Thursday, April 11, 2024
Decision Reserved in Case of Ontario Doctor Who Questioned COVID Lockdowns
An Ontario doctor who was critical of COVID lockdowns argued her case in court on April 10.
Dr. Kulvinder Kaur Gill was trying to quash three cautions placed on her public file by the College of Physicians and Surgeons of Ontario (CPSO). The cautions were made after two tweets in 2020 by Dr. Gill, in which she questioned COVID lockdowns. Dr. Gill became well known during the COVID-19 pandemic for her online challenges to the government’s public health restrictions.
The panel of three judges of the Divisional Court of the Ontario Superior Court reserved their decision on the judicial review, which means there is no set date on which the decision will be released.
Dr. Gill, who specializes in pediatrics, allergy, and clinical immunology, amassed a significant following on X, formerly known as Twitter, where she expressed opinions and concerns about government’s pandemic response, including the potential negative effects of lockdowns and other mandates.
Because of that, she became the subject of seven public complaints lodged with the CPSO, along with a separate investigation by the college’s registrar.
All eight cases were reviewed by the CPSO committee known as the Inquiries, Complaints and Reports Committee (ICRC) in February 2021.
While the committee dismissed five of the complaints, it issued orders for three separate cautions to be placed on her public file.
On March 24, Elon Musk’s X announced that it would help pay her legal bills in trying to get the cautions overturned, saying in a post, “X is proud to help defend Dr. Kulvinder Kaur Gill against the government-supported efforts to cancel her speech.”
That prompted a heartfelt thank you on X from Dr. Gill: “elonmusk’s @X contacted me directly confirming Elon’s committment to pay remainder of campaign to reach $300K AND Elon has committed to assisting my appeal of 3 CPSO cautions, for my 2020 tweets opposing lockdowns, to the very end (ONCA&SCC if needed) May Waheguru bless you.”
Dr. Gill is represented by Libertas Law. In a news release from Libertas, lawyer Lisa Bildy said, “The CPSO issued guidance that doctors’ opinions during Covid-19 had to align with the government and took steps to censure ethical physicians who raised alarm bells about public health policies.”
“But the stifling of scientific debate, especially on novel measures being imposed on a massive scale, is not reasonable, in our submission, nor is it in the public interest,” Ms. Bildy continued.
The two tweets from August 2020 that were the subject of the cautions questioned if there were valid reasons for the lockdowns.
The first said, “There is absolutely no medical or scientific reason for this prolonged, harmful and illogical lockdown.”
The second tweet said, “If you have not yet figured out that we don’t need a vaccine, you are not paying attention.”
In a series of posts on X from the judicial review on April 10, JRwatch_ON said Dr. Gill’s lawyer argued that her client’s tweets were based on evidence, and that debate is important in a democratic society.
In the news release, Libertas Law said while some have portrayed Dr. Gill as an “anti-vaxxer,” it is not true.
“She has always been a proponent of routine childhood vaccines in her clinical practice,” adding that “she also supports Covid vaccines for high-risk individuals with informed consent.”
It says there was no COVID-19 vaccine authorized anywhere in the world in August 2020 when Dr. Gill posted the tweet about vaccines.
“The comment was in relation to a press conference that day by Dr. Theresa Tam in which she stated that, despite the anticipated authorization of a vaccine, possibly by that year’s end, it would not be a silver bullet and lockdowns and restrictions could persist for at least another two or three years,” said the release.
In addition, it said that “the use of widespread and prolonged lockdowns of healthy and low-risk people was contrary to all prior pandemic planning and principles of public health,” adding “evidence of lockdown harms has continued to mount.”
For its part, the CPSO has argued that the evidence indicated lockdowns in China and South Korea were having an effect, and said Dr. Gill was making misinformed and misleading statements, adding it was irresponsible to make such statements on social media during a pandemic.
The hearing is the latest in Dr. Gill’s legal battles. Last fall, she was scheduled for a disciplinary hearing by the CPSO, which was suddenly dropped in September, without the CPSO providing any specific reasons.
In a post at the start of the April 10 judicial review, Dr. Gill posted to X, “I’m at the Divisional Court of the Superior Court of Ontario today with my brilliant lawyer @LDBildy and the support of @elonmusk’s @X.”
And at the end of the hearing, Dr. Gill posted: “and that’s a wrap. A sincere thank you to all who sent their prayers & well wishes, & all who followed along the @JRwatch_ON live-tweets.”
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High Dose Spirulina Regimen Remarkably Reduces COVID-19 Mortality, Improves Hospital Discharge Rate in 7-Day Window
A biomass of cyanobacteria, meaning blue-green algae, spirulina (arthrospira platensis), a cyanobacterium is consumed by both humans and animals, cultivated worldwide. Purported to have anti-inflammatory, antiviral and antioxidant effects, in Western society any claims must be backed by well-designed, randomized controlled trials.
The form Arthrospira is used as a dietary supplement or whole food. What’s the effect of high-dose Spirulina supplementation on hospitalized adults with COVID-19? With not a lot of research backing such a question, a Persian team of scientists affiliated with Pasteur Institute of Iran, Bahalrloo Hospital at Tehran University of Medical Sciences and even one of the scientists affiliated with Tufts University in the U.S. sought to evaluate the efficacy and safety of high-dose Spirulina platensis for SARS-CoV-2 infection.
The results are frankly remarkable, but the study has limitations—the open-label introduces the opportunity for biases, and the study size suggests the need for larger confirming studies, the results published in the Frontiers in Immunology peer-reviewed journal point to a significant finding. Western medicine would not accept these findings as particularly earth shaking but nonetheless, TrialSite points out some possibly intriguing outcomes.
Brief Background
The general class of product is used as feed supplement across aquaculture, aquariums and poultry industries. The use of this natural product started in the Americas—actually in present day Mexico by the Aztecs and other Mesoamericans until the 16th century. Upon the Spanish conquest soldiers of Cortes documented its use. Fast forward to modern day in addition to use as a supplement and for the industries mentioned above, spirulina is under investigation to address food security and malnutrition, plus as dietary support in scenarios such as space flight or even the Mars mission. With less need for land and water than livestock, the supplement represents an economical source of protein and energy.
What’s the basis for this Persian study?
In many societies, dietary supplements are reportedly helpful as supplements in response to viral infections. Take Spirulina, the filamentous, gram-negative cyanobacterium—a blue-green microalga that is a non-nitrogen-fixing photoautotroph according to the authors of this study recently published in Frontiers in Immunology.
Rich in protein (over 70%), plus vitamins, minerals (e.g., D, B12, provitamin A (beta carotene) and iron), numerous other ingredients are present such as phycocyanobilin (PCB), according to the Persian authors, which is a blue pigment protein with anti-inflammatory, anticancer and antioxidant properties.
Citing previous research, the authors of this study articulate that Spirulina consumption boosts B-group vitamins, especially B6, while decreasing interleukin-4 (IL-4) levels in persons with allergic rhinitis. But the substance also increases immunoglobulin A levels in saliva, suggesting that it could possibly enhance mucosal immunity. The supplement is also known to increase function of natural killer (NK) cells while boosting interferon-y (IFN-y) secretion, thus in aggregate overall better innate immune system health.
Finally, with a substance known as calcium spirulan (Ca-Sp) also present, the Iran-based investigators cite in vitro studies suggesting that this substance inhibits growth of select enveloped viruses, such as mumps virus, measles virus, influenza A (IAV), HIV-1, human cytomegalovirus and herpes simplex type 1. But in Western society, this is not widely touted, at least not in medical establishment circles. Evidence requires well-designed randomized studies.
Corresponding authors for this study included Seyed Ahmad Seyed Alinaghi, M.D., M.Phil, Ph.D. with Tehran University of Medical Science, Iranian Research Center for HIV/AIDs, Iranian Institute for Reduction of High-Risk Behaviors.
The Study
The Persian team designed a randomized controlled trial (IRCT20210216050373N1) investigating the research hypothesis: can high dose Spirulina supplement reduce COVID-19-related mortality or accelerate hospital discharge within seven days; secondary endpoint involved overall discharge or mortality?
This study was an open-label trial, conducted in a multi-center environment involving both Ziaeian Hospital and Baharloo Hospital, both affiliated with Tehran University of Medical Sciences. The trial site team recruited patients from July 27, 2021, through to February 17, 2022.
Importantly, the trial site team had to change the study from single-blind trial due to the patients in the Tehran hospitals not trusting the placebo, meaning recruitment was too challenging. This is why the investigators had to remove the placebo. The authors appeared to have followed good clinical practices, triggering protocol change, etc.
Randomized and controlled, the study team’s trial involved 189 patients with COVID-19, randomly assigned in a 1:1 ratio to an experimental group receiving 15.2g of Spirulina supplement plus standard of care (44 non-intensive care units and 52 ICU).
Conducted over a six-day period, the trial site team monitored immune mediators on days 1,3,5 and 7.
What were the study findings?
By day 7 of the study, no deaths associated with COVID-19 were reported in the Spirulina group. 15 deaths (15.3%) occurred in the control group. Within seven days, the Persian study team reported, “A greater number of patients discharged in the Spirulina group (97.7%) in the non-ICU compared to the control group (39.1%) (HR, 6.52; 95% CI, 3.50 to 12.17).”
The study team reports mortality was overall higher in the control group (8.7% non-ICU, 28.8% ICU) compared to the Spirulina group (non-ICU HR, 0.13; 95% CI, 0.02 to 0.97; ICU, HR, 0.16; 95% CI, 0.05 to 0.48).
Additionally, the team reports those patients in the ICU and in the Spirulina, arm evidenced “significant decrease in the levels of MIP-1α and IL-6.” Meanwhile, in those subjects in the intervention group (Spirulina) across ICU and non-ICU subgroups as intervention time increases reported IFN-y levels were significantly higher. Of course, this latter observation represents a cytokine playing a critical role in the immune response against both viral and bacterial infections, as well as in regulating immune response, inflammation and tumor surveillance.
The study authors report no presentation of side effects related to the Spirulina supplements.
Conclusion
The Persian team finds that high-dose Spirulina combined with the standard of care regimen in that part of the world targeting COVID-19 “may improve recovery and remarkably reduce mortality in hospitalized patients with COVID-19.”
Limitations
The Western medical world will not respond to this study result for a number of reasons. First, as the Persian authors self-declared, the study was not blinded, but as mentioned above, the investigators had to adjust to ensure sufficient level of recruitment.
TrialSite points out that non-blinded studies introduce several issues into interpreting the study result. From the potential of bias (selection bias, performance bias and detection bias) to placebo effect to observer bias and less objectivity, to mention some issues, blinded status becomes important for medical establishment acceptance.
Also, because use of traditional and herbal medicine is widespread among Persian (Iranian) peoples, the data obtained from follow-up post discharge can easily be unreliable. Importantly the authors point out this use of traditional and herbal medicines markedly increased during the COVID-19 pandemic. While follow-up was not part of the study protocol, the physician-scientists running this study to their credit “tried our best to follow up with patients long term.”
But many patients were not interested in follow-up post discharge due to a confluence of standard reasons one would find across much of the world.
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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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Wednesday, April 10, 2024
As an Epidemiologist, I Could See Straight Away That Covid Was Being Over-Hyped
BY DR EYAL SHAHAR
It was an evening in mid-March 2020. Almost two years had passed since I retired from the University of Arizona, where I was a Professor of Epidemiology in the College of Public Health.
I was watching the news from Israel, the country in which I lived during the first three decades of my life. The reporters were broadcasting a forthcoming catastrophe, a doomsday in the making. It was all about a new coronavirus epidemic which erupted in China and had reached Israel, Europe and parts of the U.S.
Like everyone, I have been following the news from the Far East since the beginning of the year. Although infectious diseases were not my subject matter research, epidemiologists are trained to think critically, to question what many accept at face value. The picture that emerged was far from clear. A few observations did not fit well with the apocalyptic predictions.
So, I decided to write a short article in Hebrew and submit it as an op-ed to a newspaper in Israel. That’s how the series of essays now published as The Covid Pandemic: Unconventional Analytical Essays (2020-2023) started. It was supposed to have ended about three years later with my summary of what has actually happened in Israel (as opposed to the official narrative), but I added a few more later articles on Covid vaccines. In between, I wrote about many aspects of the pandemic, drawing upon data from Sweden, Denmark, Europe, Arizona, the US, the U.K. and Israel.
Forty essays are included in the book. The first one was titled ‘Hold off on that Apocalyptic Consensus About the Coronavirus’ (March 24th 2020). All of them were written for the public at large and were data driven. They were not based on ‘opinion’ or ‘intuition’. They are science, as best as I know it. If written in a formal, academic style, many of these essays could have been submitted to epidemiology journals. Whether they would have passed the guards of official narratives is a different question.
What will you find in the book?
Back in 2020, I devoted several essays to lockdown-free Sweden and showed, unequivocally, the futility of lockdowns and the misleading comparison of Sweden to neighbouring Nordic countries. The last one in this series, published in 2022, was titled ‘Sweden or the World: Which was a Cautionary Tale?’, paraphrasing headlines that claimed the opposite in the spring of 2020.
Several essays have estimated the death toll of panic-triggered responses to the pandemic. By September 2021, before the return of the flu, between 15% and 30% of the excess mortality in the U.S. may be attributed to the so-called mitigation efforts (‘The Mystery of Unaccounted Excess Deaths in the U.S.’). These were lives that were lost in vain — at least 115,000 deaths and possibly twice as many. The consequences of lockdowns and disruptions of normal life did not end in 2021. Lives have continued to be lost in many countries, including the U.K. Some of the mechanisms are described in my essay ‘Covid: The Death Toll of Panic’.
In numerous essays, I studied excess mortality and explained why trends should be examined over an entire winter (‘flu years’), not by calendar years. Using this approach, I estimated the excess mortality in Europe (‘How Severe was the Pandemic in Europe?’). In the first year (2019-2020), it was only somewhat higher than in a previous season with severe flu (2017-2018). The second year (2020-2021) was very harsh but far from apocalyptic – about twice as severe as 2017-2018. In both years, all-cause mortality would have been lower without lockdowns.
Over a dozen essays cover various aspects of Covid vaccines. I showed severe biases in influential studies from Israel and estimated the correct effectiveness against Covid death, which ranged from mediocre to zero or sometimes negative, in the frail elderly. Using data from the U.K., I showed the questionable effectiveness of the first booster and the futility of the second (fourth dose). In three essays, I estimated the short-term fatality rate of Covid vaccines, which was unacceptable but fortunately not as high as others had suggested. Long-term fatality is difficult to estimate. One essay describes unacceptable rates of side-effects, as found in a largely unknown official survey in Israel (‘Downplaying the Side Effects of Boosters’).
Did Covid vaccines save millions of lives? Not according to a comparative analysis of Israel with Sweden in the winter of 2020-2021 (‘Thousands of Averted Covid Deaths in Israel: Science Fiction’). Nor did they reduce the delayed death toll of Covid in Denmark (‘Lockdown and Vaccines: Lessons from Denmark’).
In the last essay, which imagines a future perspective on Covid vaccines, I wrote:
Twenty years later, we are still studying the long-term morbidity and mortality consequences of disseminated lipid nanoparticles (the mRNA carriers), self- manufactured toxic spike protein and aberrant proteins in various tissues, elevated levels of IgG4 antibodies after repeated injections, and the integration of foreign DNA fragments into the genome.
These days, a group of scientists is studying cancer cells from vaccinated patients to determine if foreign DNA is present there. Chances are that you will not find much on this topic or on other vaccine-related effects in mainstream media. So, keep following the Daily Sceptic and Brownstone, as I have been doing for a long time. No end is in sight to the saga of Covid vaccines.
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UK Watchdog Accuses Pfizer of Promoting ‘Unlicensed’ COVID Vaccine on Social Media
A UK pharmaceutical watchdog said that Pfizer has breached its regulatory code five times, including “promoting an unlicensed medicine,” due to a social media post made by a Pfizer employee.
The Prescription Medicines Code of Practice Authority (PMCPA) issued the ruling after receiving a complaint in February 2023 regarding a post on X that was made by a Pfizer employee in the United States.
The post included Pfizer’s press release announcing the conclusion of the Phase 3 Study of its COVID-19 vaccine candidate, which was later shared by a Pfizer senior employee in the United Kingdom.
PMCPA ruled that Pfizer has breached its regulatory code, including “bringing discredit” on the pharmaceutical industry, promoting an unlicensed medicine, and making a misleading claim.
The pharmaceutical company was also accused of “making claims that did not reflect the available evidence regarding possible adverse reactions,” and failing to maintain high standards.
The complaint raised concerns about “Pfizer’s misuse of social media to misleadingly and illegally promote their COVID vaccine,” alleging that the post lacked safety information about the vaccine.
According to the complainant, “such misbehavior was even more widespread than they had thought, extended right to the top of their UK operation and was apparently continuing to this very day.”
The complainant argued that the post has remained visible on the Pfizer UK senior employee’s X feed for over two years.
“In the circumstances the complainant thought that the British public had the right to expect Pfizer UK to have conducted some sort of audit of its social media accounts (at least of its significant accounts, amongst which they would include its UK senior employees) to ensure that anything which was similarly in breach of the code was removed—even to the extent of deleting accounts if necessary. This clearly was not done,” the complaint stated.
Social Media Post Was Not Intended to Be Promotional
Pfizer told the PMCPA that it took its commitment to the regulatory code “extremely seriously” and that it had conducted a thorough investigation into the matter.
The company claimed that the post “was not intended to be promotional in nature” and that it contained “a statement of fact of the efficacy endpoints of the study.”
Pfizer also said that there was no intent by the UK senior employee to promote or to advertise its vaccine candidate, adding that the post was re-shared “in error.”
According to the company, the senior employee was an infrequent user of X and has only 321 followers, the majority of whom are professional individuals involved in, or with an interest in, the UK healthcare and research sector.
“Pfizer UK had a comprehensive policy on personal use of social media in relation to Pfizer’s business which prohibited colleagues from interacting with any social media related to Pfizer’s medicines and vaccines,” it said.
In its response to the PMCPA, Pfizer said it has taken actions to address the complaint, including issuing a UK company-wide instruction urging employees to check their social media accounts to ensure their activity complied with the Pfizer social media policy.
“Pfizer accepted that these colleagues acted in error and these errors regretfully were likely to have resulted in the promotion of an unlicensed vaccine to the UK public in a manner that was not consistent with the requirements of Clause 2,” it stated.
However, the PMCPA stated in its report that the post has resulted in “an unlicensed medicine being proactively disseminated on Twitter to health professionals and members of the public in the UK.”
The watchdog considered that the corrective and preventative actions taken following previous breaches of the code with respect to employee activity on social media “had not been implemented to the standard which was expected or required.”
It also stated that the post made no reference to adverse events of the vaccine.
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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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Tuesday, April 09, 2024
Scientist’s Video on Vaccination Status in Pregnancy Censored for ‘Misinformation’
A mathematician has had a YouTube video taken down after pointing out that the government is counting women who had the COVID-19 vaccines before conceiving as “unvaccinated,” effectively obscuring any potential link between the jabs and negative pregnancy outcomes.
Professor Norman Fenton, who specialises in risk analysis and decision making at Queen Mary University, London, used the example of Olympic gold medal-winning cyclist, Dame Laura Kenny, who has spoken publicly about suffering a miscarriage and ectopic pregnancy.
In the video, he speculated that Dame Laura, who is married to fellow Olympic champion Sir Jason Kenny with whom she has two sons, is likely to have received two doses of the vaccines in order to be allowed to compete at the Toyko Olympics in August 2021.
Dame Laura, 31, whose first son was born in 2017, revealed she had suffered a miscarriage at nine weeks in November 2021, shortly after the delayed Tokyo games in August. She also had an ectopic pregnancy in January 2022, before going on to have her second child in July 2023.
Mr. Fenton told The Epoch Times it was not his intention to upset Dame Laura, but she had not been in touch with him to make any comment or clarification about the video.
Women Jabbed Before Pregnancy Labelled Unvaccinated
According to the way the UK Health and Security Agency (HSA) records vaccine status, if Dame Laura did not receive any COVID-19 shots during her pregnancies, she would be counted as “unvaccinated” along with the “never vaccinated” women, even if she had received the jabs before conceiving.
Mr. Fenton said, “The way they were doing that particular pregnancy statistic is one of the worst examples of data obfuscation—to lump the never vaccinated in with the vaccinated, who in theory could have been vaccinated a day before (they got pregnant) is absolutely outrageous.”
“If there is a safety signal, it would just be hidden. You wouldn’t see it.”
In the video, he said: “She would’ve had to be double vaxxed shortly before the games to be allowed to take part. While there may be no reason to suspect this had anything to do with Laura’s two unfortunate outcomes, both would be classified in the UKHSA ‘no doses in pregnancy’ category.”
Mr. Fenton posted the censored video on YouTube at 5:30 p.m. on Good Friday, where he said it received 2,000 views within an hour. The platform took the video down after just 80 minutes, claiming it was a violation of its policy on “medical misinformation.”
‘Obfuscating Possible Vaccine Adverse Reactions’
YouTube said the “violation” occurred at three minutes and 47 seconds into the video, when Mr. Fenton said, “Once again we are reminded not just of the extent to which the government has gone to obfuscate possible vaccine adverse reactions, but also the insanity that led to the strongest and fittest people in Great Britain being forced to take a useless vaccine that they never needed and for which—even then—there were many known safety signals, and even to this day, the full vaccine pregnancy safety data has never been released.”
The platform sent Mr. Fenton a message saying he had been censored because anything that contravenes advice by the World Health Organisation is considered to be “medical misinformation.”
The British Olympic Association (BOA) said in May 2021 that “all athletes and support staff will be fully vaccinated against COVID-19 before leaving for Japan ahead of this year’s Tokyo 2020 Olympic and Paralympic Games.”
“The BOA is set to secure the vaccines after the International Olympic Committee struck a deal with Pfizer BioNtech to donate doses to athletes heading to the Games.”
Mr. Fenton shared the video on other platforms, including Odyssey, Rumble, and Bitchute.
Dame Laura is the most successful British female Olympian of all time, with only her husband, Sir Jason, and fellow cyclist Chris Hoy winning more gold medals. She retired from the track in March 2024, having suffered a series of injury problems as well as becoming a mother for the second time.
She shared her sadness over her baby losses in an Instagram post in April 2022, revealing that she had conceived just after the Tokyo games.
“Since the Olympics we haven’t had much luck and it’s been the hardest few months I’ve ever had to go through,” she wrote.
“Jason and I fell pregnant immediately after the Games and we were absolutely chuffed to bits. But unfortunately in November when commentating at the track champions league I miscarried our baby at nine weeks. I’ve never felt so lost and sad. It felt like a part of me had been torn away.”
“I then caught COVID in mid-January and found myself feeling really very unwell. I didn’t have typical COVID symptoms and I just felt I needed to go to hospital. A day later I found myself in A&E being rushed to theatre because I was having an ectopic pregnancy. Scared doesn’t even come close. I lost a fallopian tube that day.”
The government maintains the jabs are “safe and effective” for everyone, including for pregnant women, in spite of concerns raised by doctors and in several studies that women were suffering menstrual irregularities and linking the jabs to higher rates of miscarriage.
A peer-reviewed report from February suggests mRNA in the vaccines does not remain at the injection site but can “spread systemically” to the placenta and umbilical cord blood of the fetus.
The HSA said in a statement to The Epoch Times it has worked with a range of partners, “to document the benefits and safety of vaccination with respect to pregnancy, with surveillance clearly suggesting that women who have been vaccinated (both before and during pregnancy) have better COVID-19 disease outcomes than unvaccinated women for themselves, the pregnancy and for their baby.”
“The vaccination in pregnancy table in the UKHSA COVID-19 vaccine surveillance report were set up to compare the rate of adverse outcomes in women who received the vaccine during pregnancy with those who had not received the vaccine during pregnancy.
“As the report sets out these rates were estimated for “women giving birth between [the report dates], who received one or more COVID-19 vaccination doses during their pregnancy compared with those who did not (either because they were unvaccinated or had only received vaccine doses prior to pregnancy).”
The HSA pointed to research done by the University of Edinburgh, and added: “More detailed analysis taking other factors into account, including timing of vaccination, as published for Scotland, is underway.”
In its latest COVID-19 vaccine surveillance report, published in January this year, the HSA said that pregnant women are still advised to have booster shots and that this is “strongly recommended” by the Royal College of Obstetricians and Gynaecologists and the Royal College of Midwives.
‘A Statistical Illusion’
Mr. Fenton referred to the “statistical illusion” of many studies which claim to show the jabs are “safe and effective” by miscategorising partially vaccinated people as unjabbed.
He and two other academics carried out a study—accepted as a pre-print but not yet peer-reviewed—in which they examine such “miscategorisation bias” across 39 papers.
“We’ve been arguing that most of these big, well cited studies that claim 95 percent efficacy and that the vaccines are saving lives, anything claiming vaccine efficacy published in the big journals, every time we have looked at them, there [are] systemic flaws in them.
“The most common one is the miscategorisation one, where they are simply classifying people who had got COVID and hadn’t had every booster shot as unvaccinated, which obviously creates bias where you could show efficacy even with a placebo.”
“In some cases, we have written to the journals asking them to either make a clarification or correction to the paper, but they never did.”
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Some Questions Australia’s COVID-19 Inquiries Must Ask
The Australian Senate will soon release its report on the proper terms of reference for a COVID Royal Commission to be established in 2024.
During the inquiry, held by the Legal and Constitutional Affairs Committee, a large volume of submissions were submitted, while the government’s own COVID-19 Response Inquiry received over 2,000 submissions.
This indicates high public interest in getting to the truth of what happened, why particular decisions were made, and what the right lessons for the future.
This is especially important so Australia can be better prepared next time and also to put the WHO’s new pandemic accords in perspective.
Contrary to dire warnings, there have been only five pandemics in the last 105 years: the Spanish, Asian, Hong Kong, swine flus, and COVID-19.
In that time, great strides in medical knowledge, training, and technology have expanded disease response toolkits along the spectrum of prevention, treatment, and palliative care.
Average life expectancy has improved dramatically as a result. Countries have exchanged best practices on disease prevention and management.
Despite these gains in understanding and treatment protocols, when COVID-19 struck, many countries including Australia abandoned existing well-prepared plans to deal with pandemics, and instead, reacted with panic.
This is never a good basis on which to make either individual or public policy decisions.
Yet the public health messaging deliberately tried to spread panic to the population to increase compliance with pandemic management measures.
The herd panic of early 2020 led to an abandonment of good process, an abandonment of preparedness plans, and a centralisation of decision-making in a narrow circle of heads of government, ministers, and health experts.
The damage to physical health, mental health, social, educational, and economic problems will continue to impact public life for many years into the future.
Did Australia’s COVID-19 policy interventions represent the greatest triumph of public policy, with an unprecedentedly high number of lives saved as a result of timely, decisive, and appropriate measures instituted by governments acting on the science- and evidence-based advice of experts?
Or will they prove to be the biggest public policy disaster of all time?
Why Were Established Practices Swept Aside?
These are big questions that deserve a rigorous, independent, and impartial inquiry.
The first question is: why exactly were the existing pandemic preparedness plans and medical decision-making practices abandoned?
Suspect data from one city, Wuhan, in one country should not have been deemed sufficient to overturn a century of data, experience, and scientific research.
In particular, rather than responding to herd panic elsewhere to order mass house arrests for the entire population, did Australian scientists and public health officials test overseas claims against hard data locally on the extent, virulence, and lethality (the infection and case fatality rates) of the new virus?
Until these facts, as they apply to Australia, are authoritatively and credibly elucidated by a duly-empowered independent inquiry, public trust in health experts and institutions is unlikely to be restored to pre-pandemic levels.
How Was the Threat Level Assessed?
Another set of questions is about assessing the threat of a disease outbreak against other killer diseases, and the opportunity costs of allocating human, financial, and hospital resources to the different health risks.
The standard metric used to assess one side of this equation is the quality-adjusted life years (QALY) measure that, logically and sensibly, holds that the death of a healthy child, adolescent or young person is a greater tragedy and loss to society than that of someone above the average life expectancy.
From the start, it was known that the average death of those dying with COVID was higher than the average life expectancy.
That being the case, were standard cost-benefit analyses undertaken of the different policy interventions, including the risks of side effects and collateral harms?
If so, why were they not published? If not, why not?
More here:
https://www.theepochtimes.com/opinion/some-questions-australias-covid-19-inquiries-must-ask-5623457
*************************************************Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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Monday, April 08, 2024
Popular Paper on Ivermectin and COVID-19 Contains False Information
Meta analyses are very open to abuse.. I reported recently on another dubious meta-analysis of Ivermectin use. See:
https://dissectleft.blogspot.com/2024/02/effect-of-higher-dose-ivermectin-for-6.html
A popular study that claims ivermectin has shown no effectiveness against all-cause mortality contains false information but remains uncorrected.The meta-analysis, published in 2021 by the journal Clinical Infectious Diseases, explores how groups in randomized, controlled trials fared after receiving ivermectin compared to control groups.
Among five trials included for the portion on all-cause mortality, none showed an effect for ivermectin, the authors claimed.
Ivermectin “did not reduce all-cause mortality,” they wrote.
But the claim is wrong. One of the five trials was described as finding ivermectin recipients were more likely to die, but actually found that ivermectin recipients were less likely to die. “The risk base estimation ... confirmed that the average mortality obtained in all of ivermectin treated arms was 3.3%, while it was about 18.3% in standard care and placebo arms,” the authors of that paper said.
Dr. Adrian Hernandez, an associate professor at the University of Connecticut’s School of Pharmacy, and other authors of the meta-analysis are aware of the false information. The group released their study as a preprint before the journal published it. The first version included the false information. A corrected version properly portrayed the trial’s results for all-cause mortality in a figure summarizing the results, but still falsely said none of the trials showed a benefit against all-cause mortality.
Dr. Hernandez and Clinical Infectious Diseases did not respond to requests for comment.
The lingering false information is in a paper that has attracted numerous citations in other studies, in the press, and on social media. Altmetric, which tracks engagement, scores it at 5,900. A score of 20 or means a paper is doing “far better than most of its contemporaries,” according to the company.
Morimasa Yagisawa of Kitasato University and other researchers pointed out the issue in a March review of ivermectin trials, saying they were “concerned about the spread of misinformation and/or disinformation” about trial results.
“The articles on systematic reviews and meta-analyses are often erroneous or misleading. This is perhaps because the authors were not involved in the clinical trials or patient care and only searched for and analyzed articles and databases on clinical trial results,” they wrote. The problems are “particularly serious” in the paper for which Dr. Hernandez was the corresponding author, the researchers said.
“Although it was a clear error, the wrong content of the preprint was published as a major article in Clinical Infectious Diseases, the official journal of the Infectious Diseases Society of America, without being changed,” they wrote. “Many comments were made questioning the insight of the reviewers and the Editor-in-Chief for publishing a paper with such inconsistencies, but the paper is still published without correction. Since this is a prestigious journal of a prestigious society, an early corrective action is required.”
“There have been several fraudulent meta-analyses, and this is a striking one,” Dr. Pierre Kory, president and chief officer of the FLCCC Alliance and author of the book The War on Ivermectin, told The Epoch Times in an email.
“In this meta-analysis, they selected only 10 of the 81 controlled trials, 33 of which were randomized, on ivermectin that were available at the time. Eight of the ten they selected involved mild COVID-19. Typically, mild COVID does not lead to death. And here they were looking at death rates and, as expected, saw very few. The inclusion criteria they used were intended to show no effect. And they succeeded. Conflicted researchers have been doing this to hydroxychloroquine and ivermectin since the beginning of the pandemic,” he added.
Issues in other meta-analyses include the improper inclusion of papers that did not describe clinical trial results, Mr. Yagisawa and his co-authors said.
They noted that a number of trials have found ivermectin recipients were better off. That includes trials cited by the U.S. Food and Drug Administration (FDA) in its position that ivermectin is not effective against COVID-19.
The FDA recently settled a lawsuit over that position, agreeing to take down several web pages and social media posts.
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Jacinda Ardern’s zero Covid madness has finally come home to roost
When The Guardian goes into rhetorical overdrive, we can be confident the person, party or policy railed against will finish on the right side of history.
In March 2020, The Guardian lectured Swedish Prime Minister Stefan Lofven on his “Russian roulette-style” Covid-19 strategy. It reported “leading experts” were critical of Lofven for prioritising economic activity over public health. The country’s Covid death toll had reached the alarming total of 25. “How many lives are they prepared to sacrifice so as not to risk a greater impact on the economy?” asked epidemiologist Joacim Rocklov.
By contrast, The Guardian and other pro-lockdown news outlets were fulsome in their praise of Jacinda Ardern and her plan to eliminate the virus in New Zealand. Ardern had responded “with clarity and compassion”, The Guardian gushed back in April 2020.
“New Zealand isn’t just flattening the curve. It’s squashing it,” wrote Washington Post correspondent Anna Fifield.
Fifield had just been to South Korea, where she was “shocked” that airport officials had failed to take her temperature. “I was told simply to self-isolate for 14 days,” she said.
Ardern’s announcement in June 2020 that the virus had been eliminated in New Zealand proved to be somewhat premature. The curve wasn’t flattened. That was delayed until March 2022, when the country eventually crawled out from under the bed.
The chart measuring Covid cases in New Zealand from April 2022 mirrors the chart for Sweden two years earlier: a steep rise to around 2.5 million cases within the first six months, at which point it begins to flatten. New Zealand’s official tally of Covid deaths per million is 1163, 40 per cent higher than it is among the thermometer-dodging South Koreans. It is higher than every state in Australia, except Victoria. It is three times higher than Singapore and 40 per cent higher than the global average.
In October 2021, Ardern told New Zealanders “there is clear evidence the virus finds it harder to spread in vaccinated environments”. Yet in New Zealand, as in Australia, all but a handful of deaths occurred after the rollout of the vaccines, which suggests, at the very least, they were not all they were cracked up to be.
The health benefits of lockdowns were marginal at best. The costs to our social fabric and wellbeing were incalculable.
Among the hundreds of submissions to the federal government’s Covid inquiry released last week are gruelling personal testimonies that speak to the human cost: Australians trapped in India and banned from returning home; forced imprisonment in mediocre hotel rooms upon return; increases in mental illness and family violence, and; unvaccinated Australians treated as lepers.
Human Rights Commissioner Lorraine Finley concludes that Australians endured “some of the most significant restrictions of our human rights ever imposed during peacetime”.
The Commission received 2662 complaints, the biggest response to a single issue since it was established.
It would be nice to put this horrible period behind us and move on. Yet the fiscal burden of Covid will be on our shoulders for some time. Somewhere along the line, we have forgotten that closing borders and social distancing are inherently expensive. Businesses and individuals must be compensated, and even the most ridiculous regulations must be enforced.
So it is hardly surprising government spending in Australia and New Zealand was among the highest in the world. Australian governments, both state and federal, spent the equivalent of 18.2 per cent of GDP to fight Covid, according to data compiled by the International Monetary Fund.
New Zealand was second in the Covid spending rankings at 19.3 per cent of GDP. The US was in first place at 25 per cent of GDP. By contrast, South Korea spent 6.4 per cent of its GDP on pandemic management, and Sweden spent just 4.2 per cent. It would be unfair to criticise Ardern based on hindsight. Like Scott Morrison, she was not to know the path the pandemic would take, nor that attempts to flatten the curve would eventually be futile.
It seemed reasonable to use their countries’ advantages of distance, secure borders and expertise in quarantine procedures to keep the virus out. Equally, however, we must now be honest enough to acknowledge that our governments made the wrong call, unless we are determined to make the same mistakes next time around.
The New Zealand economy will be burdened with the long fiscal tail of the 2020-2022 pandemic for years, if not decades, to come. Australia’s strong economic recovery has masked the fiscal cost of Covid. It vindicates the Morrison government’s decision to direct spending to temporary programs to keep people in jobs and businesses trading rather than bake in permanent welfare spending.
In part, it stems from the good fortune of a resource-driven economy. New Zealand, however, is in a world of pain. Its debt-to-GDP ratio has risen from 27 per cent in 2019 to 37 per cent today. The cost of servicing debt is a significant budget item.
Worse still, it has the second-highest structural deficit in the world, according to the World Bank’s data. The gap between what the government is committed to spend and the revenue it can raise has considerably widened.
The country’s new Prime Minster, Christopher Luxon, has made strong progress in unwinding Ardern’s woke legacy, as the leader of a three-party coalition between the Nationals, Winston Peters’ New Zealand First and David Seymour’s ACT party.
He has reversed the Maorification program, insisting English should remain the country’s first language, begun refocusing the curriculum and banned smartphones from schools, repealed Ardern’s ute tax, scrapped the prisoner reduction target and introduced legislation to crack down on crime gangs.
But the fiscal burden remains his biggest challenge. Fixing it will need far deeper cuts to public spending than Luxon has so far countenanced. Not fixing it will place a drag on the New Zealand economy for years.
Meanwhile, lockdown-phobic Sweden’s economy isn’t exactly roaring, but it’s doing OK by European standards. Sweden’s Covid death toll is on par with or even lower than that in comparable European countries that pursued a lockdown strategy.
In 2019, its debt-to-GDP ratio was eight points higher than New Zealand’s, at 35.6 per cent. Now, it’s five points lower at around 32 per cent. Making trade-offs between health and economic goals turned out to be not such a wicked thing after all.
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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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Sunday, April 07, 2024
The biggest challenge in vaccinology: Countering immune evasion
The claim below that Covid will evolve into something that is once again novel seems reasonable but we have coped with novel viruses before so it may not be as big a problem as he prophesies. We cope with novel flu strains every year
Dr. Geert Vanden Bossche
People are rightfully concerned, some even outraged, by my predictions of how this Covid-19 pandemic will end. Understandably, some also blame me for the timeline I proposed not being accurate. Of course, not everyone understands that the interplay between the virus/pathogen and the host population's immunity is complex and constantly determined by the pressure exerted by the population's adaptive immunity on the virus and the virus's adaptation to the changing immune environment. This game of cat and mouse continues because highly Covid-19 (C-19) vaccinated populations cannot develop herd immunity.
What we will eventually observe is that this highly effective process of viral adaptation will ultimately confer an absolute fitness advantage to a Coronavirus (CoV) that is both structurally and functionally completely different from SARS-CoV-2 (SC-2) and its variants. It will be featured by many changes in spike and other viral proteins and have additional O-glycosylation sites while being resistant to neutralizing antibodies (Abs), virulent and highly productive/ replicative. It will use polyreactive nonneutralizing Abs (PNNAbs) to cause Ab-dependent enhancement of infection, thereby causing enhancement of severe disease (basically, as a result of rapid virus dissemination and replication in all organs). It will spread as a ‘strange’ but dominating lineage as a kind of ‘extraterrestrial dictator’ that outcompetes all previously circulating SC-2 lineages.
The ongoing phenomenon of immune escape runs parallel to the increasing incidence of acute (IgG4 Ab-mediated) and chronic (CD8+ T cell-mediated) immune pathology (including cancers), both of which stem from dysregulation of the adaptive immune system in C-19 vaccine recipients.
The unvaccinated individuals who are in good health and have not previously suffered from severe C-19 disease will not be affected by this new CoV (I call it ‘HIVICRON’: a highly virulent CoV that will replace the entire Omicron family). This is because, unlike those who are fully C-19 vaccinated, they have managed to train their cell-mediated innate immunity through exposure to increasingly infectious variants (through epigenetic reprogramming).
As the immune escape pandemic will transition from its ‘chronic’ phase (i.e., characterized by a high prevalence of ‘Long COVID’!) to its final, hyperacute stage, we will observe a reduction in circulating Omicron descendants, and cryptic lineages will become increasingly undetectable in wastewater. Despite low virus concentrations in wastewater and low C-19 hospitalization and C-19 mortality rates, cases of Long COVID will continue to steadily increase. Given the insidious nature of the current evolution, I am referring to the current period as 'the calm before the tsunami’ and warning that ‘societies in highly C-19 vaccinated countries will be caught off guard’.
Those who naively believe that the pandemic will simply die out without major casualties or will be controlled by regular (updated) vaccine booster doses fail to grasp that it is no longer the C-19 vaccination itself but rather the recurrent vaccine breakthrough infections (even if largely asymptomatic in terms of acute C-19 disease!), initiated by Omicron as a result of mass vaccination (hence why Omicron has been a scourge, not a blessing!), that are fueling the progression of viral immune escape and immune pathology.
In other words, neither an extended period of vaccine abstention nor a recently updated shot will affect the remaining evolutionary trajectory of this immune escape pandemic (Hence the title of my book: ‘The Inescapable Immune Escape Pandemic’).
I can't help but conclude that all pieces of the puzzle are fitting nicely together and that the science behind all this is undeniably compelling. My analysis is the result of a thorough, prolonged, and painstaking exercise in deep diving into these matters, leaving no stone unturned. My journey through this pandemic has been quite different from that of our health authorities, so-called health experts, and leading scientists. To summarize the mess they have made of it, I prefer to use a quote from a good friend: “They have been throwing shit against a wall to see what sticks”! Some of that shit did indeed stick to the wall at the very beginning of the C-19 mass vaccination campaign, but then dripped off, first as watery diarrhea, then as pure bloody diarrhea…
I seriously doubt the stakeholders of this mass vaccination program were clever enough to realize that their ‘shit’ experiment would quickly emerge as the most spectacular gain-of-function experiment ever conducted in the history of biology (one that was directly conducted on our very own human species!!!). Whether intentional or not, I won't judge. The fact remains that soon it will become evident how, due to their actions, a fairly harmless virus was transformed into a bioweapon of mass destruction.
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Experts call for more research into long COVID, as study reveals high prevalence in Western Australia
Researchers say more support is needed for patients suffering from long-term illness associated with a COVID-19 infection, with new data showing a large number of West Australians have been left unable to work due to their crippling symptoms.
The Australian National University (ANU) study surveyed 11,000 people who tested positive to COVID during a significant outbreak of the Omicron variant in WA in 2022.
The study published in March found almost 20 per cent of those patients were still suffering symptoms of fatigue, memory loss and concentration difficulties three months after they first became sick.
Lead researcher Mulu Woldegiorgis said there was little pre-existing data available on the topic, but that the new research suggested there was a high rate of long-term COVID-19 symptoms in WA.
"It is more than double the prevalence reported in a review of Australia data from earlier in the pandemic, and higher than similar studies done in the UK and Canada," she said.
In their report, Dr Woldegiorgis and her colleagues acknowledged one of the limitations of the ANU survey was that it relied on subjective symptom descriptions from patients, and the reported impact of their symptoms on work or study was not independently verified.
Dr Woldegiorgis said it was important for patients' symptoms to be taken seriously. "I think it's real and it needs more investigation," she said.
"When we see its impact on work or study, more than one in six of those who used to work before their infection were not able to fully return to work or study due to their ongoing symptoms."
'Life has become small'
Joanna Lewis caught COVID almost two years to the day. When she still had symptoms weeks later she thought she might have contracted Ross River virus again. "I could be standing at the kitchen bench and I'd feel short of breath," she said.
"It was almost like my body had forgotten to breathe, which is really bizarre."
She experienced tachycardia and POTS – postural orthostatic tachycardia syndrome – which meant her heart rate shot up more than 30 beats a minute when she sat or stood up.
She had to take leave from work and suffered financially, burning through her savings and taking on students as boarders to bring in enough money to survive.
These days the 42-year-old is most afflicted by fatigue.
"I do have, I've found, about six hours on average … upright, I do have to spend probably most of my day lying down and resting," she said. "It just means life becomes very small."
Government urged to do more
Rural GP Michael Livingston said he was seeing large numbers of people through his practice in Narembeen, in WA's Wheatbelt, with unexplained fatigue and brain fog. "I'm seeing younger people who just aren't bouncing back the way they thought they would do," he said.
"Some people think they have dementia, such is their concern about their memory and ability to recall simple tasks."
Dr Livingston suspects long COVID could be to blame and urged people not become complacent about COVID prevention. "We really need to be questioning the why of this and what personal choices we're making and how complicit we are being around this," he said.
Dr Livingston said authorities should develop a "clean air policy", and could consider fitting classrooms, workplaces and public transport with specialised air filters.
WA Health Minister Amber-Jade Sanderson said the government was keeping a close eye on any evidence relating to long COVID. "I think there's some conflicting views globally around the impact of long COVID but we continue to watch it closely," she said at a press conference on Tuesday.
https://www.abc.net.au/news/2024-04-03/research-finds-long-covid-rates-high-in-wa/103647042
*************************************************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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Thursday, April 04, 2024
Will NIH & Industry Consider Universal Coronavirus Vax Developed by Scientists in Georgia/Wisconsin & Tokyo?
Georgia Institute of Technology Scientists, in collaboration with investigators from University of Wisconsin—Madison as well as University of Tokyo continued pursuing the optimal coronavirus vaccine since the Covid-19 pandemic started. The mRNA vaccines developed through the federal government's "Operation Warp Speed" program were a massive innovation; however, annually updating those boosters for specific SARS-CoV-2 variants is inefficient for scientists and patients, although the spin given to the public by the leadership at the time at the National Institutes of Health and the companies was the opposite.
Now, the collaborators have developed a new vaccine that offers broad protection against not only SARS-CoV-2 variants, but also other bat sarbecoviruses. The groundbreaking trivalent vaccine has shown complete protection with no trace of virus in the lungs, marking a significant step toward a universal vaccine for coronaviruses. Findings were recently presented in “Broad protection against clade 1 sarbecoviruses after a single immunization with cocktail spike-protein-nanoparticle vaccine,” published in the February edition of Nature Communications.
For context, SARS-CoV-2 is just one member of the Sarbecovirus (SARS Betacoronavirus) subfamily (others include SARS-CoV-1, which caused the 2002 SARS outbreak, as well as other viruses circulating in bats that could cause future pandemics).
According to Ravi Kane, professor in the School of Chemical and Biomolecular Engineering, “We had been working on strategies to make a broadly protective vaccine for a while.” Professor Kane continued, “This vaccine may protect not just against the current strain circulating that year, but also future variants.”
Research goes back in time
Kane and his research group have been working on the technologies to develop more widely protective vaccines for viruses since he joined Georgia Tech in 2015. Although the team didn’t specifically foresee Covid-19 arising when it did, pandemics have regularly occurred throughout human history. While the team pivoted their vaccine research to address coronaviruses, they were surprised by how rapidly each new variant arose, making their broader vaccine even more necessary.
Once they realized the challenge inherent in how fast SARS-CoV-2 mutates, they had two options for how to build a vaccine: design one to be widely preventative against the virus, or use the influenza vaccine, which updates annually for the anticipated prevalent variant, as a model.
Considering Durability, Breadth
Making a broad vaccine is more appealing because it enables patients to get one shot and be protected for years. To create their general vaccine, Kane’s team capitalized on the key to the original mRNA vaccines — the spike protein, which binds the virus to healthy cells. Their vaccine uses three prominent spike proteins, or a trivalent vaccine, to elicit a broad enough antibody response to make the vaccine effective against SARS-CoV-2 variants as well as other sarbecoviruses that have been identified as having pandemic potential.
“If you know which variant is circulating, you can immunize with the spike protein of that variant,” Ph.D. student and co-author Kathryn Loeffler said. “But a broad vaccine is more difficult to develop because you’re protecting against many different antigens versus just one.”
It Starts with Preclinical Animal Research
Collaborators in the Kawaoka group at the University of Wisconsin tested their vaccine in hamsters, which they had previously identified as an appropriate animal model to evaluate vaccines and immunotherapies against SARS-CoV-2. The vaccine was able to neutralize all SARS-CoV-2 omicron variants tested, as well as non-SARS-CoV-2 coronaviruses circulating in bats. Even better, the vaccine provided complete protection with no detectable virus in the lungs.
Kane hopes that the vaccine strategy his team identified can be applied to other viruses — other coronavirus subfamilies as well as other viruses such as influenza viruses. They also expect that some of the specific antigens they describe in this paper can be moved toward preclinical trials. Someday, a trivalent vaccine could comprise a routine part of people’s medical treatment.
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Australia: COVID-19 Vaccine Side Effects Under Scrutiny: Ralph Babet initiates Senate Inquiry Targeting Excess Mortality
Babet is the lone libertarian senator so it is good to see him having an effect
Australians concerned about excess deaths in recent years are now able to have their voice heard by the parliament as a new Senate inquiry has gone online.
Following the establishment of a Senate inquiry into excess mortality in the week ending March 31, the Australian parliament has opened a new page for the inquiry on its website, allowing concerned individuals and organisations to make submissions.
According to Australian Bureau of Statistics data, excess mortality rose from minus 3.1 percent in 2020 to 1.6 percent in 2021 and 11.7 percent in 2022 before dropping to 6.1 percent in 2023.
Notably, there were almost 20,000 cases of excess deaths in 2022 alone.
The inquiry was established after the parliament narrowly passed a motion moved by United Australia Party Senator Ralph Babet with a 31-30 vote on Feb. 26.
Mr. Babet had the support of the Opposition, One Nation Party, and some independent senators, while the Labor and the Greens opposed the motion.
In a social media post, Mr. Babet said this was an opportunity for Australians to have a say on the issue.
“Many submissions are expected to be received from both individuals and professional organisations, with the opportunity for public hearings to follow later this year,” he wrote.
“This is your opportunity to have your say. If you have a personal story, knowledge, or expertise in this space, please prepare a submission for the committee.”
Australians can make submissions online via the parliament website, or they can send letters and emails to the Senate Community Affairs References Committee, which is responsible for investigating the matter.
Mr. Babet also said the committee was expected to finalise a report by the end of August. “May this committee process give a voice to the family members of the deceased and deliver the answers that our nation so desperately needs,” he wrote.
In an interview with 2GB Radio, Mr. Babet said the inquiry would look into the side effects of COVID-19 vaccines to determine whether they were connected to excess deaths.
“There would have to be at least a part of this, which is due to the vaccine,” he said.
“I want an answer at the end of this to say hey, that vaccines were a part of this, or the vaccines were not a part of the sport, or we don’t know, let’s investigate more.”
At the same time, the senator mentioned the challenges he faced during the process of establishing the inquiry, alleging that many politicians did not want to investigate the issue.
“For the last two or three years, none of the other senators … most of them have not wanted to take a look,” he said.
“They want to sweep things under the carpet. That’s what they’ve wanted to do.
“It’s not okay. It’s not how you do things. This is Australia. This is not a communist dictatorship.”
Meanwhile, Labor Senator Tim Ayres criticised the idea of having the parliament investigate excess deaths, saying it was opportunistic behaviour.
“Some people in the political system, of course, where they see fear, see opportunity. Where they see a capacity to divide people, to isolate them, and to frighten them, that is an opportunity,” he said.
While independent Senator David Pocock did not believe in COVID-19 vaccine “conspiracies,” he said there was a need to investigate the issue of excess mortality.
“I don’t accept the conspiracy theories that have been featured so heavily in Discord around COVID-19 vaccines,” he said.
“However, I do acknowledge there is data showing excess mortality rates that have increased in recent years.”
https://www.theepochtimes.com/world/inquiry-into-excess-deaths-now-open-for-submissions-5620720
*************************************************Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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Wednesday, April 03, 2024
Doctors Force FDA To Remove False Statements About Ivermectin
The U.S. Food and Drug Administration (FDA) has agreed to remove social media posts and webpages that urged people to stop taking ivermectin to treat COVID-19, according to a settlement dated March 21
The FDA has already removed a page that said:
“Should I take ivermectin to prevent or treat COVID-19? No.”
Within 21 days, the FDA will remove another page titled, “why you should not use ivermectin to treat or prevent COVID-19,” according to the settlement announcement, which was filed with federal court in southern Texas.
“The FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans or animals,” the page currently states. It also says that data do not show ivermectin is effective against COVID-19, despite how some studies it cites show ivermectin is effective against the illness.
The FDA in the settlement is also agreeing to delete multiple social media posts that came out strongly against ivermectin, including one that stated:
“You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
In exchange, doctors who sued the agency are dismissing their claims, the filing states.
“FDA loses its war on ivermectin and agrees to remove all social media posts and consumer directives regarding ivermectin and COVID, including its most popular tweet in FDA history,” Dr. Mary Talley Bowden, one of the doctors, said in a statement. “This landmark case sets an important precedent in limiting FDA overreach into the doctor-patient relationship.”
“We are extremely pleased with the outcome of the settlement as it is a victory for every doctor and patient in the United States,” added Dr. Paul Marik, chief scientific officer of the FLCCC Alliance and another plaintiff.
“The FDA interfered in the practice of medicine with their irresponsible language and posts about ivermectin. We will never know how many lives were affected because patients were denied access to a lifesaving treatment because their doctor was ‘just following the FDA.’”
An FDA spokesperson told The Epoch Times in an email that the agency:
“has chosen to resolve this lawsuit rather than continuing to litigate over statements that are between two and nearly four years old.”
“FDA has not admitted any violation of law or any wrongdoing, disagrees with the plaintiffs’ allegation that the agency exceeded its authority in issuing the statements challenged in the lawsuit, and stands by its authority to communicate with the public regarding the products it regulates,” the spokesperson said.
“FDA has not changed its position that currently available clinical trial data do not demonstrate that ivermectin is effective against COVID-19. The agency has not authorized or approved ivermectin for use in preventing or treating COVID-19.”
Ivermectin was approved by the FDA in 1996 to treat several conditions, including onchocerciasis, a tropical disease caused by a parasitic worm.
In the United States, it’s common for doctors to prescribe medicine off-label, or for a different purpose than the one for which the medicine is approved.
After some doctors began prescribing ivermectin for COVID-19, the FDA ramped up its campaign, including the Aug. 21, 2021, post on Twitter, now known as X.
Dr. Bowden and two other doctors sued the FDA, arguing the agency’s actions went beyond its authority, as conferred on it by Congress.
U.S. District Judge Jeffrey Brown dismissed the case in 2022, ruling that the FDA did not act outside the authority. But an appeals court in 2023 ruled in favor of the doctors, finding that the agency “has identified no authority allowing it to recommend consumers ‘stop’ taking medicine.”
Between the time of the ruling and the settlement, the FDA refused to change any of its statements on ivermectin, and asked for a fresh dismissal of the suit.
The Case
Drs. Robert Apter, Bowden, and Marik brought the case in 2022. They said they suffered repercussions after prescribing ivermectin to patients with COVID-19, and that the FDA was to blame.
Dr. Apter, for instance, said that pharmacists refused to fill the prescriptions, citing the FDA.
“This refusal delays his patients in obtaining their prescribed treatment—when early intervention is paramount—while they look for a pharmacy to fill their prescription, if they can find one at all,” the suit states.
He also said that insurance companies were refusing to pay for ivermectin to treat COVID-19.
The suit said the FDA illegally interfered with the relationships between the doctors and patients. The doctors said with regard to ivermectin, the FDA overstepped the authority conferred on it in the Federal Food, Drug, and Cosmetic Act.
Government lawyers argued that the FDA was acting within the confines of the law, and succeeded in getting the dismissal.
Judge Brown, appointed under President Donald Trump, said the FDA’s powers were only limited with regard to medical devices.
“As there is no statute limiting the FDA’s actions here, it cannot have acted outside of any statutory limitations,” he wrote in his ruling. “Further, it cannot be said that the FDA had no colorable basis of authority. The FDA is charged by Congress with protecting public health and ensuring that regulated medical products are safe and effective, among other things.”
A three-judge panel of the U.S. Court of Appeals for the Fifth Circuit disagreed, finding that the law did not authorize the FDA to give medical advice.
“FDA can inform, but it has identified no authority allowing it to recommend consumers ‘stop’ taking medicine,” U.S. Circuit Judge Don Willett, appointed under President Trump, wrote for the court.
The appeals court remanded the case back to the district court.
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Another Outlandish Overreach by the CDC
Easter weekend was lovely in every way.
And yet I could not stop thinking about the strange manner in which the Centers for Disease Control and Prevention (CDC) has had such an outsized role in the ruination of American rights and liberties. This agency is supposed to be tracking infectious disease and finding ways out. This mandate became the leverage to allow them to impose nationwide mask mandates, a rental moratorium, a shutdown of the cruise industry, and otherwise send the whole country into fits of hysterics for two years and more.
So it occurred to make an inquiry into how the CDC handles questions of election processes. This is rather important in a democracy. This is how we select our leaders and the central way in which we can claim that the people have some influence over the regime that rules us. It is because of elections that we can claim to be better than ancient despotisms or medieval feudalism. We rule ourselves through the vote. That’s the whole idea.
As it turns out, the CDC had quite a large role in guiding election processes. Not that you can find the evidence on their website now. Nope, it’s all been scrubbed. However, if you look at the Wayback Machine, you can find an interesting little point. The CDC strongly recommended mail-in, absentee, and early voting as a means of disease control.
The theory was that people gathering in a polling place would be a super-spreader event. What science did they cite to demonstrate this? None at all. So far as I know, and I’ve looked far and wide, there is not a single study anywhere that purports to show some relationship between disease spread and in-person voting. The CDC just made that up... for whatever reason.
The day was March 12, 2020. This was the same day that President Trump went on national television in the evening to announce that there would be no more travel from the United States to Europe, the UK, and, later, Australia and New Zealand. He further said that all Americans living abroad needed to come home right away or be stuck.
That was a pretty shocking announcement. Nothing like this had ever happened in American history, not even this broadly in wartime. It seemed to come out of nowhere, our rights to travel suddenly deleted.
It seems that President Trump was following the advice of his scientific advisors who later turned out to be snake oil salesmen. Indeed, he seemed extremely uncomfortable making this announcement, almost like he knew that it was weird and probably unwarranted. Strange night.
As it turns out, earlier that day, the CDC decided that the whole country really ought to be voting by mail. They went into the website and edited the page that very day and produced the following checklist.
You can see for yourself at the Archive link. So far, the CDC has not proven itself powerful enough to scrub also its bread crumbs from the archive source, not yet in any case. The time might come. If they succeed, their role in creating the biggest voting scandal in a hundred years might never have been known by future generations.
There is simply no way that the CDC could not have known about the uncertainties and vagaries created by absentee ballots. They are banned by half the countries in the world for that reason. Those that do allow them govern them very strictly. You have to request a ballot. They are sent to your home. You have to provide extensive identity verification. You have to have a darn good excuse. It’s only for hardship cases and never the norm.
It was the CDC that decided to throw all that in the trash. Who even cares about the whole history of democracy, because, after all, there is a virus floating around! It’s amazing that this happened. But just as amazing is the idea of throwing out property rights, which they also did. But there it is.
To be sure, they could not actually force this result. But they sure could grant some scientific heft behind the idea. It also helped that only 10 days later, the U.S. Congress voted $2 trillion in payments to the states, a portion of which was to implement CDC recommendations. Most states were happy to do so, again, with full knowledge that this strategy would yield results that were sketchy at best.
As it turns out, of course, it was the mail-in ballots that might have made the difference in the election, or seemed to in any case. Everything got so much mixed up that it’s hard to say. And it’s not like people did not have warning signs of trouble. The primary season of that spring and summer yielded a slew of controversies about what was and was not true. There were more than enough controversies swirling about by the time of the general election.
The crucial point here is that the CDC massively overstepped the bounds of its mandate by intervening in the processes by which Americans select its leaders, strongly pushing a method that was a known source of fraud. Nor has the CDC ever been held to account for this, not to my knowledge in any case.
They were sued over the rent moratorium and the evil nationwide mask mandate. They lost both cases. But there has been no litigation against the CDC for disrupting the whole system by which we regulate elections. One might suppose that if an executive agency were to do something like this, they would have needed some permission from somebody. Surely such a gigantic change would and should require more than a low-level employee with logins to change a website text.
Speaking of which, who actually did this and why? Aren’t these interesting questions? Why is no one asking them? Where are the investigations? Where is the outrage?
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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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Tuesday, April 02, 2024
Study Finds New Drugs Effective Against COVID-19 and Other Viruses
Studying the ways viruses impact cellular pathways during infection may help in developing treatments for infectious diseases such as COVID-19.
A new study, conducted by researchers at the University of Alberta and published in the npj Viruses journal found that certain cancer treatment drugs can promote cells to secrete antiviral interferons. These drugs target the SARS-CoV-2 virus, which causes COVID-19, and are also effective against multiple pathogenic RNA viruses.
Interferons are natural proteins that bolster the body’s immune system in combating infections and diseases like cancer. They earned their name because they interfere with viruses, stopping them from spreading.
Both COVID-19 and some cancers activate the Wnt/beta-catenin pathway—a chain reaction inside the cell. Drugs that block this pathway, originally made to treat cancer, might also help fight COVID-19.
When the Wnt/beta-catenin pathway gets activated, it slows down the production of interferons. This pathway also negatively impacts the immune system.
In a study, scientists tested two drugs, KYA1797K and E7449, that block the Wnt/beta-catenin pathway. They found that these drugs reduced the amount of virus in the lungs of mice. The drug E7449 was especially good at preventing weight loss and lung damage in the infected mice.
Tom Hobman, a professor of cell biology at the University of Alberta’s Faculty of Medicine and Dentistry and one of the study authors, explained in a press release that after using these drugs, cells produced interferons in response to viral infections at levels four to six times higher than before. Additionally, experiments also revealed that the virus was inactivated to less than one-ten-thousandth of its original levels.
He pointed out that interferons prevent infected cells from producing more viruses primarily in two ways, “It shuts down the infected cell, often resulting in cell death, and it also acts on the surrounding cells to prevent them from being infected.”
The researchers also tested viruses other than COVID-19 and found that the drugs exhibit broad-spectrum activity against a variety of RNA viruses. These include coronaviruses, responsible for seasonal respiratory infections, as well as mosquito-borne viruses like Zika and Mayaro.
Ongoing Drug Trials for COVID-19
In addition to drugs targeting the Wnt/β-catenin pathway, other drugs are also being explored for the potential to alleviate the COVID-19 virus.
A clinical trial published in February, which involved 1,821 mild to moderate COVID-19 patients, indicated that a drug called ensitrelvir significantly shortened the duration of symptoms in patients with COVID-19.
A phase II to III clinical trial of the anti-COVID-19 drug Simnotrelvir, involving 1,208 patients with mild to moderate COVID-19 infection, was published in the New England Journal of Medicine. The results showed that patients who received Simnotrelvir treatment within 72 hours of COVID-19 symptom onset had their “time to sustained resolution of symptoms” shortened by 35.8 hours. In a subgroup with risk factors for severe COVID-19, Simnotrelvir reduced the time by 60 hours.
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Immunologists Call Out mRNA Vaccines—The Good, Bad & Ugly: Time to Go Back to Science
More data and analysis from various peer-reviewed journals raises serious concerns about the externalities associated with the mass countermeasures developed by the United States government in response to COVID-19. While the mRNA COVID-19 vaccines have been positioned as modern marvels of medicine—safety, effective and representative of the future of medicine, mounting literature not widely touted by American media implicates a different point of view.
Microbiologist and immunologist Botond Z. Igyártó, Ph.D., from Jefferson University in Philadelphia and immunology researcher Zhen Qin in the most recent edition of the peer-reviewed journal Frontiers in Immunology suggest the latest, accumulation of data points to the need for concern covering both safety and efficacy of the mRNA vaccines developed by Moderna in partnership with the National Institutes of Health and Pfizer in partnership with Germany’s BioNTech.
TrialSite has published article after article over the past couple years hinting at considerable challenges with mRNA platforms. The literature in the peer-reviewed journals amasses leading to questions for investors in the platform developers.
The authors herein call out for a security that represents an absolute must for the scientific community. With an unprecedented mass vaccination scheme via the use of an investigational product “that minimally protects from getting infected and spreading the virus during a pandemic,” the need for critical reflection becomes of paramount concern.
Was the strategy sound? Was her immunity a realistic expectation? Did the strategy as proposed by Geert Vanden Bossche lead to an actual acceleration of mutations? Should governments have focused on more vulnerable populations during the pandemic? Why was a novel mRNA platform opted for in the emergency over more known methods? Why focus on a single virus protein with a high mutation rate as TrialSite called out early on? Were the vaccine’s benefits (supposedly faster production, ease of updating for new variants, etc.) beneficial? Why did research leadership at the NIH for example ignore basic immunology knowledge during the pandemic?
Igyártó and Qin in this latest peer-reviewed output identify safety considerations, seeking to better understand the mechanisms of observed adverse events related to the mRNA jabs. Can such identified risk factors be mitigated by altering the mRNA platforms?
Describing the standard and non-standard components of the mRNA-LNP COVID-19 vaccines, Igyártó and Qin then address what the pair of authors describe as “concerning” assumptions made in regard to this technology.
While formally, the public has been told that mRNA vaccines do not allow for reverse transcription into DNA, meaning that there is no risk of insertion into the human genome, the authors raise some questions for consideration.
In particular instances, RNA can in fact be reverse transcribed into DNA. The authors note, “With the Pfizer mRNA-LNP vaccine, it has been shown experimentally that the vaccine mRNA can be reverse-transcribed into DNA in an immortalized human hepatocyte cell line.”
Also, the pair of authors note other possibilities for this concerning action, plus localization of the spike protein. A series of studies suggest the possibility of transcribed possibilities.
The authors point out:
“While to our knowledge similar studies have not been performed with COVID-19 mRNA vaccines that code for full-length pre-fusion fixed form of SARS-CoV-2 spike protein, comparable transport of spike protein/mRNA to the nucleus could be expected. Because the mRNA can enter the nucleus, where it might be reverse-transcribed into DNA, this increases its potential to integrate into the genome.
Furthermore, the mRNA-LNP diffuses throughout the body and can accumulate in both the testes and ovaries and is reported to alter the menstrual cycle in women. Therefore, it could potentially be reaching the stem cells of the reproductive organs. These findings highlight the need to take these data and concerns seriously and conduct specific experiments to address them.”
On the topic of the mRNA vaccine product degrading in vivo in hours or a matter of a few days, the authors challenge this misinformation to argue that the vaccines do not disrupt normal cell biology.
While it’s likely that this assumption (rapid product degradation) likely arose given that unmodified mRNAs have overall short in vivo half-life, real-world since points to a very different situation.
For example, “…human lymph node biopsies taken at different time points post-exposure to the mRNA-LNP revealed detectable levels of vaccine mRNA and spike proteins up to eight weeks.” And of course, TrialSite has reported on peer-reviewed data featuring the distribution and circulation of spike protein derived from the mRNA vaccines in humans for periods over a year.
Also, the effects of modified ribonucleotides (incorporated into the vaccine products to lower innate reactogenicity) just recently became more apparent.
Igyártó and Qin point out, “Incorporation of N1-methylpseudouridine into mRNA resulted in +1 ribosomal frameshifting in vitro and cellular immunity in mice and humans to +1 frameshifted products from BNT162b2 vaccine mRNA translation occurred after vaccination.”
A key message from the authors on the overall topics: it’s dangerous to “assume and extrapolate in science” then apply existing paradigms to novel, untested platforms and technologies.
And just how safe and effective are the COVID-19 mRNA countermeasures?
Reviewing many of the same recent peer-reviewed journal entries, case reports and publicly available adverse event database as TrialSite, the current authors argue that this fact “cast doubts on the safety and effectiveness of these products.”
For example, on the topic of safety the authors point to a range of formidable entries calling out one concern to another. As TrialSite has editorialized many of the studies cited by Igyártó and Qin on the topic of COVID-19 mRNA vaccine safety suggest concern.
Similar outcomes can be found when probing efficacy. As the authors point out, “The effectiveness of these therapeutics in preventing infections and limiting the spreading of the virus has been highly eroded from the early reports, and nowadays, their efficacy is mainly limited to potentially decreasing the disease severity and death in susceptible people.” Pointing out that the efficacy that has been reported likens to the immune suppressive characteristics of these mRNA products, the authors urge for a “rigorous pre-clinical studies to limit potential unexpected consequences for novel platforms.”
Final Thoughts
Pointing out that “several fundamental questions persist surrounding the pandemic measures and the adoption of this new vaccine platform,” the scientists cogently argue “rather than advocating for retraction and censorship” rather there should be a movement in science to foster for open dialogue, considering all perspectives.
And for those that despite the findings above would still justify all that was done during the pandemic as the efforts saved lives, Igyártó and Qin point out that “the robustness of supporting data raises important inquiries.”
True trust is necessary to not undermine science and foster vaccine hesitancy, argue the authors of this important peer-reviewed paper. Seek to rebuild trust? Then, the authors argue it’s “crucial to return to the fundamental principles of scientific inquiry
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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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Monday, April 01, 2024
COVID-19 Vaccines Performance Decline--Only 38% of At Risk Immunocompromised Kept out of Hospital
TrialSite continues to monitor the observational study output of the Centers for Disease Control and Prevention (CDC) funded VISION Network, a research collaboration involving multiple hospitals/sites with integrated electronic health records (EHR) across America. This is part of an ongoing real-world data effort to evaluate how well vaccines protect against seasonal viruses such as influenza or COVID-19.
In this latest study, the substantial VISION team utilizes a test-negative design to estimate COVID-19 vaccine effectiveness (VE). And the outcomes are not great, in fact, some could argue this latest vaccine bombed.
Why? Any commercial vaccine designed to keep people, especially at-risk cohorts out of the hospital, should perform at least at 50% vaccine effectiveness. At 38% between days 7-59 and 34% in the 60-119 days after the receipt of the updated dose, the only reason CDC can justify recommending the product includes A) because they are not considering full safety risks for this cohort and B) the logic that 38% protected is better than no one and for this latter point there is some rationale. Only 14% of immunocompromised opted to get the vaccine suggesting a near collapse in market demand for COVID-19 vaccines given the risks associated with this demographic.
The data reported herein results from the CDC’s latest Morbidity and Mortality Report (MMWR) titled “Interim Effectiveness of Updated 2023-2024 (Monovalent XBB.1.5) COVID-19 Vaccines Against COVID-19–Associated Hospitalization Among Adults Aged ≥18 Years with Immunocompromising Conditions — VISION Network, September 2023–February 2024.
Background
By September 2021, the CDC’s Advisory Committee on Immunization Practices recommended updating 2023–2024 (monovalent XBB.1.5) COVID-19 vaccination for all persons aged ≥6 months to prevent COVID-19, including severe disease. The agency did not consider a risk-based approach like in most other nations at this point given the following:
Omicron has become much milder (e.g., case fatality rate at the level of influenza for most)
Large segments of the U.S. population have pre-existing immunity at some level
Growing recognition that some safety signals present (e.g., risk of myocarditis/pericarditis in young males, etc.).
Available treatments such as Paxlovid—while not accepted yet by the National Institutes of Health or the CDC,
accumulation of data that vitamin D supplementation very important to avoid more severe symptomatic COVID-19
The CDC suggests additional boosters for immunocompromised conditions should be considered, in this case representing a risk-based approach to public health.
In this latest observational study, the study team assesses how well the COVID-19 vaccines perform at helping immunocompromised persons infected with COVID-19 avoid hospitalization based on the data linked to hospitalization during the period September 2023-February 2024.
Findings
Few persons (18%) in this high-risk study population had received the updated COVID-19 vaccine. All persons aged ≥6 months should receive updated 2023–2024 COVID-19 vaccination; persons with immunocompromising conditions may get additional updated COVID-19 vaccine doses ≥2 months after the last recommended COVID-19 vaccine.
Out of 14,586 patients with immunocompromising conditions who were hospitalized with COVID–19–like illness, the study team included 1,392 case patients and 13,194 control patients.
The most common immunocompromising conditions among both case patients and control patients were solid organ malignancy (36% and 43%, respectively) and other intrinsic immune conditions or immunodeficiency (38% and 35%, respectively).
A total of 195 (14%) case patients had received an updated COVID-19 vaccine dose compared with 2,401 (18%) control patients. VE against COVID–19–associated hospitalization was 38% in the first
More Specifics
The CDC-funded VISION team reports only nine persons who received >1 updated COVID-19 vaccine dose were included!
The team estimated Odds ratios (ORs) using multivariable logistic regression comparing persons who received an updated COVID-19 vaccine dose with those who did not, irrespective of the number of previous original or bivalent COVID-19 vaccine doses received (if any), among case- and control patients.
They adjusted their regression models for age, sex, race and ethnicity, calendar time, and geographic region. While they calculated VE as (1 − adjusted OR) × 100%. Analyses were conducted using R software (version 4.3.2; R Foundation). This activity was reviewed by CDC, deemed not research, and was conducted consistent with applicable federal law and CDC policy.†† VISION activities were reviewed and approved by the Westat and site institutional review boards.
How does CDC rationalize this VE?
According to the VISION team, “Effectiveness estimates in this report were slightly lower than those in a recently published analysis from VISION and another CDC VE network showing COVID-19 VE against COVID-19-associated hospitalizations in adults without immunocompromising conditions was approximately 50%, but this report includes the analysis of an additional month of data compared with the previous report.”
The group still implies recommended vaccination because “persons with moderate or severe immunocompromising conditions are at higher risk for severe COVID-19 and might have decreased response to vaccination.” (2).
Limitations
The VISION team discloses two primary limitations to this study. These include the following:
The use of selected discharge diagnoses as surrogates for presumed immunocompromised status and the absence of medication and other relevant data might have led to misclassification of immunocompromise status, which might have biased estimated VE in either direction
Immunocompromising conditions are heterogeneous and likely to create differential risk for severe COVID-19, as well as differential response to vaccination
CDC suggested implications
Although the VE of 38% to keep immunocompromised individuals out of the hospital evidences a waning performance (in fact under 50% and regulators used to question the overall value of the vaccine), the CDC team argues that “receipt of an updated COVID-19 vaccine dose provided increased protection against COVID-19–associated hospitalization among adults with immunocompromising conditions compared with no receipt of an updated dose.”
And the CDC takes the increasingly unpopular and isolated decision to continue to recommend that all Americans age ≥6 should get the 2023-2024 COVID-19 vaccine, regardless of fundamentally changing risk-benefit calculus.
That only 14% of the immunocompromised population opted to get this latest vaccine is most certainly telling of the market’s proclivity to go out and opt for this vaccine. At TrialSite, we have reported on a growing number of peer-reviewed studies evidencing instability in the current mRNA platforms. Is it a good idea to vaccinate children 6 months and above en masse given the risk-benefit calculus factors discussed above? Even the New York Times recently reported on the fact that the U.S. was now an outlier in recommending systematic COVID-19 vaccination of young children, especially when we factor in risks for myocarditis/pericarditis in young healthy males.
We suggest this latest vaccine effectiveness performance portends an ominous future for this class of vaccine.
TrialSite Critical View
The protection of mRNA vaccines is so transient TrialSite suggests a new metric for their assessment, at least when it comes to protection against infection. Peak efficacy in the first few weeks’ post immunisation is clearly completely irrelevant. What about calculating average 6- or 12-month efficacy?
This would be akin to measuring area under survival curve. Hence depending on the shape of the curve a vaccine that had 90% efficacy at two weeks and 10% efficacy at six months, may have an overall 6-month efficacy of say 20% if the curve falls steeply at the start or 60% if it falls steeply at the end.
We know from the Israeli data in July 2021 that Pfizer had fallen to just 12% efficacy at 6 months so its true overall 6-month efficacy must have been less than 50% even although they continued to quote >90% efficacy in the media.
Also say a vaccine drops from 90% efficacy at two weeks to 0% efficacy at 4 months – how then to describe its overall efficacy over 6 months – intuitively it should be 0% not the average as over the last two months no one is protected, so everyone will now get infected if exposed, even if they got some protection over the first 4 months – i.e. their infection was just delayed.
This requires sophisticated biostatistician input. After all, COVID-19 infections are not linear over time, but highly clustered into outbreaks. If an outbreak occurs at the 5-month post vaccine point in the previous example, then true vaccine efficacy is 0% or may even go negative at least when measuring protection against infection.
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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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