Disastrous Covid vaccination campaign in Poland

Poland’s National Audit Office known as “NIK” has identified a substantial surplus of COVID -19 vaccines due to lack of demand. The nation had contracted for a full vaccination rate multiple times over, yet the national office reports vaccination rate decline. Consequently, 13.1 million doses were allowed to expire and then exposed by the end of 2022, representing PLN 1 billion (US$237.7 million). In total, Poland spent 13.9 billion PLN (US$3.3 billion) for this nation of only 37.7 million people. TrialSite reminds that this was one of the few media to cover Poland’s attempt to renegotiate the COVID-19 vaccine contract with Pfizer due to the impact of the Russian invasion of Ukraine. Pfizer refused to budge. What follows is what in reality is a damning report from the NIK as to what appears to be an unfolding scandal in the aftermath of the COVID-19 response.

The NIK reports the effort to sell, transfer or donate the COVID-19 vaccines to mitigate the effects of the excess. By 31 December 2022, the Governmental Strategic Reserves Agency (RARS) provided to other countries over PLN 27.6 million vaccine doses with an estimated value of PLN 1.4 billion or (US$333.3 million).

A Great & Deadly ‘Health Debt’ Caused by COVID-19 Response
The NIK has gone on record that the COVID-19 response caused significant disruptions in the healthcare provision. Above all, a great part of the healthcare system resources was “relocated” to control the epidemic. That resulted in shrinking access to treatment for a broad group of patients, diagnosed with diseases other than COVID-19. Hence, the so-called health debt was growing (that was a situation where the failure to provide a medical service may lead to a disease development or its worsening).

Excess Deaths during the Pandemic—Despite the Vaccine
In 2020-2021, an increased number of deaths was reported, as compared with the average of 2015?2019. In 2020, there were over 85 thousand more of them, including about 56.5 thousand deaths for reasons other than COVID-19. And in the first half of 2021, excess deaths against the number of deaths reported a year before totaled nearly 61 thousand. But what about the COVID-19 mass vaccination response?

In fact, the COVID-19 universal vaccination countermeasure was supposed to help prevent those negative phenomena. The vaccination did not succeed despite many claims that the vaccines saved millions of lives. TrialSite has reviewed dozens of observational studies suggesting that the vaccines have reduced morbidity and mortality but the nature of these studies are such that this does not prove causation.

NIK points out in line with the assumptions the vaccines should have ensured a “return to normal.” While also serving to “unblock” the healthcare system, particularly for patients with diseases other than COVID-19. As NIK declares in a recent media entry a direct objective in the COVID-19 National Vaccination System was:

to reduce the number of deaths and complications caused by the SARS-CoV-2, particularly in elderly persons,

to reduce the population “health debt” growth.

In 2021-2023, NIK conducted a range of ad hoc audits to establish if the objectives of the COVID-10 National Vaccination Programme were achieved and how. NIK carried out five audits to look into the Programme execution which cost about PLN 17 billion (US$4.05 billion).

The NIK audit revealed that:

The Minister of Health improperly estimated needs related to the purchase of an adequate number of COVID-19 vaccine doses (meaning that the Ministry ordered more doses than they needed to, which of course meant more taxpayer dollars to the pharmaceutical companies).

Poland did not have to enter into agreements - questioned by NIK - to purchase COVID-19 vaccines. The Minister of Health did not use that right.

Estimating demand

It needs to be underlined that no documents were presented showing how the number of vaccine doses, needed to satisfy the demand of Polish citizens, were estimated. There was no basis, no rationalization used to justify the large spend.

From May 2021, subsequent vaccine doses were contracted for, although Poland was bound with contracts enabling the vaccination of the entire population several times (109 million doses were contracted for at the end of April 2021).

Even assuming that every adult person in Poland, i.e., about 31 million individuals, received the third vaccine dose, the demand would be at the level of 93 million doses, i.e., lower than the number of doses contracted for before May 2021.

What did the Health Ministry Know?

Interestingly, what did the Polish Ministry of Health know about the COVID-19 pandemic that informed them to estimate such demand?

NIK reports that the Minister of Health formulated a thesis that prior to the execution of agreements indicated as improper, there were signals that vaccine boosters every 6 months are necessary to maintain the immunological response at an adequately high level. The thesis is not only unconfirmed by the evidence gathered in the audit but also it does not reflect the opinions of specialized EU institutions taking efforts to control the COVID-19 epidemic.

On 31 May 2021, the Minister of Health addressed the EU Health Commissioner concerning the vaccines purchased, pointing to the hazard of huge vaccine surplus in Europe and the need for coordinated cooperation to start talks with individual manufacturers to reduce the volumes of vaccine orders.

NIK emphasizes that the Health Ministry could have been culpable in questionably intentioned pursuits.

“It needs to be stressed that the Minister stated that the epidemiological situation is about to stabilise and pointed to the “hazard” of significant surpluses of the COVID-19 vaccines, only 11 days after signing the third agreement with Pfizer/BioNTech. It points to complete inconsistency of the Minister’s actions. According to NIK those measures were unreliable and wasteful.”

Poland’s COVID-19 Vax Contracts

As reported by the NIK, the Republic of Poland acquired the COVID-19 vaccines as part of the Agreement on the joint mechanism for the COVID-19 vaccine purchase.

The Agreement authorized the European Commission to negotiate and conclude vaccine purchase contracts, on behalf of the EU Member States. Remember, TrialSite reported on how at least part of the EC negotiation was done via private personal text between Pfizer’s CEO Albert Bourla and Commission President Ursula von der Leyen. The situation is so egregious that even the New York Times has sued the EC to get to the bottom of this possible scandal.

NIK reports that the EC as an entity took responsibility for the contracts’ content, including the principles of sharing vaccines among the EU Member States, the pool of vaccines covered by the contract, their prices and delivery dates.

The EC notified the EU member states of the former’s intention to sign the deal, and the reality that the latter had no rights to modify. NIK does inform that member states were notified that they did have the option to withdraw from the vaccine purchase contract. It was a take it or leave it deal.

NIK informs the world now that in the vaccine purchasing process two types of contracts were used: 1) contracts defining the right to purchase vaccine doses and 2) contracts defining the obligation to purchase them.

First, NIK notes that participating EU Member States were not obliged to sign that contract. With the second contractual model, the EC was obliged to inform the EU Member States about the intention to sign the contract with an obligation to purchase the vaccine doses, also defining its signing conditions. Again, Member States had not input.

NIK cites the problems with the contractual scheme as devised:

“All the contracts negatively evaluated by NIK were contracts defining the obligation to purchase COVID-19 vaccines. The states that did not agree to sign that contract or its conditions had 5 days to withdraw from the contract or declare a number of vaccines other than set out in the contract (the so-called “opt-out clause”).

NIK points out in their media entry “The opt-out clause required consent of partner states, in cooperation with the EC, to accept extra doses or to give away appurtenant doses.”

Outrageous: 117.6K Hazardous COVID-19 Vax Doses Administered to Polish Population

TrialSite also learned about this scandal in the recent NIK media piece, under the section “Supervision of the Chief Pharmaceutical Inspectorate (GIF) over the COVID-19 National Vaccination Programme.”

NIK added in its report the state’s negative evaluation supervision exercised by the Chief Pharmaceutical Inspector over the vaccine storage and distribution. The body responsible for pharmaceutical safety of the state, obliged with “special supervision”, did not know in which warehouses the vaccines were stored. This NIK reports, “The relevant information was taken from the media,” meaning the nation state had no control over the pharmaceutical product within its borders.

The Polish government found defects, yet as the government itself via the NIK reports, “GIF failed to take efforts to withdraw part of vaccines, in which some quality defects were found, also the ones posing a threat to health and life. In consequence, 117.6 thousand hazardous vaccine doses were administered to patients.”

Distribution and storage of vaccines

According to the NIK audits, 17 pharmaceutical warehouses were involved in the process of the COVID-19 vaccine distribution and storage. In the audited period, GIF carried out only two inspections in one of pharmaceutical warehouses taking part in the COVID-19 vaccine distribution.

“A lot of critical irregularities were identified, e.g., the vaccine storage conditions in special rooms or the vaccine transport from the Governmental Strategic Reserves Agency (RARS) were not registered. Also, the product safety was not provided during vaccine storage in that warehouse.”

NIK reports an alternative inspection targeting the same supply pointed to a scandalous takeaway: the “distribution process does not guarantee the safety of vaccines in terms of their quality maintenance.”

While European GIF inspectors were in fact, cognizant of the discovered irregularities adversely impacting COVID-19 vaccine safety and effectiveness, they carried out no inspections in the remaining 16 warehouses.

Consequently, Poland’s national auditor points out how the Minister of Health was culpable in an unfolding scheme:

“The Minister of Health had a significant, adverse impact on the effectiveness of actions taken by GIF. He made the following statement which was contrary to the applicable law:

the distribution of COVID-19 vaccines is not the trade in medicinal products, in the light of the Pharmaceutical Law Act, and hence,

the trade in vaccines may not be monitored via the Integrated System for Monitoring the Trade in Medicinal Products (ZSMOPL).”

Poland’s Minister of Health essentially blocked and tackled on behalf of what appears to be some kind of cabal consisting of EC bureaucrats, industry and perhaps other high placed persons. After all, thanks to the Minister’s efforts “pharmaceutical warehouses were freed from the obligation to report vaccine stock availability on a daily basis. Hence, GIF could not monitor the trade in those vaccines. The Inspectorate drew its knowledge about the COVID-19 vaccine warehouses from the media.” This unfolding scenario could only be considered an utter and complete scandal.

Risking Patient Safety

TrialSite reminds all that national health authorities exist to ensure the safety and welfare of the population, not to further endanger them.

Yet Poland’s own auditors report that “The decision of the Minister of Health not to use the monitoring system also had a negative impact on the safety of patients.”

The NIK informs the world:

“In two cases, GIF did not decide to withdraw from the market a series of vaccines, although the Inspectorate was aware of their quality defects. GIF could not withdraw the vaccines, because their distribution was not subject to the Pharmaceutical Law Act – in line with the interpretation of the Minister of Health, and so GIF had no legal grounds to withdraw them from the market. Besides, the Inspectorate did not know in which warehouses the defective vaccines were found.”

Vaccine quality defects

GIF received eight reports of actual or alleged quality defects of the COVID-19 vaccines, of which two were of significant importance, reports the NIK media entry.

Additional Notes

On 23 April 2021, the Chief Pharmaceutical Inspectorate received information in the Rapid Alert system from the European Medicines Agency, about a possible quality defect in one of the COVID-19 vaccine series, already used in Polish patients. The report dealt with the suspicion of a 2nd class defect, that is the one that could cause an illness or improper effects. GIF failed to issue a decision to withhold or withdraw that vaccine series from the market.

Meanwhile, in April 2022 the Federal Agency for Medicinal and Health Products in Belgium informed GIF about withdrawing that series from the market. Having received the report, GIF provided the relevant information to RARS, requesting the Agency to take action to identify distribution channels and inform recipients about the situation. The efforts were pointless, though, because the entire vaccine series was already administered to patients

the quality defect of the vaccine series was reported on 7 April 2022 by the Spanish Agency of Medicines and Medical Products (AEMPS).

In the second case The vaccine quality defect could pose a threat to patients’ health and life (1st class defect), which obliged GIF to withdraw the defective product from the market.

Summary of Breaches Risking Patient Health

Summarizing this scandal, NIK reports that “In both cases, GIF not only failed to withdraw the vaccine series from the market but also did not know where they can be found.”

Having received the report, information was passed on to RARS with a request to identify distribution channels and notify recipients about the situation. The Chief Pharmaceutical Inspector explained that in the light of the Minister of Health’s interpretation, the decision to withdraw the vaccine could not be issued for the product that is not in the market. That information was also provided to RARS.

The government's vaccination commissioner

The Chancellery of the Prime Minister and the Government Commissioner for the National Vaccination Programme dealt mainly with conducting campaigns encouraging Polish people to vaccinate. Over PLN 155 million (US$36.9 million) was spent in pursuit of that aim.

In parallel, no definitions were established to determine the effects of this initiative. How could they know what success is?

While the Commissioner according to the NIK had an obligation to analyze the relevant activated legislation as well as existing solutions as they relate to prophylactic vaccinations, the office failed to do so whatsoever. The Commissioner simply deferred to analyses promulgated by the Minister of Health. This is truly problematic.

The Commissioner was also obliged to prepare proposals of new legal solutions and initiatives in terms of the COVID-10 National Vaccination Programme.

“In view of the above, according to NIK, it was unjustified to appoint a vaccination commissioner, whose tasks could be discharged by the existing state bodies.”

In performing his tasks, particularly in drafting changes to resolutions on the National Vaccination Programme, the vaccination commissioner drew on the information and knowledge of the Government Analysis Centre, the Ministry of Health, the National Health Fund, the e-Health Centre, the Government Security Centre or the Chief Sanitary Inspector.

After the vaccination commissioner’s office was lifted, the Programme supervision was entrusted to the Minister of Health, meaning a complete takeover, clearing the pathway for the exact COVID-19 countermeasure execution NIK founds so many troubles with.

https://www.trialsitenews.com/a/polands-national-auditor-condemning-covid-19-report-ec-response-a-scandal-quality-chucked-vax-injury-a-certainty-e9ae0c03

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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Covid Inquiry An Embarrassment To The English Legal System

Its exorbitant costs already cannot be justified, and there is only worse to come. It should be abandoned

Of all the crass misappropriations of scientific principles during the pandemic, none did more harm than the corruption of the ‘precautionary principle’.

The notion that an action or an intervention is justified only once one is clear that the benefits exceed the harms and that, as one sociologist put it, “you have looked very hard for the harms”.1

That principle came to be almost wholly inverted in the context of the pandemic: an intervention seemingly could be justified on the ‘precautionary’ basis that if it might have any beneficial effect in slowing the course of the pandemic, it would be worthwhile.

This justified indiscriminate measures ranging from universal masking, mass testing (including of young children), 14 day isolated quarantines, and even lockdown itself, for entire healthy populations on the basis that even though the evidence base was often weak or non-existent, the intervention just might achieve something, and opened the door to a slew of harms impacting almost all cohorts of the British population.

It was to be hoped that a core task for the Covid Inquiry in this key Module 2 would have been a dispassionate objective assessment of whether the costs (financial costs, direct harms, probable indirect harms, risk of unquantified future harms) of the Government’s population-wide interventions outweighed possible benefits.

So, it was deeply disappointing last week to see not only key witnesses but the Inquiry Chair herself repeat the same dangerous misconception of the precautionary principle.

In one of the most jaw-dropping interjections of the Inquiry to date, Baroness Hallett appears to have revealed a prejudgment that if masking people could have had even the slightest of benefits, and seemingly without even contemplating that risks and known harms might need to be weighed too, it should have been imposed.

She pressed Sir Peter Horby, an esteemed epidemiologist at Oxford University, who had indicated that he believed universal masking was not a straightforward decision:

“I’m sorry, I’m not following, Sir Peter. If there’s a possible benefit, what’s the downside?”

Coming from the independent Chair of a public inquiry, this is an astonishing comment.

It betrays a presumption, or at the very least a predisposition, to accept that it was better to act than not to act — the reverse of the precautionary principle. When a comment such as this, from the Chair of the Inquiry, goes unchallenged, it risks anchoring the entire frame of reference for the Inquiry’s interrogation of this critical topic.

In our view it was a surprising and serious error of judgment for an experienced Court of Appeal judge.

What made Baroness Hallett feel this to be an appropriate thing to think, let alone say out loud? We suggest the issue may be that the Chair and the official counsel to the Inquiry appear already to have the storyline of the pandemic wrapped up.

The Inquiry’s counsel has been at pains to paint a picture of the country facing an almost existential threat from the virus. From the outset, counsel has framed their questioning on the basis that it was indisputable a “highly dangerous fatal viral outbreak was surely coming”,2 and “… by February this viral, severe pandemic, this viral pathogenic outbreak is coming, and it can’t be stopped…”.3

Even hardened lawyers and epidemiologists, it has seemed, were bunkering down because “the virus was coming, it was a fatal pathogenic disease …”.

And, with the precautionary principle inverted in the collective mind of this Inquiry, almost anything the Government then did against that backdrop was justified.

With Preference…

Worse still, it is now starkly evident that the witnesses whose opinions and perspectives support that proposition are being overtly praised and pedestaled; while those whose opinions and perspectives might cast doubt are treated with prejudice and hostility.

For those witnesses who were part of the ‘home team’ — Government-appointed advisors, and those who have already publicly ascribed to the Inquiry’s apparently favoured storyline — impeccable credentials and impartiality have been assumed.

Sir Jeremy Farrar, for example, former director of the Wellcome Trust, member of SAGE and currently chief scientist at the WHO gave oral evidence to the Inquiry in June. One can almost picture counsel for the Inquiry scattering rose petals as he sums up Farrar’s illustrious credentials:

“You trained, I believe, in medicine, with postgraduate training in London, Chichester, Edinburgh, Melbourne, Oxford and San Francisco.

You have a DPhil PhD from the University of Oxford. You were a director of the Oxford University Clinical Research Institute at the Hospital for Tropical Diseases in Ho Chi Minh City in Vietnam from 1996 to 2013.

From 2013 you were Director of the Wellcome Trust, and from May 2023 have you been the Chief Scientist at the World Health Organisation? Have you throughout your professional career served as a chair on a multitude of advisory bodies, for governments and global organisations?

Have you received a plethora of honours from a number of governments, institutes and entities?”4

Farrar is then treated to counsel’s softest underarm bowls and allowed to give unchallenged testimony in favour of an intervention-heavy approach to pandemic management:

“when you have the countermeasures you’re talking about, diagnostic tests, treatment and vaccines, together they create a Swiss cheese model of what our public health is”.5

Professor Neil Master of Disaster Ferguson of Imperial College London, and chief architect of the dramatic scientific modelling on which the global lockdown response was predicated was warmly welcomed to the witness box by counsel last week “as a world leading specialist in this field”, and was later thanked profusely for his hard work by Baroness Hallett:

“… thank you very much for all the work that you did during the pandemic”.6

Gushing perhaps, but nothing compared to the farewell given to SAGE modeller Professor John Edmunds who had been affirmed up front by counsel as, “a de facto expert in epidemiology”, and one of “a number of brilliant scientists and advisers who assisted the government and the country in the remarkable way that you did”.7

At the end of his evidence, Baroness Hallett delivered the eulogy:

“Thank you very much indeed. If I may say so, Professor, I think you were unduly harsh on yourself this morning.

You had a job, and you described it yourself, your job was to provide expert advice to the policy and decision-makers, and if the system is working properly that advice is relayed to them, then they consider advice coming from other quarters about economics and social consequences and the like.

I’m not sure you could have done more than you did, consistent with your role at the time, but you obviously did as much as you felt was appropriate. So I’m really grateful to you, I’m sure we all are.”8

This is a far departure from the rigorous testing of credentials and potential conflicts that one could expect as an expert witness in any court proceedings under the studious impartiality of the presiding judge.

It is certainly far short of what the public should rightly expect for an exercise set to spend over £55m on lawyers alone.9

None of these witnesses were asked whether their senior positions within organisations that rely on very valuable relationships with global pharmaceutical groups and private pharma-focussed organisations could have had any bearing on their advice at the time or their evidence to the Inquiry now.

Farrar was director of the Wellcome Trust throughout the pandemic. The Wellcome Trust is one of the institutions behind CEPI, a global vaccine development fund created in 2015 which partners with vaccine manufacturers, including Moderna.

During the pandemic Farrar frequently and vocally promoted his view that vaccines would be the means for us to exit the pandemic. He is plainly someone whose professional success and credibility has become indelibly attached to the pharmaceutical industry and in particular the use of pharmaceutical interventions in public health, yet counsel and the Inquiry Chair seemed uninterested in that colouring of Farrar’s evidence.

Likewise, Ferguson, of Imperial College London was not asked a single question about potential conflicts or risk of bias.

Again the Inquiry seemed unaware, or at least uninterested, that a month after Ferguson’s seismic March 2020 paper had concluded that “…epidemic suppression is the only viable strategy at the current time” and that “the major challenge of suppression is that this type of intensive intervention package – or something equivalently effective at reducing transmission – will need to be maintained until a vaccine becomes available…”, it was reported that Imperial College had received £22.5 million in funding from the UK Government for vaccine research and development; and that in that same year, 2020, Imperial received at least US$108 million in funding from the Bill and Melinda Gates Foundation.10

BMGF is a private philanthropic organisation which has been open about its ideological commitment to vaccine-based solutions for global health issues and which itself has very significant financial ties to the pharmaceutical industry.

…And With Prejudice

For witnesses such as Professor Carl Heneghan, Professor of Evidence-Based Medicine at Oxford University, but not a member of SAGE, and (unhelpfully for the Inquiry) not an enthusiastic supporter of lockdowns, the Inquiry appeared to have made somewhat less glowing presumptions:

“You are a professor of evidence-based medicine at Oxford University. Could you explain what that discipline entails?”. Heneghan’s explanation was swiftly followed with a presumptive conclusion as to the strength of his credentials:

“as you know, because I think you have been following the Inquiry, we have heard this week from a series of academics who have spent, in the main, their professional careers researching, analysing the spread of infectious diseases, developing models, to analyse how such diseases are spread and how they can be controlled, and considering large-scale public health issues relating to pandemic preparedness and so on.

You don’t have a comparable type of expertise in this area, do you?”.11

Not satisfied with having attempted his own disparagement of the man, counsel took the opportunity while having Heneghan in the witness box to ask for his perspective on two ‘home team’ scientists having described him in a private discussion as a “fuckwit” (Dame Angela McLean and Professor Edmunds) — to what ends, other than to rattle, rile or embarrass, was not clear.

It was the cheapest shot of the Inquiry so far.

During Heneghan’s evidence session, and having seemingly felt entirely comfortable to rely on the expert opinions of Farrar, Ferguson, Edmunds et al — the ‘good guy’ home team scientists —Baroness Hallett gives short shrift to the notion that Professor Heneghan’s opinion might be relied upon.

When talking about the broad scope of evidence-based medicine Heneghan explains that “even my opinion” amounts to evidence, Baroness Hallett retorted dismissively:

“Not in my world it doesn’t, I’m afraid”.12

The Inquiry is now hopelessly compromised by the seemingly presumptive words of its own Chair and leading lawyers and its failure to ask the right questions.

It is setting us up for a doom-loop of catastrophic errors we cannot afford to repeat.

It has become an embarrassment to the legal profession and is jeopardising the reputation of the English legal system.

Its exorbitant costs already cannot be justified, and there is only worse to come. It should be abandoned.

https://principia-scientific.com/covid-inquiry-an-embarrassment-to-the-english-legal-system/

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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Israeli Study: 0.62% of Healthcare Workers Jabbed with Pfizer’s mRNA Vax Show Biomarker for Myocarditis

A clinical trial (NCT05308680) in Israel was conducted by researchers at Shaare Zedek Medical Center to prospectively evaluate the incidence of myocardial injury after the administration of the fourth dose BNT162b2 mRNA vaccine (Pfizer-BioNTech) against COVID-19.

Led by principal investigator Dr. Tal Hasin, Director of the Heart Failure Unit in the Cardiology Department at Shaare Zedek Medical Center, and colleagues, the team sought to prospectively evaluate the incidence of myocardial injury after the administration of the fourth dose BNT162b2 mRNA vaccine (Pfizer-BioNTech) against COVID-19.

The findings of this study have been suppressed not discussed widely, although material. Why? 0.62% of adult healthcare workers evidenced biomarker signals for mild myocarditis. While this may not seem significant, it is. This represents an extraordinarily high percentage of cases, and importantly, the study did not focus on younger males, which are considered higher risk.

The principal investigators are very careful with their language but include subtle messaging to take very seriously. This includes the subtle insertion that the findings have “profound” implications for risk-benefit analyses concerning Pfizer’s mRNA vaccine.

Background

Registered in the American clinical trials registry, this study was based on population-based retrospective studies suggesting an association between BNT162b2 (Pfizer-BioNTech) vaccination against coronavirus disease 2019 (COVID-19) and myocarditis.

The study authors point out the lack of large-scale studies to evaluate the incidence of myocarditis after the administration of the third or fourth vaccine doses, but case reports of myocarditis in recipients of the third dose were described. Although considered to be low, the estimated risk of myocarditis and myocardial injury in vaccine recipients is believed to be underestimated.

The Study

The Israeli investigators estimate the overall incidence of myocarditis at 2.13 per 100,000 persons, the incidence of myocardial injury and subclinical myocarditis may be higher.

In the present study, the team involved adult healthcare workers who received the BNT162b2 (Pfizer-BioNTech) vaccine in two Israeli hospitals (SZMC and Shamir) during the fourth dose campaign; the study participants’ blood samples were taken for high-sensitivity cardiac troponin (hs-cTn) measurement at the time of vaccine administration and after 2-4 days.

Post-vaccine myocardial injury was defined as hs-cTn elevation above the 99th percentile upper reference limit and >50% increase from the first measurement.

Participants with evidence of myocardial injury underwent assessment for possible myocarditis, including electrocardiogram and echocardiography.

What did they find?

With results of this study recently reported in the European Journal of Heart Failure, Dr. Hasin and team reported that out of the study’s 324 participants, 192 (59.2%) were female, and the mean age was 51.8 ± 15.0 years.

Twenty-one (6.5%) participants had prior COVID-19 infection, the mean number of prior vaccine doses was 2.9 ± 0.4, and the median time from the last dose was 147 (142–157) days.

The study authors report, “Vaccine-related myocardial injury was demonstrated in two (0.62%) participants; one had mild symptoms, and one was asymptomatic; both had a normal electrocardiogram and echocardiography.”

In this prospective investigation, an increase in serum troponin levels was documented among 0.62% of healthy healthcare workers receiving the fourth dose BNT162b2 vaccine. The two cases had mild or no symptoms and no clinical sequela. Importantly, this represents a high overall percentage with implications for the hundreds of millions of persons vaccinated with the Pfizer vaccine.

For example, if these figures were extrapolated out to 100 million vaccinations, that would mean 617,284 cases involving an increase in serum troponin levels.

What do the study authors think of this output?

The authors do acknowledge a disturbing signal here, declaring: “Indeed, the current study suggests a higher incidence of myocardial injury during active monitoring for cardiac biomarkers in vaccine recipients with no clinical evidence of myocarditis. Since in our study, the average age was 51 and only 40% were male, with only 8 (2.47%) of them that were 30 years old or younger, it is currently unknown if a prospective evaluation among younger males will yield a higher incidence of myocardial injury.”

The study team further explains “Besides the pathophysiological implications, the clinical significance of the mild injury found in our study may be debated and should be further evaluated in larger studies.”

What’s the mechanism of action?

The mechanism of vaccine-induced myocarditis is unknown but may be related to the active component of the vaccine, the mRNA sequence that codes for the spike protein of SARS-CoV-2, or to an unregulated immune response that follows vaccination in certain individuals with a genetic predisposition.

The authors suggest that in some cases, acute myocardial injury may occur via a similar mechanism without material clinical myocarditis. They write, “Otherwise, a non-immune-mediated initial injury may trigger more significant immune-mediated myocarditis in susceptible individuals, but not in others.”

What are the recommendations given the findings?

Dr. Hasin and colleagues point out that given the potential magnitude of the findings (yet they downplay some more severe implications), they articulate, “A reasonable recommendation may be to withhold strenuous physical activity for a few months. Regarding the recommendation for repeat vaccine doses in the future, there is no consensus. However, given the limited clinical utility reported recently with the fourth dose against Omicron, repeat vaccination of individuals with documented post-vaccine myocardial injury deserves a profound risk–benefit consideration.”

Note, the use of the language—“profound” risk-benefit consideration moving forward!

https://www.trialsitenews.com/a/hidden-israeli-bombshell0.62-of-healthcare-workers-jabbed-with-pfizers-mrna-vax-show-biomarker-for-myocarditis-b7d9a5f4

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COVID Hospitalizations Continue to Drop, CDC Data Show

Hospitalizations for COVID-19 have continued to drop, coming after a relatively small increase in cases over the summer, according to data released by the U.S. Centers for Disease Control and Prevention (CDC).

Hospitalizations fell by 5 percent for the week ending Oct. 14, while emergency department visits also dropped by 11.9 percent, and reported case numbers decreased by 0.7 percent. Deaths rose by 4.2 percent, although officials say that deaths generally lag case and hospital numbers.

For the week ending on Oct. 7, hospitalizations were down by 8.2 percent, emergency visits fell 17.7 percent, and reported cases were down by 0.8 percent, while deaths fell 3.8 percent, the data show.

Amid the drop in hospitalizations over consecutive weeks, the CDC sent out a report earlier in October claiming the virus remains a "public health threat" for older Americans, arguing that it's a reason they should take the updated COVID-19 vaccine.

The Food and Drug Administration (FDA) and CDC both signed off last month on the updated shots made by Pfizer, Moderna, and Novavax.

Few Americans Taking Updated Shots

Around the same time, the CDC said officials are expecting a “moderate COVID-19 wave” for the winter months ahead and predicted this year's peak will match last winter’s hospitalization figures. The virus levels, however, could peak earlier this season because of "limited summer activity compared to past years,” the agency said in September.
“This increase could result from the emergence of a new COVID-19 variant with an increased ability to evade the body’s prior immunity, or from a severe influenza season combined with COVID-19 and RSV waves that are similar to last year, or, as we saw last year, an increase in RSV infections,” the CDC stated. “A key factor is the timing of the peak number of hospitalizations associated with each disease and whether those peaks coincide.”

About 3 percent of all Americans who are eligible have received the updated COVID-19 booster shot, nearly two months after it was rolled out, according to officials with the Department of Health and Human Services (HHS). Overall, about 10 million people have taken it, the data show, up from 7 million a week before.

“The administration remains committed to pulling every lever at its disposal during the fall respiratory vaccination campaign, encouraging the American public to stay up to date on their vaccines to keep themselves and their loved ones safe,” an HHS spokesperson told The Epoch Times earlier in October. “As a result of these efforts, around 10 million Americans have been vaccinated since the updated vaccines were authorized and recommended last month.”

The relatively lower pace of vaccinations prompted drug giant Pfizer to revise its revenue guidance for the year, warning that demand for COVID-19 products such as vaccines has plunged.

Pharma Profits Plunge

Pfizer, which has seen its stock drop by about 40 percent for 2023, slashed its outlook by about $9 billion due to the weakened demand, the company said on Oct. 13. It particularly expects sales of its mRNA vaccine to be about $2 billion lower than it previously anticipated.

As for Moderna, the company reiterated earlier this month that its COVID-19 vaccine sales will be between $6 billion and $8 billion. It’s still too early to predict the U.S. vaccination rate, Moderna said this month, coming as the company's stock plunged $7 billion in about a week and as its stock has dropped 83 percent since its peak in August 2021.

Some analysts said that the pharmaceutical companies should be worried about their vaccine sales.

“COVID-19 vaccine revenue concerns should be at an all-time high right now,” Hartaj Singh, an analyst at Oppenheimer, said in a recent Bloomberg report. “A good third-quarter print should allay some of these fears. And good guidance early next year on 2024 potential revenues could get the stock’s mojo back.”

It comes also as multiple U.S. hospitals in recent days have dropped their COVID-19 mask mandates after they reinstated the rule several weeks ago. A handful of hospitals across the United States reimplemented mandates over the summer, although some didn't make masks a requirement for patients or visitors, just staff such as nurses and doctors.

The largest hospital group in New Jersey, Hackensack Meridian Health, reinstated mask mandates last month. However, officials with the company have confirmed it has lifted its mandate for all its hospitals except for Bayshore Medical Center in Holmdel, Old Bridge Medical Center, and Southern Ocean Medical Center in Stafford, local media reported

https://www.theepochtimes.com/health/cdc-data-shows-covid-hospitalizations-continue-to-drop-5517385?ea_src=au-frontpage&ea_med=top-news-health-0-large-top-news-health-title-0

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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Why COVID sufferers in the US can’t get ensitrelvir, the antiviral drug better than Paxlovid

For people suffering through a bout of COVID-19, the antiviral Paxlovid has been a godsend. The medication emerged as the go-to antiviral treatment during the pandemic after the Food and Drug Administration granted it emergency-use authorization in December 2021.

Now, there’s a new antiviral that’s superior to Paxlovid — but Americans can’t get it, as it’s being held up in the lengthy FDA-approval process.

Ensitrelvir, marketed as Xocova in Japan — the only country where it’s legally available — has several advantages over Paxlovid.

However, experts lament that the newer, better drug probably won’t be available in the US until the end of 2024. The FDA seems to be “slow walking” the approval process for ensitrelvir, infectious disease specialist Dr. David Boulware, a professor medicine at the University of Minnesota, told the Atlantic.

And because the COVID-19 emergency was declared over in May of this year, ensitrelvir probably won’t be granted the same emergency-use authorization that Paxlovid received.

Nonetheless, the FDA has granted the new drug “fast-track” status, meaning its review process will be expedited once the drug’s manufacturer, Shionogi of Osaka, Japan, submits the required documentation.

People who take the drug test negative almost two days sooner than people who take a placebo. Symptoms like fever, congestion, sore throat, cough and fatigue disappear faster among some groups of people than with Paxlovid.

“Rebound” infections, in which symptoms recede and then seem to come back — common among Paxlovid users — have been rare among users of ensitrelvir. In addiction, the taste of ensitrelvir is unremarkable, according to anecdotal reports, whereas patients on Paxlovid have described the aftertaste as “a mouthful of dirty pennies and rotten soy milk.”

And ensitrelvir is easier to take, as it requires just once-a-day dosing, whereas Paxlovid users must take three pills twice daily for five days.

The two drugs have never been compared in head-to-head trials, however, so medical experts are reserving their enthusiasm for ensitrelvir until more data is available.

Loss of smell and taste

Despite this, a new study found that ensitrelvir effectively diminishes one of the most annoying and problematic effects of a COVID infection: loss of smell and taste.

After seven days, the percentage of study participants with smell or taste loss was 39% lower in a group taking ensitrelvir than in a placebo group.

“Most people will eventually recover on their own, but we know that some people have had long-term issues with smell and taste,” Dr. Yohei Doi, an infectious-disease researcher at Fujita Health University in Japan who worked on the ensitrelvir study, told Nature.

“When the omicron variants became dominant, the loss of taste and smell started to become less and less common,” Dr. Amesh Adalja, an infectious-disease specialist at the Johns Hopkins Center for Health Security, explained to Nature.

“But it still occurs, and it is a distressing symptom,” Adalja added. “What we’re trying to do is not just minimize severe disease, hospitalization and death, but also to minimize the disruption that an infection has on people’s activities.”

The drugmaker Shionogi is continuing to conduct clinical trials into the safety and effectiveness of ensitrelvir among different user groups.

https://nypost.com/2023/10/26/lifestyle/why-covid-sufferers-in-the-us-cant-get-ensitrelvir-the-antiviral-drug-better-than-paxlovid/

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Sore Arm After COVID-19 Vaccine Could Indicate Serious Complication: Doctor

Individuals who experience a sore arm after taking a COVID-19 shot may be at risk of facing cardiac issues, according to cardiologist Peter A. McCullough.

“I always ask patients if they had a sore arm or more severe reaction within the few days of the shot. It may be a harbinger of future cardiovascular serious adverse events, including myocarditis and sudden cardiac death,” Dr. McCullough said in an Oct. 27 Substack post. Myocarditis is an inflammation of a heart muscle called myocardium, which can reduce the heart’s ability to pump blood. Dr. McCullough cited a Sept. 19 study published in the Radiology journal, which states that 458 out of the 700 participants, or 65.4 percent, reported pain in the arm after COVID-19 vaccination.
“The myocardial visual score was higher in patients who reported a sore arm compared with those who did not,” the study said. The participants in the study were “competitive and recreational athletes” from Italy.

The cardiologist pointed to a July 20 study published by Taylor & Francis, which found this specific pain among the majority of participants who took COVID-19 vaccination.
Among the 460 participants in the study, 81.3 percent reported arm pain at the injection site after receiving the first dose of a COVID-19 shot. Following the second dose, 24.9 percent reported arm pain. “Male gender was more likely to present arm pain after the first and the second vaccinations,” it said.

“In our study population, arm pain was inversely associated with SARS-CoV-2 infection before vaccination.” Athletes who were previously infected with COVID-19 were found to be “less likely to present arm pain after the first-dose vaccination.”

CDC Advisers Consider Recommending Mpox Vaccines for Children
Play Video
A November 2022 study cited by Dr. McCullough looked at autopsy data from 25 individuals who had “died unexpectedly” within 20 days after COVID-19 vaccination.
Five individuals in the study received mRNA COVID-19 vaccines and died within a week of taking the shots. Four people died after the first injection, while the fifth died after the second dose.

In 80 percent of mRNA vaccine recipients, the study identified “acute (epi-)myocarditis without detection of another significant disease or health constellation that may have caused an unexpected death.”

The researchers discovered simultaneous vaccine-induced inflammation in the heart muscles and deltoid muscles crowning the shoulder. In the heart, the inflammation was found in the epicardium—the outermost protective layer of the organ located above the myocardium.

Dr. McCullough also highlighted a December 2022 report published at the National Library of Medicine, which brought attention to the issue of rising cardiac arrests among athletes.

During a two-year period “from January 2021 to the time of writing, 1,598 athletes suffered cardiac arrest, 1,101 of which with deadly outcome,” it said, citing a study.

This is a higher rate of death compared to a 38‐year timespan between 1966 and 2004 when “1,101 athletes under the age of 35 died (~29/years) due to various heart‐related conditions.”

Citing another study on 301 teenagers between the ages of 13 and 18 who received two doses of the Pfizer vaccine, the report said “29.24 percent of participants experienced cardiovascular complications such [as] tachycardia, palpitations, and 2.33 percent suffered myopericarditis.”

“It is noteworthy that no statistically significant increase in the incidence of myocarditis or pericarditis was observed in un‐vaccinated subjects after SARS‐CoV‐2 infection, in a large population study.”

On the basis of these studies, Dr. McCullough determined that a sore arm can be a “harbinger of future cardiovascular serious adverse events.”

The cardiologist said that he was “amazed at how many people have taken one or more of the COVID-19 vaccines are completely free of side effects.” He suggested that many of the vials of the vaccine may have had “little or no viable mRNA.”

A study from Germany published in the British Journal of Pharmacology journal this month found that both Pfizer and Moderna’s mRNA COVID-19 vaccines formed spike proteins in the human heart cells within 48 hours of injection. Both Pfizer and Moderna triggered different cell abnormalities.
Responding to the study, Dr. McCullough suggested that the different responses the cells had to the two mRNA vaccines could point to an mRNA toxicity reaction in these cells.

Despite studies suggesting the risk of medical complications, some experts continue to advise people to get COVID-19 jabs. According to John Hopkins Medicine, both Pfizer and Moderna are “highly effective in preventing serious disease, hospitalization, and death from COVID-19.”

It recommended people to get a COVID-19 shot as “we believe that their benefits outweigh their risks.”

However, Dr. McCullough advises people to avoid it. He wrote in an Oct. 29 Substack post: “I am not recommending COVID-19 XBB.1.5 boosters, influenza, or respiratory syncytial virus vaccines for healthy adults or children. None of these vaccines are compelling and conditions are easily treatable.”

https://www.theepochtimes.com/health/sore-arm-post-covid-19-vaccine-could-indicate-serious-complication-dr-mccullough-5518720?ea_src=au-frontpage&ea_med=us-news-left-1

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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Another Friday Hiatus

Both medical and social matters again

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.

https://www.dailymail.co.uk/health/article-12672117/Children-Covid-shot-infectious-time-non-vaccinated-study-finds.html

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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.

https://www.trialsitenews.com/a/like-pfizer-the-covid-train-may-have-run-out-of-track-for-moderna-ca6beda7

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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.”

https://www.theepochtimes.com/world/australian-state-to-host-vaccine-summit-to-combat-conspiracy-theories-5509485

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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Hiatus

Big medical day today so no time for blogging. Should be back tomorrow

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.

https://www.theepochtimes.com/article/professor-exonerated-after-being-alleged-of-unethical-practices-in-famous-covid-vaccine-study-5515403?ea_src=au-frontpage&ea_med=us-news-left-0

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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/

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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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.”

https://www.trialsitenews.com/a/yet-another-validation-of-dna-contaminants-in-covid-19-mrna-vaccines-deae0432

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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

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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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.

https://www.theepochtimes.com/opinion/the-decline-and-near-fall-of-the-covid-vaccine-makers-5513280?ea_src=au-frontpage&ea_med=opinion-6

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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

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH)

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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