Friday, April 21, 2023
Some Americans Shouldn’t Get Another COVID-19 Vaccine Shot, FDA Says
A big change: The vaccines we have all been using are now de-authorized. Only the bivalents are now approved, despite there being little evidence of their effectiveness. Amazing. A "bivalent" targets more than one strain of the virus
Some Americans cannot receive another COVID-19 vaccine dose, U.S. regulators said on April 18, as they made sweeping changes to the vaccine system.
The U.S. Food and Drug Administration (FDA) announced the changes, including replacing the old Pfizer and Moderna vaccines with updated bivalent shots that had previously only been available as boosters.
Regulators are also scaling back the number of recommended doses for most individuals, including people who haven’t received a shot.
Key changes include:
Most unvaccinated Americans are still being encouraged to get a COVID-19 vaccine but only need a single dose of a bivalent, the FDA said. The exception is young children. Children aged 6 months through 5 years can receive two doses of Moderna’s bivalent while those aged 6 months through 4 years can get three doses of Pfizer’s bivalent.
Americans who have received a primary series of a COVID-19 vaccine and one of the bivalent boosters still cannot get an additional dose, unless they’re in certain groups.
Any individual 65 years old or older can receive a bivalent dose, even if they’ve already received one, provided four months or more has elapsed since their last shot.
People aged 5 and older and deemed immune compromised can get another bivalent at least two months after their last shot, even if it was a bivalent, and can get additional doses “at the discretion of, and at intervals determined by, their healthcare provider.”
Little Data to Support Bivalents
The FDA authorized the original vaccines in late 2020 based on clinical trial efficacy data. The original vaccines targeted the Wuhan virus strain, which hasn’t circulated since 2020.
The updated bivalents target the Wuhan strain and the BA.4 and BA.5 subvariants of the Omicron strain. The subvariants were displaced in 2022.
Regulators authorized the bivalents as boosters in 2022 despite no clinical trial data being available. In letters formally announcing the bivalents as replacing the old vaccines, the FDA made clear that scientists aren’t sure whether the bivalents protect against COVID-19.
“Based on the totality of the scientific evidence available, FDA concluded that it is reasonable to believe that Pfizer-BioNTech COVID‑19 Vaccine, Bivalent may be effective in individuals 6 months of age and older for the prevention of COVID-19,” the letter to Pfizer states. The same language was used for Moderna’s shot.
Most of the data supporting Pfizer’s expanded authorization comes from the old vaccines and a bivalent that has never been used in the United States. The only trial data for the available bivalent showed that children had higher levels of neutralizing antibodies when they received a bivalent. Antibodies are thought to protect against COVID-19.
No clinical trial data for Moderna’s shot was cited, and no efficacy data was cited for either vaccine.
Dr. Peter Marks, a top FDA vaccine official, claimed in a briefing that “the available data continue [to] demonstrate that vaccines prevent all serious outcomes from COVID-19, including hospitalization and death.” It’s not clear which data he was citing, and the FDA did not respond to a request for comment.
The FDA cited a single observational study in its letter to Pfizer. English researchers reported in The Lancet that vaccination with an old vaccine in addition to previous infection provided strong protection against symptomatic COVID-19 through March 2022. Other research has found that prior infection alone is as good as or better than vaccination.
Other observational studies have found the updated vaccines provide transient protection against hospitalization and poor protection against infection.
Seroprevalence data indicates a majority of Americans have recovered from COVID-19, the FDA noted. That’s an important acknowledgement, Dr. Monica Gandhi, a professor of medicine at the University of California–San Francisco, told The Epoch Times in an email.
Gandhi said she agrees that only the elderly and immune suppressed should receive another dose, as opposed to the entire population. Dr. Harvey Risch, professor emeritus of epidemiology at the Yale School of Public Health, said that he sees the vaccines as largely unnecessary.
“The current vaccines are out-of-date, any new ones will be out-of-date by the time they are generally available, and mostly everybody already has SARS-CoV-2 antibodies anyway,” Risch told The Epoch Times via email. “At this point, the vaccines are thus not generally useful products for serving a public health function.”
Change Made to Boost Uptake
Uptake of the vaccines was high after they were authorized, but has dropped considerably since. Just 16.7 percent of the U.S. population has received a bivalent shot, compared to 69.4 percent who received a primary series of the old vaccine.
FDA officials said the changes announced on April 18 were made to simplify the vaccine composition, reduce the complexity of the available doses, and increase uptake.
“This approach will help us achieve higher vaccination coverage across the country,” Marks told reporters. “If anything comes out of this action, we’re hoping that it can encourage people who have not received the bivalent booster to go out and consider getting one.”
The newly rolled out system is for the spring, as officials are planning to meet over the summer to discuss a fall regimen. They plan to adapt COVID-19 vaccines to the influenza model, updating strains in the vaccines each year.
Advisers to the agency backed the pivot to bivalents in a January discussion. Some said they favor updating the strains in the future.
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Prominent AIIMS Physician-Scientist Suggests COVID-19 Booster Shot May Do More Harm than Good
A physician with India’s All India Institutes of Medical Sciences (AIIMS), New Delhi, a group of autonomous public medical universities of higher education under the jurisdiction of Ministry of Health and Family Welfare, went on the record for Indian media recently that for those that have already been infected by SARS-COV-2, the booster may “do more harm than good.” However, he didn’t elaborate on the basis for that statement. With rising numbers of COVID-19 cases in India, Dr. Sanjay Rai recently expressed his opinion that despite the fact that many experts are advising the COVID-19 booster, at this point during the pandemic, the booster may do more harm than good. The context is a rising COVID-19 infection rate in India but also in other Asian nations such as Japan, China, and South Korea. TrialSite’s founder Daniel O’Connor also had a fascinating discussion with Dr. Rai, who pointed to mounting evidence plus decades of public health science as backing his position. He also referenced that in addition to the 11 COVID-19 vaccines currently under emergency listing by World Health Organization (WHO), at least another 382 such products are listed by WHO in either clinical development or preclinical development. He pondered what could be driving such an enormous product development push?
Rising cases
According to multiple media and the Indian government, cases of COVID-19 have surged in India, with over 10,700 cases reported; 1,500 more cases were registered in New Delhi, with a purported infection rate at 33%. See a breakdown of India cases (and other data). Clearly, the number of cases is minuscule compared to previous waves. Hence the advisory for all to get the booster if they have not been vaccinated within a certain period of time based on the current Indian schedule.
A critical point of view
Yet Dr. Sanjay Rai, an AIIMS Hospital professor of Community Medicine in New Delhi, shared his opinion recently that the booster dose may not be advised, as reported in India Times Healthworld.
“Due to the mutation in the RNA virus, the cases will continue to increase and decrease. The situation will continue like this in the coming times as well. There is no need to panic about this. The people that will get infected with the new variants will create new immunity. But despite all this, the more important thing is whether the severity, hospitalization, or the death rate is increasing.”
He continued, “In the initial phase of COVID, when people were not infected in large numbers, people did not have herd immunity, then they needed more vaccines. But now, almost all the people have herd immunity, then they needed more vaccines. But now almost all the people in the country have been infected, after which natural immunity has been formed in them. This is more effective in protecting against any virus than the vaccine. Also, we cannot stop any new web with the vaccine, it only reduces death and severity. Giving more steroids to prevent infection may do you more harm than good.”
Further discussing the topic of natural immunity, Dr. Rai pointed to a growing body of research backing his position on natural immunity.
“And you have been protected from death and severity for a long time. At present, both corona and influenza are infecting people. Influenza is a viral infection that comes every year and infects people according to season. How effective will the booster dose of the vaccine be? No research has come to the fore regarding this. Only on the basis of possibilities we cannot say that booster dose will be beneficial for people at this time.”
Heavily vaxxed societies
Dr. Rai points out to heavily vaccinated societies such as Japan, where the cases of SARS-CoV-2 continue to come and go and come again.
“All these countries have been highly vaccinated, Japan has got 4 doses of the vaccine, yet the corona infection was once again spreading very fast there. COVID-19 spread rapidly even after vaccination in these countries because they kept zero COVID-19, people did not have natural infection due to which people got infected even after being vaccinated.”
Emphasizing the superiority of natural infection to vaccine-induced protection—not a discussion that will be as freely discussed in North America—the key point is that if a person hasn’t been infected then they should get vaccinated.
Rai continued:
“There is no research on how effective the booster dose will be if you are already infected. And if this new variant is infecting you by bypassing natural immunity, then it can also bypass the vaccine and infect you.”
TrialSite discussion
TrialSite had a brief discussion with Dr. Rai, who was familiar with the media platform. The AIIMS physician-scientist informed Daniel O’Connor that his position is based on the accumulation of evidence in clinical trials and real-world data over the past three years of the pandemic. Dr. Rai shared that the SARS-CoV-2 and COVID-19 aren't new now—“We have a lot of data, and that must truly be evidence-based, not acting out of a fear-based impulse.”
Rai emphasized that he has conducted at least ten COVID-19 vaccine clinical trials, including a booster study in India. He is very much pro-vaccine and simply is following what he knows is as the standard science and sound public health principles he has learned throughout his career.
The AIIMs doctor suggested a comparison with polio or smallpox, pointing to very good, stable sterilizing vaccines with the current COVID-19 reality. For example, Rai pointed to the World Health Organization (WHO) tracker with 11 vaccines granted emergency listing with 183 vaccines in various stages of clinical development and even another 199 vaccines in preclinical development.
Again, comparing the polio and smallpox or measles and mumps vaccine reality with COVID-19, with at least 382 COVID vaccines in either clinical or preclinical development, Rai suggested there could be other vested interests driving such a reality. See the WHO COVID-19 vaccine tracker.
Dr. Rai pondered aloud in the discussion, “What kind of vested interests are behind this global product development push?”
On to the endemic reality
The AIIMS doctor continued to emphasize that what Indian society (and other places around the world) are now dealing with will go on forever. So, assuming he is correct (and this media cannot be certain one way or another), this means that much like the flu, COVID-19 is here to stay.
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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) Also here
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH) Also here
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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Thursday, April 20, 2023
US Compensates People Injured by COVID-19 Vaccines for First Time
The United States has for the first time paid people who were injured by COVID-19 vaccines.
Three people received compensation for their injuries through the Countermeasures Injury Compensation Program (CICP), run by an agency within the Department of Health and Human Services, officials said in a new update.
One person who suffered severe allergic shock received $2,019, according to the agency, the Health Resources and Services Administration. One person who suffered heart inflammation, or myocarditis, received $1,582. Another who suffered myocarditis received $1,032.
The manufacturer of the vaccines was not made public. Information about the people who received the payments has also not been made public.
The payouts mark the first time the U.S. government has paid people who were injured by the COVID-19 vaccines, which can cause serious problems as well as death and were first introduced in late 2020.
Under the CICP, people who survive their vaccine-induced injury can receive money for unreimbursed medical expenses and lost employment income.
The newly granted compensation appears to only be for medical expenses, Wayne Rohde, author of The Vaccine Court, told The Epoch Times.
“These amounts are so low that you can credibly assume that this was just only for unreimbursed medical expenses, and that’s it,” Rohde said. “It’s unconscionable what they’re doing, but that’s this program.”
Most previous payments were for people injured by an H1N1 vaccine, including for Guillain-Barre syndrome. Some received hundreds or thousands of dollars. Eight received at least $106,723. The highest payment on record is $2.2 million.
The Health Resources and Services Administration, which runs the program, did not respond to requests for comment.
CICP
The CICP is the only venue people can get compensation from the federal government because of the COVID-19 emergency declaration first issued during the Trump administration. Most vaccines administered in the United States are covered by the National Vaccine Injury Compensation Program. People who receive compensation through the latter are eligible for more money, in part because more categories are covered, have longer to file, and can have attorney fees covered.
To get compensation from the CICP, a person must prove a “causal connection” between the vaccine taken and a serious physical injury or death, with the connection being supported by “compelling, reliable, valid, medical and scientific evidence.” The person must also show unreimbursed medical expenses or that they lost income because they were unable to work due to the injury.
Relatives of people who died can ask for survivor death benefits.
The cap for CICP on death benefits is $423,000 and the cap on lost wages is $50,000 but key questions remain, including whether survivors automatically get a full payout if their claim is approved and whether future medical care for the injured could be covered, Rohde said.
Program administrators have largely declined to share details about the program’s payments and claims that have been rejected.
While the National Vaccine Injury Compensation Program payments come from a pool formed through a tax on each vaccine, CICP payments are made from appropriations from Congress.
Still Waiting
The first COVID-19 vaccines were authorized in December 2020. A third was cleared in the spring of 2021. They were promoted widely by U.S. health officials and taken by hundreds of millions of Americans.
Historic numbers of adverse events following vaccination have been reported to the Vaccine Adverse Event Reporting System, helping authorities determine that events like severe allergic shock, or anaphylaxis, and myocarditis are caused by the vaccines.
While anyone can enter a report into the reporting system, the CICP only accepts applications filed within one year of an event. The program also only covers a small number of events at present, though what it covers exactly has not been made public.
As of April 1, 8,133 applications to CICP allege injuries and/or deaths from COVID-19 vaccines. Hundreds have been denied because of a lack of sufficient medical records or other problems, authorities say. Thousands more are pending review or are being reviewed.
Just 23 have been determined to meet the standard for compensation, including the three that were compensated.
One person suffered myocarditis from a COVID-19 vaccine but did not have “eligible reported losses or expenses,” according to CICP administrators.
Of the remaining 19 applicants waiting for compensation, 18 suffered from myocarditis, a related condition called pericarditis, or a combination of myocarditis and pericarditis. The other approved claim was for angioedema, a skin condition.
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One Moment He Was in Command of a 150,000-Pound Plane, Next He Was Technically Dead
On a clear spring day in 2022, Capt. Bob Snow steered an Airbus A321 toward its destination gate, as he had done thousands of times during his 31-year career with American Airlines.
But Snow almost didn’t live to talk about Flight 1067 from Denver to Dallas. Shortly after arriving safely in Texas, Snow collapsed in the cockpit. He was in cardiac arrest.
The crisis struck without warning; Snow had felt fine that day. He was a healthy, lean 60-year-old with no history of heart trouble.
However, Snow had taken a COVID-19 injection under the threat of being fired from his job; Snow believes the shot put him at greater risk for a sudden cardiac malfunction.
Regardless of what touched off the medical emergency, it rendered Snow unconscious. And if he had blacked out just a few minutes sooner, the plane’s co-pilot (officially called a “first officer”) would have been under extreme pressure to prevent a terrible accident.
Instead, circumstances aligned perfectly to avert tragedy for Snow, his co-pilot, and their planeload of about 175 passengers.
“I count my lucky stars, and I count my blessings,” Snow told The Epoch Times in March as the first anniversary of his near-fatal encounter approached. While grateful for being alive, Snow laments being robbed of his health, which disqualifies him from flying airplanes—a lifelong passion.
In a widely circulated video, shot while he was still hospitalized, Snow became one of the nation’s first pilots to go public with vaccine-related concerns. He remains convinced that more investigation is needed, especially because once-rare reports of pilot incapacitations seem to be happening more frequently. Seven pilot incapacitations made headlines last month.
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California Church Faces $1.2M Fine for Defying COVID-19 Mandates, Says Not 1 Case of Covid Traces Back to Worship Services
A California Superior Court judge ordered a church to pay more than $1 million in fines for refusing to comply with COVID-19 mask mandates during the pandemic.
The church, Calvary Chapel San Jose, slammed the ruling and Santa Clara County’s efforts to defend the fines in court, arguing that not one case of COVID-19 has been traced back to the church’s worship services.
“There hasn’t been a single COVID-19 case traced to the church. To claim that this about public safety is just false,” Bob Tyler, president of Advocates for Faith & Freedom, which represents the church in court, told The Daily Signal in a statement Monday following the ruling Thursday. “In actuality, this is about the right of churchgoers to freely practice their faith without interfere or discrimination.”
“The church just wants to be afforded the same treatment and consideration as liquor stores, strip clubs, and other so-called essential businesses,” Tyler added.
Judge Evette Pennypacker ruled that Santa Clara County’s masking and social distancing orders were lawful and that the church had to pay $1.2 million in fines for violating them.
While the church had pointed out that some other institutions had received conditional and temporary exemptions for mask requirements, the court rejected the claim that these exemptions undermined the county’s authority to impose requirements on the church. A fire chief, for example, legally removed his mask to exercise in close proximity to his colleagues. By contrast, Calvary Chapel worshippers removed their masks for an entire service.
The judge ruled that the Christian church’s leaders “repeatedly announced their refusal to comply with masking requirements, never reported to the county that they had come into compliance with the masking requirement, and to this day maintain that they were never required to comply with that requirement at any time under any circumstances.”
“It should appear clear to all—regardless of religious affiliation—that wearing a mask while worshiping one’s god and communing with other congregants is a simple, unobtrusive, giving way to protect others while still exercising your right to religious freedom,” Pennypacker wrote. “Unfortunately, [church leaders] repeatedly refused to model, much less, enforce this gesture. Instead, they repeatedly flouted their refusal to comply with the public health orders and urged others to do so ‘who cares what the cost,’ including death.”
However, Pennypacker rejected further fines that the county had imposed, ruling that the extra fines amounted to “fining [Calvary Chapel] for the same violation twice.”
“The court was partially correct when it declared almost $2 million of the $3 million in fines to be unlawful,” Tyler told The Daily Signal. “The State Court’s legal analysis is simply flawed as to the remaining fines.”
He said the church plans to appeal the ruling and he expressed hope that “the court of appeal will ultimately correct the error by declaring all of the fines unconstitutional.”
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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) Also here
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH) Also here
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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Wednesday, April 19, 2023
Physio-metabolic and clinical consequences of wearing face masks—Systematic review with meta-analysis and comprehensive evaluation
Kai Kisielinski et al
Background: As face masks became mandatory in most countries during the COVID-19 pandemic, adverse effects require substantiated investigation.
Methods: A systematic review of 2,168 studies on adverse medical mask effects yielded 54 publications for synthesis and 37 studies for meta-analysis (on n = 8,641, m = 2,482, f = 6,159, age = 34.8 ± 12.5). The median trial duration was only 18 min (IQR = 50) for our comprehensive evaluation of mask induced physio-metabolic and clinical outcomes.
Results: We found significant effects in both medical surgical and N95 masks, with a greater impact of the second. These effects included decreased SpO2 (overall Standard Mean Difference, SMD = −0.24, 95% CI = −0.38 to −0.11, p < 0.001) and minute ventilation (SMD = −0.72, 95% CI = −0.99 to −0.46, p < 0.001), simultaneous increased in blood-CO2 (SMD = +0.64, 95% CI = 0.31–0.96, p < 0.001), heart rate (N95: SMD = +0.22, 95% CI = 0.03–0.41, p = 0.02), systolic blood pressure (surgical: SMD = +0.21, 95% CI = 0.03–0.39, p = 0.02), skin temperature (overall SMD = +0.80 95% CI = 0.23–1.38, p = 0.006) and humidity (SMD +2.24, 95% CI = 1.32–3.17, p < 0.001). Effects on exertion (overall SMD = +0.9, surgical = +0.63, N95 = +1.19), discomfort (SMD = +1.16), dyspnoea (SMD = +1.46), heat (SMD = +0.70), and humidity (SMD = +0.9) were significant in n = 373 with a robust relationship to mask wearing (p < 0.006 to p < 0.001). Pooled symptom prevalence (n = 8,128) was significant for: headache (62%, p < 0.001), acne (38%, p < 0.001), skin irritation (36%, p < 0.001), dyspnoea (33%, p < 0.001), heat (26%, p < 0.001), itching (26%, p < 0.001), voice disorder (23%, p < 0.03), and dizziness (5%, p = 0.01).
Discussion: Masks interfered with O2-uptake and CO2-release and compromised respiratory compensation. Though evaluated wearing durations are shorter than daily/prolonged use, outcomes independently validate mask-induced exhaustion-syndrome (MIES) and down-stream physio-metabolic disfunctions. MIES can have long-term clinical consequences, especially for vulnerable groups. So far, several mask related symptoms may have been misinterpreted as long COVID-19 symptoms. In any case, the possible MIES contrasts with the WHO definition of health.
Conclusion: Face mask side-effects must be assessed (risk-benefit) against the available evidence of their effectiveness against viral transmissions. In the absence of strong empirical evidence of effectiveness, mask wearing should not be mandated let alone enforced by law.
https://www.frontiersin.org/articles/10.3389/fpubh.2023.1125150/full
*************************************************COVID-19 May Have Troubling Impacts—May Shrink Numerous Parts of the Brain
What are the prolonged neurological clinical consequences related to brain changes in persons with mild COVID-19 infection, if any? Researchers from India sought to answer this and other questions via a systemic review of investigations targeting COVID-19 and the human brain. What is the possible connection of COVID-19 and direct brain injury via encephalopathy (a disease of the brain that alters brain function or structure), for example?
In this review, the investigators, including corresponding author Puranam Revanth Kumar, Ph.D., affiliated with IFHE University, Hyderabad, found that when compared to a control group, study subjects who tested positive for COVID-19 presented more brain shrinkage, grey matter shrinkage and tissue damage. This damage primarily afflicts segments of the human brain linked to odor, ambiguity, strokes, reduced attention, headaches, sensor abnormalities, depression and mental abilities for a few months post the first infection.
Published in the Journal of Neuroscience & Biobehavioral Reviews, TrialSite provides a breakdown of this study result---outcomes which didn’t find much media attention in North America.
While SARS-CoV-2, the virus behind COVID-19, leads to respiratory disease, the novel coronavirus infection can also have negative impacts on the brain. This means that the disease symptoms are not just limited to respiratory systems but rather can impact other organs in the human body.
Viruses, in general, can affect neurological systems. With COVID-19, numerous studies point to significant incidences of neurological and cognitive abnormalities in the infected. Citing studies such as Raahimi et al., 2021, the current authors point to evidence that COVID-19 can impact the brain directly.
Does COVID-19 invade the human brain?
In this study, the authors from India point to evidence that SARS-CoV-2 is able to penetrate the brain. Here the systematic review of existing studies reveals that even mild COVID-19 infection can shrink the brain by up to 2%. The team reported that based on their evaluation of existing studies (some using various scans), patients with COVID-19, even a mild version, can lose up to 0.2% to 2% of their olfactory cortex (part of the brain that helps with smell).
Summary of review
The latest study published in the peer-reviewed journal Neuroscience and Biobehavioral Reviews, authored by Puranam Revanth Kumar, B Shilpa, and Rajesh Kumar Jha, reports that continued neurological clinical consequences related to brain changes can occur in individuals with mild forms of COVID-19. When compared to a control group, people identified as positive had more brain and grey matter shrinkage and tissue damage.
The team based in the southern India city of Hyderabad reported, “The damage occurs predominantly in areas of the brain that are associated with odor, ambiguity, strokes, reduced attention, headaches, sensory abnormalities, depression, and mental abilities for a few months after the first infection.”
Even a mild COVID-19 infection shows the potential to shrink an individual’s brain. And the symptoms are offering lots of supporting data points---after all, the viral infection can trigger all sorts of mental/behavioral health and neurologically related conditions from brain fog to loss of smell. The researchers point to numerous autopsy studies supporting the premise.
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Canadian Nurse Sues Health System for Dismissal Over Covid Concerns
The Covid pandemic introduced the world to a different form of discrimination, and fast. An intense bias against the unvaccinated, even though the science revealed by late spring 2021 that the vaccine would not stop transmission. The primary benefit of COVID-19 vaccination is that it reduced the chances of more severe symptoms leading to hospitalization or worse—but the protective effects didn’t last long hence the need for booster doses. As it’s been pointed out, vaccination is a medical procedure, and in most cases a patient has a right to participate or not participate. However, moves made by governments and private entities around the world to encourage vaccination are leading to severe restrictions on those who choose to refuse the vaccine.
In many cases a vaccine mandate was a condition of employment and resulted in lawsuits by public servants. Such vaccination requirements are actually nothing new once a vaccine has been established as safe and effective. Persons employed by the military or in health systems traditionally were required to take certain vaccines. Of course, the childhood vaccination schedule has critical vaccine recommendations adopted as mandatory by schools.
But in the case of COVID-19 with a rapidly-developed, non-sterilizing vaccine (doesn’t stop the transmission) substantial numbers were cautious or “hesitant”. About 30% of the U.S. population opted to not receive the COVID-19 vaccine. Just under 20% of Canada’s population decided to not receive the vaccines. One of those persons was a nurse now suing a healthcare provider in Canada, claiming she was wrongfully dismissed because of her views on vaccination and the Covid-19 pandemic.
Concerns About how the Pandemic was “Managed”
Debra Carritt was employed in the healthcare sector since 1993 as an emergency medical technician and paramedic. In 2012 she started working as a nurse for the Alberta Health System (AHS). She then rose to the level of a unit manager. When the pandemic hit in 2020, Carritt voiced concerns about the way AHS was handling the crisis. She was subsequently dismissed for her opinion the health system had “open discrimination judgement and hostility toward” unvaccinated patients and staff and treated them with “harassment and discrimination.” Carritt alleges AHS tried to coerce the staff into getting vaccinated.
Filed a Lawsuit After Dismissal
In September of 2021 Carritt wrote a letter to the Chief Executive Officer of AHS claiming the provincial health system was mismanaging the crisis which led to bed shortages because AHS was “supporting fear mongering by media agencies and the government by recording and sharing daily virus infection statistics despite similar statistics not being kept and shared for any previous infectious disease outbreaks”.
These concerns were outlined in both her letters, which received no response from management. After getting no response Carritt sent another letter six days later. That letter also was shunned by AHS. Carritt then gave an online interview because she felt she “had exhausted all of the formal grievance and reporting mechanisms.” The interview was conducted with a media organization labelled right wing. She was fired in December of 2021.
44 Page Claim
According to the 44 page “statement of claim” filed by Carritt with the Court of King’s Bench in Calgary, Alberta AHS failed “to acknowledge or comprehend the adverse health effects members of the public would experience though continued 'fight or flight' reactions experienced as a result of those individuals living with a continued heightened sense of fear through conditions AHS created".
Regarding her interview, the claim says, "Mrs. Carritt expressly denies that her representations and conduct during the interview violated the (social media and e-professionalism guidelines) as alleged or at all. In the alternative, Mrs. Carritt states, and the fact is, that her representations and conduct during the interview met and exemplified the standards in those guidelines by, among other things, complying with her 'professional and ethical obligations to protect the public and maintain conduct that reflects trustworthiness.” She is seeking over $420,000 in lost pay and another $250,000 in punitive damages as well as $3 million for alleged negligence. The lawsuit was filed on March 17, 2023.
Received a Disciplinary Note
In January of 2022, Carritt received a disciplinary note from the College & Association of Registered Nurses of Alberta saying Carritt "failed to demonstrate adequate judgement and failed to demonstrate a professional presence" during her media interview. The note continues saying Carritt made statement regarding the Covid-19 pandemic, Covid-19 vaccination and related issues that did not align with one or more employer policies and that were potentially misleading, after identifying herself as a registered nurse and that she worked as a unit manager working for a major health authority."
According to the note Carritt agreed to complete a “reflexive essay” and pay a fine. For whatever reason, during the Covid crisis, even with authorities claiming concern about public health and public safety, when healthcare workers voiced opinions about rules and mandates, concern got tossed, as employers and governments followed rigid, hierarchical marching orders.
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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) Also here
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH) Also here
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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Tuesday, April 18, 2023
Infant/Young Children Antibody Response Against SARS-CoV-2 Infection: Duration Markedly Superior to Adults
Push to vaccinate children not based on the facts
Researchers affiliated with Emory University in Atlanta and colleagues represented by Jens Wrammert, Ph.D., investigated the natural immune response of children. Although understudied during the earlier parts of the pandemic, it emerged that adults could mount broad and durable immune responses to SARS-CoV-2 infection. However, the natural immunity features in children remain understudied and not well understood.
Interestingly, although severe cases of SARS-CoV-2, the virus behind COVID-19, have in all reality been quite rare in the infant/child cohort, infants as young as six months old to young children became intense targets for vaccination by the Centers for Disease Control and Prevention (CDC).
In this study, the Emory University physicians and scientists, along with colleagues, investigated humoral responses to COVID-19 in 23 infants/young children prior to and post-COVID-19 infection. Finding that in this vulnerable cohort, antibody responses to SARS-COV-2 spike antigens peaked about 30 days after infection, they were maintained for 500 days with minimal decay—representing a major finding.
The results of the findings here cannot be ignored (although they need to be peer-reviewed and published)—infants and young children’s natural immune response to COVID-19 appears to last markedly longer than adults! Yet this group was targeted intensively for vaccination with little data associated with this vulnerable cohorts’ immune response and COVID-19.
The findings
Finding that the levels of humoral responses in the infant and children cohort were comparable to a recovered adult cohort who recovered from mild/moderate COVID-19, the authors report “both binding and neutralization titers in WT SARS-CoV-2 were more durable in infants/young children, with spike and RBD IgG antibody half-life nearly 4X as long as in adults.”
Addressing comparable “functional breadth” of both adults as well as young children and infants and their responses to COVID-19, they found a “similar reactivity against a panel of recent and previously circulating viral variants.”
Importantly when conducting an IgG subtype analysis, the study team reports the following observations:
IgG1 more prevalent in both adults and infants and young children response to SARS-CoV-2
IgG3 more frequently prevalent in adults
IgG2 more frequently prevalent in infants/young children
Implications
The study authors point out that these findings “raise important questions regarding differential regulation of humoral immunity in infants/young children and adults,” which could have implications for not only when vaccine boosters are given but also overall booster strategies in the age cohort.
Breakdown
First and foremost, the authors recognize that about 25% of all COVID-19 cases in infants and young children are asymptomatic and that there are few COVID-19-related deaths associated with this vulnerable age group.
But why have national health authorities been keen on vaccination of children as young as six months?
One prominent reason is because severe COVID-19 is more common in young infants as compared to older children. This is possibly because the immune system in children so young is still developing. Frankly, little is known about how the immature immune system of a six-month-old infant reacts to COVID-19, or for that matter, how COVID-19 infection may impact the young child’s immune system.
Also, the durability of the very young person to infant’s immunity is even less understood, writes the Emory University affiliated authors.
Why is it so difficult to understand young children's immune system and, thus, response to COVID-19?
It’s quite difficult to design and execute multi-sample longitudinal studies in this cohort, among other factors. Consequently, the importance of studying not only the initial magnitude but also the long-term durability of infection-induced immune responses in this vulnerable cohort (infant to young children) becomes mission critical.
So, is it possible that in absence of this vitally important data an assumption was made that vaccination for children as young as six is vitally important for protection?
Absolutely. hat assumption is bolstered by data showing (via correlates of protection) that COVID-19 vaccination induced protective antibodies in young children and infants.
But what about for a more optimized, scientifically-driven vaccination scheme in very young children and infants—isn’t more data needed?
Absolutely, and that fact represents a key driver for this study. The authors point out that “a deeper understanding of the breadth of humoral immune responses against continuously emerging viral variants in infants/young children is vital for optimizing the timing of current vaccination strategies in this age group.”
Where did the investigators in the current study obtain the data?
The study team was able to tap into and leverage findings from a prospective, longitudinal birth cohort of influenza and SARS-CoV-2 infection and vaccination in early life conducted at Cincinnati Children’s Hospital Medical Center—known as the IMPRINT study (NCT05436184).
What’s the IMPRINT study?
As reported in the preprint server medRxiv, IMPRINT involved the weekly administration of mid-turbinate nasal swabs offering the ability to identify in real-time the presence of SARS-CoV-2 infection in infants and young children.
The study team at Cincinnati Children’s Hospital Medical Center, led by Principal Investigator Mary Staat, MD, MPH, collected multiple blood samples from a targeted 1,500 infant participants over a period of up to 500 days post the initial positive SARS-CoV-2 swab.
Thereafter, the study team compared and analyzed an adult cohort (involving previously collected blood samples) from patients with PCR-confirmed COVID-19 that were followed up for up to 350 days post-infection.
Why are the findings notable in this study?
The Emory University affiliated authors and colleagues point out that:
“While the initial magnitude of the SARS-CoV-2 specific antibody response in adults and infants/young children was comparable, the titers in our infant cohort were maintained over the study period, while in adults, the titers declined with a half-life of 180 days.”
The authors point to four other studies backing these findings.
What else is noteworthy in the current study?
While the investigators' most recent finding suggests a “major difference in terms of durability of humoral immunity” between adults and children (children’s natural immunity against COVID-19 last longer!), the team reports that “the breadth of these responses was similar in adults and infants/young children.” This means that the immune response was comparable against an array of SARS-CoV-2 variants.
****************************************************
Challenging Covid’s tyranny came at a heavy personal price
Adam Creighton
Three years ago this month my life was turned upside down when I suggested in this column we might be overreacting to Covid-19.
The column triggered a torrent of hate mail that lasted well over a year, and I began to receive persistent and violent threats. I was forced to change my name on social media accounts and my parents became seriously worried for my safety. Some of the attacks were so awful, I considered taking legal action.
It was less than a month after England’s chief health officer, Chris Whitty, explained at a press conference that Covid-19 was not a particularly lethal virus, many wouldn’t get it, and of those who did the vast bulk wouldn’t know they had it, or suffer only a “mild to moderate” illness at worse.
Those facts never changed, but it was too late. By mid-April, our ostensibly civil and rational society had lost its mind, consumed by an insidious culture of consent.
All that mattered was stopping the virus – which most of us ended up getting at least once – and to hell with the human rights, social and economic costs, or earlier pandemic plans.
“Perhaps a hysteria has gripped the nation … the hankering for total lockdown was being cheered on largely by those who would be relatively unaffected by it … the costs will be profound,” I wrote, in what was the first of many criticisms that followed.
But I couldn’t have imagined back then just how damning the data would become, as a new book by Toby Green and Thomas Fazi, The Covid Consensus, now makes clear.
The benefits of our authoritarian response proved so meagre, the costs so enormous – including the inflation we’re still enduring – the last few years must qualify as the biggest public policy disaster outside of wartime.
Australian governments sprayed the best part of half a trillion dollars of public funds against the wall; not to mention the disruption they caused to ordinary lives in the community.
According to OECD data, we ended up with around the same or even a greater number of excess deaths over the last three years as Sweden, a country that was relentlessly attacked for allowing its people to maintain normal lives, with a similar rate of urbanisation and development to Australia.
“I thought Sweden would have higher excess mortality but less economic and social damage, but it had a lower mortality as well,” noted British science writer Matt Ridley last month, after it became clear no matter how the statistics were cut, Sweden emerged with relatively few excess deaths; indeed fewer, or around the same, as Australia.
“Quite astounding: Sweden took a lot of flak for its Covid-19 policies but actually it has done best in Europe,” added Danish environmental analyst Bjorn Lomborg.
On some measures, Sweden did better than any other developed nation on excess deaths. If there is a greater humiliation of experts in modern history, I’m yet to hear it.
The same was true in some parts of the US, which for political and constitutional reasons, managed to resist the zeitgeist, recording the same, or fewer deaths than other jurisdictions, without the destructive madness.
Historians will not look back at the figures of how many died from or with Covid-19. Instead they will look at excess deaths, the number of deaths compared to what might have been expected.
But the coup de grace must belong to China, whose policies in Wuhan inspired many governments to junk their pandemic plans, which had previously emphasised keeping calm and running societies as normally as possible.
In 2020, China’s response was widely praised, based on the CCP’s own dubious Covid-19 figures. But the country’s lockdowns spectacularly failed to contain the virus, and appeared to make little difference when they were ultimately lifted – to the disappointment of those desperate to keep the flame of authoritarianism alive.
Liberal democracies failed miserably during the pandemic, as our institutions, media, academia and bureaucracies careened into hysteria and authoritarianism, trashing human rights and traditional medical ethics over a virus that our grandparents would’ve barely noticed.
You can only imagine what a slightly more lethal virus would have done. As a society we are far less rational and free than we claim.
The gap between our civilisation and China’s has shrunk markedly, too, as government institutions worked hand-in-hand in the US (of all places) with social media companies to suppress dissent and bolster the “the science”, which turned out to be wrong on almost everything. The pandemic response in Australia and elsewhere was a harbinger of a totalitarian future that surely none of us want to encourage.
In my view, those deserving the greatest contempt are the tenured academics and senior public servants who, unless they were mentally deficient, must have known from a very early stage in the pandemic that “the measures” were failing, but continued to cheer them on anyway.
Only an honest evaluation of the gigantic errors of the past can steel us against a repeat of such extremism.
It is fitting, then, to quote the 17th-century Swedish statesman, Axel Oxenstierna, who once commented: “Do you not know, my son, with how little wisdom the world is governed?”
If we didn’t know then, we certainly do now.
****************************************************
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) Also here
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH) Also here
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
***********************************************
Push to vaccinate children not based on the facts
Researchers affiliated with Emory University in Atlanta and colleagues represented by Jens Wrammert, Ph.D., investigated the natural immune response of children. Although understudied during the earlier parts of the pandemic, it emerged that adults could mount broad and durable immune responses to SARS-CoV-2 infection. However, the natural immunity features in children remain understudied and not well understood.
Interestingly, although severe cases of SARS-CoV-2, the virus behind COVID-19, have in all reality been quite rare in the infant/child cohort, infants as young as six months old to young children became intense targets for vaccination by the Centers for Disease Control and Prevention (CDC).
In this study, the Emory University physicians and scientists, along with colleagues, investigated humoral responses to COVID-19 in 23 infants/young children prior to and post-COVID-19 infection. Finding that in this vulnerable cohort, antibody responses to SARS-COV-2 spike antigens peaked about 30 days after infection, they were maintained for 500 days with minimal decay—representing a major finding.
The results of the findings here cannot be ignored (although they need to be peer-reviewed and published)—infants and young children’s natural immune response to COVID-19 appears to last markedly longer than adults! Yet this group was targeted intensively for vaccination with little data associated with this vulnerable cohorts’ immune response and COVID-19.
The findings
Finding that the levels of humoral responses in the infant and children cohort were comparable to a recovered adult cohort who recovered from mild/moderate COVID-19, the authors report “both binding and neutralization titers in WT SARS-CoV-2 were more durable in infants/young children, with spike and RBD IgG antibody half-life nearly 4X as long as in adults.”
Addressing comparable “functional breadth” of both adults as well as young children and infants and their responses to COVID-19, they found a “similar reactivity against a panel of recent and previously circulating viral variants.”
Importantly when conducting an IgG subtype analysis, the study team reports the following observations:
IgG1 more prevalent in both adults and infants and young children response to SARS-CoV-2
IgG3 more frequently prevalent in adults
IgG2 more frequently prevalent in infants/young children
Implications
The study authors point out that these findings “raise important questions regarding differential regulation of humoral immunity in infants/young children and adults,” which could have implications for not only when vaccine boosters are given but also overall booster strategies in the age cohort.
Breakdown
First and foremost, the authors recognize that about 25% of all COVID-19 cases in infants and young children are asymptomatic and that there are few COVID-19-related deaths associated with this vulnerable age group.
But why have national health authorities been keen on vaccination of children as young as six months?
One prominent reason is because severe COVID-19 is more common in young infants as compared to older children. This is possibly because the immune system in children so young is still developing. Frankly, little is known about how the immature immune system of a six-month-old infant reacts to COVID-19, or for that matter, how COVID-19 infection may impact the young child’s immune system.
Also, the durability of the very young person to infant’s immunity is even less understood, writes the Emory University affiliated authors.
Why is it so difficult to understand young children's immune system and, thus, response to COVID-19?
It’s quite difficult to design and execute multi-sample longitudinal studies in this cohort, among other factors. Consequently, the importance of studying not only the initial magnitude but also the long-term durability of infection-induced immune responses in this vulnerable cohort (infant to young children) becomes mission critical.
So, is it possible that in absence of this vitally important data an assumption was made that vaccination for children as young as six is vitally important for protection?
Absolutely. hat assumption is bolstered by data showing (via correlates of protection) that COVID-19 vaccination induced protective antibodies in young children and infants.
But what about for a more optimized, scientifically-driven vaccination scheme in very young children and infants—isn’t more data needed?
Absolutely, and that fact represents a key driver for this study. The authors point out that “a deeper understanding of the breadth of humoral immune responses against continuously emerging viral variants in infants/young children is vital for optimizing the timing of current vaccination strategies in this age group.”
Where did the investigators in the current study obtain the data?
The study team was able to tap into and leverage findings from a prospective, longitudinal birth cohort of influenza and SARS-CoV-2 infection and vaccination in early life conducted at Cincinnati Children’s Hospital Medical Center—known as the IMPRINT study (NCT05436184).
What’s the IMPRINT study?
As reported in the preprint server medRxiv, IMPRINT involved the weekly administration of mid-turbinate nasal swabs offering the ability to identify in real-time the presence of SARS-CoV-2 infection in infants and young children.
The study team at Cincinnati Children’s Hospital Medical Center, led by Principal Investigator Mary Staat, MD, MPH, collected multiple blood samples from a targeted 1,500 infant participants over a period of up to 500 days post the initial positive SARS-CoV-2 swab.
Thereafter, the study team compared and analyzed an adult cohort (involving previously collected blood samples) from patients with PCR-confirmed COVID-19 that were followed up for up to 350 days post-infection.
Why are the findings notable in this study?
The Emory University affiliated authors and colleagues point out that:
“While the initial magnitude of the SARS-CoV-2 specific antibody response in adults and infants/young children was comparable, the titers in our infant cohort were maintained over the study period, while in adults, the titers declined with a half-life of 180 days.”
The authors point to four other studies backing these findings.
What else is noteworthy in the current study?
While the investigators' most recent finding suggests a “major difference in terms of durability of humoral immunity” between adults and children (children’s natural immunity against COVID-19 last longer!), the team reports that “the breadth of these responses was similar in adults and infants/young children.” This means that the immune response was comparable against an array of SARS-CoV-2 variants.
****************************************************
Challenging Covid’s tyranny came at a heavy personal price
Adam Creighton
Three years ago this month my life was turned upside down when I suggested in this column we might be overreacting to Covid-19.
The column triggered a torrent of hate mail that lasted well over a year, and I began to receive persistent and violent threats. I was forced to change my name on social media accounts and my parents became seriously worried for my safety. Some of the attacks were so awful, I considered taking legal action.
It was less than a month after England’s chief health officer, Chris Whitty, explained at a press conference that Covid-19 was not a particularly lethal virus, many wouldn’t get it, and of those who did the vast bulk wouldn’t know they had it, or suffer only a “mild to moderate” illness at worse.
Those facts never changed, but it was too late. By mid-April, our ostensibly civil and rational society had lost its mind, consumed by an insidious culture of consent.
All that mattered was stopping the virus – which most of us ended up getting at least once – and to hell with the human rights, social and economic costs, or earlier pandemic plans.
“Perhaps a hysteria has gripped the nation … the hankering for total lockdown was being cheered on largely by those who would be relatively unaffected by it … the costs will be profound,” I wrote, in what was the first of many criticisms that followed.
But I couldn’t have imagined back then just how damning the data would become, as a new book by Toby Green and Thomas Fazi, The Covid Consensus, now makes clear.
The benefits of our authoritarian response proved so meagre, the costs so enormous – including the inflation we’re still enduring – the last few years must qualify as the biggest public policy disaster outside of wartime.
Australian governments sprayed the best part of half a trillion dollars of public funds against the wall; not to mention the disruption they caused to ordinary lives in the community.
According to OECD data, we ended up with around the same or even a greater number of excess deaths over the last three years as Sweden, a country that was relentlessly attacked for allowing its people to maintain normal lives, with a similar rate of urbanisation and development to Australia.
“I thought Sweden would have higher excess mortality but less economic and social damage, but it had a lower mortality as well,” noted British science writer Matt Ridley last month, after it became clear no matter how the statistics were cut, Sweden emerged with relatively few excess deaths; indeed fewer, or around the same, as Australia.
“Quite astounding: Sweden took a lot of flak for its Covid-19 policies but actually it has done best in Europe,” added Danish environmental analyst Bjorn Lomborg.
On some measures, Sweden did better than any other developed nation on excess deaths. If there is a greater humiliation of experts in modern history, I’m yet to hear it.
The same was true in some parts of the US, which for political and constitutional reasons, managed to resist the zeitgeist, recording the same, or fewer deaths than other jurisdictions, without the destructive madness.
Historians will not look back at the figures of how many died from or with Covid-19. Instead they will look at excess deaths, the number of deaths compared to what might have been expected.
But the coup de grace must belong to China, whose policies in Wuhan inspired many governments to junk their pandemic plans, which had previously emphasised keeping calm and running societies as normally as possible.
In 2020, China’s response was widely praised, based on the CCP’s own dubious Covid-19 figures. But the country’s lockdowns spectacularly failed to contain the virus, and appeared to make little difference when they were ultimately lifted – to the disappointment of those desperate to keep the flame of authoritarianism alive.
Liberal democracies failed miserably during the pandemic, as our institutions, media, academia and bureaucracies careened into hysteria and authoritarianism, trashing human rights and traditional medical ethics over a virus that our grandparents would’ve barely noticed.
You can only imagine what a slightly more lethal virus would have done. As a society we are far less rational and free than we claim.
The gap between our civilisation and China’s has shrunk markedly, too, as government institutions worked hand-in-hand in the US (of all places) with social media companies to suppress dissent and bolster the “the science”, which turned out to be wrong on almost everything. The pandemic response in Australia and elsewhere was a harbinger of a totalitarian future that surely none of us want to encourage.
In my view, those deserving the greatest contempt are the tenured academics and senior public servants who, unless they were mentally deficient, must have known from a very early stage in the pandemic that “the measures” were failing, but continued to cheer them on anyway.
Only an honest evaluation of the gigantic errors of the past can steel us against a repeat of such extremism.
It is fitting, then, to quote the 17th-century Swedish statesman, Axel Oxenstierna, who once commented: “Do you not know, my son, with how little wisdom the world is governed?”
If we didn’t know then, we certainly do now.
****************************************************
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) Also here
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH) Also here
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
***********************************************
Monday, April 17, 2023
Bad batches of Pfizer mRNA Vaccines?
A trio of Danish researchers led by high powered physician-investigator Peter Riis Hansen, Department of Cardiology, Copenhagen University Hospital-Herleve and Gentofe recently had a research letter published in peer reviewed journal European Journal of Clinical Investigation. Titled “Batch-dependent safety of the BNT162b2 mRNA COVID-19 vaccine,” the investigators found three groupings of Pfizer-BioNTech COVID-19 vaccination batches with low, medium and high rates of adverse events. According to TrialSite contributor Dr. David Wiseman, “Is this modRNA degradation or DNA contamination.” The findings may correspond to Sasha Latypova contributions to TrialSite concerning various levels of vaccine safety associated with batches.
Background
By November 2022, 701 million doses of the Pfizer-BioNTech vaccine are linked to 971,021 suspected adverse events (SAEs) in the European Union. The authors point out that “vaccine vials with individual doses are supplied in batches with stringent quality control to ensure batch and dose uniformity.” They noted that at the individual vaccine batch level, clinical data was never reported and that a scenario “highly unlikely” would be “batch-dependent variation in clinical efficacy and safety of authorized vaccines.” Yet the prospect of investigation into “batch dependent variation” was worthy of investigation, according to the authors. Hence the study, an investigation into SAEs between the different Pfizer-BioNTech batches administered across Denmark and its 5.8 million people from December 2020, to January 11, 2022. This inquiry was possible because all SAE cases are linked with corresponding vaccine batch labels reported to and classified by the Danish Medical Agency according to seriousness of SAE as well as numbers of Pfizer-BioNTech doses in individual vaccine batches registered by the Danish Serum Institute. This data is publicly available if requested.
The study
By linking individual SAES to the batch label(s) of Pfizer-BioNTech dose(s) administered by subject, the authors could report on SAEs at the batch level in Denmark.
They divided total number of SAEs associated by batch by the number of doses in the batch to obtain the rate of SAEs per 1000 doses. They could not apply conventional regression statistics due to the significant heterogenous aspect to the observed relationship between number of SAEs and Pfizer-BioNTech vaccine doses. Rather, the authors employed use of non-hierarchical cluster analysis and general linear model (GLM) test for differences in SAE rates between batches, with reporting conforming to the EQUATOR guidelines.
So, what did they find?
52 different BNT162b2 batches was associated with 7,835,280 doses administered to 3,748,215 persons (2340-814,320 doses per batch), and 43,496 SAEs were registered in 13,365 persons which came to 3.19 ± 0.03 (mean ± SEM) SAEs per person. “In each person, individual SAEs were associated with vaccine doses from 1.531 ± 0.004 batches resulting in a total of 66,587 SAEs distributed between the 52 batches.”
The authors had to further analyze 61,847 batch-identifiable SAEs because batch labels were not fully registered or even missing for a total of 7.11% of all Danish SAEs. Out of this analysis 14,509 (23.5%0 were classified as severe SAEs with 579 (0.9%) involving SAE-related deaths.
Vaccine-related SAEs per 1000 doses varies between batches which was an unexpected find for the Danish authors. They reported “2.32 (0.09–3.59) (median [interquartile range]) SAEs per 1000 doses, and significant heterogeneity (p < .0001) was observed in the relationship between numbers of SAEs per 1000 doses and numbers of doses in the individual batches.”
As Wiseman recently noted, the authors found three groupings of Pfizer-BioNTech COVID-19 vaccination batches with low, medium and high rates of adverse events. The authors noted:
“Compared to the rates of all SAEs, serious SAEs and SAE-related deaths per 1.000 doses were much less frequent and numbers of these SAEs per 1000 doses displayed considerably greater variability between batches, with lesser separation between the three trendlines.”
They further identified:
“The observed variation in SAE rates and seriousness between BTN162b2 vaccine batches in this nationwide study was contrary to the expected homogenous rate and distribution of SAEs between batches.”
****************************************************
Big Pharma Is Coming for Your Food: All Eyes Should Be on Missouri
Two years ago, moms led a revolution. Many of us refused to accept an untested gene therapy “vaccine” rushed to market during unnecessary and prolonged Covid lockdowns. The years since have vindicated moms: Our concerns about adverse reactions and potentially life-altering complications are, unfortunately, proving to be true. Courageous patriots fought unethical vaccine mandates and drew attention to the lack of informed consent as pharmaceutical corporations experimented on the population at large.
What you might not have seen coming is that Big Pharma has a back door to mass distributing the vaccine: the food supply. Moms for America learned from industry sources that this month farmers and ranchers will begin using mRNA vaccines on cattle and pigs. From the mainstream media? Crickets.
Not everyone is accepting this unprecedented power grab. Brave legislators in Missouri are facing off against the agricultural lobbyists and big corporations. Missouri House Bill 1169 is a simple measure to require disclosure of gene therapy products in everything from food to cosmetics, including soap. This two-page bill would not ban anything. It simply requires that products we purchase to consume or apply to our bodies are appropriately labeled if they contain materials that can alter our genetic material.
The disclosure bill defines a “gene therapy” as “any product with any capacity to alter, interfere with, or otherwise act in any manner similar or equivalent to genes.” If these substances were not going into our food supply, why are the lobbyists pitching a fit? The level of outrage among agricultural associations and professional lobbyist groups suggests that this is a very big deal.
*********************************************
Civil Society Group in Canada Intensifies Its Investigation Into COVID-19: Was Pandemic Convenient Excuse for Government Overreach?
Canada’s Nationwide Citizens Inquiry (NCI) continues a private, civic society investigation into the COVID-19 response organize and led by that country’s national government. Afterall, this is the country that initially had no real strategy for COVID-19 vaccination, depending on a deal with China’s CanSino Biologics, which ultimately failed miserably. Canada, traditionally a solid long-time partner of the United States surprisingly did not participate in Operation Warp Speed initiated by former President Donald Trump.
This week the group will continue to conduct hearings this time in Winnipeg this Thursday, April 13, 2023. A group of prominent expert witnesses will offer their point of view, analysis and testimony. The country’s majority political class used the pandemic has a means to tighten their grip on power.
For example, during the well-publicized trucker protests, persons who contributed financially to those grassroots, political protests in some cases had their bank accounts frozen. Prime Minister Justin Trudeau enacted the Canadian Emergencies Act, arguing it wasn’t overreach given the mounting crisis across the country. On the other hand, an alternative point of view suggests Trudeau’s actions caused a breakdown in government, and Civil Liberties groups have claimed the use of the Emergencies Act was an abuse of government power.
NCI is a Canada-wide citizen-led and citizen-funded initiative to investigate governments’ COVID-19 policies in a fair and impartial manner that is completely independent from government. Through questioning led by lawyers, individual Canadians and experts will present evidence under oath to Independent Commissioners. The first six days of hearings were held in Truro, NS and Toronto, ON.
These expert witnesses include:
Natalie Bjorklund Gordon – Geneticist and Epidemiologist
Stephen Theriault – Medical microbiologist
Jessica Rose – Expert on the VAERS data
Staff Sgt Rick Abott – Edmonton Police Officer
Jay Bhattacharya – Professor of Medicine at Stanford, co-author The Great Barrington Declaration
Jeffrey Tucker – Founder of the Brownstone Institute
Deanne McLeod – Medical Researcher
Charley Hooper – Researcher on Early Covid Treatment
The Winnipeg hearings, from 9:00 am to 5:00 pm Central, will be broadcast live on the NCI website and on the NCI Rumble Channel. Follow the NCI on social media:
https://twitter.com/Inquiry_Canada and https://www.facebook.com/NationalCitizensInquiry
The Winnipeg venue is Holiday Inn Winnipeg – Airport West, 2520 Portage Ave., Winnipeg, MB R3J 3T6 Ph. (204) 885-4478
The conference organizations report that due to limited space in the room, the public is asked to arrange for access through Eventbrite.
Members of the media are asked to provide identification to NCI volunteers on site to obtain access. Prior notification of attendance to press@nationalcitizensinquiry.ca will assist in assuring seating.
NCI spokesperson, Michelle Leduc Catlin, will be at the hearings and is a contact for assistance.
Other hearings are planned in other locations across this vast country to the north of the U.S.
****************************************************
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) Also here
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH) Also here
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
***********************************************
Sunday, April 16, 2023
The corrupted science behind Biden’s COVID vax mandates
President Joe Biden decreed on Sept. 9, 2021, that more than 100 million Americans must get COVID-vaccine injections.
But newly disclosed emails show that the Food and Drug Administration finding behind that order, official certification of the jabs as “safe and effective,” was the result of a bureaucratic bait-and-switch.
The FDA had approved COVID vaccines on an emergency-use basis in December 2020, before Biden even took office.
The White House assumed that was the silver bullet to enable Biden to save Americans from COVID.
But it soon became clear that many Americans were hesitating to get jabbed, in part because the FDA approval was solely for emergency use.
Many Americans have long been wary of vaccines, including health-care workers who avoid flu shots.
The president championed vaccines with evangelical fervor.
“You’re not going to get COVID if you have these vaccinations,” he insisted in a July 21, 2021, CNN town hall.
Biden’s claim was false, spurred by the Centers for Disease Control and Prevention decision to ignore any “breakthrough” COVID infections that did not result in death or hospitalization.
As for the emergency-only approval, Biden assured the audience that “the group of scientists we put together” will “get a final approval” very soon.
In fact, when Pfizer applied for full approval in May 2021, the FDA said it aimed to announce a decision in January 2022.
But that wasn’t fast enough for the Biden White House.
Newly released emails reveal that Acting Commissioner Janet Woodcock was concerned because “states cannot require mandatory vaccination” without FDA final approval, according to the chief of FDA’s vaccine-review office, Marion Gruber.
Gruber warned that a thorough evaluation was needed due to “increasing evidence of association of this vaccine and development of myocarditis (especially in young males).”
After Gruber balked, Woodcock placed a loyal subordinate in charge of the process, and the vaccine got full approval Aug. 23.
Biden boasted that day of achieving a COVID “key milestone” and labeled FDA approval the “gold standard,” proving vaccines were safe and effective.
The White House arm-twisting spurred a “mutiny” at the FDA, as Politico put it: Gruber and her top deputy resigned in protest.
When Biden gave his vaccine-mandate speech Sept. 9, he promised to “finish the job [on COVID] with truth, with science.”
But the White House had already buried the truth and effectively exiled dissenting scientists.
Indeed, another key Biden claim had already fallen apart: that vaccines stop transmission.
Late July 2021 brought news that almost 500 vaccinated people contracted COVID on holiday visits to Provincetown, Mass.
On July 30, The Washington Post and New York Times published leaked Centers for Disease Control and Prevention documents warning that vaccines were utterly failing to stop transmission.
The Times tweeted, “The Delta variant is as contagious as chickenpox and may be spread by vaccinated people as easily as the unvaccinated.”
Biden White House COVID spokesman Ben Wakana hysterically denounced The WaPo as “completely irresponsible” and flogged the Times with an all-caps outburst: “YOU’RE DOING IT WRONG.”
But on Aug. 5, CDC chief Rochelle Walensky admitted that vaccines failed to “prevent transmission” of COVID.
The following week, a Mayo Clinic study indicated that the Pfizer vaccine had become only 42% effective — below the standard the FDA normally required for vaccine approval.
None of that mattered to an administration that had decided vaccines were everything: Biden announced his private-employee mandate Sept. 9.
And the FDA final approval prompted many schools, colleges and other organizations to impose their own mandates. (This, when it was already clear that young people faced minimal risk from COVID.)
Yet the vaccines were already proving less effective against the new COVID variants that experts had long predicted would occur.
By January 2022, the nation was seeing a million new COVID cases a day, and still-frightening numbers of deaths among both the vaccinated and unvaccinated — while the Supreme Court struck down Biden’s vaccine mandate for 84 million private employees on the 13th.
The COVID vaccine’s rushed approval was the pharmaceutical version of a riverboat gamble.
Yet the administration is still pushing new jabs, including boosters — ignoring risks such as the threat of myocarditis among vaccinated younger males (a four- to 28-fold elevated risk).
The CDC is investigating a possible link between Pfizer vaccines and strokes in the elderly.
COVID vaccines can still provide protection for the elderly and people with severe health problems. But since early 2022, most COVID fatalities have occurred among the fully vaccinated.
More medical research is necessary to reveal the benefits and risks of the vaccines.
Meanwhile, the House Select Subcommittee on the Coronavirus Pandemic is demanding a bevy of documents from the FDA on its rushed vaccine approval, while Biden policymakers continue to treat transparency as a plague to avoid at all costs.
If and when federal files are finally opened, how many other COVID policy scandals will be revealed?
https://nypost.com/2023/04/14/the-corrupted-science-behind-bidens-covid-vax-mandates/
******************************************************Another Doctor in Canada Investigated for Prescribing Ivermectin for COVID-19
Canadian physicians continue to get harassed and even formally disciplined for using repurposed medications to treat COVID-19, yet ones not accepted by national regulators for that particular indication. Most recently, Dr. Tshipita Kabongo at the Integrated Wellness and Health Balance Centre, part of the Saskatchewan Health Authority in Regina, Canada, found out about the professional perils of prescribing ivermectin. Because the doctor allegedly was prescribing ivermectin between April 2020 and March 2022, to prevent and or treat COVID-19, the physician faces allegations of professional misconduct.
Thus far, the allegations haven’t been admitted but now are under review by the College of Physicians and Surgeons of Saskatchewan (the College) discipline committee. This isn’t these physicians first run in with “the College”: in 2016 he was sanctioned
The recent allegations
“(Kabongo) failed to know and/or adhere to the College Policy on Complementary and Alternative Therapies.” Further, the allegations continue that the physician wrote one or more ivermectin prescriptions not “medically indicated” while precluding other “evidence-informed” regimens. Finally, medical records were not adequately documented.
While it’s acknowledged and understood by “the College” that patients maintain a right to make decisions about their own healthcare, they also inform about the doctor’s responsibilities in such scenarios, particularly during the pandemic.
Recently, the College pointed to their policies in association with the charges against the ivermectin prescriber: “It is unethical to engage in or to aid and abet in treatment which has no acceptable scientific basis, may be dangerous, may deceive the patient by giving false hope, or which may cause the patient to delay in seeking conventional care until his or her condition becomes irreversible.”
“No scientific basis”
Government and corporate health systems combined with academic medical centers uniformly take the stance that while lab studies showed the ability of ivermectin to inhibit SARS-CoV-2 entry into the body, Canadian media actually lies, declaring, “No clinical trials have reported benefits with ivermectin for COVID patients.”
While it’s true that a handful of major studies haven’t turned up conclusive evidence in the drug’s favor, some of these study designs have been challenged in that the doses were too low, the regimen was administered to late in the infection life cycle and other factors such as weight were not methodically dealt with.
But what they don’t mention is the 95 studies involving ivermectin and COVID-19 involving 1,023 scientists around the world and 134,554 patients across 27 countries. Significant data from some of these studies reveals real promise, but they are completely discounted by aforementioned entities that essentially serve as gatekeepers for medicine.
Several countries temporarily authorized the use of ivermectin on an emergency basis during the height of the pandemic, from India and Peru to Slovakia and even municipalities in southern Brazil. The Mexico City health agency conducted a large public health real time ivermectin study showing good results. Uttar Pradesh’s massive public health initiative using a combination of ivermectin and doxycycline, wildly successful, was blacked out by the press.
Although the World Health Organization (WHO) issued a press release touting that Indian state’s health agency’s success with the COVID-19 response, they omitted the components of the home medicine kit, which again included ivermectin and doxycycline. Western media has outright lied about this piece of history, calling it misinformation. The entire chapter of history during the pandemic involving ivermectin’s use in mostly low-and middle-income countries is avoided by mainstream medicine altogether.
Importantly, representatives from three separate nations were in touch with TrialSite at various stages of the pandemic asking this media to take down articles highlighting the particular nation’s authorization of ivermectin for emergency use. Why? We learned that they were afraid of WHO reprisal.
A website tracks all ivermectin studies but unfortunately, the purveyors of the study tracker choose to remain anonymous which doesn’t really contribute to credibility. Undoubtedly, fear of reprisal and loss of academic or industry jobs is likely the reason. But on the other hand, TrialSite has taken on industry or academia, when necessary, when pursuing the truth in biomedical research—and has paid the price with censorship on YouTube and social media, but during these times, has taken a stand on matters.
TrialSite also has found that as COVID-19 mutates and as new crises emerge such as long COVID and post-COVID-19 vaccine injuries, some prominent doctors that at one point or another during the pandemic prescribed ivermectin now argue that the drug provides minimal to even no value for treating conditions such as long COVID, vaccine injuries and the like.
As it continues to be a controversial topic, some doctors and supporters have embraced the drug with religious fervor with the medical establishment doing all it could to ignore or avoid any positive signals. Frankly, this is not a scientific based approach from either side.
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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) Also here
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH) Also here
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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