in negative.

The same thing could be happening right now. With April’s inflation number on the books, May and June will tell the tale of whether President Joe Biden will preside over a recession in 2022 — or perhaps in 2023 or 2024.

If inflation remains above, say, 7 percent throughout the second quarter, nominal growth appears unlikely to be that high. In just 18 economic quarters out of 127 quarters since 1989, nominal growth annualized was above 7 percent. That is only 14 percent of the time. Meaning, there’s about an 86 percent chance it will be less than 7 percent nominal growth in the second quarter.

But when one considers that there have already been massive nominal gains in GDP following the Covid lockdowns — including a monster 38 percent nominal gain in the third quarter of 2020, and a 14.5 percent nominal gain in the fourth quarter of 2021 — it is hard to imagine another big nominal GDP gain in the current environment with high inflation, the continued supply chain crisis and now the war in Ukraine.

It’s like a flock of black swans flying in a triangle formation. What else could possibly go wrong?

Again, in the first quarter, growth was almost 6.5 percent, which was the lowest reading since 2019. So, the economy is already slowing down. Before that, one has to go back to the second quarter of 2018 to find annualized nominal growth above 7 percent, and the second quarter of 2014 before that. It has not been happening a lot in the past 20 years.

Meaning, the escape route to avoid a recession right now is rapidly narrowing. It is still possible, but politically, President Joe Biden and Congressional Democrats might be better off in the long run if the recession happens right now, which would certainly impact the Congressional midterms in November, but might be far enough away from 2024 to provide ample time for a robust economic recovery.

Ronald Reagan had a massive recession in 1982, but by 1984, the recovery was fully underway and he easily defeated Walter Mondale in a 49-state landslide.

On the other hand, given the ongoing supply chain crisis and no end in sight for Russia’s war in Ukraine, which is further exacerbating oil, natural gas and wheat global supply lines, it is foreseeable that even with a recession right now, inflation could remain elevated for the foreseeable future — which could have the economy overheating once again in 2023 headed in the 2024 presidential election cycle.

The point is that it is never a great time for an administration to have to weather a recession. The American people can be quite forgiving, but in Biden’s case, if the inflation remains a going concern after 2022, their patience may end up running thin.

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com/ (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com/ (TONGUE-TIED)

https://immigwatch.blogspot.com/ (IMMIGRATION WATCH)

https://awesternheart.blogspot.com/ (THE PSYCHOLOGIST)

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Thursday, May 12, 2022



The fallacious Fauci flips

Why haven’t they fired Dr Anthony Fauci?

Although Fauci had been given the task of leading America – and by proxy, the world – out of the Covid pandemic, he has done little to help the wider cause of public faith in science.

Fauci’s inconsistent rhetoric has greatly retarded the efforts of those who were trying to combat the virus and has subsequently left the public confused and mistrustful.

Recently, on April 26, Fauci gave an interview with PBS NewsHour, where he said:

‘We are certainly, right now in this country, out of the pandemic phase.’

A day later, after his words had been enthusiastically splashed across national headlines, Fauci flipped on his message, saying that:

‘By no means does that mean the pandemic is over.’

These bafflingly contradictory pronouncements shouldn’t surprise anyone. Fauci’s ability to backflip is Olympic quality and seems to be the most consistent thing about his health approach throughout the pandemic.

For instance, in January 2020, when Covid was new and beginning to worry experts, Fauci said in a radio interview:

‘The American people should not be worried or frightened by [Covid]. It’s a very, very low risk to the United States, but it’s something we, as public health officials, need to take very seriously.’

The virus quickly spread through America as if to spite him. In a March 2020 during a CBS 60 Minutes interview, Fauci went on to say that:

‘There’s no reason to be walking around with a mask. When you’re in the middle of an outbreak, wearing a mask might make people feel a little bit better and it might even block a droplet, but it’s not providing the perfect protection that people think that it is.’

Just months later, Fauci backflipped again and said everyone should mask up. Astonishingly, he admitted that his initial advice against masking was knowingly false and made due to worries over a mask shortage instead of health reasons.

Shouldn’t he have been fired then and there?

For a physician leading the pandemic response – who had presumably taken the Hippocratic Oath – to intentionally deny people his best medical advice due to a supply issue is highly unethical.

It gets worse. Soon Fauci was telling fully vaccinated people to wear, not one, but two masks. He (unsurprisingly) flipped a short while later and admitted this suggestion was merely theatre, intended not to give mixed signals or dissuade mask-wearing. Fauci assured the public that he – as someone fully vaccinated with two shots – was in fact safe from catching the virus without a mask (or two).

But he was wrong on that also. Vaccine protection was suspected and soon confirmed to wane rapidly. Then, evidence began to accrue that Covid vaccines did not prevent transmission or infection. By November 2021, Fauci had decided that three shots may become the standard for the definition of a ‘full’ vaccination. Four days later, he flipped across the press conference a couple of times, finishing with a statement saying that booster shots were definitely not necessary to be considered ‘fully vaccinated’.

Ironically, having had four shots of the Pfizer vaccine, Fauci still doesn’t feel safe enough to attend the 2022 White House correspondence dinner.

In addition to his uniformly muddled and mendacious public health advice, the public should consider the quality of his work behind the scenes as the Chief Medical Advisor to the President and the director of the National Institute of Allergy and Infectious Diseases (NIAID).

Despite going so far as to equate himself to science, Fauci does not appear to like actual science. In late 2020, three professors from Harvard, Oxford, and Stanford universities drafted the Great Barrington Declaration, highlighting their concerns about the unintended consequences of blanket lockdowns, which they posited would do more harm than good.

They gave their considered reasons and offered less-damaging alternatives. The declaration has been signed by over 60,000 medical experts and researchers from across the world, including a Nobel Laureate. But emails have surfaced showing Dr Francis Collins, then-director of the National Institute of Health (NIH), and Fauci – rather than engaging their peers in a discussion of ideas – had conspired to denigrate the team, calling them ‘fringe epidemiologists’.

The lab-leak theory surrounding Covid’s origin remained controversial, despite significant practical, logical, and hard scientific evidence in its favour. Regardless of whether it turns out to be true or false, Fauci’s behaviour towards exploring Covid’s origin throughout the pandemic remains odd, to say the least. Fauci (and others) set out to quash the theory from its inception and to malign anyone, including respected scientists, who might entertain it. This paints Fauci as a man without scruples.

Fauci’s relationship with the Wuhan Institute of Virology, situated at the heart of the pandemic outbreak and which just so happens to be the largest institute in the world studying bat coronaviruses, is probably an uncomfortable fact. Fauci denied vehemently in the US Senate on May 12, 2021, the charge that the NIH had funded gain-of-function research in the Wuhan Institute of Virology. Two weeks later, in what may be Fauci’s most serious flip of all, he admitted to ‘modest’ NIH funding of the Wuhan lab, while denying it was for gain-of-function research. No surprises for guessing that the NIH later admitted to funding gain-of-function research in the lab a few months later.

Ordinary people would have been fired long ago for this sort of behaviour. The task of leading the world out of the pandemic mindset is too important to be left to an unreliable man who wields compromised truth.

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Hispanic Voters Are Losing Faith in the Democratic Party: Poll

The support of Hispanic voters at the midterms later this year could prove to be “extremely instrumental” in turning the tide of liberal policies of the current administration, a conservative Hispanic group says.

According to a Quinnipiac University poll published in April, only 26 percent of Hispanic survey participants approved of President Joe Biden’s job performance. This marks the lowest approval rating of any demographic group.

The Epoch Times spoke to Santiago Avila, national vice chairman of the Republican National Hispanic Assembly (RNHA), who offered a number of reasons why support among Hispanic voters is plummeting.

While Hispanics have historically registered as Democrats, Avila said their values are generally conservative. “[Many Hispanics] grow up being told that Republicans are for the rich and Democrats are for the poor.” What they should understand, he said, is that “Democrats are more liberal, and Republicans are more conservative.”

Having spoken to many different left-leaning Hispanics, Avila said, “they are really beginning to feel like the Democratic party has become too extreme to the point where it’s starting to scare some of them.” Many are beginning to turn away from the Democratic party because “they’re getting vibes of a communist Cuba and socialist Venezuela here in America. “

As a result, Avila said Hispanics are going to be “extremely instrumental” in the upcoming midterm elections. “They are starting to come to the realization that their conservative values are in opposition to what the media has been trying to feed them in favor of Biden and the Democrats.”

RNHA’s National Chairman Ronnie Lucero agreed, pointing to the liberal policies of the current administration as a problem. More often than not, “a lot of changes in policies are reflected against the values of the Hispanic community,” he said.

Lucero said progressive leaders push for abortion and the abolishment of the Second Amendment, for example. “The Hispanic community is very pro-life and does not want a power grab [that restricts the lawful possession of firearms],” he said. “These are issues Hispanics want to speak up, stand up, and be vocal about when it comes time to vote.”

Legal, Not Illegal, Immigration

The topic of immigration is often a prevailing narrative when talking to Hispanics about the policies of any administration, Avila noted. As the son of two immigrants, he wants to see immigration but said it has to be accomplished by the rule of law.

“Illegal immigration puts a burden on the country and both parties are to blame,” Avila said, pointing out that Democrats play with “emotions, sentiments, and pull at the heartstrings” when speaking about the topic. And all the while, he said, too many conservatives are assuming they’re not going to get the Hispanic vote. Yet, he said, former President Donald Trump and his administration were “very effective” at reaching the Hispanic community.

Lucero agreed that illegal immigration is harmful to the country, adding that “a country with open borders is not a country.” Rule of law must be “cherished” and “respected,” he said. “The people who take the wrong process and beat the system must be rejected.”

But for those entering the country legally, Lucero suggested that lawful immigration should be a speedier process. Raising a personal example, he said it took his mother-in-law 15 years to become a U.S. citizen. “The country does need some immigration reform, because access to citizenship should be easier for those coming to the United States to contribute to the country—and love the county,” he said.

Values and the America Dream
While immigration is a hot topic, Avila said, “it’s not the number one topic for the Hispanic community.” He said Hispanics care more about their families and their independence. “We didn’t come into this country to live off of welfare; we’re running away from that.”

Most Hispanics are “chasing the American dream,” according to Avila. Hispanics want the opportunities found in the United States and that’s why many have immigrated to the country.

“We come here, because when you become an American, you get endowed with inherent, unalienable rights that aren’t enjoyed in other countries,” he said. “We want to prosper and live out our values in this great country.”

When it comes time to vote in the midterm election, “one thing about the Hispanic voter is that we stick to our values,” Avila said. “We see ourselves as Americans and our voices will be heard at the voting booth later this year,” he said

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com/ (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com/ (TONGUE-TIED)

https://immigwatch.blogspot.com/ (IMMIGRATION WATCH)

https://awesternheart.blogspot.com/ (THE PSYCHOLOGIST)

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Wednesday, May 11, 2022


‘Non-Starter’ to Authorize COVID-19 Vaccine for Infants: Dr. Peter McCullough

Moderna has requested the U.S. Food and Drug Administration (FDA) to grant an emergency use authorization (EUA) for its COVID-19 vaccine for children as young as 6 months. However, according to Dr. Peter McCullough, such authorization shouldn’t be granted because there’s almost no clinical benefit for children that young.

Pfizer is also working on data for a three-dose regimen after the FDA postponed its decision in February on whether to authorize its COVID-19 vaccine for this age group.

“I think for children that age, it’s a non-starter,” McCullough told NTD’s “Capitol Report” program on April 30.

McCullough said a recent study from New York State showed the efficacy of Pfizer’s COVID-19 vaccine in young children was so low that “it looks like they don’t work.”

The study (pdf) analyzed the Pfizer vaccine’s effectiveness in over 1.2 million fully vaccinated children in New York state from Dec. 13, 2021, to Jan. 30, 2022. Among those vaccinated children, over 852,000 were aged 12–17, and over 365,000 were aged 5–11.

“In the papers by [Vajeera] Dorabawila and colleagues from New York state, over a couple hundred thousand children aged 5 to 11, [had] virtually no clinical benefit, no vaccine efficacy. All the vaccine efficacy was less than 25 percent,” said McCullough, a renowned cardiologist and epidemiologist.

The study found that the vaccine effectiveness against infection declined from 66 percent to 51 percent for 12 to 17-year-olds and from 68 percent to 12 percent for 5 to 11-year-olds in about one and a half months.

The Pfizer vaccine is the only one currently being administered to children in this age group.

The FDA has said that vaccines should be at least 50 percent effective in preventing infection or decreasing disease severity to receive emergency authorization. The World Health Organization says vaccines are required to be 50 percent effective or better to receive clearance.

According to Moderna’s data, the vaccine was just 43.7 percent effective in the youngest group and 37.5 percent effective in the other children during the Omicron wave. Both were below the 50 percent bar. Some doctors and experts questioned that the trial result was not strong enough to warrant a EUA.

“That’s not acceptable by the FDA’s own standards,” Dr. Steven Hatfill, a virologist who advised the Trump administration, told The Epoch Times last month.

The FDA said it would thoroughly review Moderna’s request after additional data was provided.

“We have received a request from Moderna for a EUA for its COVID-19 vaccine for children 6 months to 6 years of age. As the company has acknowledged, they still need to submit additional data to complete its request. FDA cannot reach a decision on any vaccine without a completed EUA request, which allows us to do a thorough review, which includes, among other things, a comprehensive review of all of the adverse events and replication of the key analyses,” an FDA spokesperson told The Epoch Times in an email last week.

Some experts said it doesn’t make sense for young children to receive COVID-19 vaccines, as they are at low risk for severe disease and death from the CCP (Chinese Communist Party) virus, and the possible severe side effects are a big concern.

“Parents should think twice about vaccinating their child,” Dr. Robert Malone previously told The Epoch Times, adding that serious adverse events can occur, and most “are irreversible.”

Malone is a key contributor to mRNA vaccines, and his website includes a list of peer-reviewed studies related to COVID-19 vaccine adverse events in children, the main one being myocarditis.

In March, Florida’s top health official issued guidance, saying healthy children may not benefit from receiving current COVID-19 vaccines.

“Based on currently available data, the risks of administering COVID-19 vaccination among healthy children may outweigh the benefits,” Florida Surgeon General Dr. said in a statement. “That is why these decisions should be made on an individual basis and never mandated.”

The Centers for Disease Control and Prevention (CDC) has been saying that COVID-19 vaccines are safe and effective, and severe side effects are rare. The agency also says that all children aged 5 and older should get Pfizer’s vaccine, and all children between the ages of 12 and 17 should get a booster.

However, recent studies have found that Pfizer’s COVID-19 vaccine doesn’t do well in preventing infection against the Omicron variant for children 5 to 15 years old.

McCullough pointed out that it would be unnecessary to get young children vaccinated because most of them have already contracted the virus.

“We’ve heard reports recently from the CDC that roughly 75 percent of children have already had COVID. So for them, it’s too late for any hope of a vaccine. The vaccine can’t help once somebody’s already had COVID,” McCullough said, adding that if a vaccine doesn’t have at least 50 percent coverage, it would be considered “nonviable.”

On April 26, an early release of CDC’s Morbidity and Mortality Weekly Report said that about 75 percent of children and adolescents had already developed antibodies against the disease.

McCullough said COVID-19 has become “progressively” milder through its progression of mutations and the Omicron variant caused much fewer hospitalizations or deaths.

A number of studies have found that the clinical severity of infection is much lower for Omicron than for the Delta variant. In March, a peer-reviewed study published in Lancet is the largest one to date, which analyzed data from 1.51 million COVID-infected people in England between November 2021 and January 2022. Among them, over 1.06 million were infected by Omicron.

The study found that the overall risk of hospitalization within the 14 days after a positive test was 1.64 percent with Delta and 0.9 percent with Omicron. The mortality risk in the 28 days after a positive test was 0.27 percent after Delta, falling to 0.11 percent after Omicron.

“I can tell you, we have studies now, large studies on Omicron, where there’s close to zero hospitalizations or deaths,” said McCullough. “It’s essentially a common cold.”

The Epoch Times has contacted FDA, Moderna, and Pfizer for comments.

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FDA: Americans Should Treat COVID-19 Like the Flu

Several top Food and Drug Administration (FDA) officials, including Commissioner Robert Califf, admitted that Americans will now have to accept COVID-19 as another respiratory virus, comparing it to influenza.

Califf, Principal Deputy Commissioner Janet Woodcock, and top vaccine official Dr. Peter Marks wrote for the Journal of the American Medical Association that COVID-19 will be around for the foreseeable future while suggesting that it will require yearly vaccines targeting the most threatening variations of the virus.

“Widespread vaccine- and infection-induced immunity, combined with the availability of effective therapeutics, could blunt the effects of future outbreaks,” the officials said, referring to another name for the CCP (Chinese Communist Party) virus. “Nonetheless, it is time to accept that the presence of SARS-CoV-2, the virus that causes COVID-19, is the new normal.”

The virus “will likely circulate globally for the foreseeable future, taking its place alongside other common respiratory viruses such as influenza. And it likely will require similar annual consideration for vaccine composition updates in consultation with the [FDA],” they continued.

It’s a departure from the rhetoric that was expressed by public health officials in 2020 and 2021. In late October 2020, for example, current White House COVID-19 adviser Anthony Fauci said that President Donald Trump’s comparisons to the flu were false, telling NBC at the time “it is not correct to say it’s the same as flu.”

About a year later, Fauci told CBS News that Americans will “likely” have to deal with COVID-19 in a similar manner as influenza. “That’s entirely conceivable and likely, as a matter of fact, we are not going to be in a situation of this degree of intensity indefinitely,” he said when asked about the Omicron variant.

Data published by the U.S. Centers for Disease Control and Prevention (CDC) shows that while cases have trended slightly upward in the United States, the numbers are a fraction of the cases that were reported in mid-January when the seven-day average stood at around 800,000 per day. As of May 6, the seven-day average was about 68,000 per day.

In the Journal of the American Medical Association article, the three FDA officials proclaimed that by the summer of 2022, decisions will have to be issued “about who should be eligible for vaccination with additional boosters and regarding vaccine composition.”

“Administering additional COVID-19 vaccine doses to appropriate individuals this fall around the time of the usual influenza vaccine campaign has the potential to protect susceptible individuals against hospitalization and death, and therefore will be a topic for FDA consideration,” they added.

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When Biden’s own people don’t trust him to speak, we have no real president

There is nothing more symbolic of American political power than a president of the United States holding court in the Oval Office.

Ensconced in that intimidating room, countless leaders have browbeaten, charmed, and cracked wise with the powerful and the press for generations.

But not Joe Biden.

And now we know why. According to new reporting, the reason we don’t see Joe in the Oval very often is that his team can’t install a teleprompter to keep the gaffer-in-chief on script.

So yeah, that’s where we are regarding the leader of the free world.

If one really stops and thinks about this it is simply shocking. The primary job of any politician, but especially a president, is to communicate a vision of policy and competency to the American people and the people of the world.

We have a president today who is incapable of this most basic element of his job. And whatever unelected group of White House flunkies there are — who are actually the president — can’t trust him to even open his mouth unless he can stare at a teleprompter and mouth their insights like the weatherman.

Things have gotten so obvious and awkward of late that even when Biden does have his trusty large print screen scrolling his supposed ideas he can’t even push them out. His struggle with the word “kleptocracy” in recent remarks was just sad. And fine, he grew up with a stutter, but he’s been in the public spotlight since “The Godfather” was in movie theaters.

The darkest and most troubling possibility here, but one we must face, is that we functionally have no actual President of the United States. If he can’t appear in public, in his own office, for want of a digital cheat sheet, then of course he has little if anything to do with the actual running of the country. And he’s not even a good false figurehead — using the teleprompter he often looks and sounds like he’s reading the bottom line of the eye exam.

Let’s face it. Even for an administration that thinks it’s a TV show, the construction of a White House set where Biden can wax incoherently was bizarre. But now we know this sound studio was set up to protect Biden, as much as possible, from his own words and actions. Maybe soon the president will only do live events in virtual reality where his handlers can correct his errors in deep fake real-time. Why not have the president be a programmed hologram? Is that so different from the current reality?

It’s time to talk about grandpa. He probably shouldn’t be driving or using the gas oven on his own anymore, or, you know, running the most powerful country on the planet into the ground.

Maybe the White House will overcome the great technical challenges of getting a screen with words on it into the Oval Office and we can once again see a president in his actual, natural environment. But given that this administration has given no indication in 20 months that it can even tie its shoes, I suggest we don’t hold our breath.

Pay no attention to the man behind the curtain, the wonderful Wizard of Ahs and Ums. Just go along with the joke as the Democrats would have us do. But the joke isn’t funny anymore. A president who cannot even give brief remarks in the Oval Office is no president. And that, my friends, is that sad fact.

So what are we going to do about it?

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com/ (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com/ (TONGUE-TIED)

https://immigwatch.blogspot.com/ (IMMIGRATION WATCH)

https://awesternheart.blogspot.com/ (THE PSYCHOLOGIST)

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Tuesday, May 10, 2022

Whistleblower Exposes 3 Big Issues in Pfizer’s COVID Vaccine Clinical Trials


On Nov. 2, 2021 British Medical Journal (BMJ) published an article that revealed three big issues in Pfizer’s vaccine trial based on interview with a whistleblower.

The whistle blower, Brook Jackson, was a regional director of one of Pfizer’s vaccine trial companies, Ventavia Research Group in Texas.

Beginning the fall of 2020, there were 153 institutes, including Ventavia, that assisted Pfizer’s vaccine clinical trial. Per Ventavia’s website, the company is the largest private clinical research company in Texas. Jackson found out the management of the clinical trial in the company was not organized. She reported this to the administrative level of the company, but received no response from the company. Then she reported this to the FDA.

However, after she emailed the FDA, she was fired that same afternoon. Jackson said this was the first time she was fired from her job in her 20-year career.

Finally, she contacted the international well-known journal–BMJ. She exposed 3 major issues she observed in Ventavia for Pfizer’s vaccine clinical trial.

1. Falsifying the data
2. Early unblinding of the trial, affecting the accuracy of the results
3. Very slow to respond to adverse events, and not paying attention to the safety of participants

We spoke with Dr. Sean Lin, phD, former toxicology lab director of Walter Reed Military Medical Center to discuss these issues. The interview below has been edited for brevity and clarity.

Issue 1: During the Trials, There Was Data Falsified

Health 1+1: Per Jackson, in one document dated as August 2020, before Jackson’s hiring, a Ventavia executive revealed that three site staff members were requested to go over e-diary issues and falsifying data, etc. One of them was verbally questioned for changing data and not informing the late data entry.

Jackson and Ventavia executives discussed multiple times the possibilities of an FDA inspection of their company. Another former Ventavia employee also stated that the company worried the FDA would audit the process of their company’s Pfizer’s vaccine clinical trials.

Dr. Lin: When any new vaccine or new medication goes through clinical trials, the accuracy of the data is very important.

For example, in clinical trials, to inject vaccine to a volunteer, there must be 2 people in addition to the volunteer on site. One person does the injection; the second person takes notes and watches the injection. The reason for having two people is if only one person does it, if there is any mistake in recording the procedure, or if the person changes data, the accuracy of the database will be affected significantly.

In cases where any data needs to be modified, these drug companies usually have strict procedures. First, upper management and an executive of the drug company need to be notified and approve, then the person is authorized to enter the database and modify the data. The person must record the time of modification and the reason. They need to explain that an error occurred while entering the data, or if there are other reasons. Only with strict rules can these companies guarantee that what is in the database won’t be falsified.

So by contrast, it is unbelievable that an employee at Ventavia can have the right to modify the database without permission. This can cause big problems.

Pfizer published their clinical trial report on NEJM (New England Journal of Medicine). In the report, there were 8 people infected COVID after vaccination, but there were 162 people infected COVID after placebo. So, it is easily to change the protection rate from 90% to 60% if there are wrong data on dozens of people.

Ventavia’s trial site had 1,000 volunteers participate in the COVID vaccine trials. If there are mistakes in just 50 of them, the results will be significantly different.

Issue 2: Early Unblinding of Trial Participants

Health 1+1: Based on the photos and information provided by Jackson, documents related to the clinical trials were randomly displayed, including vaccine packaging materials with clinical trial participants’ information and drug assignment confirmation labels, all these were accessible to blinded personnel. The above errors can lead the participants and the staff members to know ahead of time who would get vaccine, before the procedures were done. The errors were corrected two months after the trial started. It may have been a large range of unblinding.

Dr. Lin: Generally, people who participate in clinical trials are divided into two groups. One group would receive vaccine and the other group would receive placebo, like normal saline. None of the participants will know which they were given, otherwise it would affect the objectivity of the trial. This is called blinding.

Vaccine trials routinely use blind trials. This is because in medical field, it is well known that the mental effect plays a key role. For example, if someone knew he or she was given real medicine, they may have very positive mood which improves their immune system, and the results would not truly reflect the effect of medicine only. On the other hand, if people knew they were given placebo, they may not feel any hope, and that may also affect the results.

Besides the volunteer participants, other people who involved in the trials like physicians, nurses, and people who man database are also not allowed to know the true information regarding the distribution of the vaccine injection. This is to avoid bias. For example, if the nurse knew the participants receiving vaccine, the nurse may pay more attention to the person. This will affect the end results.

So the clinical trials are randomly assigned by computer for who receives the vaccine and who receives the placebo, and the information will be encrypted.

For early unblinding, it was not only a lapse in responsibility on Ventavia’s part, but showed problems related to Pfizer’s design and management of these COVID vaccine clinical trials. This made it so that the testing groups learned who was getting the vaccine too early. If lower level staff have authority or opportunity to unblind trials, it affects the objectivity of the data.

Issue 3: Slow Response to Adverse Events, Not Prioritizing Participant Safety

Health 1+1: Jackson pointed out that Ventavia did not pay attention to the safety of the participants during the vaccine trials. They did not contact or take care the participants who developed side effects. One email sent by the contract research organization to Ventavia mentioned that over 100 cases with issues where participants were not contacted for more than three days, including  including two participants who had developed severe symptoms. The expectation for vaccine trials is that that all issues need to be addressed within 24 hours.  Jackson also mentioned that participants were placed in a hallway after injection with no clinical staff observation.

Besides Jackson, a formal Ventavia employee also told the BMJ that the company doesn’t have enough staff to take samples from participants who developed COVID symptoms. FDA documents showed that across all clinical trials, there were 477 people who had symptoms but did not receive a PCR test for COVID. Jackson said in the 40-plus clinical trials she’s been involved with, including several large scale trials, she had never seen as much chaos as the environment she worked in under Ventavia.

In a recording of a meeting in September 2020 between Jackson and two Ventavia company directors, the company expressed they could not confirm how many types of issues had occurred because of the high volume of issues, nor could they confirm the number of errors that had occurred because there was something new everyday.

Dr. Lin: In clinical trials, the risk of the medication given to participants is unknown, and as such there needs to be enough staff to watch for side effects that could occur.

Usually, participants stay onsite, whether that is a hospital or nearby hotel, for the first 24 hours after the vaccine injection, and they are accompanied by clinical staff.  If a severe side effect occurs, it needs to be addressed right away. It is dangerous if no one is observing the participants after injection. This suggests the trial was not properly staffed.

In the past, there were clinical trials for certain medications that took a very long time before they could even begin. First you need to have enough test sites, then the standard data criterion needs to be set up to ensure the data integrity and security, among other things. If you have contractors with the capacity to test 500 people, but you sign them for contracts to test 1000 people, obviously they will have staffing and staff training issues. There’s a standard protocol that accompanies each step of these clinical trials and no short cuts can be taken, even if a pharmaceutical company wants to speed up the testing period. In this case specifically, Pfizer would have needed to monitor these testing sites, in order to ensure all these trials are using their designed process.

Ventavia’s situation implies additional risks, like the possibility of other sites having similar issues, and whether Pfizer has been correcting these in a timely manner. If the vaccine data contains errors, then wouldn’t the vaccine’s protection rate need to be reevaluated?

During the pandemic, many large pharmaceutical companies received protection from government. The entire vaccine development bill was footed by the government, as was the production and promotion costs. And even if there were problems in the process, the media was not investigating these steps and exposing the details to the public.

Pfizer’s vaccine has been so important in the US market and stricter monitoring should have been in place, rather than blanket protections.

FDA’s Poor Oversight

Health 1+1: Jackson reported the issue to the administrative level of Ventavia and received no response. Then on Sept. 25, 2020, she contacted the FDA. After sending the email, she was fired from the company.  A few days later, the FDA contacted Jackson to discuss her report. There was no further communication between Jackson and the FDA after this call. In August 2021, the FDA approved Pfizer’s COVID vaccine and listed 9 of the 153 clinical trial sites, not including Ventavia.

Jackson raised several problems in her report:

1) Participants were not monitored after receiving injections
2) There was no timely follow-up of patients with adverse side effects
3) Errors occurred during testing, and people would not report the errors
4) The vaccines were not stored at proper temperatures
5) Mislabeled laboratory specimens
6) Staff who reported these types of problems received retaliation
7) FDA told her no further information could be provided to her and ceased communications, and only nine of 153 test sites were inspected by the FDA, not including Ventavia, despite Jackson’s report

This exposes the oversight issues on the FDA’s part. In Ventavia case, FDA should have communicated with Jackson, Pfizer, and Ventavia. It stands that the FDA should have inquired about Pfizer’s trial procedures, and whether these three parties were on the same page regarding those procedures. And the public should have been made aware, because this affects human lives.

Dr. Lin: It’s more than an issue of corporate liability, there’s a matter of individual responsibility here as well. This whistleblower’s report showed that it wasn’t just Ventavia in the wrong, but Pfizer and the FDA as well. But I think the key issue is still the individual, because you have to remember that these are individuals doing all the research.

Many people think that science is noble, and all the people who work in the scientific field are pursuing truth. But in reality, in modern society, science is an industry. Especially the medical field, it’s become a large industry that involves huge profits. So in the process, the issue of how to keep research and clinical trials reliable and trustworthy has become a big challenge.

During the pandemic, the public had hope that pharmaceutical companies would develop medicine that could save lives. There’s a big profit opportunity here for the companies, especially because the government will help cover costs and also promote the products. With an upside this big, no company wants to miss out. With these conditions, it’s easy to risk the integrity of the company. Especially under the current PREP regulations, the company doesn’t take any responsibility. Pfizer and Moderna are free of responsibility involving this vaccine. People with adverse side effects from these injects can seek compensation through CICP, but it is not easy to do.

According to a Nov. 10, 2021 report from USA Today, 3,100 people developed side effects after vaccine injection during clinical trials. Following the CICP system, they filed for reimbursement, and none of them have thus far received compensation.

The government pays for production and protection, and the companies don’t need to pay out any losses from side effects. Big profits with small investments. Under these conditions how can one guarantee the integrity of the test? It in fact motivates the companies to rush their clinical trials. These are complicated procedures with many factors that can cause issues. Pharmaceutical companies should be following the basic principle of “do no harm.” Without this principle, the medical field is in peril.

Both the government and pharmaceutical companies have been focusing on the benefit rather than the drawbacks. This is a problem, because it means that something that could put someone’s life at risk can be ignored. This is irresponsible to the public.

On one hand, during a pandemic, ordinary people would of course wish that medical companies could develop medicine to save the world. Can pharmaceutical companies keep a high level of integrity through the process? I think this is a test for humanity arranged by God.

If humanity handles this test well, God creates miracles to help humanity.

If, under what is deemed an emergency condition, in the name of saving people at large a government decides to risk some people’s lives in trade, that is not right. Just like in China, the regime is behind the operation of organ harvesting ordinary citizens to make a profit. If a surgeon in China claims he saved a life through organ transplantation but had to kill another human being to do so, that is totally wrong.

Whether a physician or pharmaceutical expert, whether you can maintain morality and integrity during this pandemic is a test from God. As COVID spread across the entire world, it’s become a test not only to the medical field but all human beings.

https://www.theepochtimes.com/whistleblower-exposes-3-big-issues-in-pfizers-covid-vaccine-clinical-trials_4440371.html

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Also see my other blogs. Main ones below:

<a href="https://edwatch.blogspot.com">http://edwatch.blogspot.com</a> (EDUCATION WATCH)

<a href="https://antigreen.blogspot.com">http://antigreen.blogspot.com</a> (GREENIE WATCH)

<a href="https://pcwatch.blogspot.com">http://pcwatch.blogspot.com</a> (POLITICAL CORRECTNESS WATCH)

<a href="https://australian-politics.blogspot.com/">http://australian-politics.blogspot.com/</a> (AUSTRALIAN POLITICS)

<a href="https://snorphty.blogspot.com/">http://snorphty.blogspot.com/</a> (TONGUE-TIED)

<a href="https://immigwatch.blogspot.com/">https://immigwatch.blogspot.com/</a> <b>(IMMIGRATION WATCH)</b>

<a href="https://awesternheart.blogspot.com/">https://awesternheart.blogspot.com/</a> (THE PSYCHOLOGIST)

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Monday, May 09, 2022



Won’t Get Fooled Again

More than a century ago, Mark Twain identified two fundamental problems that would prove relevant to the Covid pandemic. “How easy it is to make people believe a lie,” he wrote, “and how hard it is to undo that work again!” No convincing evidence existed at the start of the pandemic that lockdowns, school closures, and mask mandates would protect people against the virus, but it was remarkably easy to make the public believe that these policies were “the science.” Today, thanks to two years of actual scientific evidence, it’s clearer than ever that these were terrible mistakes; yet most people still believe that the measures were worthwhile—and many are eager to maintain some mandates even longer.

Undoing this deception is essential to avoid further hardship and future fiascos, but it will be exceptionally hard to do. The problem is that so many people want to keep believing the falsehood—and it’s not just the politicians, bureaucrats, researchers, and journalists who don’t want to admit that they promoted disastrous policies. Ordinary citizens have an incentive, too. Adults meekly surrendered their most basic liberties, cheered on leaders who devastated the economy, and imposed two years of cruel and unnecessary deprivations on their children. They don’t want to admit that these sacrifices were in vain.

They’re engaging in “effort justification,” a phenomenon famously demonstrated in 1959 with an experiment involving a tame version of a hazing ritual. Social psychologists Elliot Aronson and Judson Mills offered female undergraduate students a chance to join a discussion group on the psychology of sex, but first some of them had to pass an “embarrassment test.” In the mild version of the test, some students read aloud words like “prostitute” and “petting.” Others had to pass a more severe version by reading aloud from novels with explicit sex scenes and lots of anatomical obscenities (much more embarrassing for a young woman in the 1950s than for students today). Afterward, all the students, including some who hadn’t been required to pass any test, listened in on a session of the discussion group, which the researchers had staged to be a “dull and banal” conversation about the secondary sexual behavior of lower-order animals. The participants spoke haltingly, hemmed and hawed, didn’t finish their sentences, mumbled non sequiturs, and “in general conducted one of the most worthless and uninteresting discussions imaginable.”

But it didn’t seem that way to the women who’d undergone the severe embarrassment test. They were far more likely than the other students to give the discussion and the participants high ratings for being interesting and intelligent. The experiment confirmed the then-novel theory of cognitive dissonance: the young women didn’t like thinking that they’d gone through an ordeal for the sake of a worthless reward, so they avoided this mental discomfort (cognitive dissonance) by rewriting reality to justify their effort. Other studies showed the same effect in people who had undergone real-life initiation rituals to join fraternities and other groups. The more effort involved in the initiation ritual, the more valuable seemed the reward of membership.

Researchers also reported that “shared dysphoric experiences” produced “identity fusion” within a group, making members more loyal and more willing to make further sacrifices for their comrades. Thus, fans of English soccer teams who suffered together through a losing season were more devoted to one another than were fans of a winning team, and members of Brazilian jujitsu clubs who endured a painful graduation ceremony—walking a gauntlet while being whipped by belts—became more willing to make charitable donations to their club than were members at similar clubs with less extreme ceremonies.

If one brief bad experience can transform people’s thinking, imagine the impact of the pandemic’s ceaseless misery. It’s been a two-year-long version of Hell Week, especially in America’s blue states, with Anthony Fauci and Democratic governors playing the role of fraternity presidents humiliating the pledges. Americans obediently donned masks day after day, stood six feet apart, disinfected counters, and obsessively washed their hands while singing “Happy Birthday.” They forsook visits to friends and relatives and followed orders to skip work and church. They forced young children to wear masks on the playground and in the classroom—a form of hazing too extreme even for Europe’s progressive educators.

Some Americans refused to submit to these rituals, but their resistance only intensified solidarity among the faithful. The most zealous kept their masks on even after they were vaccinated, even when walking alone outdoors. The mask became their version of a MAGA hat or a fraternity brother’s ring; some have vowed to keep wearing theirs long after the pandemic. They’ve already called for permanent masking on airplanes, trains, and buses, and they’ll probably clamor for more school closures and lockdown measures during future flu seasons.

Facts alone will not be enough to change their minds. To undo the effects of the hazing, we need to ease their cognitive dissonance by showing that they’re not to blame for their decisions. The mental mistakes were not made by citizens who dutifully sacrificed for two years. They assumed that the Centers for Disease Control knew how to control disease and that scientists and public-health officials would provide sound scientific guidance about public health. Those were reasonable assumptions. They just turned out to be wrong.

After a great disaster, the traditional response is to appoint a blue-ribbon panel to investigate it, and a bill has already been introduced in Congress to create a Covid commission. In theory, this could be a worthy public service, allowing experts to sift the evidence impartially and determine which strategies worked, which ones failed, how much needless damage was done—and whom to blame for it. But in practice, which experts would the current Democratic administration or Congress appoint? Presumably, the pillars of the public-health establishment—the same luminaries whose advice was followed so calamitously the past two years.

“CDC leaders used unrealistic projections to claim unprecedented powers and experiment with untested strategies.”

Before Covid, the United States drew up plans for a pandemic and maintained the world’s most lavishly funded scientific and medical institutions to deal with one. When the coronavirus arrived, the leaders of those institutions should have identified who was at serious risk and who wasn’t and adopted proven strategies to protect the vulnerable while doing the least harm to everyone else. They should have monitored the effects of their policies and adjusted them based on what they learned. By honestly communicating the risks and considering the overall public good, they could have tamped down needless fear and united the country behind their efforts.

Instead, they proceeded to ignore their own plans as well as the basic principles of science and public health. Leaders of the CDC terrified the public with worst-case scenarios based on computer models—and then used those blatantly unrealistic projections to claim unprecedented powers and experiment with untested strategies. Their pre-Covid planning scenarios had rejected business and school closures even for a pandemic as deadly as the Spanish flu of 1918, but when the Covid-19 pandemic came, they imposed lockdowns without even pretending to weigh the hypothetical benefits against the tangible economic, medical, and social costs—not to mention the intangible costs in emotional hardship and lost liberty. Randomized clinical trials conducted before the pandemic had repeatedly shown that masks did little or no good at preventing viral spread, but the CDC proclaimed them effective against Covid and promoted mask mandates nationwide. As the pandemic wore on, federal health officials looked for excuses to justify the lockdowns and mandates, hyping flawed studies and cherry-picked data, while failing to sponsor rigorous research testing their strategies.

They stubbornly ignored the hundreds of studies around the world showing that, except in a few isolated places, lockdowns did not reduce Covid mortality and that mask mandates were generally ineffective and senselessly cruel in classrooms. The most glaring evidence came from places with the least restrictive policies, like Florida, along with the Nordic countries Sweden, Finland, and Norway, which avoided lockdowns and mask mandates—yet did as well as, or better than, the average in preventing both Covid deaths and overall mortality during the course of the pandemic.

Instead of heeding all this evidence of their mistakes, federal officials did their best to suppress it and silence dissenters. Francis Collins, the head of the National Institutes of Health, wrote to Anthony Fauci in October 2020 urging “a quick and devastating published takedown” of the “three fringe epidemiologists” responsible for the Great Barrington Declaration. These three researchers—from the “fringe” institutions of Harvard, Stanford, and Oxford—criticized the deadly harms of the lockdowns and urged an alternative strategy of focusing protection on the high-risk elderly, allowing natural immunity to grow among the younger population at low risk. Fauci and Collins went on a media offensive, dismissing the focused-protection strategy as “very dangerous” and “not mainstream science.” Other scientists quickly joined the attack on the Great Barrington Declaration by signing a rebuttal, the John Snow Memorandum, which asserted that lockdowns were effective and dismissed the idea of natural immunity, claiming that “there is no evidence for lasting protective immunity to SARS-CoV-2 following natural infection.”

It was a remarkably irresponsible claim, given already-existing evidence at the time (the fall of 2020) that people’s immune systems developed defenses after a Covid infection. It would have been surprising if an infection didn’t produce durable protection. Yet this denial of natural immunity appeared in The Lancet and was signed by thousands of scientists and doctors, including Rochelle Walensky, who enshrined this unscientific notion as CDC policy when she became the agency’s leader during the Biden administration. It didn’t matter that natural immunity was repeatedly shown to be stronger and longer-lasting than vaccine immunity, or that other countries exempted people with natural immunity from vaccine mandates. The Biden administration insisted on vaccinating everyone—and firing workers who refused, including hospital staff and other essential workers whose prior Covid infections gave them stronger immunity than their vaccinated colleagues. Instead of uniting Americans against the virus, public-health officials chose painful policies that divided the faithful from the disobedient.

The public needs to learn what went wrong during the pandemic, but they’re not going to hear it from the Biden administration. It rewarded Fauci for his failures by giving him a new title, Chief Medical Advisor to the President, and would surely resist any serious investigation of its Covid strategies. Republicans could start the process if they win control of Congress in November and establish a Covid commission, but they’d be taking on the federal bureaucracy as well as the public-health establishment. Scott Atlas, the health-policy analyst from the Hoover Institution who joined the Trump administration’s Covid task force and fought unsuccessfully against Fauci’s pandemic policies, says that his experience in Washington has convinced him that any government-run commission would be a mistake.

“It’s massively naïve to think that our government will do anything objective,” Atlas says. “Any U.S. government panel would be viewed as, or be in reality, 100 percent partisan. It could be smarter to have an international organization do it, looking at the overall questions of management, because if it’s only an assessment of the U.S., then it naturally becomes a political blame game.” But which international organization could be trusted to do a fair investigation? The obvious candidates, like the World Health Organization or the World Bank, would presumably rely on establishment figures loath to admit their mistakes. And even if they honestly evaluated the pandemic strategies, how much impact would the report have? The mainstream press would probably either ignore it, as it ignored a recent meta-analysis concluding that lockdowns had “little to no effect” on Covid mortality, or attack it with the same tactics used to smear the Great Barrington Declaration as “not mainstream.”

The Great Barrington scientists’ ideas about focused protection and natural immunity have been vindicated—unlike the counterclaims and unproven strategies promoted in the John Snow Memorandum—but these researchers were no match for their media-savvy opponents, as Stanford’s John Ioannidis recently concluded after analyzing the credentials of the two sides. By considering how often the scientists’ research had been cited in the scientific literature, he found that the signatories of the Great Barrington Declaration included just as many top-cited scientists as did the signatories of the John Snow Memorandum. But there were a few crucial differences: the Snow signatories had many more Twitter followers, and they received a lot more attention on Twitter than in the scientific community. They had the dubious distinction of scoring much higher on a scale called the Kardashian index, named after the celebrity Kim Kardashian, which measures the discrepancy between a scientist’s social-media footprint and the citation impact of the scientist’s research. Twitter enabled activist scientists to exert an outsize impact on the public debate over Covid strategies. The lockdowns and mask mandates came to be perceived as “the science,” parroted by the mainstream press and enforced by censors on social-media platforms.

The activists kept pretending that those strategies worked, but their narrative became harder to sustain. Surveys by the Pew Research Center showed that the public’s trust in scientists rose at the start of the pandemic and then began falling. The earliest and steepest declines occurred among Republicans, so that today only 15 percent of Republicans have “a great deal of confidence” in scientists—while more than a third have “not too much” or “none at all.” Democrats remain far more trusting, but even their confidence in scientists is now lower than at the start of the pandemic.

“Public trust in science is over unless there’s a thorough review of the pandemic policies,” says Jay Bhattacharya of Stanford, one of the Great Barrington Declaration scientists. Unlike Atlas, he believes that a federal Covid commission could serve a purpose. “The harms of the lockdowns are so obvious, and the failure to protect the vulnerable so obvious, that it would be hard for a commission to whitewash the facts. It’s going to take political will, but it needs to be done to restore trust in public health.”

For now, the best opportunity for a public airing of the facts may be the 2022 election campaign. Some candidates are already attacking the lockdowns and mask mandates, and pandemic strategies could become a major issue in the 2024 presidential race, especially if Ron DeSantis runs on his success as Florida’s governor.

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com/ (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com/ (TONGUE-TIED)

https://immigwatch.blogspot.com/ (IMMIGRATION WATCH)

https://awesternheart.blogspot.com/ (THE PSYCHOLOGIST)

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Sunday, May 08, 2022


Why SOME people are 'unicorns' who will NEVER get Covid while others are infected over and over again - and others don't even know they've had it

I may be one of the "unicorns". I have had exposures that should have given Covid to me but I have had zero symptoms. My good experience could be due to the fact that I have had two shots of the AstraZenica vaccine But I was rather late in getting the vaccine and had "dangerous" exposures first without getting anything. Unlike many people I also got no perceptible side-effects from the vaccine

When James Cruickshank tested positive for Covid-19 this year, his girlfriend automatically assumed she was next. The 30 year-old fitness fanatic and his partner, Steph Grant, live together in a rented apartment in Sydney. But months later Ms Grant, 28, who admits she easily catches colds, is still Covid-free.

'I thought, if anyone is going to get it, it's for sure going to be me. But I didn't. It was super surprising,' she told SBS.

Ms Grant is not alone in being baffled at why she's avoided the much-feared virus. For every story of someone who got sick with Covid-19, there seems to be a parallel tale of someone who expected to fall ill but didn't.

Aside from how Covid-19 started in the first place, why some people don't seem to get sick from it has been one of the greatest mysteries of the pandemic.

Now it is closer to finally being answered for sure, thanks to a ground-breaking Australian research team.

After nearly two and a half years since Covid was first detected, in Wuhan, China, it is now beyond doubt that some people can be exposed but won't get sick - regardless of whether they were vaccinated or not.

In simple terms, the reason some people don't get sick is immunity - either theirs is better or it's just enough to stop them getting sick.

There's also a rare group of people who may be entirely resistant, and a global research project involving three Australian institutions, called the Covid Human Genetic Effort is investigating.

'Although this is not proven yet, there may be individuals completely resistant to the infection itself, as seen with other viruses,' a statement from the project said.

Scientists are in the early stages of finding definite answers to why - because it's only recently apparent that not everyone is going to get Covid-19. The evidence that it's more than just good luck that some people evade Covid-19 is now strong.

Partly that evidence comes from the extraordinary individual cases of people 'hyperexposed' to multiple positive cases, and sometimes caring for them, even without a facemask.

Some of these cases occurred within families where all but one person was sick with the virus, said John Christodoulou from the University of Melbourne, who is involved with the Covid Human Genetic Effort.

'We are collecting information and DNA from individuals who have been ‘hyperexposed’ to Covid but who don’t seem to contract Covid – for example, living in a household where multiple family members were infected, but one member of the household wasn’t – to see if genetic factors can be identified that might offer protection against Covid infection,' said Mr Christodoulou.

Most evidence appears anecdotally from the sheer number of people who have responded to call-outs from researchers wanting to speak to people who never got ill, despite exposure.

Several international studies are underway to answer this question, which researchers ultimately hope will help improve Covid treatment for everyone. And they have received thousands of volunteers eager to help.

Mayana Zatz, a geneticist from the University of São Paulo, went on Brazilian television asking people who had shared a bed with an infected partner but didn't get sick to contact her. She received thousands of emails.

In another study, Imperial College researchers exposed 36 healthy, unvaccinated male and female volunteers (aged between 18 and 30) with a low dose of Covid - but only half became infected.

In other words, coming into contact with Covid-19 and not getting sick - and not even becoming infected - might actually be very common, despite the high case rates

This is not to say that Covid is a hoax, or not as serious as reported.

Just this week the World Health Organisation estimated 15 million people had died from Covid-19 or as a result of the pandemic in the last two years - far more than the officially reported toll of 6.25 million.

Either way that's far more than what Covid is sometimes compared to - influenza, which WHO says kills approximately 650,000 people a year.

The number of people who have fallen sick with Covid is a now a extraordinary 516 million across the globe.

But scientists now accept hundreds of thousands who were obviously exposed did not develop Covid-19.

How did they get that sort immunity? Medics now accept that in some cases, people who did not get sick were just lucky, while others simply had better immunity.

The duration and location of exposure to the virus exposure were vital, as well as how infectious the positive case was - known as their viral load.

But even in situations that people were exposed to someone with a high viral load, they didn't catch it.

The reason some people have better immunity to Covid is believed to be either because of their genes or the way their body responded to a previous virus.

A study by the Imperial College London found that high levels of T cells (a type of white blood cell) created when the body fought off a previous virus - such as the common cold - protects against Covid-19.

'The immune system is good at recognising viruses that aren't exactly the same but come from the same family,' said immunologist Professor Stuart Tangye from the Garvan Institute of Medical Research, 9 newspapers reported.

'Studies from 2020 found that 25-45 per cent of people who were studied and had not previously been infected with SARS-CoV2 had detectable levels of T cells that cross-reacted with SARS-CoV2.'

Melbourne immunologist Vanessa Bryant, who is studying transmission within households, says our immune systems are not all equal. 'Some people might generate an immune response that just makes better antibodies … and we do think this is largely genetic,' said Ms Bryant, of the Immunogenetics Research Laboratory at the Walter and Eliza Hall Institute of Medical Research.

Part of the answer could be in so-called genetic mutations, which can be a good or a bad thing. Professor Tangye said 'genetic influences' can sometimes make people vulnerable to severe illness - or it can improve resistance.

'There are populations of people who probably should have been infected and sick but weren’t,' he said.

Scientists also suspect that genetics could be to blame for young otherwise healthy people developing severe Covid where older, apparently more vulnerable people get less severe symptoms.

'There was clearly a subset - small, rare - but there was a subset of individuals who were otherwise healthy and who developed very serious infections, life-threatening infections.'

He claimed up to five per cent of severe COVID-19 cases in people under 70 could be caused by undiagnosed genetic defects.

Those lucky 'unicorns' who manage to escape infection even at close quarters will be able to sail through the pandemic.

But medics warn against tempting fate and testing your resistance. 'I always encourage people to not go and deliberately get Covid,' added Professor Senanayake.

'Even if they’re young and healthy, they might have some unrecognised risk factor that could give them severe disease.'

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Sweden’s Covid death rate among lowest in Europe, despite avoiding strict lockdowns

Sweden’s death rate during the Covid pandemic is among the lowest in Europe, despite the country refusing to impose strict lockdowns, according to new figures from the World Health Organisation.

The UN health agency released estimates of excess deaths - people who died directly and indirectly from Covid - showing the pandemic had wrought a “staggering toll” worldwide, with 14.9 million fatalities, three times higher than fatalities officially reported.

Britain, according to the new data, had a lower excess death rate than Spain, Germany and Italy.

Experts said the difference demonstrated stringent lockdowns alone did not determine success when battling Covid-19.

The WHO analysis includes deaths directly linked to Covid but also indirect fatalities - including those unable to access healthcare for other conditions while services were overwhelmed or suspended.

It also accounts for deaths averted during the pandemic, for example because of the lower risk of traffic accidents during lockdowns.

Sweden, which was criticised in the early stages of the pandemic for resisting a mandatory lockdown, had fewer deaths per capita than much of Europe.

In 2020 and 2021, the country had an average excess death rate of 56 per 100,000 - compared to 109 in the UK, 111 in Spain, 116 in Germany and 133 in Italy.

Low obesity rates a factor

Although Sweden fared worse than its Nordic neighbours, lower rates of obesity - a key risk factor for severe coronavirus disease - and a better-resourced healthcare system helped limit fatalities in the country.

“The lesson from Sweden is to invest in your population's health and have less inequality,” Prof Devi Sridhar, the chairman of global public health at the University of Edinburgh, told The Telegraph.

She said that although the UK’s initial response was weak, the country “definitely did better post-vaccine rollout than other places”, which contributed to a lower excess death rate overall.

Dr Michael Head, a senior research fellow in global health at the University of Southampton, added: “There have been too many preventable deaths here in the UK during the pandemic. However, early rollout of the vaccines, including the booster doses, will also have averted many deaths.

“By the end of the pandemic, it's likely that the UK will probably end up mid-table on various metrics that measure pandemic performance, such as excess mortality,” he told The Telegraph.

Meanwhile some countries - including Australia, New Zealand and Japan - actually reported negative excess death rates, suggesting there were fewer fatalities than expected during 2020 and 2021.

The global disparity between official figures and excess deaths is not a surprise. Even before the pandemic, around six in 10 deaths globally went unreported.

The WHO said that middle-income countries - where both Covid testing and death registrations are patchy - account for 81 per cent of excess deaths in the first two years of the pandemic, compared to just 15 per cent in high-income nations.

Dr William Msemburi, an WHO official, added that the vast majority of deaths - some 68 per cent - were centred in just 10 countries, which include the United States, Russia and India.

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com/ (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com/ (TONGUE-TIED)

https://immigwatch.blogspot.com/ (IMMIGRATION WATCH)

https://awesternheart.blogspot.com/ (THE PSYCHOLOGIST)

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Friday, May 06, 2022


COVID-19 subvariant XE: What to know

It’s nicknamed Frankenstein, but experts say that shouldn’t scare you.

The World Health Organization (WHO) recently issued a preliminary report on the new COVID-19 "Frankenstein" subvariant called XE, which is a mix of the omicron BA.1 variant and the "stealth" variant BA.2, with the agency declaring it’s still part of the omicron variant, but not a variant of interest or concern yet, according to a recent Euronews report.

The XE strain was first detected in the United Kingdom on January 19, with now over 1,000 cases spreading by community transmission, with the majority in the east of England, London, and South East London, per the report.

A "recombinant" strain is a type of variant that occurs when an individual becomes infected with two or more variants at the same time, and are assigned the letter "X" prefix to classify them as recombinant, said Dr. Stacia Wyman, senior genomics scientist at the Innovative Genomics Institute at UC Berkeley.

Wyman noted the XE subvariant originated from someone who was infected with both the BA.1 and BA.2 variants.

"When the virus was replicating, there was an error and the two viruses combined," she said. "Then the combined virus replicates and is spread to other people."

XE’s genomic sequence is part BA.1 and part BA.2, but the gene that codes for the spike protein that helps the virus attach to healthy cells comes from BA.2. But even though it’s part BA.2, it’s still unknown if previous BA.2 infection will provide immunity to XE, Wyman said.

"Early-day estimates indicate a community growth rate advantage of ~10% [for XE] as compared to BA.2, however this finding requires further confirmation," the WHO said.

But the UK Health Security Agency (UKHSA) noted: "There is currently insufficient evidence to draw conclusions about growth advantage or other properties of this variant," according to a March 25 updated release.

People are testing positive for 10 days or more when they are diagnosed with the XE variant, said Denis Kinane, immunologist and founding scientist of United Kingdom-based Cignpost Diagnostics.

"Our current data is showing that many people are testing positive for 10 days or more rather than the 6 or 7 days we saw by frequent testing at the beginning of the omicron wave, which means the virus has more opportunity to spread more widely and this may be BA-2 and XE’s transmissibility advantage," Kinane said.

At least two XE cases have been sequenced in Wisconsin and one in New York with also two unconfirmed cases in California, according to Wyman. Japan, China, Thailand, India, New Zealand, and Israel have reported COVID-19 cases secondary to the XE subvariant, in addition to the U.K.

"We continue to monitor cases of the recombinant XE variant in the U.K., which currently represents a very small proportion of cases," said Meera Chand, director of clinical and emerging infections at UKHSA.

"Recombinant variants are not unusual, particularly when there are multiple variants in circulation - and several have already been identified over the course of the pandemic," said Dr. George Thompson, professor of medicine at the University of California, Davis, School of Medicine in the Division of Infectious Diseases.

Thompson told Fox News: "It may be slightly more transmissible than the parent variant but it is too early to known if outcomes differ from other COVID variants."

"As with other kinds of variant[s], most will die off relatively quickly," said Susan Hopkins, chief medical advisor of UKHSA.

Because viruses naturally mutate over time, recombinant strains are not surprising, so presently XE does not appear to be more effective at evading immunity from previous vaccination or prior COVID-19 infection compared with the previous strains, said Dr. Carlos Malvestutto, an infectious disease specialist at the Ohio State University Wexner Medical Center.

But Hopkins noted, "So far there is not enough evidence to draw conclusions about transmissibility, severity or vaccine effectiveness."

Some experts argue, however, because XE is a combined strain of both BA.1 and BA.2 and vaccination protects against symptomatic disease for BA.1 and BA.2 strains, it is likely vaccination will also protect against symptomatic disease caused by XE, said Dr. Andrew Badley, professor of infectious disease at the Mayo Clinic and chair of the COVID-19 Task Force for Mayo Clinic.

The most common symptoms reported of the XE strain are similar to the cold-like symptoms of original strain of omicron – especially in vaccinated people, like runny noses, sore throats and sneezing in contrast to the original strain of the virus that causes COVID-19, like fevers, cough or loss of taste or smell, according to the Independent.

Badley added: "We also know that the other therapies that are being used particularly in the outpatient setting—Paxlovid and molnupiravir—should, based on how they work, have continued activity against the XE strain."

But Badley noted because some monoclonal antibody therapies are not effective against BA.1 and BA.2, it is likely those specific antibody treatments won’t work against XE either.

"The key takeaway is that for each of these variants and subvariants, risk of hospitalization and death appears to be, on average, lower where vaccination rates are higher, indicating that vaccination, including a third dose, should be effective in reducing risk for severe disease," said Stephanie Silvera, professor of public health at Montclair State University.

Approximately 62% of all COVID-19 cases in the United States are currently BA.2, but a new BA.2 subvariant, BA.2.12.1, is now responsible for 36.5% of new coronavirus infections, according to recent data from the Centers for Disease Control and Prevention (CDC).

"We're just starting to learn about the impact of BA.2.12.1," CDC Director Rochelle Walensky said.

"It appears it might have a transmission advantage of about 25% over the BA.2 subvariant. … But importantly, we continue to believe that those who are vaccinated and especially those who are boosted, continue to have strong protection against severe disease, even from BA.2.12.1."

Wyman added the XE recombinant strain "may die out completely regionally and never spread."

"It’s something to keep an eye on, but not for the general population to worry about."

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FDA puts new limits on Johnson & Johnson vaccine due to rare blood clotting condition

The FDA revised its emergency authorization to sharply limit the use of Johnson & Johnson's COVID-19 vaccine due to a rare but potentially fatal blood clotting condition called thrombosis with thrombocytopenia syndrome (TTS).

Only individuals who are 18 years of age and older who "would otherwise not receive a COVID-19 vaccine" due to availability or their choice should now take Johnson & Johnson's one-shot regiment.

"Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals," Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, said in a statement Thursday.

COVID vaccine Johnson & Johnson
Syringes filled with the Johnson & Johnson vaccine are shown, Thursday, May 13, 2021, at a mobile vaccination site at the Greater Bethel Church in Miami. (AP Photo/Wilfredo Lee / AP Newsroom)

"We’ve been closely monitoring the Janssen COVID-19 Vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA," Marks added.

The CDC's Advisory Committee on Immunization Practices unanimously voted in December to give a preferential recommendation to Pfizer and Moderna's two-shot mRNA vaccines.

TTS is a syndrome of blood clotting in combination with low levels of platelets, which are the blood cells that help your body halt bleeding.

Health officials have confirmed 60 cases of TTS following Johnson & Johnson's vaccine, nine of which have been fatal.

Women between the ages of 30 and 49 are most vulnerable to the blood clotting disorder, according to the CDC.

About 18.7 million doses of Johnson & Johnson's vaccine have been administered in the United States.

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Nearly 15M deaths worldwide associated with COVID-19: WHO

The World Health Organization (WHO) said Thursday that its new estimates show the full death toll associated directly or indirectly with the COVID-19 pandemic between Jan. 1, 2020, and Dec. 2021 was approximately 14.9 million.

Scientists said there were between 13.3 million and 16.6 million deaths either caused directly by the coronavirus or attributed to the pandemic’s impact on health systems during that time.

That number is more than double Johns Hopkins University's official death toll of more than 6 million, with the majority of excess mortality – calculated as the difference between the number of deaths that have occurred and the number that would be expected in the absence of the pandemic based on previous data – in Southeast Asia, Europe and the Americas.

"Most of the excess deaths (84%) are concentrated in South-East Asia, Europe and the Americas. Some 68% of excess deaths are concentrated in just 10 countries globally. Middle-income countries account for 81% of the 14.9 million excess deaths (53% in lower-middle-income countries and 28% in upper-middle-income countries) over the 24-month period, with high-income and low-income countries each accounting for 15% and 4%, respectively," the agency said.

A team led by Canadian researchers estimated that there were more than 3 million uncounted coronavirus deaths in India alone, whereas WHO's new analysis estimated that missed deaths in India ranged between 3.3 million to 6.5 million.

Disputing the WHO's methodology, India's Health and Family Welfare Ministry labeled the analysis as "questionable," complaining that the estimates were released "without adequately addressing India's concerns."

The estimates for the two-year period confirm that the global death toll was higher for men than for women and higher among older adults.

The estimates are the result of a global collaboration supported by the work of the Technical Advisory Group for COVID-19 Mortality Assessment and country consultations.

While many countries still lack the capacity for reliable mortality surveillance, using publicly available methodology the WHO says countries can use their own data to generate or update their estimates.

"These sobering data not only point to the impact of the pandemic but also to the need for all countries to invest in more resilient health systems that can sustain essential health services during crises, including stronger health information systems," WHO director-general Dr. Tedros Adhanom Ghebreyesus, said in a statement. "WHO is committed to working with all countries to strengthen their health information systems to generate better data for better decisions and better outcomes."

The WHO said it wasn't yet able to distinguish between direct deaths from COVID-19 and others caused by the pandemic nothing that a future project examining death certificates would probe this.

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com/ (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com/ (TONGUE-TIED)

https://immigwatch.blogspot.com/ (IMMIGRATION WATCH)

https://awesternheart.blogspot.com/ (THE PSYCHOLOGIST)

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