Wednesday, September 27, 2023
False, Misleading Information About COVID-19 Vaccines and Myocarditis Spreads Widely
False and misleading information about COVID-19 vaccines and heart inflammation is being spread widely, including by doctors.
That includes claims that data clearly show myocarditis, or heart inflammation, is more prevalent after COVID-19 infection when compared to COVID-19 vaccination.
"Teen boys have been up to five times as likely to have heart inflammation after having a COVID infection than after getting vaccinated," Dr. Mandy Cohen, director of the U.S. Centers for Disease Control and Prevention (CDC), said in a video encouraging nearly all Americans to get one of the new COVID-19 vaccines.
A similar claim was made by Dr. Scott Rivkees, Florida's former surgeon general, to ABC.
The claims are largely based on a non-peer reviewed study from the CDC from April 2022.
"At this point it does not seem like an intellectually honest attempt to conduct a risk-benefit analysis," Allison Krug, an epidemiologist, told The Epoch Times. "I'm just dismayed that they don't seem genuinely interested in repairing the credibility with parents lost over the last two-and-a-half years."
The CDC did not respond to a request for comment.
Dr. Rivkees, presented with studies that have found people in at least some populations are at a higher risk of myocarditis after vaccination when compared to after a positive test, doubled down on his claim.
"In articles that compare risks of myocarditis from COVID vs. following vaccination ... the risk of myocarditis is greater after COVID than after vaccination," Dr. Rivkees, professor of the practice of health services, policy, and practice at Brown University, told The Epoch Times via email.
In one of the papers, English researchers found a higher risk for men under 40 who were vaccinated with Moderna's shot.
Nordic researchers also identified a higher risk for men under 40, as well as some females.
German researchers found 655 cases related to a COVID-19 vaccine, versus 77 related to COVID-19.
The CDC researchers found a higher rate of cardiac complications after a positive COVID-19 test than after COVID-19 vaccination in 40 U.S. health care systems. They did not include all COVID-19 infections.
Dr. Rivkees later sent meta-analyses that confirm the COVID-19 vaccines increase the risk of myocarditis, with no tabulations for the risk following COVID-19.
Dr. Rivkees was quoted by ABC as countering recommendations from Florida to people under 65 to avoid new COVID-19 vaccines, which have virtually no clinical trial data behind them.
Florida's recommendations contradict the CDC, which advises nearly all Americans receive one of the new shots, but align with or are close to the recommendations from much of the rest of the world, including many European countries and Israel.
Other Claims
Other recent reporting on COVID-19 vaccines also includes false or misleading claims about myocarditis.
"The risk of myocarditis from the virus is far greater than the risk of myocarditis from the vaccine,” Dr. Kawsar Talaat, an associate professor at Johns Hopkins School of Medicine, told MIT Technology Review. Dr. Talaat did not provide any citations. A request for comment returned an away message.
CBS News reporter Alexander Tin wrote in an article that "research shows people are more likely to develop myocarditis from a COVID infection than from the vaccine." Mr. Tin did not link to any of the purported research and declined to comment on the record.
USA Today reporter Karen Weintraub wrote that no myocarditis cases were recorded after receipt of the bivalent vaccines, which were available from 2022 through when the new vaccines were cleared. That's false, according to the CDC presentation (pdf) to which she hyperlinked. The CDC's Vaccine Safety Datalink alone recorded two confirmed cases, including one in a young male. Ms. Weintraub did not respond to a query.
Continues Trend
Solid information on myocarditis and COVID-19 vaccines has been hard to come by during the pandemic, with even the CDC hiding data and making false statements about the condition.
State health officials and agencies have also repeatedly offered false and misleading information, including on heart inflammation.
In guidance on its website, the North Carolina Department of Health and Human Services says that COVID-19 poses more of a risk than COVID-19 vaccination. Officials pointed to the same CDC paper cited by vaccine proponents.
That report, published by the CDC's quasi-journal, analyzed electronic health records from 40 U.S. health care systems and counted cardiac complications following a positive COVID-19 test or COVID-19 vaccination. Then they compared the rates and claimed people were at higher risk after a positive test.
"For post COVID-myocarditis, they only included young people with an official COVID diagnosis in the health system," Dr. Tracy Beth Hoeg, an epidemiologist in California, told The Epoch Times via email.
"So not only was this a non-representative sample because these were a subset of the sickest children who were seeking medical attention but happened to also have a COVID positive test," she added. "At the same time they underestimated the total number of children infected by only including those with a health system associated positive result (so this shrinks the denominator and increases the myocarditis rate per infection)," she said.
Those choices would inflate the rate of post-COVID myocarditis cases, she said.
The researchers did include in the paper calculations for post-vaccination myocarditis as high as 360 cases per million second doses in 12- to 17-year-old males, or as high as one in 2,800 second doses.
The CDC "glossed over" those calculations, Dr. Hoeg said. "I don't know how many parents would have taken the chance on vaccination if they had known this risk of myocarditis was around 1/3,000 according to the CDC's own study, which was consistent by the way with data from Hong Kong."
Dr. Hoeg and Ms. Krug previously authored a paper that found the risk of cardiac complications to young, healthy males from COVID-19 vaccines was higher than the risk from COVID-19.
Dr. Jason Block, the CDC study's corresponding author, did not respond to a request for comment. The North Carolina Department of Health and Human Services did not respond to an inquiry. Pfizer and Moderna have not responded to requests for comment.
Cases After Bivalent Shot
According to the Vaccine Safety Datalink data, through March 11, one case of myocarditis was detected after Pfizer vaccination and one case was detected after Moderna vaccination.
CDC officials did not present any data from the Vaccine Adverse Event Reporting System (VAERS). Starting in mid-2021, the CDC has analyzed reports to the system and verified some of them before regularly updating reported rates.
The CDC, asked for the data, would only provide a study that covered VAERS reports lodged through Oct. 23, 2022. The study found nine reports of myocarditis or pericarditis, seven of which were verified by medical record review.
Asked for more current data, the official said the study "is the most recent publicly available data we have on the topic" and that more current data would be made available to the public "when appropriate."
An Epoch Times search of VAERS turned up 98 myocarditis, pericarditis, or myopericarditis reports following bivalent vaccination through Sept. 8. Ms. Krug counted 10 reported cases that were or appeared to be myocarditis or pericarditis among 12- to 29-year-olds.
Dr. Rivkees said the Vaccine Safety Datalink data "show that the risk of myocarditis following COVID boosters is very rare." He did not comment on the lack of VAERS data.
Dr. Walid Gellad disagreed.
Without the VAERS data, "no risk benefit can accurately be calculated for young people," Dr. Gellad, director of the University of Pittsburgh's Center for Pharmaceutical Policy and Prescribing, wrote on X.
Dr. Rivkees said he also felt the vaccines would prevent deaths in children, pointing to observational papers on older versions of the shots. Two were non-peer reviewed studies from the CDC.
Multiple people, including children, have died from post-vaccination myocarditis. And there's no evidence the new vaccines prevent infections, hospitalizations, or deaths in any age group. Pfizer's vaccine has no human data behind it, while Moderna's vaccine was tested on just 50 people, with no efficacy estimates presented. One of those 50 suffered a medically-attended adverse event deemed related to the shot. Moderna has not disclosed what the event was.
Older Misinformation
The CDC started the trend of mis- and disinformation about COVID-19 vaccines and myocarditis in early 2021, when then-Director Dr. Rochelle Walensky falsely claimed that the agency had seen no cases of the condition.
The agency also missed or ignored a safety signal for myocarditis after COVID-19 vaccination.
Outside researchers have also downplayed the cases by citing how symptoms resolved quickly in many patients, while abnormalities on imaging and symptoms persisted in some.
They've also made false claims about deaths from post-vaccination myocarditis.
"No deaths from myocarditis post-mRNA COVID-19 vaccination have been reported in the USA, with very rare deaths reported worldwide," U.S. researchers wrote in a review article in 2022. By then, multiple deaths had been reported in the United States alone. Dr. Stephanie Chin, the study's corresponding author, did not return a query.
In another example from late 2021, Chinese researchers falsely said, "so far, all adults and adolescents with myocarditis/pericarditis following COVID-19 vaccinations, including those reported in the current study, have been mild cases." They cited a single study from California.
Severe cases, including deadly ones, were reported in the literature starting in mid-2021.
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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)
http://jonjayray.com/blogall.html More blogs
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Tuesday, September 26, 2023
Scientists ‘shocked’ and ‘alarmed’ at what’s in the mRNA shots
Early in 2023, genomics scientist Kevin McKernan made an accidental discovery. While running an experiment in his Boston lab, McKernan used some vials of mRNA Pfizer and Moderna Covid vaccines as controls. He was ‘shocked’ to find that they were allegedly contaminated with tiny fragments of plasma DNA.
McKernan, who has 25 years’ experience in his field, ran the experiment again, confirming that the vials contained up to, in his opinion, 18-70 times more DNA contamination than the legal limits allowed by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA).
In particular, McKernan was alarmed to find the presence of an SV40 promoter in the Pfizer vaccine vials. This is a sequence that is, ‘…used to drive DNA into the nucleus, especially in gene therapies,’ McKernan explains. This is something that regulatory agencies around the world have specifically said is not possible with the mRNA vaccines.
Knowing that the contamination had not been disclosed by the manufacturers during the regulatory process, McKernan raised the alarm, posting his findings to Twitter (now X) and Substack with a call-out to other scientists to see if they could replicate his findings.
Other scientists soon confirmed McKernan’s findings, though the amount of DNA contamination was variable, suggesting inconsistency of vial contents depending on batch lots. One of these scientists was cancer genomics expert Dr Phillip Buckhaults, who is a proponent of the mRNA platform and has received the Pfizer Covid vaccine himself.
In September of this year, Dr Buckhaults shared his findings in South Carolina Senate hearing. ‘I’m kind of alarmed about this DNA being in the vaccine – it’s different from RNA, because it can be permanent,’ he told those present.
‘There is a very real hazard,’ he said, that the contaminant DNA fragments will integrate with a person’s genome and become a ‘permanent fixture of the cell’ leading to autoimmune problems and cancers in some people who have had the vaccinations. He also noted that these genome changes can ‘last for generations’.
Dr Buckhaults alleges that the presence of high levels of contaminant DNA in the mRNA vaccines ‘may be causing some of the rare but serious side effects, like death from cardiac arrest’. He added, ‘I think this is a real serious regulatory oversight that happened at the federal level.’
Dr Buckhaults’ concerns are shared by McKernan, who presented his findings to the FDA in June. At the time of writing, McKernan had not received any response from the FDA on the matter. Dr Buckhaults said in the Senate hearing that he had emailed his findings to the FDA, but he had not received a response either.
In Australia, the Therapeutic Goods Administration (TGA) maintains that Covid vaccines cannot alter a person’s DNA. A spokesperson for the TGA stated, ‘The mRNA in the vaccines does not enter the nucleus of cells and is not integrated into the human genome. Thus, the mRNA does not cause genetic damage or affect the offspring of vaccinated individuals.’
They also said, ‘All batches of Covid vaccines distributed to Australians have been tested for the presence of contaminants including residual DNA template levels.’
However, a legal case filed in the Australian Federal Court in July of this year alleges that the TGA is not the appropriate regulator of Covid mRNA vaccines because, under the Gene Technology Act (2000) definition, the DNA contamination is a genetically modified organism (GMO).
The plaintiff, Victorian doctor and pharmacist Dr Julian Fidge, is seeking an injunction to stop Pfizer and Moderna from distributing their mRNA Covid vaccines because they never obtained a license from the Office of the Gene Technology Regulator (OGTR), which is the agency that oversees all GMO related products.
The TGA did not require tests for genotoxicity or carcinogenicity before providing provisional approval and, eventually, full registration of both the Moderna and Pfizer Covid vaccines. OGTR guidance strongly suggests such tests should be undertaken where there exists a risk of harm to human health.
McKernan, who provided expert advice on the case, agrees that the DNA contamination in the mRNA vaccines fits the Australian legal definition of a GMO. But there is also a second component of the mRNA vaccines that fits the definition.
That’s the mRNA itself, which is actually modified RNA wrapped in lipid nanoparticles (LNPs). The case argues that this ‘LNP-mod-RNA complex’ falls under the legal definition of a GMO and that, like the DNA contamination, it has the capacity to enter the cell nucleus and integrate into the human genome.
There is already at least one peer-reviewed scientific paper demonstrating that the Pfizer Covid vaccine mRNA can enter the human liver cell line and reverse transcribe into DNA in vitro (meaning in a lab dish).
Other studies cited in the case materials show the presence of spike protein mRNA in the nucleus of human cells, and evidence that acquired immune traits pass down to the offspring of mice pre-exposed to the Covid vaccine mRNA-LNP platform. This is suggestive that, once in the nucleus, the vaccine mRNA can be transferred and integrated with chromosomal DNA.
Taking both the LNP-mod-RNA complexes and the recently discovered DNA contamination present in the mRNA Covid vaccines, acting solicitor Katie Ashby Koppens says, ‘Every single person who has been injected with these products has received a GMO that has not been through the expert regulatory process in this country.’ She adds, ‘The human genome could be changed permanently, and no one was informed.’
Now, McKernan, Dr Buckhaults and other scientists are calling for urgent research to test whether the DNA contamination is lingering in the cells of mRNA vaccinated people, and whether the human genome has in fact been altered by mRNA Covid vaccines.
https://www.spectator.com.au/2023/09/scientists-shocked-and-alarmed-at-whats-in-the-mrna-shots
***********************************************Doctor working for US government visited Wuhan lab and raised safety concerns TWO YEARS before the pandemic hit
A doctor working for the US government visited the Wuhan facility which has faced questions over the origins of Covid-19 and raised safety concerns almost two years before the start of the pandemic.
Dr Ping Chen was director of the National Institute of Allergy and Infectious Diseases (NIAID) office in China when she went to the Wuhan Institute of Virology (WIV) in October 2017.
She wrote a report the following month in which she expressed her worries about the laboratory and the staff working in it.
'It is clear to me by talking to the technician that certainly there is a need for training support,' Dr Chen wrote in the memo seen by The New York Post.
The FBI believes Covid-19 'most likely' originated in a 'Chinese government-controlled lab' and supporters of the theory have pointed at the WIV - but there is no evidence to prove this claim.
'I think the institute would welcome any help and technical support by NIAID,' Dr Chen wrote about the Wuhan laboratory.
Senator Ron Johnson, from Wisconsin, is seeking more information about the concerns the doctor previously raised.
He believes a State Department cable from 2018 which referenced Chen and other scientists' misgivings about the WIV was more pointed.
'[D]uring interactions with scientists at the WIV laboratory, they noted that the new lab has a serious shortage of appropriately trained technicians and investigators needed to safely operate this high-containment laboratory,' it read.
Some of Dr Chen's private concerns about the Wuhan facility have previously been documented.
The Department of Health and Human Services (HSS) were pressured for more information by Johnson and Senator Rand Paul in 2021.
They got their hands on a redacted copy of Chen's report and were allowed an in camera review of it.
However, Johnson was frustrated by the large number of redactions in the version of the report he was handed.
The health department later admitted that now all of the redactions were made due to national security concerns.
'In the public FOIA document, HHS redacted Dr. Chen’s entire report claiming that it contains privacy and deliberative information,' Johnson said in a letter to the head of the HSS and National Institutes of Health on Thursday.
'It seems apparent that the only reason that HHS redacted this information was to hide the report’s contents from the American people.
'Perhaps HHS did not want the public to fully understand the fact that NIH and NIAID officials were aware of safety concerns at the WIV dating as far back as 2017.'
Those who believe the 'lab leak' theory have suggested the pandemic started at the WIV where 'gain-of-function' research on bat coronavirus was performed, with some of it funded by the US taxpayer.
The HHS told Congress on Tuesday that the Wuhan facility would no longer receive US government support until at least July 2033.
It pointed to the laboratory's failure to comply with government regulations.
Senator Johnson, who is the ranking member of the Senate Permanent Subcommittee on Investigations, has demanded an interview with Dr Chen.
He is also calling for unredacted copies of her 2017 report, her private communications on it and other material relating to the WIV.
'HHS and NIH continue to obstruct my oversight efforts. It is unacceptable that HHS and NIH had Dr. Chen’s report in its possession and only provided a slightly-less redacted version for my staff to review in camera,' he said.
Johnson sent a letter with those demands to HHS Secretary Xavier Becerra and NIH acting director Lawrence Tabak.
Almost seven million people have died due to coronavirus around the world, with 1.1 million deaths in the US.
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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)
http://jonjayray.com/blogall.html More blogs
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Monday, September 25, 2023
We’re fighting the Covid censors
Jay Bhattacharya and Martin Kulldorff
On July 4, our Independence Day, Judge Terry Doughty issued a preliminary injunction ordering the federal government to immediately cease contact with social media companies, which it had been urging to censor protected free speech. Evidence unearthed in the Missouri v. Biden case, in which we are co-plaintiffs, has revealed a vast federal enterprise dictating to social media companies who and what to censor. The Centers for Disease Control and Prevention (CDC), the Surgeon General’s office, the National Institutes of Health, the FBI, the State Department, the Department of Homeland Security and the White House itself were all closely involved.
You can get a good sense of what ideas the government finds threatening from its priority list of what it does not want Americans to talk about freely: the pandemic, vaccines, wars, concerns about election fraud and Hunter Biden’s laptop.
In the Missouri case, depositions of government officials and the discovery of email exchanges between the government and social media companies show an administration willing to threaten the use of its regulatory power to harm social media companies that do not comply with censorship demands.
Social media companies rely on Section 230 of the Communications Decency Act, which immunizes them against defamation lawsuits that traditional media are subject to. It states, “No provider or user of an interactive computer service shall be treated as the publisher or speaker of any information provided by another information content provider.” But unlike, for example, a phone company, they may still censor or decline to publish perfectly legal content protected under the First Amendment. For social media companies, losing this protection would threaten their multibillion-dollar business.
The companies understand what is at stake even if the threats are not explicit. But documents adduced in this case sometimes show explicit threats. For instance, at one point, White House communications director Kate Bedingfield announced that “the White House is assessing whether social-media platforms are legally liable for misinformation spread on their platforms, and examining how misinformation fits into the liability protection process by Section 230 of The Communication [sic] Decency Act.” The government’s message to social media companies was unmistakable: comply or else. Internal documents show company employees sometimes trying to push back on censorship demands but then capitulating.
The administration insists that without the power to censor social media, dangerous misinformation will spread unchecked. But the government also wanted social media companies to censor true information that cut against its policy goals. For instance, social media censored accurate health information like the fact that Covid recovery provides excellent natural immunity that is better than that developed from receiving the vaccines.
We both have personal experience of social media censorship. In October 2020, Francis Collins, the head of the National Institutes of Health, emailed then-director of the National Institute of Allergy and Infectious Diseases Anthony Fauci to organize a “devastating takedown” of the Great Barrington Declaration, a focused protection anti-lockdown public letter co-written by the two of us and Professor Sunetra Gupta of Oxford University. Almost immediately, tech companies such as YouTube, Google, Reddit and Facebook censored mentions of the Declaration.
In 2020, Twitter blacklisted one of us (Dr. Kulldorff) for arguing that schools should re-open. He cited an excellent study that showed Sweden safely kept its schools and daycare open for children fifteen and under in the spring, with no Covid deaths among its 1.8 million school-aged children and no excess risk for teachers. In 2021, Twitter blacklisted the other (Dr. Bhattacharya) immediately after joining for posting a link to the Great Barrington Declaration.
Ironically, even the White House itself was caught by its censorship demands. At the administration’s behest, Facebook implemented AI algorithms to suppress posts their computers deemed “antivax.” When the CDC issued a “pause” on the distribution of the Johnson & Johnson Covid vaccine because it had identified an elevated level of strokes, the Facebook algorithms tagged the White House account as “antivax.” The administration angrily ordered Facebook to stop censoring its speech while at the same time firing Dr. Kulldorff from a position as a CDC scientific advisor for arguing against the J&J “pause.” Their apparent position: free speech for the government, but not for anyone opposing the government in whatever direction.
The July 4 ruling in Missouri v. Biden restored free speech in America for ten days. On July 14, the government appealed to the Fifth Circuit Court, leading to an adminis- trative stay of the injunction. On August 10, in an oral argument, the government told the federal judges that it has a right to violate the First Amendment because there is an ongoing pandemic, including a right to censor the truth. At the time of writing the Fifth Circuit ruling is still pending, and due to its fundamental and significant implications regarding freedom of speech, the case may eventually end up at the Supreme Court.
Why were knowledgeable and outspoken scientists treated with censorship and contempt during the pandemic? The government’s smearing and censorship of scientific dissidents caused other scientists to self-censor. Its censorship enterprise created a public illusion that there was scientific consensus in favor of the government’s policies, even though many epidemiologists and public health scientists disagreed with the unscientific and ill-fated lockdown strategy that contradicted ethical principles of public health.
When there is scientific disagreement or uncertainty, the government must never pretend there is consensus and certainty. Let us learn from this shameful episode that the truth should never be censored and that the solution to incorrect information is more speech, not less.
https://www.spectator.com.au/2023/09/were-fighting-the-covid-censors/
*********************************************Pfizer-Funded Study Shows Poor Effectiveness for COVID-19 Vaccine in Young Children
A new study funded by Pfizer found the company's COVID-19 vaccine did not perform well in children under 5. Children aged 6 months to 4 years are supposed to receive three shots of the Pfizer-BioNTech vaccine. The number was increased from two when early testing showed little effectiveness.
Three doses of the Pfizer vaccine provided little protection against emergency room visits, urgent care encounters, or outpatient visits, according to the new study.
Researchers with and funded by Pfizer analyzed records from Kaiser Permanente Southern California. They included patients who tested for COVID-19 at an emergency department, urgent care, or outpatient setting along with being diagnosed with acute respiratory infection. The date range was July 23, 2022 through May 19, 2023.
Positive cases were those with a positive test result. Controls tested negative and had no evidence of prior infection in the past 90 days. Children were only counted as vaccinated if they received a second or third shot two or more weeks before being exposed to COVID-19. Children were excluded if they only received one dose, received any doses from a different company, or did not follow the recommended dosing schedule.
After adjusting for factors such as age and sex, researchers estimated just 12 percent effectiveness against medically-attended encounters for children who completed the three-dose primary series.
Confidence intervals crossed well over one, indicating that the effectiveness might actually be worse or even negative.
The effectiveness was estimated to be higher, or 44 percent, for children who received two doses of the regimen.
Researchers speculated that the difference stemmed from more immune-evasive virus variants becoming dominant in the United States by the time children received a third dose.
"Updated vaccines will likely be needed to maintain protection against contemporary Omicron strains in young children," they wrote.
The study was published by the Journal of the American Medical Association.
Sara Tartof, the study's corresponding author and an employee of Kaiser Permanente Southern California, did not answer questions, including why researchers included those with two doses but not those with one dose.
Among the key problems with the research were only including children who were diagnosed with acute respiratory infection (ARI), Dr. Robert Malone, who was not involved in the research, said.
That "may predispose to young children that lack a primary care physician/pediatrician," Dr. Malone, who helped invent the mRNA technology Pfizer's vaccine utilizes, told The Epoch Times via email.
"Likewise, the control group of non-vaccinated with ARI will also have selection bias. These intrinsic study biases make the relevance of the measured outcome to the general population quite problematic."
The newly reported results are based on a test-negative design, which is inappropriate for measuring effectiveness, said Dr. Jay Bhattacharya, professor of health policy at Stanford University.
"The design starts with children who are already seeing a doctor and then makes strong and unsupportable statistical assumptions to derive the probability of seeing a doctor for vaccinated and unvaccinated children," Dr. Bhattacharya, who was not involved in the research, told The Epoch Times via email.
"What is needed to answer this question without bias is a randomized control trial. I am shocked that the FDA has not asked Pfizer and Moderna to conduct such a study," he added.
The U.S. Food and Drug Administration (FDA) cleared Pfizer's shot on the basis of immunobridging, or comparing antibody levels in children after vaccination with levels in adults after vaccination.
Antibodies are believed to protect people against COVID-19.
The authorization has been the subject of protests, including a complaint that said the FDA violated its own standards with the clearance.
A single dose of a bivalent shot, introduced in the fall of 2022, boosted protection to 61 percent, but no estimates were available over time and the estimate was based on just eight vaccinated patients who tested positive.
"This imprecision indicates that the actual [effectiveness] could be substantially different," the CDC 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)
http://jonjayray.com/blogall.html More blogs
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Sunday, September 24, 2023
They Suffered Myocarditis After COVID-19 Vaccination. Years Later, Some Still Haven't Recovered
Mr. Cohen did not want to receive a COVID-19 vaccine. He knew the shots had not been available for long. He was worried about their safety.
While Mr. Cohen initially resisted receiving a shot, he faced restrictions such as being forced to remain on base while vaccinated soldiers left. He was also pressured by military commanders, who scheduled a vaccination appointment for him and contacted his mother as part of a multipronged campaign.
"They told me, 'Come on. It's your mother. She's crying. She's worried. What wouldn't you do for her?'" Mr. Cohen, who asked to be identified by a pseudonym because of concern about repercussions for going public, told The Epoch Times.
"I didn't want to take the vaccine. I didn't believe in it," he said. But he wanted to appease his mother. "I would do anything for her."
Mr. Cohen received his first shot, manufactured by Pfizer, on Sept. 22, 2021. He was 21.
Two weeks later, he was awakened by a sharp pain at 3 a.m. "I felt like my heart was trying to get out of my chest," Mr. Cohen said. The soldier has felt pain before. "I never felt something like this," he said.
Mr. Cohen went with a friend to the hospital, where he was placed in quarantine because he wasn't fully vaccinated. Thirty minutes ticked by.
"I felt like it was the first time in my life I actually started seeing flashbacks of things that I did in my life—I felt like I was truly dying," Mr. Cohen said.
Doctors finally came in and ran tests. They diagnosed Mr. Cohen with perimyocarditis, or inflammation of the heart muscle and the tissue around the heart.
They said Mr. Cohen was lucky. If he had come just a little later, he would have needed open heart surgery.
He spent three days in the hospital, taking medication and pills. When he was discharged, he was told not to engage in any physical activity for at least six months. He also needed to report for regular checkups and take a pill every day.
Six months after leaving the hospital, Mr. Cohen's cardiac MRI showed concerning results. His heart still hadn't recovered.
Doctors gave him more pills. "They told me maybe I will need them for the rest of my life," Mr. Cohen said. The military marked him as unable to serve for the rest of his life, and released him.
To this day, he suffers. "I've been feeling, I'm not sure if it's trauma or something, but it feels sometimes like a sting there, a short sharp pain," Mr. Cohen said.
He's also unable to do all he used to do before. "I was training. I was playing soccer. I did a lot of physical things, which now I can't afford ... to do anymore," Mr. Cohen said.
Dr. Adam Hirschfeld was among the first people to receive a COVID-19 vaccine in the United States. The orthopedic surgeon was motivated by a desire to prevent his patients from becoming sick. "I didn't want to put any of my patients at risk," Dr. Hirschfeld told The Epoch Times. He received a Moderna primary series, composed of two doses, in January 2021. He was 36.
Three days after the second shot, Dr. Hirschfeld felt discomfort in his chest and numbness in his left arm. A cardiac MRI confirmed evidence of heart inflammation. Dr. Hirschfeld was prescribed medicine and discharged two days later.
Dr. Hirschfeld has since undergone about a dozen electrocardiograms, another half a dozen echocardiograms, and a follow-up cardiac MRI.
"I went from being completely healthy—no issues, no medications—to seeing 10 different doctors in the blink of an eye," Dr. Hirschfeld said.
The follow-up MRI, conducted about 18 months after the vaccinations, showed normal cardiac function. But Dr. Hirschfeld still experiences pain.
"I have continued chest pain on the right side, and then I have neuropathic type pains in my neck and shoulder areas," he told The Epoch Times. "I have it when I wake up, and it's there when I go to sleep."
The suffering affects the doctor physically and mentally. "Having chest pain every day for two and a half years is very disconcerting," he said.
Mr. Cohen lives in Israel. Dr. Hirschfeld lives in the United States. The first myocarditis cases after COVID-19 vaccination were reported in those countries in January 2021. Only a few weeks had elapsed since authorities cleared and recommended the shots for large portions of the population, including many young, healthy people.
At first, authorities hid reports of myocarditis from the public. Israel first acknowledged there was a likely link between the shots and the inflammation. The United States finally followed in June 2021, when the U.S. Centers for Disease Control and Prevention (CDC) said there was a "likely association."
Even after the association was made public, officials and many experts claimed that the myocarditis cases were mild. Most patients were hospitalized, authorities acknowledged, but they said patients could expect to recover without treatment and with rest.
The myocarditis is "rare but mild," Dr. Rochelle Walensky, the CDC's director at the time, said on "Good Morning America" on June 24, 2021. Dr. Walensky said the cases were "self-limited," or didn't require treatment to resolve.
Dr. Jeremy Faust, editor-in-chief of MedPage Today and a teacher at Harvard Medical School, on Twitter two days later described the cases as "self-limited troponinemia," or elevated troponin levels that would resolve on their own. Troponin is a protein in the heart that's a marker of heart injury.
Those claims were already wrong at the time, based on case reports alone. A previously healthy 24-year-old man in Massachusetts, for example, experienced chest pain so serious that he went to an emergency department, doctors reported on May 18, 2021. He was eventually discharged with a prescription for a beta-blocker and anti-inflammatory drugs and told not to engage in strenuous activity for three months.
Another early case involved a previously healthy 16-year-old boy in California who experienced "stabbing chest pain" and went to the emergency department for help. He described the pain as 6 to 8 on a scale of 1 to 10. The symptoms prompted doctors to admit him to intensive care. He spent six days in the hospital before being discharged.
Like many early case reports, no follow-up data were reported, making it impossible to say that the cases had fully resolved.
"Unless you've experienced it individually, you can't tell somebody that their case was mild," Dr. Hirschfeld said. "If you have elevated troponin, that's your cardiac muscle breaking down. "That's something that's permanent. And so to tell me that my cardiac muscle breaking down is mild is pretty insulting."
Signs of persistent symptoms appeared in the literature before long. U.S. military researchers, for instance, stated on June 29, 2021, that seven of 23 patients continued to have chest discomfort weeks or even months later. Dire outcomes were known even earlier. Two deaths were reported to U.S. authorities in February 2021, while another two were reported in Israel in the spring. Both of the Israelis who died were previously young and healthy.
Professional Biker Affected
Kyle Warner was a professional mountain bike racer when he received his first COVID-19 vaccine in May 2021. He completed a primary series the following month. Mr. Warner, who lives in the western United States, teaches older people and wanted to protect them from COVID-19. The CDC and others promoted the idea that the vaccines curbed or even prevented transmission based on observational data.
"The sentiment was these are safe and effective. If you get them, you don't need to wear a mask anymore, and you can't transmit COVID or catch COVID," Mr. Warner told The Epoch Times. "I spend quite a bit of time around older people and help them learn.
"I wasn't necessarily afraid of COVID myself. Not that I did respect it, but I wasn't worried it was going to kill me," he added. "But I was worried about getting someone else sick, especially when I'm with our older clients."
Mr. Warner was diagnosed with myopericarditis after COVID-19 vaccination and was hospitalized. After being discharged, Mr. Warner was bedridden for weeks.
"There's points where I was unable to even get up out of bed without passing out or blacking out," Mr. Warner told The Epoch Times. "It was really eye-opening. I felt like I went from being 28 years old to being 88 years old."
Mr. Warner was diagnosed with myopericarditis and two other conditions—postural orthostatic tachycardia syndrome and mast cell activation syndrome—that others have also been diagnosed with following COVID-19 vaccination.
Hyperbaric oxygen, which has relieved some of Dr. Hirschfeld's pain, helped bring Mr. Warner's energy levels back up.
But the cyclist, who didn't ride again until February 2022, still struggles with pain, especially when he exercises in the summer.
Mr. Warner utilizes a heart rate monitor, which he became familiar with in his racing career. During a recent ride, Mr. Warner pushed himself, trying his hardest for four minutes. That sent his heart rate up to 189 beats per minute—the highest since the injury.
"I did OK, but then the next few weeks, I had a kind of a lingering chest pain and tightness. And about four days after, it was pretty significant where I was having a hard time sleeping and my heart felt like it was palpitating every once in a while, and then—even more than a week later—I still had a little bit of chest tightness and pain," Mr. Warner said.
"It kind of scared me because it's been well over a year since my last treatment with hyperbaric and I'm still dealing with it. And when I do try to push myself harder, then I have to pay for the next few days to a week. "Back in the day, I would be able to do that with no problem at all."
Doctors who have spoken to Mr. Warner have told him that when his heart becomes stressed, it signals his immune system to attack and inflame it. He tries to keep his heart rate under 160 beats per minute.
14-Year-Old Rushed to Hospital
Aiden Ekanayake woke up in the middle of the night.
"Every breath deeper in was like knives in my chest," Aiden, who is from Georgia, said during a podcast appearance.
It was June 12, 2021, two days after Aiden received a second shot of Pfizer's vaccine. He was 14.
Aiden was able to fall asleep through shallow breathing, but was soon awakened. He went to his mother, who rushed him to the hospital.
Tests revealed abnormalities. Aiden was taken to the acute cardiac unit, where more tests confirmed that the vaccine was the cause. Aiden spent four days in the hospital. After being discharged, he was inactive for more than four months.
"I don't know where they get this 'two days and you're done, you're good.' That's a crock of [expletive]," Emily Ekanayake, Aiden's mother, told The Epoch Times.
Ms. Ekanayake had read early studies from Israel that found an elevated risk for myocarditis among young males who had received the Pfizer vaccine, but concluded with her son that the benefits of the vaccine outweighed the risks. "I was really scared of COVID," Ms. Ekanayake said.
Aiden said he wanted to get vaccinated to help protect himself and his brother, both of whom have asthma.
Aiden's doctor also recommended the shot. Shortly before Aiden was vaccinated, the CDC director said the agency found no safety signal for myocarditis. U.S. officials cleared and recommended the vaccine to virtually all children aged 12 to 15, after initially only making it available to those 16 and older.
Aiden eventually resumed exercise after being cleared by a cardiopulmonary stress test.
The result of the test was "probably more like that of an old man," Ms. Ekanayake said. "His CO2 was low. He wasn't able to run much. He's got a lot of work in that way to go still. But he does like walking.
"I still worry about strenuous activity. I can't help it. I don't know that that will ever go away."
More here:
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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)
http://jonjayray.com/blogall.html More blogs
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Friday, September 22, 2023
Another Friday Hiatus
I have had a busy day today so not much time for blogging. Will be back on Sunday.
My health is slowly improving
Note that I have recently done a substantial update to my big article on the nature of conservatism. Some interesting new reading there I hope. Find the article here:
http://jonjayray.com/rightism.html
Thursday, September 21, 2023
Breakthrough Infections and the elderly
A breakthrough infection is when a vaccinated person still gets the disease. Study suggests that the elderly are LESS affected by breakthrough infections. The study authors were Chinese but their data was international, not Chinese
Published in the journal of Infectious Disease by Jing et al., “SARS-CoV-2 vaccine breakthrough infection in the older adults: a meta-analysis and systematic review,” as the durability challenges of the COVID-19 vaccines lead to waning vaccine effectiveness, associated breakthrough infections tend to rise.
The study authors, affiliated with the Tianjin University of Traditional Chinese Medicine in the northern coastal metropolis of about 14 million people, come to the bombshell conclusion contrary to popular understanding: elderly persons face far less risk for breakthrough infection than is popularly understood, and that the risk of severe COVID-19, hospitalization and death due to breakthrough infection remains perhaps even lower risk than for breakthrough infection alone.
Do these findings alter the risk-benefit calculus for vaccination? Could these results be because of vaccination or natural Immunity? These are important questions. While TrialSite doesn’t anticipate that this important meta-analysis will be picked up by mainstream press in the West the outcomes, limitations aside, are important for further consideration.
The study, published in BMC infectious Diseases and represented by corresponding author Xiaohui Jing with the Tianjin University of Traditional Chinese Medicine in Tianjin, China raises significant questions. Much of the data generated by U.S. public health sources points to far more COVID-19 risk associated with older individuals. Yet this study out of China points to an opposite conclusion.
The Study
Designed as a systematic review or meta-analysis, from November 2, 2022, the study team reviewed 30 studies published across English language journal platforms from PubMed and Embase to Cochrane Library and Web of Science. Employing the use of a random-effects model the team calculated pooled estimates of the prevalence and occurrences of COVID-19 breakthrough infections in elderly persons.
Mindful of the influence of bias, the study team employed use of funnel plots, Egger’s regression test, as well as sensitivity analyses while following standard guidelines for this class of study-- Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA).
The Results
The study authors report across 30 publications reveals a pool prevalence of COVID-19 breakthrough infection among the elderly at 7.7 per 1,000 individuals (95% CI, 4.0-15.0), with pooled incidence equaling 29.1 per 1000 person-years (95%CI 15.2–55.7).
The China-based researchers take away from their meta-analysis that the prevalence and incidence of SARS-CoV-19 breakthrough infection in older adults was low. But more eye opening was the finding associated with the risk of hospitalization, severe disease and death associated with the elderly and breakthrough infections, which was even lower than the risk of breakthrough infection.
Study Limitations
Jing and colleagues disclosure a handful of limitations including 1) study data restricted to publications in English, 2) the inclusion of studies with a sample size greater than 500 may result in the loss of small eligible studies; 3) Lots of heterogeneity was observed in the included studies; 4) most of the studies included in this study were observed within six months of vaccination; 5) some studies provided little information about the potential influencing factors such as vaccine type, vaccine dose, gender, prior infection, time from vaccination to breakthrough infection, comorbidity, and lifestyle of the included older adults on the prevalence and incidence of COVID-19 breakthrough infection and finally 6) It was also impossible to conduct meta-analyses among some groups due to the less information from studies assessing those factors. Clearly more research is required.
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Supreme Court Issues Pause on Banning Biden Administration from Contacting Social Media Platforms
In early September, a federal appeals court in New Orleans ruled that the White House, the Federal Bureau of Investigation (FBI) and social media companies to remove content or posts the Biden administration considers to be misinformation. This included posts about COVID-19.
The court ruled the government had most likely overstepped the First Amendment by urging major social platforms to remove the content the Biden administration thought was misleading.
The decision came down from a three-judge panel for the Fifth Circuit in New Orleans, ruling that the White House and the Surgeon General had “coerced the platforms to make their moderation decisions by way of intimidating messages and threats of adverse consequences” and “significantly encouraged the platforms’ decisions by commandeering their decision-making processes.” The court also found the FBI used coercion in its interactions with the social media companies which took down 50% of the online posts the bureau’s agents deemed “troublesome”.
A theme generally considered to be a pattern during COVID-19: that the Biden administration was directly, or indirectly censoring Americans, attacking any critical voices not concurring with the standard pandemic narrative.
The New Orleans panel upheld a decision by a lower court judge declaring that the government pressured Facebook, Google, X (Twitter) and YouTube into censoring posts related to COVID-19 and allegations of election fraud.
But the Fifth Circuit judges also put a 10-day injunction, or hold, on the lower court’s ruling in order to give the Justice Department, which is defending the Biden administration, a chance to appeal to the Supreme Court. And, last week the highest court in the land responded.
Temporary Hold
Last Thursday, the U.S. Supreme Court temporarily put on hold an order restricting the ability of President Joe Biden's administration to encourage social media companies to remove content it considers misleading, including about the Covid-19 pandemic. The order was issued by Conservative Supreme Court Justice Samuel Alito, and it pauses the lower court ruling until September 22.
In their filing against the lower court ruling, the Justice Department said, “The court cited no precedent for that boundless theory, which would allow any state or local government to challenge any alleged violation of any constituent’s right to speak.” Additionally, the Justice Department said, “The Fifth Circuit’s decision contradicts fundamental First Amendment principles. It is axiomatic that the government is entitled to provide the public with information and to ‘advocate and defend its own policies.’”
Missouri AG Plans to Oppose Appeal
A spokesperson for Missouri Attorney General Andrew Baily said he plans to oppose the administration's Supreme Court appeal. "We are rooting out this censorship enterprise and will hold any wrongdoers accountable," Bailey said in a statement. Missouri and Louisiana were the original plaintiff’s in the lawsuit claiming the administration threatened the social media platforms with antitrust enforcement and reforms to tech platforms’ liability shield, known as Section 230 of the Communications Decency Act, if they didn’t comply with the government’s takedown requests.
The Justice Department said there was no coercion beyond the private and public appeals to companies by officials. “Rather than any pattern of coercive threats backed by sanctions, the record reflects a back-and-forth in which the government and platforms often shared goals and worked together, sometimes disagreed, and occasionally became frustrated with one another, as all parties articulated and pursued their own goals and interests during an unprecedented pandemic,” the Department of Justice said in their filing.
TrialSite’s main news website, on the topic of censorship has experienced continuous problems, not directly because the website is independent, but indirectly as groups such as News Guard have attempted to challenge content, all clearly labeled as opinion, on the TrialSite platform.
Also, TrialSite content has been censored on social media platforms such as YouTube. For example, a documentary about Ivermectin, balanced, objective and not taking any sides, was deleted by the subsidiary of Google. Another example when the nation of Slovakia authorized on an emergency basis the use of ivermectin during the COVID-19 pandemic, Facebook deleted the TrialSite post even though the article was based on a formal government ruling. It was as if facts didn’t matter.
Censorship is alive and well in America during the age of COVID-19.
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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)
http://jonjayray.com/blogall.html More blogs
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Wednesday, September 20, 2023
Eris (E.G5) –The Current Variant of Interest
The new SARS-CoV-2 subvariant EG.5, also called Eris, is responsible for the increase in COVID-19 infections and is currently causing concern. The Centers for Disease Control and Prevention (CDC) estimates that about 24.5% of the total number of cases in the United States reported from Feb 2023 up until September 2023 are due to EG.5. Researchers are trying to update the COVID-19 vaccines to target the new variants. TrialSite previously reported on the World Health Organization’s (WHO) concerns about this strain.
Eris is a sub-variant of the Omicron variant. The first case of EG.5 was reported on Feb 17, 2023. Similar to other variants, it shows symptoms like fever, nausea, headache, sore throat, etc. It also demonstrates high transmissibility, which is concerning for researchers. Additionally, the variant can evade the immune response generated by antibodies that were developed either by vaccination or previous infection with other variants.
How concerning is this new variant?
EG.5 has one mutation in its spike protein that makes it different from the Omicron variant. This genetic change helps it to escape the immune response, which makes it more contagious. The World Health Organization (WHO) has declared it a “variant of interest” which means there is a need to focus on it because its transmissibility may cause a rapid increase in hospitalization.
Stanley Martin, MD., the Director of Infectious Diseases at Geisinger Medical Centre said that there is no need to worry about this variant unless you are above 65 or immunocompromised. However, you should be aware of this variant and take precautionary measures if you live around immunocompromised or elderly people because there is a risk of passing this variant on to them.
Dr. Brett Osborn, a board-certified neurosurgeon, said that in most cases, it is a self-limiting variant, so there is nothing to be concerned about.
Will the updated vaccine protect against EG.5?
There is currently no specific vaccine against EG.5; however, an updated version of the COVID-19 vaccine is expected to be released in September 2023. The vaccine manufacturing companies Pfizer/BioNTech, Moderna and Novavax are creating COVID-19 booster vaccines that will target XBB.1.5 (a subvariant of Omicron), but they expect that this booster will also provide some level of protection against EG.5 because they are closely related strains. The U.S. Food and Drug Administration (FDA) has recommended these booster vaccines and explained that they will continue to monitor the safety and effectiveness of COVID-19 vaccines. Anyone above the age of two is eligible for this booster vaccine.
Moderna’s clinical trials have confirmed that the booster vaccine will effectively target EG.5 and FL.1.5.1 (another subvariant of Omicron). The antiviral medicine, Paxlovid, also provides protection and works well against EG.5.
Experts' opinions on COVID-19 variants and vaccines
Osborn said that SARS-CoV-2 and its variants are here to stay, and we have to live with them because their mutation rate is high, like the influenza virus. Mostly, RNA viruses (those containing RNA as genetic material) become less harmful with time and pose less threat to lives, but there is also a chance that one of the strains will become virulent, which may lead to an increase in the death rate.
Scott Roberts, MD, an infectious diseases specialist, said that the vaccine takes about three months to provide high efficacy. The people who get vaccinated immediately after the vaccine release in September will have the maximum protection in the upcoming year.
Updated vaccine or booster shot?
The FDA and other health authorities have shifted in language from “booster” to “updated COVID-19 vaccine” because the booster only reinforces the immunity obtained from the previous vaccines, while the updated COVID-19 vaccine is designed to induce a new immune response against the existing variants. The term “updated COVID-19 vaccine” helps to normalize the idea of getting the COVID-19 vaccine on a regular basis, just like annual flu shots.
Bottom line
The current death rate associated with the Eris variant appears low. On the other hand, since many medical experts are warning the public about its high contagiousness, preventive measures such as mask-wearing, handwashing and maintaining appropriate distance remain important.
Current evidence suggests that updated COVID-19 booster shots can be an effective tool for prevention, especially for high-risk people such as the elderly or those suffering from severe health conditions. Still, vaccine hesitancy might affect the vaccination rates. This emphasizes the importance of transparent sharing of information with the public about COVID-19 vaccines.
https://www.trialsitenews.com/a/eris-e.g5-the-current-variant-of-interest-7e43740f
*************************************************Viral RNA Can Persist for 2 Years After COVID-19: Preprint Study
A new study may explain why some people who get COVID-19 never return to normal and instead experience new medical conditions like cardiovascular disease, clotting dysfunction, activation of latent viruses, diabetes mellitus, or what’s known as “long COVID” after SARS-CoV-2 infection.
In a recent preprint study published on medRxiv, researchers conducted the first positron emission tomography (PET) imaging study of T cell activation in individuals who previously recovered from COVID-19 and found that SARS-CoV-2 infection may result in persistent T cell activation in a variety of body tissues for years following initial symptoms.
Even in clinically mild cases of COVID-19, this phenomenon could explain the systemic changes observed in the immune system and in those with long COVID symptoms.
However, most of the participants were vaccinated and the study didn't investigate the link between the existence of viral RNA and vaccination.
To carry out the study, researchers conducted whole-body PET scans of 24 participants who were previously infected with SARS-CoV-2 and recovered from acute infection at time points ranging from 27 to 910 days following COVID-19 symptom onset.
A PET scan is an imaging test that uses a radioactive drug called a tracer to assess the metabolic or biochemical function of tissues and organs and can reveal both normal and abnormal metabolic activity. The tracer is usually injected into the hand or vein in the arm and collects in areas of the body with higher levels of metabolic or biochemical activity, which can reveal the location of the disease.
Using a novel radiopharmaceutical agent that detects specific molecules associated with a type of white blood cell called T lymphocytes, researchers found uptake of the tracer was significantly higher in post-acute COVID-19 participants compared to pre-pandemic controls in the brain stem, spinal cord, bone marrow, nasopharyngeal and hilar lymphoid tissue, cardiopulmonary tissues, and gut wall. Among males and females, male participants tended to have higher uptake in the pharyngeal tonsils, rectal wall, and hilar lymphoid tissue compared to female participants.
Researchers specifically identified cellular SARS-CoV-2 RNA in the gut tissue of all participants with long COVID symptoms who underwent biopsy—in the absence of reinfection—ranging from 158 to 676 days following initial COVID-19 illness, suggesting that tissue viral persistence could be associated with long-term immunological concerns. Although the uptake of the tracer in some tissues appeared to decline with time, the levels still remained elevated compared to the control group of healthy pre-pandemic volunteers.
"These data significantly extend prior observations of a durable and dysfunctional cellular immune response to SARS-CoV-2 and suggest that SARS-CoV-2 infection could result in a new immunologic steady state in the years following COVID-19," the researchers wrote.
To determine the association between T cell activation and long COVID symptoms, researchers compared post-acute COVID-19 participants with and without long COVID symptoms at the time of PET imaging. Those with long COVID symptoms reported a median of 5.5 symptoms at the time of imaging. Findings showed a “modestly higher uptake” of the agent in the spinal cord, hilar lymph nodes, and colon/rectal wall in those with long COVID symptoms.
In participants with long COVID who reported five or more symptoms at the time of imaging, researchers observed higher levels of inflammatory markers, “including proteins involved in immune responses, chemokine signaling, inflammation responses, and nervous system development.” Compared to both pre-pandemic controls and those participants who had COVID-19 and completely recovered, people with long COVID showed higher T cell activation in the spinal cord and gut wall.
All But 1 Participant Was Vaccinated
Researchers attribute their findings to SARS-CoV-2 infection, although all but one participant had received at least one COVID-19 vaccination prior to PET imaging.
To minimize the impact of vaccination on T cell activation, PET imaging was performed more than 60 days from any vaccine dose, except for the one participant who received a booster vaccine dose six days prior to imaging. Others who had received a COVID-19 vaccine within four weeks of imaging were excluded.
Researchers also grouped participants by receipt of a COVID-19 dose greater than or less than 180 days prior to PET imaging.
The researchers said their study had several other limitations, including small sample size, limited correlative studies, evolving variants, rapid and inconsistent rollout of COVID-19 vaccines, which required them to shift their imaging protocols, using pre-pandemic individuals as controls, and the extreme difficulty of finding people who had never been infected with SARS-CoV-2.
"In summary, our results provide provocative evidence of long-term immune system activation in several specific tissues following SARS-CoV-2 infection, including in those experiencing Long COVID symptoms," the researchers concluded. "We identified that SARS-CoV-2 persistence is one potential driver of this ongoing activated immune state, and we show that SARS-CoV-2 RNA may persist in gut tissue for nearly 2 years after the initial infection."
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CDC Director Responds to COVID-19 Mask Mandate Speculation
The director of the U.S. Centers for Disease Control and Prevention (CDC) responded to speculation that COVID-19-related mask mandates or lockdowns could return, coming after the agency recommended new vaccine boosters for nearly all Americans.
CDC Director Mandy Cohen was asked on Sept. 12 whether she feels confident that there won't be widespread lockdowns, school closures, and a reversion to mask mandates.
"Right now, we have all the tools we need to keep this virus at bay if we use the vaccines and we use testing and treatment," Ms. Cohen told WCNC, a Charlotte, North Carolina, TV station.
"What I see is I don’t see any need for mandates or those kinds of things right now. But we have to keep watching this virus, seeing how it changes, and if we need to make other recommendations, we will," the CDC head said.
Her comment comes as the CDC issued a recommendation that people should receive the updated COVID-19 booster shot that targets the XBB1.5 subvariant. The U.S. Food and Drug Administration similarly authorized and approved the new mRNA-based shots, made by Pfizer and Moderna.
Meanwhile, since mid-August, there has been widespread speculation that the CDC and other federal agencies may attempt to recommend or push lockdowns, vaccine mandates, or masking mandates because of a small upswing in COVID-19 cases across the United States. A small number of schools, colleges, hospitals, and private businesses have implemented masking mandates, sparking alarm among some GOP officials and candidates.
CDC Advisory Committee on Immunization Practices Meet on COVID-19 and Vaccines
Several weeks ago, meanwhile, the Transportation Security Administration told The Epoch Times that claims that the agency held discussions that it would be reimplementing mandates or lockdowns are incorrect. Meanwhile, a spokesman for the CDC told the Associated Press around the same time that reports of pending lockdowns are "utterly false."
When asked by The Epoch Times about discussions around a possible federal mask mandate recommendation, a spokesperson said late last month that COVID-19 hospital admission levels "are currently low for 96 percent" of the United States. A separate spokesperson told other outlets that there were no agency discussions about bringing mask mandates back, and no new masking guidelines have been issued on the CDC's website in recent days.
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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)
http://jonjayray.com/blogall.html More blogs
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Tuesday, September 19, 2023
Myocarditis and COVID-19 Vaccines: How the CDC Missed a Safety Signal and Hid a Warning
Even after deaths from myocarditis—inflammation of the heart—were reported and myocarditis was designated as a likely side effect of the shots, U.S. officials kept recommending vaccination for virtually the entire populace.
That led to millions of young people receiving a vaccine.
Many of those people suffered.
Aiden Ekanayake, 14, was one of them. He received a dose of the Pfizer-BioNTech vaccine in May 2021, and a second dose in June 2021.
Two days after the second dose, Aiden was woken in the middle of the night with pain that was comparable to when he tore his anterior cruciate ligament. His mother, Emily, rushed him to the hospital, where he spent days receiving care. Even after he was discharged, his exercise was limited for more than four months.
Ms. Ekanayake trusted the U.S. Centers for Disease Control and Prevention (CDC) before the experience. Now, she does not. "I hate them. I think they're evil," Ms. Ekanayake told The Epoch Times.
No Transparency
The CDC, America's public health agency, was warned by Israel on Feb. 28, 2021, about a "large number" of myocarditis cases after Pfizer COVID-19 vaccination, documents obtained by The Epoch Times show.
Internally, the warning was designated as "high" importance and set off a review of U.S. data. The review found 27 reported cases in the United States, according to a U.S. government memorandum dated March 9, 2021. The incidence rate was low, but "missing and incomplete data make it challenging to assess causation," the memo stated. The U.S. Food and Drug Administration (FDA), it said, "has not made a final determination regarding the causality."
Weeks later, neither the CDC nor the FDA had alerted the public to the issue, even after the death of a previously healthy 22-year-old Israeli woman and briefings from Israeli officials and U.S. Department of Defense (DOD) researchers.
Like Israel, the DOD was recording a higher-than-expected number of myocarditis cases. Patients were mostly young, healthy males.
The CDC met with military officials twice behind closed doors in April 2021. Military officials presented data during at least one of the meetings to the CDC. That presentation, which has never been released to the public, "included our preliminary patient data and analysis that suggested to us that myocarditis was indeed a possible side effect to the messenger RNA COVID-19 vaccines (within the US military)," Dr. Jay Montgomery, one of the presenters, told The Epoch Times via email.
The Pfizer and Moderna vaccines use messenger RNA (mRNA).
On April 27, 2021, after the meetings, then-CDC Director Dr. Rochelle Walensky finally spoke about the matter in public, during a White House briefing.
Dr. Walensky said "we have not seen any reports" of myocarditis after vaccination. That's false, according to CDC data—the agency received 141 reports of myocarditis in the Vaccine Adverse Event Reporting System (VAERS) by the end of March 2021. Another 24 cases were recorded in the Vaccine Safety Datalink, a second system run by the CDC.
Additionally, before the briefing, Dr. Walensky was copied on multiple threads discussing myocarditis and a related condition, pericarditis, including a thread about doctors in California seeing the cases, internal emails obtained by The Epoch Times show. She responded to one of the threads, saying the information was "super helpful."
"We have not seen a [safety] signal," Dr. Walensky also told reporters during the briefing, "and we’ve actually looked intentionally for the signal in the over 200 million doses we’ve given."
The CDC and FDA are supposed to monitor data from VAERS, which officials have described as the country's "early warning system" for possible vaccine problems. But they failed to detect a safety signal for myocarditis after COVID-19 vaccination that triggered on Feb. 18, 2021, when using a statistical analysis method called Proportional Reporting Ratio (PRR), according to archived VAERS data from the National Vaccine Information Center, The Epoch Times confirmed.
The CDC initially said it started running PRRs in February 2021, but later acknowledged that was false. The agency now says it did not start PRRs until 2022. The first time the CDC ran complete PRRs, officials detected a signal for myocarditis, according to files obtained by The Epoch Times.
"It's unimaginable that they wouldn't have seen the signal," Brian Hooker, senior director of science and research at Children's Health Defense, who detected an early signal for myocarditis in VAERS using a different method, told The Epoch Times. "They were alerted by the DOD. They were alerted by the Israeli Ministry of Health. And so, if they just didn't know then, they have absolutely no excuse because they were warned."
Children's Health Defense, a nonprofit that says its mission is to end childhood health epidemics, first obtained the emails between Israel and the CDC.
Dr. Walensky, who has since departed the CDC, has not responded to a request for comment about her myocarditis claims.
A CDC spokesperson told The Epoch Times via email: "CDC has been continuously monitoring the safety of COVID-19 vaccines since they began to be administered in the United States. At the time of the director’s press conference, CDC did not have sufficient evidence to conclude there was a safety signal for myocarditis following mRNA COVID-19 vaccination."
The CDC has said it did not run PRRs in 2021 because officials were relying on a different analytic method, called Empirical Bayesian data mining. It's unclear when that method, utilized by the FDA, first detected a signal for myocarditis. The FDA has declined to answer questions on the matter. The CDC has told The Epoch Times that its 2022 detection of a signal for myocarditis using PRRs was "consistent with" the data mining results.
Both the CDC and FDA use contractors to process VAERS data.
"Even FDA doesn't really know the mechanics of how its contractor does the data mining," one CDC official said in an email obtained by The Epoch Times. The official and the FDA did not respond to requests for comment on the email.
A safety signal is a sign that an adverse event may be caused by a vaccine. Authorities say signals can only be substantiated with further research.
"Once the safety signal comes up, why not start warning the public about the fact that' hey, you can take it if you want, but understand that there is this risk that we have discovered and we are looking into it," Dr. Anish Koka, an American cardiologist, told The Epoch Times.
One possible motivation for not fully examining the issue was that it could have led to a halt in vaccination. The CDC and FDA essentially imposed a pause on Johnson & Johnson's shot on April 13, 2021, after a small number of blood clotting cases.
"A pause of the Pfizer/Moderna administration (much like the J&J blood clot pause) will have an adverse impact on US/CA vaccination rates," one military official said in a message obtained by The Epoch Times that was flagged for top CDC officials.
Between February 2021 and May 2021, the percentage of the U.S. population that had received a COVID-19 vaccine soared from 14.2 percent to 50.5 percent.
"It was most likely a strategic move in order to make sure that they didn't curtail vaccination rates," Mr. Hooker said.
"Due to the large number of reports that we are receiving at this time, processing is taking longer than usual," one official said. The message was sent to a woman who said she'd filed a VAERS report for her son's myocarditis on April 21 but that the report had still not appeared in the system days later.
Elaine Miller, a CDC official, wrote around the same time that there were "processing delays" for VAERS reports.
One of the contractors used by the CDC estimated before the vaccines were rolled out that no more than 1,000 reports would be filed per day. The number soared above that estimate by the end of 2020, internal documents obtained by The Epoch Times show.
Workers for the contractor, General Dynamics Information Technology, increased the speed at which they processed but were "unable to keep up with the increased surge in reports at current staffing levels," the contractor informed the CDC in one message.
The backlog increased to nearly 94,000 reports even after the contractor hired nearly 300 additional staff members.
Dr. Adam Hirschfeld, 36, of Ohio, submitted a report to VAERS soon after suffering myocarditis following COVID-19 vaccination in January 2021. It took months for the CDC to respond to him. "I could have been dead by then," Dr. Hirschfeld told The Epoch Times.
Health care providers who administer COVID-19 vaccines are required to report serious adverse events, including all cases of myocarditis, to VAERS.
But not all doctors were following the rules, other emails show.
"Providers aren't reporting these cases to VAERS," Dr. John Su, one of the CDC's top vaccine safety officials, wrote to colleagues on May 17, 2021. He also wrote that the "myocarditis thing" was "exploding."
CDC officials, in correspondence with officials in Washington state, said around the same time that nine post-vaccination myocarditis cases had not been reported to VAERS.
The backlog was eventually cleared. VAERS data show that 146 cases of myocarditis or pericarditis were reported by the end of March 2021. An additional 158 cases were reported in April 2021 and 487 more were entered in May 2021.
Just a third of the cases reported to VAERS through April 26, 2021, were fully processed as of May 3, 2021, according to an internal presentation.
In addition to Dr. Walensky's false claim, the CDC has falsely told other health officials and media outlets that it did not receive any reports until May or June 2021, internal emails show.
Another CDC vaccine safety monitoring system, V-safe, did not include myocarditis despite the CDC and FDA identifying the heart inflammation as an adverse event of special interest, or a possible side effect, for the COVID-19 vaccines before they were authorized. The Vaccine Safety Datalink did include myocarditis but did not detect a signal until 2022, possibly because it was using a too-narrow case definition. A fourth system, run by the FDA and partners like CVS, detected a signal in 2023.
Cases Started in January
Doctors started seeing postvaccination myocarditis cases in January 2021, months before the public was informed about them.
The U.S. military researchers, for instance, detailed in a paper that 22 previously healthy service members suffered from myocarditis after vaccination as early as January 2021.
Seventeen cases happened in January 2021 alone in Israel, Israeli researchers reported in another study.
Dr. Dror Mevorach, a co-author of the paper, said he tried warning Pfizer of the possible link between myocarditis and its shot.
"They refused to believe me for a period of four months," Dr. Mevorach told Haaretz. Pfizer did not respond to a request for comment.
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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)
http://jonjayray.com/blogall.html More blogs
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Monday, September 18, 2023
FDA Has 'Gone Rogue' in Its Approval of New COVID-19 Boosters: Dr. Robert Malone
The Food and Drug Administration (FDA) has "gone rogue," according to virologist Dr. Robert Malone, who accused the federal agency of sacrificing its own rules and regulations with its decision to recommend the latest batch of COVID-19 boosters, which only have limited clinical trial data attesting to their efficacy and safety.
Dr. Malone made the remarks in an interview with EpochTV's "Crossroads" program on Sept. 11, the day that the FDA cleared new COVID-19 vaccines in a bid to counter the waning effectiveness of the currently available shots.
"It's difficult to conclude anything other than the FDA is no longer feeling bound by their own rules and regulations," Dr. Malone said. "The term is—they've gone rogue."
Dr. Malone objected to the lack of clinical trial data on humans demonstrating effectiveness and safety of the updated vaccines, arguing that should preclude their approval by the FDA.
He said that, essentially, the FDA allowing the new vaccines to be used under an emergency use authorization on the premise that “neutralizing antibodies as detected in mice and their cross-reactivity are a correlative protection—That's a lie. There are no established correlates of protection for SARS-CoV-2."
FDA officials didn't respond by press time to a request by The Epoch Times for comment.
However, in a statement announcing its approval, the FDA said that the decision was supported by its evaluation of "manufacturing data" from vaccine producers and "non-clinical immune response data on the updated formulations including the XBB.1.5 component."
The benefit-risk profile of previously approved mRNA COVID-19 vaccines is "well understood," the FDA said, adding that the similar manufacturing process for the updated vaccines "suggests that the vaccines are a good match for protecting against the currently circulating COVID-19 variants."
Advisers to the Centers for Disease Control and Prevention (CDC) followed with their own recommendation on Sept. 12, urging nearly all Americans to get the new vaccines, which will be available to children as young as 6 months old this month.
The new vaccines target XBB.1.5, a sub-type of the Omicron variant of the SARS-CoV-2 virus, which causes the disease COVID-19. However, the XBB.1.5. subvariant has already largely been displaced by newer strains of the quickly evolving virus, including EG.5, according to the CDC.
"There's essentially no data," Florida Surgeon General Dr. Joseph Ladapo said at a recent news conference, where he suggested that people might be better off passing on the new round of shots.
"Not only that, but there are a lot of red flags," Dr. Ladapo added, while pointing to studies finding that the effectiveness of the vaccines turns negative over time.
“There's been no clinical trial done in human beings showing that it benefits people, there's been no clinical trial showing that it is a safe product for people."
He also noted that studies have linked previous versions of the COVID-19 vaccine to cardiac problems such as heart inflammation.
"It's truly irresponsible for FDA, CDC, and others to be championing something ... when we don't know the implications of it," Dr. Ladapo said.
While acknowledging the current vaccines' waning effectiveness, CDC Director Mandy Cohen penned an op-ed in The New York Times on Sept. 13, in which she called the updated COVID-19 vaccines "one of the most effective tools in combating the virus."
"Covid-19 vaccines are the best way to give the body the ability to keep the virus from causing significant harm. Extensive studies and real-world experience have shown that they are safe and they work," she wrote. "And most Americans take them."
Dr. Cohen said the vaccines were put through extensive clinical trials before they were introduced in 2021 and "since then, their safety has been intensely monitored."
She didn't address criticism, such as that the updated vaccines haven't been subjected to clinical trials.
In its green-light statement, the FDA said it's "confident in the safety and effectiveness of these updated vaccines and the agency's benefit-risk assessment demonstrates that the benefits of these vaccines for individuals 6 months of age and older outweigh their risks."
That FDA endorsement, however, stands in contrast to remarks made by Dr. Paul Offit, an FDA adviser, who suggested to the UK's Daily Mail that younger, healthy people who have already been vaccinated don't need one of the new doses.
"We are best served by targeting these booster doses to those who are most at risk of severe disease," such as people older than 75, Dr. Offit said. "Boosting otherwise healthy young people is a low-risk, low-reward strategy."
In his remarks at the news conference, Dr. Ladapo asked people to make decisions based on their “resonance of truth” rather than depending on “very educated people telling you what you should think.”
“When they try to convince you to be comfortable and agree with things that don't feel comfortable and don't feel like things you should agree with, that's a sign ... And I encourage you and certainly beg and hope that you do listen to it, because it will serve you right,” he said.
A January–July 2023 study that analyzed data from 33 California state prisons found that individuals who received new COVID-19 booster shots were more likely to contract COVID-19 compared to those who didn't receive the jabs.
The infection rate among the group that received the bivalent booster shots came in at 3.2 percent—higher than the 2.7 percent among the unvaccinated.
Late last month, the CDC conceded that the new BA.2.86 strain can cause infection even among people who have previously been vaccinated against COVID-19.
“The large number of mutations in this variant raises concerns of greater escape from existing immunity from vaccines and previous infections compared with other recent variants,” the agency said in its assessment.
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Dr. Marty Makary Weighs in on the New COVID Vaccines Biden Is Pushing
Dr. Marty Makary — a rare voice of reason and sanity throughout the COVID-19 pandemic — is out with a review of the "real data" behind the new vaccines being pushed by the Biden administration and Democrat leaders around the country.
Makary, along with Dr. Tracy Høeg, open their analysis of the new vaccines Biden & Co. are pushing for Americans as young as six months old with an alarming scenario that's anything but hypothetical.
What if I told you one in 50 people who took a new medication had a 'medically attended adverse event' and the manufacturer refused to disclose what exactly the complication was — would you take it?
And what if the theoretical benefit was only transient, lasting about three months, after which your susceptibility goes back to baseline?
And what if we told you the Food and Drug Administration cleared it without any human-outcomes data and European regulators are not universally recommending it as the Centers for Disease Control and Prevention is?
Writing in The New York Post, Makary and Høeg say that's all scientists know about the new vaccines from Pfizer and Moderna that are being more than recommended by the Biden administration.
"The push is so hard that former White House COVID coordinator Dr. Ashish Jha and CDC head Mandy Cohen are making unsupported claims the new vaccine reduces hospitalizations. long COVID and the likelihood you will spread COVID," the doctors' analysis explains. "None of those claims has a shred of scientific support," and "if the manufacturers said that, they could be fined for making false marketing claims beyond an FDA-approved indication."
Yet, the Biden administration is plunging ahead with another push to drive up the use of these new vaccines, a push that blows past what The Science™ says or The Experts™ have concluded.
"The questions surrounding Moderna’s new COVID vaccine approved this week are still looming," Makary and Høeg say of the reality being ignored by the White House. "Pfizer’s version, approved this week as well, also has zero efficacy data and has not been tested on humans at all," they note. "We only have data about antibody production from 10 mice."
Does the Biden administration view the American people as any better than lab rats? It seems not based on this situation.
What's more, the doctors note that neither the FDA nor Moderna have disclosed "what happened to the patient who took the new vaccine and had a complication that required medical attention."
Were there contributing factors to the complication? How serious was it? Are there any long term effects from the complication?
None of these answers have or are likely to come from the Biden administration in their push to get the new vaccine administered far and wide. Why even have regulators if they are apparently unwilling to scrutinize the things they approve?
Despite the White House's refusal to give Americans the full, honest picture, Makary and Høeg are among those reminding America's leaders that "[t]he public has a right to know." Indeed.
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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)
http://jonjayray.com/blogall.html More blogs
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