Tuesday, July 18, 2023
COVID-19 mRNA Vaccine Impacts on Menstrual Cycles—The Unfolding Science
A recent study led by researchers at Boston University (BU) looked into the impact of COVID-19 vaccines on menstrual cycles.The researchers sought to better understand what have been many anecdotal reports that vaccines were changing women’s periods. Reports of cycles arriving earlier with heavier bleeding were relatively commonplace. Interestingly, the recent study results represented by corresponding author Amelia Wesselink, Ph.D., MPH Department of Epidemiology, BU’s School of Public Health reported that indeed, there can be observed changes in menstrual cycle, however, such changes are likely not the fault of the COVID-19 vaccines but rather the result of individual’s immune system reacting to the vaccine.
Yet this very answer implies an impact of the vaccine. What do other studies suggest? The overall data ranges but generally, point to some impact of COVID-19 vaccination on menstrual cycle, at least temporarily. Of course, long term study data is needed.
In an underlying prospective cohort study, the BU-led researchers found one-day average delay I menses plus a higher incidence of long menstrual cycles post COVID-19 vaccination. However, these deviations mostly were resolved by the next menstrual cycle. The study team argued, “Other menstrual cycle characteristics, including cycle regularity, bleed length, heaviness of bleed and menstrual pain, were not strongly associated with COVID-19 vaccination.”
What are the findings of another research?
TrialSite has covered the topic as objectively as possible, chronicling several studies involving menstrual cycles and COVID-19 vaccines. For example, a retrospective study published in the journal Women’s Health found some interesting results. Led by Maria Christina Martinez-Avila, a clinical epidemiologist at the BIOTOXAM Research Group, University of Cartagena, the team conducted via survey across targeted social networks. The Columbian investigators queried 950 women in the 18–41-year age range between July and September 2021, to better understand the impact of COVID-19 vaccination on menstrual cycles. Ultimately, 408 of the subjects met the inclusion criteria. The study authors concluded that “SARS-CoV-2 infection and COVID-19 vaccination can influence the menstrual cycle and cause alterations.” This class of study comes with limitations.
In another piece in 2021, TrialSite surveyed unfolding reports of menstrual cycle issues possibly linked to the COVID-19 vaccines.
In the heavily vaccinated Mediterranean nation social media was abuzz during 2021, with women sharing their experiences, ranging from irregularity to unusual amounts of bleeding. In other cases, postmenopausal women report bleeding. At the same time, medical establishment experts cannot explain the observations or even link such a phenomenon to the jabs, perhaps in part, because these observations could be associated with any number of other causes.
Regardless of the ever-growing number of complaints after vaccination by 2021, clinical investigators sought to study the situation in more detail. For example, the American government has put $1.76 million to study the subject in a study led by Johns Hopkins University’s Mostafa Borahay, M.D., Ph.D., associate professor of gynecology and obstetrics at Johns Hopkins University School of Medicine. In Israel, chairman of the Israel Society of Obstetrics and Gynecology, Professor Roni Maimon of Shamir Medical Center, initiates Israel’s first investigation into the matter.
By early 2022, another major National Institutes of Health (NIH) funded study sponsored by Oregon Health and Science University (OHSU) and led by Dr. Alison Edelman, a professor of obstetrics and gynecology, demonstrated that COVID-19 vaccination can cause changes to the timing of menstruation. A survey conducted by anthropologists found numerous reports of unusually heavy flows and even breakthrough bleeding among some people who hadn't menstruated in years. However, the results of the study also show the effects are temporary.
By quarter one 2023, Dr. Peter McCullough reported that according to the “EVA Project,” 78% of participating women reported at least some menstrual changes post COVID-19 vaccination. In regard to both the Pfizer-BioNTech and Moderna vaccines, McCullough wrote, “Both forms of the vaccine use lipid nanoparticles which for years have been known to be taken up by reproductive glands (ovaries and testes) and dump their payload of genetic code for the WIV BA4/BA5 Spike protein which starts producing the tissue damaging Spike within an hour .” The mainstream fact checkers would label this “misinformation” but was it fully that?
The outspoken critic of the COVID-19 vaccines continued:
“The mRNA is now known to circulate in the bloodstream for 28 days and continues to bombard the ovaries with more mRNA throughout the ovulatory cycle. Genetic vaccines loaded on lipid nanoparticles, are almost by design as depicted by Wang et al. destined to influence ovulatory cycles, gametocyte production and viability, thus interfering with the complex and delicate reproductive cycle of human beings.”
By April 2023, TrialSite reported that even the mainstream Washington Post was allowing editorials with a critical view of the mRNA jabs. Were they impacting women’s menstrual cycles?
Arnie Mazer reported for TrialSite that in the recent editorial, Kate Clancy, a biological anthropologist and professor at the University of Illinois, wrote about how after she received her first dose of the Covid vaccine she got her period, and the bleeding was so heavy she “was swapping out overnight-strength pads every hour.”
In one TrialSite reporter’s review of possible COVID-19 vaccine side effects, Simay Bayatli shared case series involving alternations to menstrual cycles associated with the COVID-19 vaccine. Yet this evidence isn’t as strong.
In an opinion piece, Ronald Kostoff showcases the high number of menstrual issues reported in association with the COVID-19 vaccines when compared to influenza vaccine. This data was derived from the Vaccine Adverse Event Reporting System, which was designed to detect safety signals, but individual cases are often not conclusive proof as often they are not adjudicated.
A group of outspoken critics of the COVID-19 vaccines, including McCullough and women’s health physician Dr. James Thorpe and others, again used VAERS data to identify safety signals involving menstruation.
The group, criticized by the medical establishment, reported that “COVID-19 vaccines, when compared to the Influenza vaccines, are associated with a significant increase in AE with all proportional reporting ratios of > 2.0: menstrual abnormality, miscarriage, fetal chromosomal abnormalities, fetal malformation, fetal cystic hygroma, fetal cardiac disorders, fetal arrhythmia, fetal cardiac arrest, fetal vascular mal-perfusion, fetal growth abnormalities, fetal abnormal surveillance, fetal placental thrombosis, low amniotic fluid, and fetal death/stillbirth (all p values were much smaller than 0.05). When normalized by time-available, doses-given, or persons-received, all COVID-19 vaccine AE far exceed the safety signal on all recognized thresholds.”
Thorpe et al. concluded in a preprint that pregnancy and menstrual abnormalities are significantly more frequent following COVID-19 vaccinations than that of influenza vaccinations.” Again, mainstream critics would argue that self-reported cases in VAERS isn’t necessarily conclusive proof.
The Centers for Disease Control and Prevention (CDC) organized a working group looking into the matter. The VSD Menstrual Irregularities Working Group (MI-WG) protocol sought an evaluation of possible association between COVID-19 vaccination and abnormal uterine bleeding. In partnership with Kaiser Permanente, their researchers included Stephanie Irving, Tia Kauffman, Allison Naleway, Kim Vesco, Michelle Henninger while CDC VSD Site Investigators included Heather Lipkind, Malini DeSilva; and CDC Investigators included Naomi Tepper, Christine Olson and Eric Weintraub.
The CDC-sponsored investigation included “Background Reports” acknowledging that “menstrual irregularities following COVID-19 vaccine have been increasing, especially on social media platforms and in the Vaccine Adverse Event Reporting System.”
The reports prompted the National Institutes of Health (NIH) to release a Notice of Special Interest for investigating these claims. While there are a handful of publications around menstrual changes and COVID-19 infection, the conclusions range from “women should be reassured that SARS-CoV-2 has no impact on abnormal uterine bleeding (AUB) of any type including the symptoms of heavy and/or irregular menstrual bleeding” to “patients had various extents of transient menstrual changes, mainly manifesting as prolonged cycles and decreased volume.”
This research team shared a report of one study indicating 16% of female or non-binary patients with COVID-19 infection reported changes in menstruation, which correlated with a greater number of COVID-19 symptoms. See the link.
A large observational study in Sweden found that COVID-19 vaccination was not tied to an increase in hospital admissions or visits with a healthcare professional due to menstrual changes or bleeding in premenopausal women. This study included 2,946,448 Swedish participants aged 12 to 74 years.
The study team did report, “Postmenopausal women were more likely to have contact with the healthcare system because of vaginal bleeding in the months following their shot compared with when they were unvaccinated, with the highest risk after the third dose, although the associations were weak.”
“These findings do not provide substantial support for a causal association between SARS-CoV-2 vaccination and healthcare contacts related to menstrual or bleeding disorders,” the researchers wrote in The BMJ.
The EMA COVID-19 vaccine safety update identified the distinct possibility of an association of menstrual irregularities, such as heavy menstrual bleeding, to the Moderna mRNA vaccine (mRNA-1273).
Prasad S. Nishtala, Department of Life Sciences, University of Bath and colleague conducted a systematic review of safety incidence associated with COVID-19 vaccines including menstrual cycle and other related issues.
One cohort study examined reports made to V-Safe, finding that from 63,815 respondents who reported irregularities or vaginal bleeding, 41.9% received the mRNA-1273 vaccine, demonstrating a plausible link between mRNA-1273 and menstruation. See the study.
One study suggests that “many of these reports could be a case of positive rechallenging where the menstrual change has occurred after the first dose and has resumed following the second dose, indicating the possibility that the vaccine has triggered the irregularities.” See EMA report.
Prasad Nishtala and colleague reports that the study could confirm this hypothesis, meaning more monitoring is necessary.
According to another study, menstruation represents “a process of endometrium shedding, which occurs monthly as the body discards the buildup of the uterus lining and is regulated by levels of estrogen and progesterone hormones.” See the link.
The UK-based study authors point out that the immune response to the Moderna mRNA COVID-19 vaccine may lead to the endometrium (a component of the immune system) to adapt its immune environment to protect the uterus leading to abnormal menstrual changes such as those observed, as suggested in a piece published by the University of British Columbia.
Yet the phenomenon of menstrual irregularities, common with women, can also be observed in the absence of COVID-19. Can a true correlation between Moderna’s mRNA COVID-19 vaccine and such irregularities be established, especially if select studies cannot compare incidence with baseline rates? See the link.
In another study, Edelman A, Boniface ER, Benhar E, et al., “Association between menstrual cycle length and coronavirus disease 2019 (COVID-19) vaccination: a U.S. Cohort Obstet Gynecol. 2022,” the group investigated menstrual cycle data between vaccinated and unvaccinated individuals finding that less than 1-day change in cycle length in association with both COVID-19 vaccine doses (0.64 day-increase (98.75% CI 0.27–1.01). Of this population, 35% had received the mRNA-1273 vaccine. The authors suggest the boost in cycle length is mostly driven by persons who received their COVID-19 vaccine doses within a single cycle period.
In 2023, Iranian investigators from University of Tehran had their systematic review published in the August 2023 edition of the Journal of Reproductive Immunology, finding that 1) many women experience menstrual disturbances post COVID-19 jab 2) vaccine-induced menstrual disturbances raises the concern among reproductive-age women and 3) COVID-19 vaccines can lead to menstrual disturbances through changes in immune and endocrine pathways.
As observed above, is it a bit disingenuous to evade vaccine root cause by pointing to an immune system response?
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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, July 17, 2023
Fauci’s Fraudulent ‘Cover-Up’ of the True Origins of Covid Revealed In Un-Redacted Docs
After the House Select Subcommittee on the Coronavirus Pandemic unearthed newly redacted documents this week, a former State Department pandemic investigator suggested there is proof Dr. Anthony Fauci knew about the gain-of-function research.
In the redacted documents, Fauci wrote a letter on February 1, 2020, to "folks,” suggesting that the viral sequence found in the coronavirus strain contained "mutations in the virus that would have been most unusual to have evolved naturally in bats," adding there had been "suspicion that this mutation was intentionally inserted.”
He said it was possible the Coronavirus could have evolved naturally with these mutations.
Additionally, the scientists at Wuhan University are known for working on gain-of-function experiments that lead to the determination of the molecular mechanisms associated with bat viruses adapting to human infection and the Covid-19 outbreak, which originated in Wuhan.
Rep. Rich McCormick (R-GA) suggested that Fauci intentionally misled the public.
“He absolutely knew what was going on,” McCormick said. “As a matter of fact, several scientists were discussing this and agreeing with each other that it made no sense that it came from a natural selection process.”
The Republican was unsurprised that Fauci has shied away from the lab leak theory because as more and more evidence comes to light, theory is beginning to ring true.
Earlier this year, Sen. Rand Paul (R-KY) claimed Fauci didn't want to draw attention to the lab-leak theory because his office had supported and allegedly funded gain-of-function research with U.S. taxpayer funds for years.
“He's even quoted as saying in 2012 if a pandemic should occur if a scientist should be bitten by an animal and the virus gets out of the lab, it would be worth the knowledge," Paul said in March.
Citing emails between Fauci and now-retired NIH Director Francis Collins, Paul said another reason the corrupt Democrat didn’t want the damming evidence revealed is that it would not be good for China or “the money that changes hands.”
Former State Department investigator Dr. David Asher also accused Fauci of covering up significant facts behind the true origins of COVID-19, telling Fox News Fauci orchestrated an extensive cover-up to his the fact he was involved in COVID’s release.
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Affordable Diabetes Drug Reduces Long-COVID Risk by 41 Percent
Is there a way to prevent long COVID? A new study in the United States found that taking metformin, an affordable first-line Type 2 diabetes drug, shortly after diagnosis of COVID-19 can reduce the risk of developing long COVID by about 41 percent.
The study was conducted by researchers from the University of Minnesota, and the paper was published in the international medical journal The Lancet Infectious Diseases in June.
Long COVID refers to persistent discomfort for weeks or months after being infected with COVID-19. Common symptoms include fatigue, shortness of breath, cognitive impairment, headache, chest pain, and joint pain, among others, which affect daily life.
Through remote recruitment, the researchers screened 1,126 participants who agreed to long-term follow-up. They were overweight and obese people aged 30 to 85, had symptoms of COVID-19 infection for fewer than seven days, tested positive for COVID within three days of trial enrollment, and had no previous known SARS-CoV-2 infection.
In this randomized trial, about half of the participants took metformin, and the other half took a placebo. They were also randomly assigned to receive either ivermectin, fluvoxamine, or placebo.
After 300 days of follow-up, 10.4 percent of participants who took the placebo were diagnosed with long COVID, while 6.3 percent who took metformin were also diagnosed.
The results of the study showed that taking metformin reduced the risk of developing long COVID by 41 percent. In subjects who took metformin within three days of symptom onset, the risk of developing long COVID was reduced by 63 percent.
The study also proved that taking metformin reduced the risk of developing long COVID in people infected during the peak period of the three SARS-CoV-2 variants, Alpha, Delta, and Omicron.
However, the study found that taking ivermectin or fluvoxamine showed no signs of protection against long COVID.
Metformin, originally developed from the French lilac (Galega officinalis), is inexpensive and has no significant side effects. For decades, it has been the drug of choice for Type 2 diabetes treatment worldwide.
Researchers believe metformin could be used as a therapeutic drug for outpatients infected with COVID-19. It has the merits of proven clinical efficacy, is available all over the world at a low cost, and is safe to use.
It is important to note that the trial did not demonstrate whether metformin was effective in preventing COVID-19 in patients requiring emergency treatment or hospitalization due to COVID-19, nor did it prove that metformin was effective in people who already had long COVID.
The study is not without its limitations. First, there is an obvious sample selection bias, because the people who participated in the clinical trial and completed the 10-month follow-up survey may not represent the general population affected by COVID-19 and long COVID. The trial also excluded low-risk groups for severe COVID-19, namely adults with a normal body mass index (BMI), and people under the age of 30. Whether the above findings apply to these groups remains to be seen.
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Risk of Autoimmune Diseases Triples After COVID-19 Infection, 6 Tips to Reduce Susceptibility to Long COVID
The long-term chronic effects of COVID-19 cannot be ignored. Studies have shown that six months after being diagnosed with COVID-19, the risk of developing an autoimmune disease is three times that of an uninfected person. Virology experts say following six health guidelines can help reduce the incidence of long COVID.
A research team analyzed data from TriNetX, a global electronic medical records database, which included more than 3.81 million participants (880,000 confirmed and more than 2.9 million undiagnosed) who underwent PCR screening from 2020 to 2021. After tracking them for 180 days, the risk of autoimmune diseases in those diagnosed was three times that of those not infected.
Compared with the undiagnosed control group, the probability of suffering from various immune system diseases in confirmed patients was as follows:
2.98 times for rheumatoid arthritis
3.21 times for ankylosing spondylitis
2.99 times for systemic lupus erythematosus
1.96 times for vasculitis and dermatopolymyositis
2.58 times for systemic sclerosis
2.62 times for Sjögren’s syndrome
3.14 times for mixed connective tissue disease
2.32 times for Behçet’s disease
2.90 times for polymyalgia rheumatica
2.91 times for psoriasis
1.78 times for inflammatory bowel disease
2.68 times for celiac disease
2.68 times for Type 1 diabetes
1.20 times for mortality rate
The research results were published in EClinicalMedicine, a sister journal of The Lancet Discovery Science.
Dr. Wei Zhengzong, the paper’s author and vice director of the Affiliated Hospital of Chung Shan Medical University in Taiwan, said that a confirmed case of COVID-19 will activate the immune response, resulting in a cytokine storm. The structure of the virus antigen may also be similar to one’s self-antigen, causing a cross-reaction that attacks self-tissue cells and organs, inducing autoimmune diseases.
Dr. Wei said that if the diagnosed person suffers long-term joint pain, skin rash, unexplained hair loss, fever, mouth ulcers, etc., after recovery, he or she is advised to seek medical attention immediately.
Pathogenesis of Long COVID
An article published in Nature Immunology in 2022 explored the pathogenesis of long COVID, including the persistent chronic inflammatory state the disease induces, autoimmune system abnormalities, and the virus’ long-term existence in the body.
Dr. Dong Yuhong, a European expert in virology and infectious diseases, explained on the NTDTV program “Health 1+1” that although the virus may no longer be detected in the respiratory tract, it does not mean it is no longer in the body. It may lurk in relatively hidden tissues like the brain and gastrointestinal tract.
A study published in Nature showed that about four months after the infection of 14 asymptomatic infected persons, half of them had the COVID-19 virus’ nucleic acid in their intestines, indicating that the virus can remain in the body for a long time.
In addition, some inflammatory factors will still be present in the patient’s body. One of these is interleukin-6, related to many diseases, including mental anxiety and depression.
Moreover, COVID-19 patients’ inflammatory cells will continue to be activated, causing dysfunction of monocytes, T cells, and dendritic cells. This activation is closely related to immune system dysfunction, leading to pulmonary fibrosis and chronic inflammation of the neurological system.
6 Health Guidelines to Reduce Risk of Long COVID
Dr. Dong emphasized that long COVID is primarily a result of insufficient immunity, leading to the loss of one’s normal ability to clear the virus. An unhealthy lifestyle will further aggravate long COVID. The more severe the inflammatory state, the harder it is for the body to eliminate the virus.
She cited a study published in JAMA Internal Medicine that indicates adhering to the following six guidelines can reduce your risk of developing long COVID. If you follow at least five of these six, you will reduce the risk of developing long COVID by 49 percent:
Maintain a healthy body mass index (BMI): This is your weight in kilograms divided by the square of height (in meters). A healthy BMI is between 18.5 and 24.9.
Don’t smoke: This includes e-cigarettes.
Exercise regularly: Get at least 150 minutes of moderate-intensity physical activity weekly.
Drink alcohol in moderation: Consume only 5 to 15 grams (0.2 to 0.5 ounce) of alcohol daily. Dr. Dong pointed out that drinking a small amount of alcohol may stimulate blood circulation but that everyone’s ability to metabolize alcohol differs.
Eat a high-quality diet: Dr. Dong said a high-quality diet should be based on natural, unrefined whole foods. The less processed the food, the more nutrients available.
Get enough sleep: An average adult needs at least seven hours of sleep every day. However, more sleep is not always better. Studies have found that people who sleep less than seven hours have a 12 percent higher risk of death, and those who sleep more than nine hours have a 30 percent higher risk of death. More sleep does not equate to quality sleep.
Dr. Dong added that a healthy lifestyle can prevent other common chronic diseases, such as hyperlipidemia, high blood pressure, and hyperglycemia.
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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, July 16, 2023
Case Series: 3rd Pfizer mRNA Booster Triggers Giant Cell Arteritis
A group of physicians at Toho University in Tokyo, Japan conducted a case series study concerning a 77-year old male who developed fever, general fatigue and headache after receiving the third dose of COVID-19 vaccination (Pfizer-BioNTech BNT162b2). Observing nodular (lump-like) swelling plus tenderness of the bilateral temporal arteries, the study team determined that an autoimmune vasculitis affecting large and medium-sized blood vessels known as giant cell arteritis (GCA) was the culprit, likely linked to the mRNA vaccination.
It turns out, although not widely published in American trade media and especially not in mainstream press, COVID-19 mRNA vaccines have been associated with the development of immune-mediated diseases, such as this one--a condition that if left undiagnosed can lead to blindness and stroke due to inflammation and damage to the affected blood vessels.
What is giant cell arteritis?
GCA can also be called temporal arteritis and represents a chronic inflammatory disease mostly impacting the large arteries, but especially the temporal arteries located in the head. Characterized by inflammation and damage to the arterial walls, it can lead to other symptoms and complications. Importantly, if left undiagnosed, GCA can lead to serious complications ranging from permanent vision loss or stroke.
The case series
The Toho University-based group of physician-researchers report in the peer-reviewed journal Medicine that the patient was given methylprednisolone 1000 mg for 3 days. That regimen was followed up with prednisolone 1 mg/kg/d, which was decreased by 10 mg every week to 30 mg. From day 16 of hospitalization, the patient received tocilizumab 162 mg/wk every other week. After a 38-day hospitalization, the doctors tapered his regimen of prednisolone to 30 mg/d as the patient’s condition improved.
Takeaway
The COVID-19 mRNA vaccines are associated with the development of immune-mediated diseases. In this case, the Pfizer-BioNTech third dose triggered immediately thereafter an incident of GCA.
Corresponding author Kaichi Kaneko, based in the University of Toho Department of Internal Medicine, Division of Rheumatology, and colleagues note that doctors should be on the lookout for the signs of mRNA vaccine induced GCA including fever, fatigue and headache, even though these are also standard side effects as well. Should these symptoms persist, GCA may be a factor.
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New Omicron Vaccine will be Obsolete on Arrival
From Rita Rubin, Science Reporter for JAMA: “On June 15, members of the US Food and Drug Administration’s (FDA) Vaccine and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend updating the COVID-19 vaccine composition to a monovalent XBB lineage.”
On June 16, the FDA announced that it had advised manufacturers planning to update their COVID-19 vaccines that they should specifically target XBB.1.5. Scientists from Moderna, Novavax and Pfizer had told the FDA and its advisory committee that their XBB.1.5 monovalent vaccines could be ready to inject into arms by late July or early fall.
Although the FDA decides what antigens the COVID-19 vaccines should include, the US Centers for Disease Control and Prevention (CDC) is responsible for deciding who should get them and when. As soon as the FDA greenlights an XBB.1.5 vaccine, “I’m sure the ACIP will have a specially called meeting to decide how it should be used,” William Schaffner, M.D., chair of the department of preventive medicine at the Vanderbilt University School of Medicine, said in an interview.
ACIP stands for the CDC’s Advisory Committee on Immunization Practices, on which Schaffner serves as the liaison representing the National Foundation for Infectious Diseases, where he is medical director. At the ACIP meeting on an XBB.1.5 vaccine, “I think there will be a rather elaborate discussion on who will receive this vaccine,” Schaffner predicted.”
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Australia: Protecting children takes courage: Just ask Dr Jillian Spencer, a child and adolescent psychiatrist
Julie Sladden
The announcement of the Labor Government’s proposed ‘misinformation’ Bill, while alarming, is not surprising. Anyone paying attention in recent years, especially the last three, will have noticed that our ‘freedom of speech’ has already been significantly curtailed through online censorship, government censorship (thank you, Department of Home Affairs), and self-censorship.
Nowhere has this been more palpable or alarming than the censorship of freedom of inquiry in science and medicine. During the Covid years, we discovered just how captured the medical profession is. Like lifting the lid on Pandora’s box, anyone who spoke out soon discovered the evil treasures in store for those who dared to question the narrative. The result was spectacular and tragic. Doctors who wanted to keep their jobs had to shut up, roll up their sleeves, and work on it. Those who spoke up or questioned the forced jab were marginalised, censored, sacked, or suspended. The message was clear, speak out at your peril. Despite the messaging, I was still shocked at how many capitulated. Surely this was the time we were meant to speak up and ask questions? Especially the hard ones. Isn’t this what we trained for?
Every so often, I meet someone who helps restore my hope in the medical profession. Last week that person was Dr Jillian Spencer, a senior staff Child and Adolescent Psychiatrist who was recently suspended from clinical practice at the Queensland Children’s Hospital. She now faces serious threats to her position, professional career, and livelihood, including potential regulatory action. Her crime, it seems, is to question out loud the affirmation model of transgender care.
Spencer says she is not alone in her concerns, ‘I would say that the vast majority of Child and Adolescent psychiatrists hold very serious concerns about the affirmation model, but to speak up in the current climate or even to take a more cautious clinical approach puts their employment at risk,’ she shared at a recent forum.
If there is any doubt that questioning ‘the narrative’ is dangerous for medical professionals, Spencer can set the record straight. Her experience of raising concerns within the organisation through the ‘proper channels’ has not gone well.
‘The process is to raise concerns internally (within an organisation) so that you’re doing it professionally and appropriately, rather than having to speak out. But when I pushed that to the maximum internally, it went very badly. So now I’m in the position of speaking out (publicly). The majority of child psychiatrists (are silent) for good reasons and self-preservation. The good reasons being wanting to be available to help people and to not be perceived as biased. But also, a lot of it is fear. And I don’t think my case has helped either, as I’m at risk for my employment and my (registration). It’s very serious. And so, I can’t blame them.’
But the costs of speaking out extend beyond the doctor involved. Patient care and service delivery stand to suffer too.
‘The danger of speaking out is that you lose the capacity to help more people,’ Spencer shares. ‘For example, a gender-questioning young person might be reluctant to see me now that I’ve spoken out, and that’s not something I want because I want young people to feel comfortable with me. My job is to listen and understand and to do what I can to help them.’
Now, this job is on hold indefinitely. However, Spencer is undeterred. Rather than quietly waiting for the ‘powers that be’ to hand down judgment, she demonstrates a commitment to her convictions by continuing to speak out. Loudly and often. To an outsider, it would appear Spencer has reached a point of reluctant acceptance of her situation and that she might as well go ‘all in’. Arriving at this point has come through painful reflection, ‘dark times’, and the realisation that the organisation Spencer has served faithfully for decades has apparently abandoned her.
‘It’s a really difficult employment situation,’ says Spencer. ‘Some people say, “Well, if your organisation is doing something that you disagree with, then the appropriate pathway is to resign.” But if you’ve been with an organisation for 20 years, you feel a part of that organisation. I feel like part of the family and part of changing the culture internally. It’s part of my job.’
‘People say “You need to resign or accept it.” But it’s also a responsibility to try and help your organisation do the right thing and… ‘speak up for safety.’
Listening to her speeches, presentations, and interviews, it is hard to argue that Spencer is motivated by anything other than safety. Child safety appears at the core of her message time and again.
‘It’s a really hard situation for child and adolescent psychiatrists… and for any mental health clinicians who work with children. Because there’s a lot of organisational and social pressure to affirm children,’ Spencer shares. ‘But when we start to look at the evidence base behind the affirmation model, we find the studies have major flaws, and they don’t show sufficient benefit to outweigh the risks and the harms.’
‘Previously, our discipline always took a developmental approach, which means that the years of childhood and adolescence were understood to be a period of incredible growth and change. We didn’t label children with long-term conditions, such as personality disorders, because we knew that a lot of conditions would ease with maturity, and indeed, the eleven studies that were conducted before the affirmation model was in use when they used a watchful waiting approach found that 60 to 90 per cent of children with gender dysphoria became comfortable in their own bodies with maturity.’
‘I assure you that this is not part of a culture war. This is a really serious child protection issue. We entered our field to try to assist children to thrive, but the gender clinics have been set up, and psychiatrists are being forced to affirm the social transition of all children and go along with the idea that puberty blockers and cross-sex hormones will lead to benefit.’
Spencer’s words highlight the dangerous waters our children are in. Treatment pathways and models of care are being imposed while the evidence is unclear, pathways that have modalities with irreversible and devastating consequences for children in terms of fertility, sexual and long-term health. Anyone who would step into these waters without a cautious approach does not understand the potential ramifications.
One of the arguments used to justify support for the use of cross-sex hormones and puberty blockers is mental distress and the risk of suicide in those experiencing gender dysphoria, as highlighted in a recent Four Corners report. However, Spencer paints a broader picture. ‘There’s no evidence to show that the social transition or the use of puberty blockers or cross-sex hormones reduces the death rate or improves psychological functioning.’
‘What we know from the eleven studies that were conducted before the affirmation model was in use – so that’s when they didn’t use puberty blockers and cross-sex hormones – is that the vast majority of (children with gender dysphoria) grew up to become comfortable with their body if they’re allowed to go through the full course of adolescence.’
‘My personal opinion is that we could disallow the prescription of puberty blockers… (and)… Australia aligned itself with all the European countries that have conducted systematic reviews of the evidence behind puberty blockers and cross-sex hormones. From those systematic reviews, they realised that no child should be prescribed puberty blockers outside of a clinical research trial or in exceptional circumstances. And in the UK, they’ve even gone further in recommending caution around social transition.’
In voicing concerns at a recent rally, Spencer stumbled on another issue facing doctors who dare speak out. Soon after, the hospital told Spencer she allegedly broke the Queensland public services Code of Conduct through her public statements. It’s an allegation Spencer contests, saying she was speaking as a private citizen. In the speech, Spencer neither identifies herself as a doctor nor makes mention of her role or employer. The question is, where does a doctor’s autonomy begin and the employer’s jurisdiction end?
Have we already entered the era where the reach of our employers and regulatory authorities extends fully into our capacity to speak publicly anywhere?
The AHPRA Code of Conduct for medical professionals outlines several expectations of health professionals to question, examine and discuss the potential risks and benefits of treatment in addition to advocating for vulnerable communities, including children. It would seem, therefore, that Dr Spencer is simply doing her job.
‘We are not being allowed any professional discretion,’ she argues. ‘It is incredibly distressing to be forced into harming other people’s children, or otherwise face the potential loss of one’s career, livelihood or to be cast out of the workplace as has happened to me. But this is too important, so I will not be silenced.’
Dr Spencer is calling for an urgent Federal inquiry into the model of care for the treatment of children with gender dysphoria.
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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A group of physicians at Toho University in Tokyo, Japan conducted a case series study concerning a 77-year old male who developed fever, general fatigue and headache after receiving the third dose of COVID-19 vaccination (Pfizer-BioNTech BNT162b2). Observing nodular (lump-like) swelling plus tenderness of the bilateral temporal arteries, the study team determined that an autoimmune vasculitis affecting large and medium-sized blood vessels known as giant cell arteritis (GCA) was the culprit, likely linked to the mRNA vaccination.
It turns out, although not widely published in American trade media and especially not in mainstream press, COVID-19 mRNA vaccines have been associated with the development of immune-mediated diseases, such as this one--a condition that if left undiagnosed can lead to blindness and stroke due to inflammation and damage to the affected blood vessels.
What is giant cell arteritis?
GCA can also be called temporal arteritis and represents a chronic inflammatory disease mostly impacting the large arteries, but especially the temporal arteries located in the head. Characterized by inflammation and damage to the arterial walls, it can lead to other symptoms and complications. Importantly, if left undiagnosed, GCA can lead to serious complications ranging from permanent vision loss or stroke.
The case series
The Toho University-based group of physician-researchers report in the peer-reviewed journal Medicine that the patient was given methylprednisolone 1000 mg for 3 days. That regimen was followed up with prednisolone 1 mg/kg/d, which was decreased by 10 mg every week to 30 mg. From day 16 of hospitalization, the patient received tocilizumab 162 mg/wk every other week. After a 38-day hospitalization, the doctors tapered his regimen of prednisolone to 30 mg/d as the patient’s condition improved.
Takeaway
The COVID-19 mRNA vaccines are associated with the development of immune-mediated diseases. In this case, the Pfizer-BioNTech third dose triggered immediately thereafter an incident of GCA.
Corresponding author Kaichi Kaneko, based in the University of Toho Department of Internal Medicine, Division of Rheumatology, and colleagues note that doctors should be on the lookout for the signs of mRNA vaccine induced GCA including fever, fatigue and headache, even though these are also standard side effects as well. Should these symptoms persist, GCA may be a factor.
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New Omicron Vaccine will be Obsolete on Arrival
From Rita Rubin, Science Reporter for JAMA: “On June 15, members of the US Food and Drug Administration’s (FDA) Vaccine and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend updating the COVID-19 vaccine composition to a monovalent XBB lineage.”
On June 16, the FDA announced that it had advised manufacturers planning to update their COVID-19 vaccines that they should specifically target XBB.1.5. Scientists from Moderna, Novavax and Pfizer had told the FDA and its advisory committee that their XBB.1.5 monovalent vaccines could be ready to inject into arms by late July or early fall.
Although the FDA decides what antigens the COVID-19 vaccines should include, the US Centers for Disease Control and Prevention (CDC) is responsible for deciding who should get them and when. As soon as the FDA greenlights an XBB.1.5 vaccine, “I’m sure the ACIP will have a specially called meeting to decide how it should be used,” William Schaffner, M.D., chair of the department of preventive medicine at the Vanderbilt University School of Medicine, said in an interview.
ACIP stands for the CDC’s Advisory Committee on Immunization Practices, on which Schaffner serves as the liaison representing the National Foundation for Infectious Diseases, where he is medical director. At the ACIP meeting on an XBB.1.5 vaccine, “I think there will be a rather elaborate discussion on who will receive this vaccine,” Schaffner predicted.”
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Australia: Protecting children takes courage: Just ask Dr Jillian Spencer, a child and adolescent psychiatrist
Julie Sladden
The announcement of the Labor Government’s proposed ‘misinformation’ Bill, while alarming, is not surprising. Anyone paying attention in recent years, especially the last three, will have noticed that our ‘freedom of speech’ has already been significantly curtailed through online censorship, government censorship (thank you, Department of Home Affairs), and self-censorship.
Nowhere has this been more palpable or alarming than the censorship of freedom of inquiry in science and medicine. During the Covid years, we discovered just how captured the medical profession is. Like lifting the lid on Pandora’s box, anyone who spoke out soon discovered the evil treasures in store for those who dared to question the narrative. The result was spectacular and tragic. Doctors who wanted to keep their jobs had to shut up, roll up their sleeves, and work on it. Those who spoke up or questioned the forced jab were marginalised, censored, sacked, or suspended. The message was clear, speak out at your peril. Despite the messaging, I was still shocked at how many capitulated. Surely this was the time we were meant to speak up and ask questions? Especially the hard ones. Isn’t this what we trained for?
Every so often, I meet someone who helps restore my hope in the medical profession. Last week that person was Dr Jillian Spencer, a senior staff Child and Adolescent Psychiatrist who was recently suspended from clinical practice at the Queensland Children’s Hospital. She now faces serious threats to her position, professional career, and livelihood, including potential regulatory action. Her crime, it seems, is to question out loud the affirmation model of transgender care.
Spencer says she is not alone in her concerns, ‘I would say that the vast majority of Child and Adolescent psychiatrists hold very serious concerns about the affirmation model, but to speak up in the current climate or even to take a more cautious clinical approach puts their employment at risk,’ she shared at a recent forum.
If there is any doubt that questioning ‘the narrative’ is dangerous for medical professionals, Spencer can set the record straight. Her experience of raising concerns within the organisation through the ‘proper channels’ has not gone well.
‘The process is to raise concerns internally (within an organisation) so that you’re doing it professionally and appropriately, rather than having to speak out. But when I pushed that to the maximum internally, it went very badly. So now I’m in the position of speaking out (publicly). The majority of child psychiatrists (are silent) for good reasons and self-preservation. The good reasons being wanting to be available to help people and to not be perceived as biased. But also, a lot of it is fear. And I don’t think my case has helped either, as I’m at risk for my employment and my (registration). It’s very serious. And so, I can’t blame them.’
But the costs of speaking out extend beyond the doctor involved. Patient care and service delivery stand to suffer too.
‘The danger of speaking out is that you lose the capacity to help more people,’ Spencer shares. ‘For example, a gender-questioning young person might be reluctant to see me now that I’ve spoken out, and that’s not something I want because I want young people to feel comfortable with me. My job is to listen and understand and to do what I can to help them.’
Now, this job is on hold indefinitely. However, Spencer is undeterred. Rather than quietly waiting for the ‘powers that be’ to hand down judgment, she demonstrates a commitment to her convictions by continuing to speak out. Loudly and often. To an outsider, it would appear Spencer has reached a point of reluctant acceptance of her situation and that she might as well go ‘all in’. Arriving at this point has come through painful reflection, ‘dark times’, and the realisation that the organisation Spencer has served faithfully for decades has apparently abandoned her.
‘It’s a really difficult employment situation,’ says Spencer. ‘Some people say, “Well, if your organisation is doing something that you disagree with, then the appropriate pathway is to resign.” But if you’ve been with an organisation for 20 years, you feel a part of that organisation. I feel like part of the family and part of changing the culture internally. It’s part of my job.’
‘People say “You need to resign or accept it.” But it’s also a responsibility to try and help your organisation do the right thing and… ‘speak up for safety.’
Listening to her speeches, presentations, and interviews, it is hard to argue that Spencer is motivated by anything other than safety. Child safety appears at the core of her message time and again.
‘It’s a really hard situation for child and adolescent psychiatrists… and for any mental health clinicians who work with children. Because there’s a lot of organisational and social pressure to affirm children,’ Spencer shares. ‘But when we start to look at the evidence base behind the affirmation model, we find the studies have major flaws, and they don’t show sufficient benefit to outweigh the risks and the harms.’
‘Previously, our discipline always took a developmental approach, which means that the years of childhood and adolescence were understood to be a period of incredible growth and change. We didn’t label children with long-term conditions, such as personality disorders, because we knew that a lot of conditions would ease with maturity, and indeed, the eleven studies that were conducted before the affirmation model was in use when they used a watchful waiting approach found that 60 to 90 per cent of children with gender dysphoria became comfortable in their own bodies with maturity.’
‘I assure you that this is not part of a culture war. This is a really serious child protection issue. We entered our field to try to assist children to thrive, but the gender clinics have been set up, and psychiatrists are being forced to affirm the social transition of all children and go along with the idea that puberty blockers and cross-sex hormones will lead to benefit.’
Spencer’s words highlight the dangerous waters our children are in. Treatment pathways and models of care are being imposed while the evidence is unclear, pathways that have modalities with irreversible and devastating consequences for children in terms of fertility, sexual and long-term health. Anyone who would step into these waters without a cautious approach does not understand the potential ramifications.
One of the arguments used to justify support for the use of cross-sex hormones and puberty blockers is mental distress and the risk of suicide in those experiencing gender dysphoria, as highlighted in a recent Four Corners report. However, Spencer paints a broader picture. ‘There’s no evidence to show that the social transition or the use of puberty blockers or cross-sex hormones reduces the death rate or improves psychological functioning.’
‘What we know from the eleven studies that were conducted before the affirmation model was in use – so that’s when they didn’t use puberty blockers and cross-sex hormones – is that the vast majority of (children with gender dysphoria) grew up to become comfortable with their body if they’re allowed to go through the full course of adolescence.’
‘My personal opinion is that we could disallow the prescription of puberty blockers… (and)… Australia aligned itself with all the European countries that have conducted systematic reviews of the evidence behind puberty blockers and cross-sex hormones. From those systematic reviews, they realised that no child should be prescribed puberty blockers outside of a clinical research trial or in exceptional circumstances. And in the UK, they’ve even gone further in recommending caution around social transition.’
In voicing concerns at a recent rally, Spencer stumbled on another issue facing doctors who dare speak out. Soon after, the hospital told Spencer she allegedly broke the Queensland public services Code of Conduct through her public statements. It’s an allegation Spencer contests, saying she was speaking as a private citizen. In the speech, Spencer neither identifies herself as a doctor nor makes mention of her role or employer. The question is, where does a doctor’s autonomy begin and the employer’s jurisdiction end?
Have we already entered the era where the reach of our employers and regulatory authorities extends fully into our capacity to speak publicly anywhere?
The AHPRA Code of Conduct for medical professionals outlines several expectations of health professionals to question, examine and discuss the potential risks and benefits of treatment in addition to advocating for vulnerable communities, including children. It would seem, therefore, that Dr Spencer is simply doing her job.
‘We are not being allowed any professional discretion,’ she argues. ‘It is incredibly distressing to be forced into harming other people’s children, or otherwise face the potential loss of one’s career, livelihood or to be cast out of the workplace as has happened to me. But this is too important, so I will not be silenced.’
Dr Spencer is calling for an urgent Federal inquiry into the model of care for the treatment of children with gender dysphoria.
https://www.spectator.com.au/2023/07/protecting-children-takes-courage/
*************************************************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, July 14, 2023
Thursday, July 13, 2023
University of Zurich COVID-19 Vax Adverse Effect Study
A team at the University of Zurich, Epidemiology, Biostatistics and Prevention Institute (EBPI) led a population-based cohort study involving 575 individuals who received a SARS-CoV-2 vaccine, and as part of the study, were monitored and followed up over 12 weeks, with participants sharing commonly reported adverse effects, mostly local pain, fatigue, headache and fever. Not surprisingly, a majority of adverse effects were mild to moderate and resolved within three days. The findings here are comparable to other reported prevalence and severity of adverse effects in randomized controlled trials. Hospitalizations out of the cohort totaled 0.7%.
Context
The results of this Swiss study concerning the prevalence and severity of adverse effects are overall similar to previously reported data from randomized controlled trials and other observational studies as cited by the Swiss-based study authors.
The team provides an overview of other important safety surveillance studies for some perspective. For example, in one online survey among persons who received either the Pfizer (BNT162b2), Moderna (mRNA-1273) or J&J (JNJ-78436735), study team of Beatty et al. reported that 80.3% of participants experienced adverse effects, with comparable estimates for each vaccine type.
The proportion of adverse effects that were self-reported as severe or required hospitalization in the current study (14.7%) was well below that of Swiss and European governmental surveillance systems (37.9% in Swiss ElViS). These are actually high rates.
Furthermore, safety surveillance systems in America reveal higher estimates of serious adverse events based on hospitalization rates, serious illness and deaths (9.2% vs. our 0.7%). The Swiss authors propose: “These higher estimates from governmental reporting systems are likely related to the underreporting of mild symptoms and underscore the importance of real-world data.”
Reports on prevalence of anaphylaxis and severe allergic reactions vary from 0.03% to 3% based on differing definitions. In the current University of Zurich study, two (0.4%) participants reported allergic reactions, without the need to consult a medical professional.
The study
Data is derived from participants at a University of Zurich vaccination center. Individuals receiving BNT162b2 or mRNA-1273 vaccines were recruited between March 10, 2021, and July 21, 2021, while participants receiving JNJ-78436735 were recruited between October 20, 2021, and January 27, 2022.
The findings
Out of the entire study population, 454 participants reported experiencing at least one adverse event up to three months post-vaccination equaling 79.0% of the total. The study showed a total of 2233 adverse events meaning on average there were 3.88 adverse events reported per study participant.
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Canadian Investigators Discovery Unique Blood Plasma Protein Patterns in Long COVID Patients
A Canadian research unit may come up with a way to treat at least some long COVID patients more effectively. The condition has emerged since the pandemic as a real problem. With anywhere from 10-20% of people that have been infected with SARS-CoV-2 susceptible to long COVID, some estimate north of 14 million people in America alone struggling with the condition, which can last for many months. Often impacting the quality of life, symptoms from brain fog and fatigue to breathing difficulties can be outright debilitating. Led by Dr. Douglas Faser, a professor in pediatrics at Schulich School of Medicine & Dentist, and physician at London Health Sciences Centre (LHSC) a team of Canadians designed a study using artificial intelligence (AI) as part of advanced research to discover unique patterns of blood plasma proteins in patients with suspected long COVID, with an aim on improving patient outcomes. Enter the “plasma proteome,” as the research centers on proteins identified in blood plasma, released by cells often playing a vital role in pathogen immune response.
With study results recently published in the Journal of Translational Medicine this study team sought out to better understand how these plasma cells impact patients with long COVID, and why some patients struggle more than others.
Corresponding authors Dr. Douglas Faser and Cristiana Losef, both with Children’s Health Research Institute, Victoria Research Laboratories, and colleagues investigated possible mechanisms, and to inform the prognosis and treatment of long COVID.
This technology allowed researchers to determine unique patterns in the blood proteins. The team discovered that people with suspected long COVID have prolonged inflammation associated with changes in their immune cells and blood vessels. These changes may lead to problems in specific organs, like the brain and the heart, as reported by Western University.
Called “the plasma proteome,” the proteins are found in blood plasma and are released by cells that often play an important role in the body’s immune response to viruses. The research team is studying how those proteins adapt and change in long COVID.
The study
With a green light from the local Ethics Committee (Western University), the study team enrolled patients from London Health Sciences Center in London, Ontario, Canada and St. Joseph's including patients diagnosed with long COVID as well as acutely ill COVID-19 patients.
Upon diagnosis of long COVID, study patients were referred to a specialist clinic based on prolonged, diffuse symptoms according to the author's account in the Journal of Translational Medicine.
Conducting a series of tests including venous blood work, the study team analyzed patient plasma. COVID-19 patients were approached when they were admitted to the hospital or medical ward or intensive care unit. Healthy subjects were included—persons without disease, acute illness or any prescription medicine, but previously banked by the Translational Research Center in London, Ontario.
All samples in the study were matched by age and gender (e.g., long COVID patients to acutely ill patients to healthy controls).
Results
Unlike acutely ill COVID-19 patients as well as healthy subjects---both matched by age and sex—the long COVID outpatients evidenced natural killer cell redistribution with a dominant resting phenotype, opposite to active and neutrophils formed in extracellular traps.
The study team reports a possible “resetting of cell phenotypes” likely resulting from “prospective vascular events mediated by both angiopoietin (ANGPT1) and vascular endothelial growth factor-A (VEGFA).
Validating several biomarkers (ANGPT1, VEGFA, CCR7, CD56, citrullinated histone 3, elastase) the authors report also that “Signaling of transforming growth factor-β1 with probable connections to elevated EP/p300” pointed to both vascular inflammation as well as tumor necrosis factor- α driven pathways. The authors suggested that the progression from acute COVID-19 to long COVID was “a vascular proliferative state associated with hypoxia-inducible factor 1 pathway.”
Fraser and Losef write that this “vascular-proliferative process predicted in Long-COVID might contribute to changes in the organ-specific proteome reflective of neurologic and cardiometabolic dysfunction.”
PI Point of View
Cristiana Losef, a research analyst at Children’s Health Research Institute (CHRI), a program of Lawson went on the record, “We used novel technologies for this study, allowing us to analyze more than 3,000 proteins in blood plasma at the same time with multiple patients.”
Losef continued:
“We used a novel bioinformatic pipeline, a form of artificial intelligence (AI), to analyze the proteins to determine the specific changes that occur in long COVID.”
Dr. Michael Nicholson, associate scientist at Lawson, and respirologist at St. Joseph’s Health Care London reports on the influence of this study, “Trying to understand this mechanism is quite important because it provides further insight into how patients are affected,” says Dr. Michael Nicholson. He continued, “This paper sheds further light on a possible mechanism that may provide insight into why some patients have certain symptoms.”
Michael Knauer, an associate scientist at Lawson shared for Western University, “The saved blood plasma samples we are using helped us determine the long-term responses to COVID-19; serial blood plasma samples from individuals that had a COVID-19 infection and now presumed long COVID will help us determine how proteins are changing over time.”
What’s the potential value from a therapeutic perspective?
Dr. Faser, a professor at Schulich Medicine, said the proteins discovered could act as a potential drug target. The team is now examining potential new drug therapies with the hopes of improving outcomes for these patients.
Fraser emphasized:
“When we identify these signaling patterns within the blood plasma, we can then take the information and screen drug databases to better understand which drugs would be best to target the changes we identified in long COVID patients.” Pointing to the potential of these findings, “With this understanding, the identified drugs may be used in future long COVID clinical trials.”
Key Point: This research, which used multiple state-of-the-art technologies, was enabled by existing expertise and infrastructure through Children’s Health Research Institute (CHRI). It reveals that the findings point to a “vascular-proliferative process in Long-COVID that is likely initiated either prior hypoxia (localized or systemic) and/or stimulatory factors (i.e., cytokines, chemokines, growth factors, angiotensin, etc.). Analyses of the plasma proteome, used as a surrogate for cellular signaling, unveiled potential organ-specific prognostic biomarkers and therapeutic targets.”
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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, July 12, 2023
Text Messages of Top Scientists Shed Light on COVID Origin Response
A new report released by Republican members of the House Select Subcommittee on the Coronavirus Pandemic includes new evidence that a group of scientists who received funding from the National Institute of Allergy and Infectious Diseases (NIAID), conspired to dismiss the origin of the pandemic in order to protect China.
The text messages were exchanged between authors of the Proximal Origin paper, initiated by then-NIAID Director Anthony Fauci, which had the explicit purpose of dismissing the lab leak theory for the pandemic’s origin. The Proximal Origin paper, which declared that no “laboratory-based scenario is plausible,” became one of the most cited science papers of all time and was prominently used by Dr. Fauci as proof that the COVID-19 virus came from nature.
While Dr. Fauci’s role in directing the paper’s creation as well as the paper’s many scientific and logical flaws have been widely documented, the exact circumstances of the paper’s origin have remained unclear. Text messages released by the Subcommittee on the Coronavirus Pandemic now reveal that it was fear of upsetting international relations, and the Chinese regime in particular, that drove the inception of Proximal Origin.
According to emails obtained by the Subcommittee on the Coronavirus Pandemic, concerns regarding COVID-19’s engineered-looking features were first discussed by Proximal Origin author Eddie Holmes of the University of Sydney and British pharmaceutical trust director Jeremy Farrar on Jan. 8, 2020. Mr. Farrar is now the World Health Organization’s chief scientist. Dr. Francis Collins, then-director of the National Institutes of Health (NIH), as well as unnamed Chinese officials were also included in these early, behind-the-scenes discussions.
It remains unknown why Mr. Farrar—who later co-organized with Dr. Fauci a Feb. 1, 2020, teleconference that resulted in the drafting of Proximal Origin—was deeply entangled in the effort to suppress the lab leak theory and instead elevate the natural origin narrative. Notably, Mr. Farrar is a close personal friend of Gao Fu, who was at the time the head of the Chinese Center for Disease Control. Mr. Farrar later admitted in his book “Spike” that he was concerned at the time about Sino–U.S. relations.
While Mr. Holmes, Mr. Farrar, Dr. Collins, and the unnamed Chinese officials were discussing the virus’s unusual features, NIAID-funded scientist Kristian Andersen of the Scripps Institute contacted Mr. Holmes to share his own concerns about the new virus, in particular its unusual receptor binding domain and furin cleavage site. Mr. Andersen had also uncovered that the director of the Wuhan Institute of Virology (WIV), Shi Zhengli, had—together with Ralph Baric of the University of North Carolina, who is sometimes referred to as the godfather of gain-of-function experiments—inserted furin cleavage sites into SARS viruses. In other words, Mr. Andersen had detected a highly unusual furin cleavage site in COVID-19, a site that has to this day never been observed in naturally occurring viruses of this kind, and found direct evidence that the WIV had inserted such sites into coronaviruses. Mr. Holmes responded, “[expletive], this is bad” and “oh my god what worse words than that.”
On Jan. 31, 2020, Mr. Farrar talked to Dr. Fauci about the virus’s unusual features. At the same time, Mr. Andersen contacted Dr. Fauci by email, saying that the virus’s features looked potentially engineered and that its genetic makeup was “inconsistent with expectations from evolutionary theory.”
It was at this point that Dr. Fauci and Mr. Farrar organized the teleconference, which was held the next day, on Feb. 1, 2020. The ostensible purpose of the teleconference was to develop the Proximal Origin paper to counter the lab leak theory. Mr. Andersen became the paper’s lead author and was joined by fellow teleconference participants Mr. Holmes, Andrew Rambaut of the University of Edinburgh, and Robert Garry of Tulane University as co-authors.
A fifth co-author, Ian Lipkin of Columbia University, was brought on board later in February 2020. Mr. Lipkin did not participate in the teleconference and has since distanced himself from the natural origin narrative. Chairman of the Subcommittee on the Coronavirus Pandemic Rep. Brad Wenstrup (R-Ohio) has stated that Mr. Lipkin is cooperating with congressional investigators.
The new text messages released by Mr. Wenstrup’s Committee reveal for the first time that the four Proximal Origin authors who attended Dr. Fauci’s teleconference started a Slack group to discuss the paper. In a message sent in the morning of Feb. 2, 2020, the day after the teleconference, Mr. Rambaut told co-authors Mr. Andersen, Mr. Holmes, and Mr. Garry:
“Given the [expletive] show that would happen if anyone serious accused the Chinese of even accidental release, my feeling is we should say that given there is no evidence of a specifically engineered virus, we cannot possibly distinguish between natural evolution and escape so we are content with ascribing it to natural process.”
Within three minutes, Mr. Andersen replied:
“Yup, I totally agree that that’s a very reasonable conclusion. Although I hate when politics is injected into science – but it’s impossible not to, especially given the circumstances. We should be sensitive to that.”
These messages contradict the public claims by Mr. Andersen that he was not concerned with politics and that it was others who politicized the question of COVID-19’s origin.
The exchange between Mr. Rambaut and Mr. Andersen indicate that the efforts of Dr. Fauci’s group to elevate the natural origin theory had nothing to do with science and were driven from the start by a desire to protect China. Mr. Rambaut’s admission that it is not possible to distinguish between natural evolution and lab creation and that the Proximal Origin group should therefore simply blame natural processes is tantamount to a smoking gun. It suggests the authors never had the intention of writing a scientific paper—instead, they were focused on covering up the pandemic’s true origin.
Mr. Andersen went even further, telling his co-authors that given the political concerns, the preprint site bioRxiv should “start screening submissions – it’s a slippery slope, but it’s justified at this stage.” A preprint site is a site where scientists can upload their research prior to peer review. Mr. Andersen was essentially proposing to censor scientists who did not toe the political line on COVID-19’s origin.
The political motivations of the origins cover-up are further corroborated by a previously released message from Ron Fouchier, who also attended the teleconference. At the same time that the Proximal Origin authors were having their discussion on Slack on Feb. 2, Mr. Fouchier wrote an email to the teleconference group stating that “further debate about such accusations would unnecessarily distract top researchers from their active duties and do unnecessary harm to science in general and science in China in particular.”
Mr. Fouchier is a Dutch virologist whose controversial gain-of-function experiments, whereby he created airborne viruses, led the Obama administration to impose its 2014 moratorium on such experiments. The moratorium was later lifted by Dr. Fauci and Dr. Collins during the Trump administration.
In response, NIH head Dr. Collins chimed in, telling the group, “the voices of conspiracy will quickly dominate, doing great potential harm to science and international harmony.”
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Is CDC Manipulating ICD Codes Involving COVID-19 Vaccine Side Effects on Death Certificates?
A review of Minnesota death certificates from an embedded source in that state reveals that of all the death certificates in Minnesota between 2015-Q1 2023, ten CoDs clearly identify a vaccine as a Cause of Death (CoD), including nine identifying a covid vaccine.
Surprisingly, our group discovered that on seven of these nine death certificates, the CDC had failed to apply an appropriate ICD-10 diagnostic code for vaccine side effects (either T88.1 or Y59.0).
I authored an article delineating the details that was republished in Brownstone. As a result of that investigation, multiple reporters contacted the CDC requesting a response to our allegations that the CDC had inappropriately omitted these ICD codes. The CDC issued the following statement to a reporter from Just The News:
“Thanks for reaching out to CDC. The claim in this post is incorrect. The ICD-10 codes in question pertain to adverse effects of vaccines, not vaccination. Vaccination is not a disease or cause of death, so simple mention of the vaccine or vaccination without mention of adverse effects will not get coded. The examples in the article for which the adverse effects codes are included are those that mention adverse or side effects of the vaccine. The examples for which the codes are not included do not contain such language.
COVID-19 vaccines are undergoing the most intense safety monitoring in U.S. history. To date, CDC has not detected any unusual or unexpected patterns for deaths following immunization that would indicate that COVID vaccines are causing or contributing to deaths, outside of the nine confirmed TTS deaths following the Janssen vaccine.
When an adverse event, including death, is reported to CDC’s Vaccine Adverse Event Reporting System, it is classified as serious or non-serious. The code of Federal Regulation defines “serious” as: death, life-threatening illness, hospitalization or prolongation of hospitalization, permanent disability, congenital anomalies or birth defects. For reports classified as serious, CDC requests and reviews the available medical records, examines death certificates and autopsy reports. The determination of the cause of death is done by the certifying official who completes the death certificate or the pathologist who conducts the autopsy.”
The CDC’s response induces considerable concern. Far from resolving this important public health-related issue, the agency’s statement, in fact, raises critical questions about the intentions and integrity of at least some aspects of the large, sprawling public health agency.
The CDC claims that they only apply ICD codes for vaccine side effects where the death certificate documents a vaccine as a CoD using language materially similar to “side effects of vaccination”--semantics that explicitly attributes the CoD to side effects from the vaccine as opposed to the act or fact of vaccination itself.
So, the CDC stipulates that a coroner who writes language such as “vaccinated 10 hours before death” as a Cause of Death means to convey that the decedent did NOT experience any adverse effects from the vaccine and that the vaccine did NOT contribute to the demise of the decedent.
But it seems implausible that a coroner or medical professional filling out a death certificate would choose to convey clinically irrelevant and misleading information about the decedent’s vaccination by writing it as a Cause of Death on the death certificate. This is all the more so regarding the Covid vaccines, where there was and still is intense professional, social, and political pressure to avoid doing or saying anything that can promote “vaccine hesitancy”.
Additionally, the standard articulated by the CDC presumes that medical professionals would be aware that in order to document a vaccine as a CoD, they must use language that explicitly describes “side effects of” a vaccine. Considering the extreme rarity of vaccines being documented on a death certificate – there was only ONE such instance in Minnesota from 2015-2019, out of >230,000 death certificates – it is highly unlikely that medical professionals would be aware of such a requirement.
The conceptual basis of the distinction drawn by the CDC’s standard likewise seems deficient. It is axiomatic that vaccine side effects must be caused by the vaccine. Thus, any medical sequelae precipitated or initiated by vaccine side effects by definition, are attributable to the vaccine itself. Furthermore, the CDC does not draw any such distinctions regarding any other medical product or substance when listed as a CoD, even though a similar argument can be made that “the ICD-10 codes in question pertain to adverse effects of [the medical product or substance]”, “not the [medical product or substance itself]” which “is not a disease or cause of death.”
It is critical to note that the CDC does not dispute our characterization of the CDC’s role of assigning and adjudicating ICD codes for death certificates and admits the decision to omit ICD codes for vaccine side effects on the death certificates we identified was a conscious and deliberate choice.
Another troubling assertion from the CDC’s statement is their claim that “to date, CDC has not detected any unusual or unexpected patterns for deaths following immunization that would indicate that COVID vaccines are causing or contributing to deaths, outside of the nine confirmed TTS deaths following the Janssen vaccine.”
There are numerous case report studies documenting autopsies of deaths that occurred shortly after vaccination with one of the mRNA vaccines in the scientific literature, many of which have already passed peer review.
A recent meta-review of these studies found that “a total of 240 deaths (73.9%) were independently adjudicated as directly due to or significantly contributed to by COVID-19 vaccination.” The study concludes, “The consistency seen among cases in this review with known COVID-19 vaccine adverse events, their mechanisms, and related excess death, coupled with autopsy confirmation and physician-led death adjudication, suggests there is a high likelihood of a causal link between COVID-19 vaccines and death in most cases. Further urgent investigation is required for the purpose of clarifying our findings.”
It is inconceivable that anyone could still claim that there have been ZERO deaths linked to the mRNA vaccines. TrialSite has chronicled deaths recognized by government health agencies around the world, such as Taiwan, Vietnam and the UK. The CDC’s insistence to contradict in defiance of numerous published studies is puzzling and possibly indicative that the CDC, or at least some factions within, lacks honesty in its appraisal of overall mRNA vaccine safety.
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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, July 11, 2023
Researcher’s Latest Stats Suggest Strong Influence of COVID Vax on Excess All-Cause Mortality
In a recent paper uploaded to ResearchGate, author Hervé Seligmann argues that data associated with 2021 excess all-cause mortality is most likely attributable to what he describes as the “secondary effects of COVID-19 injections.” While his paper is not peer-reviewed, and thus no claims should be made based on the findings, generally, governments are avoiding their responsibility to systematically look into the topic of excess death causation between 2020, and 2023. Consequently, civil society drives research and media investigations.
Seligmann’s CV shows he earned both his B.Sc. Biology and MSc in Plant Physiology from Hebrew University of Jerusalem; his Ph.D. earned in 1995 also from the same Israeli university focused on “lizard microevolution.” Seligmann doesn’t appear to be a frequent outspoken activist, which caught this media’s attention. We increasingly distrust academics and activists that exclusively make a living off of COVID-related crises, as the risk of interest-induced subjectivity and bias becomes an ever more uncomfortable dynamic.
Most of Seligmann’s publications uploaded to the open-source research repository involve mainly investigations into his core interest of cellular molecular machinery origins, with an emphasis on genetic code.
The author used data from the Centers for Disease Control and Prevention (CDC) National for Health Statistics as well as a 2019 National Vital Statistics Report to access and attempt to analyze deaths and death rates on a state-by-state basis across America. Claiming that when comparing the year 2021 to 2019 there was a total of 613,779 deaths, the academic points out 114,336 deaths comparing 2021 to 2020. See the mortality table from NIH for 2016-2020 and 2020.
The author presents a graph based on the data inputs that need to be peer-reviewed for validation, showing “excess 2021 state-wise all-cause mortality increases proportionally to state-wise VAERS death rates." This is based on the number of COVID-19 vaccination-associated VAERS reports per 100,000 individuals who received at least one dose in that specific state.
In 2021, Seligmann and Spiro Pantazatos uploaded a non-peer-reviewed paper titled “COVID Vaccination and age-stratified all-cause mortality risk” that used regional variation in vaccination rates as a basis to predict all-cause mortality and non-COVID deaths in ensuing periods based on two independent, publicly available datasets. In that paper, they said that “Vaccination correlated negatively with mortality 6-20 weeks post-injection, while vaccination predicted all-cause mortality 0-5 weeks post-injection in almost all age groups and with an age-related temporal pattern consistent with the US vaccine rollout.”
Seligman now has an update on that assessment based on the latest numbers. He posits now that based on a series of his calculations (which again need to be vetted by multiple independent reviewers) increase in all-cause death rates based on CDC VAERS data “shows that excess death rates increase 19 times faster than the VAERS death rate.” According to the author, this calculated rate “is very close to 21 times” the estimation done by himself and Pantazatos in 2021.
One challenge using the VAERS database is that the deaths cannot be automatically attributable to the vaccine, even though that’s why the system was established in the first place—safety signal detection/surveillance. But each case must be verified. Some research uses timing as an indicator of the likelihood of causation.
While no evidentiary claims can be made from this latest Seligmann paper as it is, this could change with multiple independent peer reviews by credible academic research sources. This media has tracked reports of excess mortality figures around the world. The most prominent explanation involves the pandemic, and the residual impacts of the crisis, in this case, a pandemic and its direct, secondary and tertiary effects. The COVID-19 pandemic has taken a horrific toll on the world.
Some media have shown an interest in probing this matter. For example, the Economist used machine learning algorithms to estimate that anywhere from 16.8 to 28.1 million excess deaths occurred due to all causes since the onset of the COVID-19 crisis. All sorts of problems can be derived from the pandemic including the ripple effects of myriad health concerns, put off by the pandemic, which have spiraled since then. Other factors include the widening wealth gap—the social determinants of health in many cases intensified due to pandemic conditions from 2020 to 2023.
But this media has found it quite fascinating how mainstream media and fact-checkers refuse to even consider the obvious possible impacts of the mass emergency countermeasure programs as a potential contributing force to excess deaths. The mainstream summarily dismisses any such questions as merely anti-vax hyperbole.
TrialSite is unapologetically pro-vax and is one of the few if perhaps, the only media that has consistently reported on study data evidencing both the positive and negative elements of the COVID-19 vaccines. This is just called journalism, with a biomedical research focus.
While the reality is that no pathbreaking studies have produced conclusive evidence as to what’s behind all-cause deaths since the pandemic this is in part, due to the fact that governments are generally avoiding any substantial investment to research the matter from the perspective of causation. Itself an interesting, and disturbing trend.
Hence, the importance of such research supported by civil society, that is, the community of citizens linked by common interests and shared activity for the betterment of humankind.
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Time to Regulate mRNA Vaccines as Gene Therapies: French Biomedical Scholar
Published in the International Journal of Molecular Sciences, independent French researcher Helene Banoun, Ph.D. asks the question: Why are the COVID-19 mRNA vaccines not regulated as gene therapies? TrialSite has reported that technically, at least according to the vaccine manufacturers’ investor disclosures, the products are in fact, a form of gene therapy.
But these investigational products—now licensed, were developed in an unprecedented manner under heretofore not considered regulatory, environmental and political conditions given the state and nature of the COVID-19 pandemic.
Banoun, a Ph.D. at the French Institute of Health and Medical Research/INSERM recently raised profound regulatory issues involving the COVID-19 mRNA vaccines in “mRNA: Vaccine or Gene Therapy? The Safety Regulatory Issues.” The French researcher frames the real challenge in the context that at the time of the release of these products “no specific regulations existed.” But now with the passing of the COVID-19 emergency, isn’t it time to reconsider not only the regulations of this class of product but also the true safety considerations?
According to various stances from apex research institutes, regulators and public health authorities, the mRNA vaccines are not gene therapies as biased fact checker after fact checker “busts the myth” that the mRNA products are gene therapies. The argument goes that with the mRNA vaccines, because the mRNA itself doesn’t enter the cell nucleus or for that matter, interact with the DNA whatsoever, these products fail to meet the gene therapy test.
However, as TrialSite has reported, in fact, the mRNA vaccines are very much considered gene therapies when reviewing Moderna’s own investor disclosures to the Securities and Exchange Commission, for example. See “Are mRNA COVID-19 Vaccines a Form of Gene Therapy? Yes, According to a Bayer Pharma Exec & Moderna.”
Dr. Banoun also concurs, declaring in her latest paper, “The mode of action of COVID-19 mRNA vaccines should classify them as gene therapy products (GTPs), but they have been excluded by regulatory agencies.”
But the French scholar’s concerns with the vaccines rise well above baseline concerns of definition, as she points to a regulatory track record of “non-compliant results in terms of purity, quality and batch homogeneity.”
It’s as if every validation talking point from the vaccine companies themselves, to regulators poses an ideal story of what the vaccines are supposed to be, yet the reality on the ground portends a troubling direction. Did the spike protein remain stable and localized like industry and authorities declared they would do? No, as persistent biodistribution of mRNAs and their protein products, like the spike protein, turn out to travel to every organ and cell in the body, often many months after the vaccination event.
Does this wandering spike protein threaten human health? While industry, regulators and public health agencies declare a resounding no. Unfortunately, that’s not the case. TrialSite has accumulated dozens of studies in peer-review journals evidencing a spike protein capable of inducing inflammation and more, and likely at least somehow a factor in post-COVID-19 vaccine adverse events. Of course, more research and data are necessary for conclusive understanding, but who and what will finance the research needed? What happens if the very entities that are supposed to police and regulate need policing and monitoring themselves?
Dr. Banoun’s concerns are not necessarily conclusively proven, but nonetheless valid. “Post-marketing studies have shown that mRNA passes into breast milk and could have adverse effects on breastfed babies. Long-term expression, integration into the genome, transmission to the germline, passage into sperm, embryo/fetal and perinatal toxicity, genotoxicity and tumorigenicity should be studied in light of the adverse events reported in pharmacovigilance databases.”
While a collection of anti-vaxxers, medical freedom fighters and libertarian types pounce on COVID-19 as a cause immediately promote the scary concept of vaccine shedding, and TrialSite has, on a handful of occasions, scanned the literature for any scientific validity, Banoun raises the specter that such a phenomenon must be evaluated. As well, she argues, “in-depth vaccinovigliance” all as part of a series of expectations civil society will demand of the industry, regulators and public health agencies for any future mRNA-based products.
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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, July 10, 2023
The Media’s Hypocrisy on Vaccines
Since Robert F. Kennedy Jr. tossed his hat into the 2024 presidential ring, his detractors have repeatedly pointed to one issue as evidence that he’s unfit to be president: his skepticism of the COVID-19 vaccines. The reality, however, is that the same media institutions depicting Kennedy as a wingnut spreading fringe conspiracy theories played a key role in popularizing vaccine resistance.
The sheer volume of sudden reversals in public health policy makes it difficult to recall what anyone was claiming a few years ago, but there is a simple formula to understand why “the science” keeps changing: It’s often about who benefits politically. In the months before the 2020 election, the Trump administration seemed close to hitting its stated goal of delivering a COVID vaccine by the end of the year. That would have been a clear boost to the president’s electoral chances.
Evidently alarmed by this prospect, the mainstream media, led by The New York Times, hit on the novel tactic of claiming that Big Pharma had used its financial might to corrupt government oversight of their development. The storyline had the distinct benefit of being a direct offshoot of the media’s larger narrative about Trump’s thoroughgoing and relentless corruption.
One of the first, most detailed and fleshed-out versions of the Big Pharma-COVID vaccine theory can be found in the early days of The New York Times’ COVID-19 reporting. On May 20, 2020, the Times launched its first broadside in this effort. The headline of the article, “Trump’s Vaccine Chief Has Vast Ties to Drug Industry, Posing Possible Conflicts,” painted a picture of lurking corruption, invoking a network of malfeasance reminiscent of Hillary Clinton’s “vast right-wing conspiracy.”
The first paragraph underscored this point, alleging that Trump’s new virus “czar,” Moncef Slaoui, former head of vaccines at GlaxoSmithKline, had “intricate ties to big pharmaceutical interests.” The Times went on to enumerate the $12.4 million worth of Slaoui’s shares in Moderna—even though Slaoui had sold those shares as he stepped into his government role. The Times also repeatedly implied that administration officials involved in the development of the vaccines possessed vast conflicts of interest, writing that Health Secretary Alex Azar “is a former Eli Lilly executive” and former FDA commissioner Scott Gottlieb “has moved in and out of government twice.”
The paper’s later stance on the integrity of the vaccine development process aside, this all would have been worthy reporting, important for the American public to know. But the Times went far beyond showing the ties of officials to the pharmaceutical industry and—months before a single vaccine had been produced—began insinuating that any vaccine produced could carry major risks. “[Moderna’s vaccine] technology, which uses genetic material from the virus called mRNA, is relatively new and unproven. And many vaccine candidates fail after showing preliminary promise, or cause serious side effects in later human trials,” the Times wrote in its May 2020 piece (emphasis added).
Just two weeks later the paper went much further, implying in a June 3, 2020 article that COVID vaccine corruption was systematic and political. “Operation Warp Speed amounts to a sprawling, on-the-fly experiment in industrial policy by a Republican administration that has been otherwise dedicated to giving private industry a free hand,” two Times reporters asserted.
There is a simple formula to understand why ‘the science’ keeps changing: It’s often about who benefits politically.
There were, to be sure, irregularities and conflicts of interest in the emergency authorization to produce the COVID vaccines (not surprising given that pharma is the largest and most powerful lobby in the United States). But the media coverage of the issue, which reached a fever pitch in the Trump years but fell mostly silent on the topic once Trump was out of power, ignored nuances to score political points. The unintended consequence was that, imbued with more than a grain of truth, the story about Big Pharma putting profit ahead of prudence took on a life of its own. Now that the political winds have shifted, the media is essentially fighting a narrative of its own creation.
By late summer 2020, this narrative was braided with another about vaccine malfeasance, simultaneously slamming Trump for rushing the vaccine development process and for allegedly lying about the rollout date. In May 2020, after Trump said he was “confident” vaccines would be available by the end of the year, it triggered a barrage of snark from supposedly neutral fact-checkers attempting to refute the president’s claim. NBC’s fact-check offers an example of the genre: “experts say [Trump] needs a ‘miracle’ to be right.” Trump was simultaneously painted as an unreliable fibber who would never be able to follow through on his promises while being accused of rushing to get the vaccines ready ahead of the November election.
But the gut punch came when the Times again questioned the safety of the vaccines being produced. “Under constant pressure from a White House anxious for good news and a public desperate for a silver bullet to end the crisis, the government’s researchers are fearful of political intervention in the coming months and are struggling to ensure that the government maintains the right balance between speed and rigorous regulation,” the Times reported in an August 2020 piece.
By that month, the media’s effort began to pay dividends. A week after the Times claimed the Trump administration was “desperate for a silver bullet,” news broke that House Democrats had opened an investigation into Slaoui on the basis of the Times’ unfounded allegations. NBC News, citing the Times’ claims, reported that Democratic Rep. Jim Clyburn had called financial arrangements involving Operation Warp Speed “opaque.”
In September, the Times ran an op-ed by American historian Rick Perlstein that cast the government’s plan to use emergency authorization for the COVID vaccine as Trump’s “most reckless obsession yet.” This bid, the Times op-ed blared in alarm, could end with the vaccines being distributed “before some scientists believe it would be safe to do so” and in a way that could “further erode public confidence in vaccines—and possibly kill.”
Those tropes in fact were and are similar to those advanced by Robert F. Kennedy Jr.—tropes that, as if by magic, are now roundly condemned by the media that lent them credibility and seeded them into the public consciousness.
By the time of the 2020 election, the notion that Big Pharma had unduly influenced the COVID vaccines for profit was media gospel. The accepted narrative was that, with a nod from Trump, Big Pharma had rushed out potentially dangerous experimental vaccines with a bevy of unknown side effects. With so much momentum behind it, this idea continued to gather steam. And now it’s more like an out-of-control freight train than the power-corridor Acela it was supposed to be. The media is reaching for the brakes but the public, long since convinced, is racing full steam ahead.
https://www.tabletmag.com/sections/news/articles/media-hypocrisy-on-vaccines
*****************************************************Research Review at Univ. of Patras: COVID-19 Vax Can Induce Liver Injury
An internist and infection expert, and colleagues at University of Patras in Greece’s third largest city and regional capital of Western Greece, in the northern Peloponnese approximately 130 miles west of Athens, investigated whether the COVID-19 vaccines associated with the occurrence of autoimmune phenomena involving the liver.
Karolina Akinosoglou and colleagues find that while rare, several studies indicate an increase in the incidence of vaccine-induced live injury pointing to specific instances of hepatocellular injury that involve immune-mediated pathways. Professor Akinosoglou, and colleagues from University of Patras conduct a mini review, looking into the underlying pathophysiology involving immune-mediated liver injury post COVID-19 vaccination. The team located in Western Greece also investigated the most widely distributed vaccine formulations’ autoimmune and hepatotoxic potential.
Recent findings from a Patras led investigation were published in the World Journal of Virology.
Background: rare but real--liver injuries
A rare injury secondary to COVID-19 vaccine administration, the incidence of such injuries became a topic of research given the continuous pharmacovigilance post the mass immunization program across much of the world including Greece.
The Greek medical internists represented by the corresponding author Dr. Akinosoglou declare on absolute terms that the three most commonly used COVID-19 vaccines (other than in China and parts of Asia) including the two mRNA -based products (Pfizer-BioNTech—BNT162b2 and Modena—mRNA-1273) plus the AstraZeneca/Oxford jab (ChAdOx1-S) “can induce liver injury that may involve immune-mediated pathways and result in autoimmune hepatitis-like presentation that may require therapeutic intervention in the form of corticosteroid administration.”
But what is causing these rare, but real injuries?
Review of the research
Various investigations have sought to establish vaccine and liver injury causality involving attempts to highlight immune checkpoint inhibition. Moreover, when vaccine-induced liver injuries are established, researchers search for underlying vaccine mechanisms across the different platforms.
To date, the Greek team points to evidence that both mRNA-containing lipid nanoparticles and adenoviral vector platforms “contribute to the inflammatory background that leads to an exaggerated immune response, while patterns of molecular mimicry between the spike (S) protein and prominent liver antigens may account for the autoimmune presentation.”
What is proposed vaccine-induced immune mediators?
Akinosoglou and team point to unfolding research that suggests that the combination of ingredients in the COVID-19 vaccines, plus autoreactive antibodies, cytokines as well as cytotoxic T-cell populations are possible culprits behind hepatocellular damage via well-established pathways.
Concluding thoughts
Overall, COVID-19 vaccine injuries are rare, and liver injury as a result of some immune-mediated process remains an even rarer incidence. Thus, the authors declare “Immune-mediated liver injury remains an elusive, but rare entity following COVID-19 vaccination.” They encourage investigators and scientists around the world to keep an eye out for these and other injuries, no matter how rare. Yet the study authors remind all that at least according to their logic, the benefits of COVID-19 vaccination outweigh the higher risks associated with the disease itself.
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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, July 09, 2023
COVID-19 Vaccines Linked to Kidney Disease Safety Signal—Fujita Health University Investigation
Clinical investigators across disciplines affiliated with Fujita Health University in Toyoake, Japan, south and west of Tokyo, review the large national pharmacovigilance database capturing real-world spontaneous adverse event (AE) reports to identify any signals involving the most common form of glomerular injury post-COVID-19 vaccination known as IgA nephropathy (IgAN).
Represented by corresponding author Mizuno Tomohiro in the Department of Clinical Pharmacy at Fujita Health University, the team sought to investigate the frequency of IgAN post-COVID-19 vaccination based on a designed study of the Japanese Adverse Drug Event Report (JADER) database. Reviewing a total of 697,885 cases, Tomohiro and colleagues detected safety signals for IgAN (ROR: 6.49, 95% CI: 4.38–9.61; IC: 2.27, 95% CI: 1.70–2.83). Identifying a total of 30 COVID-19 vaccine-associated IgAN cases, 16 of these had information about the cases at the time of onset.
Of these, 11 of the cases occurred 2 days after vaccination, and two occurred >28 days after vaccination. Safety issues are raised by these findings as the Japanese clinical investigators write “These results suggest that compared with other drugs, COVID-19 vaccination is associated with a higher frequency of IgAN. Monitoring of gross hematuria following COVID-19 vaccination should be needed.”
The recent results of the study titled “COVID-19 mRNA Vaccination is associated with IgA nephropathy: an analysis of the Japanese adverse drug event report database” were published in the Journal of Pharmacy & Pharmaceutical Sciences.
Before delving into study findings, a brief overview of the condition—IgAN.
What is IgAN?
Also known as IgAN or Berger’s disease, IgA nephropathy is a chronic kidney disease characterized by the deposition of immunoglobulin A (IgA) antibodies in the glomeruli, which are the filtering units of the kidneys. It is the most common form of glomerulonephritis worldwide.
With this disease, there is an abnormal immune response where IgA antibodies, which are part of the immune system and normally help protect against infections, become deposited in the glomeruli instead of being cleared from the body. This deposition triggers an inflammatory response and can lead to kidney damage over time.
The study
This study team analyzed data on drug-associated AEs reported between April 2004, and May 2022, via the JADER database on the Pharmaceuticals and Medical Devices Agency website. The team calculated reporting odds ratios (RORs), information components (ICs), and their 95% confidence intervals (CIs) using two-by-two contingency tables in the study team’s quest to evaluate the safety signals for the targeted AEs.
Findings
The authors report, “A total of 697,885 cases were included in the analysis. Safety signals were detected for IgAN (ROR: 6.49, 95% CI: 4.38–9.61; IC: 2.27, 95% CI: 1.70–2.83). Of 30 cases of IgAN associated with COVID-19 mRNA vaccines, 16 had information available on time to onset. Of the 16 cases, 11 occurred ≤2 days after vaccination, and two occurred >28 days after vaccination.” Note, 11 cases never recovered, at least not to date.
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Canadian Investigators Discovery Unique Blood Plasma Protein Patterns in Long COVID Patients
A Canadian research unit may come up with a way to treat at least some long COVID patients more effectively. The condition has emerged since the pandemic as a real problem. With anywhere from 10-20% of people that have been infected with SARS-CoV-2 susceptible to long COVID, some estimate north of 14 million people in America alone struggling with the condition, which can last for many months. Often impacting the quality of life, symptoms from brain fog and fatigue to breathing difficulties can be outright debilitating.
Led by Dr. Douglas Faser, a professor in pediatrics at Schulich School of Medicine & Dentist, and physician at London Health Sciences Centre (LHSC) a team of Canadians designed a study using artificial intelligence (AI) as part of advanced research to discover unique patterns of blood plasma proteins in patients with suspected long COVID, with an aim on improving patient outcomes. Enter the “plasma proteome,” as the research centers on proteins identified in blood plasma, released by cells often playing a vital role in pathogen immune response.
With study results recently published in the Journal of Translational Medicine this study team sought out to better understand how these plasma cells impact patients with long COVID, and why some patients struggle more than others.
Corresponding authors Dr. Douglas Faser and Cristiana Losef, both with Children’s Health Research Institute, Victoria Research Laboratories, and colleagues investigated possible mechanisms, and to inform the prognosis and treatment of long COVID.
This technology allowed researchers to determine unique patterns in the blood proteins. The team discovered that people with suspected long COVID have prolonged inflammation associated with changes in their immune cells and blood vessels. These changes may lead to problems in specific organs, like the brain and the heart, as reported by Western University.
Called “the plasma proteome,” the proteins are found in blood plasma and are released by cells that often play an important role in the body’s immune response to viruses. The research team is studying how those proteins adapt and change in long COVID.
The study
With a green light from the local Ethics Committee (Western University), the study team enrolled patients from London Health Sciences Center in London, Ontario, Canada and St. Joseph's including patients diagnosed with long COVID as well as acutely ill COVID-19 patients.
Upon diagnosis of long COVID, study patients were referred to a specialist clinic based on prolonged, diffuse symptoms according to the author's account in the Journal of Translational Medicine.
Conducting a series of tests including venous blood work, the study team analyzed patient plasma. COVID-19 patients were approached when they were admitted to the hospital or medical ward or intensive care unit. Healthy subjects were included—persons without disease, acute illness or any prescription medicine, but previously banked by the Translational Research Center in London, Ontario.
All samples in the study were matched by age and gender (e.g., long COVID patients to acutely ill patients to healthy controls).
Results
Unlike acutely ill COVID-19 patients as well as healthy subjects---both matched by age and sex—the long COVID outpatients evidenced natural killer cell redistribution with a dominant resting phenotype, opposite to active and neutrophils formed in extracellular traps.
The study team reports a possible “resetting of cell phenotypes” likely resulting from “prospective vascular events mediated by both angiopoietin (ANGPT1) and vascular endothelial growth factor-A (VEGFA).
Validating several biomarkers (ANGPT1, VEGFA, CCR7, CD56, citrullinated histone 3, elastase) the authors report also that “Signaling of transforming growth factor-β1 with probable connections to elevated EP/p300” pointed to both vascular inflammation as well as tumor necrosis factor- α driven pathways. The authors suggested that the progression from acute COVID-19 to long COVID was “a vascular proliferative state associated with hypoxia-inducible factor 1 pathway.”
Fraser and Losef write that this “vascular-proliferative process predicted in Long-COVID might contribute to changes in the organ-specific proteome reflective of neurologic and cardiometabolic dysfunction.”
PI Point of View
Cristiana Losef, a research analyst at Children’s Health Research Institute (CHRI), a program of Lawson went on the record, “We used novel technologies for this study, allowing us to analyze more than 3,000 proteins in blood plasma at the same time with multiple patients.”
Losef continued:
“We used a novel bioinformatic pipeline, a form of artificial intelligence (AI), to analyze the proteins to determine the specific changes that occur in long COVID.”
Dr. Michael Nicholson, associate scientist at Lawson, and respirologist at St. Joseph’s Health Care London reports on the influence of this study, “Trying to understand this mechanism is quite important because it provides further insight into how patients are affected,” says Dr. Michael Nicholson. He continued, “This paper sheds further light on a possible mechanism that may provide insight into why some patients have certain symptoms.”
Michael Knauer, an associate scientist at Lawson shared for Western University, “The saved blood plasma samples we are using helped us determine the long-term responses to COVID-19; serial blood plasma samples from individuals that had a COVID-19 infection and now presumed long COVID will help us determine how proteins are changing over time.”
What’s the potential value from a therapeutic perspective?
Dr. Faser, a professor at Schulich Medicine, said the proteins discovered could act as a potential drug target. The team is now examining potential new drug therapies with the hopes of improving outcomes for these patients.
Fraser emphasized:
“When we identify these signaling patterns within the blood plasma, we can then take the information and screen drug databases to better understand which drugs would be best to target the changes we identified in long COVID patients.” Pointing to the potential of these findings, “With this understanding, the identified drugs may be used in future long COVID clinical trials.”
Key Point: This research, which used multiple state-of-the-art technologies, was enabled by existing expertise and infrastructure through Children’s Health Research Institute (CHRI). It reveals that the findings point to a “vascular-proliferative process in Long-COVID that is likely initiated either prior hypoxia (localized or systemic) and/or stimulatory factors (i.e., cytokines, chemokines, growth factors, angiotensin, etc.). Analyses of the plasma proteome, used as a surrogate for cellular signaling, unveiled potential organ-specific prognostic biomarkers and therapeutic targets.”
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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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