Friday, October 27, 2023
Thursday, October 26, 2023
Children who get Covid shot are infectious for same amount of time as non-vaccinated, study finds
Children vaccinated against Covid are infectious for the same amount of time as their non-vaccinated peers, a new study out of California has found.
Whether or not students had received their bivalent Covid booster made no difference to the length of time they shed pieces of the virus after testing positive.
Both groups of kids aged seven to 18 were infectious for three days on average, according to the results from April to September 2022.
The study adds more doubt about the importance of giving Covid booster shots to children. Until earlier this year, several states including California and Illinois mandated the vaccines in schools.
Experts from Stanford University and the University of California, Los Angeles, who carried out the study: ‘Return-to-school policies may not need to discriminate by vaccine or booster status.’
Crucially, though, lead author Dr Neeraj Sood said the team did not look at the vaccines' abilities to prevent infection in the first place.
The study also took place before Pfizer's original bivalent booster was approved. That vaccine offered better protection against the Omicron subvariants that were circulating at the time. The youngest children in the study likely did not receive a booster but rather the standard two-dose vaccine course.
Levels of immunity and protection have ebbed and flowed with different vaccines and virus variant combinations.
The report was published in the journal JAMA Pediatrics. The 76 children involved in the study were from the Los Angeles-area included in the study ranged in age children seven to 18 years old.
The goal was to measure the impact of the virus on the children's cells to better understand how it behaves and for how long it is contagious.
The researchers studied their level of viral shedding, the number of virus particles that a child emits through coughing, sneezing, or talking that are then spread throughout the environment.
WHO says healthy kids and teens don't need Covid vaccinations
The World Health Organization (WHO) revised its Covid vaccine recommendations and suggested that healthy children and adolescents may not need a shot.
Every child tested positive for the Covid-19 Omicron variant. Of the 76 children, including 41 seven to 12-year-olds, 52 were vaccinated.
Children who had been vaccinated were infectious for three days, the same duration as children who were not vaccinated.
Researchers did not say whether they were surprised by their results. But what they found was similar to a study in adults with the Omicron variant, which also could not find an association between the length of time that a person is contagious and their vaccination status.
The Centers for Disease Control and Prevention recommends that all children, including babies as young as six months, receive a bivalent booster shot containing components of both the original virus strain as well as the omicron variant.
Yet uptake has remained low. A July 2023 study published in the journal Annals of Medicine reported that just 39 percent of children aged five to 11 and 55 percent of teenagers have gotten a booster dose.
Bivalent boosters have been shown to be highly effective at preventing severe enough cases to land a child in the hospital or at an urgent care clinic, but it is not clear to what extent the shots can prevent infection in the first place.
Covid vaccines are highly effective at preventing severe illness in the elderly, but protection against initial infection tends to be much weaker.
And children do not typically get dangerously sick with Covid, which has led many parents to believe there is not enough benefit to justify the shot.
Pandemic fears prompted many state and local officials to shutter schools in 2020 in order to protect children.
However, children are typically not nearly as vulnerable to severe illness as older adults, especially seniors.
This fact has contributed to an overall lack of enthusiasm among parents for pediatric booster shots, as many parents simply do not believe they are worth getting.
There is a tiny risk of heart inflammation in younger people after being vaccinated with the mRNA vaccines, but the majority of cases are mild and subside on their own.
Still, the tiny risk of a severe Covid infection has left many parents wary.
Widespread school closures have been blamed for fomenting a mental health crisis among school-aged children, as well as causing a downward spiral in academic performance overall.
A Brookings Institution study last year found that average fall 2021 math test scores in grades three to eight were 0.20 to 0.27 standard deviations (SDs) lower relative to same-grade peers in fall 2019.
Standard deviations are used to show how much test scores vary from the overall average, and a decrease of 0.20 to 0.27 SDs suggests a major decline in math performance.
At the same time, reading test scores decreased by 0.09 to 0.18 SDs.
Proponents for keeping schools open, which includes about 60 percent of American parents, have cited plummeting academic achievement as a clear indication that in-person instruction is far superior to consigning children to learn via Zoom at home.
*************************************************
Like Pfizer, the Covid Train May Have Run Out of Track for Moderna
It appears the Covid party for big pharma may finally be coming to an end. Last week, TrialSite reported on the fact that Pfizer will be lucky to generate $13 billion for their Covid product line. With a stagnant to declining stock price, sophisticated investors are concerned. The analysts are still generally upbeat (after all, the company is diversified both in product portfolio and R&D pipeline). But an ominous sense, one based on behavior over the past couple of years, brings dark clouds over the company. Cash flow for the pharmaceutical giant for the twelve months ending June 30, 2023, at $51.168 billion represented a 36.44% decline year-over-year. Pfizer's annual cash flow from operating activities for 2022 was $29.267 billion, a 10.17% decline from 2021. In August of this year, TrialSite speculated Pfizer’s Covid train could be out of track. Now, it looks as if the train has pulled out of another station.
Moderna Loses Value
Moderna became famous during the Covid pandemic because of their mRNA vaccine. The company was named after their innovative shot. But now demand for the jab has waned, and the company appears rudderless. Last week, it was reported Moderna erased $6.8 billion in market value after rival shot maker Pfizer slashed its profit outlook the previous Friday, sounding the alarm on dwindling demand for its Covid shots and pills. Moderna’s stock closed at the lowest since November 2020, when the company was still trying to get its Covid serum authorized for use in the United States.
“Covid-19 vaccine revenue concerns should be at all time high right now,” said Hartaj Singh, an analyst at Oppenheimer. “A good third-quarter print should allay some of these fears. And good guidance early next year in 2024 potential revenues could get the stock’s mojo back.”
Moderna’s stock has dropped about 83% from its August 2021 high when the company’s market capitalization was almost $200 billion. This isn’t good for a company which was once compared with Tesla, but this year, Moderna is one of the worst performing S&P 500 companies.
“Too Early to Predict”
According to Moderna’s management, the company still expects between $6 billion to $8 billion from the Covid shots, while cautioning it is still too early to predict US vaccination rates. Wall Street analysts predict Moderna’s Covid sales will be lower based on an updated guidance range from Pfizer. However, Pfizer has recovered a bit recently, gaining 3.6% as the drug maker’s post-pandemic growth strategy was weighed and investors’ expectations were reset, according to some on Wall Street. Similar to Moderna, Pfizer’s stock has dropped, losing about half its value from its pandemic record high. As with Pfizer, the Covid train tracks appear to have run out for Moderna. They better be ready for the next engine.
*************************************************
Increasing Recognition Of Vaccine Injuries
The push to increase vaccination rates comes amid an increasing recognition of vaccine injuries in Australia and overseas.
In Australia, the government operates a vaccine injury compensation scheme that has paid out over $7.3 million (US$4.87 million) to 137 claimants. It has received 3,501 applications and is progressing with 2,263, according to figures obtained by News.com.au in March this year.
The Department of Social Services has previously estimated the government could be liable for a payout of $77 million (US$49.35 million).
In the UK, the increasing number of vaccine adverse effects had resulted in a lawsuit against vaccine manufacturer AstraZeneca, with families and patients arguing that their loved ones died or suffered severe reactions after taking its vaccine, according to their lawyers.
Meanwhile, multiple doctors and COVID-19 patients have also reported that their discussion of vaccine adverse effects has been labelled as misinformation.
The former president of the peak medical body, the Australian Medical Association, came out in December last year to say that discussion around vaccine injuries is being “censored” despite data confirming COVID-19 vaccines can cause adverse reactions.
Dr. Kerryn Phelps said she herself had suffered from a vaccine injury and that she faced “obstruction and resistance” to openly discuss the issue, according to a submission to the federal Parliament’s inquiry into Long COVID.
She said that while current COVID-19 vaccines may reduce the risk of developing Long COVID by an estimated 15 to 41 percent, recent data shows the risk remains for most people after immunisation, with some adverse events going on to cause “long-term illness and disability.”
Dr. Phelps also revealed in her case, that the vaccine injury resulted in dysautonomia with intermittent fevers and cardiovascular implications including breathlessness, inappropriate sinus tachycardia, and blood pressure fluctuations.
“I have spoken with other doctors who have themselves experienced a serious and persistent adverse event including cardiological, rheumatological, autoimmune reactions and neurological consequences,” she wrote in her submission.
She said while there is higher awareness about the unusual blood clotting from AstraZeneca, “less generally recognised are the reported adverse reactions after mRNA vaccines by Pfizer and Moderna beyond myocarditis and pericarditis.”
********************************************************
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
***************************************************
Tuesday, October 24, 2023
Skeptical Professor Exonerated After Being Accused of 'Unethical Practices' in Famous COVID Vaccine Study
The vaccine establishment applied irrelevant standards to his work in their zeal to discredit it
A professor from the Michigan State University (MSU) has been exonerated from charges of “unethical practices” related to a study claiming that the COVID-19 vaccines may have resulted in hundreds of thousands of deaths in the United States.
In January, Dr. Mark Skidmore, a professor at the MSU’s Department of Economics with over 90 published papers, published a study in the BMC Infectious Disease, which suggested that the total number of COVID-19 vaccine fatalities in the United States could be “as high as 278,000.”
It soon came under criticism and Dr. Skidmore was accused of using “unethical practices” in the study. Subsequently, the journal retracted the research.
Following a seven-month ethics investigation by the university’s Institutional Review Board (IRB), Dr. Skidmore has now been cleared of any wrongdoing. The board stated that they did not find any “noncompliance” to their protocols by the study, according to an Oct. 17 press release by the Christian ministry Liberty Counsel.
The complaints against Dr. Skidmore alleged he did not follow rigorous oversight procedures that are mandated for clinical studies. If the university were to find him “guilty,” it would have had serious consequences for Dr. Skidmore’s credibility and career.
This is because clinical studies involving human subjects have strict protocols to ensure that no harm comes to the participants. As such, any fault in this regard would be a significant blemish on the reputation of the researchers.
The university’s IRB found that Dr. Skidmore’s study did not involve any clinical work. Instead, it relied only on an online survey, which posed no risk to human participants. The IRB therefore deemed the study to be “exempt” from the protocols of clinical study and cleared it to proceed.
“The allegations against Dr. Mark Skidmore were baseless,” Liberty Counsel Chairman Mat Staver said. “Researchers with integrity like Dr. Skidmore are using rigorous scientific protocols to validate the dangers of the COVID-19 shots.”
“Censoring scientific debate is reprehensible and our researchers need to be free to conduct proper science without fear of later being the subject of an ethics investigation because their findings contradict a certain narrative.”
Top Research Paper
While Dr. Skidmore’s study at the BMC Infectious Disease journal remains retracted, an updated version was recently published in the Science, Public Health Policy & the Law journal.
The study involved an online survey completed by 2,840 participants between Dec. 18 and Dec. 23, 2021, which collected data on COVID-19 health experiences. “The primary aim of this work is to identify factors associated by American citizens with the decision to be vaccinated against COVID-19,” it read.
The survey collected information on why respondents chose to take COVID-19 vaccinations or refused to do so. It also collected details on respondents’ experiences with COVID-19 illnesses and inoculations. With regard to COVID-19 vaccines, the survey found that:
Respondents that knew someone who had experienced a health problem following vaccination were less likely to be vaccinated.
Out of the 2,840 participants, 612 (22 percent) said they knew at least one individual who experienced a health problem after taking a COVID-19 shot.
Dr. Skidmore extrapolated the numbers from the survey to the national level to estimate that COVID-19 vaccine fatalities in America could be as around 289,789. The COVID-19 vaccine fatality number in the revised study published in the Science, Public Health Policy & the Law journal is higher than the original study by 11,789 deaths.
According to the BMC Infectious Diseases journal, Dr. Skidmore’s original study was retracted after “concerns were raised regarding the validity of the conclusions drawn after publication.”
A peer review of the study conducted after publication found that “the methodology was inappropriate as it does not prove causal inference of mortality, and limitations of the study were not adequately described.”
Despite being retracted, the study remains in the top 1 percent of shared research worldwide, according to data science firm Altmetric. The study is ranked number one among all outputs from BMC Infectious Diseases tracked by Altmetric.
In April, Dr. Skidmore claimed that the study at BMC Infectious Diseases journal went viral on social media and reached up to 17 million Twitter users prior to being retracted.
He attributed the vast exposure of the study to two factors. “First, the finding resonated with many who have loved ones who they believe experienced harm from the COVID-19 vaccine. Second, for a variety of reasons, many were angered by the study,” he said.
Other studies have also found links between COVID-19 vaccines and excess deaths. A March report from global macro-investment firm Phinance Technologies calculated that COVID-19 vaccines resulted in around 310,000 excess deaths in the United States.
Some studies have reported otherwise. A study from The Commonwealth Fund estimated that 2 million deaths were prevented in the United States through March 2022 due to COVID-19 vaccination efforts.
Another serious concern regarding the vaccine is the persistence of spike proteins for a prolonged period of time after the vaccination.
Even though the CDC claims that mRNA from COVID-19 vaccines is “broken down within a few days after vaccination and doesn’t last long in the body,” recent research reveals that spike proteins are retained in the biological fluids of people who received an mRNA COVID-19 vaccine six months after vaccination.
**************************************************
More Research Refutes Efficacy of Masks Against COVID-19
As flu—and coronavirus—season approaches, Dr. Anthony Fauci is again saying that wearing face masks protects individuals from spreading the coronavirus.
Some colleges and hospitals are reinstating mask mandates.
Politics and the fear of coronavirus may have held sway the past few years, but common sense and rational science need to prevail now. Masks are ineffective, and mask mandates are unnecessary.
We offer several explanations from our National Association of Scholars report and peer-reviewed study to refute doomsayers’ warnings about the effectiveness of wearing masks.
Viruses Go Around, Through Masks
Coronaviruses are very small, with a size range of 0.06 to 0.16 micron. For perspective, 1,000 microns equals 1 millimeter. Respiratory viruses like the coronavirus are transmitted through secretion fluids during breathing in the form of small aerosols (less than 5 microns in size) or larger droplets (greater than 5 microns in size), rather than isolated viruses.
When viral-infected humans breathe, talk, eat, cough or sneeze, they emit aerosols and droplets containing viruses.
Aerosols emitted from simple breathing are small (size range 0.2 to 0.6 micron), and once emitted can be present in an enclosed setting for several hours. A person showing no symptoms of viral infection does not cough and sneeze, and therefore they do not emit large droplets.
Aerosols less than 0.5 micron are not easily filtered out of air by any physical mechanism. The openings in medical masks range from 0.3 to 10 microns in size. The latter dimension is much larger than small aerosols emitted from an infected person.
Now, there are a couple of ways in which virus-laden aerosols can infect a person wearing a mask when the aerosols are present in their breathing zone. One way is aerosol penetration through the mask during breathing because mask openings are too large.
A second way is breathing air containing aerosols from the side of a mask due to incorrect wear, increased mask resistance, or poor string tension. A mask wearer breathes out moist air, which increases mask resistance by plugging up the openings. Simple breathing has been shown to emit up to 7,200 aerosols per liter of exhaled air. While this can reduce aerosol penetration through a mask, it worsens the problem of inhaling virus-laden aerosols from the side of the mask.
Controlled Trials Show Masks Not Effective
The leading Cochrane Database of Systematic Reviews published a review in 2020 and a reanalysis in 2023 of human controlled trials using masks to slow the spread of respiratory viruses.
Both of these studies concluded that it is uncertain whether wearing masks help to slow the spread of respiratory viruses. Outside of the Cochrane organization’s influence, one of the senior authors of both studies (Jefferson) was more to the point: “There is just no evidence that [masks] make any difference. Full stop.”
Jefferson’s findings are consistent with viral transmission basics. Is he right? To answer this, we independently evaluated his data used in the 2020 review using a novel statistical p-value plot.
A p-value plot is used to visually inspect characteristics of a set of test statistics addressing the same research claim; for example, do masks make any difference? The plot is well-respected, being cited more than 500 times in the literature. The plot examined whether p-values support no association (randomness) or a real association between community mask use and viral infections.
Jefferson’s 2020 review looked at 15 separate community (that is, non-health care worker) controlled trials comparing medical masks to no masks. We took the results from these 15 trials—risk ratios and confidence intervals—and converted them to p-values.
If p-values approximately follow a line with a flat/shallow slope, where most of the p-values are small (less than 0.05), then the set of p-values provides evidence for a real association; that is, masks work.
The p-value plot of the 15 controlled trials clearly shows p-values aligned approximately 45 degrees, indicating randomness. This is consistent with what Jefferson found: Masks don’t work.
A Natural Experiment Shows Ineffectiveness
A final explanation is a natural experiment of World Health Organization-reported daily new COVID-19 deaths in Germany and Sweden during the second wave (October 2020 through July 2021). At the time, Germany had a mask mandate, whereas Sweden did not, as they followed a strategy to let herd immunity develop naturally.
Many factors contribute to mortality risk. Numerous influences may be at play in the airborne respiratory virus-mortality chain across populations; for example, access to health care, health status, lifestyle, standard of living, etc., which complicates efforts to draw conclusions from observational data.
However, Germany and Sweden are members of the European Union with similar national health policies. Both should have had similar capacities to respond to the COVID-19 pandemic. Also, in 2020, Germany and Sweden ranked closely in the top 10 countries of the world with the United Nations Human Development Index: Germany sixth and Sweden seventh. So, comparing the two should control for many factors affecting mortality.
Moreover, mask wearing was very dissimilar in the two countries. Survey data on mask compliance during the pandemic was captured in many countries by the University of Maryland Social Data Science Center and Facebook. Using these data, we observed that monthly average mask compliance in Germany was never less than 80%, whereas in Sweden it was never more than 21%, during the second wave.
Those figures shows that mask use had little or no benefit in preventing COVID-19 deaths in Germany and Sweden during the second wave. Despite similar health care capacities, similar Human Development Index measures, and obvious differences in mask compliance for the two countries, daily COVID-19 deaths per million population were not much different.
Policymakers Should Learn From Experience
It is the obligation of those espousing a theory to provide solid supporting evidence. Undoubtedly, more studies on the medical maskrespiratory virus infection research question, including COVID-19, will be presented in literature in the coming years as those in favor of mask mandates look for empirical support.
However, the evidence to date offers no support for mask mandates.
https://www.dailysignal.com/2023/10/12/evidence-again-shows-masks-dont-stop-viruses/
********************************************************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
***************************************************
Monday, October 23, 2023
Yet Another Validation of DNA Contaminants in COVID-19 mRNA Vaccines
TrialSite recently covered the unfolding “plasmidgate” controversy involving DNA contamination found in same of COVID-19 mRNA vaccine product. To date, this media reported on four such studies featuring what some experts are declaring are unacceptable amounts of DNA contamination in the mRNA vaccines, with an emphasis on the Pfizer-BioNTech product.
A new study has been uploaded to OSF Preprints, and one of the authors is a regular TrialSite contributor, David Wiseman, Ph.D., but also includes none other than Kevin McKernan of Medicinal Genomics in Beverly, Massachusetts, the investigator leading the first study verifying that DNA contaminants in the mRNA vaccine vials exceeded the European Medicines Agency 330ng/mg requirement and the Food and Drug Administration (FDA) 10g/dose requirements.
The new study is titled “DNA fragments detected in monovalent and bivalent Pfizer/BioNTech and Moderna modRNA COVID-19 vaccines from Ontario, Canada: Exploratory dose response relationship with serious adverse events.” While this study is not yet peer reviewed, meaning as a matter of scientific practice the findings should not be cited as evidence, the combination of seriousness, relevance and timeliness of findings merit high level introductory overview in the TrialSite.
Representing the study as corresponding author is Dr. David J. Speicher, Ph.D., DTM, a molecular virologist and clinical epidemiologist whose Ph.D. thesis in 2012, on the detection and characterization of HHV-8 led to the first HHV-8 quantitative PCR assay in Australia. He currently teaches and does research at University of Guelph.
Other authors involved with this study include Jessica Rose, Ph.D. and Maria Gutschi, a research pharmacist and drug assessor in Canada.
The study team acknowledges in their study paper the recent studies covered by TrialSite pointing to significant levels of plasmid DNA in both mRNA COVID-19 vaccine products (Pfizer-BioNTech and Moderna). But the authors acknowledge that the previous study findings were based on output based on a limited number of lots, as well as questions linked to variance and quality of the underlying samples used in those studies.
The Study
In vitro transcription employed to generate nucleoside RNA (modRNA) for SARS-CoV-2 vaccines to date relies on an RNA polymerase transcribing from a DNA template, meaning DNA is required in the mRNA production process.
In this context, as an example, the manufacture of the modRNA used in the original Pfizer randomized clinical trial was based on such PCR-generated DNA template.
In fact, by generating clones into a bacterial plasmid vector for amplification in Escherichia coli before linearization, part of the second process making up this study, the team can expand the size and complexity of possible residual DNA, while bringing sequences not present in the template mentioned above.
Articulating that Moderna’s vaccine, both clinical trials and post authorization mRNA product, is based on a comparable plasmid-based set of processes, the present authors used quantitative polymerase chain reaction (qPCR) and Qubit® fluorometry as part of a process to test the additional 27 vials of mRNA COVID-19 vaccine product obtained in Canada.
With the samples drawn from 12 unique lots including:
5 lots of Moderna child/adult monovalent
1 lot of Moderna adult bivalent BA.4/5
1 lot of Moderna child/adult bivalent BA.1
1 lot of Moderna XBB.1.5 monovalent
3 lots of Pfizer adult monovalent
1 lot of Pfizer adult bivalent BA.4/5
To better understand safety profile, the authors queried the U.S. Vaccine Adverse Event Reporting System (VAERS) database for the number and categorization of adverse events (AEs) reported for each of the lots tested. Using Oxford Nanopore sequencing, this helped the team investigate the content of one of the previously studied Pfizer COVID-19 vaccine vials as part of the quest in this study to determine the size distribution of DNA fragments.
Speicher and team also used the sample to verify if the “residual DNA is packaged in the lipid nanoparticles (LNPs) and thus resistant to DNaseI or if the DNA resides outside of the LNP and is DNaseI labile.”
Findings
Based on the dose response model established, Speicher and team conducted an exploratory analysis, finding at least early evidence of a dose response relationship of the amount of DNA per dose and the frequency of serious adverse events (SAEs). Could it be that COVID-19 mRNA vaccine safety as reflected in the number of safety incidences could be predicted based on this model?
The study authors report that the Pfizer and Moderna products differed based on size distribution analysis---mean and maximum DNA fragment lengths of 214 base pairs (bp) and 3.5 kb, respectively.
Disturbingly, the study authors write, “The plasmid DNA is likely inside the LNPs and is protected from nucleases.”
Takeaway
Of course, this study output needs to be vetted via peer review, but the authors demonstrate the presence of billions to hundreds of billions of DNA molecules per dose in the studied Pfizer and Moderna mRNA 19 vaccines.
The study team was able to verify using fluorometry that “all vaccines exceed the guidelines for residual DNA set by FDA and WHO of 10 ng/dose by 188 – 509-fold.”
During this study, Speicher et al. point to the need for methodological clarity and consistency when interpreting quantitative guidelines based on observations for instance, that the qPCR residual DNA content in all vaccines were below established guidelines.
They point out, “The preliminary evidence of a dose-response effect of residual DNA measured with qPCR and SAEs warrant confirmation and further investigation.”
Perhaps most importantly is the overall mounting unease about the COVID-19 mRNA vaccines. This concern is expressed by the present authors:
“Our findings extend existing concerns about vaccine safety and call into question the relevance of guidelines conceived before the introduction of efficient transfection.”
***************************************************
Ivermectin/Hydroxychloroquine Lawsuits Continue On
Physicians in Iowa are suing the state’s licensing boards to overturn restrictions associated with repurposed drugs used for COVID-19, including Hydroxychloroquine and Ivermectin. The physician has filed a civil lawsuit seeking a court order to force pharmacies to fill prescriptions for these drugs.
This news was reported by the Des Moines Register and other sources. Why is Iowa doctor David Hartsuch pursuing a lawsuit against the Iowa Board of Medicine and Iowa Board of Pharmacy? He is accusing them of dissuading members against use of hydroxychloroquine and ivermectin as a regimen for COVID-19.
Citing one study published in the Journal of the American Medical Association, the plaintiff points out that despite the fact that the FDA doesn’t authorize the drugs for COVID-19, approximately 1 in 20 U.S. adults are identified as using hydroxychloroquine or ivermectin for COVID-19 treatment.
Briefly authorized as an emergency medicine during COVID-19, Hydroxychloroquine’s status was revoked when ensuing research suggested the potential for harm. Although conflict ensued thereafter over the research, with some studies showing efficacy and others not. Ivermectin was never authorized in the United States although at least a dozen nations, mostly in low-and middle-income countries, authorized ivermectin on an emergency basis against COVID-19.
While some prominent larger studies (TOGETHER, COVID-OUT, ACTIV-6) showed no efficacy, many others have shown promise. For example, a website tracks ongoing studies which now total 99 studies covering 137,255 patients across 28 countries. The takeaway: the drug can statistically lower risk for mortality, ventilation, ICU and other targeted outcomes. But critics in institutions such as the NIH suggest these studies are not trustworthy, with poor design, questionable data, and the like.
Regardless, by 2021, weekly ivermectin prescriptions, according to one study, skyrocketed from 3,000 per week to nearly 90,000 per week!
The FDA joined in on an information war against the drug, labeling it only as an animal drug, when of course hundreds of millions of doses are administered to humans per year.
Iowa Clash
Dr. Hartsuch’s conflict with the Iowa licensing boards emerged in March 2020. While during summer and late 2020 growing ivermectin use across America was generally accommodated, as Biden entered the White House, the conditions changed.
This market demand triggered a massive industry, government and academic medical system response. TrialSite examined how the federal government went after doctors indirectly in December 2021. In “Feds coming after Doctors & Pharmacies that Market Ivermectin as Safe & Effective for COVID-19” for example, the FDA wrote letters to group such as the Federation of State Medical Boards (FSMB) warning state groups to monitor members for espousing misinformation involving ivermectin.
This campaign spooked doctors and pharmacists around the nation. By the fall of 2021, it was becoming harder for doctors such as Hartsuch to prescribe the off-label drug to his patients. Pharmacies were increasingly on alert.
So, a patient of Dr. Hartsuch for example, could not get ivermectin prescriptions filled, which led to investigations by the Board of Medicine into the doctor’s ivermectin prescribing trends.
But the Iowa physician points out in his complaint that warning letters received by the Iowa Board of Medicine were violative of core free speech rights, during his professional brand reputation.
Now seeking the court to expunge the warning letter from his record, he demands an injunction requiring pharmacies to fill prescriptions for the off-label drugs.
The Iowa physician’s point of view: doctors’ rights to consider and prescribe repurposed off-label drugs is a basic physician right, as long as they follow their professional standards (e.g., consent, etc.).
In other states such as Nebraska, the attorney general doesn’t enforce disciplinary measures should physicians prescribe drugs like ivermectin or hydroxychloroquine for COVID-19.
Before COVID-19 physicians routinely would prescribe off label drugs typically with little to no problems.
https://www.trialsitenews.com/a/ivermectinhydroxychloroquine-lawsuits-continue-on-81c1b8ee
********************************************************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
***************************************************
Sunday, October 22, 2023
The Decline and Near Fall of the COVID Vaccine Makers
The uptake of the latest version of the COVID vaccines, which underwent almost no testing but were rubber-stamped by regulators anyway, has been far lower than expectations. The CDC is not publishing real-time data but what we know so far suggests that it is in the realm of 2 percent.
This is incredibly low. The most pessimistic prediction I had heard was 5 percent. This is a deep failure by any standard. That is precisely why the numbers are not being advertised. The average person has stopped buying what they are selling.
Initially, the excuse was that drug stores faced logistical problems. Then it was widely suggested that they were too expensive. For a few weeks, such diversions dominated the messaging. But in the end, the reality is here: people just don’t want them.
Now we see why the shot pushers were so intent on mandates wherever and however they could. The makers always claimed that the shots were safe and effective but that bypasses a more fundamental question: were they necessary?
The demographics of risk of COVID have been published and unchanged since February 2020, fully a year before the shots became generally available. By that time, millions were already exposed and gained immunity without the shots.
From the beginning, the claims for what they called a vaccine were wildly exaggerated and obviously so. Vast numbers of people had figured this out by the time they were rolled out.
The Biden administration was advised early on that ending the pandemic required 70 percent uptake, which is consistent with the pharmaceutical target for herd immunity. But that goal presumes an absence of natural immunity, which the crowd in charge at the time pretended did not exist or that there was not enough evidence to rely upon it.
When that number failed to stop the spread, the Biden White House kept expanding the goal, from 70 percent to 85 percent to 90 percent to everyone. Finally, they said that the whole reason COVID still existed was due to the unvaccinated, which most every expert knew was false but the needs of industry at that point overrode all science.
The main competitor to the two mRNA shots of Pfizer and Moderna was Johnson & Johnson, which was a more traditional vaccine and required only one shot. But that was withdrawn briefly for safety concerns by the Food and Drug Administration (FDA) in 2021, which wrecked its market share, leaving only two giants to scoop up the fiduciary rewards of public panic.
Keep in mind that these vaccines were developed by tax dollars. The companies enjoyed patent protection. Briefly, the Biden administration toyed with the idea of giving away the formulas so that anyone could make them but that idea faded quickly following panicked industry protests. Then they relied on mandates, which is a form of conscription. Further, they enjoyed indemnification against harms. Finally, they are publicly listed companies so could reap the whirlwind of profits, and they did.
After three years, where does the stock price of Pfizer and Moderna stand? Moderna has lost 74 percent of value in two years, while Pfizer has lost 46 percent. No question that the time to have sold these stocks was two years ago. The layoffs have already started and their valuation will likely crawl back to what it was two years ago.
There is a temptation to cheer when big shots bite the dust, and I share that sense. And yet, nothing about a fallen stock price undoes the tremendously terrible history of these shots: the expense, the coercion, the harms, and the wealth transfer associated with them.
All of which is to say: they will likely get away with the whole thing.
I often think back to what we knew about coronaviruses from the first days. Such viruses are mostly unstable, prone to constant mutation. They are not candidates for viable vaccines. At best, pharmaceuticals can chase down the last variant and provide some therapeutic benefit. They are completely unlike polio, measles, rubella, or smallpox, which are stable viruses against which there have been sterilizing vaccines for a very long time.
Again, this is not wisdom we recently discovered. It was widely known, and has been for many decades. You could find it in any medical textbook. You could even learn about it in 9th grade biology class a generation or two ago.
For some strange reason, by the time 2020 came around, enough people had forgotten or never learned that bad actors were able to manipulate the public into believing that a magic shot could make a respiratory virus go away. There was never any chance that we could vaccinate our way out of this one. Never.
As for safety and efficacy of the shot, I can only quote Tracy Høeg: “There was thus no informed consent and, as stated, safety and efficacy almost entirely unknown when the vaccine was administered to the public.”
Meanwhile, the FDA had a strong team focused on vaccines, which resigned when they saw what was coming with the first booster and how the manufacturers were essentially buying their way into the approval process. Those who remain, it is widely acknowledged, are entirely in the pay of the industry.
Will they get away with all of this? Certainly the public and the financial markets are now in a punishing mode. It’s about time. As for larger accountability, it’s unclear. We had investigations going and some focus on Capitol Hill but all that might be shelved now in light of the huge attention being paid to war in the Middle East. War tends to do this: put everything else on the back burner.
No question that we urgently need reforms, particularly with the problem of regulatory capture and indemnification against harms. The 1986 act (National Childhood Vaccine Injury Act [NCVIA]) that protects vaccine makers against harms needs an urgent repeal. That will bring an element of reality back to these markets.
And measures need to be taken to restore integrity and science at the FDA. That’s just the beginning.
At the start of this entire mess, thinking and writing not as an expert but as a literate human being, I pretty much assumed that the vaccine would be a great distraction from the need for good protocols for dealing with the sick. It turned out to be far worse than a distraction. Many people have been injured and many have died. The entire fiasco has massively raised public doubt about all vaccines, pharmaceuticals, medical services, and public health generally.
What this means is that even without serious efforts at reform, we could see de facto refusal of the public to go along anymore. Public health in this country and around the world squandered decades of goodwill and built up reputational capital on an unworkable project that was never necessary for the vast majority. Now we are stuck with the consequences.
Given all this, a lowered stock valuation for the main two vaccine distributors is small consolation.
*****************************************************
COVID-19 Vaccines and Reports of Deep Vein Thrombosis (DVT)
Reports of deep vein thrombosis (DVT), the formation of blood clots, as an adverse effect associated with COVID-19 vaccines, are increasing. TrialSite has reported before on the blood clot crisis linked to COVID-19 and its vaccines. A compilation of such hematological case reports has been contributed by Aaron Hertzberg. We will summarize some of them here.
Deep vein thrombosis (DVT) is a medical condition where blood clots form in a deep vein; usually in the lower leg, thigh, or pelvis. However, sometimes they can form in the arm.
Case reports of the adverse events following the COVID-19 vaccine administration are appearing after the massive vaccination campaigns to control the pandemic. Studies have been conducted to investigate the link between these vaccines and blood clot formation. Here we present a summary of case reports of DVT, post-COVID-19 vaccination.
Case 1
The first paper mentioned here entitled “Deep vein thrombosis (DVT) occurring shortly after the second dose of mRNA SARS-CoV-2 vaccine” was published in the Internal and Emergency Medicine journal in 2021.
This case involved a 66-year-old female who received two doses of the Pfizer vaccine. Before vaccination, the woman had been completely healthy and did not smoke or have any allergies. She just had a history of left leg neuropathy (damage to peripheral nerves in the leg) after a trauma. A day after receiving her second dose, she had a persistent fever with chills, fatigue, muscle pain, and discomfort. To control these symptoms, she was administered acetaminophen, a drug used for bringing down fever and easing pain. The fever had not resolved by the next day and the patient had also developed acute pain in her right calf in the absence of any trauma. On the third day post vaccine administration, she could not walk and was admitted for investigations. She had mild swelling in her right calf. A diagnosis of DVT was confirmed through a color-doppler ultrasound scan, a non-invasive method to test for deep vein thrombosis. To treat this condition, she was given 10 mg of apixaban, an anticoagulant, for a week. The dose was later reduced to 5 mg and the symptoms resolved rapidly.
Case 2
The second case study was published in the American Journal of Case Reports in 2021. It is titled “A 59-Year-Old Woman with Extensive Deep Vein Thrombosis and Pulmonary Thromboembolism 7 Days Following a First Dose of the Pfizer-BioNTech BNT162b2 mRNA COVID-19 Vaccine”.
It involved a 59-year-old female who reported to a hospital in Oman after suddenly experiencing pain in her left leg. She had a medical history of type 2 diabetes mellitus (T2DM), a condition in which there is a decrease in the insulin secretion to metabolize glucose in the body, osteoarthritis, a degenerative joint disease, and COVID-19 pneumonia. She had been diagnosed with COVID pneumonia in September 2020 for which she had been hospitalized for a week, but the condition had not been complicated. Seven months later, she received the Pfizer BioNTech vaccine, and seven days after that, she developed leg pain with swelling and tenderness. Acute DVT was diagnosed by performing duplex ultrasonography, a test to visualize how blood travels through arteries and veins. The patient experienced tachycardia for which computed pulmonary tomography angiography (CTPA) was performed to look for blood clots within the arteries of the lungs. The test confirmed the presence of blood clots in her pulmonary arteries. For treatment, she was given enoxaparin, an injectable anticoagulant. This was later switched to rivaroxaban – an oral anticoagulant – due to a positive heparin-induced thrombocytopenia test (HIT).
Case 3
The third case report entitled “An unusual presentation of acute deep vein thrombosis after the Moderna COVID-19 vaccine-a case report” was published in 2021 in the Annals of Translational Medicine journal.
It involved a 27-year-old female who had been completely healthy before receiving the second dose of mRNA-1273 (Moderna) COVID-19 vaccine. She had an unremarkable medical history. On the third day after receiving the dose, she reported to the hospital with swelling, redness, and pain with bruising in her upper right arm. (The first dose of this vaccine had been well-tolerated by her with mild soreness at the injection site which had lasted for a few days.) An acute thrombosis in her subclavian and axillary veins was diagnosed using venous duplex ultrasound. For treatment, she was given a heparin infusion to clear the blood clots. After that, she was given rivaroxaban for three months. Her symptoms significantly improved two weeks after being discharged.
Case 4
The fourth case titled “Deep Vein Thrombosis and Pulmonary Thrombosis After BNT162b2 mRNA SARS-CoV2 Vaccination” was published in Circulation Journal in 2022.
This case involved a 14-year-old male who presented at the clinic with pain in his left lower leg 24 hours after receiving the second dose of the Moderna vaccine. He had no family history of juvenile thrombosis or medical history of thrombosis. A contrast-enhanced computed tomography scan revealed multi-organ thrombosis. The patient was administered heparin initially and then shifted to an oral anticoagulant.
The bottom line
While COVID-19 vaccines have been promoted as safe and effective by the World Health Organization (WHO) and public health organizations like the Centers for Disease Control and Prevention (CDC), several adverse events have been associated with them. These include musculoskeletal events, neurological and cardiovascular events as reported in this article.
While some of these adverse events are manageable, several vaccine-injured individuals are yet to recover completely from the effects of these vaccines. This highlights the need for in-depth investigations into the safety profile of these vaccines, as well as the possible link between adverse effects and the vaccines.
https://www.trialsitenews.com/a/covid-19-vaccines-and-reports-of-deep-vein-thrombosis-dvt-a874d074
********************************************************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
***************************************************
Friday, October 20, 2023
DNA contamination with residual bacterial plasmids and truncated mRNA from the manufacturing process
The more I hear about mRNA vaccines, the more pleased I am that I had only the British AstraZeneca shot, which was a more conventional product. I deliberately chose it because I thought it would be safer. Sadly, it was never approved for use in the USA. I guess I should mention that I had zero after effects from my two injections: Not even a sore arm
We highlight the inherent safety issues associated with a lax regulatory framework for approval of the COVID-19 mRNA vaccines. In this article, we consider how lax regulation is related to DNA and RNA contamination issues.
Summary of Key Facts
Concerns have been raised about DNA contamination in the mRNA COVID-19 vaccines. The specific concern is the presence of higher-than-expected residual DNA plasmids used in the original mRNA production. Independent investigations suggest that the Pfizer mRNA vaccine may have high levels of DNA contamination, potentially exceeding regulatory limits.
There are theoretical risks associated with plasmid DNA expression and migration to the gut, which could affect human health and the microbiome. Concerns have also been raised about the quality control and manufacturing oversight of mRNA vaccines.
The European Medicines Agency (EMA), Europe's drug regulatory authority, noted the presence of truncated and modified RNA as impurities in the mRNA COVID-19 vaccines, raising the need for oversight.
Related to the manufacturing process, a Danish study compared the rate of adverse events to the batch size (number of doses in a batch) and found a correlation.
The Advisory Committee on Immunization Practices met last week to recommend the updated COVID-19 vaccine. However, the manufacturers presented little data from testing in humans. Moderna was the only manufacturer to present safety and antibody response data from experience with 101 individuals. Pfizer presented antibody response data from 20 mice and is currently collecting data from 400 individuals in clinical testing. No data on manufacturing oversight was presented during the meeting.
As part of the safety evaluation of drug approval, the CMC (chemistry, manufacturing, and controls) process becomes critical in identifying and eliminating impurities. It sets strict standards and product specifications to maintain the purity of each batch. Compliance with these standards is essential for obtaining approval from global health authorities.
Imagine you're a coffee drinker, and you decide to buy a bag of premium, freshly ground coffee beans from your favorite store. You expect that each bag contains pure, high-quality coffee grounds to brew that perfect cup of coffee. However, when you open the bag, you discover that it isn't just coffee grounds; it also contains a mixture of sand and other foreign particles. This unexpected impurity completely ruins your experience.
Just as you rely on the purity of your coffee grounds for a great cup of coffee, the pharmaceutical industry, including vaccine production, has regulations in place to ensure good manufacturing practices. Patients and consumers expect that these guidelines mean that drug or vaccine formulations are free from unwanted substances, ensuring their safety and effectiveness.
Controlling impurities in traditional chemical products is a well-established practice, but for biological products such as mRNA-based vaccines, managing impurities presents unique challenges.
mRNA Products Contain 'Gene Factories'
Double-stranded DNA (dsDNA) is used to make the mRNA contained in the COVID-19 vaccines. Tiny dsDNA plasmids are small engineered gene factories (Figure 1). These factories produce the mRNA strands contained in the LNPs. A plasmid appears like a tiny micro-bracelet with different segments representing different pieces of genes.
Regulatory agencies like EMA—Europe's drug regulatory authority—set limits for the number of plasmids in the final lots distributed for injection. New questions have been raised about how much contamination there is, and whether the FDA is monitoring this. It is also unclear whether the plasmids can merge with human genes within the cell or travel to the gut.
The EMA standard for DNA contamination of vials is 0.33 percent (330 pg/mg), or roughly one DNA molecule for every 3,000 mRNA molecules. Although the Moderna mRNA-1273 vaccine meets this standard, the actual volume may be higher due to poor quality control. The DNA must be removed from the final product before distribution, but some residual amount is expected to remain.
Unanswered questions include: How much DNA is in the vials? Is it over the limit? Is the FDA tracking this? And what are the implications, if any, with regard to persistence in the recipient?
There are at least two independent groups of investigators who have conducted lab tests and confirmed the mRNA vaccine of Pfizer has been contaminated by DNA.
One team of scientists, led by microbiologist Kevin McKernan, published a preprint paper showing that the Pfizer/BioNTech BNT162b2 vaccine has DNA “orders of magnitude higher than the EMA’s limit.” His paper has not yet been peer-reviewed. The batches examined, provided by an anonymous source, were unopened, expired vials that were not delivered on dry ice. If these data hold, the actual amount of plasmids was 18 to 70 times higher than the EMA limit. (Table 3, page 12.)
Obviously, future investigations should attempt to establish contamination levels using unexpired doses with an intact cold chain.
Professor Phillip Buckhaults, who holds a doctorate in biochemistry and molecular biology and is considered an expert in cancer genomics research at the University of South Carolina, performed an independent analysis for the presence of DNA in Pfizer batches.
Professor Buckhaults in testimony stated the following:
"The Pfizer vaccine is contaminated with plasmid DNA. It's not just mRNA. It's got bits of DNA in it. This DNA is the DNA vector that was used as the template for the in vitro transcription reaction when they made the mRNA. I know this is true because I sequenced it in my own lab."
We will continue to follow this line of research.
Theoretical Risk of Plasmid DNA Contamination
While having some DNA in a sample is unavoidable and deemed acceptable, some have raised questions about the possibility for genomic integration of the DNA. Our cells use DNA in the nucleus to make protein, so if the plasmid DNA gets into the nucleus, there is a theoretical risk that it can get transcribed and make a protein.
About 5 to 10 percent of our human genome contains ancient retroviral DNA. However, this DNA is mutated to a point that is no longer harmful. Any further research on this topic will therefore need to establish not just the presence of DNA plasmid integration, but also its biological activity.
Professor Buckhaults further commented in his testimony:
"I am kind of alarmed about the possible consequences of this—both in terms of human health and biology—but you should be alarmed about the regulatory process that allowed it to get there."
Concerns About DNA Migration to the Gut
Related to the DNA contamination is the concern about residual expression vectors, or plasmids, in the vials. To make a billion doses of mRNA vaccine, more than a kilogram of DNA is required. Plasmids help produce the DNA by splicing in the desired sequence into a bacterial plasmid (Figure 1).
Then workhorse bacteria, often E. coli, help spin out the DNA for production. These bacteria have an extra burden: They must replicate not only their own genome but also the plasmid DNA inserted within their genome. This takes slightly more time, so the bacteria without the additional DNA will eventually outcompete those with the DNA.
To solve this problem, scientists also splice in an antibiotic resistance gene. The entire pool of bacteria is then treated with an antibiotic to kill the faster-replicating bacteria without the conferred antibiotic resistance. This selective elimination allows the plasmid-carrying antibiotic-resistant bacteria to continue growing. In other words, this antibiotic resistance gene confers an advantage that drives selection pressure to favor the bacteria producing the desired DNA.
However, some scientists are concerned that exceeding EMA standards for DNA plasmid contamination could affect an already growing antibiotic resistance problem. This would be a potential concern only if plasmids containing the antibiotic resistance gene migrate to the gut, integrate with bacterial targets in the gut flora, and disrupt the microbiome of the gut accordingly. Diseases, including obesity, diabetes, cardiovascular disorders, cancer, hypertension, and irritable bowel syndrome have been loosely linked with disturbances of the gut microbiome.
Truncated mRNA Contamination
Nucleic acid contamination with truncated, or shortened, mRNA fragments is something that EMA has been following since February 2021. On page 35 of the EMA assessment report (pdf) on the BNT162b2 mRNA vaccine reviewed in Part 1, the EMA states, "Truncated and modified RNA are present as impurities." The agency noted that the impurities were found at different levels during production. For instance, levels may be higher in smaller test batches than in larger commercial batches.
In fact, Danish scientists, Max Schmeling, Vibeke Manniche, and Peter Riis Hansen linked adverse events with vaccination records and found that smaller batches of the BNT162b2 mRNA vaccine may have a higher rate of adverse events (AEs). While this finding is intriguing, the authors call for more research to see if this is a consistent pattern. We reviewed the raw data provided by the authors and agree that a clustering of AEs seems to be found with batches having fewer than 100,000 doses.
It has already been demonstrated in vitro in a laboratory experiment that mRNA can be reverse-transcribed to DNA within six hours. A remaining question is whether this can happen in a live organism. Thus far, there is no evidence that a reverse-transcribed DNA product can merge with a human cell’s genome. Claims about integration are solely speculative and based upon an evolutionary precedent for such a process.
The EMA asked for additional testing but allowed distribution to go forward. The scientists believed these fragments were unlikely to be intact mRNA fragments. An intact mRNA fragment needs to have a cap and a tail. The cap and tail are needed to tell the cell when to start and stop producing the spike protein.
Nevertheless, the EMA requested additional reports. The agency was concerned that an autoimmune reaction could be triggered if fragments' potentially encoded proteins resemble human proteins. In other words, if the fragments "mimic" human proteins, antibodies could be developed against our own bodies.
"Any homology between translated proteins (other than the intended spike protein) and human proteins that may, due to molecular mimicry, potentially cause an autoimmune process should be evaluated. Due date: July 2021. Interim reports: March 2021, and on a monthly basis," the EMA stated.
It is clear that the mass production of mRNA at an industrial scale carries potential risks. This issue has been raised recently by other researchers pointing out the role of manufacturing quality control. For instance, The Epoch Times has previously investigated the link between quality issues and clotting risk (Part 1, Part 2, and Part 4).
This issue of contamination by DNA and mRNA fragments should also be explored further to understand whether certain lots were affected more than others. We also need to know whether DNA contamination is linked to adverse events. The EMA should strictly follow its monitoring standards.
The issue of having any DNA contamination is biologically unavoidable given that the mRNA is transcribed from DNA vectors. The potential issue here is the unusually high level of DNA contamination involved in the mRNA vaccines.
However, pivoting these RNA therapeutics to a vaccine platform in the context of a lagging regulatory framework has left us with many unanswered questions. Public health officials, nevertheless, were adamant that this new product should be deployed in a one-size-fits-all manner ignoring differential COVID-19 risk profiles across a broad population. This, in turn, we believe, set the stage for policy overreach resulting in unethical and harmful mandates.
********************************************************
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
***************************************************
Thursday, October 19, 2023
Rome-Based IRCCS Team Find Distinct Markers Linked to mRNA COVID-19 Vax-Induced Myocarditis
A large team of Italian specialist physician-investigators represented by corresponding author Paolo Palma, affiliated with Rome Italy’s prestigious Instituto di Ricovero e Cura a Carattere Scientifico (IRCCS), the Research Unit of Clinical Immunology and Vaccinology at Bambino Gesu Children’s Hospital, and colleagues conducted a prospective observational study including 15 pediatric patients referred to the hospital’s emergency department for cardiac events (namely suspected acute myocarditis/pericarditis) after receiving a COVID-19 mRNA vaccine.
In this study, all patients were hospitalized and had samples taken on admission or within 48 hours for baseline evaluation, as well as within six months for follow-up evaluation. The study team performed cardiological evaluation with electrocardiogram (ECG) as well as echocardiogram. In this study, the physician-scientists examined the inflammatory features of the Rome children’s hospital pediatric patients developing myocarditis post the mRNA COVID-19 jab. The team combined clinical and routine laboratory data along with high-dimensional proteomic analysis.
Patients meeting the clinical case definition of the CDC (probable myocarditis, confirmed myocarditis, or acute pericarditis) were deemed “c-AEFI patients,” and compared to children with MIS-c and cardiac involvement, SARS-CoV-2 infected children and healthy controls. The Rome-based team was able to confirm a “distinct inflammatory and androgenic profile in patients developing c-AEFI following mRNA vaccination which persists months after the acute event, whereas excluding a pathogenic role of autoantibodies.”
Dr. Palma heads up the pediatric department at the tertiary care academic children’s hospital in Rome that is under extraterritorial jurisdiction of the Holy See—the jurisdiction of the Pope in his role as the bishop of Rome and sovereign of Vatican City.
The study team reports that the subjects represent the clinical and demographic characteristics in line with previously published case series, including class of vaccine product, dose linked to the injury, and the gender ratio.
All the patients in this study developed symptoms following the second or third dose except those who already experienced SARS-CoV-2 infection, who developed symptoms after the first dose. Could this point observed indicate that previous exposure to spike protein may play a role in the pathogenesis of this condition? The study authors believe so.
Study Methods
During this study, the study team investigated the inflammatory features of pediatric patients developing myocarditis following mRNA COVID-19 vaccination, by combining clinical and routine laboratory data along with high-dimensional proteomic analysis.
During the study period the team enrolled 17 patients who met the criteria for the study—CDC work case definitions for myocarditis. These patients all went into observation due to chest pain after COVID-19 mRNA vaccine (BNT162b2 mRNA-Pfizer-BioNTech and the mRNA-1273-Moderna), from August 2021 to February 2022.
The study authors report the exclusion of two patients due to not meeting the study inclusion criteria. The study team used CDC work case definitions to categorize case definitions, fitting as probable myocarditis, confirmed myocarditis or cute pericarditis. All are referred to as c-AEFI.
The Rome-based team was able to use other cohorts for comparison participant data from the CACTUS study—these children were affected by SARS-CoV-2 infection; or had MIS-C with cardiac involvement all before any treatment, as well as healthy children collected in the pre-pandemic period.
Addressing the possibility of confounding factors of age, the team age matched patients, using for comparison of proteomic analysis 21 children with acute COVID-19 infection, 14 children with MISC-C and 31 healthy children. Also, the study team compared androgen levels in children with myopericarditis.
So, what did the Italian researchers find under Dr. Palma and colleagues? TrialSite breakdowns down the outcomes.
Why conduct this study?
Because the risk of acute myocarditis linked to the mRNA vaccines developed in response to COVID-19 attracts lots of attention, and is hotly debated, particularly in the pediatric population. This is a cohort where the risk-benefit of the vaccine must be carefully evaluated. Moreover, the pathogenesis of COVID-19 mRNA vaccine-linked myocarditis remains poorly understood. Several mechanisms are possible.
What are the possible mechanisms involved with COVID-19 mRNA vaccine-induced myocarditis?
The authors suspect one or more of the following:
Immune reactivity
Cross-reacting antibodies to SARS-CoV-2 spike glycoproteins with myocardial contractile proteins
Hormonal differences
So, what were the team’s finding?
Cardiac adverse Events Following COVID-19 Immunization (c-AEFI) have been reported, are a real-world phenomenon, although rare, and were distinctly identified in this study.
Such events not to mention the severe cardiac involvement reported in Multisystem inflammatory syndrome in children (MIS-C) appear more frequent in young adult males. The team here investigates the inflammatory profiles of patients experiencing c-AEFI in comparison with age, pubertal age and gender matched MIS-C with cardiac involvement. Interestingly the study team reports when comparing MIS-C patients to vaccine injured myocarditis patients (c-AEFI), the former possess higher levels of proteins related to systemic inflammation than compared to the latter c-AEFI. But higher levels in proteins related to myocardial injury were found in c-AEFI.
In addition, higher levels of hormones such as DHEAS, DHEA, and cortisone were found in c-AEFI which continued months later during ongoing follow-up. No anti-heart muscle and anti-endothelial cell antibodies have been detected. Overall current comparative data showed a distinct inflammatory and androgens profile in c-AEFI patients which results in being well restricted on heart and to persist months after the acute event.
**************************************************
COVID-19 Vaccines and Reports of Deep Vein Thrombosis (DVT)
Reports of deep vein thrombosis (DVT), the formation of blood clots, as an adverse effect associated with COVID-19 vaccines, are increasing. TrialSite has reported before on the blood clot crisis linked to COVID-19 and its vaccines. A compilation of such hematological case reports has been contributed by Aaron Hertzberg. We will summarize some of them here.
Deep vein thrombosis (DVT) is a medical condition where blood clots form in a deep vein; usually in the lower leg, thigh, or pelvis. However, sometimes they can form in the arm.
Case reports of the adverse events following the COVID-19 vaccine administration are appearing after the massive vaccination campaigns to control the pandemic. Studies have been conducted to investigate the link between these vaccines and blood clot formation. Here we present a summary of case reports of DVT, post-COVID-19 vaccination.
Case 1
The first paper mentioned here entitled “Deep vein thrombosis (DVT) occurring shortly after the second dose of mRNA SARS-CoV-2 vaccine” was published in the Internal and Emergency Medicine journal in 2021.
This case involved a 66-year-old female who received two doses of the Pfizer vaccine. Before vaccination, the woman had been completely healthy and did not smoke or have any allergies. She just had a history of left leg neuropathy (damage to peripheral nerves in the leg) after a trauma. A day after receiving her second dose, she had a persistent fever with chills, fatigue, muscle pain, and discomfort. To control these symptoms, she was administered acetaminophen, a drug used for bringing down fever and easing pain. The fever had not resolved by the next day and the patient had also developed acute pain in her right calf in the absence of any trauma. On the third day post vaccine administration, she could not walk and was admitted for investigations. She had mild swelling in her right calf. A diagnosis of DVT was confirmed through a color-doppler ultrasound scan, a non-invasive method to test for deep vein thrombosis. To treat this condition, she was given 10 mg of apixaban, an anticoagulant, for a week. The dose was later reduced to 5 mg and the symptoms resolved rapidly.
Case 2
The second case study was published in the American Journal of Case Reports in 2021. It is titled “A 59-Year-Old Woman with Extensive Deep Vein Thrombosis and Pulmonary Thromboembolism 7 Days Following a First Dose of the Pfizer-BioNTech BNT162b2 mRNA COVID-19 Vaccine”.
It involved a 59-year-old female who reported to a hospital in Oman after suddenly experiencing pain in her left leg. She had a medical history of type 2 diabetes mellitus (T2DM), a condition in which there is a decrease in the insulin secretion to metabolize glucose in the body, osteoarthritis, a degenerative joint disease, and COVID-19 pneumonia. She had been diagnosed with COVID pneumonia in September 2020 for which she had been hospitalized for a week, but the condition had not been complicated. Seven months later, she received the Pfizer BioNTech vaccine, and seven days after that, she developed leg pain with swelling and tenderness. Acute DVT was diagnosed by performing duplex ultrasonography, a test to visualize how blood travels through arteries and veins. The patient experienced tachycardia for which computed pulmonary tomography angiography (CTPA) was performed to look for blood clots within the arteries of the lungs. The test confirmed the presence of blood clots in her pulmonary arteries. For treatment, she was given enoxaparin, an injectable anticoagulant. This was later switched to rivaroxaban – an oral anticoagulant – due to a positive heparin-induced thrombocytopenia test (HIT).
Case 3
The third case report entitled “An unusual presentation of acute deep vein thrombosis after the Moderna COVID-19 vaccine-a case report” was published in 2021 in the Annals of Translational Medicine journal.
It involved a 27-year-old female who had been completely healthy before receiving the second dose of mRNA-1273 (Moderna) COVID-19 vaccine. She had an unremarkable medical history. On the third day after receiving the dose, she reported to the hospital with swelling, redness, and pain with bruising in her upper right arm. (The first dose of this vaccine had been well-tolerated by her with mild soreness at the injection site which had lasted for a few days.) An acute thrombosis in her subclavian and axillary veins was diagnosed using venous duplex ultrasound. For treatment, she was given a heparin infusion to clear the blood clots. After that, she was given rivaroxaban for three months. Her symptoms significantly improved two weeks after being discharged.
Case 4
The fourth case titled “Deep Vein Thrombosis and Pulmonary Thrombosis After BNT162b2 mRNA SARS-CoV2 Vaccination” was published in Circulation Journal in 2022.
This case involved a 14-year-old male who presented at the clinic with pain in his left lower leg 24 hours after receiving the second dose of the Moderna vaccine. He had no family history of juvenile thrombosis or medical history of thrombosis. A contrast-enhanced computed tomography scan revealed multi-organ thrombosis. The patient was administered heparin initially and then shifted to an oral anticoagulant.
https://www.trialsitenews.com/a/covid-19-vaccines-and-reports-of-deep-vein-thrombosis-dvt-a874d074
********************************************************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
***************************************************
Wednesday, October 18, 2023
FDA Finds Safety Signal for COVID-19 Vaccination Among Toddlers
A safety signal is a sign that a health condition may be caused by vaccination, but further research is required to verify a link.
A safety signal of seizures for young children following COVID-19 vaccination has been detected by the U.S. Food and Drug Administration (FDA).
Seizures/convulsions "met the statistical threshold for a signal" in children aged 2 to 4 following receipt of a Pfizer COVID-19 vaccine and children aged 2 to 5 following receipt of a Moderna COVID-19 vaccine, researchers with the FDA and three large healthcare companies said in a new preprint study.
A safety signal is a sign that a health condition may be caused by vaccination, but further research is required to verify a link.
The data came from three health claims databases run by Optum, Carelon Research, and CVS Health, supplemented with vaccination information from state and local systems. The health claims databases are part of the FDA's Biologics Effectiveness and Safety System, a drug safety monitoring system.
Researchers looked at 15 health conditions following vaccination entered in the commercial databases and compared rates among children aged 6 months old to 17 years old to background rates from 2019, 2020, or both.
Overall, 72 cases of seizures/convulsions were recorded within seven days of a shot among toddlers and other young children. Most happened within three days of a shot.
When stratifying the data by dose, the researchers found signals for dose one and dose two for Pfizer's shot in two of the three databases in children aged 2 to 4. They also found a signal following dose two of Moderna's shot in children aged two to five.
The signal for seizures/convulsions for the young children "has not been previously reported for this age group in active surveillance studies of mRNA COVID-19 vaccines," the researchers said, referring to the Pfizer and Moderna shots.
There are reports of seizures and convulsions after COVID-19 vaccination among children in the Vaccine Adverse Events Reporting System, the researchers noted. Though anybody can lodge reports with the system, most are made by health care professionals.
Another five convulsions were reported after Pfizer vaccination in Pfizer's clinical trial.
The research did not cover the bivalent COVID-19 vaccines, which were introduced for some populations in 2022 and completely replaced the old vaccines in April, or the newest versions of the vaccines that were rolled out in September.
It's not clear when the signal was first detected. The FDA and Patricia Lloyd, an FDA statistician who is the study's corresponding author, did not respond to requests for comment. Pfizer and Moderna did not return inquiries.
Caution Warranted: Researchers
The researchers said the signal "should be interpreted with caution and further investigated in a more robust epidemiological study."
That's partly because the signal disappeared when changing background rate years. The signal was detected when comparing rates with background rates from 2020. But when using background rates from 2022, which were about 2.3 times higher, a signal was not detected.
The higher number of cases in 2022 may stem from an increased incidence of respiratory infections such as influenza, the researchers posited.
The case count may have also included seizures "unrelated to vaccination," the researchers said.
Similar to previously analyzed data from the same system, the researchers also detected a signal for heart inflammation and a related condition, or myocarditis and pericarditis, for children aged 12 to 17. Because that signal has been known since 2021, researchers did not attempt to further explore it.
No other signals were detected.
Strengths of the study include the population covered by the databases being large and geographically diverse. Limitations include a lack of control of confounding factors.
Stroke Risk in Elderly
The FDA and the U.S. Centers for Disease Control and Prevention in January announced they detected a signal for ischemic stroke for people aged 65 or older following receipt of Pfizer's bivalent vaccine. Ischemic stroke is a type of stroke caused by blood clotting.
In another preprint paper published on Oct. 15, FDA researchers said they analyzed Medicare data to estimate the risk of stroke after bivalent vaccination.
They included Medicare beneficiaries aged 65 or older who received a bivalent shot or an influenza vaccine and suffered stroke, except for stroke cases deemed to have been caused by something other than a COVID-19 shot.
The primary analysis did not identify an increased risk of stroke, but stratifying the population by age showed an increased risk after Pfizer vaccination for people aged 85 or older of non-hemorrhagic stroke and for non-hemorrhagic stroke/transient ischemic attack. An increased risk was also found for Moderna recipients aged 65 to 74 for non-hemorrhagic stroke/transient ischemic attack.
No increased risk was found for hemorrhagic stroke.
For people who received a Pfizer jab with an influenza shot, an elevated risk of non-hemorrhagic stroke was detected. For people who received a Moderna jab with an influenza shot, an elevated risk of transient ischemic attack was detected.
A separate analysis of only influenza vaccination detected an increased risk of non-hemorrhagic stroke following receipt of a high-dose/adjuvanted influenza shot, and signals for different ages upon stratification.
"Our study did identify an elevated risk of stroke when the COVID-19 bivalent vaccines were administered with a concomitant high-dose/adjuvanted influenza vaccine. However, the observed effects were not consistent," the researchers, with the FDA and Acumen, said.
A similar finding was detected in a study of data from the Centers for Disease Control and Prevention's Vaccine Safety Datalink system.
The researchers said that the study's findings suggest the elevated risk of stroke in the group that received influenza and COVID-19 vaccines together "was likely driven by influenza vaccination alone rather than concomitant administration."
******************************************************
Collapsing Demand for Pfizer products leads to price RISES
On Thursday, Oct. 12, the Director of the Centers for Disease Control and Prevention (CDC) perhaps, inadvertently shared the current state of COVID-19 vaccine demand, which appears fairly abysmal. Mandy Cohen mentioned at a mobile clinic situated in an elderly community center in California late last week in California that to date, since the vaccine was recommended Sept. 12 by her agency, 7 million doses of the monovalent COVID-19 booster targeting XBB.1.5 have been administered. This represents 2.1% of the total population. For comparison purposes, ultimately about 56.4 million people across the USA opted for the bivalent booster made available last September, representing about 17% of the nation’s population. Pfizer recently predicted the rate of vaccination with the new monovalent vaccine would hit 24%. Director Cohen’s reference to the total number vaccinated was first picked up by the San Jose Mercury News, then later other media such as Reuters and CNN.
Various news agencies attempted to spin the weak turnout for the inoculation noted by some of the right-leaning media such as The Blaze, Glen Beck’s media outlet. For example, CNN positioned the vaccinated figure in a positive light given the “rocky rollout.” COVID-19 has surged somewhat, and based on CDC data, by Sept. 30, approximately 11% of all COVID-19 tests making their way to the national public health agency evidenced a positive for the virus. In this latest surge, 1.6% of all emergency department visits are associated with COVID-19.
Not surprisingly, the weak demand impacts the COVID-19 vaccine manufacturers’ revenue and profit forecasts. With a deceptively innocuous title, Pfizer issued somewhat of a bombshell report on Friday, October 13, titled “Pfizer Amends U.S. Government Paxlovid Supply Agreement and Updates Full-Year 2023 Guidance.”
Among other things, Albert Bourla disclosed in a video the updated Pfizer—U.S. government arrangement. By January 2024, Paxlovid will be available via commercial payers, not just the U.S. government via the emergency use authorization. In what clearly hints at mounting pressure on the Pfizer chief, he noted the parties agreed to a Paxlovid stockpile for the U.S. government until 2028, “at no cost to the taxpayer.” This stockpile will include 1 million courses.
The dropping demand for COVID-19-related products impacts the company’s full 2023 guidance. Some key notable points:
Paxlovid revenues are estimated to decline by approximately $7 billion ($4.2 billion of this part of the non-cash revenue revealed for the return of the approximately 7.9 million treatment courses of EUA labeled U.S. government inventor)
COVID-19 vaccine Comirnaty revenues decline by $2 billion
A $5.5 billion non-cash charge in 2023 in Q3 due to inventory write-offs caused by lower-than-expected demand for the company’s COVID-19 products.
While Pfizer’s other pharmaceutical products appear to likely meet full-year expectations (6% to 8% growth), the company is cutting $3.5 billion, including $1 billion this year and $2.5 billion in 2024. The company holds its analyst and investor call today at 8 AM EDT.
How will Pfizer attempt to overcome this COVID crisis? Much like the large pharmaceutical companies did during the last couple of decades, by raising vaccine prices. In fact, TrialSite reported in March 2021, at the height of the pandemic that Pfizer informed investors the company would find ways to monetize the pandemic products---meaning extract as much money out of them as possible.
At the time Frank D’Amelio, Pfizer’s Chief Financial Officer called pricing at $19.50 “pandemic pricing.” He shared candidly with investors, “[There’s] significant opportunity for those margins to improve once we get beyond the pandemic environment that we’re in.”
That’s happening now as the company’s Comirnaty list price skyrocketed to $120 to $130 per dose covered last month by AP. While mainstream media avoids coverage of the price surge in any material way, that’s likely due to the reality that pharmaceutical advertising represents a sizable portion of overall ad revenue for media companies.
But some media have become more critical, such as the Washington Post. In a piece authored by Jenna Portnoy, a chief operating officer at a Maryland-based hospital shared that the price of the jab has risen to $150 in some cases. Jenna Vallejo told the reporter, “That’s ridiculous.” Meanwhile, the company is pricing what the market will bear, and even though technically under federal law the jabs should still be covered by public or private payers, the company and its fulfillment chain will likely try to squeeze as much out of consumers as possible.
What did Pfizer’s disclosure do to the stock price? At 3:30 PM on Thursday, Oct. 12, the company’s stock price equaled $33.10. While Pfizer is a huge company with blockbuster and innovative niche medicine, the company’s stock is in trouble. And as the reality of how the company behaved during the pandemic comes to light, likely investors may see more troubles with this stock.
To put it all in perspective, the company’s stock was priced at 59.48, an all-time high on December 13, 2021, at the height of the pandemic. But aside from the temporary surge, Pfizer equity has been on a cascading slide downward since then. It’s the artificial nature of the pandemic surge in revenues that likely helped spook investors, along with other disturbing behavior such as how the company abused its position in contracting during the crisis. As of today, Oct. 16, 2023, Pfizer’s price is $32.11.
TrialSite reported that Pfizer recently sought out unorthodox financing, inking a deal with Blackstone, a private equity group investing in drug development.
Meanwhile, TrialSite has predicted that Moderna faces real trouble when the market rejects their Spikevax COVID-19 vaccine—the only revenue-generating product.
Presently priced at $98.30 per share, Moderna’s slide throughout 2023 is apparent upon instant gaze of their chart. By Sept. 6, 2021, again right in the middle of the pandemic, Moderna’s stock hit an all-time high of $449.38. It’s been all downhill since then, currently priced at 98.30.
********************************************************
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
***************************************************
Tuesday, October 17, 2023
Australian Medical Society Investigating Excess Deaths—Suspects the Population Faces a doctor-caused Crisis
The Australian Medical Professionals Society (AMPS) recently launched an inquiry into Australia’s excess mortality: Unveiling an overlooked crisis. Throughout the medical system, the political system and the media, the fact that there are too many Australian people dying is being ignored. And the group of providers seeks to change that. The group has commissioned studies and expressed concern that mass COVID-19 countermeasures have led to excess mortality.
Recently, the society was in touch with TrialSite, sharing updates on imminent activity and events involving the controversial, but important topic.
This Wednesday, October 18, in Parliament House, Canberra, the AMPS holds an inquiry, addressing the alarming rise in excess mortality in Australia since 2021. This timing is of deep concern given the mass vaccination scheme occurred right at this time.
This inquiry aims to uncover the most pressing question: What is causing Australians to die at unprecedented rates? Why has the death rate rocketed? In response to the Senate's extraordinary decision on 23 March 2023, against investigating this sudden excess mortality, a committed group of Australians, in collaboration with international colleagues, has undertaken the investigation that, unfortunately, Australian political and medical authorities thus far have refused to pursue.
Delving deeper into the regulatory failures hindering the proper analysis of preclinical data concerning experimental COVID-19 vaccines, the Australian Medical Society reports serious shortcomings, potential data discrepancies, and alarming signals of harm being overlooked.
It is hoped that this investigation will in fact shed light on the inadequacies within the Therapeutic Goods Administration's (TGA) pharmacovigilance systems. The TGA regulates drugs and vaccines in Australia.
The analysis conducted by AMPS indicates that Australia is facing an iatrogenic crisis – one that has resulted from policies based on insufficient evidence. A bombshell of an allegation, AMPS alleges that the COVID-19 mass countermeasure response is likely linked to the death signals.
Conclusions from AMPS are documented in a book due for release titled, Too Many Dead – An Inquiry into Australia’s Excess Mortality. In collaboration with peers around the world, the group calls for an immediate suspension of the vaccination rollout, pending a full and transparent investigation.
Invitations have been issued to hundreds of politicians especially ministers; and to health authorities, medical colleges and associations Australia-wide including all members of ATAGI, the TGA, and academics in the health fields.
As a society committed to the well-being of all Australians, AMPS shares its commitment to ensuring accountability, transparency and justice, even when the facts may be unpalatable.
******************************************************
Yale Medicine Refers to the ‘Tripledemic’ That Never Was
Major academic medical institutions such as Yale Medicine go on record that the United States already experienced a “Tripledemic.” That’s the implication of a headliner accompanying the recent piece by Kathy Katella writing for Yale Medicine, implying that the presence of influenza, respiratory syncytial virus (RSV), and COVID-19 over the past few years led to such an event.
Well, another fact check is in order: one covering one of the most elite of medical institutions. Yes, there was a COVID-19 pandemic, but never a “tripledemic.” But it’s true that all three viral infections can raise the risk of morbidity and mortality in vulnerable individuals, typically the elderly and individuals with comorbidities but also in some cases children.
Katella, a senior clinical writer for Yale Medicine, follows her hyperbolic headline with a report that this year, for the first time vaccines are available that help to “prevent these diseases, including an updated COVID vaccine, as well as vaccines and a monoclonal antibody injection for those most vulnerable to RSV.”
The Yale article borders on misinformation right at the onset with the title: “Can RSV and COVID Vaccines Prevent Another Tripledemic?”
First, it should be noted that there was never a tripledemic over the past “several” years as Katella states. So why refer to “another tripledemic” unless the author purposely seeks attention for this headline? Disingenuous, we expect a lot more from a prestigious place like Yale.
Does the piece fall under the category of misinformation or disinformation? Very possibly. Importantly, the distinction is that the former is false or inaccurate information—getting the facts wrong, while the latter represents false information which is deliberately intended to mislead—intentionally misstating the facts. Based on these definitions including a clearly inaccurate headline likely means the whole piece falls in the latter category, unfortunately.
The writer turns to be honest when addressing actually how helpful would the three vaccines be for individuals this winter, especially vulnerable persons to these viruses, stating it “is still difficult to say.”
But how to know how these vaccines can help? We cannot know for sure, more honestly, thus academia’s penchant for models. The Yale writer refers to the positive prospects of the use of “predictive models” citing a quote from infectious disease specialist Shana Gleeson, M.D.. Honesty again prevails, as the Yale doc states, “But we can’t say for sure how it’s all going to play out.”
Have any formal clinical trials testing approved COVID-19, influenza and RSV vaccines ever been undertaken and completed? Not at all, but you won’t get that information from Yale. What about the fact that Moderna is currently testing its mRNA vaccine with influenza vaccine for safety? Not a peep. But at TrialSite, you can learn more about these unfolding activities. See TrialSite in “Is it Safe to Receive both Moderna mRNA COVID-19 Vaccine Influenza Vaccine—Clinical Trial Designed to Find Out.” Why Yale doesn’t take the time for basic research 101 we cannot say, other than it’s following some top-down approach to research and health communications.
Meanwhile, the influenza jab vaccine effectiveness was an abysmal 16% effective in the 2021-22 season. This is NOT to discourage those in high-risk cohorts from getting that vaccine. But for a healthy young person, we should ensure to understand a rational risk-benefit analysis and understand with such low effectiveness many of the vaccinated will still pass on the virus. So like COVID-19, the only reason to get vaccinated at this point is if one falls at risk for more severe flu, or for that matter, if one’s preference is to bolster their protective probabilities, even if it’s more psychological than scientific, for some.
The public health tools definitely help, but they are not the panacea promoted by the government, academic medicine and industry. And there are externalities involved, especially for the COVID-19 mRNA products. During emergency times the math of acceptance was more liberal, than today.
COVID-19 vaccines in the age of Omicron involve many breakthrough infections, meaning vaccinated persons can and do carry and spread the disease. With the COVID-19 vaccines, TrialSite started reporting on this scientific understanding by spring of 2021.
Yet Dr. Gleeson assumes all three of these vaccines are essentially sterilizing, in that they will stop viral transmission in all three viruses. She exhibits this bias upon addressing factors as to their effectiveness and impact. Dr. Gleeson states that one potential factor is how many people get the new shots. She implies the more people that get the shots, the more people will avoid infection, and consequently not spread the disease to others.
But given we don’t know the true effectiveness rates yet, and that these are not necessarily sterilizing vaccines, how can she be certain the volume of shots will make a difference at all? The truth is that she cannot. True, she can look back at epidemiological data and find some correlations, but this does not mean causation.
Other factors according to Gleeson such as masking, and the assumption that fewer people will take their masks off in the forthcoming season, along with crowding and get-togethers in enclosed places (think Holiday Season) all spell potential trouble for the “tripledemic.”
More here:
https://www.trialsitenews.com/a/yale-medicine-refers-to-the-tripledemic-that-never-was-6b0fbe6a
********************************************************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
***************************************************
Subscribe to:
Posts (Atom)
