Covid-19 News

    Indian Regulators Authorize for Emergency Use Needle-Free DNA Plasmid COVID-19 Vaccine for Young People 12-18


    Indian Regulators Authorize for Emergency Use Needle-Free DNA Plasmid COVID-19 Vaccine for Young People 12-18
    An Indian biotech received an Emergency Use Authorization (EUA) from the Drug Controller General of India (DCGI) for what they have declared as the
    trialsitenews.com


    An Indian biotech received an Emergency Use Authorization (EUA) from the Drug Controller General of India (DCGI) for what they have declared as the world’s first world’s first Plasmid DNA Vaccine for COVID-19. Developed by Zydus Cadila, the biotech declared in a press release that ZyCoV-D is a three dose vaccine which will be administered first on day zero, day 28th and then on the 56th day. With this approval, India now has its first COVID-19 vaccine for the adolescents in the 12-18 age group, besides the adult population. Of interest, the ZyCoV-D vaccine is delivered via needle-free method, using what’s called The PharmaJet® a needle free applicator, which ensures painless intradermal vaccine delivery. Zydus Cadila stated they would produce 100-120 million doses of the novel product annually.


    The Investigational Product

    ZyCoV-D is a plasmid DNA vaccine that triggers the spike protein of the SARS-CoV-2 virus and elicits an immune response mediated by the cellular and humoral arms of the human immune system reports the company. The company lists some facts about the investigational product including: 1) ZyCoV-D is an intradermal vaccine, which will be administered in three doses; 2) It will be applied using The PharmaJet® needle free system, Tropis®, which can also lead to a significant reduction in any kind of side effects; 3) ZyCoV-D is stored at 2-8 degree C but has shown good stability at temperatures of 25 degree C for at least three months. The thermostability of the vaccine will help in easy transportation and storage of the vaccine and reduce any cold chain breakdown challenges leading to vaccine wastage; 4) The plasmid DNA platform provides ease of manufacturing with minimal biosafety requirements (BSL-1); 5) Also being a Plasmid DNA vaccine, ZyCoV-D doesn’t have any problem associated with vector based immunity; 6) The Plasmid DNA platform also allows generating new constructs quickly to deal with mutations in the virus, such as those already occurring; 7) The results of the Phase I part of the Phase I/II clinical trial have already been published in the EClinical Medicine Journal of Lancet.


    For more on the PharmaJet® needle free system, Tropis we refer to the manufacturers website.


    Novel Vaccine–Flexible

    Claiming that this is the first time that a technologically advanced vaccine has been successfully developed on the Plasmid DNA platform for human use, the company posits another major benefit targeting SARS-CoV-2. That is, it’s purpose-designed to deal with a rapidly evolving virus, mutations ongoing. That’s because of what they call their “rapid plug and play technology” that supports and facilitates updates to the product specifically for variants.


    Vaccination Young People

    By using the needle-free technology the company seeks to be at the forefront of offering vaccine products to the age group 12-18.


    Why a DNA-based vaccine”


    Zydus Cadila suggests that DNA vaccines trigger both humoral and cellular arms of the adaptive immune system. That is a more comprehensive, value-added form of antigen-specific immunotherapy and purportedly “safe” and “stable” while easy to produce.


    Collaborations, Partnerships and Public Backing

    The company benefited from significant collaboration and government support in the research and development and clinical development processes, from the National BioPharma Mission and BIRAC to India’s Department of Biotechnology, the National Institute of Virology, India Council of Medical research and PharmaJet.®


    How do Plasmid NDA vaccines compare to mRNA?

    Academia, government research institutes and biotech ventures have been working on both approaches for nearly three decades, interest in mRNA accelerated due to breakthroughs in the veterinary vaccine markets. Over the years intensive efforts have focused on boosting potency by direct engineering of the mRNA or plasmid DNA experimental candidates or via adjuvants and immunomodulators or other delivery systems or formulations writes Margaret A Liu, in “A Comparison of Plasmid DNA and mRNA as Vaccine Technologies.” Ms. Liu is a Board Chair, International Society of Vaccines.


    Liu notes some of the greater risks, and upside with mRNA-based vaccines declaring “The greater inherent inflammatory nature of the mRNA vaccines is discussed for both its potential immunological utility for vaccines and for the potential toxicity.” This piece was authored in 2019 prior to the pandemic but nonetheless offers an important overview.


    The Company

    An Indian multinational, Zydus Cadila primarily is known for its production of generic drugs and is ranked 100th in the Fortune India 500 list in 2020. The company actually goes back to 1952 to its founding by a former lecturer in pharmacy, Ramanbhai Patel (deceased in 2001) and industrialist Indravadan Modi (deceased 2012) who is known as “the medicine man” in India.


    Historical Intrigue

    The company’s original founders, the Patel’s and the Modi families, split in 1995. As a consequence the Modi group formed a new company called Cadila Pharmaceuticals Ltd., while Cadila Healthcare Ltd. became the Patel’s family holding. The latter went public on the Bombay Stock Exchange in 2000 (532321). Thereafter Cadila Healthcare went on to make a handful of acquisitions including Zydus Healthcare Brasil Ltda.


    The company was one of the largest pharmaceutical companies in India by early 2000s but by 2005 other companies emerged and the company’s ranking waned. Pankaj R. Patel, serves as the Chairman.


    Financials

    With 25,000 employees the company reports turnover of $2.1 billion with profits of $300 million.


    Zydus Cadila secured authorization to start clinical trials testing ZyCoV-D from India’s DCGI last July, 2020. They also inked a deal with Gilead to produce remdesivir in India for the COVID-19 market as reported in the Business Standard.


    Price Fixing Scandal & U.S. Lawsuit

    TrialSite reported in 2019 that over 40 state Attorney Generals in the United States filed a lawsuit accusing dozens of the largest generic producers, including Zydus Cadila, of conspiring to inflate drug prices by over 1000% in some cases.


    Filed in the United District Court for the District of Connecticut, the large, complex and ongoing suit is led by Connecticut Attorney General William Tong. In fact Tong recently filed a new complaint along with 51 other states and territories (the third lawsuit) originating from the ongoing antitrust investigation we reported on. The original lawsuit centers on a vast, widespread conspiracy by generic drug makers (Zydus included) to artificially inflate and manipulate drug prices.

    1918 U.S. Navy Controlled Clinical Experiments Contradict Influenza Transmission: Implications for COVID-19


    1918 U.S. Navy Controlled Clinical Experiments Contradict Influenza Transmission: Implications for COVID-19
    Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite. Dr. Ron Brown – Opinion
    trialsitenews.com


    1918 U.S. Navy Controlled Clinical Experiments Contradict Influenza Transmission: Implications for COVID-19



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


    Dr. Ron Brown – Opinion Editorial


    August 21, 2021


    More U.S. military personnel died from influenza and pneumonia during the 1918 pandemic than from combat during World War I. The U.S. Military and the Influenza Pandemic of 1918–1919 (nih.gov). Military medical officers implemented the same preventive measures during WWI that we are continuing to use during the current COVID-19 pandemic with the same poor results, including quarantining, temperature taking, patient isolation, limits on group gatherings, face masks and gowns, improved ventilation, screens between bunk beds, sprays to prevent infections, and experimental vaccines. The U.S. Army Medical Department during WWI admitted that “the best result to be expected from any or all of these measures is a slowing of the progress of an epidemic rather than any considerable diminution in the number of cases.” Sound familiar? To prove the hypothesis that influenza was transmitted from person to person during the 1918 pandemic, the U.S. Navy organized clinical experiments on healthy military personnel and hospitalized influenza patients. Influenza: history, epidemiology, and speculation (nih.gov).


    The first influenza experiment was carried out by the U.S. Navy in Boston, Massachusetts in 1918. Military doctors exposed 62 healthy male sailors to direct contact with the exhaled breath, coughs, and sputum from hospitalized influenza patients. None of the healthy sailors became ill with confirmed cases of influenza, although one healthy sailor developed a sore throat which was not considered influenza. Clinical results were the same when the identical experiment was repeated later in San Francisco, California.


    These U.S. Navy controlled clinical experiments could not verify the hypothesis of interpersonal influenza transmission (contagion). Yet, military medical officers had no other choice but to continue to use the usual ineffective preventive measures for influenza control, which have remained in place in the military and civilian worlds to the present day.


    Contradicting or even refuting the hypothesis of interpersonal transmission of influenza is not sufficient to prevent the disease, and one must provide a viable alternate theory or hypothesis to explain how influenza infections spread within a population. Virologist Robert Doerr of the early 20th century proposed that viral diseases can arise without exposure to outside infectious agents, and that these infectious diseases can have non-specific causes. (PDF) When did virology start?, ASM News 62 (March) (1996), 142-5 | Ton van Helvoort – Academia.edu.


    Doerr’s findings suggest that rather than specific exogenous disease determinants, like spreading microorganisms in bad air (miasma or malaria, which literally means bad air), infections are caused internally by endogenous disease determinants such as compromised nutritional and immunological status.


    Nutritional epidemiology and nutritional immunology

    World Health Organization pointed out that susceptibility to infection is increased by immunocompromised status and nutritional status. WHO/Europe | Nursing and midwifery – Infections and infectious diseases. A manual for nurses and midwives in the WHO European Region. The more a population shares nutritional and immunologic disease determinants which increase susceptibility to infection, the more people may appear to “catch” the infection from one another.


    If you want to know where the coronavirus comes from, take a look in the mirror. You manufacture the virus yourself as part of the quadrillion viruses in your human virome. Rampant microbiophobia is out of control! New insights on the true nature of viruses (trialsitenews.com). Whether viruses accumulate in sufficient numbers to cause an infection depends on how efficient your immune system functions to eliminate them, and that depends on your overall state of health which is determined by lifestyle factors, including nutrition.


    Nutrition during WWI

    WWI had “disrupted most economies, due both to destruction as well as the diversion of resources to help the war effort. Many countries saw production of key crops and livestock fall by 50 to 75% relative to prewar levels.” The 1918 Influenza Pandemic and its Lessons for COVID-19 | NBER.


    Highly processed foods in cans were also introduced during WWI. World War I Centenary: Canned Food (wsj.com). Highly processed foods are also the greatest source of added salt in our diets, Sodium and Food Sources | cdc.gov, and sodium chloride is associated with many contributing conditions in COVID-19 such as hypertension, cardiovascular disease, and chronic kidney disease. Association of cardiovascular disease and 10 other pre-existing comorbidities with COVID-19 mortality: A systematic review and meta-analysis (plos.org).


    As living conditions improved after WWI, including improved access to a prewar diet of healthy fresh foods, the pandemic began to decline in 1919.


    For more information on nutritional epidemiology and nutritional immunology in COVID-19, see: Medicina | Free Full-Text | Sodium Toxicity in the Nutritional Epidemiology and Nutritional Immunology of COVID-19 (mdpi.com).

    Asymptomatic SARS-CoV-2 infection: A systematic review and meta-analysis


    Asymptomatic SARS-CoV-2 infection: A systematic review and meta-analysis
    Asymptomatic infections have been widely reported for COVID-19. However, many studies do not distinguish between the presymptomatic stage and truly…
    www.pnas.org


    Significance

    Asymptomatic infections have been widely reported for COVID-19. However, many studies do not distinguish between the presymptomatic stage and truly asymptomatic infections. We conducted a systematic review and meta-analysis of COVID-19 literature reporting laboratory-confirmed infections to determine the burden of asymptomatic infections and removed index cases from our calculations to avoid conflation. By analyzing over 350 papers, we estimated that more than one-third of infections are truly asymptomatic. We found evidence of greater asymptomaticity in children compared with the elderly, and lower asymptomaticity among cases with comorbidities compared to cases with no underlying medical conditions. Greater asymptomaticity at younger ages suggests that heightened vigilance is needed among these individuals, to prevent spillover into the broader community.


    Abstract

    Quantification of asymptomatic infections is fundamental for effective public health responses to the COVID-19 pandemic. Discrepancies regarding the extent of asymptomaticity have arisen from inconsistent terminology as well as conflation of index and secondary cases which biases toward lower asymptomaticity. We searched PubMed, Embase, Web of Science, and World Health Organization Global Research Database on COVID-19 between January 1, 2020 and April 2, 2021 to identify studies that reported silent infections at the time of testing, whether presymptomatic or asymptomatic. Index cases were removed to minimize representational bias that would result in overestimation of symptomaticity. By analyzing over 350 studies, we estimate that the percentage of infections that never developed clinical symptoms, and thus were truly asymptomatic, was 35.1% (95% CI: 30.7 to 39.9%). At the time of testing, 42.8% (95% prediction interval: 5.2 to 91.1%) of cases exhibited no symptoms, a group comprising both asymptomatic and presymptomatic infections. Asymptomaticity was significantly lower among the elderly, at 19.7% (95% CI: 12.7 to 29.4%) compared with children at 46.7% (95% CI: 32.0 to 62.0%). We also found that cases with comorbidities had significantly lower asymptomaticity compared to cases with no underlying medical conditions. Without proactive policies to detect asymptomatic infections, such as rapid contact tracing, prolonged efforts for pandemic control may be needed even in the presence of vaccination.


    Discussion

    The SARS-CoV-2 pandemic infected more than 80 million people within a year and is still spreading rapidly despite widespread control efforts. The elements of the global response are similar to those deployed during the SARS-CoV-1 outbreak: detecting new cases through symptom-based surveillance, subsequent testing, and isolation of confirmed cases. In 2002, these measures achieved containment within 8 mo and fewer than 8,500 cases worldwide. Given that the aerosol and surface stability of the two viruses are similar (406), a crucial difference between the two outbreaks could be the role of silent infections in propagating transmission chains. Multiple clinical studies have indicated that viral loads in asymptomatic and symptomatic infections of COVID-19 may be similar (11⇓⇓–14, 354). Furthermore, the presymptomatic phase of SARS-CoV-2 is highly infectious (53), and transmission from those in this phase may be responsible for more than 50% of incidence (16). This is a striking difference from SARS-CoV-1 in which the infectiousness peaked at 12 d to 14 d after symptom onset (407). Although silent infections of SARS-CoV-1 were reported, no known transmission occurred from silently infected or even mildly symptomatic SARS cases.


    Since the emergence of COVID-19, there has been much speculation about the silent transmission of the disease. Cross-sectional studies testing exposed individuals who do not exhibit symptoms often conflate asymptomatic infections with those in the presymptomatic phase, leading to substantial overestimation of asymptomatic infection. Longitudinal studies without sufficient follow-up similarly lead to overestimation of asymptomaticity (408). Additionally, inconsistent use of terminology has led to confusion, particularly when distinguishing infections which are silent at the time of testing from those which are truly asymptomatic (4, 5). A previous meta-analysis, for example, incorrectly includes infections in the presymptomatic phase to calculate pooled estimate of asymptomatic percentage (409). By contrast, several studies conducted early in the pandemic reported few asymptomatic infections, primarily due to restrictive testing criteria which focused on testing of severe cases that required hospitalization (410, 411). Inaccuracy in either direction is detrimental for public health. Overestimation of asymptomaticity engenders a perception that SARS-CoV-2 is less virulent, whereas underestimation skews key epidemiological parameters such as infection fatality rate and hospitalization rate upward, leading to suboptimal policy decisions.


    To robustly estimate the asymptomatic percentage from studies with varying degrees of methodological vigor, we conducted two separate meta-analyses. In the first analysis, we estimated the asymptomatic percentage as 35.1% (95% CI: 30.7 to 39.9%), by including all studies with a duration of follow-up sufficient to identify asymptomatic infections. In the second analysis, we only included studies that both delineated silent infections at the time of testing and conducted follow-up to distinguish the presymptomatic stage from asymptomatic infections. With this analysis, we estimated the asymptomatic percentage as 36.9% (95% CI: 31.8 to 42.4%). Our estimates have overlapping CIs, which suggests that our pooled analysis is robust to methodological differences in symptom assessment. Our estimates are higher than the 15.6% (95% CI: 10.1 to 23.0%), 17% (95% CI: 14 to 20%), and 20% (95% CI: 17 to 25%) reported by three previous meta-analyses using 41 studies (7), 13 studies (8), and 79 studies (9). In large part, this difference arises because we excluded index cases from our calculation, correcting a bias that leads to underestimation of asymptomaticity. Our estimates of asymptomatic percentage without excluding index cases were 27.8% and 29.4%, for our two approaches. The lower bounds of 24% and 25%, for the two analyses overlaps with the range of the previous largest meta-analysis. Compared with other respiratory infections, the lower bound of our analyses is higher than the 13 to 19% estimated for influenza (412, 413), and the 13% for SARS-CoV-1 (414).


    We found that 42.8% (95% prediction interval: 5.2 to 91.1%) of infections were silent at the time of testing. These cases have been incorrectly referred to as asymptomatic in previous studies (4, 5, 189, 239). This rate is context specific, as it is likely influenced by the association between symptomaticity and the time window when an infection is detectable or tested by RT-PCR. Additionally, the proportion of silent infections at the time of testing is highly sensitive to the efficiency of contact tracing. If most contacts are identified and tested swiftly, then nearly all infections will be silent at the time of testing. By contrast, if contact tracing is slow and incomplete, then a larger fraction of individuals will have developed symptoms by the time they are approached for testing, and a smaller proportion of those tested will be symptom-free. Reports of silent infections at the time of testing are also likely impacted by epidemic trajectory largely due to the predominance of recent infections in samples taken during the growth phase, in contrast with a higher proportion of older infections in samples taken during the declining phase. Unbiased measures of asymptomaticity, on the other hand, should be consistent across similar demographic settings, regardless of contact tracing and epidemic trajectory.


    Several gaps remain in our understanding of asymptomatic carriage of COVID-19. Particularly, it is unclear why certain infections remain asymptomatic while the majority develop clinical symptoms. Our results indicate that children have greater asymptomaticity compared to the elderly. We also found that cases with comorbidities have lower asymptomaticity compared with cases with no underlying medical conditions. Additionally, studies on long-term care facilities reported lower asymptomaticity compared to other study settings. Given that the risk of severe illness is high among the elderly, the age association identified by our study implies that absence of symptoms may correlate with the tendency of developing milder symptoms. Case severity in SARS-CoV-2 patients has been linked to a cytokine storm which occurs more frequently in elderly patients (415, 416). Genetic (417), environmental risk factors, sex-linked differences (418), and cross-reactive immunity (419) might also contribute, although no studies have unequivocally demonstrated their association with either symptom status or severity.


    Higher representation of asymptomatic SARS-CoV-2 infections among younger people has grave implications for control policies in daycares, schools, and universities. Settings with close, extensive contact among large groups of younger individuals are particularly susceptible to superspreader events of COVID-19 which may go undetected if surveillance focuses on symptomatic cases. This close congregation of relatively large groups similarly explains why influenza, mumps, and measles often spread more rapidly in schools and college campuses than in the broader community (420⇓–422). As schools and universities convene in the midst of the COVID-19 pandemic, campus outbreaks are increasingly reported (423). Although COVID-19 severity is lower among young people, campus transmission with a large undetected component could more easily bridge to the rest of the population, fueling local and regional resurgence.


    Our meta-analyses are subject to limitations, many related to the unprecedented pace of clinical research since the emergence of COVID-19. First, we found considerable heterogeneity in the percentage of asymptomatic infections. Subgroup analysis revealed that studies with longer follow-up reported lower asymptomaticity. Second, all reports of asymptomatic cases are confounded by the subjective and shifting definition of symptoms. For instance, the list of clinical manifestations associated with COVID-19 has expanded since the initial definitions (424). These changing definitions impact the classification of infections as asymptomatic or silent, and the more limited suite of symptoms initially considered indications of COVID-19 could bias early studies toward higher percentages in these categories. Nonetheless, we found no statistically significant differences in asymptomatic percentage when we stratified studies based on publication date. Third, in the studies included in our meta-analysis, it is possible that early mild symptoms occurring before a positive PCR test might go unrecorded, biasing the studies toward higher asymptomaticity. Fourth, although we corrected for the bias introduced by inclusion of predominantly symptomatic index cases, our estimates are still likely affected by sample selection bias, as participation is expected to be highest among those experiencing symptoms (10). Additionally, factors such as socioeconomic position, occupation, ethnicity, place of residence, internet and technological access, and scientific and medical interest could have contributed to nonrandom enrollment (425). To evaluate the effect of these biases, we calculated the pooled asymptomatic percentage using 25 studies that reported screening of all individuals in the study setting. Asymptomaticity among this smaller subset of studies was 47.3% (95% CI: 34.0 to 61.0%), with CIs that overlap with our primary analysis but the point estimate is higher than the base case CI. We therefore cannot rule out nonrandom sampling as a source of bias for estimation of the asymptomatic percentage.


    In our meta-analysis, we excluded 225 studies that did not identify index cases. Additionally, 223 studies reported silent infections at the time of testing but were excluded from analysis of asymptomaticity for not reporting symptom assessment during follow-up for at least 7 d or for not specifying the duration of follow-up. Large-scale longitudinal surveys should prioritize the inclusion of these data to facilitate accurate estimation of the asymptomatic percentage. At minimum, such studies should report the number of index cases among their study participants, the clinical symptom status of individuals at the time of testing, the duration of symptom follow-up, and symptom status during the follow-up. Ideally, studies would additionally provide a full symptom profile both at time of testing and by the end of follow-up, to facilitate reclassification as case definitions are updated.


    Estimating the extent of COVID-19 asymptomaticity is critical for calculating key epidemiological characteristics, quantifying the true prevalence of infection, and developing appropriate mitigation efforts. This meta-analysis also establishes a baseline for asymptomaticity, prior to widespread vaccination coverage. Amid concerns that vaccines may be less protective against infection than disease, widespread vaccination coverage may soon lead to a rise in the percentage of infections that present asymptomatically. The high prevalence of silent infections even at baseline, coupled with their transmission potential, necessitates accelerated contact tracing, testing, and isolation of infectious individuals, as symptom-based surveillance alone is inadequate for control.

    Quote from Fm1

    Highly processed foods in cans were also introduced during WWI. World War I Centenary: Canned Food (wsj.com). Highly processed foods are also the greatest source of added salt in our diets, Sodium and Food Sources | cdc.gov, and sodium chloride is associated with many contributing conditions in COVID-19 such as hypertension, cardiovascular disease, and chronic kidney disease.

    The first generation of cans had lead seals. That's how already many Romans killed themselves. Soldiers had to wear uniforms and got no sun at all --> low V-D. Fear lowers the readiness of the immune system

    Two Great Virologists’ Frightening Warnings Ignored by Government and Big Media


    Two Great Virologists’ Frightening Warnings Ignored by Government and Big Media
    Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite. By: Joel S. Hirschhorn When two
    trialsitenews.com





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


    By: Joel S. Hirschhorn


    When two great minds come to similar conclusions about the current global push to vaccinate everyone with the COVID experimental vaccines we should pay close attention. Both highly experienced scientists have a totally negative view of the vaccination effort. Worse than being ineffective, they point to negative health outcomes for the global population. These two truth-telling acclaimed medical researchers make Fauci look as inept, deceitful and dangerous as he is.


    The point made in this article is not only has Fauci pushed the wrong potentially disastrous pandemic solution, he has blocked the right one.


    Much of what the two virologists say is very technical in nature. This article simplifies their controversial messages without losing their essential meanings. The public needs to understand their warnings that refute all the propaganda pushing vaccines from government and public health agencies as well as big media.


    Warning: Keep reading and you may become depressed.


    Dr. Luc Montagnier

    First considered is the thinking of Dr. Luc Montagnier, a French virologist and recipient of the 2008 Nobel Prize in Medicine for his discovery of the human immunodeficiency virus (HIV). He has a doctorate in medicine. But there is a lot more to conclude he is a great expert: He has received more than 20 major awards, including the French National Order of Merit and the Légion d’honneur. He is a recipient of the Lasker Award, the Scheele Award, the Louis-Jeantet Prize for medicine , the Gairdner Award the Golden Plate Award of the American Academy of Achievement, King Faisal International Prize (known as the Arab Nobel Prize), and the Prince of Asturias Award.


    He has worked hard to expose the dangers of the COVID-19 vaccines, still experimental but sadly may soon be fully approved. The vaccines don’t stop the virus, argues the prominent virologist, they do the opposite — they “feed the virus,” and facilitate its development into stronger and more transmittable variants. These new virus variants will be more resistant to vaccination and may cause more health implications than their “original” versions.


    Montagnier refers to the mass vaccine program as an “unacceptable mistake” and are a “scientific error as well as a medical error.” His assertion is that “The history books will show that…it is the vaccination that is creating the variants.” In other words: “There are antibodies, created by the vaccine,” forcing the virus to “find another solution” or die. “This is where the variants are created. It is the variants that “are a production and result from the vaccination.” Stop and think about these thoughts. Have you heard a better explanation of variant creation? I doubt it.


    He is talking about the mutation and strengthening of the virus from a phenomenon known as Antibody Dependent Enhancement (ADE). ADE is a mechanism that increases the ability of a virus to enter cells and cause a worsening of the disease.


    Data from around the world confirms ADE occurs in SARS-CoV-2, which causes COVID-19, says Montagnier. “You see it in each country, it’s the same: the curve of vaccination is followed by the curve of deaths.” Sounds like what we are now hearing more about, namely escalating breakthrough infections that kill some people. And this spiral into disaster may have no end.


    In a November 2020 documentary he emphasized harmful and irrational mask mandates as well as lockdowns, quarantines, abuses of government overreach, and supported use of effective COVID treatments such as hydroxychloroquine. The film was banned by YouTube and most other mainstream outlets. At that time Fauci had succeeded in blocking wide use of the cheap generic based treatments for COVID and pursued the wait for the vaccine strategy.


    Montagnier has been a vocal critic of the mass vaccination campaign. In a letter to the President and Judges of the Supreme Court of the State of Israel, which unrolled the world’s speediest and the most massive vaccination campaign, Montagnier argued for its suspension. He said: “I would like to summarize the potential dangers of these vaccines in a mass vaccination policy.” Here they are:


    1.Short-term side effects: these are not the normal local reactions found for any vaccination, but serious reactions involve the life of the recipient such as anaphylactic shock linked to a component of the vaccine mixture, or severe allergies or an autoimmune reaction up to cell aplasia. In this group we should include a number of lethal blood problems involving clots and loss of platelets that cause strokes, brain bleeds and other impacts.


    2. Lack of vaccine protection:


    2.1 In induced antibodies do not neutralize a viral infection, but on the contrary facilitate it depending on the recipient. The latter may have already been exposed to the virus asymptomatically. Naturally induced antibodies may compete with the antibodies induced by the vaccine.


    2.2 The production of antibodies induced by vaccination in a population highly exposed to the virus will lead to the selection of variants resistant to these antibodies. These variants can be more virulent or more transmissible. This is what we are seeing now. An endless virus-vaccine race that will always turn to the advantage for the virus.


    3. Long-term effects: Contrary to the claims of the manufacturers of messenger RNA vaccines, there is a risk of integration of viral RNA into the human genome. Our cells have the ability to reverse transcriptase from RNA into DNA. Although this is a rare event, its passage through the DNA of germ cells and its transmission to future generations cannot be excluded.


    His bottom line: “Faced with an unpredictable future, it is better to abstain.” But most people will find it extremely difficult to resist all the coercion and vaccine mandates.


    Back in April 2020, before all the talk of variants and before the rollout of the experimental vaccines, Montagnier urged people to refuse vaccines against COVID-19 when they become available. His main point should always be remembered: “instead of preventing the infection, they [would] accelerate infection.” Today, the newly occurring variants of SARS-CoV-2 that affect vaccinated people prove his thesis. With his scientific thinking, mass vaccination may cause a new, more deadly wave of pandemic infection.


    As to the much talked about and hope for herd immunity, he has said: “the vaccines Pfizer, Moderna, Astra Zeneca do not prevent the transmission of the virus person-to-person and the vaccinated are just as transmissive as the unvaccinated. Therefore the hope of a ‘collective immunity’ by an increase in the number of vaccinated is totally futile.”


    On the positive side, he advocated this: “The early treatment of infection with ivermectin and bacterial antibiotic because there is a bacterial cofactor that amplifies the effects of the virus. “


    Dr. Vanden Bossche

    The stark views of Montagnier have been shared by the esteemed Belgium virologist Dr. Vanden Bossche. He too has considerable credentials that make his views worth consideration. He has PhD degree in Virology from the University of Hohenheim, Germany. He held faculty appointments at universities in Belgium and Germany. He was at the German Center for Infection Research in Cologne as Head of the Vaccine Development Office. He has been in the private sector at several vaccine companies (GSK Biologicals, Novartis Vaccines, Solvay Biologicals) where he worked on vaccine R&D as well as vaccine development. He also worked with the Global Alliance for Vaccines and Immunization (GAVI) in Geneva as Senior Ebola Program Manager.


    His views have been analyzed in a recent article. He too has loudly called for a halt to mass-vaccination programs. He believes that if the jabs are not halted, they could lead to the evolution of stronger and stronger variants of the virus until a “supervirus” takes hold and wipes out huge numbers of people.


    This is his bold view:


    “Given the huge amount of immune escape that will be provoked by mass vaccination campaigns and flanking containment measures, it is difficult to imagine how human interventions would not cause the COVID-19 pandemic to turn into an incredible disaster for global and individual health.”


    Here is an essential element of his thinking. Pretty much everything being done in the pandemic doesn’t guarantee elimination of the virus. What is happening is selective viral ‘immune escape’ where viruses continue to be shed from those who are infected [both vaccinated and nonvaccinated] because neutralizing antibodies fail to prevent replication and elimination of the virus.


    The evolutionary selection pressure on the virus through ‘immune escape,’ creates ever more virulent strains of the virus that have a competitive advantage over other variants and will increasingly have the potential to break through the antibody defenses. Defenses provided by the vaccine induced immune system. This is ‘vaccine resistance.’ What happens is that vaccine makers keep trying to outsmart variants, but fail. So, they keep pushing boosters and yearly vaccine shots. This is the more is better approach. This is aided by suppression of many negative facts about the vaccines by big media.


    A frightening forecast by Bossche is that the worst of the pandemic is still to come. Hard to believe considering all the bad news propaganda about cases, hospitalizations and deaths. But he thinks we are now experiencing the calm before the ultimate storm. Imagine a new wave of infection far worse than anything we’ve seen so far is how Bossche thinks.


    How does this happen? There will be more mutants or variants to which the adaptive immune system from vaccine shots provides little resistance. At the same time there will be decreased innate or natural immune effectiveness. Unless people take a number of steps to boost their natural immunity.


    Bossche consistently points to a lack of evidence that the existing global, mass vaccination program that has been mounted while there is still significant infection around, is unprecedented and there is no scientific evidence that this will work. This is why he is largely ignored.


    He stresses that historic vaccination programs have always emphasized the importance of vaccinating populations prophylactically in the absence of infection pressure.


    He also argues that if different types of vaccine were used that provided sterilizing immunity i.e., that prevented immune escape and killed all viruses in those vaccinated, the situation would be entirely different. Most people do not understand that the current experimental vaccines do not actually kill the virus; and that both the vaccinated and nonvaccinated shed the virus. These vaccines do not stop viral transmission. And all the contagion control measures simply to not work effectively enough to stop wide spread of the virus in its various forms.


    Here is his big picture view: “There is only one single thing at stake right now and that is the survival of our human race, frankly speaking.”


    But there are more strong words recently said by Bossche to pay attention to: “every person out there who is ‘partially’ or ‘fully’ vaccinated is a walking disease incubation system that puts everyone else at risk of contracting a deadly, vaccine-caused ‘variant’ that could kill them. The ‘vaccinated’ are walking murderers spreading disease to others. Getting injected for the Fauci Flu is not only foolish; it is also a form of murder in that unvaccinated people are now at risk of contracting the deadly diseases being manufactured inside the bodies of the vaccinated. If Trump had never introduced the vaccine in the first place, the pandemic would have long ago fizzled out. Since his vaccines continue to be pushed … however, the ‘Delta’ variant is spreading like wildfire, soon to be followed by other ‘variants’ as we enter the fall season.”


    This too is a very strong view. The “mass vaccination program is…unable to generate herd immunity.” If true, there is little hope of seeing the COVID pandemic ending.


    What is the solution? Bossche has identified the needed alternative to the current massive vaccine effort. It is this; “This first critical step can only be achieved by calling an immediate halt to the mass vaccination program and replacing it by widespread use of antiviral chemoprophylactics while dedicating massive public health resources to scaling early multi-drug treatments of Covid-19 disease.” This is referring to the early home/outpatient treatment protocols based on cheap, safe and fully approved generics like ivermectin and hydroxychloroquine; these also work as preventatives. Pandemic Blunder provides much data and advice on using this treatment approach. So, both virologists support use of what Fauci has blocked.


    These action recommendations were also made by Bossche “Provide – at no cost – early multidrug treatment to all patients in need. Roll out campaigns to promote healthy diets and lifestyle.” In other words, people need to take actions to boost their natural immunity, this should include vitamins and supplements, including this cocktail: vitamin C, vitamin D, zine and quercetin.


    Conclusions

    Take a moment to consider that Patrick Wood on the Bannon show on August 21 concluded that all the available data from the US and Europe shows some 100,000 people have died from the COVID experimental vaccines. I agree with that assessment. And by the time you read this FDA may have given full approval to the Pfizer vaccine.


    Also worth noting is that data from Israel revealed “A full course of the Pfizer-BioNTech vaccine was just 39% effective at preventing infections and 41% effective at preventing symptomatic infections caused by the Delta Covid-19 variant, according to Israel’s health ministry.” And 60 percent of COVID hospitalized patients were vaccinated.


    Latest Public Health England data on the delta variant showed vaccine effectiveness down to just 15% in the over-50s, 37% in the under-50s and deaths cut by 80% in over-50s, but just 12% in under-50s.


    The point is simple. There is daily information on how COVID vaccines are increasingly found both dangerous and ineffective.


    After considering what these two experts have said it is appropriate to criticize what current government officials say, namely blame the unvaccinated for the surges in COVID cases, hospitalizations and deaths. The major alternative to this thinking is that it is the vaccinated people who are creating pandemic problems, including the variants.


    What is needed is an entirely new approach to COVID vaccines. Perhaps there are companies working on this. This would threaten the trillion-dollar business of the current vaccine makers.


    If the people, agencies and institutions with all the power listening to these two very smart people they would devote all their energies to using alternatives to the current vaccines. We have them. Notably, the treatment protocols that so many great doctors have created and used to help their patients. Doctors Bryan Tyson and George Fareed, for example, have treated 6,200 patients, keeping them alive and out of hospitals.


    Many other physicians and medical researchers have called for a halt to the current vaccine bonanza for big drug companies. In the meantime, on a daily basis for all those willing to look at the facts, it is clearer and clearer that the experimental vaccines are not effective. It is insanity to keep doing or expanding what is not working. That is the insane world we are now experiencing even as more and people die from breakthrough infections, blood problems and other bad vaccine health impacts.


    Perhaps the ugly truth about the vaccines will be widely revealed only when there are massive, widespread deaths despite all the shots and jabs. That will be too late to change pandemic management from money-driven stupidity to life-saving, medically moral actions.


    Analysis: What Vanden Bossche Got Right — and Wrong — About Mass Vaccination
    Robert Verkerk, Ph.D., of Alliance for Natural Health International, weighs in on the recent debate sparked by Geert Vanden Bossche, Ph.D., concerning immune…
    childrenshealthdefense.org


    Latest PHE Data Shows Vaccine Effectiveness Down to Just 15% in the Over-50s, 37% in the Under-50s. Deaths Cut by 76% in Over-50s, But Just 12% in Under-50s – The Daily Sceptic
    The latest data from PHE shows vaccine effectiveness against Delta infection has dropped to just 15% in the over 50s. Protection against death is holding up –…
    dailysceptic.org

    Quote from THHuxleynew

    Lack of fear gets you killed

    I agree: The live of soldiers is unhealthy...

    Quote from Fm1

    Asymptomatic SARS-CoV-2 infection: A systematic review and meta-analysis

    I'm not a big fan of meta studies as these only show you the least common divider. This one lacks the Ct value for the positive tested. So it is basically worthless.

    People should look at the serum prevalence studies and just compare it with the known PCR+. Or should use the test positive rate that is also a good indication how many untested got it.

    https://www.covid19.admin.ch/de/epidemiologic/test Test positive rate


    With the "0" version we had 3 undetected cases for one PCR+ confirmed in many early studies (D,CH,AU)- test positive rate around 5%. Later with Alpha this number did increase (test positive rate 10%) but measurement was spoiled by vaccination. (3 of 4 vaccinated could have had it already) Now with delta our positive rate soared to 20% peek what is 4x what we had with alpha. This and also US data indicates that for one PCR+ case we now have at least 10 undetected cases.

    Be also aware that antibody tests just deliver the minimal number of infected as they do not look at the basic immune memory and mostly only match IgA for the spike.

    Most face masks won’t stop COVID-19 indoors, study warns


    Most face masks won't stop COVID-19 indoors, study warns
    Despite wearing a face mask, the study finds a large buildup of aerosol droplets suspended in the air coming from wearers.
    www.studyfinds.org


    New research reveals that cloth masks filter just 10% of exhaled aerosols, with many people not wearing coverings that fit their face properly.

    WATERLOO, Ontario — N95 or KN95 face masks may be the best way to avoid COVID-19 during crowded indoor events. That’s the recommendation from a new study reporting most cloth masks just don’t do the job when it comes to stopping the spread of coronavirus within enclosed spaces.

    Researchers from the University of Waterloo simulated a person breathing in a large room with a cloth face mask on. Despite wearing a mask, the study finds a large buildup of aerosol droplets suspended in the air. Besides raising awareness on the vulnerability of certain face masks, these findings also emphasize the need for proper ventilation indoors. More ventilation means less of a chance for potentially viral aerosols to linger around.

    There is no question it is beneficial to wear any face covering, both for protection in close proximity and at a distance in a room,” says study leader Serhiy Yarusevych, a professor of mechanical and mechatronics engineering, in a university release. “However, there is a very serious difference in the effectiveness of different masks when it comes to controlling aerosols.”


    Studies continue to show that aerosols exhaled by infected individuals can indeed infect others with COVID-19, even if someone is standing more than six feet away.


    Why do most face masks fail to offer adequate protection?

    Researchers theorize many people wear masks that don’t fit their face properly. As a result, many cloth and surgical masks only filter about 10 percent of exhaled aerosols. The rest make their way past the mask, most through the top, and spread into the surrounding environment. Conversely, higher-quality, more expensive N95 and KN95 masks filter over 50 percent of all aerosol droplets.

    In light of these findings study authors recommend that everyone wear a N95 or KN95 mask if possible whenever indoors in the company of others.


    “A lot of this may seem like common sense,” Prof. Yarusevych comments. “There is a reason, for instance, that medical practitioners wear N95 masks – they work much better. The novelty here is that we have provided solid numbers and rigorous analysis to support that assumption.”

    It’s also worth mentioning that ventilation tests show even modest ventilation rates provide about the same level of protection as the highest quality masks.

    The findings appear in the journal Physics of Fluids.

    Quote from Fm1

    Perhaps the ugly truth about the vaccines will be widely revealed only when there are massive, widespread deaths despite all the shots and jabs. That will be too late to change pandemic management from money-driven stupidity to life-saving, medically moral actions.

    From the link!

    For deaths, PHE reports 27 in the double vaccinated and 66 in the unvaccinated in the under-50s in this period. This works out (1-(27/26%)/(66/56%)) at a vaccine effectiveness against death of just 12%. Why this would be so much lower than in the over-50s is unclear, but it’s worth bearing in mind that these are small numbers of deaths which may make the estimate unreliable.


    Age < 50 12% protection from death by vaccines.... No more questions

    Metabolic Regulation of SARS-CoV-2 Infection


    Metabolic Regulation of SARS-CoV-2 Infection
    Research Square is a preprint platform that makes research communication faster, fairer, and more useful.
    www.researchsquare.com


    Abstract

    Viruses are efficient metabolic engineers that actively rewire host metabolic pathways to support their lifecycle, presenting attractive metabolic targets for intervention. Here we chart the metabolic response of lung epithelial cells to SARS-CoV-2 infection in primary cultures and COVID-19 patient samples. Bulk and single-cell analyses show that viral replication induces endoplasmic stress and lipid accumulation. Protein expression screen suggests a role for viral proteins in mediating this metabolic response even in the absence of replication. Metabolism-focused drug screen showed that fenofibrate reversed lipid accumulation and blocked SARS-CoV-2 replication. Analysis of 3,233 Israeli patients hospitalized due to COVID-19 supported in vitro findings. Patients taking fibrates showed significantly lower markers of immunoinflammation and faster recovery. Additional corroboration was received by comparative epidemiological analysis from cohorts in Europe and the United States. A subsequent prospective interventional open-label study was carried out in 15 patients hospitalized with severe COVID-19. The patients were treated with 145 mg/day of nanocrystallized fenofibrate (TriCor®) in addition to standard-of-care. Patients receiving fenofibrate demonstrated a rapid reduction in inflammation and a significantly faster recovery compared to control patients admitted during the same period and treated with the standard-of-care. Taken together, our data show that elevated lipid metabolism underlies critical aspects of COVID-19 pathogenesis, suggesting that pharmacological modulation of lipid metabolism should be strongly considered for the treatment of coronavirus infection.


    DOI:

    10.21203/rs.3.rs-770724/v1

    Israel began a booster program 6 weeks ago and are already experiencing breakthrough infections. How are they going to spin this?


    Just 0.2% of Israelis who got booster shot then caught COVID — report

    In further indication of effectiveness of third vaccine dose, Health Ministry said to report just 88 serious cases among 1.1 million recipients of booster


    Just 0.2% of Israelis who got booster shot then caught COVID -- report | The Times of Israel

    Quote from Fm1

    Just 0.2% of Israelis who got booster shot then caught COVID — report

    The Pfizer immune deficiency induced CoV-19 rate for the second jab is is.0.3% (1.2% for the first) is it's 0.2% now for the third. It's lower most likely due to the fact that the sensitive ones are either dead or now have a better natural protection.


    Quote from Fm1

    Metabolic Regulation of SARS-CoV-2 Infection

    Fenofibrate : https://en.wikipedia.org/wiki/Fenofibrate

    A soft statine replacement. People took it already for months. So may be this is a lucky side effect! Whether short time application helps must be tested.

    Israel starts Covid-19 antibody testing for children aged three and older


    Israel starts Covid-19 antibody testing for children aged three and older
    Israel on Sunday launched antibody testing for children aged as young as three, seeking information on the number of unvaccinated youths who have developed…
    amp.france24.com



    Despite surging daily infections caused by the highly transmissible Delta variant, Israel's government insists it wants to avoid the hardships and developmental setbacks caused by school closures.


    Israel has already begun vaccinating children aged 12 and above.


    The national serological survey is focused on pupils between the ages of three and 12 who are not yet eligible for the jab, nearly 1.5 million children.


    It is aimed at discovering how many children developed strong antibody protection against coronavirus after having an unrecorded or latent case, according to the education ministry.


    Those children with sufficient antibodies will not be forced to quarantine when exposed to a Covid patient, a move aimed at limiting school-year disruptions.


    In a statement Sunday from the Jerusalem municipality announcing Israel's "largest serological operation", Mayor Moshe Leon urged parents to bring their children for the free 15-minute test done by finger pin-prick.


    The survey is being conducted jointly by the health and education ministries and by the army's Home Front command, which told AFP Sunday that its antibody testing operation had begun.


    At a serological testing site in the coastal city of Netanya, Zohar was pleasantly surprised to discover that her son had been infected with Covid.


    "My son got a positive result for Corona antibodies, apparently he was sick and we did not know about it," she told AFP.


    "That means now that he will get a 'green pass' and be able to go to school safely," she said.


    Her younger daughter, also tested on Sunday, did not have the antibodies.


    'Emotional damage'


    A pilot programme conducted last week focused on mainly ultra-Orthodox Jewish communities found that roughly a fifth of children had developed antibodies, army radio reported Sunday.


    Education ministry director general Yigal Slovik said in a statement last month that last year's school closures caused "emotional and social damage" to students.


    "The lockdowns and remote learning caused a 44 percent increase in referrals for suicidal risk diagnosis," among other impacts, he said.


    Israel was one of the first countries to launch a vaccination drive in mid-December via an agreement with Pfizer to obtain millions of paid vaccine doses in exchange for sharing data on their effectiveness.


    The inoculation campaign was hailed as a success story that helped drastically reduce infections, but Israel is again registering thousands of daily cases.


    As it launches the serological survey, Israel is also pushing forward with vaccinations, offering a third, or booster, shot to everyone over 40 while urging the unvaccinated to get the jab.


    More than 5.4 million of Israel's roughly 9.3 million people have received two doses of the vaccine, while 1.2 million have had a third jab.


    Israel has recorded nearly 980,000 coronavirus infections since the pandemic started early last year, and over 6,700 deaths

    Mandatory Vaccination: The Greater Evil of Society


    Mandatory Vaccination: The Greater Evil of Society
    Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite. COVID-19 has been tragic for
    trialsitenews.com


    Mandatory Vaccination: The Greater Evil of Society


    AbirBallan

    August 23, 2021

    0 Comments

    Mandatory Vaccination: The Greater Evil of Society



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


    COVID-19 has been tragic for vulnerable populations. Many of us have lost loved ones and witnessed immense suffering brought on by the direct effects of the virus and the indirect effects of the pandemic response. The unprecedented measures that were implemented almost worldwide mark a drastic departure from pre-COVID-19 public health guidelines and pandemic preparedness plans. Lockdowns shift the burden of herd immunity to “essential workers”. They fail to protect the vulnerable and kill many people by denying treatment for other diseases and harming mental health. They destroy livelihoods and cause immense collateral damage, particularly to the young and the poor.


    COVID-19 presents a serious risk of severe illness and death to the high-risk population (the elderly and individuals with multiple health problems) and a negligible risk to the vast majority of people. 95% of deaths occur in individuals with 1 or more existing health problems. As with many health issues, the social determinants of health -education, socio economic status, healthcare… have a pronounced impact on the risk from SARS-CoV-2. This is reflected in an increased risk of adverse outcomes among low income individuals, blacks and minority groups.


    Looking at the cup half full, real-life data shows that the median age of death with COVID-19 is similar to that of natural mortality in most countries. The survival rate of individuals below 70 is 99.95% . This estimate includes individuals with comorbidities, which implies that it is significantly higher for healthy individuals. Children and young people have almost zero risk of death from COVID. In fact, children are at far greater risk from the flu than from COVID.


    The epidemiological reality of COVID-19 lends itself to a focused protection approach that prioritises those most at risk while minimizing collateral harm to others. Consequently, vaccine deployment should also follow a focused vaccine approach by offering a safe and efficacious vaccine to high-risk individuals (mostly people above 50, with other health problems) when the benefit of the intervention clearly outweighs the risk. This strategy achieves the best outcome for all.


    Mandatory vaccination has no place in a free society. Public health policy should never be coercive and should always be participatory. Decisions must be made by those who have skin-in-the-game and not by bureaucrats or a conflicted elite that will never have to live with the consequences of their actions. The role of public health agencies is to provide the public with accurate information and respect individuals and communities to make their own decisions.


    Seven ethical principles of public health should be at the heart of any public health intervention: non-maleficence, beneficence, respect for autonomy, health maximisation, efficiency, justice, and proportionality. Human rights, scientific facts and common sense should also be applied.


    Ten reasons why COVID-19 vaccination should never be mandatory:


    Non-maleficence – the Hippocratic duty of ‘first, do no harm’. There is mounting evidence of serious adverse events, particularly myocarditis in the young, following COVID-19 vaccination. Adverse events reporting systems act as a signalling system so immediate action can be taken to prevent greater harm. There are currently strong enough signals to warrant an investigation. Vaccines are also contraindicated for individuals with certain health conditions. Vaccination of pregnant/breastfeeding women must be approached with great care – pregnant women were excluded from the vaccine trials; COVID-19 risk is low in healthy women of child-bearing age, while vaccine risks to the foetus/infant cannot be determined yet.

    Beneficence – the duty to produce benefit for the individual. Health interventions should be based on individual needs. Vaccination is only indicated when the intervention clearly represents a greater benefit than risk for the individual. This criteria is not met for children and young people, individuals below 60 with no existing health problems, and individuals with past SARS-CoV-2 infection (including asymptomatic infection).

    Respect for autonomy – allowing individuals to pursue their wellbeing as they perceive it. “Every person has a high value and cannot merely be treated as a means to the end of others’ good”. This entails seeking the individual’s informed consent before any medical intervention: informing them of the risks and the benefits of the intervention and getting their voluntary consent without “any element of force, fraud, deceit, duress, overreaching or other ulterior form of constraint or coercion”. Currently, individuals cannot be provided with full information on vaccine side effects as no long-term data exists yet. The results of the vaccine trials should be replicated by independent scientists prior to vaccine rollout to the high risk group. Public transparency of all efficacy and safety data is necessary.

    Health Maximisation – maximizing the health of all members of the general public requires a holistic and multi-layered approach: educating the public about a healthy lifestyle to improve their chronic illness, the importance of Vitamin D in fighting respiratory infections, the importance of home-based early treatment, the availability of life saving treatment protocols, safe and effective drugs (such as Ivermectin), as well as vaccines for the high-risk group. Vaccinating individuals who incur greater risk from the vaccine than benefit increases total harm.

    Efficiency – the duty to produce as many benefits to as many people given limited resources. Vaccinating individuals who do not benefit from the intervention diverts valuable resources away from the vulnerable as well as from far more devastating global health issues like TB, HIV, diabetes, cancer and cardiac diseases.

    Justice – all humans have equal worth and no one should be discriminated against based on their health choices. Unfair practices such as denial of services, requirements for employment, restrictions on travel, higher insurance premium for the unvaccinated create a two-tiered society. It breaks social solidarity and cohesion.

    Proportionality – the reasonable balance between the benefits and costs of an intervention in terms of individual welfare versus collective benefit. Vaccines are designed to confer protection on the vaccinated. It is unethical for a person to incur any vaccine risk or lose personal freedoms for the sake of somebody else.

    Transmission of SARS-CoV-2 can result from both vaccinated and unvaccinated individuals. The virus can also be transmitted among animals. Even if everyone is vaccinated, transmission will continue and variants will keep on evolving. A Zero COVID strategy is unrealistic and unachievable.

    Herd immunity can be reached through a combination of natural infection and vaccination. Natural immunity to SARS-CoV-2 is broad and long-lasting – more so than vaccine-induced immunity, especially in combating variants. Recovery from infection prevents serious illness if reinfected. It is not necessary to vaccinate the entire planet for the ‘greater good’ of society.

    Non-derogable rights as stated in Article 58 of the The Siracusa Principles on the Limitation and Derogation Provisions in the International Covenant on Civil and Political Rights (1958) apply under all circumstances, even under threat of ‘national security’:

    “No state party shall, even in time of emergency threatening the life of the nation, derogate from the Covenant’s guarantees of the right to life; freedom from torture, cruel, inhuman or degrading treatment or punishment, and from medical or scientific experimentation without free consent; … and freedom of thought, conscience and religion. These rights are not derogable under any conditions even for the asserted purpose of preserving the life of the nation.”


    We face two scenarios. Either the vaccines work, delivering protection to the vaccinated and eliminating the claim that everyone needs to be vaccinated. Or the vaccines don’t work, and therefore no one should get vaccinated. On both counts, vaccine passports are a pointless ‘public health’ tool that will undermine trust in the medical profession and vaccination programs. They seem to serve economic, financial, political and ideological agendas. Most fundamentally, they are unethical. They swing the gate wide open for totalitarian rule through a digital social credit system.


    Vaccine passports represent the epitome of the greater evil of society. This is the inch we must not yield.


    About the author


    Abir Ballan has a Masters in Public Health and a background in psychology, and education. She is a member of the Executive Committee at PANDA (Pandemics—Data & Analytics). She is a passionate advocate for the inclusion of students with learning difficulties in schools. She has also published 27 children’s books in Arabic. Twitter handles: @abirballan, @pandata19

    Comedy from the competition: A new twist in the Ivermectin debate


    Comedy from the competition: A new twist in the Ivermectin debate
    Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite. Eduardo Medina, an assistant
    trialsitenews.com


    Comedy from the competition: A new twist in the Ivermectin debate


    dscheim

    August 23, 2021

    0 Comments

    Comedy from the competition: A new twist in the Ivermectin debate



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


    Eduardo Medina, an assistant professor from Cali, Colombia, who has been funded by three drug companies that offer COVID-19 therapeutics in competition with ivermectin, and who received personal fees from one of these,1,2 effused alarm about ivermectin in an opinion piece in the New York Times (August 21, 2021).3 Citing reports to a poison control center in Mississippi from people who took ivermectin in unspecified animal formulations, with no resulting hospitalizations among any,4 Medina characterized ivermectin as dangerous, with several potential serious side effects.


    In fact, Ivermectin, a drug of Nobel prize-honored distinction, has been used safely in 3.7 billion doses worldwide since 1987 to treat a variety of human diseases.5-7 One of the safest drugs in modern medicine, it is well tolerated even at ten times the standard dose of 200 µg/kg,8,9 including for COVID-19 treatment.1,10 Cancer patients who were administered ivermectin at five times that standard dose daily for up to 180 consecutive days had no serious adverse effects from it, even in experimental protocols with harsh additional drugs.11 Nineteen patients who either tried to commit suicide (15) or took an accidental overdose (4) of either ivermectin or the closely related avermectin at up to 1,000 times the standard dose, using veterinary forms, had little success in harming themselves.12 Only one 72-year-old male who took 440 times the standard dose died. The others, including a 61-year-old female who took 77 times the standard dose of ivermectin, survived. Twelve of these 19 patients recovered within two days with minimal supportive care.


    Medina’s New York Times piece picked up from a press release of February 4, 2021 issued by Merck, which is developing its own COVID-19 therapeutic, molnupiravir. Merck’s press release lamented “a concerning lack of safety data in the majority of studies” of ivermectin.4 Merck was evidently troubled by the lack of safety data for ivermectin from Mars or Jupiter. Medina had previously mounted an equally clumsy effort to try to undermine ivermectin by conducting a clinical study in Cali, Columbia in which ivermectin doses were mistakenly switched with placebo doses for 38 patients, and in which blinding was grossly violated by use of sugar water as the placebo for many of the other patients.1,2 In his New York Times piece, Medina noted that ivermectin is not FDA approved for COVID treatment, but ivermectin is an FDA approved drug, and all but one of current COVID-19 treatment drugs are likewise not FDA approved for COVID and are used off label. More generally, 21% of all drug prescriptions in the US are off-label.13,14 It is clear that Medina and his industry sponsors are alarmed indeed as to the dangers posed by ivermectin to their billions in planned profits by ivermectin’s increasingly successful use for COVID-19 treatment worldwide.


    To consider the safety and efficacy data for ivermectin treatment of COVID-19 based upon peer-reviewed scientific publications rather than regurgitated drug company press releases, this recently published paper, https://doi.org/10.1016/j.nmni.2021.100924,15 provides a concise review.


    David E. Scheim, PhD


    US Public Health Service, Commissioned Corps, Inactive Reserve


    [email protected]


    1. López-Medina E, López P, Hurtado IC, et al. Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild COVID-19: A Randomized Clinical Trial. JAMA. 2021;10.1001/jama.2021.3071.


    2. Scheim DE, Hibberd JA, Chamie JJ. Protocol violations in López-Medina et al.: 38 switched ivermectin (IVM) and placebo doses, failure of blinding, ubiquitous IVM use OTC in Cali, and nearly identical AEs for the IVM and control groups. OSF Preprints. https://doi.org/10.31219/osf.io/u7ewz. Published 2021. Accessed August 22, 2021.


    3. Medina E. Health officials warn people not to treat Covid with a drug meant for livestock. New York Times. August 21, 2021. https://www.nytimes.com/2021/0…orld/ivermectin-fda-covid 19-treatment.html.


    4. Mississippi State Department of Health. Increased Poison Control Calls due to Ivermectin Ingestion and Potential Toxicity. https://msdh.ms.gov/msdhsite/_static/resources/15400.pdf. Published August 20, 2021. Accessed August 22, 2021.


    5. Yagisawa M, Foster PJ, Hanaki H, et al. Global Trends in Clinical Studies of Ivermectin in COVID 19. The Japanese Journal of Antibiotics. 2021;74(1).


    6. Campbell WC. History of avermectin and ivermectin, with notes on the history of other macrocyclic lactone antiparasitic agents. Curr Pharm Biotechnol. 2012;13(6):853-865.


    7. Crump A. Ivermectin: enigmatic multifaceted ‘wonder’ drug continues to surprise and exceed expectations. J Antibiot (Tokyo). 2017;70(5):495-505.


    8. Guzzo CA, Furtek CI, Porras AG, et al. Safety, tolerability, and pharmacokinetics of escalating high doses of ivermectin in healthy adult subjects. J Clin Pharmacol. 2002;42(10):1122-1133.


    9. Navarro M, Camprubí D, Requena-Méndez A, et al. Safety of high-dose ivermectin: a systematic review and meta-analysis. Journal of Antimicrobial Chemotherapy. 2020;75(4):827-834.


    10. Krolewiecki A, Lifschitz A, Moragas M, et al. Antiviral effect of high-dose ivermectin in adults with COVID-19: A proof-of-concept randomized trial. EClinicalMedicine. 2021;37.


    11. de Castro CG, Jr., Gregianin LJ, Burger JA. Continuous high-dose ivermectin appears to be safe in patients with acute myelogenous leukemia and could inform clinical repurposing for COVID-19 infection. Leuk Lymphoma. 2020;61(10):2536-2537.


    12. Chung K, Yang CC, Wu ML, et al. Agricultural avermectins: an uncommon but potentially fatal cause of pesticide poisoning. Ann Emerg Med. 1999;34(1):51-57.


    13. Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med. 2006;166(9):1021-1026.


    14. Stafford RS. Regulating Off-Label Drug Use — Rethinking the Role of the FDA. N Engl J Med. 2008;358(14):1427-1429.


    15. Santin AD, Scheim DE, McCullough PA, et al. Ivermectin: a multifaceted drug of Nobel prize honored distinction with indicated efficacy against a new global scourge, COVID-19. New Microbes and New Infections. 2021;https://doi.org/10.1016/j.nmni.2021.100924:100924


    You all I hope all remember Luc Montaigner who went off the rails proposing DNA that could teleport through some unevidenced quantum mechanism. More on him here.


    Addressing Geert Vanden Bossche’s Claims — Deplatform Disease
    The short version : Geert Vanden Bossche has recently published a letter in which he argues that the vaccination campaign against COVID-19 is going to…
    www.deplatformdisease.com


    (see link for pics as well as text)


    Short Version


    Geert Vanden Bossche has recently published a letter in which he argues that the vaccination campaign against COVID-19 is going to precipitate a public health disaster because the vaccines will select for viral variants that can escape their protection and drive them towards higher virulence. His claims are speculative, he offers no evidence to support his arguments, and makes several comments which are blatantly incorrect. The core of his argument relies on the assumption that COVID-19 vaccines do not have a significant effect on transmission. This has been repeatedly confirmed to be false in multiple studies. Furthermore, even if his assumptions about the effects of the vaccine on transmission are true, his conclusions are incorrect based on established precedent from Marek’s disease, a viral illness of birds with a vaccine that does not strongly affect transmission- but it still shows meaningful public health benefits in the populations of chickens where it is used. The vaccines will absolutely be critical to ending the pandemic, and fortunately the modular nature of the technology allows for rapid reformulation and adjustment as necessary (and thus far, though precautions are being taken with novel variants to produce vaccines specific to their set of problematic mutations, there isn’t significant enough evidence to suggest that total reformulation of the vaccines is needed), but no issues raised in this letter warrant a re-evaluation of our current COVID-19 vaccination policy.


    Details


    I won’t be addressing the contents of Dr. Vanden Bossche’s resume as it’s irrelevant to the fact that he is currently making unsupportable claims, but for those seeking a backgrounder on the subject, Dr. Iannelli has graciously obliged. I also won’t be linking to his original letter.

    I’ll be blunt: there is very little within this letter that is even close to being correct, and there is almost no evidence presented to support any of its claims. I’ll now go through it point-by-point to explain where it’s wrong.

    It's not exactly rocket science, it’s a basic principle taught in a student’s first vaccinology class: One shouldn’t use a prophylactic vaccine in populations exposed to high infectious pressure (which is now certainly the case as multiple highly infectious variants are currently circulating in many parts of the world).

    There is no such principle. It in fact directly goes against current policies for responding to outbreaks of e.g. measles, mumps, meningococcal disease, etc. and more generally is directly at odds with the incredibly effective ring vaccination strategy.

    ###b class=" sqs-block-image-button lightbox " data-description="###https://www.nature.com/articles/s41586-021-03324-6.pdf Figure 1i; note that in some individuals there is preserved antibody neutralization with the constellation of problematic mutations in the spike protein that are noted to reduce binding affinity. Red circles indicate that the patient received Pfizer’s vaccine while white circles indicate Moderna’s vaccine.


    Wang Z, Schmidt F, Weisblum Y, et al. mRNA vaccine-elicited antibodies to SARS-CoV-2 and circulating variants. Nature [Internet] 2021;Available from: https://www.nature.com/articles/s41586-021-03324-6.pdf Figure 1i; note that in some individuals there is preserved antibody neutralization with the constellation of problematic mutations in the spike protein that are noted to reduce binding affinity. Red circles indicate that the patient received Pfizer’s vaccine while white circles indicate Moderna’s vaccine.

    To fully escape selective immune pressure exerted by vaccinal antibodies, Covid-19, a highly mutable virus, only needs to add another few mutations in its receptor-binding domain

    COVID-19 is a clinical syndrome, and therefore incapable of mutating; the virus causing it is SARS-CoV-2.


    This claim remains to be substantiated and in fact has considerable evidence against it. While it’s true that variants of concern demonstrate reduced antibody neutralization, we do not have an absolute correlate for which antibody levels would be protective and therefore the meaning of this is hard to determine. The antibody titers induced by the vaccines are MUCH higher than those seen with infection, and we see hallmarks of memory responses induced by these vaccines from even a single dose, meaning that even though there is a drop in neutralization, it may not mean a loss in protection. Novavax’s recent Phase 3 clinical trial did show reduced efficacy against B.1.351 which has a constellation of problematic mutations that manage to reduce antibody binding affinity and also increase affinity for ACE2, however the key point is that: no one in the vaccinated group developed severe disease. The simplest explanation I can propose for this is: there is no significant change to the T cell response with the variants in either recovered or vaccinated individuals and T cell responses are critical determinants of patient clinical course. Importantly, it is possible that vaccines may simply need a bit more time for high-affinity antibodies against the variants to be generated (see “affinity maturation”; also addressed in more detail in the context of HIV here). It is also worth noting that in studies examining the antibody responses to variants of concern, some individuals do already exhibit antibodies that cross-neutralize problematic strains at similar levels. Nonetheless, it is not as though we are sitting idle and allowing SARS-CoV-2 to accumulate escape mutations. For one thing, Moderna has completed enrollment of a phase 1 trial for a variant-specific mRNA vaccine targeting B.1.351 which bears a constellation of concerning mutations in its spike protein shown to dramatically reduce antibody binding. Evidence has already confirmed that antibodies against B.1.351 cross-neutralize with ancestral variants. Pfizer and Novavax are also working on updated vaccines against the variants of concern in case they may be needed. Critically, it would seem that immunocompromised individuals are critical in the evolution of problematic SARS-CoV-2 variants, and thus protecting them from infection is imperative (and a vaccination strategy -our current vaccination strategy- will play a key role in that, but I’ll revisit this shortly when discussing evidence for the effects of the vaccines on transmission).

    Not only would people lose vaccine-mediated protection but also their precious, variant-nonspecific (!), innate immunity will be gone (this is because vaccinal antibodies outcompete natural antibodies for binding to Covid-19, even when their affinity for the viral variant is relatively low).

    This is absolute, unvarnished nonsense. Bossche is referencing the production of natural IgM, which is generated by B1-B cells as a stopgap measure against infections until more potent responses can be initiated; these antibodies are polyreactive, nonspecific, and critically: constitutively produced. They are always present for as long as B1-B cells generating them live. IgM is pentameric and thus even though it has lower affinity than antibodies that have had the opportunity to evolve superior binding affinity, it can compensate with the fact that it has 10 binding sites instead of 2. However, IgG antibodies bear many of the same effector functions (actually, they tend to be better at many of them, as Table 10.27 shows) and they can diffuse into extravascular sites unlike IgM. Principally, antibodies against SARS-CoV-2 could be of value if they are neutralizing. Bossche presents no evidence to support that natural IgM is neutralizing (rather than just binding) SARS-CoV-2.

    Bossche subsequently goes on to define:

    *NACs: Natural asymptomatic carriers ; refers to subjects who do not develop any clinical symptoms at all, or develop at most mild (involving upper respiratory airways only), after PRIMARY CoV infection
    **nonNACs: Relates to subjects who develop severe Covid-19 symptoms after PRIMARY infection

    Firstly, an asymptomatic patient does not develop mild symptoms. This is not what asymptomatic means. An asymptomatic patient does not develop ANY symptoms. There is another term -paucisymptomatic- which describes individuals who develop only mild disease.

    He then argues that in NACs, the reason for their lack of progression to the disease state is a rapid NK cell response that clears the virus. This is possible, but he presents no evidence to support it. Current models attribute the lack of progression to (severe) disease in these patients to a rapid interferon response, and while interferon responses can promote NK cell activity to clear virally infected cells, the literature does not discuss a role for the cells, given that interferon can induce direct intracellular effectors that suppress viral replication and furthermore the presence of antibodies among asymptomatic individuals. Overexuberant NK cell responses are implicated in the development of severe COVID-19: afucosylated antibodies are extremely potent inducers of NK cell antibody-dependent cellular cytotoxicity (ADCC), and these are noted to be enriched in severe COVID-19. NK cell-mediated ADCC is extremely powerful for controlling viral infections, particularly before the adaptive immune system gets an opportunity to produce its effectors, and afucosylated antibodies are valuable players in that process, but the inflammation that results can be harmful to the health of the host if uncontrolled, such as if SARS-CoV-2 is given an opportunity to replicate extensively in a host, as might be the case in an individual whose immune system has not been primed against the virus with vaccination.

    He then commits an immunological faux pas so egregious that it genuinely shocks me where he shows a dendritic cell (DC) activating an NK cell via antigen presentation on an MHC class I protein. It is basically at this point that I cannot presume that this letter is written in good faith given Dr. Bossche’s background. This is absolutely not how NK cells work. For one thing, the presence of MHC class I protein on a cell indicates to an NK cell that no viral infection is present and functions as an inhibitory signal (indeed, it is a common feature that viruses suppress expression of MHC class I proteins on cells they infect because this prevents them from being recognized by cytotoxic T cells that can kill the cell they are relying on to replicate). For another, NK cells do not examine the contents of the antigen in the MHC binding cleft. They do not have T cell receptors (with the exception of iNKT cells) and therefore have no ability to do this. There ARE reciprocal NK cell-DC interactions where each supports the other (e.g. DCs may produce cytokines promoting the activation of NK cells and NK cell cytokines can promote DC maturation, and NK cells have been known to kill immature dendritic cells in the body) but the mechanism proposed here is overtly at odds with decades of immunology research.

    Frankly, to focus on NK cells for a vaccine against an infectious disease is extremely unusual (they can be very important in cancer immunotherapy though). The goal of vaccines broadly is to elicit long-lived immunological memory against a particular infectious agent. NK cells are part of the innate immune system, and while they do exhibit epigenetic modifications after infection in what has been termed trained immunity, this is not the principle by which most vaccines work. Vaccines have to achieve robust activation of dendritic cells because they are key antigen presenting cells and they need to trigger generation of memory helper T cells, ideally T follicular helper cells, memory B cells, long-lived plasma cells, and potentially cytotoxic T cells (depending on the agent)- they act virtually independently of NK cells (though NK cells may play a supportive role through ADCC on challenge with the antigen).

    It is very much downhill from here. While he does not use the term, the rest of the argument Bossche makes relies on a false assumption: currently available vaccines for COVID-19 are leaky vaccines. Correlates of vaccine-induced protection: methods and implications defines leaky vaccines as follows:

    According to [the leaky vaccine model], the risk of infection/disease in all vaccinees is reduced (by VE %) compared to non-vaccinees, none of the vaccinees being fully protected.
    The assumption that no vaccinee is totally or permanently protected implies one or both of the following:
    i) No amount (titre) of the immune marker is totally protective or, if it is, no individual can maintain that titre for a long period (because of waning or transient immunosuppression);
    ii) The degree of protection is a function of the level of the immune marker – the simplest explanation being that protection is a function of both the level of the immune marker and the challenge dose.

    In other words, leaky vaccines are vaccines which are not able to significantly affect transmission of the pathogen. The critical question here is firstly: are COVID-19 vaccines leaky vaccines?

    1. This study compared PCR positivity among asymptomatic individuals who had received an RNA vaccine to those who had not been vaccinated and found it was approximately 80% lower. This is a very strict bar and it likely underestimates the ability of the vaccines to reduce transmission, because PCR can detect as few as ~100 copies of viral RNA. SARS-CoV-2, being a coronavirus, likely requires several hundred viral copies to initiate productive infections from one person to the next. An asymptomatic individual who tests positive may not necessarily be contagious.
    2. Novavax’s vaccine demonstrated sterilizing immunity (the virus failed to even initiate infection) in nonhuman primate studies.
    3. ChAdOx-nCoV-2019 also showed significant reductions in PCR positivity among vaccinees compared with unvaccinated controls.
    4. The SIREN study showed that Pfizer’s vaccine prevents infection with B.1.1.7 variants.
    5. Pfizer’s vaccine was able to reduce viral load by a factor of about 4 among vaccinees compared with unvaccinated controls.
    6. The Johnson and Johnson/Janssen vaccine showed significant reductions in PCR positivity among vaccinees compared with controls.

    And so on. In short, nothing about the COVID-19 vaccines suggests that they are leaky.

    For a moment though, let’s entertain the notion that the vaccines are leaky. In general, you would have a hard time identifying any human vaccine that could be called leaky (though emerging findings regarding influenza vaccines give hints that there may be a leaky vaccine effect involved, given their excellent efficacy among children, who are critical vectors, I am not so convinced- though if we do grant that they are leaky, this only serves to undermine Bossche’s argument). The classic example of a leaky vaccine is actually the one for Marek’s disease, caused by a herpesvirus that infects chicken and causes lymphoma among other illnesses. It has been observed that over time Marek’s disease virus has become more virulent, and this has been attributed classically to a leaky vaccine effect. Still, as Osterrieder et al write (emphasis mine):

    Box 2 | Marek’s disease vaccines — an open-ended success story Immunization against Marek’s disease (MD) was started in the late 1960s and first used avirulent Marek’s disease virus (MDV) or a virus very closely related to MDV, turkey herpesvirus 1 (HVT), which does not cause disease. Vaccination reduced the incidence of MD by 99% and presents a unique example of the successful application of a modified-live virus (MLV) vaccine against an extremely aggressive agent that can routinely causes >90% morbidity and mortality in susceptible, unvaccinated hosts7,116. Because MDV strains are constantly evolving towards greater virulence in the face of vaccination109 (BOX 1), combination vaccines consisting of HVT and gallid herpesvirus type 3 or an attenuated MDV strain, CVI988-Rispens, are currently used117–119.

    Clearly then, even a leaky vaccine can be used with great efficacy. What’s more is there is new research challenging the dogma of leaky vaccines selecting for greater virulence (emphasis mine):

    We used controlled experiments involving natural virus transmission to reveal that vaccination with a leaky vaccine, which only marginally reduces transmission, can significantly reduce post-transmission disease development and mortality among unvaccinated contact individuals. Our analysis indicates that this effect is mediated by a reduction in exposure dose experienced by susceptible individuals when exposed to vaccinated shedders, leading to lower pathogen load and concomitant reduced symptoms in contact birds. The primary objectives of vaccination of livestock with leaky vaccines are to improve animal welfare and to reduce production losses caused by disease symptom development. Our results show that even partial vaccination against MD can substantially reduce disease symptoms and mortality in the whole flock, leading to universally positive impacts on animal welfare and productivity, and these conclusions may extend to leaky vaccines used in other systems.

    Ending COVID-19 will require vaccination- this is not a matter of debate or discussion. Viruses evolve towards greater transmissibility, but they cannot evolve unless they have hosts. Fortunately, SARS-CoV-2 and other coronaviruses are unique in that they have a proofreading RNA-dependent RNA polymerase that slows mutation rates by a factor of about 20, which means they are slower to mutate, but this is irrelevant if they can infect well over 20 times more people than other RNA viruses. Vaccines clearly reduce viral load, prevent severe disease, and disrupt transmission, and they can thankfully be readily modified to address problematic variants as is done every season for influenza with great effect. They are the way out until someone proposes something better. Bossche doesn’t and his claims are baseless.

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    TrialSite Reviews NPR’s Take on Why Highly Vaccinated Israel Experiences the Latest Surge


    TrialSite Reviews NPR’s Take on Why Highly Vaccinated Israel Experiences the Latest Surge
    The COVID-19 pandemic continues to rage in Israel despite high levels of vaccination. This fourth surge could become the most severe as measured by the
    trialsitenews.com



    TrialSite Staff

    August 23, 2021

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    TrialSite Reviews NPR’s Take on Why Highly Vaccinated Israel Experiences the Latest Surge



    The COVID-19 pandemic continues to rage in Israel despite high levels of vaccination. This fourth surge could become the most severe as measured by the average number of daily new cases should the rise in infections continue. Given the nation’s high overall vaccination rate, especially among at-risk demographic cohorts, the world watches Israel as it serves as an early warning indicator as to what may come in highly vaccinated places during this pandemic. TrialSite has reported on the surge of breakthrough cases, including numbers of breakthrough hospitalizations. With an unprecedented nationwide vaccine booster initiative—just six months since many are already receiving their second shot—ever-growing numbers of people want to understand why this is occurring. NPR’s All Things Considered recently covered the topic. Led by Daniel Estrin, this media source declared six (6) lessons are apparent from the experience of Israel to date, including 1) Waning vaccine immunity, 2) Stronger variants capable of overcoming the vaccine, 3) Vaccination reduces risks of more severe problems, 4) the present-day vaccination rate in Israel isn’t sufficient, 5) Better adherence to measures such as social distancing plus isolating “Palestinian hesitancy,” and 6) need for booster shots.


    NPR actually stands for National Public Radio, replacing its predecessor organization, the National Educational Radio Network, which was initiated in 1970, after the Public Broadcasting Act of 1967 was signed into law by President Lyndon B. Johnson establishing the Corporation for Public Broadcasting and Public Broadcasting Services (PBS) for television. NPR produces and distributes news and cultural programming with public and private financing, including the renowned show All things Considered.


    TrialSite recently probed NPR’s Daniel Estrin’s “six lessons learned” for education, enlightenment, and hopefully clarity.


    Underlying the first lesson, that “Immunity from the vaccine dips over time,” of course, didn’t come to us as a surprise. Many critics called out the fact that we don’t know how long the vaccines effectively would last. After all, technically, the clinical trials for these vaccines are still ongoing. Although the U.S. Food and Drug Administration (FDA) could later today change this status for at least one of the vaccines, Pfizer’s BNT162b2, with the prospect of full regulatory approval imminent. TrialSite reports concerns with lack of transparency and undue acceleration for political purposes.


    Estrin points to the second lesson as the “perfect storm,” that is, “The delta variant broke through the vaccine’s waning protection.” Coronaviruses mutate, and many scientists, virologists, and others have suggested variants will overcome present vaccines. Some scientists, while not popular, even suggest that the vaccination can trigger mutation, while the dominant narrative seems to be the opposite.


    The All Things Considered show reminded all in the third point that vaccinated people experience less severe symptoms, including hospitalization, than the unvaccinated. Selecting data from last Thursday, the NPR host declares Israel Health Ministry data reveals that unvaccinated patients over 60 experience serious cases nine times more than vaccinated. The rate of severe cases for that Thursday among unvaccinated people under 60 was only twice that of the vaccinated.


    Estrin acknowledges that “half of Israel’s seriously ill patients who are currently hospitalized were fully vaccinated at least five months ago. Most of them are over 60 and have comorbidities.” While he pointed out that among the unvaccinated, they find more serious cases involving hospitalization.


    Key in NPR’s interpretation for the challenges that lie ahead are reflected in the fourth point, “Israel’s high vaccination rate isn’t enough,” indicating the media’s 100% commitment to a vaccine-centric strategy.


    Despite 78% of eligible Israelis over 12 being vaccinated, only 58% of the total population is vaccinated, and NPR’s Estrin shared, “Experts say that’s not nearly enough.” In what continues to be a universal message among governments, academics, and the behind-the-scenes industry, Estrin refers to a Weizmann Institute of Science computational biologists, an academician, Eran Segal, an expert in quantitative models but not real-world public health and epidemiology, nor a medical doctor. Segal announced, “We have a large fraction of our population who are paying the price for a small fraction of the population who did not get the vaccine.”


    Of course, this fits squarely into the “Pandemic of the unvaccinated,” which at least some American leadership is carefully trying to backtrack from, as transmissibility among the vaccinated is now commonplace.


    Here NPR explicitly aligns with and reinforces what a growing number of concerned doctors, scientists, and public health professionals believe is an incorrect assessment of the problem. After all, while unvaccinated people may pay the price by getting sicker, TrialSite suggests Estrin’s claim that “Unvaccinated people helped fuel the rapid spread of the virus” is not proven.


    Interestingly, NPR’s fifth lesson, “Vaccinations are key, but they are not enough,” confused us more than added clarity. While Estrin acknowledges that further lockdowns can “destroy the future of the country,” importantly, the country’s health authorities issue edicts to control the spread of the disease, such as “placing caps on gathering, increasing hospital staff and pleading for unvaccinated people to get immunized.” But again, as we mentioned previously, the virulent variant combined with waning vaccine effectiveness led to what appears to be substantial rates of transmissibility among the inoculated.


    Estrin points them to Palestinians and the fact that only 8% of that population has actually been vaccinated. Estrin does acknowledge that “Palestinians are “not a source of transmission in Israel” because “Only vaccinated Palestinians” access permits to get into the country in the first place. Yet again, the NPR host omits the fact that the vaccinated now can serve as viral vectors. NPR then emphasizes the “vaccine hesitancy” among the Palestinians according to a World Health Organization representative.


    Interestingly, Estrin omits important information involving vaccine equity and unequal distribution of the current spike. First, the aggressive vaccine campaign in Israel completely excluded this group, as reported by The Guardian, declaring the highly unequal vaccination push around the world was mirrored by the situation in Israel and the Palestinian territories, providing “a stark example of the divide.” By February 2020, an article in The Lancet declared, “Ensure Palestinians have Access to COVID-19 Vaccines.” Apparently, the rollout precluded that minority group for a substantial while, when access was afforded only for the less desirable vaccine product.


    An anomaly not explained by Estrin concerns the unequal distribution of COVID-19 infections in Israel and adjacent Palestine territories. As the pandemic reaches possibly new record highs in heavily-vaccinated Israel, Palestinian head to near-record low cases. That’s right; presently, according to data from Reuters, cases in Palestinian territories are at 29% of the peak.


    How can Israel, with such a highly vaccinated population, experience such a spike along with a substantial breakthrough infection rate, while a group directly adjacent is at a near low point during the pandemic with only an 8% vaccination rate? What explains this dynamic, and why isn’t it discussed more? While an overall theme in the NPR piece is that universal vaccination is the answer to overcome at least the present surge in Israel, this doesn’t necessarily align with unfolding realities.


    The NPR point of view continued in their sixth and final lesson thus far, that “Booster shots offer more protection—if you are one of the world’s lucky few to get them.” With Israel representing the world’s first major booster program, Estrin first immediately legitimizes this approach by introducing preliminary research from Maccabi Healthcare Services, a national HMO, that led a preliminary study showing high effectivity rates associated with booster shots. Declaring the data associated with boosters from Pfizer and Moderna “provides a glimpse at booster effects in a real-world setting,” he also shared that Israel will include boosters for people as young as 40.


    Maccabi executive Anat Ekka Zohar is convinced even though the data is preliminary and only has a “glimpse” into the situation. Ms. Zohar announced, “The triple dose is the solution to curbing the current infection outbreak.” While the NPR piece does at least introduce the prospect continuous six month boosters the host reminds all that according to unnamed experts those “countries that do not vaccinate their population, more variants will develop, threatening even vaccinated nations.”


    Some Final Thoughts & Questions

    Premised on the increasingly questionable assumption that vaccination is the answer to overcoming viral transmission, NPR’s answers disappoint. Although they acknowledge growing breakthrough cases, they still defer to experts that propagate the “pandemic of the unvaccinated” message. Again, this argument weakens as we know the vaccinated serve as vectors in many cases.


    While Estrin acknowledges health inequity as a concern worldwide, he makes no mention that Palestinians were precluded from the first waves of vaccination. While emphasizing that more Palestinians need to get inoculated, the media doesn’t bother to look at the extreme difference in COVID-19 rates in those territories, where infections have dipped to nearly a fifth of the peak.


    While the esteemed NPR show does at least raise the concern of continuous boosters they don’t probe into the possible problems associated with that direction, nor do they remind that the vaccine effectiveness could continue to diminish. Estrin refers to an executive from an HMO that believes the booster is the absolute answer to the present problem based on early data from a preliminary study. NPR doesn’t really question this. But they do refer to another Maccabi representative, Ido Hadari, who did declare in regards to a regular six month COVID-19 vaccine booster program, “I don’t know of any disease where we are vaccinated every six months, and to be honest, I don’t think the public will come to get vaccinated every six months.”


    Ido Hadari, of HMO Maccabi, questioned whether regular shots will become the norm. “I don’t know of any disease where we are vaccinated every six months, and to be honest, I don’t think the public will come to get vaccinated every six months,” Hadari said. “But you cannot predict anything with this disease.”

    A related analysis


    Israeli data: How can efficacy vs. severe disease be strong when 60% of hospitalized are vaccinated?


    Israeli data: How can efficacy vs. severe disease be strong when 60% of hospitalized are vaccinated?
    A surge involving the rapidly-transmitting Delta variant in heavily vaccinated countries has led to much hand-wringing that the vaccines are not effective…
    www.covid-datascience.com


    If you just run the raw numbers for "severe disease" .... Pfizer efficacy comes in at 67.5%

    But that's an example of "Simpson's Paradox" -- when you don't take into account the greatly differing risks and vaccinations status by age.


    If you re-analyze by age, the lowest efficacy is 81.1% (80-89) and many age brackets are 100%

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