Saturday, December 09, 2023

Another Friday hiatus

Big day at the hosptal today. Not enough time to blog

Thursday, December 07, 2023

Next Generation mRNA COVID-19 Vax Shows Promise in Preclinical Studies

A novel mRNA vaccine developed by GreenLight Biosciences demonstrates significant potential in preclinical animal studies. Does the market need more COVID-19 vaccines? Well, while the market for the existing COVID-19 vaccines have collapsed for now, COVID-19 will likely be around ongoing. As surges may worsen in the future, next generation vaccines will be needed, ones that are more effective, including ones more durable and safer.

This experimental mRNA vaccine encodes for the full-length SARS-CoV-2 Wuhan wild-type spike protein.

What’s the candidate?

GLB-COV2-043, positioned to be a low-cost mRNA vaccine targeting COVID-19.

So how does this early-stage, investigational vaccine differ from say Pfizer-BioNTech’s BNT162b2 or Moderna’s mRNA-1273?

For starters, TrialSite has referred to the above vaccines as version “1.0” or first-generation mRNA vaccines. The current authors concur, however, and not surprisingly, are very careful with their language in the journal entry. Referring to those first mRNA vaccines as “the first-generation mRNA vaccines, encoding for a prefusion stabilized version of the spike (S) protein of SARS-CoV-2 wild-type (Wuhan-Hu-1) strain,” they insert the customary (and likely mandatory) reminder that these current vaccines are considered “safe and highly effective in preventing severe COVID-19 disease, hospitalization, and death in clinical trials,” and therefore authorized for emergency use in humans.

But the authors go on to discuss in pre-clinical research the promise for GLB-COV2-043-driven durability. That is the ability for the vaccine to induce long-term memory responses and durability of binding and neutralizing antibodies against homologous strain and several heterologous variants of SARS-CoV-2.

Also investigating a third booster jab, the data at least thus far suggests GLB-COV2-043 elicits short and long-term potent humoral and cellular immune responses in C57BL/6 mice.

They also point out the success of GLB-COV2-043 in protecting Golden Syrian hamsters in a challenge model against Omicron BA.1 virus.

What about safety?

Thus far tests (cGLP Toxicology study) in Sprague Dawley Rats suggest that GLB-COV2-043 is well-tolerated and effects attributed were consistent with the immunological and inflammatory changes associated with the intramuscular administration of an immunogenic mRNA vaccine.

What’s the delivery technology?

The delivery mechanism involves modified mRNA and lipid-nanoparticle (LNP) technology.

What are pre-clinical results to date?

Studying the vaccine in mice, the researchers from GreenLight finding that GLB-COV2-043 induces robust antigen-specific binding and virus-neutralizing antibody responses targeting both homologous and heterologous SARS-CoV-2 variants and a TH1-biased immune response, as reported by the study authors in a recent entry in the peer-reviewed journal Nature.

The authors point out:

“Boosting mice with monovalent or bivalent mRNA-LNPs provided rapid recall and long-lasting neutralizing antibody titers, an increase in antibody avidity and breadth that was held over time and generation of antigen-specific memory B- and T- cells.”

Further study in hamsters found injecting GLB-COV2-043 led to lower viral loads, reduced incidence of SARS-CoV-2-related microscopic findings in lungs, and protection against weight loss after heterologous challenge with Omicron BA.1 live virus.

What’s the takeaway?

Results show that the “GLB-COV2-043 mRNA-LNP vaccine candidate elicits robust protective humoral and cellular immune responses and establishes our mRNA-LNP platform for subsequent clinical evaluations.”


UK Covid Inquiry Continues with New Testimony, Some Provocative Speakers Show Up

The ongoing Covid Inquiry in the United Kingdom continues this week with former prime minister Boris Johnson finally facing two days of questions about the British government’s actions during the pandemic. The Inquiry is being led by Baroness Heather Hallett in several locations in London. As TrialSite has reported the Inquiry aims to offer a review of the government pandemic response, lessons learned from mistakes with the goal of improving the next pandemic response. Some speakers considered proactive traveled across the pond to discuss problems with the COVID-19 vaccine response at the request of controversial MP Andrew Bridgen. The MP doesn’t trust the formal COVID-19 narrative.

Dealing with the Pandemic

So far, the inquiry has covered topics such as, Resilience and Preparedness, Core UK Decision Making and Political Governance, the impact of Covid-19 on the healthcare system and Vaccines and Therapeutics. On that note, one specific conference led by KC Anne Morris deals with the Vaccine Injured. The vaccine compensation system is a disaster, much like in the United States. According to Morris, the vaccine scheme doesn’t work, it’s not “fit for purpose….”

Apparently, the Inquiry has some influence and can determine if reform to the compensation scheme is necessary. According to the Daily Mail, at least 6,399 claims have been filed with over 500 individuals waiting over a year to get a decision. 166 are “stuck in limbo for more than 18 months,” lawyers told the Inquiry. And as mentioned previously, 127 claims have been approved, state-funded financial support totaling over $18.7 million.

A Different Narrative: COVID-19 Vax Critics Contribute
Yesterday, a panel of experts well known to openly question governments’ top down, rigid response to COVID-19—some even attacked and branded as “conspiracy theorists” testified in front of over twenty members of parliament.

The panel of experts included Dr David E. Martin, Dr Robert Malone, Dr Ryan Cole, Dr Pierre Kory, Professor Angus Dalgleish and Steve Kirsch, the latter being a particularly extreme anti-COVID-19 vaccine advocate. Steve Kirsch has gone on the record that far more people have been killed by the vaccines than saved. While the mainstream medical establishment evades Kirsch, the wealthy Silicon Valley entrepreneur continuously seeks to find smoking gun evidence to shut down the countermeasure program.

Dr. Robert Malone became relatively famous, or infamous, when he went on the Joe Rogan show, and is associated with at least one of the types of research workstreams involved in early mRNA laboratory work. Malone has branded himself as “the inventor of mRNA technology” and has established a substantial platform to call out and question governments’ responses to the pandemic.

Malone, who is now branded an anti-vaxxer by elements within the U.S. said about the Covid vaccine, “What we have here is a rushed product. A rushed technology. A failure to provide respect for humans in not allowing them to have informed consent. And furthermore, actively deploying the most massive propaganda campaign in the history of the modern world, to suppress the ability of the public to gain access-merely to have the knowledge- of what the adverse event risks are. I come to you with one request- open the books! Let’s see the data and let’s allow the data to be examined so we can actually get to the bottom of the most important question the world is facing: were these products actually safe and effective?”

They also mentioned the question of the origin of the Covid virus, and the cover up of early treatments for the disease. Malone also brought up the side effects of the Covid vaccine including myocarditis and the possibility of reproductive damage to women. While there is some peer -reviewed evidence for at least temporary altering of menstrual cycles, there is no direct evidence that the vaccines permanently damage the reproductive system. Malone also emphasized the importance of transparency and the need to access COVID-19 vaccine injury data.

Boris Johnson Expected

The British mainstream media acknowledges members of their Government are under examination and should be treated as severely as how Britons were treated by the Government during what is being referred to as “the Great Panic of 2020-21.” Boris Johnson, the former prime minister, is expected to appear at the inquiry and will be questioned.

The questioning will be a rare opportunity for Johnson to face close scrutiny about the decisions he made during the pandemic, a time when he breached the lockdown rules which he was urging others to follow. The ex-PM is also expected to apologize to the Covid Inquiry because he didn’t get everything right during the pandemic, but he was correct on the “big calls”. Apparently, Johnson has to do some reputation management.

Johnson’s Skill Set

According to Johnson’s former director of communications, Lee Cain, the pandemic was the wrong crisis for Johnson’s skill set, with Cain saying there was “dithering and delay”. This is not the only criticism coming from people who served in the UK government with Johnson. The former chief scientific officer, Sir Patrick Vallance claims Johnson was "bamboozled" by scientific data. Vallance has contradicted himself by also saying “we should have "Locked down harder, earlier.”

The chief scientific adviser to the government did a complete U-turn on what he said to start with! Vallance also revealed he was “reprimanded” by a couple of civil servants when calling for the lock down action by mid-March 2020. While Boris Johnson announced the Covid-19 response by March 23, Vallance shared he privately thought the lockdowns should commence on March 14 or 15. Another former advisor, Dominic Cummings, described the former prime minister as “the trolley” due to his tendency to veer around and constantly change his mind. Johnson’s sister, Sarah, claims the inquiry is just a “show trial” to scapegoat those who were in government during Covid.

Boris Johnson is expected to make an apology on behalf of the government over his early handling of the pandemic, but he’ll defend his personal behavior, obviously over the “party gate” scandal when the PM didn’t adhere to the rules he set for others. Ironically, in Sir Patrick Vallance’s diaries, he claims Johnson, when he was prime minister, pushed to “punish people who aren’t doing the right thing” and for “massive fines” when it came to lockdown rules.

Former Prime Minister to Face Tough Questions

Johnson may be asked specific questions like, “Was the UK too slow to impose lockdowns?” “Did the former PM really say, “let the bodies pile high?” and other similar statements when discussing the idea of a lockdown in 2020. It’s also claimed Johnson said, “Covid is nature’s way of dealing with old people.”

Families of Covid victims are expected to confront Johnson at the inquiry. The former prime minister will be quizzed under oath, and reportedly, Johnson is uncomfortable taking questions so much so, supposedly he once hid in a refrigerator in order not answer inquiries. However, as uncomfortable as Johnson is, the British public may finally get some answers.




Wednesday, December 06, 2023

Systematic Study Finds No Good Evidence for Masking Benefit for Children Inhibiting SARS-CoV-2 Transmission & Infection

A group of physician-researchers from the San Francisco Bay Area screened 597 studies culling that number down to 22 in a systematic analysis investigating the benefits of children masking during the pandemic. Adversely impacting the weight of the evidence is the fact that no randomized controlled trials involving children were used. So, any findings one way or the other in regard to its impact on SARS-CoV-2 infection or transmission would benefit for more evidence. The six observational studies reporting an association between child masking and lower infection rate or antibody seropositivity had critical (n=5) or serious (n=1) risk of bias, according to the study’s authors.

All six of those studies are likely confounded by important differences between masked and unmasked groups. Upon reanalysis, two of the studies were shown to have non-significant results. Sixteen other observational studies found no association between mask-wearing and infection or transmission. The authors such as Dr. Tracy Hoeg, known to be critical of the government’s response to COVID-19, used this systematic review to assess the state of mask wearing in children, what are the outcomes? The authors report that based on the observation of real-world outcomes, the evidence for the benefit of child masking as a non-pharmaceutical intervention to reduce COVID-19 transmission or infection is weak.

During the pandemic, one of the most controversial interventions was the use of masking requirements to improve public health to protect against COVID-19. This research divulges that such requirements—to enforce masking in places like public schools, “appear to be entirely based on mechanistic and observational data, and a systematic review assessing the evidence has not been performed.”

This counters others meta-analysis studies showing masking actually helped. On the other hand, reviews of some of the evidence suggest dependence on “junk science.”

Here, the peer-reviewed systematic study published in The BMJ showed 16 studies point to a lack of mask efficacy, while six studies point to some associated protective outcome, but the limitations of these latter investigations cannot be ignored due to the risk of bias. had critical or serious risk of bias.

The authors point out, “Because benefits of masking for COVID-19 have not been identified, it should be recognized that mask recommendations for children are not supported by scientific evidence.”


The Epistle of Paul to the Americans: Exposing White Coat Supremacy

“Why would a virologist, who is also the head of the CDC not be included in discussions concerning the origin of COVID-19?” wonders Sen. Rand Paul (R-Ky.), the only member of Congress to call out Dr. Anthony Fauci in a conflict thoroughly chronicled in his latest book, Deception: The Great Covid Cover-Up.

That CDC leader is Dr. Robert Redfield, a veteran of the Army Medical Corps, co-founder of the University of Maryland’s Institute of Human Virology, and vice chair of medicine at the University of Maryland. Dr. Fauci, head of the National Institute of Allergy and Infectious Diseases (NIAID) since 1984, excluded Redfield from meetings because “[he] was open to the possibility that COVID-19 could have leaked from the Wuhan lab,” Sen. Paul tells his readers. For that position, Redfield received death threats.

“COVID-19 seemed to show up in Wuhan instantly pre-adapted to transmit easily in humans,” notes Paul, a medical doctor. His account shows, in an understandable way, how this can be achieved, and how gain-of-function research can make viruses more lethal and transmissible.

As Sen. Paul pointed out, Dr. Fauci funded that kind of research at the Wuhan Institute of Virology (WIV) and then lied about it to Congress, which is a crime. Readers get full exchanges, and Dr. Fauci’s deception stands out in stark relief. Paul also exposes Fauci’s “yes-men,” who spotted the lab origin but changed their mind under pressure from the NIAID boss who controls their funding.

Sen. Paul Calls Out Fauci’s Lies

Fauci “commissioned and pre-approved” a paper titled “The proximal origin of SARS-CoV-2,” to back the position that the COVID virus arose naturally in the wild. To refute the paper, Paul taps scientists much more qualified than Fauci or Peter Daszak, the conduit for U.S. funds to the WIV. As Paul contends, “the viral backbone could simply have been one of the many unreported viruses held at the Wuhan Institute of Virology.” Many of them were in fact reported, right from the start.

In January 2020, Israeli molecular biologist Dr. Dany Shoman published China and Viruses: The Case of Dr. Xiangguo Qiu. According to Dr. Shoham, the “main culprit” in the transfer of deadly pathogens to China is Xiangguo Qiu, an “outstanding Chinese scientist” who came to Canada for graduate studies in 1996 and came to head the Special Pathogens program at Canada’s National Microbiology Laboratory (NML) in Winnipeg. Since 2006, Dr. Qiu has been “studying powerful viruses—Ebola most of all—at the NML.”

The viruses that were surreptitiously shipped from the NML to China included Machupo, Junin, Rift Valley Fever, Crimean-Congo Hemorrhagic Fever, and Hendra. In 2017 and 2018 alone, Qiu made at least five trips to the Wuhan lab. This too was ignored by the establishment media, which hurled charges of “conspiracy theory” at anything less than worshipful of Dr. Fauci. As Paul notes, in the spring of 2021, CNN was still claiming that the lab leak hypothesis was “a controversial theory without evidence.”

Fauci and his men “had a conflict of interest,” and were fully aware that “the billion-dollar ‘business of science’ could be damaged if the public becomes aware that the pandemic may have originated in a lab.” At the time of his writing “not one Democrat committee chairman has consigned the release request for COVID records from the Biden administration.” As Paul learned from experience, “[N]ot only is the intelligence community hiding documents that implicate China in the origins of the pandemic, they are now directing social media companies to restrict speech across America.”

As Paul recalls, some people had little to no symptoms with COVID infection, “but as usual, Fauci was convinced that anything that gave hope to people, anything that might lessen the arguments for lockdowns, mask mandates and universal vaccines must be dismissed out of hand.” COVID vaccine mandates, “should not be dictated by anyone who stands to gain monetarily,” but Paul finds this simple principle “still not understood or accepted.”

During the pandemic, “fear gripped the nation, and where we needed calming and reasoned voices, alarming sirens of hysteria dominated the airwaves. A free people let down their guard and the impulse to authoritarianism sprouted and multiplied.” All true, but there was more to it.

White Coat Supremacy

In the pandemic, “we had entered a frightening new era of medicine, where the training and expertise of one’s physician are secondary to the rigid rules and edicts of government bureaucrats.” Sen. Paul charts the dangers and dynamics of white coat supremacy, and he hasn’t forgotten Fauci. The NIAID boss wielded executive-level power without ever facing the voters.

“Despite his extraordinary accumulation of power over nearly four decades,” Paul observes, “the Senate never once voted to confirm Anthony Fauci.” As readers of Deception should know, the reality is much worse.

Fauci earned a medical degree in 1966 but if he ever practiced medicine it was only for a short time. In 1968, to avoid service treating American GIs, Dr. Fauci took a cushy “yellow beret” job with the National Institutes of Health. Dr. Fauci’s bio showed no advanced degrees in biochemistry or molecular biology but by 1984 he was heading the National Institute of Allergy and Infectious Disease (NIAID).

Back in the 1990s Nobel laureate Kary Mullis, inventor of the polymerase chain reaction (PCR), went on record to say that Fauci “doesn’t understand electron microscopy and he doesn’t understand medicine. He should not be in a position like he’s in.” Fauci should never had the job in the first place.

The NIAID boss predicted that AIDS would ravage vast swaths of the population, which never happened. (See Inventing the AIDS Virus by Peter Duesberg and The Myth of Heterosexual AIDS by Michael Fumento.) Despite the failure, Fauci expanded his power in devious ways.

In 1995, NIH nurse Christine Grady authored The Search for an AIDS Vaccine: Ethical Issues in the Development and Testing of a Preventative HIV Vaccine. The author justifies dangerous drug trials on children and pregnant women and touts Dr. Fauci without revealing that she had been married to him for 10 years.

The NIH failed to reveal the relationship when they named Grady chief of the Department of Bioethics of the NIH Clinical Center in 2012. It was the mother of all conflicts of interest, justifying Fauci’s drug trials with black foster children in New York, as Robert F. Kennedy noted in The Real Anthony Fauci.

During the 1980s, Fauci fast-tracked approval of AZT (azidothymidine), a DNA chain terminator forced on the foster children with tragic results. Biologist Rebecca V. Culshaw, author of The Real AIDS Epidemic, finds a parallel with the rush to approve mRNA vaccines for COVID. That was “essentially a massive clinical trial was conducted in real time on the entire population,” including children, the group least vulnerable to the disease. Children also lost valuable school time due to Fauci’s lockdown policies.

Sen. Paul was the only member of Congress to challenge Dr. Fauci, a Lysenko figure wielding extraordinary power but never held to account. Invaluable for the general reader, Deception: The Great Covid Cover-up would be a fine Christmas gift for members of Congress. At first opportunity Congress, should slash the NIAID budget, limit the director to one four-year term, and above all investigate Dr. Anthony Fauci. The struggle against white coat supremacy is the struggle of memory against forgetting.




Tuesday, December 05, 2023

CDC Study of Young Children: COVID-19 mRNA Vaccines Bomb, Fail WHO Threshold--Agency Still Promotes Universal Immunization

The Centers for Disease Control and Prevention (CDC) sponsored the latest Morbidity and Mortality Weekly Report (MMWR) focusing on the epidemiology of COVID-19 mRNA vaccine effectiveness concerning young children ranging in age from 6 months to 4 years. tracking vaccine effectiveness from July 2022, to September 2023.

Represented by epidemiologist and corresponding author Heidi Moline, M.D., Ph.D., a large study team acknowledges first and foremost, that “SARS-CoV-2 infection in young children is often mild or asymptomatic; however, some children are at risk for severe disease.” While agencies such as the CDC have promoted universal vaccination for children aged 6 months and up regardless, data as to the protective effectiveness of the mRNA vaccines developed as countermeasures by Pfizer-BioNTech and Moderna have been limited.

The results here, while touted by the authors as reinforcing the universal vaccination position of the CDC, fail a standard World Health Organization threshold for vaccine effectiveness. In fact, Moderna’s vaccine effectiveness in preventing ER or hospitalization equals 29% for two-dose mRNA primary series. This is not preventing infection, but more severe outcomes.

To be approved, vaccines are required to have a high efficacy rate of 50% or above according to the World Health Organization (WHO). After approval, they continue to be monitored for ongoing safety and effectiveness. See link to the WHO.

In this CDC-sponsored study, the investigators use data from a prospective population-based surveillance system called the New Vaccine Surveillance Network.

Tapping into collecting, categorizing and analyzing this data led to estimates of vaccine effectiveness using a test-negative, case-control design. Including 7,434 children included, 5% received a positive SARS-CoV-2 test result, and 95% received a negative test result; 86% were unvaccinated, 4% had received 1 dose of any vaccine product, and 10% had received ≥2 doses.

According to this observational class of study when comparing unvaccinated children with those children receiving ≥2 COVID-19 mRNA vaccine doses the authors report a 40% effective (95% CI = 8%–60%) rate in preventing ED visits and hospitalization. The authors exclude any investigation into vaccine safety, suggesting a form of bias, as a true risk-benefit analysis would need such information.

What is the New Vaccine Surveillance Network (NVSN)?

NVSN conducts population-based, prospective surveillance for acute respiratory illness (ARI) in children at seven pediatric medical centers. The centers include Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania; Children’s Mercy Hospital, Kansas City, Missouri; Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio; Golisano Children’s Hospital, Rochester, New York; Seattle Children’s Hospital, Seattle, Washington; Texas Children’s Hospital, Houston, Texas; Vanderbilt University Medical Center, Nashville, Tennessee.

How many children received no vaccine?

Were there racial and ethnicity differences in COVID-19 vaccination rates for this vulnerable cohort?

Yes. Compared with White children, Black children were about seven times less likely, and Hispanic/Latino children were approximately three times less likely to have received ≥2 doses of the COVID-19 vaccine.

What was the overall incidence of COVID-19?

Low. Only 5% of children with symptoms turn out to be COVID-19 positive. Also, the authors report co-detections of other respiratory viruses were present in approximately one-third of children who received positive SARS-CoV-2 test results.

So, what was the vaccine's effectiveness in preventing ED visits and hospitalization?

40%. It ranges as low as 8%. Moderna primary series equals 29%.

Do the CDC authors acknowledge the impact of previous exposure/natural immunity in reducing severity of COVID-19 in this young cohort?


So, is 40% vaccine effectiveness sufficient for typical standards?

No, especially not 40% against ER or hospitalization. As TrialSite suggests above, WHO recommends 50%. See the link.

What is the rationale for the ongoing recommendation?
According to the authors' own logic, we are not certain. It appears that it's just a generic stance the CDC takes without critically vetting the data. The study authors point out that “Despite low vaccination coverage and the circulation of several Omicron subvariants, COVID-19–associated ED visits and hospitalization among children with ARI enrolled in NVSN were rare, suggesting most children in this age group experience mild illness from these subvariants or have immune protection from previous SARS-CoV-2 exposure (7). These findings indicate that COVID-19 mRNA vaccines are protective and are consistent with other VE estimates for this age group, ranging from 29% for 2-dose Moderna coverage to 43% for 3-dose Pfizer-BioNTech coverage (5); however, low vaccination coverage and low incidence of medically attended COVID-19 limit precision in these VE estimates.”

What are some key limitations?

First and foremost, a vaccine’s efficacy is measured in a controlled clinical trial and is based on how many people who got vaccinated developed the ‘outcome of interest’ (usually disease) compared with how many people who got the placebo (dummy vaccine) developed the same outcome. This class of study does not indicate causation.

Other limitations provided by the authors include

1) seroprevalence of infection-induced SARS-CoV-2 antibodies in children and adolescents has increased over time, which might affect vaccine effectiveness estimates and assessment of severe outcomes, as more children have immunity from previous SARS-CoV-2 infection

2) low vaccination coverage might indicate that vaccinated children are systematically different from unvaccinated children;

3) NVSN data might be subject to enrollment biases that might vary by site, such as number of enrollment days per week and availability of interpreters for non-English speakers;

4) low vaccination coverage and disease incidence limit the precision of the point estimates and were too low to analyze data by time since dose or to stratify by setting or product and

5) Moderna vaccine is administered as a 2-dose primary series whereas Pfizer-BioNTech requires 3 doses, and receipt of ≥2 doses might underestimate the protection afforded by the complete 3-dose Pfizer-BioNTech primary series.


Skin Disorders Post-COVID-19 Vaccinations

The purpose of the present Op-ed is to identify the scope and number of occurrences of skin and subcutaneous tissue disorders (hereafter abbreviated as skin disorders) that occur following COVID-19 vaccinations.

What are skin disorders? “Skin diseases are conditions that affect your skin. These diseases may cause rashes, inflammation, itchiness or other skin changes. Some skin conditions may be genetic, while lifestyle factors may cause others”. For purposes of this Op-ed, skin disorders encompass Angioedema and urticaria, Cornification and dystrophic skin disorders, Cutaneous neoplasms benign, Epidermal and dermal conditions, Pigmentation disorders, Skin and subcutaneous tissue disorders Not Otherwise Classified, Skin and subcutaneous tissue infections and infestations Not Otherwise Classified, Skin appendage conditions, Skin neoplasms malignant and unspecified, Skin vascular abnormalities.

While cardiovascular disorders, cancers, immune system disorders, and neurological disorders post-COVID-19 vaccination have been studied to a modest extent, skin disorders following COVID-19 vaccination have not been studied to nearly the same extent. This Op-ed will examine a very broad spectrum of skin disorders following COVID-19 vaccinations as reported by VAERS (Vaccine Adverse Events Reporting System). Additionally, the COVID-19 results will be compared to similar results following influenza vaccinations.


Because of the extensive use of the MedDRA (Medical Dictionary for Regulatory Activities) vocabulary in this study, the MedDRA vocabulary will be discussed before the specific methodology is presented. “VAERS uses the MedDRA vocabulary to represent each of the ~18,000 symptoms listed in VAERS. MedDRA consists of five hierarchical levels of symptoms/diseases: System Organ Class (SOC), High-Level Group Terms (HLGT); High-Level Terms (HLT); Preferred Terms (PT); Lower Level Terms (LLT). Only a subset of the bottom level (LLT) is used for the VAERS terminology”. There are 27 SOCS in MedDRA, one of which is Skin and Subcutaneous Tissue Disorders. In the present Op-ed, all the LLT terms that are contained within the Skin and Subcutaneous Tissue Disorders SOC in the full MedDRA database are used to query the VAERS database.

Also, as stated by Medalerts, “the full MedDRA has 87,592 LLT [lowest level terms) symptoms, but VAERS uses only 17,679 (20%).” The MedDRA terms in any category are determined by groups of experts, and are associated with subjectivities and uncertainties that accompany any group decisions.

Now, the specific methodology used to obtain the results will be described. On 23 November 2023, the VAERS database (current as of 27 October 2023), was accessed through CDC Wonder, and all the symptoms were retrieved for COVID-19 vaccines, including those with zero entries. The same type of retrieval was done for influenza vaccines. To obtain the VAERS results for post-COVID-19 vaccination skin disorders, the final list of 6033 MedDRA LLT terms (see Appendix 1 for the specific MedDRA query used to identify skin disorder-related symptoms in VAERS) was intersected with all the ~18,000 VAERS terms to identify VAERS symptoms related to skin disorders post-COVID-19 vaccination (see Appendix 2 for the VAERS COVID-19 results).

Selected VAERS skin disorder results post-COVID-19 vaccinations were also compared to selected VAERS skin disorder results post-influenza vaccinations, using similar numbers of vaccine doses administered. To generate these similar numbers of vaccine doses administered, the influenza VAERS results were retrieved for the period 2019-2023, while the COVID-19 VAERS results were retrieved for the period 2021-2023.

To obtain the VAERS results for post-influenza vaccination skin disorders, the final list of 6033 MedDRA LLT terms was also intersected with all the ~18,000 VAERS terms to identify VAERS symptoms related to skin disorders post-influenza vaccination (see Appendix 3 for the VAERS influenza results).


VAERS Symptoms Related to Skin Disorders Post-COVID-19 Vaccination

The VAERS symptoms related to skin disorders that occurred post-COVID-19 vaccinations are listed in Appendix 2, Table 1. There were 766 symptoms with a non-zero number of events, and a total of 448,517 events. The parallel numbers for post-influenza vaccination are 317 symptoms with a non-zero number of events, and a total of 29,592 events.

To translate from VAERS numbers to real-world numbers, the VAERS numbers (which are strongly under-reported) must be multiplied by an under-reporting factor (URF), to produce real-world numbers. My latest Op-eds use a URF of 66. With that assumption, the total real-world number of skin disorder symptom events post-COVID-19 vaccinations is 448,517 x 66, which equals approximately 29.6 million skin disorder-related events post-COVID-19 vaccinations.

The skin disorders post-COVID-19 vaccinations cover a wide range of symptoms, some of which can be very serious. These latter symptoms include (but are not limited to) Pemphigus vulgaris (52 events), Stevens-Johnson syndrome (43), Toxic epidermal necrolysis (8), Toxic shock syndrome (5), Necrotising fasciitis (16), DRESS syndrome (30) and myriad Skin cancers that are addressed later in this study (168) (link#1; link#2).

Comparison of Skin Disorders Post-COVID-19 Vaccinations and Post-Influenza Vaccinations

Table 1 contains a comparison of selected high/mid-frequency VAERS-related skin disorders terms post-COVID-19 vaccinations and post-Influenza vaccinations. It has been subdivided into five groups. The first group shown in the table (HIGH #COV; ZERO #FLU) contains symptoms that occurred moderately frequently in VAERS post-COVID-19 vaccinations, but did not occur at all in VAERS post-influenza vaccinations.

The second group shown in the table (HIGH #COV; 1 #FLU) contains symptoms that occurred moderately frequently in VAERS post-COVID-19 vaccinations, and once in VAERS post-influenza vaccinations. As in the first group, the most frequent symptom relates to increased skin sensitivity.

The third group shown in the table (HIGH #COV; 2 #FLU) contains symptoms that occurred moderately frequently in VAERS post-COVID-19 vaccinations, and occurred twice in VAERS post-influenza vaccinations.

The fourth group shown in the table (HIGH #COV/#FLU RATIO) contains symptoms that occurred frequently in VAERS post-COVID-19 vaccinations, and occurred much less frequently in VAERS post-influenza vaccinations. As in the first three groups, many types of skin disorders are shown, and there appears to be no central theme.

The fifth group shown in the table (HIGH #COV; HIGH #FLU) contains symptoms that occurred moderately frequently in VAERS post-COVID-19 vaccinations, and occurred moderately less frequently in VAERS post-influenza vaccinations. It is a small group, with symptoms mainly related to injection site issues.




Monday, December 04, 2023

US Military Study on Postvaccination Myocarditis Released

A small U.S. military study on postvaccination myocarditis has been quietly released, with authors saying they found no overt or subclinical heart inflammation.

Outside experts said the study did show some concerning signs and that the military researchers failed to explore those signs further.

The U.S. military was one of the first entities in the world to detect myocarditis and a related condition, pericarditis, after COVID-19 vaccination. The military also mandated COVID-19 vaccination for the force.

With those facts in mind, "it is particularly important to understand the prevalence of subclinical myocarditis/pericarditis along with the potential for additional complications," the authors of the new paper said.

The researchers recruited people who received a Pfizer or Moderna modified messenger RNA (mRNA) shot, were between 12 and 40 years of age, and were enrolled in TRICARE, which provides health care for many service members and their family members. The people received a second or subsequent dose of a vaccine between June 2022 and June 2023.

Participants visited investigators within 24 hours of and three to seven days after vaccination. Their symptoms, troponin T levels, and C-reactive protein were measured. Researchers also used electrocardiograms on the patients.

Thirty people ended up being part of the study, with 23 being active-duty military members. Four had a jump in troponin T, an indicator of subclinical heart damage, from 1 to 16 nanograms a liter after vaccination. However, the researchers said none had subclinical myocarditis because they defined subclinical myocarditis as an increase of more than 20 nanograms a liter. A fifth participant reported chest pain and shortness of breath, two possible signs of heart inflammation, but did not have a rise in troponin T.

"This is the first study to report on signs or symptoms of myocarditis/pericarditis collected through active surveillance following administration of mRNA vaccination in a military setting," Dr. Richelle Homo, a pediatric resident at Madigan Army Medical Center and a fellow at Brooke Army Medical Center, and her co-authors wrote.

The authors acknowledged that the study was not large enough to estimate the incidence of myocarditis after vaccination "due to the unpredictable nature of the pandemic and delays in recruitment." By June 2022, many people, including military members, had stopped getting COVID-19 vaccines.

"Nonetheless, the absence of myocarditis/pericarditis in this study offers some reassurance. As mRNA technology continues to advance, a deeper understanding of the incidence and extent of these complications will be necessary to ensure populations are well informed on the risks, benefits and potential need for monitoring following administration," the authors added.

The paper was published by the British Medical Journal.

Experts Weigh In

Several experts who reviewed the paper said the study did not provide any reassurance due to its small population and the definition of subclinical myocarditis.

Rates of clinical myocarditis, or heart inflammation manifesting through symptoms, run around 1 in 3,000 to 6,000 in multiple previous studies.

Defining subclinical myocarditis as troponin raised to a certain level without cardiac MRI cannot rule out the condition, doctors said.

The levels recorded in some of the participants indicate that there was "some damage to the myocardium," according to Dr. Kirk Milhoan, a pediatric cardiologist. He said he'd have liked to see cardiac MRIs performed on those participants.

"Why don't we look further and see what that is, as opposed to saying, 'well, since nothing was over 20, it was just ignored,'" he told The Epoch Times.

Dr. Sanjay Verma, a cardiologist in California, said that elevated troponin, especially at low levels, can have non-vaccine causes and that cardiac imaging helps differentiate between the causes.

Dr. Verma said the study population was important, noting that researchers only included people who received at least their second dose of a vaccine.

"This inclusion criteria by definition would exclude those who may have already had myocarditis after dose 1. Furthermore, 70% of the study population received a fourth dose (i.e., they did not have myocarditis after the first 3). The study therefore is a self selected population of those who didn’t have myocarditis from dose 1-3," Dr. Verma told The Epoch Times in an email.

"Therefore, the study doesn’t prove or disprove anything about the true rate of myocarditis or subclinical myocarditis in all comers who receive dose 1 and 2 of mRNA COVID-10 vaccination."

It's unclear why the researchers chose the 20 nanograms per liter definition. The first study from the military used a definition of 10-fold to 400-fold the upper limits of reference ranges, which, according to the Cleveland Clinic, can be as low as 0.01 nanograms per liter. The first study did require acute chest pain as well, as it looked at clinical myocarditis.

A newer study from Switzerland examining subclinical myocarditis used a minimum of 8.9 nanograms per liter in women and 15.5 nanograms per liter in men, although other requirements were also considered for the final diagnoses.

Dr. Homo did not respond to emailed questions, nor did the Defense Health Agency, which funded the study.


New Report Reveals Biden Admin Pressured YouTube To 'Crack Down On Vaccine Misinformation'

According to a new report, the Biden Administration pressured YouTube to target alleged misinformation relating to the draconian COVID-19 vaccines.

Documents obtained by the House Judiciary Committee show that the Biden White House forced the streaming platform to suppress any negative COVID-19 vaccine information to push more people to get the jab.

In April 2021, President Joe Biden's former Director of Digital Strategy, Robert Flaherty, emailed Google team members to "connect […] about the work you're doing to combat vaccine hesitancy, but also crack down on vaccine misinformation."

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Flaherty continued, asking for trends surrounding vaccine misinformation on the website while offering government assistance in the form of COVID experts at the White House to partner in product work with YouTube. Google, in an internal email, noted that after a subsequent meeting with Flaherty, the White House staffer "particularly dug in on our decision making for borderline content" — which is content that doesn't cross Community Guidelines but rather brushes up against it, according to YouTube. A week later, Google acknowledged that it sent the White House the total amount of videos removed for COVID-19 vaccine misinformation, while discussing the government's desire for even more data. The next day, YouTube's Government Affairs team emailed YouTube's Product team, flagging the interactions with the White House.

An internal email from YouTube revealed a "high degree of interest" coming from the White House regarding vaccine misinformation and hesitancy.

"Unfortunately, the role of tech in addressing vaccine hesitancy is about to come under a massive spotlight, particularly as the supply of the vaccine is soon to outpace demand," the email continued. "The White House is very interested in our work on borderline content, and more specifically vaccine-related content as well as our work to promote authoritative sources for vaccines."

House Judiciary Chairman Jim Jordan (R-OH) told FOX Business that they knew the White House was working closely with Big Tech to censor the First Amendment and that "internal documents from Google obtained by the Judiciary Committee and Select Subcommittee show that their scheme extended to YouTube."


Big Korean Study of Post-COVID-19 Vax Inflammatory Musculoskeletal Conditions

University researchers from Ewha Womans University College of Medicine, Mokdong Hospital and University Guro Hospital, both in Seoul, Korea conducted a retrospective nationwide cohort study tapping into data at the Korean National Health Insurance Service (NHIS) database. With a total of 2,218,715 patients from January 1, 2021, to 12 weeks post the second dose of vaccine for vaccinated persons and 12 weeks after September 30, 2021, for unvaccinated persons, the study team sought to investigate the incidence rates of inflammatory musculoskeletal disorders post COVID-19 vaccination, comparing to the unvaccinated cohort.

Among the two cohorts, the vaccinations included mRNA vaccine (Moderna/Pfizer-BioNTech), viral vector (AstraZeneca, J&J) and mixing and matching. Multivariate logistic regression analysis was used to determine the risk factors of musculoskeletal disorders after adjusting for potential confounders.

The authors report in their still-to-be-reviewed study paper that individuals who received any COVID-19 vaccine were more likely to be diagnosed with inflammatory musculoskeletal disorders than those who did not. The authors believe that the information will be useful in clarifying the adverse reactions to COVID-19 vaccines and informing people about their potential for inflammatory musculoskeletal disorders after vaccination.

The authors point out that earlier research on COVID-19 vaccines points to a range of adverse reactions related to proinflammatory actions that can lead to an excessive immune response and sustained inflammation. However, they claim no study has been conducted on the association between inflammatory musculoskeletal disorders and COVID-19 vaccines.

A strong study, the 2+ million individuals randomly selected from the Korean NHIS offers a substantial national cohort. Because Korea uses comprehensive medical databases for population-level analysis, overall, the reliability and representativeness bolsters these findings. The authors report that such large population-based databases, which are available only in Taiwan, Sweden, and Korea, offer “excellent resources for answering questions that are difficult to address using single-institution or small-scale studies.”

Conditions such as adhesive capsulitis, also known as frozen shoulder, an inflammatory condition characterized by shoulder stiffness, pain, and significant loss of passive range of motion, can debilitate individuals, interfering with work and quality of life. Long-term disability has been reported at 10-20% in patients, and the persistence of symptoms at 30-60%.




Sunday, December 03, 2023

These Experts Advocated for Lockdowns; Now They Say They Were Wrong

As the dust settles from the COVID-19 pandemic and the fallout over lockdown policies becomes more pronounced, some lockdown proponents, like New York University Professor Scott Galloway, have admitted they were wrong for supporting lockdowns.

"I was on the board of my kid's school during COVID. I wanted a harsher lockdown policy. In retrospect, I was wrong," Mr. Galloway told Bill Maher.

"The damage to kids of keeping them out of school longer was greater than the risk. But here's the bottom line, myself, our great people at the CDC, I'd like to think the governor, we were all operating with imperfect information, and we were doing our best." he said, referring to the Centers for Disease Control and Prevention and then-New York Gov. Andrew Cuomo.

"Let's learn from it. Let's hold each other accountable, but let's bring a little bit of grace and forgiveness," he said.

Mr. Galloway isn't the only one to admit he was wrong for supporting lockdowns, especially for children.

However, some others aren't as quick to blame "imperfect information," and plead for forgiveness.

Dr. Ari Joffe, a clinical professor of pediatrics at the University of Alberta, Canada, and an attending physician in Pediatric Critical Care Medicine, initially supported lockdowns.

So did Kevin Bass, a seventh-year medical student and researcher at a Texas medical school.

Both now say they were wrong because of "groupthink" and "fear-mongering," rather than imperfect information.

And both push back against Mr. Galloway's notion that the powers that be were "doing [their] best."

On March 16, 2020, the Imperial College COVID-19 Response Team published modeling that showed without lockdowns enforced for more than two-thirds of the time over two years, "there would be 510,000 deaths in Great Britain and 2.2 million deaths in the United States by mid-April, surpassing ICU demand by 30 times," Dr. Joffe reported in his peer-reviewed paper, "COVID-19: Rethinking the Lockdown Groupthink."
The Imperial College estimated that there would be "7.0 billion infections and 40 million deaths" globally in the first year.

The result from that modeling was widespread fear, Dr. Joffe said, of which he was not immune.

Consequently, he fully supported government-imposed lockdown measures at the beginning of the pandemic because he believed "lockdowns would reduce viral transmission and deaths, as famously, inaccurately, and tautologically modeled at Imperial College," Dr. Joffe told The Epoch Times.

Mr. Bass, who said at the beginning of the pandemic he was a hard-core Covidian (someone who elevated COVID prevention and mitigation to an almost religious persuasion), said the Imperial College's modeling highly influenced his initial support for lockdowns, as did reports from the World Health Organization (WHO).

"They said it kills 3.4 percent of the people it infects—that was the World Health Organization's figure until early April—3.4 percent, that's way too many people! That's like one out of every 30 people is going to die," Mr. Bass told The Epoch Times.

"And then we had these Imperial College London models which modeled how many deaths there would be due to the pandemic in different scenarios, whether mitigated or unmitigated, with no lockdowns or measures taken.

"And there was essentially no other data. I think, because of the hysteria, the fear, the example of China perhaps, people had an excessive amount of confidence—scientists, social scientists—in the Imperial College of London models."

But as the pandemic unfolded, Dr. Joffe and Mr. Bass began to rethink their early lockdown support.

Recognizing Groupthink

"In the first few months of lockdown, I realized that my (and similarly trained medical colleagues) expertise was poorly suited to give advice during a pandemic," Dr. Joffe said.
He added that when he first saw the Imperial College's modeling, he failed to note that "the high-risk groups were those aged 70 years and older (especially in long-term care), and those aged 60 to 69 with severe comorbidities."

But that fact soon became apparent, and the infection fatality rate was more than 10 times lower than the reported case fatality rate.

"The modeling was flawed, and in general, modeling (forecasting) failed during the pandemic. This was because the models were based on flawed assumptions and non-transparent methods," Dr. Joffe said.

"If you put in inaccurate assumptions (e.g., the infection fatality rate was way too high; the population was modeled as homogeneous when in reality it is highly heterogeneous in terms of risk and exposure; the outbreak was modeled as never-ending exponential increase, unlike any epidemic in history; the herd immunity threshold was assumed to be far too high; and more), the model will show what you want it to show."

Dr. Joffe said that he also saw the effect of lockdowns on students at the university and came to recognize that his support of lockdowns was from a privileged position that "failed to recognize that loneliness, unemployment, and adverse childhood experiences are top risk factors for shortened lifespan, mental health problems, and chronic non-communicable diseases."

Plus, he'd "failed to recognize that missing school will affect an entire generation with reduced social development, executive function (i.e., decision-making ability), earning potential, and future lifespan, and lead to marked increases in adverse mental health outcomes."

Once he recognized those facts, Dr. Joffe began researching lockdowns and his paper was published on Feb. 26, 2021.

In his conclusion, Dr. Joffe states, "The economic recession, through austerity in government spending on the social determinants of health, can be expected to cause far more loss of life and wellbeing over the long-run than COVID-19 can.

"We must open up society to save many more lives than we can by attempting to avoid every case (or even most cases) of COVID-19. It is past time to take an effortful pause, calibrate our response to the true risk, make rational cost-benefit analyses of the trade-offs, and end the lockdown groupthink."

For Mr. Bass, the road to rethinking his lockdown support was more circuitous.

He said that in early 2022, he was trying to find new topics to discuss in health and, as a popular figure on social media, was becoming more skeptical of "things in general." Simultaneously, Mr. Bass realized his online audience was primarily peers, not the everyday person looking for health answers, so he decided to explore a "range of different issues."

"Even though I was very, very closely following the science, I was reading papers super closely, super carefully, and knew what I was talking about, I got a lot of pushback from the very same community that I had been a part of which used to cheer me on about debunking misinformation," Mr. Bass said.

"They started accusing me of misinformation! I started getting mobbed by my own team."

The pushback forced Mr. Bass to recognize the tribalism within his community and that they weren't following the facts but instead following conventional thinking and so-called experts with the most prominent online platforms.

"Once I realized that, I started to see it in many different things, and I started questioning," he said.

That questioning came to a head when, in 2022, Elon Musk bought Twitter, now X, and posted his pronouns as "Prosecute Fauci."

"I retweeted that, or maybe even heightened, quote-tweeted that, like approvingly, and I just got dogpiled," Mr. Bass said. "I was always a Covidian. I always thought that we should have lockdowns, we should have mask mandates, and vaccine mandates, and I was very authoritarian.

"Looking back on it now, it's embarrassing."

During that time, he was also listening to other luminaries who questioned the government response, and that gave rise to his own questions.

"They were saying things about COVID, and I thought, 'Well, that's very interesting. Maybe that's true. Maybe it's important for us also to keep an open mind about critical perspectives.' So, during this entire time, I was doubting and thinking about things," Mr. Bass said.

"And it became obvious that this whole zero-COVID narrative … was [expletive]. Like we weren't ever going to control COVID, and it just became obvious that lockdowns, in general, were a pipe dream, a fantasy. And to the extent that they could, you'd end up with a totalitarian nightmare."

Recognizing his error and wanting to acknowledge it, Mr. Bass posted to X on Dec. 12, 2022, "I was wrong about lockdowns and mandates. I was wrong and the reason I was wrong was my tribalism, my emotions, and my distorted understanding of human nature and of the virus. It doesn't matter much, but I wanted to apologize for being wrong."

Avoidable Mistakes

Dr. Joffe said, "governments put the wrong people in charge of advising and managing the public emergency of the pandemic.
"The public health medical officers were not trained nor experienced in managing a public emergency. The medical expert groups also were not trained nor experienced in managing a public emergency. All were susceptible to groupthink."

Dr. Joffe, along with David Redman, a retired lieutenant colonel at the Alberta Emergency Management Agency, said in a paper that emergency management agencies, with their specific procedures, should have managed the pandemic.

Instead governments controlled the response and focused only on things like "flattening the curve" and "protecting the healthcare system" and failed to calculate the impact that lockdowns would have on society against their true efficacy.

"A common mistake was to consider correlation as causation—meaning, when lockdowns were implemented, cases and hospitalizations sometimes decreased, and this was incorrectly interpreted as lockdown efficacy," Dr. Joffe said.

"The problem was, this was not due to causation … it was clear that regardless of lockdown, the trajectories of the pandemic were the same."

Mr. Bass agrees, "When the pandemic started, I was very aware of the downsides of this ideology, but still, I went along with it. My ultimate belief—and I think many people shared this—was that every human life is precious. I mean, nobody can argue with that, right?

"We thought, basically, 'Yes, we might have some economic devastation for a short period. Or yes, there might be some inconvenience,' as Fauci used to put it whenever he dealt with lockdown protesters or international leaders. But nonetheless, like these inconveniences, these slight mild economic recessions, they might not be all bad, and we'll rebound, was a thing we told ourselves. And so, we had this overwhelming focus on the positives."

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