Covid-19 News

    Quote from Wyttenbach

    Here we agree. But already Pfizer gen therapy induced myocarditis is 5x above background according the US military study we here once linked. 500 adverse reaction half with with live long damage among 1 mio gen therapies is way (> 10x) above background.

    Yes to 5X myocarditis, but the VIM is very mild (would not normally be diagnosed as such) and nothing like normal myocoarditis, which is serious and can have long-term side effects. And 5X very very small is still very very small.


    One thing - background is continuous, and 2nd vaccination is a one-off event, so you need to state over what time you are measuring background for this comparison to be meaningful. VIM occurs within a week of the vaccination since it is essentially a temporary allergic reaction in the heart muscle. It is guaranteed you gte your 5X choosing a suitable period.


    No to 250 life-long damage. Only thing I can't tell you without a lot of details is which of the various anti-vax "make the numbers look bigger" tricks that numb er comes from. And given your lack of clearly linked evidence I'm not likley to do so.

    Quote from Wyttenbach

    For your personal illumination once look into https://www.adrreports.eu/de/search_subst.html# letter "C"

    so far 20'000 cardiac disorders in the EU

    Sorry - what does the EU prevalence of cardiac disorders have to do with vaccines?


    Unless - you are saying every background heart attack in a vaccinated person is caused by the vaccine. That is anti-vax lie #1.

    Anti-vaxers very understandably make this mistake because they know vaccines are bad, so it is their firm conviction that everyone who supports vaccination lies. They assume the notes about VAERS which say why its data cannot be used for quantitative comparisons are false - and just go ahead and do that without any understanding of why the number of reported possible AEs is so different the real number of AEs: public reported AEs depend on popular sentiment and concern, HCC AEs vary as in Alan's post.


    VAERS is a passive reporting system, meaning it relies on individuals to send in reports of their experiences to CDC and FDA. VAERS is not designed to determine if a vaccine caused a health problem, but is especially useful for detecting unusual or unexpected patterns of adverse event reporting that might indicate a possible safety problem with a vaccine. This way, VAERS can provide CDC and FDA with valuable information that additional work and evaluation is necessary to further assess a possible safety concern.

    Quote from THHuxleynew

    Yes to 5X myocarditis, but the VIM is very mild

    You mix up children cases with male grown up. 6 deaths/mio is not so mild....

    Quote from THHuxleynew

    No to 250 life-long damage. Only thing I can't tell you without a lot of details is which of the various anti-vax "make the numbers look bigger" tricks that numb er comes from.

    FUD. Look at the database and read the case reports. All e.g. heart inflammations lead to live long damage. May be for you as a lab rat 2% reduction in hart power won't hurt. But if you did plan a sports carrier its the end. It will take a young boy/girl 5-10 years until he/seh knows this...


    Quote from THHuxleynew

    Sorry - what does the EU prevalence of cardiac disorders have to do with vaccines?

    FUD. All symptoms within 48 hours are vaccine related. Only a tiny number is background. Of course nobody counts 100% but the reported cases are also only 10%....



    Quote from THHuxleynew

    VAERS is a passive reporting system, meaning it relies on individuals to send in reports of their experiences to CDC and FDA.

    70% of all reports come from professionals. But big pharma pays hospitals for not reporting. Its' a part of the contracts.

    I understand that you as a vaccine terrorist always have problems with facts...


    In the middle of the page you find a sample Astra Zeneca contract (in English..) with an EU state...


    Behörden täuschen Öffentlichkeit über Corona-Haftungsklauseln - infosperber
    Haftpflichtig seien die Impfstoffkonzerne und nicht der Bund, insistiert das BAG. Doch das erweist sich als warme Luft.
    www.infosperber.ch

    Quote from Wyttenbach

    FUD. All symptoms within 48 hours are vaccine related. Only a tiny number is background. Of course nobody counts 100% but the reported cases are also only 10%....

    It is only you (and other anti-vax-lite people) who have this idea that no-one reports cardiac arrest within 48 hours of a new (COVID) vaccine injection. Of course such would be reported.


    So what is the background rate of cardiac arrests?


    In 2005 CVD was the underlying cause of death in 864,480 of the approximately 2.5 million total deaths in the U.S., and adults aged ≥65 years accounted for 82% of all deaths attributable to CVD (Figure 1). In terms of morbidity, an estimated 80 million Americans have at least one form of CVD, and nearly one-half of these are aged ≥60 years [3], reflecting a marked increase in the incidence and prevalence of CVD with advancing age. The prevalence of CVD, including hypertension, CHD, HF, and stroke, increases from about 40% in men and women 40-59 years of age, to 70-75% in persons 60-79 years of age, and to 79-86% among those aged 80 years or older (Figure 2) [3]. Similarly, the incidence of CVD, including CHD, HF, and stroke or intracerebral hemorrhage, increases from 4-10 per 1,000 person-years in adults aged 45-54 years to 65-75 per 1,000 person-years in adults aged 85-94 years (Figure 3) [3,4].


    if we have a 48 hour window we get a background rate of 4.5 * 2/365 * 1000 per million events =

    25 events per million for 45-54 year olds

    up to

    380 events per million for 85-94 year olds


    Given the EU has roughly 116% vaccine jabs per person and has a population of 448 million the expected background number of cardiac events within 48 hours of an EU COVID vaccination is:


    519 * 25 (assuming average risk is as for 45-54) = 12,975

    519 * 380 (assuming average risk is as for 85-94) = 197,220


    These don't look like tiny numbers to me?


    LOL - anti-vax web sites are not the best way to get accurate info. If you read them uncritically it would explain your false statements here?


    Homepage | UKColumn


    In this case those reports are of thing happening to people who have been vaccinated - not of vaccine caused things.


    Since some 50M people in UK have been vaccinated a lot of things happen to them. To see whether this number is above the background rate, and also what these things are, we would need more analysis. Not however something I'd expect from UkColumn, whose mission appears to be to spread false information and scare people.


    UK Column: Covid conspiracy theories run wild on the channel for lockdown sceptics
    At first glance the slick production looks like the work of Sky News or the BBC but this is not a conventional news channel. Brian Gerrish, a former Royal Navy…
    www.thetimes.co.uk

    Quote from THHuxleynew

    Given the EU has roughly 116% vaccine jabs per person and has a population of 448 million the expected background number of cardiac events within 48 hours of an EU COVID vaccination is:

    You should not do calculations of things you don't understand at all. First 48 hours is just the longest I would accept. Normally symptoms start the first 3 hours. (See VERS data details). Second we do not count jabs we count persons...

    Third. Death probability are given by a year so if death occurs lets say within a week of teh jab then you have to divide the number (probability) by 52.


    Here some real death data Death and its main causes in Switzerland 2016.pdf

    Please note that half of cardio vascular events have a second diagnoses.


    So may be you once can try to understand the problem and then redo your FUD.


    Dilettante!

    All the mild US reactions

    COVID Vaccine Landing


    Wrong - the vaers data is not vaccine reactions - it is chronologically correlated events happening to people who have been vaccinated. Mostly serious, not mild.


    The VAERS (serious events chronologically correlated with vaccinations) data are available - nicely searchable, from CDC

    How to Access VAERS Data through VAERS WONDER System | Vaccine Safety | CDC


    http://www.openvaers.com is a specially formatted version of this arranged to make it seem as scary as possible. (Not sure whether it is accurate). But I'm happy to assume it is accurate, although missing information that we could gte from the real VAERS database.


    Anyway, some homework for W is to work out what is the expected background number of VAERS reports in any given catagory, assuming no vaccine side effects?


    I am sure he has done that work and can give us at least approximate answers. Let me say that the answers "zero" and "very small" are not acceptable, being either false or non-informative.

    Games Regulators & Lawyers Play as Pfizer FDA Authorization Not Fully That


    Games Regulators & Lawyers Play as Pfizer FDA Authorization Not Fully That
    The U.S. Food and Drug Administration's (FDA) recent authorization of Pfizer's BNT162b2, now known as Comirnaty, the first COVID-19 vaccine fully
    trialsitenews.com


    The U.S. Food and Drug Administration’s (FDA) recent authorization of Pfizer’s BNT162b2, now known as Comirnaty, the first COVID-19 vaccine fully registered and approved in the United States was expected by many and shocked some. With growing challenges to vaccine mandates, part of the current POTUS vaccine-centric strategy to transcend the COVID-19 pandemic, a major argument—that the vaccines are only authorized under emergency use—is now gone for plaintiffs in various lawsuits. But TrialSite, an online media and social platform dedicated to clinical research raises some key questions: Why are growing mandates necessary if herd immunity is impossible via vaccination? Secondly, what’s the plan for boosters after eight months? Third, what happens with the next variant? Other considerations involve liability concerns. On to this most interesting and novel-like regulatory authorization. TrialSite conveys now that there are two legally distinct (Pfizer vs. BioNTech) but otherwise identical products based on two FDA letters. First, in the letter to Pfizer, the FDA conveys a number of interesting points. The letter doesn’t give full approval but rather extends the EUA to allow a supply of current Pfizer under EUA that does not impact safety or effectiveness, as viewed on page #2 of the letter.


    Interestingly, TrialSite points out that in this letter, the FDA carefully admits that the licensed Pfizer vaccine and the authorized Pfizer vaccine are identical with regard to safety/efficacy, but they are “legally distinct.” That’s code for one has manufacturer liability, while the other doesn’t. It is also code for “we don’t want to impose a mandate on the EUA product because it is illegal, but we can probably get away with a mandate on the licensed product.” Could this be framed also under the title “Games Regulators & their Lawyers Play.”


    TrialSite brings the reader’s attention to page 12 A.A. (Conditions With Respect to Use of Licensed Product), informing the reader that the regulator has licensed the vaccine, but…there is a lot of the old vaccine out there, actually “a significant amount” and this amount will be considered a EUA and will continue to be used.


    But why would the FDA do that? Why specify that identical versions of the product will be legally different? That’s because they need the license to impose the mandates. But the EUA is needed to evade liability. Understand, along with the license comes liability for the manufacturer. (While all EUA products were given a liability shield.)


    So what does this mean for the public? TrialSite suggests the federal government seeks to protect the manufacturer, e.g., not allow recourse for liability to the injured, thus keeping Pfizer out of expensive court battles.


    Interpreted another way, the federal government’s goal is to, on the one hand, deliver to the public a licensed vaccine, thus backing the growing number of mandates such as the ones in the City of San Francisco we wrote about recently. The public will more readily submit to such a federally licensed product as well, thus contributing to less vaccine hesitancy, or that’s the hope.


    Yes, there is a highly likelihood that the public may actually receive the EUA product vials instead. A CICP injury program exists, but it has not paid out for a single COVID vaccine injury yet, to our knowledge. Already, there are recognized issues such as myocarditis and pericarditis but as several have published in the TrialSite OpEd, many other adverse events appear prominent yet not acknowledged.


    The BioNTech Letter

    On August 23, 2021, “FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.”


    This particular letter, signed by Mary Malarkey, issued a BLA to that company based in Germany and Pfizer partner.


    In this letter, the BLA award goes for “active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.”


    The letter notes, “Analysis of […] adverse events reported […] not be sufficient to assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis.”


    Post Marketing Studies


    The FDA requires 13 post-marketing studies, including A) Pediatric (3 studies) < 6m to <15 y


    Myocarditis and pericarditis (6 studies), with UP TO 5 years follow up; C) Pregnancy – teratology (1 study) and D) Dose levels, V.A., effectiveness in Kaiser system (3 studies)

    Transparency of Process?


    The FDA bypassed/disregarded the normal advisory committee and public comment process for this license, as TrialSite discussed recently. On page 2 in the letter, it’s noted:


    “We did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues that would have benefited from an advisory committee discussion.”


    What about the Efficacy Claims?


    TrialSite argues that the efficacy claims are based on outdated data. The FDA press release indicates that the basis of the efficacy claims was as quoted below. However, those data are outdated and captured with strains of the virus (Alpha, Beta) that are no longer predominant. The efficacy claims are therefore invalid – it is quite clear that the vaccine is much less effective in preventing infection by the currently circulating strain (Delta)


    “Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.”


    They further wrote, “Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease. “While continuing “More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.”


    Finally, the FDA declared, “The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.”


    Why is the Decision Premature?


    Many experts in the TrialSite network argue that this decision was rushed through, perhaps driven by political or socio-economic considerations as much as public health factors. For example, regarding myocarditis and pericarditis risks, the CDC acknowledges that these risks are still actively assessed and could be at least 2.5 times higher than previously known. The FDA doesn’t have access to the new assessment as it hasn’t been completed.


    The FDA wrote, “the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes.”


    What about Ongoing Safety Data Monitoring?


    A growing chorus within the TrialSite network suggests the ongoing safety data monitoring is, in fact, inadequate. But according to the FDA, that’s not the case because “The FDA and Centers for Disease Control and Prevention have monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner. In addition, the FDA requires the company to conduct post-marketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty.”


    The FDA wrote that “We have determined that an analysis of spontaneous post-marketing adverse events reported under section 505(k)(1) of the FDCA will not be sufficient to assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis. Furthermore, the pharmacovigilance system that FDA is required to maintain under section 505(k)(3) of the FDCA is not sufficient to assess these serious risks.”


    While in the first sentence, the agency indicates that the CDC tracking system VAERS will be incapable of assessing known serious risks they also declare that the other pharmacovigilance systems that by law FDA employs (supposedly about 20 different databases when they were bragging about them last October) are similarly incapable of assessing known serious risk.


    What about Risks in Pregnancy?


    These are not known at this time. The FDA notes, “although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.”


    While the prescribing info says: “There is a pregnancy exposure registry for COMIRNATY. Encourage individuals exposed to COMIRNATY around the time of conception or during pregnancy to register by visiting https://mothertobaby.org/ongoingstudy/covid19-vaccines/.”


    Could a pregnancy study represent a politically motivated delaying action by the FDA to give the White House the license it demanded, which will not go into effect until the new product arrives? FDA presumably knows how long that will take, whether soon or not. Pfizer might already have the newly labeled vials ready to go in factories but not yet shipped across state lines.


    What about 16 and Up?


    The FDA licensed the BioNTech vaccine to ages 16 and up. The FDA has licensed the BioNTech vaccine for 16 and up. They note that all of the authorized vaccines on shelves and in freezers will remain only authorized until the new product with Comirnaty labeling arrives. A third booster dose as well as vaccine for those 12-15 remains under the EUA.


    TrialSite Questions for the Agency & the Public to Process

    TrialSite concludes with some questions for the public to ponder, process, and consider. Why wasn’t the Pfizer version approved? Why was it left under a EUA? The way this authorization works, although the press declares the “Pfizer vaccine is fully approved,” it is not.


    The vaccine is likely to be supplied for some time, but will this be the Pfizer – EUA vaccine?


    So certainly, an argument can be made that mandates based on full approval are meaningless.


    THE BLA acknowledges LONG term myocardial issues with a 5 year follow-up consistent with the lower range for LTFU for Gene Therapy Products. Is FDA quietly acknowledging the Gene Therapy classification? These products have been classified by FDA as Gene Therapy Products, which require UP to 15 years long term follow-up in studies. This was acknowledged by Moderna in their 2Q 2020 filing.

    Will FDA collect other long-term data on autoimmune disease, cancer, and other disorders as contemplated in their Gene Therapy Guidance document?

    VAERS system is clearly broken, with underreporting and discrepancies as to what should be and what is reported. Cannot attribute causality.

    Safety signal detection using disproportionality analysis (PRR) is known to be inadequate.

    Using CDC published methods, some experts estimate the under-reporting of VAERS deaths to be 5-15x. In Israel, the Ministry of Health combined with the Dagan study reveal excess deaths not acknowledged.

    Alarming safety signals related to death, along with a host of cardiac, neurological, and thromboembolic events, warrant to the adoption of the term a handful have coined: “Post Covid Vaccine Syndrome – pCoVS”

    A syndrome occurring after injection of antigen-inducing, gene therapy vaccines to SARS-Cov-2 virus. The syndrome is currently understood to manifest variously as cardiac, vascular, hematological, musculoskeletal, intestinal, respiratory, or neurologic symptoms of unknown long-term significance, in addition to effects on gestation. Manifestations of the syndrome may be mediated by the spike protein antigen induced by the delivered nucleic acids, the nucleic acids themselves, or vaccine adjuvants. As more data become available, subsets and longer-term consequences of pCoVS may become apparent, requiring revision of this definition. Sub-categories may be designated by suffix, for example:

    -C Cardiac

    -N Neurologic

    -H Hematologic

    -V Vascular

    Regarding the Pediatric Indication Requirements applied to the BioNTech license, Postmarketing requirements include multiple “deferred” studies.

    Deferred pediatric Study C4591001 to evaluate the safety and effectiveness of COMIRNATY in children 12 years through 15 years of age.

    Deferred pediatric Study C4591007 to evaluate the safety and effectiveness of COMIRNATY in infants and children 6 months to <12 years of age.

    Deferred pediatric Study C4591023 to evaluate the safety and effectiveness of COMIRNATY in infants <6 months of age.

    What about General Post marketing Requirements?


    AS noted above, the FDA acknowledges that “We have determined that an analysis of spontaneous post-marketing adverse events reported under section 505(k)(1) of the FDCA will not be sufficient to assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis. Furthermore, the pharmacovigilance system that FDA is required to maintain under section 505(k)(3) of the FDCA is not sufficient to assess these serious risks.”


    Note the agency conveyed that the following studies are therefore required:


    Study C4591009, entitled “A Non-Interventional Post-Approval Safety Study of the Pfizer-BioNTech COVID-19 mRNA Vaccine in the United States,” evaluate the occurrence of myocarditis and pericarditis following administration of COMIRNATY.

    Study C4591021, entitled “Post Conditional Approval Active Surveillance Study Among Individuals in Europe Receiving the Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine,” to evaluate the occurrence of myocarditis and pericarditis following administration of COMIRNATY.

    Study C4591021 sub study, to describe the natural history of myocarditis and pericarditis following administration of COMIRNATY.

    Study C4591036, a prospective cohort study with at least 5 years of follow-up for potential long-term sequelae of myocarditis after vaccination (in collaboration with Pediatric Heart Network).

    Study C4591007 sub study, to prospectively assess the incidence of subclinical myocarditis following administration of the second dose of COMIRNATY in a subset of participants 5 through 15 years of age.

    Study C4591031 sub study to prospectively assess the incidence of subclinical myocarditis following administration of a third dose of COMIRNATY in a subset of participants 16 to 30 years of age.

    Study C4591007 sub study to evaluate the immunogenicity and safety of lower dose levels of COMIRNATY in individuals 12 through <30 years of age.

    Study C4591012, entitled “Post-emergency Use Authorization Active Safety Surveillance Study Among Individuals in the Veteran’s Affairs Health System Receiving Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) Vaccine.”

    Study C4591014, entitled “Pfizer-BioNTech COVID-19 BNT162b2 Vaccine Effectiveness Study – Kaiser Permanente Southern California.”

    Another study is mandated in terms of post-marketing requirements: Study C4591022, entitled “Pfizer-BioNTech COVID-19 Vaccine Exposure during Pregnancy: A Non-Interventional Post-Approval Safety Study of Pregnancy and Infant Outcomes in the Organization of Teratology Information Specialists (OTIS)/MotherToBaby Pregnancy Registry.”

    Ivermectin Fact Check—An Independent TrialSite Breakdown


    Ivermectin Fact Check—An Independent TrialSite Breakdown
    While a growing body of research indicates the potential of ivermectin as a possible treatment targeting COVID-19, much of the mainstream press of late
    trialsitenews.com


    While a growing body of research indicates the potential of ivermectin as a possible treatment targeting COVID-19, much of the mainstream press of late has either focused on a few studies that failed to show any statistical benefit or warnings against the use of the veterinary drug. Presently, the drug is under study by prominent groups such as the University of Minnesota (in partnership with UnitedHealthcare’s Optum), the National Institutes of Health (NIH) via its Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) “ACTIV-6” study led by Duke University, and at least 43 active clinical trials as documented in Clinicaltrials.gov. The drug was first identified as a possible inhibitor of SARS-CoV-2 due to lab experiments at Australia’s Monash University Biomedicine Discovery Institute (BDI) in partnership with Peter Doherty Institute of Infection and Immunity.


    That’s when TrialSite first started tracking this drug and its applicability to COVID-19. While the doses in the initial lab experiments were much higher, what ensured was a combination case series, observational studies, randomized controlled trials, and real-world, off-label usage. Since April 2020, TrialSite has tracked dozens of studies and interviewed nearly one hundred doctors, researchers, and health professionals from almost 20 nations. The drug is used around the world off-label, targeting COVID-19 except in a few countries where the health authorities either directly authorized its provisional use or indicated its acceptance of off-label use. Indian included the drug in its national COVID-19 guideline for a handful of months.


    What’s the ivermectin story?

    This drug has been called a “wonder drug,” given its safety profile and contribution to eradicating certain parasitic diseases. Approved by the U.S. Food and Drug Administration (FDA), ivermectin is used to treat certain parasite-based medical conditions in the United States and much of the world.


    In fact, billions of drug doses have been administered—hundreds of millions every year—as part of a global effort to eradicate diseases such as river blindness. A centerpiece of this effort is Merck’s Mectizan program, which helped dramatically eliminate the parasite-born, tropical disease in Africa, Latin America, and Yemen. The discoveries of ivermectin went on to win the Nobel Prize, including Merck’s Dr. William Campbell and Satoshi Ömura of Japan.


    As TrialSite describes below, a preclinical in vitro study in Australia early on during the pandemic revealed powerful inhibitory forces against SARS-CoV-2. Conducted in a lab, translating those findings via clinical trials and the standard lengthy process of medicine development was constrained by pandemic conditions and several low-and-middle-income countries (LMICs) that sought imminent off-label approaches. As TrialSite will discuss below, 63 studies have been completed, and nearly 50 active studies are ongoing. TrialSite produced a documentary in Peru investigating why that nation accepted the drug so early on.


    Is the drug safe?

    Ivermectin’s general safety profile cannot be challenged. However, like any drug, if used in the wrong way, it can be harmful. According to ivermectin experts at Spain’s IS Global (Barcelona Institute for Global Health), “When used for the current indications, at the currently approved doses, ivermectin is a very safe drug.” The Spanish group shares, “To date, more than three billion treatments have been distributed in the context of the Mectizan Donation Program alone with an excellent safety profile. Most adverse reactions are mild, transitory and associated with parasite death rather than the drug itself.”


    Edenbridge Pharmaceuticals develops ivermectin in the United States—the U.S. FDA approves their product, and their label is included here.


    But what about for COVID-19?

    It depends on who one listens to. Organizations such as the Front Line COVID-19 Critical Care Alliance (FLCCC) have developed protocols for the use of ivermectin that have treated many thousands already with no reported problems. Dr. Jacques Rajter, Broward Health, conducted a case series study (ICON) that led to peer-reviewed published findings that the drug could become a safe tool in the war against COVID-19. TrialSite has interviewed many dozens of physicians worldwide using the drug in research or in care who report it’s very safe.


    Yet alternatively, there is concern that if the drug isn’t recommended by the NIH or approved by the FDA, it’s inherently risky and could be misused off label. That’s because drugs are heavily regulated.


    Moreover, authorities grow increasingly concerned with self-medicating with the veterinary version. Ultimately the FDA is the administrative branch agency that enforces food and drug laws in the United States, and recently, they have grown concerned during the pandemic with self-medication using the animal variety. No one should self-medicate with any prescription-based drug. And no one should inappropriately access and consume an animal drug.


    Does the FDA represent the “Gold Standard” of national drug regulatory agencies?

    Yes. The FDA regulates all drugs in the United States. The FDA was created over a century ago to protect consumers from unhealthy to dangerous treatments put into the stream of commerce in the late 1800s into the early 1900s. The 1906 enactment of the Pure Food and Drug Act led to the new agency. It’s long been considered the leader of food and drug regulatory agencies, a Gold Standard agency.


    What’s the FDA’s position on off-label prescribing?

    The FDA declares that generally, “…healthcare providers…may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient.”


    Why are there growing media accounts of warnings involving ivermectin?

    Typically, this involves the use of ivermectin for animal use. Physicians may not prescribe off-label animal ivermectin. There is growing concern that people may be obtaining animal ivermectin and self-medicating, as recently reported by the New York Times.


    In the U.S., only the human version of the drug can only be prescribed off-label. That’s at the discretion of the doctor and consenting patient, per the FDA. The media generally has evidenced bias against ivermectin, not mentioning many of the positive data points from around the world, but rather centering attention on negatives. An example of another drug is remdesivir. The World Health Organization (WHO) Solidarity trial established that remdesivir doesn’t help treat COVID-19 at all. Yet in America, remdesivir is embraced by the FDA, NIH, and market with $3 billion in sales during the first nine months of the pandemic. Much of the U.S. media focused on those successes, not other material data points from elsewhere.


    Is ivermectin a cure for COVID-19?

    No. There is no cure for COVID-19.


    What about a Silver Bullet?

    No. There are no silver bullet therapies for COVID-19. Rather, ivermectin used off-label in the U.S. (e.g. physician assessing risk-benefit with consenting patient) is a potential tool, along with other possible treatments, for early care used by some physicians combined with safe and effective vaccines and other precautionary measures from social distancing to other sanitary practices. Notably, in America and most jurisdictions in other countries, ivermectin isn’t recognized as a COVID-19 treatment and, therefore, would only be legally usable off-label if allowed in any particular nation. Some countries have formally authorized its use, but it’s not a “silver bullet.”


    How many studies in the context of COVID-19?

    Presently, the drug has been used in 63 completed studies involving 613 scientists and 26,398 patients. 31 of those studies are actually randomized controlled trials. A few meta-analyses from accomplished physicians/researchers indicate significant promise. See Bryant et al. and Kory et al., while another one led by Dr. Andrew Hill reveals promise but calls for more clinical trials data.


    What is the critique of most ivermectin studies?

    The NIH, FDA, and numerous academicians don’t buy into the positive results thus far. They believe that the studies are either too small (lack of statistical power), have methodical limitations, or have too much variability in dosage or study outcome measures. These institutions call for more numerous, extensive studies for more dependable data. In some cases, TrialSite completely agrees with the NIH. In other cases, we question some of their points of view.


    What does research detect about mechanisms of action?

    Again, the interest in ivermectin as a possible treatment for COVID-19 resulted from an in vitro study in Australia with published results here.


    One recent evidence-based review article published in the Journal of Antibiotics suggests numerous mechanisms of action targeting SARS-CoV-2, including a description of proposed cellular and biomedical interactions between the drug, host cell, and novel coronavirus pathogenesis. Other suggested mechanisms of action are proposed in “Repurposing Ivermectin for COVID-19: Molecular Aspects and Therapeutic Possibilities.” Researchers out of India probe mechanisms of action in “Ivermectin as a potential drug treatment for COVID-19; an in-sync review with clinical and computational elements.” Several other studies and papers cover the topic, as do YouTube videos such as Whiteboard Doctor and Drbeen Medical Lectures.


    What’s the position of health-related authorities in the U.S.?

    The U.S. FDA cautions against the use of the drug in the context of COVID-19 because, first and foremost, the Gold Standard agency hasn’t authorized the drug for the indication of SARS-CoV-2, the virus behind COVID-19. TrialSite has issued critiques of some of the agency’s statements, and that can be read here. As SARS-CoV-2 is a new pathogen, the FDA has concerns about off-label use, but it is allowed under the law.


    The National Institutes of Health (NIH) updated its treatment guidelines after meeting with the authors of two of the meta-analysis studies back in January 2021. Specifically, the NIH’s COVID-19 Treatment Guideline Panel changed its statement on the ivermectin topic from recommending only for clinical trials to a more neutral position, declaring a lack of sufficient data to declare for or against. Of course, this position is subject to change. Individuals in the NIH, such as Dr. Anthony Fauci, have been on the record that they don’t recommend use until more substantial clinical trial data is available.


    Can doctors prescribe ivermectin off-label in the United States?

    Yes. As mentioned previously, the FDA supports this within various legal boundaries. There are many doctors now prescribing ivermectin for COVID-19. Prominent among them is the Front Line COVID-19 Critical Care Alliance (FLCCC).


    Why are there a growing number of lawsuits involving patients/families that are denied access to ivermectin?

    Suppose a COVID-19 patient is in a hospital or health system. In that case, most often, the policies of the particular institution will preclude the use of ivermectin off-label because it’s not on the NIH panel’s recommendation list as an example. Attorney Ralph Lorigo has been involved with dozens of cases involving patients’ family members pleading with hospitals for access to their dying parents or other family members. TrialSite has reported on a few of these lawsuits and interviewed Mr. Lorigo.


    Is there absolute proof that ivermectin can consistently treat early-stage COVID-19 patients?

    No. Some researchers and physicians point to studies and real-world data that indicate the drug has a positive impact if used early on at symptom onset. Others, in fact, a majority of influential health authorities, research institutes, and the like, declare that there isn’t enough evidence based on the current data. The medical world is highly influenced by regulatory agencies (e.g., FDA), medical societies and boards, and the like. At least some of these institutions would need to embrace the data for a more confidential declaration of affirmative proof. Otherwise, it’s a niche off-label use case, but that doesn’t equal a more universally accepted norm.


    Has the Delta variant impacted the use of ivermectin?

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


    What are some prominent initiatives TrialSite investigated?

    A large population health study in Mexico City, widespread use in various Indian states, including the Uttar Pradesh battle against Delta, and prominent studies in Bangladesh, parts of Brazil, Latin America, and Eastern Europe, and Africa.


    Did India authorize ivermectin use at the national level?

    Yes, for at least a handful of months. An Indian biotech was even issued a license to produce the drug, TrialSite reported. There was a split at the national level, and the DGHS issued a statement that ivermectin would be dropped from the national list as the Delta surge declined there.


    Was ivermectin involved with the state of Uttar Pradesh’s dramatic turnaround in COVID-19 cases?

    Yes. TrialSite monitored this closely. See “Unprecedented Turnaround in Uttar Pradesh with Dramatic Decline in Cases..” However, because there was no systematic real-world evidence-based study, there is probably not a way to prove that ivermectin was a factor or not. Yes, the drug was involved, but was a causal relationship proven? Not one that can be proven. That would require study conditions, rigorous registry documentation, or some combination thereof.


    Does ivermectin compete in the early onset COVID-19 home care market?

    Possibly in a minimal way. The drug is not approved for this use by the FDA, so that will fundamentally limit its reach. Right now, there are no approved drugs for the early care COVID-19 space, a market that is potentially massive given that about 90% or more of COVID-19 cases are mild-to-moderate in nature.


    Presently, a handful of pharmaceutical companies are working on antiviral, orally administered antiviral drugs to target this space, including Merck (Molnupiravir), Roche (AT-527), and Pfizer (PF-07321332).


    In other parts of the world, a drug called Favipiravir is used.TrialSite has reported extensively on this antiviral, while U.S. media rarely mentions it, if at all. This antiviral could have some modest positive impact on the observational studies, but it doesn’t appear to be a game-changer.


    What other therapies look promising as prophylactic or early care?

    While AstraZeneca’s long-acting antibody therapy (AZD4772) is designed in the same class based on recent preliminary trial results, the investigational product shows promise as a prophylaxis—but only time and data will tell. Recent preliminary data was highlighted by TrialSite.


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

    No. If ivermectin is used off-label in the U.S. for early-onset COVID-19, this would be in alignment with what multiple pharmaceutical companies are working on in the clinical pipeline. In fact, it’s been known by the pharma industry and government research institutes like the NIH that the use of antivirals as a tool to help treat COVID-19 will be indispensable. That’s why, for example, the U.S. government awarded $356 million to Merck and $486 million to AstraZeneca (not an antiviral but cocktail antibody). The latter’s recently announced clinical trial for a prophylactic use case, for example, isn’t considered competitive to vaccines but an alternative approach for select cases. The U.S. NIH is on record as to the importance of antivirals (or similar) medicines to treat COVID-19 early on.


    Is there an industry, government, or WHO-led effort to block the use of ivermectin around the world?

    TrialSite cannot say for certain, but there are some questionable data points. For example, ivermectin was used extensively in Uttar Pradesh to combat the Delta variant-driven surge there as part of a proactive public health initiative using home medical kits. The World Health Organization (WHO) praised the Indian state’s public health effort but omitted the fact that they were using ivermectin.


    TrialSite now has several data points that the WHO or elements within appear hostile to countries that formally embrace the use of the drug other than for clinical trials. Sources have informed that if a nation’s public health or comparable group formally embraces the drug for use targeting COVID-19 at this point, it’s not looked upon well. That has implications as WHO’s budget of nearly $5 billion is allocated to various nations for health efforts. TrialSite is aware of one case where a government is afraid of announcing that it’s accepted the drug in national guidelines.


    Merck, a producer of ivermectin, went on the aggressive against ivermectin’s use for COVID-19, even questioning the drug’s safety profile. As TrialSite reported, Merck received $356 million from taxpayer-originated sources to develop a pharmaceutical antiviral targeting COVID-19. Recently, under the Biden administration, they secured a guaranteed contract worth $1.2 billion should the drug get authorized on an emergency basis or approved.


    No conspiracy theories here! Often a confluence of interests may align on a particular paradigm or point of view. What looks to be an orchestrated coordinated set of actions is merely various groups conducting business in similar ways, based on shared understanding and shared values and perceptions. Of course, active lobbying by industry can help shape interests. One only needs to look at the opioid crisis as an example. And TrialSite reminds all “history is just a series of coincidences.”


    Does TrialSite recommend ivermectin?

    No, that’s not TrialSite’s place. That should be a topic between a patient and their physician. TrialSite is a rapidly growing online media and social network platform centering on transparent, accessible biomedical and health-related research, emphasizing awareness building, information exchange, and hopefully empowerment. Generally pro-pharma, pro-free markets with sensible regulatory oversight, we are committed to driving more transparency, accessibility, and openness while providing more informative awareness about potential breakthrough medicines that can save human life.


    Does the drug development system in the U.S. favor branded, new drugs versus cheap repurposed drugs?

    Generally yes. There is much literature on this topic. See “Drugs Money and Secret Handshakes: the unstoppable growth of prescription drug prices” by Robin Feldman, for example. Developing pharmaceuticals is a high-risk, high-cost affair, and investors seek considerable returns. Thus market forces drive companies to find high-value medicines that address unmet needs, for example. See TrialSite’s “Is the Departure of NCATS Director Indicative of NIH’s Repurposing Track Record” to learn more.

    Comparison of Antibody Levels in Response to SARS-CoV-2 Infection and Vaccination Type in a Midwestern Cohort


    Comparison of Antibody Levels in Response to SARS-CoV-2 Infection and Vaccination Type in a Midwestern Cohort
    We present preliminary data in an ongoing observational study reporting SARS-CoV-2 spike protein reactive antibody levels from a convenience cohort of over 200…
    www.medrxiv.org


    Abstract

    We present preliminary data in an ongoing observational study reporting SARS-CoV-2 spike protein reactive antibody levels from a convenience cohort of over 200 individuals in Kansas City. We observe stable antibody levels over 11 months in individuals who recovered from COVID19 infection caused by SARS-CoV-2. Our data revealed higher-than recovered levels from naïve individuals vaccinated with Pfizer or Moderna vaccines and similar-to recovered levels from Johnson & Johnson (J&J) recipients. For all vaccines, inoculation after recovery resulted in higher antibody levels than vaccination alone. Responses to Pfizer and Moderna vaccines decreased over time from high initial levels but at the time of publication remain higher than those for recovered or J&J recipients. Within our limited cohort we did not see strong demographic trends other than higher antibody levels in recovered female individuals.


    Discussion

    Key Results

    We have measured IgG in human serum via binding to spike protein in an automated ELISA assay over time for a small cohort in Kansas City undergoing frequent PCR testing. Our cohort showed sustained antibody signals after infection, extending to ten months after infection. Responses to vaccines from Moderna, Pfizer, and J&J were clearly seen ten days after the first dose and more consistently after 20 days. Antibody signals in individuals who received the J&J vaccine were significantly lower than in those who received vaccines from the other manufacturers and in recovered individuals, correlating with the reduced efficacy reported for the J&J vaccine (Sadoff et al., 2021). After vaccination with Pfizer and Moderna vaccines, responses peaked around 40 days after the first dose and trended downwards over 120 days. Future testing is needed to determine whether antibody levels continue to decline or whether responses tend to remain at levels similar to those seen in recovered individuals. In agreement with previous studies, the J&J vaccine elicited a clear increase in signal for those vaccinated after recovery, with a similar trend from Pfizer and Moderna recovered samples.


    We observed little in the way of demographic impacts on antibody production, with only gender impacting infection recovery and no impact of gender, age, or race on responses elicited by the Pfizer and Moderna vaccines.


    Limitations

    Perhaps the biggest limitation of our data set is the focus on IgG binding to a single spike isoform. Variations in the spike protein as well as variations in the epitopes presented to serum antibodies are known to cause significant changes in antibody binding. In addition, IgA and IgM antibodies represent a strong initial antibody response to vaccination and infection and are well known to decay following response. Those limitations likely explain our lack of decay after recovery as reported elsewhere. Our assay also does not measure immune cell populations or viral neutralization, which are well known components of the immune response. Therefore, our antibody measurement represents a biased indicator of immune response over time and should not be interpreted on its own.


    We also rely on self-reported vaccine data. Our data set suggests that that data is fairly accurate but when considering outliers reporting inaccuracies could have a significant impact.


    Another limitation is uncertainty in collection method and timing. Samples were self-collected during a 24-hour period prior to serum preparation and freezing. While check-in steps should eliminate poorly collected and preserved samples, there is a possibility of contamination, timing error, and unknown collection factors that should be considered when interpreting the data.


    Finally, it is important to note that our cohort, being volunteers from an academic research center, is a biased representation of our local community as a whole. As such, they are likely more educated and financially stable than our surrounding community. Racially, our cohort is more dominated by Asian and White participants than the general population. These factors dramatically affect access to and knowledge of health care and thus, our findings should be interpreted with those factors in mind.

    W - you are welcome to post corrections to anything I post. I will happily agree any error I find corrected.


    Claiming other make errors without detailing them is what BSers do: so if you are able to do otherwise I'd suggest you do so, and if not all can see that.

    Preventative COVID-19 Treatments Full Steam Ahead: North Carolina Sets up Phase 3 Trial for Molnupiravir


    Preventative COVID-19 Treatments Full Steam Ahead: North Carolina Sets up Phase 3 Trial for Molnupiravir
    In Hampton Roads, North Carolina, a phase three clinical trial is being set up at TPMG Williamsburg to help people who are unvaccinated from getting
    trialsitenews.com


    In Hampton Roads, North Carolina, a phase three clinical trial is being set up at TPMG Williamsburg to help people who are unvaccinated from getting COVID-19. The study will include Molnupiravir, taken twice a day for five days. Participants will also be compensated.


    Medical Director Comments

    “This is a medicine that’s designed to fight the virus so you don’t get symptoms or you don’t develop COVID. It’s more of a preventative treatment,” said Dr. Vijay Subramaniam, the medical director for clinical research at TPMG Williamsburg.


    “The concern is by the time people test positive they’ve already spread the virus to their household members, so the purpose of this is to prevent the virus from actually taking hold in the household members,” said Subramaniam.


    He adds, “There are treatments for numerous other viruses to help prevent symptoms or progression, so it’s a similar approach they’re using.”


    About Molnupiravir

    TrialSite reported on this drug’s unique journey to development. We shared that the drug manufacturer, Merck, made “the decision to discontinue development of MK-7110 for COVID-19. The company will focus its pandemic efforts on advancing molnupiravir and on producing Johnson & Johnson’s COVID-19 vaccine.”


    Molnupiravir (EIDD-2801/MK-4482) is an orally administered form of a potent ribonucleoside analog that inhibits the replication of multiple RNA viruses including SARS-CoV-2. Molnupiravir is being developed in collaboration with Ridgeback Therapeutics. The companies recently reported data from two trial, the phase 3 MOVe-OUT trial in Outpatients and the phase 2/3 MOVe-IN trial in hospitalized patients. Molnupiravir was not clinically beneficial in hospitalized patients, and hence the development of molnupiravir will proceed in non-hospitalized patients only.


    Call to Action: If you’re interested in participating, email [email protected] or call (757) 707-3503.

    Quote from THHuxleynew

    Given the EU has roughly 116% vaccine jabs per person and has a population of 448 million the expected background number of cardiac events within 48 hours of an EU COVID vaccination is:


    519 * 25 (assuming average risk is as for 45-54) = 12,975

    519 * 380 (assuming average risk is as for 85-94) = 197,220


    These don't look like tiny numbers to me?

    You are using arithmetic. No fair.

    Questions for the FDA


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    The long-term effects of the vaccine are unknown but starting from a very very low level. The long-term effects of COVID are also unknown - but starting from a known much higher level, and frankly the uncertainty (what is long COVID?) is much scarier since we know it exists, whereas it is highly unlikely any vaccine long-term effects could exist.

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