Covid-19 News


  • I love the way TSN misdirects its readership through omission and damning with faint praise. I actually find the TSN editorial slant here DDD (despicable, deceitful and dangerous). So even though 50% of the content in that article I like, overall it is not a helpful contribution.


    In this case what it omits is that the Norwegian system, like many, is a no-fault compensation system. In other wards, if something bad happens to you that might possibly be due to some medical treatment, you do not seek to establish whether this is really true, but pay up anyway. out of insurance money provided by govt or industry.


    I think these are great schemes:

    • avoids feeding lawyers
    • compensates people for tragic no fault of their own losses
    • keeps legal battles out of medicine


    Anyway there is extra reason to want such schemes for COVID vaccination:


    DEFINE_ME


    No-fault compensation schemes for severe adverse events can help build confidence in vaccine safety after marketing.1
    25 of the 194 WHO member states have implemented such no-fault vaccine injury compensation programmes.2
    Although the USA is covering COVID-19 vaccine-associated adverse events with the US Countermeasures Injury Compensation Program (CICP) for the duration of the public health emergency declaration, the country is having challenging issues as CICP does not have the ease of access to, and levels of compensation provided by the US National Vaccine Injury Compensation Program available at normal times, exacerbating long-standing inequities based on income, race, and ethnicity.3

    Japan has a long-established no-fault compensation scheme for people who have adverse drug reactions from vaccines or drugs. The vaccine health damage relief system (a no-fault compensation scheme authorised by the Immunisation Act of 1976 is managed by the Japanese Ministry of Health, Labour and Welfare (MHLW) and prefectural governments.4
    Between February, 1977, and December, 2019, 3419 people were certified by the MHLW.5
    In fiscal year 2019, the MHLW received 134 health damage relief claims of which 88 were certified; the annual MHLW budget for these claims in 2019 was US$10·8 million.5


    Japan is unique in that it has a no-fault compensation scheme for drugs financed mainly by contribution from pharmaceutical companies. France, Germany, New Zealand, Taiwan, Denmark, Norway, Sweden, and Finland have similar systems.6
    In Japan, the scheme for drugs was introduced in 1979 and is authorised by the Pharmaceuticals and Medical Devices Agency (PMDA).7
    In fiscal year 2019, the PMDA received 1590 relief claims, 1285 of which were certified, and US$22·6 million was paid within the same fiscal year.8

    The COVID-19 pandemic presents an opportunity not only for vaccines, but also for covering drugs under no-fault compensation schemes.



  • I know people say that no-one here is anti-vax. In that case why do they go on posting anti-vax links as above which are bat-crazy? I mean, i can understand taking a balanced bview, but this is not that...


    It you read it, the telltale sign of a view (mRNA vaccines are bad) seeking evidence is pretty clear - with a scattergun approach that rolls together a whole load of different alarmist and un-evidenced speculations. I thought I'd shown you another example of Seneff craziness to provide some context:


    MIT Screwball Blames Glyphosate for COVID, and Everything Else
    Q: Where do you go to find overpaid, under-sane professors, talking about chemistry when they know nothing about it? A: MIT, the home of Dr. Stephanie Seneff,…
    www.acsh.org

    When I saw that Dr. Stephanie Seneff, a seriously flipped out professor at MIT, wrote an article entitled Connecting the Dots: Glyphosate and COVID-19 I knew this was going to be fun. And the fact the article was on a blog page hosted by Jennifer Margulis, an alternative medicine aficionado, who hates chemicals because they're not natural, made me drool (a little more than usual). After all, I had some fun with Senneff in 2017 when she claimed that half of the American children will be autistic by 2025 because of glyphosate. Right, and I'm Wilma Flintstone.

    An anti-glyphosate article by Seneff is about a surprising as a cockroach in a Manhattan restaurant. But this one is special. Seneff performs a series of exorcism-like "logical" gyrations to support her claim that the COVID pandemic is a result of...glyphosphate. I s##t you not.

    Before we get started, let's examine why Dr. Seneff is uniquely unqualified to be writing about medicine, chemistry, or toxicology. She is not an M.D.; far from it. Senneff's advanced degrees include M.S. and E.E. degrees in Electrical Engineering, and Ph.D. in Electrical Engineering and Computer Science. Her position is Senior Research Scientist at the Computer Science and Artificial Intelligence Laboratory at MIT, which can only lead me to conclude that I should have an electrician remove my gallbladder.

    "Connecting the Dots: Glyphosate and COVID-19" is a 5925-word masterpiece consisting of embarrassingly terrible science, paranoid conspiracy theories, and some really good yuks. Let's get started with Margulis' introduction:

    "Are glyphosate and COVID-19 connected"

    Yes, they are. They both contain the letter "O."

    "Glyphosate, one of the most toxic chemicals in the world..." (Margulis)

    This is just a teensy bit inaccurate. Glyphosate is one of the least toxic chemicals you'll ever come across. I'll even supply some data, you know, that stuff that scientists are supposed to use to use to draw conclusions, to back this up (Table 1).

    Screen%20Shot%202020-04-13%20at%203.37.26%20PM.png

    Table 1. Relative oral acute toxicity of some common substances in rats. Source: US National Library of Medicine (NIH). *The LD50 (in milligrams of the chemical per weight of the animal in kilograms) is the single dose of the substance that will kill 50% of the rats when administered orally. The lower the LD50 the more toxic the chemical. Glyphosate, which can be found right near the top of the table (the safest chemicals), is a bit more toxic than ethanol (alcohol) and a little less so than salt.

    So much for that claim. All the remaining quotes come from Seneff.

    SS: "My research strongly suggests that glyphosate (the active ingredient in the weed killer Roundup) is a primary cause of the autism epidemic in the United States."

    Well, this is a bit odd because in 2012 Seneff wrote:

    "Our results provide strong evidence supporting a link between autism and the aluminum in vaccines"

    So, what really causes autism? Is it glyphosate? Vaccines? Pop-Tarts?

    (Now we begin to enter Crazyville)

    SS: "When the COVID-19 pandemic began its march across the world, I started to consider whether glyphosate might play a role."

    No way. It's the Pop-Tarts. I have evidence. At least one person who died from COVID ate a Pop-Tart.

    SS: "Corona viruses [sic] are the cause of the common cold"

    Well, that's not exactly true. Harvard Medical School seems to disagree: "The virus family that causes the most colds is called rhinovirus."

    SS: Robert and Elizabeth Mar were a couple who lived in Seattle... tragically, they both succumbed to COVID-19 and died within two days of each other... but perhaps a more significant factor was the fact that [the restaurant [they owned] was located just a few blocks from Interstate 5, an 8-lane highway where trucks, buses, and cars passed by all day long, spewing out toxic exhaust fumes.

    I could be wrong, but:

    1. Both of the victims were in their 70s. There is no question that age is one of the primary risk factors in death from COVID.
    2. The Mars are probably not the only people in the world who lived or worked near a highway.
    3. It is probably not difficult to find two people living near a highway that didn't die from coronavirus...
    4. ...as well as two people who died from the infection who lived nowhere near a highway.
    5. No matter what did or did not happen to them, there is not one single conclusion that can be drawn from one story about one couple.

    So, what does this have to do with glyphosate? (prepare yourself)

    SS: "My hypothesis is that the biofuel industry is inadvertently introducing glyphosate into fuels that power our cars, trucks, buses, airplanes, and ships"

    Her hypothesis is not accompanied by one single piece of data. None. Just speculation.

    My own hypothesis is that I'll be spending New Year's Eve in a hot tub with a zebra. I have no data either, however, my hypothesis is more likely to be true.

    Screen%20Shot%202020-04-12%20at%205.45.35%20PM.png

    SS: "Carbon emissions have become a focal issue in the fight to reverse climate change. One promising approach has been to convert waste biomass into oil-based fuels to augment diesel fuel...waste vegetable oils, such as olive oil...woody biomass..and the stalks of corn and wheat post-harvest into biodiesel fuel...All of these sources can be expected to be contaminated with glyphosate."

    Once again, no data. No measurement of any fuel, no nothing. Pure speculation. How much biofuel is used in the US? Has anyone ever measured the amount glyphosate in the biofuel that may or may not be used? Just a crazy assumption.

    SS: "In high doses, it is clear that glyphosate has a profound damaging effect on the lungs, even when taken orally. We know that a farmer who tried to commit suicide by drinking a cup of a glyphosate-containing herbicide formulation..."

    A couple of problems here.

    1. Please tell me what intentionally drinking a glass of the stuff has to do with minuscule (if any - we don't know) amount that may or may be found in biofuels that may or may not be used in unknown quantities.
    2. Note the term glyphosate-containing herbicide formulation. There are a number of surfactants (1) that are mixed with glyphosate that turn it into Roundup. Was it the surfactant or the glyphosate that failed to kill the farmer?

    (It gets worse... e-cigarettes)

    SS: "[A] newly emergent disease has been given the name, E-cigarette, or Vaping, Product Use-Associated Lung Injury (EVALI)... The symptoms of COVID-19 are remarkably similar to the symptoms of EVALI."

    Do you see where this is going?

    SS: "Propylene glycol and glycerol are important additives in e-cigarettes. These are often sourced from waste from the biodiesel manufacturing process."

    Aha! So, people are getting sick from e-cigarettes because there might be a molecule of non-toxic glyphosate in the propylene glycol and glycerol (nicotine carriers) in the device because the two chemicals might come from biomass.

    SS: Furthermore, vitamin E acetate is sometimes used as a thickening agent in e-cigarette production, and it has been identified as a candidate source of the lung problems associated with vaping, although no biological mechanism has been offered

    Actually, that's wrong. I offered one (based on chemistry) and it turned out to be correct. But, why is she picking on vitamin E acetate? The same twisted reasoning...

    What scientists are missing is that vitamin E is commonly sourced from soybean oil, probably from GMO “Roundup-ready” soybeans... And the biodiesel fuel industry relies on the debris on GMO roundup-ready corn fields...sprayed with glyphosate just before the harvest. Since vaping involves heat, vapors are released that likely contain vaporized glyphosate, which is then breathed into the lungs and directly impacts the lung tissues.

    Yep, it's the (non-existent) glyphosate in the vitamin E acetate (which, by the way, people added to solubilize CBD oil and THC for the purposes of vaping) is making the e-cig deadly. This is one of the dumbest things I've ever read.

    I'll spare you details about the rest of Seneff's imaginary glyphosate-related maladies, but she tries to implicate a chemical that is less toxic than salt in fatty liver disease, dysfunction of the biome, and persistent rectal itch (OK, I made that one up).

    I'm gonna go out on a limb with a few predictions...

    • If I'm the parent of a high school graduate hunting for colleges and happen to step into one of Seneff's classes the $76,150 that MIT now costs isn't going to look like a screaming bargain.
    • She probably doesn't like me very much, which is going to make for an awkward situation if we run into each other at a Monsanto/Bayer stockholder meeting. But this is unlikely.
    • MIT professors earn on average $185,900. ACSH could afford two scientists who actually know what they're talking about for that.

    Life ain't fair.

    NOTE:

    (1) Surfactants are emulsifying agents used to evenly mix insoluble chemicals. This is a bit of an oversimplification.

  • Whatever the reason these kids are suddenly vulnerable, IMO these new developments are changing the benefit/risk analyses to favor vaccinating the younger people who are obese, or have some of the other underlying health issues.


    This virus has shown incredible adaptation and looks to be with us for a long time to come, so perhaps it is time to be realistic and accept vaccines as part of the arsenal to combat it?


    I believe, as do you, that had Iver+ been included in the US Standard of Care, it would have helped these kids avoid hospitalization, but after being so thoroughly stigmatized, it's being accepted here in the US is not going to happen anytime soon. Maybe in time, after the countries which embraced it, or one of the THH approved RCT's, show beyond doubt it's efficacy, it will be adopted here. Until then, the only option is the vaccine.

    Google says, in Switzerland there are ca. 150 kids already suffering from Long-Covid (PIMS syndrome), numbers expect to grow with increasing Delta infections (hypothesis). So not an easy deal, unfortunately.

  • Will an Israeli vaccine be the solution to new variants?

    Injectable and oral vaccines under development in Israel may prove significant in protecting people from mutations of the SARS-CoV-2


    Will an Israeli vaccine be the solution to new variants? - ISRAEL21c
    Injectable and oral vaccines under development in Israel may prove significant in protecting people from mutations of the SARS-CoV-2 coronavirus.
    www.israel21c.org


    Several Covid-19 vaccines under development in Israel hold out promise for their ability to protect against variants of the virus that are challenging existing vaccines.


    Back in May 2020, research groups across the world were racing to formulate vaccines against the SARS-CoV-2 coronavirus.

    Realizing it was not going to win that race, Israel purchased millions of Pfizer-BioNTech and Moderna mRNA vaccines from the United States and led the world in getting eligible citizens vaccinated.


    Israel was the first country to offer the vaccine to 12 -to 15-year-olds and to offer booster shots to immunocompromised people and those over 60.


    However, domestic inoculations still to come may become significant as primary vaccinations or as boosters against highly contagious variants of the virus.


    BriLife


    US-based NRx Pharmaceuticals will receive a license for exclusive worldwide development, manufacturing and marketing rights to the novel BriLife coronavirus vaccine developed by the Defense Ministry’s Israel Institute for Biological Research (IIBR).


    BriLife is based on a previous, FDA-approved vaccine platform that was further optimized by IIBR and targeted towards Covid-19. Because it is a live-virus vaccine, NRx anticipates rapid and affordable industrial scaleup and manufacturing.

    Vials of BriLife, the experimental Covid-19 vaccine from the Israel Institute for Biological Research. Photo courtesy of the Ministry of Defense Spokesperson’s Office

    “As the first-generation Covid vaccines are increasingly challenged by rapid mutation of the coronavirus, we aim to develop a vaccine that can rapidly scale at low cost to serve the needs of both the developed and the developing world,” said Chaim Hurvitz, who is director of NRx, chairman of Israeli private equity group CH Health, former director of Teva Pharmaceuticals and former president of the Teva International Group.


    Hurvitz is co-leading this initiative with NRx Pharmaceuticals chairman and CEO Dr. Jonathan Javitt, a public health expert who had leadership roles in seven successful healthcare IT and biopharma startups and led drug-development programs for Merck, Allergan, Pharmacia, Novartis and Pfizer.


    Javitt tells ISRAEL21c that BriLife presents the entire spike protein of the coronavirus to the body’s immune system, while mRNA vaccines present a small slice of the spike protein to the immune system.


    “We expect BriLife will create a broader immunological response and will enhance protection against Covid-19 and its variants,” says Javitt.


    BriLife is continuing Phase II clinical trials in Israel and the nation of Georgia. Phase III trials are to take place in Georgia, Ukraine and other European countries.


    MigVax


    MigVax, a vaccine-development startup spun out of the Israeli Science and Technology Ministry’s Migal Galilee Research Institute, is developing an oral Covid-19vaccine, MigVax-101.


    This “sub-unit” vaccine contains pieces of coronavirus protein (not live or dead virus) delivered by mouth to stimulate antibodies and immune cells to fight coronavirus in mucosa, blood and cells.

    By Abigail Klein Leichman AUGUST 9, 2021, 9:00 AM

    A nurse preparing aCovid-19 vaccination in Jerusalem. Photo by Olivier Fitoussi/Flash90

    SHARETWEETSHARECOMMENTEMAIL

    Several Covid-19 vaccines under development in Israel hold out promise for their ability to protect against variants of the virus that are challenging existing vaccines.


    Back in May 2020, research groups across the world were racing to formulate vaccines against the SARS-CoV-2 coronavirus.


    UNCOVER ISRAEL - Get the ISRAEL21c

    Weekly Edition free by emailSign Up Now!

    Realizing it was not going to win that race, Israel purchased millions of Pfizer-BioNTech and Moderna mRNA vaccines from the United States and led the world in getting eligible citizens vaccinated.


    Israel was the first country to offer the vaccine to 12 -to 15-year-olds and to offer booster shots to immunocompromised people and those over 60.


    However, domestic inoculations still to come may become significant as primary vaccinations or as boosters against highly contagious variants of the virus.


    BriLife


    US-based NRx Pharmaceuticals will receive a license for exclusive worldwide development, manufacturing and marketing rights to the novel BriLife coronavirus vaccine developed by the Defense Ministry’s Israel Institute for Biological Research (IIBR).


    BriLife is based on a previous, FDA-approved vaccine platform that was further optimized by IIBR and targeted towards Covid-19. Because it is a live-virus vaccine, NRx anticipates rapid and affordable industrial scaleup and manufacturing.


    Vials of BriLife, the experimental Covid-19 vaccine from the Israel Institute for Biological Research. Photo courtesy of the Ministry of Defense Spokesperson’s Office

    “As the first-generation Covid vaccines are increasingly challenged by rapid mutation of the coronavirus, we aim to develop a vaccine that can rapidly scale at low cost to serve the needs of both the developed and the developing world,” said Chaim Hurvitz, who is director of NRx, chairman of Israeli private equity group CH Health, former director of Teva Pharmaceuticals and former president of the Teva International Group.


    Hurvitz is co-leading this initiative with NRx Pharmaceuticals chairman and CEO Dr. Jonathan Javitt, a public health expert who had leadership roles in seven successful healthcare IT and biopharma startups and led drug-development programs for Merck, Allergan, Pharmacia, Novartis and Pfizer.


    Javitt tells ISRAEL21c that BriLife presents the entire spike protein of the coronavirus to the body’s immune system, while mRNA vaccines present a small slice of the spike protein to the immune system.


    “We expect BriLife will create a broader immunological response and will enhance protection against Covid-19 and its variants,” says Javitt.


    BriLife is continuing Phase II clinical trials in Israel and the nation of Georgia. Phase III trials are to take place in Georgia, Ukraine and other European countries.


    MigVax


    MigVax, a vaccine-development startup spun out of the Israeli Science and Technology Ministry’s Migal Galilee Research Institute, is developing an oral Covid-19vaccine, MigVax-101.


    This “sub-unit” vaccine contains pieces of coronavirus protein (not live or dead virus) delivered by mouth to stimulate antibodies and immune cells to fight coronavirus in mucosa, blood and cells.


    David Zigdon, CEO of Migal Galilee Research Institute and interim CEO of MigVax. Photo courtesy of OurCrowd

    On June 10, MigVax released results from preclinical tests on lab rats that demonstrated the potential effectiveness of MigVax-101 as an antibody booster for previously vaccinated people.


    Now the company is raising funds to launch Phase I and Phase II human clinical trials. If such trials prove successful, the vaccine could be commercialized within a year after the trials begin.


    An oral vaccine offers significant advantages over injected vaccines because it could be taken at home – no appointments, waiting for turns, or sore arms. Although it would have to be refrigerated, it would not need “deep freeze” conditions that make the mRNA vaccines expensive and difficult to ship and store.


    MigVax says its vaccine candidate is uniquely positioned to tackle new variants because the subunit can be adapted quickly to novel variants.


    And its protein components are stable, meaning the vaccine may remain effective for longer periods before requiring a booster.


    Furthermore, MigVax-101 could be more acceptable to a wider population, including people wary of receiving injections of genetic or viral material, as well as infants, children, pregnant women and others.


    “The results of this trial increase our confidence that our MigVax-101 subunit oral vaccine will make a positive contribution to a world coming to grips with the new post-pandemic reality,” commented Prof. Itamar Shalit, MigVax’s infectious disease expert.


    “Oral boosters such as our MigVax-101 will be key enablers that will help health organizations the world over transition from ‘panic mode’ to routine, due to their ability to reduce the cost and expand the reach of ongoing vaccination programs.”


    Oravax


    Another oral Covid-19 vaccine is under development at Oravax Medical, a subsidiary of Jerusalem-based Oramed Pharmaceuticals formed last March as a joint venture with India-based Premas Biotech.


    Oravax capitalizes on Oramed’s proprietary protein oral delivery (POD) technology and Premas’ exclusive virus-like particle vaccine technology, which will target three SARS CoV-2 virus surface proteins– including proteins less susceptible to mutation.


    That could make Oravax potentially effective against current and future mutations both as a standalone vaccine as well as a booster for previously vaccinated people.


    “Our vaccine is a particularly strong candidate against the evolving Covid-19 virus due to its unique targeting of three proteins rather than one,” said Nadav Kidron, CEO of Oramed.


    Oravax completed a successful pilot study on animals. Now the vaccine candidate is being tested in animals against variants including the Delta variant.


    Proof-of-concept clinical trials are soon to start in Israel at Tel Aviv Sourasky Medical Center to measure the level of antibodies and other immunity indicators.


    Kidron has said that Oramed initially wants to target its vaccine to countries that haven’t been able to afford mRNA vaccines for their populations. An oral vaccine, as stated above, is less costly to ship, store and administer without the need of healthcare professionals.


    Early stages


    Several other potential Israeli vaccines are in early stages of development, some of them in labs at universities including the Technion-Israel Institute of Technology, Tel Aviv University and Bar-Ilan University.


    An oral sub-unit coronavirus vaccine being developed in Rehovot at TransAlgae would use an edible delivery vehicle based on engineered algae.


    Bioencapsulated inside the algae, a specific coronavirus protein molecule travels intact through the digestive system to stimulate its target, the immune system.

    SHARETWEETSHARECOMMENTEMAIL

    Several Covid-19 vaccines under development in Israel hold out promise for their ability to protect against variants of the virus that are challenging existing vaccines.


    Back in May 2020, research groups across the world were racing to formulate vaccines against the SARS-CoV-2 coronavirus.


    UNCOVER ISRAEL - Get the ISRAEL21c

    Weekly Edition free by emailSign Up Now!

    Realizing it was not going to win that race, Israel purchased millions of Pfizer-BioNTech and Moderna mRNA vaccines from the United States and led the world in getting eligible citizens vaccinated.


    Israel was the first country to offer the vaccine to 12 -to 15-year-olds and to offer booster shots to immunocompromised people and those over 60.


    However, domestic inoculations still to come may become significant as primary vaccinations or as boosters against highly contagious variants of the virus.


    BriLife


    US-based NRx Pharmaceuticals will receive a license for exclusive worldwide development, manufacturing and marketing rights to the novel BriLife coronavirus vaccine developed by the Defense Ministry’s Israel Institute for Biological Research (IIBR).


    BriLife is based on a previous, FDA-approved vaccine platform that was further optimized by IIBR and targeted towards Covid-19. Because it is a live-virus vaccine, NRx anticipates rapid and affordable industrial scaleup and manufacturing.


    Vials of BriLife, the experimental Covid-19 vaccine from the Israel Institute for Biological Research. Photo courtesy of the Ministry of Defense Spokesperson’s Office

    “As the first-generation Covid vaccines are increasingly challenged by rapid mutation of the coronavirus, we aim to develop a vaccine that can rapidly scale at low cost to serve the needs of both the developed and the developing world,” said Chaim Hurvitz, who is director of NRx, chairman of Israeli private equity group CH Health, former director of Teva Pharmaceuticals and former president of the Teva International Group.


    Hurvitz is co-leading this initiative with NRx Pharmaceuticals chairman and CEO Dr. Jonathan Javitt, a public health expert who had leadership roles in seven successful healthcare IT and biopharma startups and led drug-development programs for Merck, Allergan, Pharmacia, Novartis and Pfizer.


    Javitt tells ISRAEL21c that BriLife presents the entire spike protein of the coronavirus to the body’s immune system, while mRNA vaccines present a small slice of the spike protein to the immune system.


    “We expect BriLife will create a broader immunological response and will enhance protection against Covid-19 and its variants,” says Javitt.


    BriLife is continuing Phase II clinical trials in Israel and the nation of Georgia. Phase III trials are to take place in Georgia, Ukraine and other European countries.


    MigVax


    MigVax, a vaccine-development startup spun out of the Israeli Science and Technology Ministry’s Migal Galilee Research Institute, is developing an oral Covid-19vaccine, MigVax-101.


    This “sub-unit” vaccine contains pieces of coronavirus protein (not live or dead virus) delivered by mouth to stimulate antibodies and immune cells to fight coronavirus in mucosa, blood and cells.


    David Zigdon, CEO of Migal Galilee Research Institute and interim CEO of MigVax. Photo courtesy of OurCrowd

    On June 10, MigVax released results from preclinical tests on lab rats that demonstrated the potential effectiveness of MigVax-101 as an antibody booster for previously vaccinated people.


    Now the company is raising funds to launch Phase I and Phase II human clinical trials. If such trials prove successful, the vaccine could be commercialized within a year after the trials begin.


    An oral vaccine offers significant advantages over injected vaccines because it could be taken at home – no appointments, waiting for turns, or sore arms. Although it would have to be refrigerated, it would not need “deep freeze” conditions that make the mRNA vaccines expensive and difficult to ship and store.


    MigVax says its vaccine candidate is uniquely positioned to tackle new variants because the subunit can be adapted quickly to novel variants.


    And its protein components are stable, meaning the vaccine may remain effective for longer periods before requiring a booster.


    Furthermore, MigVax-101 could be more acceptable to a wider population, including people wary of receiving injections of genetic or viral material, as well as infants, children, pregnant women and others.


    “The results of this trial increase our confidence that our MigVax-101 subunit oral vaccine will make a positive contribution to a world coming to grips with the new post-pandemic reality,” commented Prof. Itamar Shalit, MigVax’s infectious disease expert.


    “Oral boosters such as our MigVax-101 will be key enablers that will help health organizations the world over transition from ‘panic mode’ to routine, due to their ability to reduce the cost and expand the reach of ongoing vaccination programs.”


    Oravax


    Another oral Covid-19 vaccine is under development at Oravax Medical, a subsidiary of Jerusalem-based Oramed Pharmaceuticals formed last March as a joint venture with India-based Premas Biotech.


    Oravax capitalizes on Oramed’s proprietary protein oral delivery (POD) technology and Premas’ exclusive virus-like particle vaccine technology, which will target three SARS CoV-2 virus surface proteins– including proteins less susceptible to mutation.


    That could make Oravax potentially effective against current and future mutations both as a standalone vaccine as well as a booster for previously vaccinated people.


    “Our vaccine is a particularly strong candidate against the evolving Covid-19 virus due to its unique targeting of three proteins rather than one,” said Nadav Kidron, CEO of Oramed.


    Oravax completed a successful pilot study on animals. Now the vaccine candidate is being tested in animals against variants including the Delta variant.


    Proof-of-concept clinical trials are soon to start in Israel at Tel Aviv Sourasky Medical Center to measure the level of antibodies and other immunity indicators.


    Kidron has said that Oramed initially wants to target its vaccine to countries that haven’t been able to afford mRNA vaccines for their populations. An oral vaccine, as stated above, is less costly to ship, store and administer without the need of healthcare professionals.


    Early stages


    Several other potential Israeli vaccines are in early stages of development, some of them in labs at universities including the Technion-Israel Institute of Technology, Tel Aviv University and Bar-Ilan University.


    An oral sub-unit coronavirus vaccine being developed in Rehovot at TransAlgae would use an edible delivery vehicle based on engineered algae.


    Bioencapsulated inside the algae, a specific coronavirus protein molecule travels intact through the digestive system to stimulate its target, the immune system.


    Algae growing at TransAlgae in Rehovot. Photo: courtesy

    Eyal Ronen, VP for business development, tells ISRAEL21c this vaccine candidate is undergoing preclinical trials. TransAlgae is seeking collaborations and strategic partnerships with American companies to advance development.


    The company’s main field of expertise is animal and fish vaccines as well as crop insecticides.


    “We are not a pharma company and were not interested in going into human health at this moment. But our shareholders were asking us, why not use this for human beings? We took the challenge,” says Ronen.

  • Long-term perturbation of the peripheral immune system months after SARS-CoV-2 infection

    It looks like the study has missing data. Table S1 with recruitment data is missing. Further Table 4 shows a strange shift among the so called healthy ones. Either they screwed up something or the healthy later also had some virus contacts.

    Worse than the disease?

    The original paper: Worse Than the Disease Reviewing Some Possible Unintended Consequences of the mRNA Vaccines Against COVID-19 .pdf

  • Google says, in Switzerland there are ca. 150 kids already suffering from Long-Covid (PIMS syndrome), numbers expect to grow with increasing Delta infections (hypothesis).

    Thanks for reminding for giving the Swiss long CoV study, that shows some problems with the awareness of kids... Sometimes healthy ones have more symptoms... So good studies should focus on biomarkers not on general health.


    https://www.medrxiv.org/content/10.1101/2021.05.16.21257255v1.full.pdf


    Overall, 1355 of 2503 children with a serology result in
    October/November 2020 and follow up questionnaire in March/April 2021 were included.
    Among seropositive and seronegative 6- to 16-year-old children and adolescents, 9% versus
    10% reported at least one symptom beyond 4 weeks, and 4% versus 2% at least one symptom
    beyond 12 weeks. None of the seropositive children reported hospitalization after October
    2020. Seropositive children, all with a history of pauci-symptomatic SARS-CoV-2 infection,
    did not report long COVID more frequently than seronegative children. This study suggests a
    very low prevalence of long COVID in a randomly selected population-based cohort of
    children followed over 6 months after serological testing.

  • BS. I can fill pages with all the anti-Iver evidence if I wanted to belabor my point. They are all over the net. Just type in Ivermectin and most of what pops up is negative and amount to little more than scaremongering.

    And I can fill pages of pro-ivermectin articles. What is your point? The impact of press reporting and web pages cannot be measured simply by the number of articles. It depends on where the articles are published, who reads them, and what they say. The one you posted here did not seem particularly opposed to ivermectin so much as being opposed to feckless doctors who do not know what they are prescribing.


    Many such examples have been posted here, discussed, but you and THH seem to always miss them...how convenient.

    I have not missed them. I am saying that the effect of these articles is unclear. There does not seem to be significant opposition to ivermectin among experts. The New York Times, which is the most establishment media there is, said that ivermectin might work and then again it might not. That is not an attack. I think that is the (non)-consensus of the medical establishment. They don't know what to make of it. I do not know why you do know what to make of it. Are you sure you understand this better than the doctors and researchers?


    Mainstream researchers are not attacking it or defending ivermectin in the technical literature as far as I can tell. It seems they are ignoring the arguments in the mass media. That's what you want them to do, I assume. You would not want them to be swayed by amateurs. Here is a negative report. I would not call this an attack:


    Outcomes of Ivermectin in the treatment of COVID-19: a systematic review and meta-analysis
    Background To assess the outcomes of ivermectin in ambulatory and hospitalized patients with COVID-19. Methods Five databases and websites for preprints were…
    www.medrxiv.org


    It is one of these things that is up in the air. No answer so far. Science is chock full of such things. The more we learn about any natural phenomenon, the more unanswered question arise. People think science expands our knowledge. It does, but mostly it expands our ignorance. We become aware of how much we do not know. Hume wrote the lions eat only meat, not vegetables (which is more or less true) because that is their essential nature. That's true as far is goes, but it does not explain much. Nowadays, a biologist could cite hundreds of pages describing feline digestion and what lions can and cannot eat; the biochemistry, the evolutionary roots, and so on. Thousands of details have emerged, but for every detail there are dozens of new mysteries, contradictions, and unanswered questions. Perhaps in a hundred thousand years we will understand just about everything about feline biology, but I wouldn't bet on that.

  • problems with the awareness of kids... Sometimes healthy ones have more symptoms... So good studies should focus on biomarkers not on general health.

    Whereas when children complain about long term effects of PIMS (an extremely severe multi-organ failure syndrome caused by COVID) we should only believe them if they have the right biomarkers?

  • There does not seem to be significant opposition to ivermectin among experts. The New York Times, which is the most establishment media there is, said that ivermectin might work and then again it might not. That is not an attack. I think that is the (non)-consensus of the medical establishment. They don't know what to make of it. I do not know why you do know what to make of it. Are you sure you understand this better than the doctors and researchers?

    Jed has it right that there is no consensus on ivermectin - because the studies are not convincing. and like many questions this is one that stays open till there is good positive or negative evidence.


    Perhaps there is one other thing confusing Shane - which the authorities are so against ivermectin?


    (1) Doctors are allowed to prescribe it off-label.

    (2) There are dangers with people taking ivermectin themselves; using animal versions, using too high a dose, using it with other medicines whose action it changed

    (3) Most scientists reckon it is as likely to harm people as help them, given what we now know.

    (4) Many people, if given a drug claimed to stop COVID, will not take other actions needed to keep safe


    All of which makes the public statements about ivermectin negative rather than neutral. And that is caused by the large social media pro-ivermectin PR campaign.

  • They stated that there is "no scientific basis for a potential therapeutic effect against COVID-19 from pre-clinical studies". This is contradicted by many papers and studies, including [Arévalo, Bello, Choudhury, de Melo, DiNicolantonio, DiNicolantonio (B), Errecalde, Eweas, Francés-Monerris, Heidary, Jans, Jeffreys, Kalfas, Kory, Lehrer, Li, Mody, Mountain Valley MD, Qureshi, Saha, Surnar, Udofia, Wehbe, Yesilbag, Zaidi, Zatloukal].

    And it is supported by many other scientific papers. What is your point?


    The question is unanswered. Some studies are positive, some are negative, and some inconclusive. That is not a conspiracy. It is, unfortunately, the normal situation with drug research into difficult diseases. Drugs do not often produce dramatic, easily measured results. It often takes a double-blind test, and the results are often marginal. If the results were dramatic, you would not need the double blind test. They did not need one for penicillin, for example.


    If ivermectin dramatically cured patients, doctors would know that, and they would use it no matter what the pharma companies say. It does not produce dramatic results. The positive studies show that it may reduce hospital stays by a few days. Perhaps. Depending on the study, which may in turn depend on the dose or what strain of COVID the patients have, or some other unknown variable. Reducing hospital stays is good, but not something to celebrate on the streets. It is not 0.0001% as good as the vaccines, which have saved hundreds of thousands of lives and which could easily drive COVID into extinction in humans, if only people would get themselves vaccinated.

  • One meme above often misrepresented is about the toxicity of spike proteins.


    The S1 protein of SARS-CoV-2 crosses the blood–brain barrier in mice - Nature Neuroscience
    Rhea at al. show that intravenously injected, radiolabeled SARS-CoV-2 spike 1 protein crosses the mouse blood–brain barrier, likely through the mechanism of…
    www.nature.com


    Here we assess whether one viral protein of SARS-CoV-2, the spike 1 protein (S1), can cross the BBB. This question is important and clinically relevant for two reasons. First, some proteins shed from viruses have been shown to cross the BBB, inducing neuroinflammation and otherwise impairing CNS functions11,12,13,14,15,16,17. Second, the viral protein that binds to cells can be used to model the activity of the virus; in other words, if the viral binding protein crosses the BBB, it is likely that protein enables the virus to cross the BBB as well18,19. S1 is the binding protein for SARS-CoV-2 (ref. 20); it binds to angiotensin-converting enzyme 2 (ACE2)21,22,23 and probably other proteins as well.

    In this study, we show that I-S1 readily crossed the murine BBB, entered the parenchymal tissue of the brain and, to a lesser degree, was sequestered by brain endothelial cells and associated with the brain capillary glycocalyx. We describe I-S1 rate of entry into the brain after intravenous (i.v.) and intranasal administration, determine its uptake in 11 different brain regions, examine the effect of inflammation, APOE genotype and sex on I-S1 transport, and compare I-S1 uptake in the brain to the uptake in the liver, kidney, spleen and lung. Based on experiments with the glycoprotein WGA, we found that brain entry of I-S1 likely involves the vesicular-dependent mechanism of adsorptive transcytosis.


    So spike proteins could in principle affect the brain but that problem would be 1000s of times worse in natural COVID infection than from the vaccine, for the reasons oultined below


    Spike Protein Behavior | In the Pipeline
    I’ve been getting a lot of questions in the last few days about several Spike-protein-related (and vaccine-related) topics, so I thought this would be a good…
    blogs.sciencemag.org

    Consider what happens when you’re infected by the actual coronavirus. We know now that the huge majority of such infections are spread by inhalation of virus-laden droplets from other infected people, so the route of administration is via the nose and/or lungs, and the cells lining your airway are thus the first ones to get infected. The viral infection process leads at the end to lysis of the the host cell and subsequent dumping of a load of new viral particles – and these get dumped into the cellular neighborhood and into the bloodstream. They then have a clear shot at the endothelial cells lining the airway vasculature, which are the very focus of these two new papers.

    Compare this, though, to what happens in vaccination. The injection is intramuscular, not into the bloodstream. That’s why a muscle like the deltoid is preferred, because it’s a good target of thicker muscle tissue without any easily hit veins or arteries at the site of injection. The big surface vein in that region is the cephalic vein, and it’s down along where the deltoid and pectoral muscles meet, not high up in the shoulder. In earlier animal model studies of mRNA vaccines, such administration was clearly preferred over a straight i.v. injection; the effects were much stronger. So the muscle cells around the injection are hit by the vaccine (whether mRNA-containing lipid nanoparticles or adenovirus vectors) while a good portion of the remaining dose is in the intercellular fluid and thus drains through the lymphatic system, not the bloodstream. That’s what you want, since the lymph nodes are a major site of immune response. The draining lymph nodes for the deltoid are going to be the deltoid/pectoral ones where those two muscles meet, and the larger axillary lymph nodes down in the armpit on that side.

    Now we get to a key difference: when a cell gets the effect of an mRNA nanoparticle or an adenovirus vector, it of course starts to express the Spike protein. But instead of that being assembled into more infectious viral particles, as would happen in a real coronavirus infection, this protein gets moved up to the surface of the cell, where it stays. That’s where it’s presented to the immune system, as an abnormal intruding protein on a cell surface. The Spike protein is not released to wander freely through the bloodstream by itself, because it has a transmembrane anchor region that (as the name implies) leaves it stuck. That’s how it sits in the virus itself, and it does the same in human cells. See the discussion in this paper on the development of the Moderna vaccine, and the same applies to all the mRNA and vector vaccines that produce the Spike. You certainly don’t have the real-infection situation of Spike-covered viruses washing along everywhere through the circulation. The Spike protein produced by vaccination is not released in a way that it gets to encounter the ACE2 proteins on the surface of other human cells at all: it’s sitting on the surface of muscle and lymphatic cells up in your shoulder, not wandering through your lungs causing trouble.

    Some of the vaccine dose is going to make it into the bloodstream, of course. But keep in mind, when the mRNA or adenovirus particles do hit cells outside of the liver or the site of injection, they’re still causing them to express Spike protein anchored on their surfaces, not dumping it into the circulation. Here’s the EMA briefing document for the Pfizer/BioNTech vaccine – on pages 46 and 47, you can read the results of distribution studies. These were done two ways – by using an mRNA for luciferase (and thus looking at the resulting light emission from the various rodent regions!) and by using a radioactive label (which is a more sensitive technique). The great majority of the radioactivty stays in and around the injection site. In the first hours, there’s also some circulating in the plasma. But almost all of that ended up in the liver, and no other tissue was much over 1% of the total. That’s exactly what you’d expect, and what you see with drug dosing in general: your entire blood volume goes sluicing through the liver again and again, because that’s what the liver is for. But when things like this hit the hepatic tissue, they stay there and eventually get chewed up by various destructive enzymes (that’s also a big part of what the liver is for). It’s a one-way ticket.

    So the reports of Spike protein trouble are interesting and important for coronavirus infection, but they do not mean that the vaccines themselves are going to cause similar problems. In fact, as mentioned above, the fact that these vaccines are aimed at the Spike means that they’re protective in more ways than we even realized.

    Update: there’s another level of difference that I didn’t mention. In the Moderna, Pfizer/BioNTech, J&J, and Novavax vaccines, the Spike protein has some proline mutations introduced to try to hold it in its “prefusion” conformation, rather than the shape it adopts when it binds to ACE2. So that should cut down even more on the ability of the Spike protein produced by these vaccines to bind and produce the effects noted in the recent papers. That comes in particularly handy for the Novavax one, since it’s an injection of Spike protein itself, rather than a vaccine that has it produced inside the cells. Notably, the AstraZeneca/Oxford vaccine is producing wild-type Spike (although that’s still going to be membrane-anchored as discussed above!)

  • To Mask or Not to Mask? What does the Data Say?


    To Mask or Not to Mask? What does the Data Say?
    To mask or not to mask? What's the answer? There are conflicting views, opinions, and data regarding the whole subject. And as back-to-school time nears,
    trialsitenews.com


    To mask or not to mask? What’s the answer? There are conflicting views, opinions, and data regarding the whole subject. And as back-to-school time nears, it’s most certainly a relevant topic. According to a recent Wall Street Journal (WSJ) opinion piece authored by two well-known physicians/researchers, including Dr. Marty Makary, a professor at the Johns Hopkins School of Medicine as well as editor-in-chief of Medpage Today, and Dr. Cody H. Meissner, chief of pediatric infectious diseases at Tufts Children’s Hospital, recent mask edicts by the U.S. Centers for Disease Control and Prevention (CDC) aren’t necessarily grounded in the latest science. What these two impressively credentialed experts have to say may go against the conventional wisdom grain, but that’s what truly progresses science. That is not mass groupthink, but rational and reasonable scientific questioning and, when appropriate, dissent. While the authors declare that the CDC doesn’t have sufficient data yet for any conclusive declarations, a review of studies introduced by the CDC certainly has limitations and some points. The authors remind us all that masking isn’t necessarily just harmless for all, at least for a subset of conditions and situations. Finding a universal answer isn’t probably possible at this point. But directed, study-driven dialogue, debate, and constructive argument will only serve to progress society’s knowledge closer to a better understanding.


    CDC Edict

    Drs. Makary and Meissner reminded all in this recent opinion piece in the WSJ that just a couple of weeks ago, the CDC declared that regardless of vaccination status, and for that matter, the prevalence of infection locally, 56 million U.S. children and adolescents would need to cover their faces. Of course, what followed in many localities were immediate pronouncements from public health authorities for mask mandates, regardless of what actual underlying data supported the CDC, and for that matter based on an apparent assumption “that masks can’t do any harm.” On the other hand, some other state leadership declared no local school district-level mask mandates would be legal and that parents would decide whether a child was to wear a mask or not.


    But the WSJ opinion piece authors argued that they could only find one single retrospective study centering on the efficacy of masks as a defense against COVID-19. And the results of this study were inconclusive, according to the authors.


    Assumptions around Severity

    While the mainstream press carries scary stories of children getting sick and even dying from COVID-19, is this the case in any material number of cases? The opinion piece authors refer to a CDC report that at least for the end of July, COVID-19 hospitalization rates for children ages 5 to 17 equated to 0.5 million, which translates to about 25 hospitalized patients nationwide. And the CDC goes on the record that not all of these hospitalizations are due to COVID-19.


    What’s the actual reality? How many children are ill with COVID-19 to the point of needing hospitalization? We know there are cases, but much of the mainstream press seems written to elicit more broad-based fear as they don’t drill into the real numbers, actual risks, and the like. Yet, on the other hand, COVID-19 is a serious disease to be taken seriously. More data-driven analyses need to be the norm moving forward.


    Where do the NIH Billions go?

    While public health officials self-righteously declare that all of their decisions are based on “the latest science,” Makary and Meissner share a new study revealing that of the $42 billion spent by the National Institutes of Health (NIH) on research, less than 2% went to COVID-19 clinical research. Not one study was dedicated to the safety and efficacy of masks. Here is the study led by Makary. Why on earth would this support the case? We know that billions of dollars of taxpayer funding went into the subsidy of vaccine and pharmaceutical therapeutic clinical trials.


    What about Long-Covid?

    Can masks prevent children from succumbing to long covid? How much actual risk do children have with long covid? The opinion piece author’s point to a recent study published in The Lancet that reveals, “Almost all children had symptom resolution by 8 weeks, providing reassurance about long-term outcomes.”


    What about stopping transmission?

    While we know that children do transmit the disease, we don’t know the levels to which that occurs, at least not in any scientific way. The authors point to one pre-vaccination study out of North Carolina demonstrating that “not one single case of student-to-teacher transmission” occurred when 90,000 students were in school.


    Moreover, the authors declare, “The CDC’s mask decrees are perversely permissive as well as needlessly strict.” They point out that while cloth masks aren’t as effective as N95 respirators, the CDC directive “ignores the distinction.”


    The WSJ opinion piece authors quote a Biden transmission team member Michael Osterhold, an epidemiologist who declared recently on CNN, “Many of the face cloth coverings that people wear are not very effective in reducing any of the virus movement in or out.” He had to emphasize in July that he wasn’t “anti-mask.”


    Scientific Dissent

    So do we just assume that masks can do no harm or do we question such assumptions? That’s what these two doctors do here, declaring that those with myopia could struggle with masks as well as those prone to acne and other dermatological issues that masks can trigger. Makary and Meissner point out that in some cases, masks can lead to higher levels of carbon dioxide in the blood, and for some kids, they get in the way of focus and hence, study. If masks are used for too long, the doctors caution, the masks themselves can also become “vectors for pathogens.”


    On the other hand, as we show below, the two authors didn’t mention several studies that the CDC do refer to. They are listed next.


    CDC’s basis

    What’s the scientific basis for broad-based, strict mask mandates? The CDC declares, “masks work best when everyone wears one.” The CDC backs this statement by referring to a handful of studies and its claims with the following inquiries.


    An investigation of a high-exposure event, in which 2 symptomatically ill hair stylists interacted for an average of 15 minutes with 139 clients during eight days, found that none of the 67 clients who subsequently consented to an interview and testing developed an infection. The stylists and all clients universally wore masks in the salon as required by local ordinance and company policy at the time. Source.

    In a study of 124 Beijing households with > 1 laboratory-confirmed SARS-CoV-2 infection, mask use by the index patient and family contacts before the index patient developed symptoms reduced secondary transmission within the households by 79%. Source.

    A retrospective case-control study from Thailand documented that, among more than 1,000 persons interviewed as part of contact tracing investigations, those who reported having always worn a mask during high-risk exposures experienced a greater than 70% reduced risk of acquiring infection compared with persons who did not wear masks under these circumstances. Source.

    A study of an outbreak aboard the USS Theodore Roosevelt, an environment notable for congregate living quarters and close working environments, found that the use of face coverings on-board was associated with a 70% reduced risk. Source.

    Investigations involving infected passengers aboard flights longer than 10 hours strongly suggest that masking prevented in-flight transmissions, as demonstrated by the absence of infection developing in other passengers and crew in the 14 days following exposure. Source.

    Are these studies sufficient? It’s more than Makary and Meissner credit to the agency, but TrialSite’s not in a position to declare a conclusive reality. There isn’t sufficient data as of yet.

  • University of Minnesota’s COVID-OUT Investigation into Ivermectin—A Potential Early-Onset Treatment for Some COVID-19 Cases


    University of Minnesota’s COVID-OUT Investigation into Ivermectin—A Potential Early-Onset Treatment for Some COVID-19 Cases
    In May, TrialSite introduced one of the largest ivermectin-based studies in the United States—the “COVID-OUT” study led by principal investigator Carolyn
    trialsitenews.com


    In May, TrialSite introduced one of the largest ivermectin-based studies in the United States—the “COVID-OUT” study led by principal investigator Carolyn Bramante, MD, University of Minnesota. The study was initially funded by UnitedHealthcare’s OptumLabs, a division of one of America’s largest health insurers, and the Parsemus Foundation. More recently, additional funds helped the study expand—via a $1 million grant from the Rainwater Charitable Foundation and a $500,000 grant from Fast Grants. Not only did these funds help to expand the study, but the investigation is one of the first randomized clinical trials for COVID-19 to include pregnant women. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), is on the record that what’s needed now are orally administered antiviral treatments to address COVID-19 infection early on as the vast majority of cases are mild-to-moderate in symptom. The key to managing this pandemic, in addition to safe and effective vaccines and sound, situational, and contextual public health policy, are low-cost treatments that can reduce the likelihood of infection progression. About 90% of COVID-19 cases end up becoming something akin to a flu-like infection that is very manageable, and Fauci is on the record now declaring as much. That’s not to minimize what happens when the disease progresses. With greater risks in unvaccinated populations and/or those with serious risk profiles such as co-morbidity profiles in lower-income socioeconomic strata, SARS-CoV-2 can quickly turn into a nightmare. This can overwhelm hospital ICU capacity due to the inflammation and cytokine storms that manifest when the disease advances to lung infections. However, even with the Delta strain, the overall mortality rate appears to be on a downward trend, according to some analysts, and the time is now to support clinical trials such as COVID-OUT. While the conventional wisdom is that vaccination is the only pathway to beating COVID-19, economically viable early care options are fundamentally critical. Dr. Anthony Fauci all but declares this in the recent interview summarized here.


    Recently covered in a local Indiana media called The Times, TrialSite provides more exposure to COVID-OUT, a study investigating different low-cost, repurposed drugs to target COVID-19 disease progression, from metformin to ivermectin. In addition to providing necessary, economical, early-onset COVID-19 treatments for the population subject to long-COVID, the hope is that broader segments of the medical community can formally accept treatments such as ivermectin.


    Background

    As reported in The Times, COVID-OUT derived from work done at the University of Minnesota, via computer modeling and observational studies, that showed outpatient metformin use could decrease the probability of death or hospitalization due to COVID-19. Their research was published in the Journal of Medical Virology and in The Lancet Healthy Longevity, in partnership with UnitedHealth Group’s OptumLabs, writes Angel Mendez.


    The studies mentioned herein, plus numerous studies in low-and-middle-income countries (LMICs), reveal the potential of ivermectin as a treatment for at least some patients early on in the COVID-19 life cycle. Needed for broader societal acceptance in America, Canada, and other developing economies are larger randomized controlled trials, such as COVID-OUT.


    TrialSite has interacted with principal investigator Dr. Bramante and has helped the study by posting a link to the study in order to hopefully help recruitment levels. The study ships the investigational product same day to participants via a decentralized study model.


    Participating Research Centers

    Participating research centers include M Health Fairview, Hennepin Healthcare in Minneapolis, Chicago’s Northwestern University, and in Los Angeles Olive View—UCLA Education & Research Institute. Also, Optum’s operations in Colorado and Indiana and the University of Colorado Denver participate.


    TrialSite Comment

    There has been a great deal of hostility in the mainstream press toward low-cost, repurposed drugs as possible treatments for COVID-19. Such antagonism is unfortunate. Ivermectin has been used successfully in dozens of COVID-19 trials reflected in a few respectable meta-analyses. Moreover, public health initiatives from Mexico City to Uttar Pradesh have contributed to fighting the pandemic in these locales. Various fact-checking organizations are typically employed via media and social media to attack any causation, but that misses the point. Even if the remarkable turnaround in Uttar Pradesh against the Delta variant, for example, involved ivermectin, various public health entities such as the World Health Organization, heavily impacted by academia and industry, won’t acknowledge such a reality. But for those who study these matters carefully, we know that while 100% proof of correlation is difficult, sufficient real-world evidence indicates promise. Otherwise, the University of Minnesota wouldn’t bother with an expensive Phase 3 trial.


    As we frequently mention, transcending this pandemic requires a combination of safe and effective vaccines, early-onset antiviral and other treatments, and smart and targeted local public health responses that understand and acknowledge the importance of maintaining local economic growth. Ivermectin is one of many that must be investigated, from generics to branded pharmaceuticals under development by Merck, Pfizer, and Roche.


    Lead Research/Investigator

    · Carolyn Bramante, MD, MPH


    · Hrishikesh Belani, MD


    · Michelle Biros, MD


    · David Boulware, MD


    · David Leibovitz, MD


    · Jacinda Nicklas, MD


    · David Odde, PhD


    · Matt Pullen, MD


    · Mike Puskarich, MD


    · Christopher Tignanelli, MD


    Call to Action: COVID-OUT’s website can be visited here.

  • Will an Israeli vaccine be the solution to new variants?

    In Israel...The R rate has risen despite Pfizer..

    Maybe its the kids?


    Perhaps ivermectin...Jerusalem Post..

    Israeli scientist says COVID-19 could be treated for under $1/day
    Double-blind study shows ivermectin reduces disease’s duration and infectiousness • FDA and WHO caution against its use
    www.jpost.com

    Schwartz.

    "

    “There is a lot of opposition,” he said. “We tried to publish it, and it was kicked away by three journals. No one even wanted to hear about it. You have to ask how come when the world is suffering.”

    “This drug will not bring any big economic profits,” and so Big Pharma doesn’t want to deal with it, he said.

    SOME OF the loudest opposition to ivermectin has come from Merck Co., which manufactured the drug....






  • I do not find that reassuring. How many is "almost"?

    A reporter asked Gov. DeathSantis of Florida about this, and got the following innumerate response:



    "The fact is, in terms of the risk to schoolkids, this is lower risk than seasonal influenza," DeSantis said, during an Aug. 10 televised roundtable discussion on education.


    DeSantis' assertion got us wondering, so we asked the governor's office what evidence it had to back up the claim.


    LOOKING AT THE NUMBERS


    A spokesperson responded with data from the Florida Department of Health showing the state's COVID-19 mortality rate is 0.02% for people 24 and younger. That's the same as the influenza mortality rate for this age group.


    But for children 14 and younger, the spokesperson said, Florida's COVID-19 mortality rate is 0.009%, far below the 0.01% for flu for that age group. . . .


    True or False? DeSantis Says COVID Is a Lower Risk for School-Aged Kids Than Flu.
    Kaiser Health News examined the claim and found it "mostly true."
    www.healthleadersmedia.com



    O.009 is not far below 0.01. It is 0.001 below. Given the small number of cases, this difference is probably not significant. For all anyone knows, pediatric Delta COVID might be twice as fatal as influenza. Here we see that not only is the governor and his spokesperson innumerate, but evidentially, so is this reporter.


    It should also be noted that influenza does not produce long haul effects, whereas these have been observed in children.

  • There's one kind of mask that won't protect you from the delta variant

    “We need to talk about better masking.”


    There's one kind of mask that won't protect you from the delta variant
    “We need to talk about better masking.”
    thehill.com


    Story at a glance:


    Regular paper masks and bandanas may not be as effective at preventing the spread of the coronavirus as other masks, one expert says.

    When it comes to masks, KN95 masks or N95 masks could be the best option against spreading the coronavirus.

    "Many of the face cloth coverings that people wear are not very effective in reducing any of the virus movement in or out."

    When it comes to wearing masks, cloth face coverings may not be the most effective tool in reducing the spread of the coronavirus and preventing infection, one expert says.


    Michael Osterholm, director for the Center for Infectious Disease Research and Policy at the University of Minnesota, spoke to CNN on Monday and said that people should upgrade from cloth masks, bandanas and gators to more-effective N95 respirators.

    Face masks do not prevent the spreading as effectively as some like to believe, Osterhold said.


    The Centers for Disease Control and Prevention (CDC) says cloth masks still offer some protection and their effectiveness depends on the type of fabric, number of layers and the fit of the mask. The CDC is continually studying these factors.


    Studies have shown that multiple layers of cloth with higher thread counts are more effective than single layer cloths, in some cases filtering 50 percent of fine particles, according to the CDC. Overall, analysis has demonstrated that universal masking has led to a significant drop in new infections.


    "We need to talk about better masking," Osterholm said. "We need to talk about N95 respirators, which would do a lot for both people who are not yet vaccinated or are not previously infected. Protecting them as well as keeping others who might become infected having been vaccinated from breathing out the virus."


    The CDC classifies KN95 and N95 masks as those that are "designed and tested to ensure they perform at a consistent level to prevent the spread of COVID-19."


    "You know I wish we could get rid of the term masking because, in fact, it implies that anything you put in front of your face works, and if I could just add a nuance to that which hopefully doesn't add more confusion is we know today that many of the face cloth coverings that people wear are not very effective in reducing any of the virus movement in or out," Osterholm said.


    He then pointed out that people who wear cloth masks in the Northwest can still smell the wildfires.


    "Either you're breathing out or you're breathing in and in fact if you're in the upper Midwest right now anybody who's wearing their face cloth covering can tell you they can smell all the smoke that we're still getting," he added.


    Similarly, Scott Gottlieb, former Food & Drug Administration (FDA) commissioner, said in July that the right quality mask was necessary to protect against a strain as contagious as the delta variant.


    "It's not more airborne, and it's not more likely to be permeable to a mask. So a mask can still be helpful," Gottlieb told host John Dickerson. "I think, though, if you're going to consider wearing a mask, the quality of the mask does matter. So if you can get your hands on a KN95 mask or an N95 mask, that's going to afford you a lot more protection."

  • Gov. DeSantis and other members of the GOP Death Cult have recently claimed the Delta COVID surge was caused by Biden. They say he is allowing hoards of sick illegal immigrants in from Mexico, putting them on buses, and sending them to Florida and other states. Most unvaccinated people are Republicans, and most of them believe this, as shown in this public opinion poll:



    This graph is a little confusing. The opinions of unvaccinated people are shown in the purple lines. ~35% of them (a plurality) believe that "Foreign travelers" are to blame for rising coronavirus cases. Vaccinated people (the orange line) blame "The unvaccinated" for the rising number of cases. This graph came from a WaPost article that refutes the claim:


    https://www.washingtonpost.com/politics/2021/08/06/why-we-can-be-confident-that-surge-coronavirus-cases-isnt-fault-immigrants/


    This illustrates the toxic stew of misinformation, lies, racism and delusion embraced by the GOP, the anti-vaxxers, and the unvaccinated, who are putting the nation through hell and will kill tens of thousands more people and cause billions or trillions more damage to the economy, all to win an election and to "own the libs." Never has there been so much mass murder been committed for such a trivial cause. The pandemic could be stopped in a few weeks if Trump, DeSantis and other GOP leaders would tell their followers "get vaccinated!" They will not do this. They would rather kill another 50,000 to 100,000 people in the service of their short-term political goals.

  • This article was from last year (8/10/2020), with the televised roundtable "Governor DeathSantis" participated in taking place 8/10/2020.


    They ended up concluding he was right:


    "Studies show the numbers of COVID-related deaths and hospitalizations among children are lower than the average rates for flu. Still, it's uncertain if these lower rates among children were partly because schools were closed since March and whether those rates will rise as classrooms reopen this fall. It's also unclear whether opening schools — particularly in communities with a high number of people testing positive — will lead to more spread of the disease.

    We rate the claim as Mostly True."

Subscribe to our newsletter

It's sent once a month, you can unsubscribe at anytime!

View archive of previous newsletters

* indicates required

Your email address will be used to send you email newsletters only. See our Privacy Policy for more information.

Our Partners

Supporting researchers for over 20 years
Want to Advertise or Sponsor LENR Forum?
CLICK HERE to contact us.