All of a sudden, ivermectin is safe again

Dr. Julie Sladden is writing from Australia:

Has anyone else noticed a pattern around the Covid-related restrictions of the past three years?

Each infringement felt like a wave crashing on the shore of Australian freedoms, which, after a while, would quietly recede into the background with little fanfare, media, or attention. So it was with the introduction of lockdowns, masks, and mandates.

No wonder we’ve all felt ‘at sea’.

On May 3, 2023, the TGA quietly announced it was removing the prescribing restrictions on ivermectin. These restrictions were imposed on September 10, 2021 in an effort to stop doctors prescribing the drug to treat Covid.

These original restrictions were described as an ‘extraordinary intervention’.

Ivermectin is an (actual) ‘safe and effective’ medication with decades of safety data and known side effects. Heck, it’s even on the World Health Organisation’s list of essential medications. At the time, ivermectin was being used by several countries around the world to treat Covid and several studies were in process of being conducted.

But why would the TGA restrict ivermectin? Good question. The reasons given for the amendment to the Poisons Standard include:

A rise in the number of off-label prescriptions of ivermectin.

A significant increase in personal importation of ivermectin into Australia.

Concern that people who had been prescribed ivermectin might believe themselves to be protected and therefore not get vaccinated.

Concern that ivermectin would come into short supply in Australia.

Ivermectin also has the potential to cause severe adverse events, particularly when taken in high doses; though oral ivermectin is generally well-tolerated at recommended doses.
Nowhere, back in September 2021, did the TGA say there had been a rise in serious adverse events associated with ivermectin. The closest the regulator came was stating a ‘potential’ to cause severe adverse events.

Hmm… So, if a therapeutic agent is restricted for ‘potentially’ causing serious adverse events, what happens when a therapeutic agent actually causes serious adverse events?

Let’s move on.

The concern that ivermectin would come into short supply is perplexing. As an ‘off-patent’ drug, ivermectin is incredibly cheap to make (around 55 US cents per course of treatment) and widely available. As one commentator ponders, ‘If the TGA foresaw a potential shortage, why did no one in the Australian government think to phone an order through to Indiamart?’ Another good question.

In light of the above, the rise in number of off-label prescriptions of ivermectin and increase in personal importation is no reason to restrict a medication. These signals should be taken as an indication to investigate (why is it being used and what is the ‘front-line’ experience) and educate (regarding potential side effects). According to Dr Peter McCullough, ‘About two dozen countries have ivermectin as a first-line treatment for Covid in their government guidelines.’ They can’t all be wrong.

Furthermore, the increased prescription and importation heralds another consideration, something prohibition taught our friends across the Pacific: when you prohibit something the people want, you just drive it underground.

The reason that incited me most back in September 2021 was the ‘concern that people who had been prescribed ivermectin might … not get vaccinated’.

So, as the government funneled the Australian people down the ‘vaccine or bust’ pathway with mass coercion, an essentially safe and potentially significant therapeutic option was removed. This was done not because it was causing harm, but because it might stop people from getting the ‘experimental’ injection.

I find this outrageous.

Why? Because in a time of ‘unknowns’, the TGA put its weight behind an injection with minimal safety data over a medication with a known safety and therapeutic profile.

So, in what seems like a miracle, ivermectin is now deemed ‘safe’ again.

‘How can ivermectin go from being a toxic horse de-wormer in 2021 and then be declared to have a low safety risk in 2023?’ asks Pharmacologist and Drug Regulatory Affairs consultant Dr Philip Altman. Yet another good question.

In my opinion, the only reason a therapeutic agent like ivermectin, with a proven track record, should be restricted is a demonstrated safety signal that truly indicates the health of Australians is at risk. To do otherwise makes no sense to me.

Dr Philip Altman takes it further, ‘If the Australian TGA cannot tell the difference between a toxic horse deworming medicine and a potentially life-saving, widely used, essential safe medicine – they should not exist.’

https://www.spectator.com.au/2023/05/all-of-a-sudden-ivermectin-is-safe-again/

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Fired Teachers Who Refused COVID Vaccine to Get Full Reinstatement and Back Pay

Three Rhode Island teachers who were fired for refusing the COVID-19 vaccine have been offered their jobs back with full back pay after reaching a settlement with the school district.

Teachers Stephanie Hines, Brittany DiOrio, and Kerri Thurber were terminated from their positions in Barrington Public Schools after they had requested a religious exemption after the school mandated employees get the vaccine.

Last week, their attorney, Greg Piccirilli, and the school district said they had reached a settlement, allowing the teachers to return to their jobs. They are also each entitled to $33,333 in damages along with their back pay. DiOrio will get $150,000, Thurber will get $128,000, and Hines will receive $65,000 under the agreement.

“The three teachers have the opportunity to return to teaching positions within the Barrington School District should they choose to do so, at the steps they would have been at had they worked continuously,” the Barrington Public Schools district said in a statement on May 11.

In a statement to the Boston Globe, Piccirilli said that his clients are “extremely gratified that they’ve been vindicated in their position,” adding that he will get $50,000 in attorneys fees as part of the settlement. “A lot of people were dismissive and skeptical of their claims at the time,” he told the Boston Globe. “They went through a lot of personal trauma dealing with this. Their faith has gotten them through this.”

Meanwhile, Barrington Public Schools told the Providence Journal that it reached the settlement because the litigation would likely put a drag on the school’s resources and funding. It attempted to distance itself from its own vaccine mandate by claiming that it was dealing with the spread of COVID-19, although there is a growing body of evidence that shows the vaccines do not prevent the spread of the virus.

“Our district was navigating an unprecedented health pandemic and leaned on the important recommendations by the CDC and the Rhode Island Department of Health to ensure the safety of our students and school community,” the Barrington School Committee said Thursday, according to the outlet. “Our then-policy helped combat the pressing public health crisis of the time, while keeping schools open, and [was] one that nearly all faculty and staff adhered to.”

It added that “we determined this ongoing, expensive litigation” would likely continue for a lengthy period of time, and a resolution should be reached because the “administration’s time, and our district’s financial resources, should be spent on the daily work and mission of Barrington Public Schools … our School Committee looks forward to continuing to support this important work.”

Details
The three were first placed on unpaid leave in late 2021 before they were fired in January 2022, according to statements made by the district and the teachers. During a hearing in Barrington in October 2021, DiOrio said that she “did nothing wrong.”

“I have done nothing wrong. This is destroying my future ability to earn a living,” she said of the mandate. “What makes me more of a threat now? Is this how a highly-rated school department treats its people?”

At the time, Sara Rapport, a lawyer representing the School Committee, said that the teachers were violating the school policy for not complying, adding that committees have the plenary authority over school interests. She said that the teachers’ decision not to get vaccinated pose a greater risk to students.

“Teachers have a right not to be vaccinated,” she said in late 2021. “But every decision has consequences. Religious beliefs do not override the health and safety of the community.”

It’s not clear if Thurber, Hines, or DiOrio will return to their previous teaching positions. During an interview with Legal Insurrection, Piccirilli said that the settlement should be seen as a victory for others who were fired because they refused to take COVID-19 vaccines.

“They’ve shown amazing resilience to stick by their faith. A lot of other people with similar situations have gone through this. And hopefully [this resolution] will serve as an example of how others should be vindicated the same way, for sticking up for what they believe in,” he said.

Last year, a Rhode Island Superior Court judge issued a ruling in favor of the three teachers who were fired, saying the district violated the state’s Open Meetings Act laws over their mandating the vaccine. The Barrington School Committee said after the ruling that officials disagree with the judge’s opinion.

“This case is not about whether mandating vaccinations is appropriate. Regardless of the significant political stance which the public may take for or against that issue, the issue here is whether the Barrington School Committee provided sufficient notice before enacting the Emergency Policy on COVID-19 Related Issues in August and September 2021. This Court finds that violations occurred,” Judge Jeffrey Lanphear wrote at the time.

Piccirilli, meanwhile, has said that the school committee did not possess the legal authority to implement a vaccine mandate and asserted it didn’t follow proper procedures in carrying it out. For example, he said that the district didn’t advertise it correctly.

“It’s shocking to me that the rule of law seems to have gone out the window in a lot of these situations,” Piccirilli said in 2021, reported the Globe. “There’s supposed to be a process.”

https://www.theepochtimes.com/fired-teachers-who-refused-covid-vaccine-to-get-full-reinstatement-and-back-pay_5264466.html

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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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Officials Neglect Covid Vaccines’ Side Effects

Brianne Dressen was an energetic mom, an avid hiker and a preschool teacher—until she got a Covid vaccine.

Ms. Dressen, 42, was among the first Americans to be vaccinated. She volunteered to participate in AstraZeneca’s trial, and she received her first dose on Nov. 4, 2020, at a clinic in West Jordan, Utah. “I am pro-science and pro-vaccine,” Ms. Dressen says. “I was more than glad to participate in the scientific process.”

But even highly beneficial vaccines can have rare serious side effects. Minutes after the shot, Ms. Dressen’s arm began to tingle, her vision grew blurry, and sounds became muffled. The clinic suggested she see a neurologist, who directed her to the emergency room. The ER couldn’t figure out what was wrong and sent her home.

Her condition steadily deteriorated over the next 2½ weeks. She experienced extreme nausea, diarrhea, dizziness, painful vibrating sensations, pins and needles in her arms and face, numbness, tremors, brain fog, heart palpitations and fever. Physicians were mystified. They diagnosed her with a “silent migraine” and “anxiety due to the Covid vaccine” after a hospital stay. She was provided occupational and physical therapy but spent weeks in bed, unable to tolerate sound, light or even her children’s touch.

In the ensuing months, she faced not only debilitating symptoms but also bureaucratic indifference—though government officials tried to be helpful at first. On Jan. 11, 2021, her husband, Brian, a U.S. Army chemist, contacted Avindra Nath, intramural clinical director of the National Institute of Neurological Disorders and Stroke. Dr. Nath responded immediately that he would discuss her condition with other National Institutes of Health neurologists. He asked for blood and spinal-fluid samples for analysis, and he ominously mentioned that “the current political climate is another aspect that we need to keep an eye on.”

Dr. Nath didn’t elaborate, but by now the politics of the Covid vaccines are familiar. Bitter disputes over mandates fed skepticism of the shots and claims, often false and outlandish, about their dangers. At the same time, public-health authorities, anxious to promote vaccination, played down risks that were real if rare, leaving patients like Ms. Dressen in limbo.

After failed attempts to work remotely with Ms. Dressen’s home medical team, Dr. Nath invited her to an NIH facility in Bethesda, Md., for examination. Physicians there diagnosed her with postvaccine neuropathy and severe postural orthostatic tachycardia syndrome, or POTS, which causes rapid heartbeat on standing up. She was treated with intravenous immune globulin, an infusion of antibodies from healthy donors that can modulate an overactive immune response.

The treatment helped, but symptoms persisted and would wax and wane. She learned that many others were experiencing similar symptoms after getting vaccinated. She organized online support groups, but Facebook shut them down under its “misinformation” policy, which bans information that is “likely to directly contribute to the risk of imminent physical harm, including by contributing to the risk of individuals getting or spreading a harmful disease or refusing an associated vaccine.” This includes “claims about the safety or serious side effects of COVID-19 vaccines”—even, it appears, when such claims are truthful.

The Facebook censorship and government inaction spurred her to launch React19, a “science-based nonprofit offering financial, physical, and emotional support” for people who suffered severe reactions after Covid vaccines. React19 has more than 21,000 members in the U.S. and another 20,000 in 24 international partner organizations. It also has a Facebook page.

“We are not antivax and are neutral on the Covid vaccines,” Ms. Dressen says. “But doctors need to be aware of what’s going on so they can treat patients.” Ms. Dressen and others have pressed the NIH, the Centers for Disease Control and Prevention and the Food and Drug Administration to acknowledge their symptoms so patients don’t feel shunned and can obtain the medical care they need.

Interviews with React19 members and emails they shared with me show that public-health authorities haven’t been transparent about these adverse events. Officials privately expressed concern to patients but kept mum about the issue in public and failed to keep promises to investigate the side effects thoroughly. With the Covid public-health emergency over at last, perhaps they will get the attention they deserve.

Ms. Dressen says NIH officials were initially solicitous. They brought at least a dozen patients like Ms. Dressen to their facilities for tests and treatment as part of an informal study. “Good that you are getting the word out,” Dr. Nath wrote her on June 27, 2021. “Maybe the issue has not received the deserved attention, but there [sic] now an increasing number of publications in the literature documenting the complications. Considering over a billion doses administered, the complications are still rare. From my stand point the important message to get out is that they are treatable, so should treat early or do it in the context of a clinical trial. Keep me posted.”

But the NIH didn’t get the word out. Ms. Dressen kept updating Dr. Nath and his assistant clinical investigator, Farinaz Safavi, about her symptoms. She complained about the cost of her intravenous immune globulin treatments—$2,200 a month out of pocket. She told Dr. Nath that she had communicated with FDA officials, including Peter Marks, head of the Center for Biologics Evaluation and Research, which oversees vaccines.

FDA officials, she told him, were passing the buck to the NIH. “You and I both know that it isn’t fair to your small team there to take on all of these people,” she wrote on Sept. 16, 2021, referring to other patients with postvaccine neurological conditions. “Is there something I am missing with this? Or someone I should be appealing to there at the NIH to encourage further research? Funding for care?”

“Ordinarily when any drug is released it is the manufacturers responsibility to investigate and treat the side effects,” Dr. Nath replied. “Where are the vaccine manufacturers in all of this? Have you tried to contacting [sic] them? It cannot be the government’s responsibility to pick up after them. They are a profit company and they should be the ones taking change [sic]. Don’t you think?”

Ms. Dressen says AstraZeneca offered her $1,243.30 if she agreed to waive “any additional claims.” She turned it down. AstraZeneca says the offer was a reimbursement for medical expenses and tests rather than a legal settlement, and its independent experts determined the injury wasn’t vaccine-related. AstraZeneca’s vaccine was never authorized in the U.S. (It has been in Canada, Europe and the U.K. and is widely used in poor countries.)

Other React19 members I spoke with said they didn’t receive responses from Pfizer or Moderna about adverse-event reports they filed with the companies. A Pfizer spokesperson said its “medical team thoroughly assesses and reviews medical documentation to further understand the event,” and “reports are shared regularly with federal and global regulatory and health authorities for further review.” Moderna didn’t respond to requests for comment.

The U.S. Countermeasure Injury Compensation Program, which covers vaccines and treatments used during public-health emergencies, has received 11,686 Covid-related claims, only 23 of which have been ruled eligible for compensation. React19 members say their claims are under review or have been rejected.

In the fall of 2021, as some Americans resisted vaccination, the Biden administration mandated vaccines for healthcare workers and employees of large corporations. Although it was becoming clear that vaccines didn’t prevent infection, officials claimed mandates were necessary to ensure “employee safety and health.”

At the same time, FDA and NIH officials received a growing number of reports of severe side effects—including from medical professionals who had been among the first to get vaccinated. One was Danice Hertz, a 66-year-old now-retired gastroenterologist in Santa Monica, Calif.

Dr. Hertz received her first Pfizer dose on Dec. 23, 2020. Within 30 minutes, her face began to burn and tingle, her vision grew blurred, and she became lightheaded. She took Benadryl and prednisone at her home to no effect. Over the next 24 hours, she developed intense burning in her face, numbness in her mouth and scalp, chest pain, dizziness, twitching and a feeling that her whole body was vibrating. “I had pain to the degree of screaming out loud.”

She contacted a neurologist at a local hospital, who was flummoxed. “I was in bed for several weeks and barely able to emerge,” she says. After consulting two dozen doctors around the country, she was diagnosed with small-fiber neuropathy, tinnitus, dysautonomia, POTS and mast cell activation syndrome, a condition that causes severe allergic symptoms affecting multiple parts of the body.

Dr. Hertz spent her days in bed searching the internet for a medical explanation: “I was desperately ill. I was unable to get medical care. I was suicidal at times. A lot of others went through this. I wrote goodbye letters to my family. It was too miserable to live with this.”

On Feb. 4, 2021, she stumbled on an article from Neurology Today in which Anthony Fauci sought to correct his earlier recommendation that people with a history of Guillain-Barré syndrome, a rare disorder in which the immune system attacks the nervous system, shouldn’t get vaccinated because it might trigger a recurrence. After drawing pushback from the medical community, Dr. Fauci retracted his statement because it clashed with the CDC. “As soon as the CDC recommendations came out, I began advising people according to the recommendations. I do stand corrected,” he told Neurology Today.

Dr. Hertz posted in the comments section on the article that she developed severe parathesias—pins and needles, a classic symptom of Guillain-Barré and other neurological disorders—30 minutes after vaccination. “Despite my multiple reports to Pfizer, the CDC and FDA, no one has recognized my complication or reported it,” she wrote. “I wonder how many other cases there are like mine.” The FDA has reported a link between Johnson & Johnson’s vaccine and Guillain-Barré syndrome.

She says she filed nine reports with the Vaccine Adverse Event Reporting System, or Vaers, the government surveillance system that is supposed to track possible side effects, and “nobody has ever contacted me.” She also filed reports with Pfizer, which she says didn’t respond.

But two weeks after posting her comment on the journal article, she received an email from Sheryl Ruettgers, who had experienced similar symptoms. Ms. Ruettgers said she also filed a Vaers report and had contacted Dr. Marks of the FDA’s Biologics Center.

“I read a transcript from a web-lecture you gave on 1/29/2021 highlighting your commitment to medical safety as it relates to the vaccine,” Ms. Ruettgers wrote to Dr. Marks on Feb. 21. “I have been unable to find answers and have been frustrated by the lack of transparency as it relates to adverse reactions.” She didn’t receive a response.

Dr. Hertz soon received more emails, including one from Ms. Dressen. They organized an email list and later a Facebook group. In March Dr. Hertz also contacted Dr. Nath and sent her lab work to the NIH for analysis. Dr. Safavi noted in an email to her that more than 1,000 neurological side effects had been reported in Vaers, “but in order to present it to scientific community we have to gather as much information as we can before sending it out.”

“We need to be patient and scientifically follow the appropriate path to br [sic] able to push this work forward,” Dr. Safavi wrote on April 17, 2021. Over subsequent months, Dr. Hertz and Ms. Dressen referred members of their group to the NIH, whose neurologists reviewed patient medical records and helped them obtain treatment.

While NIH scientists were privately validating their vaccine-related injuries, FDA officials had yet to acknowledge them. On May 24, 2021, Ms. Dressen emailed Janet Woodcock, then acting FDA commissioner, attaching letters from 17 other patients detailing their postvaccine nervous-system problems.

Dr. Woodcock replied solicitously: “We take your experiences seriously and are evaluating all reports of adverse events associated with vaccination. I will follow up with individuals who do research into these types of conditions.” She added: “I hear you and understand that you are asking that more attention be directed to what you are experiencing. I will see if more studies can be undertaken. It is not really possible to provide good medical care without understanding what is going on with the patients.”

The correspondence between FDA officials and React19 members continued. Dr. Woodcock responded to each of Ms. Dressen’s emails with compassion and promises to investigate. “I need to get with people who are studying this issue,” she wrote on July 22, 2021. “I know I need to make progress on this and I have been working with the Biologics Center on this issue.”

Dr. Marks also repeatedly assured Ms. Dressen that the agency was investigating and that its reporting systems would identify “safety signals.” “We have a staff of epidemiologists at FDA involved in safety surveillance activities, and these individuals are looking into this,” Dr. Marks wrote on Nov. 12, 2021. “Though I am unable to give you a definitive time when they will be done with their analyses, I will certainly let you know when I hear anything.”

Tired of waiting, React19 began doing its own research. On Jan. 9, 2022, Ms. Dressen sent FDA officials an email with 850 case reports and medical-journal articles related to severe adverse vaccine reactions. She noted that the European agency responsible for regulating vaccines in October identified parathesias as a potential Pfizer vaccine side effect.

“Thanks so much for all of this information,” Dr. Marks replied. “We really appreciate this and will start working through the papers and contacting investigators to better understand things.”

Ms. Dressen kept sending Dr. Marks published research on neurological adverse events, and Dr. Marks kept assuring her the FDA was investigating. FDA leaders regularly met with React19 members. “We were getting lip service over and over again,” Dr. Hertz says.

A senior FDA official told me the agency has strong surveillance systems in place to identify adverse events, including for small-fiber neuropathy, but that it hasn’t detected an increase in neurological cases among Pfizer and Moderna recipients. “For those individuals affected, we can’t confirm or deny. We will continue to work and be receptive,” the official said.

“FDA likes to say there’s no safety signal in Vaers data, but the problem is that it’s not complete,” says Joel Wallskog, a React19 member who practiced orthopedic surgery in Wisconsin before he had a neurological reaction after a Moderna shot.

Because Vaers relies on self-reporting, it is both under- and overinclusive. Some people don’t report adverse reactions that are likely caused by vaccines, while others report events that probably aren’t. Dr. Wallskog says healthcare providers should be mandated to report potential adverse effects to Vaers whether or not they think the vaccine was the cause.

Patients may also report their diffuse neurological symptoms under different headings, making it harder for public-health officials to detect links. Some reports that patients claim to have filed also don’t appear in the public database. A React19 review found that 12% of Vaers reports filed by members had been deleted and 22% lacked a permanent identification number so they weren’t publicly visible.

A CDC spokesperson says that “all reports to Vaers are publicly available and can be examined,” but “due to privacy and confidentiality, CDC cannot confirm which reports have been reviewed and what the review revealed.” For reports classified as serious, CDC says, it requests and reviews all available medical records.

“Serious” is defined as death, life-threatening illness, hospitalization or prolongation of hospitalization, permanent disability, congenital anomalies, or birth defects. A CDC presentation on Jan. 26, 2023, showed that 883 Vaers reports of “pain in extremity” following Moderna and Pfizer bivalent boosters were categorized as nonserious.

“Vaers is not designed to determine if the vaccine caused the reported adverse event,” the CDC spokesperson says. “The determination of the cause of serious adverse events is done by healthcare providers.” But React19 members say the CDC didn’t follow up on their complaints.

Doctors are typically reluctant to ascribe a rare adverse event to a vaccine unless the FDA and CDC validate the association. Postvaccine neurological symptoms are relatively rare, and it is nearly impossible to conclude whether they were caused by the vaccines. Some patients who get infected with Covid also report developing neurological disorders after their illness. It’s unclear if these symptoms are more common after vaccination or infection, or if they have become more common during the pandemic than before.

More than 600 million doses of Pfizer and Moderna vaccines have been given in the U.S., so even a 1-in-100,000 adverse effect would result in 6,000 cases. Postvaccine neurological conditions appear most common in young and middle-aged women, the demographic most prone to autoimmune diseases.

It’s possible vaccines are the proximate but not the ultimate cause—that they trigger autoimmune conditions in patients with underlying genetic predispositions. That hypothesis is bolstered by the observations from the NIH’s informal study, which it published in a preprint paper on May 17, 2022. Of 23 patients studied, the median age was 40, and 21 were women. The paper concludes “that a variety of neuropathic symptoms may manifest after SARS-CoV-2 vaccinations and in some patients might be an immune-mediated process.” An NIH spokesperson says the observational study has concluded. In an April 25, 2023, article for the journal Neurology, Dr. Nath wrote that “there is a great need to conduct research for identifying the underlying factors and subcellular mechanisms that result in the neurological manifestations from vaccines.”

Ms. Dressen says institute scientists stopped corresponding with React19 members at the end of 2021. “Sorry, we do not have any clinical trial for such vaccine related complications. It is best for such patients to receive care from their local physicians,” Dr. Nath wrote Ms. Dressen on Dec. 15, 2021.

The NIH says the FDA and CDC are best able to address questions and concerns about possible vaccine side effects and that its clinical center is a research hospital, not a routine medical center.

FDA officials continued to meet and correspond regularly with React19 members until this past December. They still haven’t warned the public about potential vaccine-related neurological complications. “FDA has made us many, many promises, and I think they’ve followed up on one or two,” Ms. Dressen says. Public-health officials, she adds, have misled the public by claiming they have a robust system to identify rare adverse events from vaccine: “I trusted that these programs that they are telling the public are there, but they are not.”

Officials may worry that recognizing severe side effects will fuel vaccine opposition and hesitancy. But the lack of transparency can only feed public distrust. And the lack of recognition “has left us as further collateral damage from the pandemic,” Ms. Dressen says.

One silver lining is that advocacy is giving purpose to the lives of those who have been harmed. “I worked 12- to 14-hour days as a physician,” Dr. Hertz says. “Now I have a new job—advocating for the injured, helping them get medical care and treatment. People contact me every day. So I feel like I am helping and using my medical background to help people. This new job honestly saved my life.”

https://www.wsj.com/articles/the-covid-vaccines-neglected-side-effects-neuropathy-nih-fda-cdc-transparency-react19-8afa87b1

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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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Messenger RNA COVID-19 Vaccines Had No Effect on Overall Mortality: Trial Data Reanalysis

The Pfizer and Moderna COVID-19 vaccines did not impact overall mortality, a reanalysis of clinical trial data found.

The two vaccines, both based on messenger RNA (mRNA) technology, protected against deaths from COVID-19 but that effect was offset by vaccinated trial participants being more likely to die from cardiovascular problems, Christine Stabell Benn, a health professor at the University of Southern Denmark, and other researchers reported in April in the Cell journal.

On the other hand, vaccines that utilized adenoviruses, such as the Johnson & Johnson vaccine, had a favorable impact on both COVID-19 mortality and overall mortality, according to the reanalysis.

The research analyzed data from randomized clinical trials (RCTs) reported by the companies that manufacture the vaccines.

“In the RCTs with the longest possible blinded follow-up, mRNA vaccines had no effect on overall mortality despite protecting against some COVID-19 deaths. On the other hand, the adenovirus-vector vaccines were associated with lower overall mortality,” researchers said.

“The differences in the effects of adenovirus-vector and mRNA vaccines on overall mortality, if true, would have a major impact on global health,” they added later.

Study

Benn and colleagues took data from three RCTs for the mRNA vaccines and six RCTs for the adenovirus-vector vaccines that had mortality data available. They compared the overall deaths in the vaccinated arms with the placebo arms. They also broke deaths down into different categories: attributed to COVID-19, cardiovascular problems, other non-COVID-19 causes, accidents, and non-accident, non-COVID-19 causes.

“We extracted the number of deaths from the studies that led to approval of the new mRNA and adenovirus-vector COVID-19 vaccines. We calculated the relative risk of dying, overall, and for various causes of death, for each vaccine type,” Benn told The Epoch Times in an email.

The Pfizer and Moderna vaccines, the researchers found, were associated with lower COVID-19 mortality but higher cardiovascular and non-accident, non-COVID-19 mortality. There was no difference in overall mortality between the vaccinated arms and the placebo groups.

The Johnson & Johnson vaccine was associated with lower overall mortality and with lower non-COVID-19 mortality, with no effect on COVID-19 mortality. AstraZeneca’s shot, never authorized in the United States but cleared in some other countries, performed well against overall mortality and other categories across several trials, except for one trial where slightly more vaccinated people died from non-COVID causes or non-accident, non-COVID-19 causes.

“The results suggest that adenovirus-vector vaccines compared with placebo have beneficial non-specific effects, reducing the risk of non-COVID-19 diseases. The most important cause of non-COVID-19 death was cardiovascular disease, against which the data for the current RCTs suggest that the adenovirus-vector vaccines provide at least some protection,” researchers said.

They noted that trial populations were largely healthy adults and that in the real world, even mRNA vaccines were expected to reduce overall mortality. But “the intriguing differences in the effects on non-accident, non-COVID-19 mortality are likely to persist and should be investigated in future studies,” they added.

Overall mortality spiked in a number of highly vaccinated countries after the vaccines were rolled out, including the United States. Researchers are divided as to the causes, with some arguing the vaccines primarily drove the increases and others blaming COVID-19 and other factors.

The study was published ahead of peer review in 2022, but the authors struggled to find a journal that would accept the paper, Benn said. Several journals rejected it without explaining why, causing a delay in publication.

Immune System Impact

Several experts complimented the paper. “This is a good article that raises food for thought,” Dr. Peter Gotzsche, professor emeritus and director of the Institute for Scientific Freedom in Denmark, told The Epoch Times via email.

Gotzsche wrote about research conducted by Peter Aaby, one of Benn’s co-authors, in his book “Vaccines: Truth, Lies, and Controversy.” Some of Aaby’s other papers have supported the hypothesis that live attenuated vaccines like adenovirus vectors help decrease overall mortality while vaccines that contain the killed version of a germ that causes a disease increase total mortality.

Such “unexpected results” can complicate public health messaging, Gotzsche wrote.

Previous research, including a 2013 paper from Benn and Aaby, has suggested that some vaccines provide non-specific effects, or increased protection against unrelated pathogens. They posited that the adenovirus-vector COVID-19 vaccines might “prime the immune system in a way similar to a ‘live’ vaccine,” while noting that the Pfizer and Moderna vaccines increase inflammation, which could lower the immune system’s protection against other illnesses.

Benn, Aaby, and other experts said in a separate paper in April that the current framework for testing and regulating vaccines needs to be updated because of how vaccines may impact the risk of contracting unrelated diseases.

Criticism

Dr. David Boulware, a professor of medicine at the University of Minnesota’s Medical School, was among the critics of the new study. He told The Epoch Times in an email that it was poorly designed because of differences in where the trials were conducted. That’s because some countries, such as the United States, have better health care, he said.

The researchers acknowledged that might be true in the limitations section, writing that “differences between the study populations in the RCTs of the two vaccine types could have biased the comparison as different disease patterns and level of care could have influenced the measured effect of the vaccines on overall mortality.”

The researchers added: “More individuals were infected with COVID-19 in the mRNA RCTs than in the adenovirus-vector vaccine RCTs, but there were more COVID-19 deaths in the adenovirus-vector RCTs. This suggests that participants in the mRNA RCTs may have had access to better health care during COVID-19 infection, and this may have reduced the impact of mRNA vaccination on overall mortality.”

Boulware also said that real-world data “does not support the conclusions of the paper,” pointing to observational data from Israel and Minnesota. “Clearly the mRNA vaccines protect better against COVID than adenovirus vector vaccines,” he said.

Benn said the study was “built on a meta-analysis of placebo-controlled RCTs—the highest degree of evidence in the evidence pyramid.” and that the key point of focus was overall mortality.

“He is discussing COVID-19—we are studying all-cause mortality,” Benn said. “It is irrelevant if a vaccine protects better against COVID-19 than another vaccine, if it reduces overall mortality to a lesser degree—unless you think that COVID is worse than death.”

https://www.theepochtimes.com/messenger-rna-covid-19-vaccines-had-no-effect-on-overall-mortality-trial-data-reanalysis_5258825.html

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Judge Orders FDA to Speed Up Release of COVID-19 Vaccine Trial Data From 23.5 Years to Just 2

A federal judge in Texas this week ordered the Food and Drug Administration (FDA) to make public data it relied on to license COVID-19 vaccines—Moderna’s for adults and Pfizer’s for children—at an accelerated rate, requiring all documents to be made public by mid-2025 rather than, as the FDA wanted, over the course of around 23.5 years.

In a decision hailed as a win for transparency by the lawyer representing the plaintiffs (the parents of a child injured by a COVID-19 vaccine) in a lawsuit (pdf) against the FDA, the Texas judge ordered the FDA to produce the data about ten times faster than the agency wanted.

“Democracy dies behind closed doors,” is how U.S. District Judge Mark Pittman opened his order (pdf), issued on May 9, which requires the FDA to produce the data on Moderna’s and Pfizer’s COVID-19 vaccines at an average rate of at least 180,000 pages per month.

The FDA had argued it would be “impractical” to release the estimated 4.8 million pages at more than between 1,000 and 16,000 pages per month, which would have taken at least 23.5 years.

Aaron Siri of Siri & Glimstad, who represents the plaintiffs in the legal action against the FDA, called the decision “another blow for transparency and accountability” that builds on an earlier court order targeting Pfizer’s COVID-19 vaccine data for those aged 16 and older.

The January 2022 order (pdf), also issued by Pittman, forced the FDA to produce all its data on Pfizer’s COVID-19 vaccine for those aged 16 and older at a rate of 55,000 pages per month, or much faster than the 75 years the agency had sought.

“That production should be completed in a few more months,” Siri said in a statement, referring to the earlier Pfizer data for those aged 16 and up.

The latest order requires the FDA to produce all of its data on Pfizer’s COVID-19 vaccine for 12- to 15-year-olds (and Moderna’s product for adults) by June 31, 2025.

‘Stale Information Is of Little Value’

While the judge noted in his order that the court recognizes the FDA’s limited resources dedicated to freedom of information requests (FOIA), he argued that “the number of resources an agency dedicates to such requests does not dictate the bounds of an individual’s FOIA rights.”

“Instead, the Court must ensure that the fullest possible disclosure of the information sought is timely provided—as ‘stale information is of little value,'” Pittman wrote.

In order to ensure the FDA can meet the accelerated deadline—so around ten times faster than the agency wanted—the judge ordered the parties to the lawsuit to confer and submit a joint production schedule for the data by May 23, 2023.

In the earlier case adjudicated by Pittman, the FDA had argued it only had the bandwidth to review and release around 500 pages per month of an estimated total 450,000 pages of material about the Pfizer COVID-19 vaccine for those aged 16 and older.

The FDA has not disputed in either case that it has an obligation to make the information public but it has argued that its short-staffed FOIA office could not meet the pace of production sought by the plaintiffs.

The judge disagreed, arguing in both cases that the imperatives of transparency and accountability are of paramount importance.

In the January order, Pittman said that too much foot-dragging and secrecy on the part of federal agencies feeds conspiracy theories and reduces the public’s trust in government.

Confidence in the FDA over COVID-19 vaccine approvals was shaken by the disclosure that regulators sped up the approval of Pfizer’s vaccine.

Republicans on the House Select Subcommittee on the Coronavirus Pandemic in March announced they were seeking answers after recently released emails indicated that the FDA rushed the approval of COVID-19 vaccines and boosters to accommodate vaccine mandates.

https://www.theepochtimes.com/judge-orders-fda-to-speed-up-release-of-covid-19-vaccine-trial-data-from-23-5-years-to-just-2_5263217.html

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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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Brief hiatus

I am at the moment recovering from a mild virus. I think it will help my recovery if I take it easy for a couple of days. So I am doing no blogging today and tomorrow. I should however be back to strength on Sunday

The shocking refusal of medical treatment to the unvaccinated

Vicki Derderian desperately needs a lifesaving heart. She suffered from heart failure in 2020 before doctors inserted a ventricular assist device, a mechanical pump that circulates blood to help both sides of her heart function. However, she has been turned away by the Alfred Hospital in Melbourne because of vaccine mandates which are still enforced by the Victorian government.

The Hospital insists that she must receive the Covid vaccine even though Vicki has a permanent vaccine exemption provided by the Australian Technical Advisory Group (ATAGI). As reported, the Hospital has refused to recognise her permanent vaccine exemption. ‘They want her to have three vaccines so they can do surgery on her.’

Vicki, a wife and a mother of three, has not been vaccinated because of concerns that her medical condition makes her unsuitable to receive a Covid vaccination. She insists that she is not an ‘anti-vaxxer’ and only decided against such a vaccine after ‘reading up on all the information’. Indeed, Dr Peter McCullough, a leading and renowned cardiologist, agrees with her that ‘under no circumstances’ should she, or any heart transplant patient, receive a Covid vaccine ‘because of the damage it can do to the heart’. According to him, ‘if Vicki’s heart sustains any more damage it is almost certainly going to be lethal’. This is so because evidence shows that heart damage can be caused by an mRNA vaccine.

Vicki’s reluctance to receive vaccinations, especially in her perilous condition, is a sensible and understandable response to the realisation that Covid vaccines remain experimental and their long-term effects on its recipients are largely unknown. Dr Jessica Rose, a Canadian researcher with multiple degrees in immunology, computational biology, molecular biology, and biochemistry, says that, while conventional vaccines take approximately 10 years to be available in the market, the Covid mRNA vaccines were rushed through clinical trial testing in less than a year. According to her, ‘these trials were basically the foundations upon which all the decisions were made and the mantra that we’ve been hearing for three years, “safe and effective”, were based on’.

The rigid enforcement in Victoria of its vaccine mandate in hospitals is reminiscent of its ‘no jab, no job’ mandate. While such a mandate destroys the livelihood of people, withholding medical care may be a matter of life or death. In this context, Ed Yong, in a perceptive article published in The Atlantic, argues that ‘medical care should be offered according to the urgency of a patient’s need, not the circumstances leading up to that need’. Carla Keirns, a professor of medical ethics and palliative medicine at the University of Kansas Medical Center, told Yong that it is a fundamental medical principle that ‘everyone has an equal claim to relief from suffering, no matter what they’ve done or haven’t done’.

The refusal to operate upon Vicki is a baffling and despotic example of bureaucratic decision-making. Even the Australian Human Rights Commission, on its website, encourages service providers ‘to carefully consider the position of vulnerable groups in the community before imposing any blanket Covid vaccination policies or conditions’.

In addition, the Australian Medical Council’s Good Medical Practice: A Code of Conduct for Doctors in Australia stipulates, in Article 2.4, that decisions about patients’ access to medical care ‘need to be free from bias and discrimination’ and exhorts doctors not to prejudice the care of their patients on the ground that ‘a patient’s behaviour has contributed to their condition’. Relevantly, the Code also states that even if a patient poses a risk to their treating doctors and staff, ‘a patient should not be denied care’ if reasonable steps can be taken to protect the treating staff.

Indeed, a refusal to treat a patient because of their vaccine status adversely affects the democratic principle of equality before the law. The deliberate exclusion of unvaccinated Australians from life-saving medical treatment discriminates against them on the ground of vaccine status. In other words, if the unvaccinated face such serious restrictions of fundamental rights to bodily autonomy and lifesaving medical treatment, these restrictions directly violate the principle of equality before the law. Accordingly, in Leeth v Commonwealth, Justice Deane and Justice Toohey argued that ‘the essential or underlying theoretical equality of all persons under the law and before the courts is and has been a fundamental and generally beneficial doctrine of the common law and a basic prescript of the administration of justice under our system of government’.

Furthermore, even international law fully recognises that certain inalienable rights must never be violated. Accordingly, the right of an individual to refuse vaccination is codified in the Nuremberg Code, an ethics code. This Code has as its first principle the willingness and informed consent by the individual to receive medical treatment or to participate in an experiment. To deny a patient much needed medical assistance – a potentially life-saving transplant – because she did not give consent to vaccination, constitutes a gross violation of this Code.

To make Vicki’s plight worse, scientists have now discovered that mRNA vaccines, not Covid infection itself, may cause brain and heart damage. For instance, a study published in October 2022 in the journal Vaccines reports the fascinating results of the autopsy of a patient who had no history of Covid infection. The article provides compelling evidence that the patient’s death was directly caused by the mRNA vaccine. ‘In the heart, signs of chronic cardiomyopathy as well as mild acute lympho-histiocytic myocarditis and vasculitis were present. Although there was no history of Covid for this patient, immunohistochemistry for SARS-CoV-2 antigens (spike and nucleocapsid proteins) was performed’.

Dr Young Dong, a medical doctor who has more than 20 years of experience in virological and immunological research, believes that, at the general population level, the risks of imposing vaccine mandates substantially exceeds the benefits. According to John Ionnidis, professor of medicine and epidemiology at Stanford University, the average rate of death for Covid, when adjusted from a wide age range and unreported cases, could be as low as to that of influenza. According to him, more than 80 per cent of those who get the virus have no symptoms or these symptoms are actually very mild. In fact, even the World Health Organisation (‘WHO’) acknowledges that ‘most people infected with the virus will experience mild to moderate respiratory illness and recover without requiring special treatment’.

Jennifer Margulis and Joe Wang report that, in the 2021-22 period, there has been a sudden and unexplained surge of age-inappropriate deaths in at least 30 countries in the industrialised world. They refer to research undertaken by Ed Dowd for his book Cause Unknown: The Epidemic of Sudden Deaths in which he argues that ‘the sudden deaths in young people in industrialised countries are due to mRNA vaccines’. Relevantly, Dowd shows that ‘the number of excess deaths in America attributed to Covid in 2020 was actually much lower than the huge spike in sudden deaths that began in 2021 after the Covid vaccines started being widely distributed’.

With such low risks for most people, why is the entire population of Australia being coerced to be vaccinated with Covid vaccines? This is especially so given the potential for side effects which can lead to death, as is demonstrated by the dramatic surge in sudden deaths in countries around the world, including Australia, Canada, the United States, and the United Kingdom, of which many have been causally related to mRNA vaccines.

Australia closely followed World Health Organisation’s guidelines since the start of the pandemic. By the end of 2021, the nation reached a vaccination rate of 80 per cent of the population. Despite having such an impressive vaccination rate, last year, 174,000 deaths were registered in Australia, which is 20,000 more than projections estimated. This represents the highest number of excess deaths on record since the end of the first world war.

These excess deaths are mostly related to cancer and heart issues, including heart failure, stroke, atrial fibrillation, myocardial infraction, and heart disease. The U.S. Centers for Disease Control and Prevention has acknowledged that the evidence shows that mRNA vaccines have caused many types of heart conditions, including myocarditis. Myocarditis is a condition that inflames and weakens the heart muscle, which can result in death. In fact, a considerable number of blind-reviewed academic papers have directly linked these vaccines with a higher risk of myocarditis, and even Pfizer scientists now acknowledge that there may have been increased cases of myocarditis after vaccination. Dr Ross Walker, a practicing cardiologist with 40 years of clinical experience, believes that mRNA vaccines are ‘very pro-inflammatory’, and so they should never have been mandated. On 24 November 2022, he stated the following about such vaccines and heart conditions:

I don’t think we should be having the mRNA vaccines. I’ve seen in my own practice as a private cardiologist 60-70 patients over the past 12 months who have had similar reactions to this. Whether it’s pericarditis or the more serious myocarditis. I’ve seen a lot of people get chest pain, shortness of breath, heart palpitations.

Dr Kenji Yamamoto, a cardiovascular surgeon who works at Okamura Memorial Hospital in Shizuoka, Japan, recently called for the discontinuation of Covid booster shots. In a letter to the peer-reviewed journal Virology, he explains that he and his colleagues have ‘encountered cases of infections that are difficult to control’ including some that occurred after open-heart surgery and were still not under control after several weeks of treatment with multiple antibiotics. ‘As a safety measure, further booster vaccinations should be discontinued,’ Dr Yamamoto wrote.

Given the already known potential harms of mRNA vaccines, the decision of the Alfred Hospital to force Vicki to receive such vaccination regardless of her health conditions is plainly wrong and not scientific. It is now patently clear that mRNA vaccines prevent neither infection nor transmission. Speaking on these very vaccines, a member of the Australian Technical Advisory Group on Immunisations (ATAGI), now acknowledges that ‘the more doses you get, the less benefit you derive from them and then we start to worry about causing side effects’.

The latest research confirms that mNRA vaccines are not being able even to stop the spread of the disease. Those who are vaccinated can still catch and transmit Covid. As evidence of the inefficacy of these vaccines, in a study supported by Centers for Disease and Prevention contracts, members of the Upper Midwest Regional Accelerator for Genomic Surveillance founded by the Rockefeller Foundation, concluded that vaccinated people can still catch and transmit Covid and, once infected, the vaccinated are as likely to infect others as the unvaccinated.

In other words, these Covid vaccines do not stop transmission of the virus, and the protection provided at best is very limited. Dr Jayanta Bhattcharya, a professor of medicine, economics, and health research and policy at Stanford University, believes that, from a medical perspective, the necessary conditions for vaccine mandates are not present. If a vaccine fails to stop disease transmission, then ‘the idea that you need to vaccinate other people so that I’m protected is just false’, he says.

These sobering scientific facts militate against the imposition of vaccine mandates and make the refusal to treat people like Vicki particularly odious.

With such high risks for some people, particularly those with heart conditions, why is Vicki being forced to be vaccinated with defective Covid vaccines? Indeed, the Alfred Hospital, which is owned by the State Government, has denied Vicki a place on the transplant list because she has not received Covid vaccines. They are trying to force a person in desperate need of a heart transplant to get a vaccine that has known cardiac side effects, in order to get a heart transplant!

To add insult to injury, as mentioned above Vicki actually has a legitimate vaccine exemption which the hospital is deliberately choosing to deny. In an attempt to get the authorities to respect her vaccine exemption, Vicki and her husband, John, have asked Senator Ralph Babet to raise her case in the Senate, which he did. ‘We’re being pushed in the corner and coerced to take something that goes against what we believe in, or not receive lifesaving treatment,’ she says. She has recently applied to the Victorian Civil and Administrative Tribunal (VCAT) to have her case heard. Let’s hope that justice finally prevails, and Vicki can undergo a desperately needed heart transplant regardless of her vaccination status.

https://www.spectator.com.au/2023/05/the-shocking-refusal-of-medical-treatment-to-the-unvaccinated

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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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Another blow for the statin religion: Negligible benafit found from taking statins

Evaluating the Association Between Low-Density Lipoprotein Cholesterol Reduction and Relative and Absolute Effects of Statin Treatment

Paula Byrne et al.

Abstract

Importance The association between statin-induced reduction in low-density lipoprotein cholesterol (LDL-C) levels and the absolute risk reduction of individual, rather than composite, outcomes, such as all-cause mortality, myocardial infarction, or stroke, is unclear.

Objective To assess the association between absolute reductions in LDL-C levels with treatment with statin therapy and all-cause mortality, myocardial infarction, and stroke to facilitate shared decision-making between clinicians and patients and inform clinical guidelines and policy.

Data Sources PubMed and Embase were searched to identify eligible trials from January 1987 to June 2021.

Study Selection Large randomized clinical trials that examined the effectiveness of statins in reducing total mortality and cardiovascular outcomes with a planned duration of 2 or more years and that reported absolute changes in LDL-C levels. Interventions were treatment with statins (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) vs placebo or usual care. Participants were men and women older than 18 years.

Data Extraction and Synthesis Three independent reviewers extracted data and/or assessed the methodological quality and certainty of the evidence using the risk of bias 2 tool and Grading of Recommendations, Assessment, Development and Evaluation. Any differences in opinion were resolved by consensus. Meta-analyses and a meta-regression were undertaken.

Main Outcomes and Measures Primary outcome: all-cause mortality. Secondary outcomes: myocardial infarction, stroke.

Findings Twenty-one trials were included in the analysis. Meta-analyses showed reductions in the absolute risk of 0.8% (95% CI, 0.4%-1.2%) for all-cause mortality, 1.3% (95% CI, 0.9%-1.7%) for myocardial infarction, and 0.4% (95% CI, 0.2%-0.6%) for stroke in those randomized to treatment with statins, with associated relative risk reductions of 9% (95% CI, 5%-14%), 29% (95% CI, 22%-34%), and 14% (95% CI, 5%-22%) respectively. A meta-regression exploring the potential mediating association of the magnitude of statin-induced LDL-C reduction with outcomes was inconclusive.

Conclusions and Relevance The results of this meta-analysis suggest that the absolute risk reductions of treatment with statins in terms of all-cause mortality, myocardial infarction, and stroke are modest compared with the relative risk reductions, and the presence of significant heterogeneity reduces the certainty of the evidence. A conclusive association between absolute reductions in LDL-C levels and individual clinical outcomes was not established, and these findings underscore the importance of discussing absolute risk reductions when making informed clinical decisions with individual patients.

https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2790055

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Local and Private COVID Vaccine Mandates at Health Care Facilities Being Reversed, Struck Down Across US

Efforts to overturn vaccine mandates for both hospital patients and health care workers appear to be gaining momentum across the United States.

In what’s seen as a major victory for transplant patients who didn’t take the COVID-19 vaccine, one of the largest transplant centers in the United States reversed its policy to require the vaccine in order to be eligible for an organ transplant.

The University of Michigan (UM) announced its new policy on May 4, just before court proceedings started in a lawsuit filed against it for declaring patients ineligible for an organ transplant unless they agreed to receive the vaccine.

The suit was filed on behalf of several patients by David Peters of Pacific Justice Institute, who, in celebrating the reversal, simply said “We’re winning!”

According to a written statement by UM, “new information” led to the “voluntary decision” to reverse its policy.

“The University hereby gives notice to the Court that in light of developing epidemiological and other actuarial circumstances, effective April 27, 2023, it has changed its Transplant Center COVID-19 Vaccination Requirement for Adult Transplant Candidates,” the statement reads. “Relevant to this litigation, COVID-19 vaccine will no longer be required prior to wait-listing of potential adult solid organ transplant recipients.”

The UM decision came on the same day that a federal judge chastised Maine Assistant Attorney General Kimberly Patwardhan for filing a motion to dismiss a lawsuit filed on behalf of health care workers who lost their jobs for refusing to get the COVID-19 vaccine.

“You obviously have not been reading the U.S. Supreme Court precedent on this or else you would not have filed your motion to dismiss,” Judge Sandra Lynch said to Patwardhan.

Lynch made the comments during oral arguments in the case before a three-judge panel of the 1st Circuit Court of Appeals in Boston. The case is being argued by Matt Staver, founder of Liberty Counsel, on behalf of the health care workers.

In addition to the ban, Maine Gov. Janet Mills also threatened to revoke the licenses of all health care employers who fail to mandate the COVID-19 vaccine for all workers.

Maine is one of six states—along with New York, California, Connecticut, West Virginia, and Mississippi—that banned religious exemptions from vaccine mandates.

In April, in Mississippi, in what many parents opposed to vaccines are hoping will become a national precedent, a federal judge ruled that outlawing religious exemptions from vaccines, including school-required immunization, was unconstitutional and ordered the provision restored.

Such rulings follow a Supreme Court decision that found that it’s discriminatory for states to consider other kinds of exemptions from the vaccine while denying religious ones.

However, Peters said he believes that the SCOTUS ruling is only part of the reason hospitals are starting to voluntarily reverse COVID-19 vaccine mandates.

Peters, who holds a doctorate in medical sociology and a master’s in medicine, said the hospitals are starting to own up to the reality that the vaccines are “if not hurtful, useless.”

He has several other pending cases against transplant centers that have denied patients a spot on a list, including some in need of life-saving heart transplants, because they weren’t vaccinated against COVID-19.

Peters said he’s planning to file “tons” more across the country.

Liberty Counsel has also partnered with lawyers in states including Florida to bring similar lawsuits on behalf of patients and health care workers.

Florida attorney Jenna Vasquez represents nursing students on behalf of Liberty Counsel in pending litigation against their colleges for refusing to let them complete their clinicals unless they get the COVID-19 vaccine.

“And yet we are being told we are in a nursing crisis,” she told The Epoch Times.

In Maine, another group, Health Choice Maine, has filed a separate lawsuit on behalf of EMTs who were fired for not taking the vaccine.

The Mills administration continues to enforce the mandate for EMT workers despite a critical shortage of technicians and drivers in Maine, which has the largest elderly population in the United States.

One of the largest U.S. hospitals has also been taken to court over its denial of religious exemptions from the COVID-19 vaccine.

Oral arguments are scheduled for May 10 in a case against Mass General Brigham in Boston.

In the lawsuit, 159 workers question why the hospital granted 230 employees religious exemptions but denied their requests. The hospital cited “hardship” as the reason but didn’t explain what it meant, the complaint shows.

The hospital has filed a summary judgment asking the court to dismiss the case.

Massachusetts attorney Ryan McLane of McLane & McLane, a law firm affiliated with Liberty Counsel, is representing the 159 health care workers in the case.

https://www.theepochtimes.com/covid-vaccine-mandates-for-patients-healthcare-workers-being-reversed-overturned-across-the-u-s_5248633.html

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Increased Risk of Serious Eye Problem After COVID-19 Vaccination: Study

People who received a COVID-19 vaccine have an increased risk of a serious eye problem, according to a new study.

The risk of retinal vascular occlusion “increased significantly” after a first or second dose of the messenger RNA (mRNA) COVID-19 vaccines, researchers reported in a study published by Nature.

The Pfizer and Moderna COVID-19 vaccines both use mRNA technology.

Retinal vascular occlusion refers to the blockage of veins or vessels that carry blood to or from the retina. It can cause sudden vision loss.

Out of 207,626 Pfizer vaccine doses administered in the population that was studied, 226 cases of the eye problem were detected after two years. Among 97,918 Moderna vaccine doses administered, 220 cases were detected over the same time.

While some cases were detected among AstraZeneca recipients, the risk wasn’t statistically significant.

The risk of retinal vascular occlusion was 3.5 times for vaccinated people compared to an unvaccinated group after 12 weeks and 2.19 times higher after two years. An increased risk was found shortly after vaccination.

“We demonstrated a higher risk and incidence rate of retinal vascular occlusion following COVID-19 vaccination, after adjusting for potential confounding factors,” Chun-Ju Lin, an eye doctor, and other Taiwanese researchers reported in the study.

Patients on medications that could alter blood osmolarity should be especially aware of the risks identified in the study, although further research is needed to figure out whether COVID-19 vaccines actually cause the eye problem, the researchers said.

They drew data from TriNetX, a global network, and adjusted the results with a model that included excluding people with a history of retinal vascular occlusion.

Limitations include not confirming the accuracy of diagnoses listed in the system

https://www.theepochtimes.com/health/increased-risk-of-serious-eye-problem-after-covid-19-vaccination-study_5249288.html

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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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NIH Clinical Investigator Acknowledges Rare Neurological-Related Injuries Associated with COVID-19 Vaccines: What Are You Going to Do About It?

Avindra Nath, M.D. knows a thing or two about the COVID-19 vaccines and the neurological issues, although rare, that may ensue. Far earlier in the pandemic when the AstraZeneca vaccine was still undergoing testing in clinical trials, a group of patients including React19 co-founder Brianne Dressen engaged with Nath and others at the National Institutes of Health (NIH). Dressen and some others experienced neurological problems associated with the AstraZeneca COVID-19 vaccine.

In fact, as myriad issues emerged with that experimental product the decision was made to not consider that particular COVID-19 vaccine for distribution as a countermeasure under the Emergency Use Authorization. Nath and others conducted an observational study that was never peer-reviewed, uploaded to the preprint server medRxiv and essentially forgotten.

TrialSite reported on the study where Nath and colleagues emphasized that more time was necessary for scientists and physicians to determine the true nature of any causal relationship between the COVID-19 vaccines and neuropathies. So, lots of time has passed—what more does the NIH Principal Investigator have to say on the topic?

It should be noted that during those early days of the pandemic not only Nath via his National Institute of Neurological Disorders and Stroke (NINDS), part of the NIH but also representatives from other federal agencies such as the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) were aware of these early reports of neurological-related vaccine injuries.

Brianne Dressen has explained to TrialSite that numerous upbeat promises were made by the agencies to support the COVID-19 vaccine injured with research and access to care. But particularly after the political winds blew hard as 2020 transitioned to 2021, with the outgoing Trump administration fiasco, the January 6th uprising, plus Biden’s new intensified focus on vaccination, it led to the worst possible political storm impacting the vaccine injured, raising questions about the COVID-19 vaccine or unbelievably just claiming an industry tarnished a person in the eyes of many. Essentially the topic was intensely politicized and remains so. In some societal circles, it’s a taboo topic, one that can divide what were friends, even family.

In Nath’s most recent article in the journal Neurology titled “Neurologic Complications with Vaccines: What We Know, What We Don’t, and What We Should Do” Nath, an NINDS Senior Investigator highlights first the impact of vaccination generally over the last half century, nearly eradicating potentially deadly infections that in days gone by were constantly taking lives. He is correct. Vaccination has played a vital role in individual and collective health despite the trendiness of elements in the medical freedom movement to deny that reality.

However, Nath and most in positions of influence and power in health-related research today treat vaccines as if they were all alike. But they are not. Importantly, not all vaccines are the same, even when the FDA has approved them as safe and effective. But it’s as if this classification immediately delegitimizes any critique of these medicinal-based products. An either-or false dilemma narrative is set up. Either you believe that it's universally good or you don’t. But that’s not how the real world works, especially with medical products with side effects.

The reality is that some vaccines have better safety track records than others, and at least historically, the vaccines that we have that are tried and true have a lengthy development lifecycle and several iterations of advancement.

The number of vaccines on the CDC childhood schedule continues to grow. As of this writing, there are 18 vaccines on the CDC’s Child and Adolescent Immunization Schedule for children from birth to 18 months, and this includes the COVID-19 vaccine. Importantly, the particular version of the vaccine now in circulation remains experimental (investigational) in that only the bivalent Omicron BA.4/BA.5 product became available as recently reported by TrialSite.

There are another 18 vaccines on the CDC’s schedule from the age of 18 months to 18 years. While many of these vaccines remain a bedrock of personal and public health, TrialSite continues to have questions about the placement of the COVID-19 vaccine, again, still investigational (despite the licensure that did occur with the monovalent product), on the childhood vaccination schedule from birth to 18 months.

Nath in his generally cursory piece emphasizes that despite an evolution toward more sophisticated vaccines (mRNA or protein-based) and “well-defined” manufacturing process (see Emergent BioSolutions fiasco for glaring examples of production problems with the COVID-19 vaccines) he acknowledges that well, “despite such measures, vaccines are not without side effects including those that impact the nervous system.”

So, there is an explicit acknowledgment that neurological issues are present, at least on rare occasions. A wealth of information exists in various monitoring systems today, yet as will be noted below Nath calls for a more complex reporting scheme, involving global platforms, with full industry buy-in. A tall order that in all reality is years away. What about people with debilitating conditions today?

Nath points to “numerous case reports and case series” implying “possibilities” of such potential serious adverse events. But the NIH scientist isn’t squaring with the American public. The “React19 Scientific Publications & Case Reports,” database houses a collection of 3,400 peer-reviewed case reports and studies involving post-COVID-19 vaccine reports of serious adverse events. Including 24 therapeutic categories, the repository includes 628 studies associated with neurological issues associated with post-COVID-19 vaccine adverse events. 628 studies, even if only case series, is a lot and should be well studied, reported on and translated to the clinic to educate and empower more doctors and health care professionals to help patients. Isn’t that what it’s all about?

The NIH scientists remind all of the universal immunity the U.S. government grants to bio-pharmaceutical companies developing vaccines during the national public health emergency under the Public Readiness and Emergency Preparedness (PREP) Act. Industry, and in fact, the entire value chain of vaccination from pharma companies to healthcare clinics has absolutely no liability associated with the mass vaccination campaign during the emergency. Any compensation for injury must come from what TrialSite has identified as a dismal failure—the Countermeasures Injury Compensation Program (CICP). To date, despite over 11,000 claims only three have been awarded. This is an outrageous reality. This demonstrates the government’s intention, which is to leave the vaccine injured to fend for themselves.

Importantly, vaccine makers generally don’t have liability for any injuries even before COVID-19. That dismissal of liability emerged with the National Childhood Vaccine Injury Act of 1986 which shifted liability from industry to government under the National Vaccine Injury Compensation Program (VICP)---an alternative to traditional products liability and medical malpractice litigation for people injured by the receipt of one or more standard childhood vaccines. While VICP is far better than CICP, it as well needs to be updated and modernized.

Nath reminds us of all that the government is busy monitoring for COVID-19 vaccine injuries thanks to both the “active and passive surveillance programs” in place by the CDC and FDA (think VAERS). TrialSite has reported on heretofore not conceivable volumes of adverse event reports in the VAERS system. Yet we are constantly reminded that despite the fact that the system was billed as a key to monitor for safety signals, VAERS doesn’t do much to help us because causation isn’t proven. This is true, however, when the incidence is reported in VAERS just one or two days after the administration of the COVID-19 vaccine the probability of some causal connection markedly increases, all things being equal.

With 672 million doses of COVID-19 vaccines administered in the United States from December 14, 2020, through March 1, 2023, serious adverse events are indeed rare. But they are occurring. Out of the 19,476 preliminary reports of deaths associated with the vaccines a substantial percentage of these occurred shortly after vaccination. Again, that doesn’t mean the vaccine triggered the death. But deaths are occurring—we have been reporting on them around the world. Some nations such as Taiwan and Singapore seem to have more reasonable and responsible government compensation schemes as compared to the United States, United Kingdom and Canada.

Nath continued in his journal entry, “While most side effects of vaccines are benign and transient, such as headache or fatigue, more serious side effects, including devastating neurological complications may occur.”

So, what does Nath propose to do to help this vulnerable population? Where is the health equity agenda in this case? According to his paper, “future research” is necessary to better understand the neurological complications of the COVID-19 vaccines (which he acknowledges involve other vaccines as well

Nath is also big on working to build influential, global monitoring systems with complete industry buy-in. Does he understand how difficult, how time-consuming the realization of such a vision entails?

What about the patients with vaccine injuries struggling now? Does he care about this vulnerable population? Nowhere therein does Nath really address what to do with the COVID-19 vaccine-injured population today.

The stakes here are bigger, more severe given the intense mandates and societal pressures that emerged during the pandemic, along with what was clearly federal agencies playing fast and loose with the law. True informed consent for example wasn’t really practiced during the pandemic in most cases. Although classified as rare, considerable risks continue to be associated with the COVID-19 vaccines, particularly for certain cohorts (Myocarditis for young men as an example), but during the emergency, the specter of catching COVID terrified the society far more than the rare prospect of an injury, which most likely would be mild.

At TrialSite we continue to carefully monitor the topic, and while we cannot prove our vaccine-injured estimations, we consider them reasonable. The extent to the scope and scale of the vaccine-injured population varies depending on point of view, outrageously, often even political point of view given the overall politicization of the topic.

We’ll simplify and call out two extremes—the so-called medical freedom movement extreme and the mainstream medical establishment, which we believe systematically suppresses accurate insight into the topic.

While the more extreme groups classified as “anti-vax” may declare millions have died from the COVID-19 vaccines in all reality there is no real evidence to make this claim. Any algorithms used to generate such high numbers are quite suspect and not validated anywhere. We are concerned by the growing tendency toward sensationalism to drive attention and eyeballs and in many cases monetization among the anti-vax crowd.

On the other hand, from a mainstream point of view, government estimates may vary but there is no formal, systematic research on the matter, at least that we are aware of. The government has only acknowledged a few deaths associated with the COVID-19 vaccines even though nearly 20,000 were registered in VAERS (again that doesn’t mean they are connected to the vaccine).

At least some of the research Nath proposes in his paper has been suppressed, or even shut down. There isn’t much money in studying COVID-19 vaccine injuries. And this is unlikely to change barring some extreme unforeseeable changes.

TrialSite reminds all that in the United States 270 million people alone received their primary series and based on nearly 2.5 years of ongoing monitoring of data and study sources worldwide, we estimate that a range from anywhere from half a million to 2 million people are struggling with material health issues that persist since the administration of the COVID-19 vaccine. We acknowledge that not all of these are because of the vaccine solely—long COVID and other issues very well could be factors. It’s a complex difficult situation for those that are struggling, ill, in pain and left to fend for themselves in most cases.

https://www.trialsitenews.com/a/nih-clinical-investigator-acknowledges-rare-neurological-related-injuries-associated-with-covid-19-vaccines-what-are-you-going-to-do-about-it-b10cfa3a

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Climate misinformation from "The Guardian"

Leftist organ quick to misallocate blame

The Guardian Australia has made multiple corrections to content it published about misinformation and Sky News Australia.

The online news outlet published a podcast titled, “Fox News and the consequences of lies with Lenore Taylor”, only to later amend it after making false claims relating to Sky News.

A note published on the Guardian’s website underneath the podcast by Taylor, the editor of the Guardian Australia, read: “An earlier version referred to adverse findings by the Australian Communications and Media Authority against Sky News Australia in respect of programs containing misinformation ​about C​ovid-19,” the correction states.

“This was incorrect.

“The programs were broadcast by Foxtel Cable Television Pty Limited on the Daystar channel.”

The embarrassing correction comes just one week after the Guardian also made false claims in relation to complaints lodged with the media regulator, the Australian Communications and Media Authority.

The complaints were made about content relating to commentary by Sky News Australia host Rowan Dean on climate science, however the article incorrectly said the complaints were made by “Australians for a Murdoch Royal Commission”.

In a statement on its website it later corrected the record to state the complaints were made by former prime minister Kevin Rudd.

“This article was amended on 28 April 2023 to clarify that the initial complaints to ACMA were made by Kevin Rudd personally, not by Australians for a Murdoch Royal Commission,” the correction said.

A Sky News Australia spokeswoman said in a statement: “This latest factual error is particularly ironic given the purported expertise of the presenters on the podcast, discussing misinformation.”

https://www.couriermail.com.au/business/guardian-australia-corrects-false-comments-published-online-about-sky-news-australia/news-story/2da6f114413b4c9abec03155eb2d3a10

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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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COVID-19 Vaccine Effectiveness Drops Near Zero Within Months

The effectiveness of COVID-19 vaccines fell below 20 percent a few months after vaccination, with booster shots seeing effectiveness drop below 30 percent.

The review, published in the JAMA Network journal on May 3, analyzed 40 studies estimating vaccine effectiveness (VE) over time against laboratory-confirmed COVID-19 infection and symptomatic disease. The studies were selected from 799 original articles, 149 reviews published in peer-reviewed journals, and 35 preprints. The review found that the vaccine effectiveness of a primary vaccination cycle against the Omicron infection and symptomatic disease was lower than 20 percent at 6 months from the administration of the last dose.

Booster doses restored vaccine effectiveness to levels similar to those seen after administration of the primacy cycle dose. However, nine months after the booster dose, vaccine effectiveness against Omicron was found to be lower than 30 percent against infection and symptomatic disease.

“The half-life of VE against symptomatic infection was estimated to be 87 days for Omicron compared with 316 days for Delta. Similar waning rates of VE were found for different age segments of the population.”

“These findings suggest that the effectiveness of COVID-19 vaccines against laboratory-confirmed Omicron or Delta infection and symptomatic disease rapidly wanes over time after the primary vaccination cycle and booster dose,” the study said.

“Putting together the bulk of available evidence on the waning of VE over time against COVID-19 variants has crucial implications for future interventions and vaccination programs.”

Effectiveness by Vaccine Brand

Vaccine effectiveness against Omicron infection was 44.4 percent a month after the completion of the primary vaccination cycle. This fell to 20.7 percent at six months and then to 13.4 percent at nine months. Vaccine effectiveness was found to be higher against the Delta variant as compared to the Omicron variant.

“Pooled estimates of VE after any primary vaccination cycle against symptomatic disease after Omicron infection show a marked waning over time,” the study stated.

Effectiveness against symptomatic disease fell from 52.8 percent a month after completion of the primary vaccination cycle to 14.3 percent at six months and 8.9 percent at nine months.

“Our estimates suggest that the initial VE could be different depending on the vaccine product, with higher VE found at one month from the second dose administration for Moderna and Pfizer-BioNTech compared with AstraZeneca and Sinovac.”

With regard to age, vaccine effectiveness was found to be similar in younger and older age groups against the Omicron variant infection.

No “significant differences” were observed between the two age groups regarding vaccine effectiveness against Delta variant infection. “A significantly lower VE was found for both age groups for Omicron compared with Delta,” it stated.

Vaccine Harms

COVID-19 vaccines have been known to lead to several medical conditions. One study that examined 9,500 women found that those who had taken COVID-19 shots had a slightly higher risk of heavier menstrual bleeding. In the study, 40 out of 1,000 women saw bleeding increase after just a single dose of a vaccine.

Earlier research from the same team had found that the length of the menstrual cycle increased by 3.7 days on average among women who had taken two doses of COVID-19 vaccines compared to those who hadn’t taken a shot.

According to a study from February published in the British Medical Journal, heart failure and deaths have occurred among those who have taken COVID-19 shots.

Researchers found that more people experienced myocarditis after COVID-19 vaccination than after being infected by the virus. Myocarditis is a type of heart inflammation.

A March report from Phinance Technologies, a global macro investment firm co-founded by former BlackRock portfolio manager Edward Dowd, estimates that COVID-19 vaccine damages in the United States resulted in more than 26 million people being injured last year, with such injuries costing almost $150 billion to the economy.

Misleading Effectiveness Claims, Compensation for Injuries
Texas Attorney General Ken Paxton is also looking at whether Pfizer, Moderna, and Johnson & Johnson misrepresented the efficacy of their COVID-19 vaccines.

According to Paxton, the companies may have violated the Texas Deceptive Trade Practices Act, which bars people intending to sell a product from disseminating a statement that they know “materially misrepresents the cost or character of tangible personal property, a security, service, or anything he may offer.”

It also bans representing that a product is “of a particular standard, quality, or grade … if they are of another.”

Paxton has asked the three companies to submit relevant documents and information, including any concerns with regard to the vaccine trials.

Meanwhile, letters from U.S. officials that were reviewed by The Epoch Times show that authorities rejected multiple individuals who had sought compensation for injuries suffered as a result of taking a COVID-19 shot despite diagnoses from doctors.

One such individual is agricultural pilot Cody Flint who began suffering from adverse reactions to Pfizer’s COVID-19 vaccine after taking a shot. Four doctors confirmed that his medical complication, including experiencing intense head pressure, were linked to the COVID-19 vaccine.

Flint sent the medical files to the U.S. Countermeasures Injury Compensation Program (CICP), which is tasked with compensating people who prove that they were injured due to getting vaccinated against COVID-19.

However, CICP rejected Flint’s claim, saying that it did not find the “requisite evidence” necessary to prove that his health issues were caused by the Pfizer vaccine.

https://www.theepochtimes.com/covid-19-vaccine-effectiveness-drops-near-zero-within-months-study_5242659.html

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Delirium Cases in the Elderly After COVID-19 Vaccination

The elderly are a particularly vulnerable population to COVID-19 infection so they were prioritized when it came to the COVID-19 vaccination. However, we now know that COVID-19 vaccines might also on rare occasions cause some adverse events. One of these that has been reported is delirium, and it appears to affect mainly the elderly. TrialSite previously reported on the neurological side effects of COVID-19 vaccines. This article will summarize a case series that reports delirium in the elderly after COVID-19 vaccines.

Delirium is characterized by poor concentration, disorientation, paranoia, memory loss, agitation and sometimes hallucinations. The presentation of these symptoms varies from person to person and symptoms may also involve sleep problems and behavioral disruptions such as hyper or hypoactivity. The symptoms of delirium should not be explained by any other neurocognitive condition but rather by an underlying medical problem. Causes of delirium can vary widely from stress to anesthesia due to surgery.

The case series

Researchers conducted the study at a nursing home (NH) with 514 beds during the period of COVID-19 vaccination for the residents. Participants were 70 years and older. Participants who had positive COVID-19 results or who had a history of alcoholism, were nonverbal, were deaf or blind, or could not speak English were excluded.

After the participants had been recruited, they were examined for conditions that could cause a change in their health status. The study considered vaccination against COVID-19 as a condition that might affect the health status. A day after the vaccination, participants were tested using the Confusion Assessment Method-Severity (CAM-S) instrument, a method used to assess the severity of delirium symptoms. A random sample was selected based on the results of CAM-S. After the initial selection, participants completed a more structured assessment involving the following:

Severe Impairment Battery?8 (SIB?8), a brief assessment method for people with severe Alzheimer’s disease.

The Montreal Cognitive Assessment (MoCA), a screening test for mild cognitive impairment (MCI). This condition is characterized by a cognitive decline that does not affect an individual’s daily functioning but is still noticeable to others.

The Confusion Assessment Method (CAM), a method to use to identify delirium.

Researchers diagnosed delirium using the criteria listed in the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM?5), a reference manual for the diagnosis of mental illness and neurocognitive disorders, based on the residents’ test results at baseline and after vaccination. The participants were diagnosed either with delirium or subsyndromal delirium, defined as a condition where one shows delirium symptoms but does not meet the DSM-5 criteria.

Demographic information was also collected from the participants including:

Previous delirium history
Presence of dementia
Presence of MCI

Results

The study involved 40 participants; 39 of them had their third dose of the COVID-19 vaccine and one received the second dose.

Demographic information was as follows:

The average age of the participants was 82 years.
45% of them were males.

13% of the ethnicity was Latino/Hispanic and non-Whites were 43%.

65% of the participants had dementia and 35% had MCI.

18% of the participants had a previous history of delirium.

Out of the 40 participants, 10% showed symptoms; three showed delirium (7.5%) a day after the vaccination and one participant was diagnosed with subsyndromal delirium (2.5%). A day after the vaccination, these four participants had increased CAM-S scores and decreased MoCA scores compared to their baseline scores.

Within two weeks participants’ scores went back to normal and delirium was resolved. SIB-8 scores also showed the same pattern.

Among 26 people with dementia, three (26%) experienced delirium; among 14 cases without dementia, one (7%) experienced delirium, among seven cases of participants with a previous history of delirium, none experienced delirium after the COVID-19 vaccine, and among 33 participants without a previous delirium history, four (12%) experienced delirium.

https://www.trialsitenews.com/a/delirium-cases-in-the-elderly-after-covid-19-vaccination-927f9650

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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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