Covid-19 News

Scotland COVID cases are now rising sharply - while England cases are more or less flat.

What is the difference? FM1 please note Scottish weather is similar to English, on average quite a bit wetter.

The difference is Scottish schools went back last week. COVID in the UK is a disease of the young, since they are pretty well the only ones unvaccinated. (We don't allow < 16 years, and only 1 week ago allowed 16-17).

THH

PS - some here will no doubt look at that graph and be sure that the sudden rise is fueled by a lack of ivermectin - it proves beyond doubt that Scotland was successfully using ivermectin prophylaxis over the Summer but has now, due to evil machinations of pharma companies who gain money from COVID, stopped using it.

Take that one up with Nichola Sturgeon - not me!

Delta Variant May Acquire Total Vaccine Resistance

Delta Variant May Acquire Total Vaccine Resistance

A new preprint study out of Japan titled “The SARS-CoV-2 Delta variant is poised to acquire complete resistance to wild-type spike vaccines” was

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A new preprint study out of Japan titled “The SARS-CoV-2 Delta variant is poised to acquire complete resistance to wild-type spike vaccines” was published online on August 23. The first listed author is Yafei Liu, who works at the Department of Immunochemistry, Research Institute for Microbial Diseases, Osaka University and the Laboratory of Immunochemistry, World Premier International Immunology Frontier Research Centre Osaka. According to this paper, while our mRNA vaccines are effective against the most common SARS-CoV-2 variants, “identifying likely breakthrough variants is critical for future vaccine development.” The researchers found that the Delta variant escaped from anti-N-terminal domain (NTD) neutralizing antibodies and increased responsiveness related to anti-NTD infectivity-enhancing antibodies. Although, the Pfizer-BioNTech product BCT162b2 neutralized the Delta variant, “when four common mutations were introduced into the receptor-binding domain (RBD) of the Delta variant (Delta 4+), some BNT162b2-immune sera lost neutralizing activity and enhanced the infectivity.” Mutations in the Delta NTD were related to enhanced infectivity by the BNT162b2-immune sera.

RBD and ACE2

SARS-CoV-2 variants have had many mutations throughout their genomes, and they are highly infectious compared to the original strain. The current mRNA vaccines are based on the original spike protein without mutations, but they have been effective against variants of concern (VOC). The spike protein’s receptor-binding domain (RBD) attaches to the host cell ACE2 receptor, and this interaction “mediates membrane fusion during” infection. The body’s neutralizing antibodies related to SARS-CoV-2 are mostly directed to the RBD and thereby stop the interaction between RBD and ACE2. Most VOC’s have developed mutations of the neutralizing antibody epitopes of the RBD, leading to escape from neutralizing antibodies. Sine mutations in the RBD tend to affect binding to ACE2, “there is a tradeoff in the evolution of the RBD between mutations that maintain ACE2 binding while escaping the recognition by neutralizing antibodies.” It is important to figure out if variants that are completely resistant to the mRNA vaccines are to emerge.

Mutations in Delta Variant

In their Discussion section, the authors note that Delta is highly infectious and that breakthrough infection in vaccinated folks is common, likely meaning that the neutralizing antibodies in the vaccinated are not adequate to protect against Delta. While anti-RBD likely play a large role in avoiding infection with the virus, Delta’s L452R and T478K mutations in the RBD, and the former has been shown to be an epitope for neutralizing antibodies. And mutation in the RBD may not explain the lessened neutralizing titers of BNT162b2-immune sera against Delta. Also, Delta has mutations T19R, G142D, E156G, F157del, and R158del in the NTD. In the study, anti-NTD antibodies failed to recognize the spike in the Delta variant, suggesting that this variant is totally resistant to anti-NTD neutralizing antibodies elicited by the wild-type spike protein. This is the antigenic part of the widely used mRNA vaccines. On the other hand, most anti-NTD related antibodies did recognize the Delta spike at the same level as the “wild-type spike.” And some of these antibodies showed infectivity enhancement by a Delta pseudovirus when compared to the wild-type pseudovirus.

Delta 4+ Pseudovirus

Given that Delta kept its enhancing antibody epitopes and is hyper-sensitive to enhancing antibodies, it is probably that enhancing antibodies are implicated in augmentation of SARS-CoV-2 infectivity in vivo. BNT162b2 immune sera demonstrated neutralizing activity against Delta 4+ pseudovirus at a dilution of 1:10, yet increased infectivity was shown at 1:30 dilution. Usually, antibody behavior does not change so much with this three-fold concentration difference. So, the action of BNT162b2 immune sera towards Delta 4+ pseudovirus is not explained by the concentration of neutralizing antibodies. And the sera showed no enhanced infectivity re Delta 4+ pseudovirus, “with wild-type NTD at any serum concentration.” Given that the effects of anti-NTD infectivity-enhancing monoclonal antibodies are impacted by the anti-RBD neutralizing antibody concentration, “the effect of infectivity-enhancing antibodies in BNT162b2 immune sera is likely to be more pronounced when the concentration of anti-RBD neutralizing antibodies falls below a certain threshold.”

Delta 4+ Infectivity Enhanced

Some mouse sera did show enhancement of the Delta 4+ pseudovirus infection, and others demonstrated neutralization regardless of serum concentration. There is a delicate balance among antibody titer, affinity, or epitope between neutralizing and enhancing antibodies that can affect infectivity. It is vital to study further the profile of neutralizing and enhancing antibodies made after an immunization. Since the virus has acquired several mutations to date, “new variants are likely to emerge more frequently in situations where many people are infected. Due to the explosive spread of Delta, it has already gained numerous further mutations in the spike protein-coding area. This suggests that Delta will keep mutating. Next, some of the mutations seen in the RBD of Delta have also been reported to be epitopes regarding anti-RBD neutralizing antibodies. And any new variants which adapt to one’s immune system will be selected and grow or expand. Notably, “The Delta variant with 4 additional mutations in the RBD were not neutralized by most BNT162b2-immune sera because of unique mutations in the NTD.” Even more important, Delta 4+’s infectivity was enhanced by some of the BNT162b2 immune sera under study.

Mutations Need to be Considered in Vaccine Development

In light of the currently high mutation rate of SARS-CoV-2, it is important to predict emerging spike mutations to develop vaccines against emerging variants. Even though a third round of boosting immunization is headed our way, the data “suggest that repeated immunization with the wild-type spike may not be effective in controlling the newly emerging Delta variants.” The researchers showed that “immunization by Delta spike induces antibodies that neutralize not only the Delta variant but also wild-type and the Delta 4+ variant without enhancing the infectivity.” While mRNA vaccination might produce a different result from our animal model, it should be the case that “development of mRNA vaccine expressing the Delta spike might be effective for controlling the emerging Delta variant.” Yet, epitopes of enhancing antibodies, versus neutralizing antibodies, are conserved in most variants, including Delta. So, further immunization of variant spike protein may help to enhance antibodies more than neutralizing antibodies in folks previously infected with a wild virus or immunized with wild-type spike protein vaccines. One possible strategy for vaccination would be to use RBD alone, avoiding the induction of anti-NTD antibodies. Yet RBD immunization alone does not induce neutralizing antibodies. The authors conclude that “Whole spike protein containing RBD mutations observed in major variants but lacking the enhancing antibody epitopes may need to be considered as a booster vaccine.”

https://www.biorxiv.org/content/10.1101/2021.08.22.457114v1.full.pdf

Number of new COVID cases ‘seems to be plateauing’ around the world, WHO says

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After nearly a two month-battle against the fast-spreading delta variant, the number of new COVID cases reported around the globe “seem to be plateauing,” according to the World Health Organization.

The global health agency on Monday reported more than 4.5 million new cases and 68,000 new deaths in the week ending Aug. 22 , bringing the the global cumulative total to more than 211 million people infected, including more than 4.4 million who have died. The weekly caseload marked only a slight increase from the more than 4.4 million cases and 66,000 deaths reported the prior week, according to the WHO’s weekly epidemiological update.

Health experts said the figures are a sign the number of new cases appear to be stable for the first time since May. In weeks leading into June however, outbreaks fueled by the highly-contagious delta variant contributed to case surges around the globe

Just last week, the United States reported more than 1,020,072 new infections, a 15% increase from the week prior and the most cases ever recorded in a seven-day window. Iran, India, the United Kingdom and Brazil also reported significant spikes.

And while the Pacific Region and the Americas saw its largest increase in cases last week — at 20% and 8% respectively — Southeast Asia and Eastern Mediterranean reported a decline in infections, while the other regions saw cases remain stagnant, according to WHO.

WHO, in its weekly report, also noted that variants including the delta mutation, remain a top concern for health officials. They urged local leaders to carefully consider lifting restrictions and to push harder for vaccination.

Relaxation of public health and social measures should therefore be carefully and cautiously balanced against levels of vaccination coverage, and the circulation of Variants of Concern,” WHO said.

This is the way it is. I think what people who disagree with these conclusions might do is look at GRADE approach used here and see whether it is wrongly applied - with specific examples.

Abstract

Background and purpose The objective of this systematic review is to summarize the effects of ivermectin for the prevention and treatment of patients with COVID-19 and to assess inconsistencies in results from individual studies with focus on risk of bias due to methodological limitations.

Evidence review We searched the L.OVE platform through July 6, 2021 and included randomized trials (RCTs) comparing ivermectin to standard or other active treatments. We conducted random-effects pairwise meta-analysis, assessed the certainty of evidence using the GRADE approach and performed sensitivity analysis excluding trials with risk of bias.

Results We included 29 RCTs which enrolled 5592 cases. Overall, the certainty of the evidence was very low to low. Compared to standard of care, ivermectin may reduce mortality, may increase symptom resolution or improvement, may increase viral clearance, may reduce infections in exposed individuals and may decrease hospitalizations (Risk difference (RD) 21 fewer per 1000, 95%CI: 35 fewer to 4 more). However, after excluding trials classified as “high risk” or “some concerns” in the risk of bias assessment, most estimates of effect changed substantially: Compared to standard of care, low certainty evidence suggests that ivermectin may not significantly reduce mortality (RD 7 fewer per 1000, 95%CI: 77 fewer to 108 more) nor mechanical ventilation (RD 6 more per 1000, 95%CI: 43 fewer to 86 more), and moderate certainty evidence shows that it probably does not significantly increase symptom resolution or improvement (RD 14 more per 1000, 95%CI: 29 fewer to 71 more) nor viral clearance (RD 12 fewer per 1000, 95%CI: 84 fewer to 76 more). It is uncertain if ivermectin increases or decreases severe adverse events and symptomatic infections in exposed individuals.

Conclusions and Relevance Ivermectin may not improve clinically important outcomes in patients with COVID-19 and its effects as a prophylactic intervention in exposed individuals are uncertain. Previous reports concluding significant benefits associated with ivermectin are based on potentially biased results reported by studies with substantial methodological limitations. Further research is needed.

Multiple systematic reviews have assessed the benefits and harm of ivermectin for COVID-19
patients with inconsistent findings and conclusions.[7] Although some organizations and groups
have argued strongly in favor of implementing ivermectin for treatment and/or prevention of
COVID-19,[8] current key clinical practice guidelines recommend against its use outside the
context of clinical trials.[9-12]

Reasons for these major discrepancies are probably related to different evidence analytical and/or
interpretation approaches. Assessing the risk of bias is one of the pillars of any systematic review
and has proven to be essential for evidence interpretation in the present pandemic context where

results of studies with major methodological limitations have led to erroneous conclusions, waste
of resources and patients’ exposure to potentially harmful interventions.[3,13,14] Nevertheless,
most available systematic reviews on ivermectin for COVID-19 have not appropriately assessed
risk of bias as a potential explanation for inconsistency between trial results. Therefore, this
systematic review aims to summarize the best available evidence on ivermectin for prevention
and treatment of COVID-19 patients and explore potential explanations for heterogeneity in
RCTs results with focus on studies methodological limitations.

This systematic review and meta-analysis provide a comprehensive overview of the available
evidence on ivermectin for prevention and treatment of COVID-19. Overall, the body of
evidence suggests that ivermectin may reduce mortality, may increase symptom resolution or
improvement, may decrease hospitalizations, may increase viral clearance, and may decrease
symptomatic infection in exposed individuals. However most trials have serious methodological
limitations including lack of allocation concealment and lack of blinding, and reported results
varied significantly from striking benefits to null effects. GRADE assessment resulted in low or
very low certainty of the evidence for all the outcomes, due to risk of bias, inconsistency, and
imprecision. Visual inspection of funnel plot constructed for mortality outcome suggest possible
publication bias which rises additional concerns about the certainty of the evidence on
ivermectin’s effects.

After excluding trials with significant methodological limitations inconsistency disappeared and
results changed substantially. We found low certainty, due to imprecision, that ivermectin may
not significantly reduce mortality, nor reduce invasive mechanical ventilation, and moderate
certainty evidence that ivermectin probably does not significantly increase viral clearance or
symptom resolution or improvement. Regarding hospitalizations, results did not change
significantly suggesting that ivermectin may modestly reduce hospitalizations. However,
certainty of the evidence remained low due to very serious imprecision. It is uncertain if
Ivermectin reduces or increases symptomatic infections in exposed individuals or increases
severe adverse events as no trials classified as “low risk of bias” were identified, or the certainty
of the evidence was very low.
Our systematic review has several strengths. The search strategy was comprehensive with
explicit eligibility criteria, and no restrictions on language or publication status. We used a
validated tool for risk of bias assessment and performed a thorough assessment providing details
of trial limitations and potential significant imbalances in baseline participant characteristics. We
assessed the certainty of the evidence using the GRADE approach and interpreted the results
considering absolute rather than relative effects.
Reporting was poor for a significant number of included trials. For risk of bias assessment, we
adopted a conservative approach and rated as low risk of bias only those trials for which it was
clearly reported that no significant methodological limitations existed. Hence, we may have
inappropriately classified some well executed trials as “some concerns” or “high risk of bias”

due to their suboptimal reporting methods. Although for some trials we intended to contact the
authors for clarification, most did not answer.
Multiple systematic reviews assessed ivermectin for COVID-19.[7] Most of these reviews were
already outdated at the time of writing this manuscript.[55] Only four reviews included a
substantial proportion of the studies assessed in our review.[56-59] In agreement with our
findings, all these reviews concluded that most of the studies assessing ivermectin for COVID-19
have considerable methodological limitations, and two judged the certainty of the evidence as
low to very low for all outcomes[56] or not robust enough to justify ivermectin’s use.[57] The
authors of one systematic review concluded that ivermectin “may have a role in decreasing
mortality in mildly/moderately ill COVID-19 patients” although they graded the certainty on
ivermectin’s effect on mortality as very low.[58] Bryant el at. graded the certainty of the
evidence as low or very low for all outcomes except mortality for which they report moderate
certainty in important mortality reduction. In contrast to our analysis, they reached this
conclusion by not downgrading the certainty of the evidence for inconsistency even though they
reported there was significant, not fully explained, heterogeneity in studies’ results. In addition,
for mortality outcome, they report a sensitivity analysis excluding high risk of bias studies
which, in contrast to our findings, did not result in different estimates of effect from the primary
analysis. This can be explained by the fact that the authors did not exclude a significant number
of studies with important methodological limitations, that they classified as “unclear” risk of
bias.[24]

Virologist Geert Vanden Bossche Responds to Attacks From Dr. David Gorski

Virologist Geert Vanden Bossche Responds to Attacks From Dr. David Gorski

Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite. My name is Geert Vanden Bossche.

trialsitenews.com

Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite.

My name is Geert Vanden Bossche. I received my PhD in Virology at the University of Hohenheim, Germany, and I have held adjunct faculty appointments at universities in Germany and Belgium. I also have worked in R&D and vaccine development for GSK, Novartis, and Solvay Biologicals. Next I was a Senior Program Officer for the Gates Foundation’s Global Health Discovery team, and from there went to the Global Alliance for Vaccines and Immunizations (GAVI) and was the Senior Ebola Program Manager. Then I joined the German Center for Infection Research as head of the Vaccine Development Office. Currently, I work as a consultant on biotech/vaccine issues, and I also does his own research on “natural killer” cell-based vaccines. I have argued that immune escape due to the current COVID-19 vaccines is driving new variants as the virus evolves its way around the inoculation. Dr. David Gorski is a Wayne State University of Medicine (Detroit) associate professor in oncology and surgery. He is also chief of the breast surgery division. Gorski has launched several “hit pieces” about me and my views. In one article, he attacks the notion that vaccines have a part in driving variants. He also has criticized YouTuber/intellectual Brett Weinstein for supporting the use of ivermectin in our pandemic.

Lack of Expertise

In my view, Gorski is both stigmatizing honest scientists and seemingly trying to create socially-dangerous tensions between the vaxed and the unvaxed and between medical experts who hold different views on our current vaccines. Gorski creates false dichotomies wherein one is good (pro-vaccine, put faith in government) or bad (anti-vaccine, open to alternate views and arguments), and this type of discourse and rhetoric is incompatible with science.

Gorski is also largely scientifically illiterate in the fields of virology, immunology, vaccines, and evolutionary biology. He cannot see that both the vaccinated and the unvaccinated are involved in the evolutionary dynamics of the pandemic; his effort to blame the latter category is unfair and potentially dangerous. Dr. Gorski is quick to mix up unrelated topics to create parallels that don’t make sense. He unscientifically conflates or compares data about: live vaccines and inactivated vaccines; epidemics and pandemics; measles and SARS-CoV-2; herd immunity and vaccine coverage rates; efficacy with effectiveness in vaccines; and sterilizing immunity with transmission-reducing immunity.

He also unfairly lumps me in with anti-vaxxers when I am pro (beneficial) vaccines. Much of this is likely based on the fact that Gorski’s expertise is largely lacking. His professional expertise in breast surgery seemingly does not allow him to opine intelligently about the topics at hand. And he regularly gets tangled up in his own misunderstandings and contradicts himself. Also, he sets himself up as a maximal “pro-vaxer” despite the noted lack of expertise in the various disciplines that apply to vaccination during a pandemic.

Innate Immunity

Gorski possesses no understanding of the workings of innate immunity, i.e., innate oligospecific antibodies or natural killer cells. He does not know the difference between innate (i.e.,, polyreactive), and naturally-acquired (i.e., antigen-specific) antibodies. This is clearly reflected by Gorski’s list of ‘factors proposed to explain the difference in the severity of COVID-19 in children and adults’. None of these factors could explain why not only children, but any young and healthy individual, could become susceptible to Covid-19 disease only a few months after they got asymptomatically infected. This can only be explained as a result of suppression of protective, innate antibodies by spike-specific antibodies (including vaccinal antibodies) as the latter outcompete innate antibodies for binding to SARSs-CoV-2. Gorski’s list, therefore, is completely irrelevant in regard to the overarching mechanism of natural immune protection against Covid-19.

He doesn’t have the wherewithal to understand the difference between naturally acquired immunity’s sterilizing cell-mediated immunity (CMI) and the S-based vaccines’ lack of CMI. He fails to see that there is currently no evidence of population-level immune selection pressure on CMI-mediated, sterilizing immunity induced in previously symptomatically infected persons. He doesn’t seem to realize that only a minor fraction of the population acquires protective immunity against COVID-19, whereas the vast majority are naturally protected by their first line of innate immune defense (a notion, he obviously didn’t even hear about).

Gorski specifically claims that younger people are now getting infected more because, “the variant is so much more transmissible and, therefore, the higher the percentage of the population that needs to be immune.” He doesn’t even seem to realize that these younger (<65 years) and healthy people (i.e., the majority of the population) proved to be immune during the previous waves. So why would they all of a sudden lose their immunity a few months later? Further hurting his credibility, Gorski refers to ivermectin as an “anti-worm” drug and wildly misrepresents the evidence so far showing that it can help with COVID-19. Again pushing the false either/or paradigm, he puts ivermectin in the “bad” category without any nuances.

Contradictio in Terminis

The doctor seems to miss the fact that, “spreading” SARS-CoV-2 relates to infection or pathogens, not to the disease they may potentially cause. Gorski seems to forget that despite the fact that all knew that the efficacy of these vaccines was not 100%, the primary goal of these mass vaccination campaigns was to generate herd immunity. Now, maybe GorkiGorski doesn’t really understand what herd immunity is about, but it suffices to remind him that it relates to the observation that unimmunized people can be protected provided the vaccine coverage rate in the population is high enough to prevent viral transmission. Gorski is trying to make people believe that herd immunity would imply vaccination of the total population, which is almost a contradictio in terminis.

By going to ridiculous extremes to make his case, Gorski is basically just making himself ridiculous. He also lumps me in with folks claiming that stray spike proteins from the vaccinated are causing major harm, when I have never taken that view. He thinks that because a virus has a somewhat higher infectiousness, it will in no time dominate all other circulating variants, no matter the pressure that is exerted by the human population. All of the more infectious variants were isolated before end 2020. So why is it that only quite recently have the more competitive ones started to spread widely? For somebody who obviously has big holes in his knowledge of virology and basic immunology, it can, indeed, be difficult to understand that viral spread in a population is determined by the interplay between viral infectious pressure and population-level immune pressure. The most blatant example of this is where he contradicts himself in saying: ‘Vaccines is a selective pressure’. Per definition, though, selective pressure is known to drive immune escape. And thus, according to Gorski, ‘vaccinating as many people as possible as fast as possible’ is the way to go!

“Quo vadis, homo sapiens?”

It is simply impossible to achieve herd immunity with these vaccines for reasons I clearly explained in my contribution titled, “Quo vadis, homo sapiens?” No matter the level of uptake of these vaccines, they’ll never produce any kind of herd immunity, as they’re merely turning young and healthy people (who’re naturally capable of eliminating the virus) into asymptomatic spreaders. Secondarily, herd immunity has nothing to do with immune selection pressure. On the contrary: neither innate antibodies nor immunity induced by recovery from disease (i.e., the only 2 types of immunity that contribute to herd immunity) are spike (S)-directed, so they do not exert selection pressure on viral infectiousness (i.e., determined by S), in contrast to the immune response induced by vaccination. Gorski is among the many stubborn know-it-alls who pretend that further increasing vaccine coverage rates will stop the virus from spreading and further evolving. All this without any single scientific argument backing his statement. Substantial outbreaks are still taking place in countries with high vaccine coverage rates, clearly demonstrating that vaccine-induced herd immunity is a myth.

Gorski is also completely missing the point on the lambda variant. He stares at different variants in regard to their sensitivity to vaccine-induced neutralization whereas the key message of the publication I alluded to was that i) increased viral infectiousness is insufficient to ensure sustained viral transmission in a massively vaccinated human population (i.e., a population that exerts widespread spike-directed immune pressure on viral infectiousness and ii) that additional mutations in the N-terminal domain (NTD) of the spike protein may substantially contribute to the decreased neutralizing capacity of vaccine-induced antibodies against any given variant (as mutations in the RBD alone may not explain the decreased neutralizing titers). In other words, variants may incorporate additional mutations in the NTD to dramatically increase their resistance to vaccine-induced anti-S antibodies. This mechanism of escape neutralization is of course very problematic if it occurs in a variant that has already a high level of infectiousness (e.g., delta variant) as this may lead to a steep increase in morbidity and mortality rates in the population. Gorski’s conclusion that ‘there is plenty of reason to conclude that the vaccines offer considerable protection against at least severe disease from these variants’ is, therefore, anything but based on an understanding of the virus’ evolutionary adaptation to enhanced, widespread immune pressure on viral infectivity. As a matter of fact, a such dramatic combination of high infectiousness and complete resistance to wild-type spike vaccines has recently been reported https://www.biorxiv.org/conten…1.08.22.457114v1.full.pdf. We’re curious to learn about Gorski’s predictions on how much protection the vaccines are going to provide against high infectious variants that are completely resistant against the vaccines…

Vaccine efficacy versus vaccine effectiveness

Regardless of the fact that Gorski does not understand the difference between vaccine efficacy and vaccine effectiveness, he doesn’t even realize that the main issue is not whether or not the vaccine protects 100% or less; the real issue is that imperfect vaccines will enhance the propagation of naturally selected immune escape variants, especially if high infectious pressure is combined with widespread immune pressure (due to mass vaccination).

Lies

If Gorski is unable to make his point otherwise, he’ll rely on lies:

GeertVandenBossche

Geert Vanden Bossche received his DVM from the University of Ghent, Belgium, and his PhD degree in Virology from the University of Hohenheim, Germany. He held adjunct faculty appointments at universities in Belgium and Germany. After his career in Academia, Geert joined several vaccine companies (GSK Biologicals, Novartis Vaccines, Solvay Biologicals) to serve various roles in vaccine R&D as well as in late vaccine development. Geert then moved on to join the Bill & Melinda Gates Foundation’s Global Health Discovery team in Seattle (USA) as Senior Program Officer; he then worked with the Global Alliance for Vaccines and Immunization (GAVI) in Geneva as Senior Ebola Program Manager. At GAVI he tracked efforts to develop an Ebola vaccine. He also represented GAVI in fora with other partners, including WHO, to review progress on the fight against Ebola and to build plans for global pandemic preparedness. Back in 2015, Geert scrutinized and questioned the safety of the Ebola vaccine that was used in ring vaccination trials conducted by WHO in Guinea. His critical scientific analysis and report on the data published by WHO in the Lancet in 2015 was sent to all international health and regulatory authorities involved in the Ebola vaccination program. After working for GAVI, Geert joined the German Center for Infection Research in Cologne as Head of the Vaccine Development Office. He is at present primarily serving as a Biotech/ Vaccine consultant while also conducting his own research on Natural Killer cell-based vaccines.

Quote from Fm1

Has the Delta variant impacted the use of ivermectin?

Yes. TrialSite reported that the FLCCC updated its protocol as the Delta variant has a much stronger viral load. If variants get stronger, it could be that the purported effect of this generic drug could diminish further.

Viral load is only a problem for long time indoor exposed people. Uttar Pradesh now is 6 weeks below 50 cases and 2 weeks below 30 cases all with Delta and Ivermectin. Vaccination is very low.

For early treatment I see no need to change the dose but I would mandatory add the bromhexin a gargeling V-D, Zinc.

Quote from Fm1

Do ivermectin & other potential early care treatments compete with vaccines?

This statement is nonsense. In Bulgaria - with Ivermectin -nobody wants the vaccine anymore! What for some old people could be the wrong decision.

Quote from THHuxleynew

W - you are welcome to post corrections to anything I post.

I usually do not correct your nonsense. You have to live with it.

Quote from THHuxleynew

(what is long COVID?) is much scarier since we know it exists,

Here we have many people with long Vaxx! Same symptoms but no known treatment. For long Covid we have I-Recover. https://covid19criticalcare.co…ocols/i-recover-protocol/

Quote from Fm1

Then I joined the German Center for Infection Research as head of the Vaccine Development Office. Currently, I work as a consultant on biotech/vaccine issues, and I also does his own research on “natural killer” cell-based vaccines. I have argued that immune escape due to the current COVID-19 vaccines is driving new variants as the virus evolves its way around the inoculation. Dr. David Gorski is a Wayne State University of Medicine (Detroit) associate professor in oncology and surgery. He is also chief of the breast surgery division. Gorski has launched several “hit pieces” about me and my views.

This is reality. Some doctors believe they are allowed to discuss with people that have real background. So basically an idiot sponsored by the FM/R/XXX/B mafia is wiping off his ass on the neck.

Here we see the same. We have a doctor (Cory) that daily successfully treats some hundred CoV-19 sick people with Ivermectin and some idiots here believe that's not real. It can't work....

The world weird....

Speaking of Scotland

A case in favor of Ivermectin

A case in favor of Ivermectin | Laurinburg Exchange

If there were an exceedingly safe and effective treatment for COVID that would dramatically reduce deaths, hospitalizations and transmission, we would be…

www.laurinburgexchange.com

If there were an exceedingly safe and effective treatment for COVID that would dramatically reduce deaths, hospitalizations and transmission, we would be insane not to use it. There is such a medication: ivermectin. It must be immediately deployed to prevent and treat COVID-19. Naturally derived from soil flora, it boasts a 40-year safety record of 4 billion doses in humans, and widely available and inexpensive. But, insanity prevails.

Privileged to practice medicine in this community for over 30 years, I am also honored to serve as the chairman of the Quality Committee of our Scotland Health Care System and as the physician on the Scotland County Board of Health. Advocating for ivermectin is the single most important thing I have ever done to try save lives. Many of my colleagues agree with me, but, I am writing my own professional opinion after months of intense study.

Both Moderna injections went in my deltoid as soon as possible in the first wave – health care workers. At 67 years old and working in a hospital, vaccination was an easy decision. Older people and those with compromising conditions should absolutely be vaccinated. But, the current vaccines are less effective against the variants, and are not as safe as we hoped. For the young and healthy a more cautious approach to the vaccines is totally reasonable.

Ivermectin’s effectiveness first became known to me in December 2020, when Dr. Pierre Kory testified before the US Senate. (YouTube finally gave up blocking video of his testimony.) The data-driven case for it becomes stronger by the day. There is now a mountain of clinical studies showing ivermectin yields dramatic reductions in COVID deaths, cases, disease severity, hospitalizations, and transmission. There is no evidence of harm. Several expert peer-reviewed meta-analyses by impartial researchers conclude that death from COVID can be reduced by as much as 80% with Ivermectin. The most compelling data is epidemiological, graphically revealing dramatic decreases in cases and deaths seen in areas all over the world as soon as it was widely distributed to their people. Mexico, India, and Peru are examples. Because of its safety and effectiveness, more placebo-controlled randomized trials are simply unethical.

I presented earlier data several months ago to my local colleagues through a Zoom meeting. Some of them began prescribing ivermectin. I felt morally and professionally compelled to spread the word as widely as I could, so I contacted influential doctor-leaders in the Atrium/Wake Forest University system, with which independent Scotland Memorial is affiliated. That was futile. There is irrational resistance to any deviation from the official cookbook handed down by the commissars on high. The basic recipe which is widely used is outdated, and biased toward expensive medications that are marginally effective and toxic.

In frustration, I now turn to the public, my patients, my friends, through my local newspaper. I appreciate the courage of The Laurinburg Exchange and its editor to allow me to speak. (Facebook has censored me.)

On this topic, like many these days, information and debate – free speech – is not allowed. Open scientific discussion, especially of ivermectin, and other potentially helpful, inexpensive and safe treatments, has been blocked by the social media oligarchs. The ruling elite, big pharma, and big media are on board with this Orwellian and deadly censorship.

The FDA and WHO also say “no” to ivermectin for Covid. (The NIH actually revised their stance to neutral – the same as for the monoclonal antibody products such as Regeneron.) Why? Follow the money. These agencies are corrupted by their funding and their intimacy with “big Pharma.” Companies manufacturing these novel vaccines are immune from legal liability for any harm they may cause, and are guaranteed payment for them. Remdesivir (not effective and toxic) and the antibody infusions (they help if given very early) are expensive, patented products which are pushed for profit. Further, the vaccines are only approved under an “emergency use authorization,” which means that if there is a safe and effective treatment alternative, their conditional approval is in jeopardy.

The Merck Company, which has an expensive unproven antiviral in the pipeline, is out with negative statement, without any supporting data, about ivermectin for COVID — a medicine for which they used to hold the patent. Soon after their statement, Merck received over 250 million government dollars to support their work. Microbiologist and ivermectin co-Nobel Prize holder Satoshi Omura, who actually discovered this naturally-derived medicine in the Japanese soil and brought it to Merck, said that “special approval for ivermectin to treat Covid-19 should be given”.

Ivermectin is so safe, well-tolerated, and effective that virtually everyone infected or exposed to this virus, and every hospitalized patient, would benefit greatly from taking it. And it is effective against all of the variants. Earlier treatment is better, but it works late, and even for “long COVID.” Giving it to household members of Covid infected patients, and prophylactic dosing to health care workers is effective as well. Preventative dosing is a reasonable alternative for the vaccine hesitant, even while they wait to decide about the vaccine.

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I have prescribed ivermectin widely for prevention and treatment to hundreds of people nationwide, including some of my orthopedic patients, and for my friends and family. I have colleagues prescribing it for me and my immediate family. Many have been taking it regularly for months. Even though vaccinated, I can still contract COVID, and though it is unlikely I would become very ill, I take it myself when I think I may have been exposed. No family member of mine will face this disease without a liberal dosing of ivermectin.

Do your own research. The best resouces are http://www.flccc.net, and the BIRD group. Then ask for it. It is likely that if you do, the prescriber will feel “off the hook”. Most of us will not deny a reasonable request for a safe medication. Ivermectin is approved by the FDA for use in humans for parasites (worms, scabies), just as yet not officially for COVID. That means it is prescribed “off-label”, as are 20% of prescriptions in the US. Around the

world a growing number of governments have enthusiastically approved it, and their state health agencies have incorporated into inpatient and outpatient treatment. Many have distributed it in kits to their population. Those who have embraced ivermectin largely do not have the moneyed opposition, the big pharma factories, and many cannot afford the vaccines or cannot get them because the affluent countries are hording them. I support the vaccines for the vulnerable. With ivermectin used widely, vaccine deployment could be more strategic and equitable, worldwide.

Most of these types of appeals end with, “we are not giving medical advice.” Well, I am. I am a physician. I have studied this extensively. It is my professional and moral duty to spread this life-saving information. Every person is different, and I direct you to your own provider for that final prescription decision. But, the circumstances where ivermectin should not be used for COVID-19 are exceedingly rare. The potential benefit is huge. Resistance to it has cost a lot of lives.

In the words of BIRD (British Ivermectin Research Development) researcher, Dr. Tess Lawrie, of England, in a video to her prime minister, “please, can we start saving lives now?” She and her group have organized “World Ivermectin Day,” next Saturday, July 24.

Anti-IVM hysteria takes hold in the US, fueled by the FDA's recent marketing campaign warning against it's use for COVID. Here local government officials run around in circles cackling like chicken little's, after learning of a local doctor prescribing it. Doctor not backing down:

Arkansas doctor gives animal deworming drug to inmates with COVID

Jail physician Dr Rob Karas (pictured) has been using ivermectin to treat inmates with Covid-19 in Washington County even though the FDA has specifically…

www.dailymail.co.uk

Quote from Shane D.

Anti-IVM hysteria takes hold in the US, fueled by the FDA's recent marketing campaign warning against it's use for COVID.

From text: 'Ivermectin is not an anti-viral drug,' the FDA said, adding that the formula can be 'highly toxic' to humans.

Why do they not force the FDA people to retract for spreading outraging medical lies?

In this e-mail Fauci has been informed that Ivermectin kills CoV-19 and thus must be an antiviral!

Fauci mails:

From: Coleman, Amanda (NIH/ NIAID) [C] (b)(6)

Date: Thu, Apr 9, 2020 at 6:18 PM

Further most Ivermectin animal versions are 100% safe for human use but factors cheaper...

In any case lock up the package leaflet and check all add-ons.

Horse Equarell apple tabs are 100% conform.

Also the bird version is normally safe as it usually only contains a conserving ingredient that is also used in human medicine.

Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting

https://www.nejm.org/doi/full/10.1056/NEJMoa2110475

Abstract

BACKGROUND

Preapproval trials showed that messenger RNA (mRNA)–based vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) had a good safety profile, yet these trials were subject to size and patient-mix limitations. An evaluation of the safety of the BNT162b2 mRNA vaccine with respect to a broad range of potential adverse events is needed.

METHODS

We used data from the largest health care organization in Israel to evaluate the safety of the BNT162b2 mRNA vaccine. For each potential adverse event, in a population of persons with no previous diagnosis of that event, we individually matched vaccinated persons to unvaccinated persons according to sociodemographic and clinical variables. Risk ratios and risk differences at 42 days after vaccination were derived with the use of the Kaplan–Meier estimator. To place these results in context, we performed a similar analysis involving SARS-CoV-2–infected persons matched to uninfected persons. The same adverse events were studied in the vaccination and SARS-CoV-2 infection analyses.

RESULTS

In the vaccination analysis, the vaccinated and control groups each included a mean of 884,828 persons. Vaccination was most strongly associated with an elevated risk of myocarditis (risk ratio, 3.24; 95% confidence interval [CI], 1.55 to 12.44; risk difference, 2.7 events per 100,000 persons; 95% CI, 1.0 to 4.6), lymphadenopathy (risk ratio, 2.43; 95% CI, 2.05 to 2.78; risk difference, 78.4 events per 100,000 persons; 95% CI, 64.1 to 89.3), appendicitis (risk ratio, 1.40; 95% CI, 1.02 to 2.01; risk difference, 5.0 events per 100,000 persons; 95% CI, 0.3 to 9.9), and herpes zoster infection (risk ratio, 1.43; 95% CI, 1.20 to 1.73; risk difference, 15.8 events per 100,000 persons; 95% CI, 8.2 to 24.2). SARS-CoV-2 infection was associated with a substantially increased risk of myocarditis (risk ratio, 18.28; 95% CI, 3.95 to 25.12; risk difference, 11.0 events per 100,000 persons; 95% CI, 5.6 to 15.8) and of additional serious adverse events, including pericarditis, arrhythmia, deep-vein thrombosis, pulmonary embolism, myocardial infarction, intracranial hemorrhage, and thrombocytopenia.

CONCLUSIONS

In this study in a nationwide mass vaccination setting, the BNT162b2 vaccine was not associated with an elevated risk of most of the adverse events examined. The vaccine was associated with an excess risk of myocarditis (1 to 5 events per 100,000 persons). The risk of this potentially serious adverse event and of many other serious adverse events was substantially increased after SARS-CoV-2 infection. (Funded by the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.)

HOUSTON DOCTOR TOUTS IVERMECTIN AS PART OF COVID TREATMENT, AGAINST FDA WARNING

Houston doctor Joseph Varon touts Ivermectin as part of COVID treatment, against FDA warning | abc13.com

HOUSTON, Texas (KTRK) -- Ivermectin was developed to treat parasites in both humans and animals.

It's an FDA-approved drug for that specific purpose at a very specific dose, but for more than a year, Dr. Joseph Varon said he has proudly been using it, off-label, to treat thousands of COVID-19 patients admitted to United Memorial Medical Center.

"I have used Ivermectin in a few thousand patients," he said. "I cannot tell you the exact number, but I know that it's been quite a large number of patients and I have not seen a single significant side-effect. Not one," said Varon.

He and his colleagues began touting the drug last December, holding a press conference to implore the medical community to use it as part of COVID-19 treatment.

But a recent surge on animal feed stores, where the drug is sold as a de-wormer for cows and horses, has the FDA sending out a warning, saying Ivermectin should not be used to treat or prevent coronavirus.

It is not approved for that use.

Furthermore, the animal version of the drug, according to the FDA, is different than the human version, saying in part, "animal drugs are often highly concentrated because they are used for large animals like horses and cows, which can weigh a lot more than we do-a ton or more. Such high doses can be highly toxic in humans."

Dr. Jill Weatherhead, an assistant professor of infectious diseases and tropical medicine at the Baylor College of Medicine, shares the same warning.

"When you start treating off-label without any scientific evidence of benefit, without standardized dosing or duration of therapy, you can run into significant problems in terms of adverse effects," she said.

Varon tells ABC13 his team began using the drug last summer, saying "people were dying."

We were in the middle of a pandemic," he said. "You have to try things. You have no choice."

He said based on his data, Ivermectin, in combination with COVID therapies, saves lives.

"It's not just Ivermectin," he said. "That's where people get confused. Ivermectin helps you, but it helps you when you are giving it in addition to other components of treatment protocols that are out there."

Once again, it's important to note that Ivermectin is not FDA approved for COVID treatment or prevention and the agency strongly suggests you should never ingest drugs developed for animals.

Going against FDA warnings, Arkansas physician gives anti-parasite drug to jail inmates with COVID-19

Going against FDA warnings, Arkansas physician gives anti-parasite drug to jail inmates with COVID-19

FDA warns that the anti-parasite drug ivermectin shouldn't be used for COVID-19 and can be harmful.

www.cbsnews.com

A detention center in Washington County, Arkansas, has been using the anti-parasite drug ivermectin to treat inmates who have COVID-19, local officials say, even though the U.S. Food and Drug Administration has specifically warned against it. The FDA says the drug, which is frequently used as a dewormer in animals, is not an approved or recommended treatment for COVID-19, and "can cause serious harm."

Eva Madison, a county elected official, raised the issue during a finance and budget committee meeting Tuesday night. Jail officials were presenting their 2022 budget, which included the jail's physician, Dr. Rob Karas, asking for a 10% increase in the medical services contract.

Madison informed committee members and the jail officials that a county employee, who has opted to stay anonymous to the public, told her that he had been sent to the jail's clinic to get tested for COVID-19. When the person tested negative, they were given a $76 prescription for ivermectin. He was concerned about the prescription and asked his primary care physician about it, and the the physician told him to "throw that in the trash," Madison said.

While this individual "had the good fortune to have a physician that he could go to and ask for a second opinion," Madison said at the meeting, "our inmates do not have that choice."

The FDA has warned against using ivermectin to treat or prevent COVID-19 in humans — but misinformation and unsubstantiated claims touting the drug have spread widely on social media. The agency said it has received "multiple reports" of people whose use of the drug required them to seek medical support or hospitalization.

"Ivermectin tablets are approved at very specific doses for some parasitic worms, and there are topical (on the skin) formulations for head lice and skin conditions like rosacea," the FDA says. "Ivermectin is not an anti-viral (a drug for treating viruses)."

Large doses of ivermectin are "dangerous and can cause serious harm," the agency added.

There have even been reports from several states of people ingesting highly concentrated forms of ivermectin that are used to prevent heartworms and other parasites in animals, including horses and cows. These formulations can be "highly toxic" to humans, the FDA says.

Ivermectin has been used for COVID-19 in Latin America, where vaccines and proven treatments are less available, but scientists say claims of its supposed benefits were based on questionable and possibly manipulated data. Other studies have found no benefit.

Merck, the company that makes ivermectin, also said in February that there is "no scientific basis for a potential therapeutic effect against COVID-19" and that the majority of studies about the drug's potential effect on COVID have a "concerning lack of safety data."

Karas Health Care, Dr. Karas' practice, has been touting ivermectin for months. On July 16, the practice posted on Facebook, "if anybody you know test positive send them or [sic] way and we'll get them started on doxy, singular, ivermectin, vitamin d, vitamin c and zinc."

The post was flagged by Facebook with the message: "Some unapproved COVID-19 treatments may cause serious harm."

Madison told CBS News on Wednesday that after learning of the prescription, she contacted the county sheriff, Tim Helder.

The sheriff defended it, said that Karas has been regularly prescribing ivermectin at the jail during the pandemic," Madison said.

CBS News has reached out to the Washington County Sheriff's Office and Karas Health Care for comment.

Madison said that when she spoke to Karas, he confirmed he had been prescribing the medicine to detainees at the jail, and that he and his family members were also taking it. She said he cited the National Institutes of Health, which said in February that laboratory research suggests ivermectin may inhibit viruses in test-tubes. However, the NIH also said no clinical trials have reported a benefit for human patients with those viruses. The NIH says there is "insufficient evidence" to make a recommendation on ivermectin and that it is not approved to treat any viral infection.

"It's very disturbing to me that that's the level of care we're providing to folks down at the jail," Madison said at Tuesday's meeting.

The jail representatives at the meeting said that the only oversight of the doctor's practices was the state medical board, which issued his license.

"He's state licensed, board approved," one of the officials said.

If inmates have concerns about their medical care, he said, "certainly they can write a letter or address the state board of health about any concern they have about any physician."

Even with all of the warnings from public health officials, there's growing concern around the country about people attempting to self-medicate with ivermectin. Mississippi recently reported an increase in calls to the poison control center, with at least 70% being related to ivermectin.

In Oklahoma, a local investigation by KFOR found that at least 12 Tractor Supply stores had sold out of animal-grade ivermectin. One store told KFOR that they have even posted a "Please don't eat" sign.

CBS affiliate KWTV reports that the Oklahoma Center for Poison and Drug Information has received at least 11 calls since May about people experiencing adverse reactions after using animal-grade ivermectin.

Most of those have been people who have purchased and used an animal formulation, a veterinary formulation of the drug," Scott Schaeffer, pharmacist and managing director of the center, told KWTV. "There's always the temptation to look for the next best treatment. Ivermectin, in my opinion, is not it."

Quote from Fm1

(Funded by the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.)

This might explain the following conclusion...

In this study in a nationwide mass vaccination setting, the BNT162b2 vaccine was not associated with an elevated risk of most of the adverse events examined.

May be risk of getting shooted, falling from tree, normal strokes

But:

lymphadenopathy risk difference, 78.4 events per 100,000 persons; 780/million vaccinated or 400'000 for all in Europe

increased risk of myocarditis risk difference, 27 events per 1'000'000 (normally 10% die)

herpes zoster infection risk difference, 158 events per 1'000'000 persons

It's all just a piece of cake ... eaten by the Harvard FM/R/J/B mafia members.

And they did not even look at ADE that recently clearly did show up in UK/Israel...

One interesting find is : Appendicitis +50 /mio. This and herpes Zoster (+158) is a clear sign of immune suppression.

Do not forget: This study has been made among freshly vaccinated people. Some effects will still increase!

Israel up to 80% vaccinated just passed the 10'000 infections rate again and deaths are passing 25/day. Will be 40 for 10'000. A 0.4 death rate is still high just a bit below a strong flu with 0.5

So the side effect of vaccination is a CoV-19 Delta infection...

My guess: At the end we will know that vaccines will only short time delay the death of people at risk. It's all about your health and readiness to fight virus.

Pfizer boosters increase antibody levels by 3x above the two jabs level but for wild strain only. This will also mean that ADE will at least tripple also all immune defect induced illness.

Get a natural infection soon instead of the booster!

The last 3 weeks we (Switzerland) had a strong boost in cases due to holiday returns that caused 40% of all positive tested.

It looks like we just reached the peek now. But the vaccine mafia is still trying to divide the population with certificates that have no foundation at all...

Now which experts should we listen to, Collins and Fauci, architects of the 37th ranked healthcare system or the WHO............. Confusion continues to rule!!!

WHO says no conclusive data yet on need for COVID-19 booster shot

WHO says no conclusive data yet on need for COVID-19 booster shot

m.jpost.com

The World Health Organization Director General Tedros Adhanom Ghebreyesus said on Wednesday that the data on the benefits and safety of a COVID-19 vaccine booster shot is inconclusive.

"When some countries afford to have the booster and others are not even vaccinating the first and second round, it's a moral issue," he said during a media briefing.

What kind of vaccination should I get for a trip to the United States, I'm going to go to Silicon Valley, who works there in this regard...

Quote from Fm1

Do your own research. The best resouces are http://www.flccc.net, and the BIRD group. Then ask for it. It is likely that if you do, the prescriber will feel “off the hook”. Most of us will not deny a reasonable request for a safe medication. Ivermectin is approved by the FDA for use in humans for parasites (worms, scabies), just as yet not officially for COVID. That means it is prescribed “off-label”, as are 20% of prescriptions in the US. Around the

This shows why this guy does not understand how to evaluate the evidence that is out there! And he is counselliung people to pressure their doctors into doing something against their best judgement. On the other hand, if that leads to a full discussion with patients about rsisks and benefits that would be good. I'd recommend the paper from RE: Covid-19 News as a starting point for that discussion rather than the FLCC propaganda.

FLCC is a thoroughly biassed pressure group - not a scientific resource.

You need to look at the totality of the study data scientifically. As has been done.

Thus far it is negative. This does not mean ivermectin is known not to work - just that there is no strong positive evidence it does work.

When you find - rigorously - that the low quality studies look positive, the high quality studies look negative - that is a strong indication any effect is very small, if one exists at all. See this post and the next one for details.

One interesting (still imprecise and therefore uncertain) possibility is that ivermectin reduces hospitalisation - although not anything else. That would make sense if it acted to reduce some symptoms without changing the course of the disease. Hospitalisation is the one outcome where the size of the effect stays the same when you remove the less reliable trials. Looking at the forest diagrams you can see that it remains uncertain because the 95% markers cover no effect. But it interests me.

Whether symptomatic relief from ivermectin (and therefore fewer people with the same level of disease severity going to hospital) is a good idea I'm not sure.

Anyway - more evidence on ivermectin continues to come in, and lots of people are looking at this. The good news is that there is no clear evidence ivermectin causes harm, so those many people who are prescribed it off-label are probably not being medically disadvantaged, just as they are also probably not being medically advantaged - though if it leads them to a false sense of security it would remain disadvantageous overall.