The Playground

    2022 Cambridge Conference on Catastrophic Risk: 19th – 21st April

    CSER’s biennial conference will this year focus on Future Risks; Real Catastrophes, and Global Solutions. It will feature presentations by Tina Park (Partnership on AI), Joachim Isacsson (DCDC), Robin Gorna (Global Fund to fight AIDS, TB and Malaria), Bryan Walsh (Vox), Jenty Kirsch-Wood (UNDRR), and Oliver Letwin (KCL Project for Peaceful Competition) in a a program of lectures, panels, workshops, and lightning talks.

    On-line registration for this hybrid event is open at www.cccr2022.com (free)

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    Combined Therapy with Ivermectin and Doxycycline can effectively alleviate the Cytokine Storm of COVID-19 Infection amid Vaccination Drive: A Narrative Review


    https://www.sciencedirect.com/…le/pii/S1876034122000727#!


    Abstract

    An unprecedented global health crisis has developed due to the emergence of the mysterious coronavirus-2 of the severe acute respiratory syndrome, which has resulted in millions of deaths around the globe, as no therapy could control the ‘cytokine storm’. Consequently, many vaccines have been developed and several others are being developed for this infection. Although most of the approved vaccines have been highly effective, many developing, and economically poor countries are still deprived of vaccination against SARS-CoV-2 due to the unequal distribution of vaccines worldwide. Furthermore, the uncertainty about the effectiveness of the available vaccines against the emerging mutants and variants also remains a matter of concern. Due to the multistep pathogenesis and unique features, combination therapy using safe immunomodulatory and antiviral drugs should be considered as the most effective and acceptable therapeutic regimen for this infection. Based on a thorough assessment of the literature, it was determined that it would be interesting to study the therapeutic potential of ivermectin and doxycycline, given their roles in several biological pathways involved in SARS CoV-2 pathogenesis. Following that, a comprehensive literature search was undertaken using Scopus, Web of Science, and Pubmed, depending on the inclusion and exclusion criteria. The present study provides a mechanism and comprehensive report, highlighting the role of combined therapy with ivermectin and doxycycline in alleviating the ‘cytokine storm’ of COVID-19 infection.

    Quote from Fm1

    Based on a thorough assessment of the literature, it was determined that it would be interesting to study the therapeutic potential of ivermectin and doxycycline, given their roles in several biological pathways involved in SARS CoV-2 pathogenesis.

    This is an euphemizing statement... > 100'000'000 India folks did receive this treatment. So no study is needed. Just looking at what the result is would be enough! The Ziverdo kit is 1000x better than vaccines!

    Quote from Fm1

    Bottom line less mortality in the ivermectin arm and isn't death the true defining stat? As for vitamins, studies have shown the benefit of increasing vitamin D levels as well as vitamin B and iron. Long COVID is a result of vitamin deficiencies and doctors are now using vitamins to treat it. Now, why do you supplent vitamin d Thomas???

    FM1 - I think you don't understand stats? the 18% mortality is well into the error here.


    Bottom line is more likely those other measures, because they are more sensitive to anything that works - there are so few deaths - even in big trials you get only approximate info.


    I supplement Vit D because all far N hemisphere people should do it. Our typical diet + time in sun is not enough.


    My main concern is bones


    THH

    Quote from Wyttenbach

    This is an euphemizing statement... > 100'000'000 India folks did receive this treatment. So no study is needed. Just looking at what the result is would be enough! The Ziverdo kit is 1000x better than vaccine


    Indian & Saudi Research: Time to Take Combination Therapy of Ivermectin & Doxycycline Serious as a possible Regimen Targeting SARS-CoV-2 Cytokine Storm


    Indian & Saudi Research: Time to Take Combination Therapy of Ivermectin & Doxycycline Serious as a possible Regimen Targeting SARS-CoV-2 Cytokine Storm
    A group of Indian and Saudi physician-investigators reviews the use of combination therapies as a regimen to help address the COVID-19 pandemic. After a
    trialsitenews.com


    A group of Indian and Saudi physician-investigators reviews the use of combination therapies as a regimen to help address the COVID-19 pandemic. After a comprehensive review of the medical literature, the research team zeroed in on the combination of doxycycline and ivermectin, given these generic drugs’ roles in numerous biological pathways involved in SARS-CoV-2 pathogenesis. The authors suggest a role for the combined therapy as a regimen for early care targeting COVID-19 but declare the need for well-designed, randomized controlled trials.


    Early on during the pandemic, TrialSite tracked researchers around the world involved in ivermectin study, including Dr. Tarek Alam and others in Bangladesh. Called “the People’s Drug,” in that country of 165 million people, the combination of doxycycline and ivermectin was embraced by other physicians and scientists, such as Thomas Borody in Australia.


    While a few high-profile studies such as the Together trial haven’t produced sufficient endpoints—leading mainstream media to declare ivermectin useless in the search for effective and safe off-label medications for early care, this remains an important topic. Even the author of the Together trial, Ed Mills, has declared in private emails that there are potential efficacy signals in the Together trial data.


    In America, monoclonal antibodies are difficult to access. This is also true for the great majority of people worldwide living in low-and middle-income countries (LMICs) that become infected with SARS-CoV-2.



    Meanwhile, access issues continue to manifest at least in some regions with two recently authorized antivirals–Pfizer’s Paxlovid and Merck’s molnupiravir, while drug interaction considerations may impact actual real-world value.


    Some prominent physicians in top research institutions have questioned the safety and benefits of molnupiravir, including the chief medical officer of India’s Apex Research Institute India Council of Medical Research (ICMR).


    Dozens of nations still allow the use of ivermectin as an off-label treatment against COVID-19. In places like India (Uttar Pradesh), ivermectin was combined with antibiotics. In America, the use of ivermectin off-label exploded during the pandemic, yet mounting federal scrutiny on physician and pharmacy licensing boards put intense pressure on them at the state level to resist and reject such off-label prescriptions.


    Background

    A group of pharmaceutical-focused scientists and physicians from India and Saudi Arabia teamed up to perform a comprehensive literature review on that combination therapy regimen known as the people’s drug in Bangladesh. Titled “Combined Therapy with Ivermectin and Doxycycline can effectively alleviate the Cytokine Storm of COVID-19 Infection amid Vaccination Drive: A Narrative Review,” Combined Therapy with Ivermectin and Doxycycline can effectively alleviate the Cytokine Storm of COVID-19 Infection amid Vaccination Drive: A Narrative Review – ScienceDirect the output was published in the Journal of Infection and Public Health still to be reviewed by peers.


    Driving this research is the hypothesis that the mass vaccination of the world’s population against COVID-19 continues to be more of a theoretical exercise than a practical reality. In fact, the authors declare, “The current global trend in vaccination drive indicates 100% immunization is a distant reality.” Moreover, the authors question “the uncertainty about the effectiveness of vaccines worldwide.” This concern becomes magnified when considering emerging variants. As a consequence, the authors report, “Drug therapy should be considered as the mainstay for the treatment of this disease.”


    The “multi-character and multistep pathogenesis” of SARS-CoV-2 suggests combination therapies are probably a superior pathway for treatment versus the use of just one category of drug. The authors point out, “Given the unique nature of the disease, combination therapy with an antiviral and immunomodulatory drug should be considered as the most effective and acceptable therapeutic regimen for the management of this disease.” These authors opted for ivermectin and doxycycline as a target for this investigation.


    IVM Mechanism of Action

    The authors describe their search methodology and sources and discuss the targeted therapies and discuss the evidence for the efficacy of ivermectin against viruses. They speculate that ivermectin’s mechanism of action involves the drug’s ability to selectively inhibit the α/β1 transporter, thereby “preventing the entry of the viral nucleocapsid protein (NCP) into the nucleus as well as possibly selectively inhibits IMPα/β1 while not impacting other nuclear import pathways.” Thus, the authors argue “Ivermectin has been reported to act by binding to IMPα/β1 through NLS binding pocket,” referring to research undertaken in Australia previously. Here, the authors argue, however, that the antiparasitic drug approved by the FDA may also suppress the formation of IMPα/β1.


    Summary

    Describing possible mechanism of action for doxycycline involving SARS-CoV-2, the authors suggest that the combination of doxycycline and ivermectin involves dynamic, diverse mechanisms of action that may be of tremendous therapeutic value in treating infected patients in the dangerous cytokine storm stage of the disease which can lead to excessive irreversible damage to the lungs and death.


    Establishing a bold claim, the authors argue they “established the therapeutic efficacy of ivermectin against various viral infections, including COVID-19 infection.” Given the evidence observed in this literature review, the author suggests ivermectin should be considered as an off-label regimen in combination with doxycycline given the latter’s established antiviral and immunomodulatory activity. According to a survey of the literature, “doxycycline can be useful in controlling the severity of infection” along with offering “the additional benefit of reducing the cytokine storm.”


    Existing Evidence for the Combination Therapy

    The research team included a summary of clinical trials involving what’s known as “the people’s drug” in Bangladesh. Note, TrialSite has interviewed Dr. Tarek Alam, involved in some of this research—see the link.


    Short Title/NCT # Intervention Sponsor Outcomes

    An Outpatient Clinical Trial Using Ivermectin and Doxycycline in COVID-19 Positive Patients at High Risk to Prevent COVID-19 Related Hospitalization NCT04729140 Drug: Ivermectin Tablets Drug: Doxycycline Tablets Drug: Placebo Max Health, Subsero Health Decreased admission rate to the hospital secondary to respiratory illness related to COVID-19 (5 week)

    Clinical Trial of Ivermectin Plus Doxycycline for the Treatment of Confirmed Covid-19 Infection NCT04523831 Drug: Ivermectin and Doxycycline Drug: Standard of care Dhaka Medical College Body temperature remains normal for at least 3 days (ear temperature is lower than 37.5 °C).Respiratory symptoms are significantly improved. Lung imaging shows obvious improvement in lesions. There is no comorbidities or complications which require hospitalization.SpO2, >93% without assisted oxygen inhalation.

    Efficacy and Safety of Ivermectin and Doxycycline in Combination or IVE Alone in Patients With COVID-19 Infection. NCT04407130 Efficacy and Safety of Ivermectin and Doxycycline in Combination or IVE Alone in Patients With COVID-19 Infection. International Centre for Diarrheal Disease Research, Bangladesh Presence of virus will be negative on Day 7 detected by RT PCR, Body temperature will be < 37.5 C by day 7 detected by Infrared thermometer, Remission of cough: No signs of cough showing respiratory rate within 12-20/ min, on day7

    Effectiveness of Ivermectin and Doxycycline on COVID-19 Patients NCT04591600 Drug: Ivermectin and Doxycycline Drug: Standard of care Alkarkh Health Directorate-Baghdad The effect of the experimental drugs to reduce the mortality rate (death rate) of treated patients, rate of patients under treatment who undergo progression of disease to a more advanced stage

    Recommendation: More Randomized Controlled Trials

    Given the positive findings in the literature for this three-step mechanism of action of the combined therapy, the authors call for “well-designed controlled trials” to establish the necessary evidence for therapeutic efficacy against SARS-CoV-2. While 81 ivermectin studies have been conducted overall, many of them don’t have the scale or statistical power to establish formal evidence, and many in the medical research community, particularly, in rich economies, question some of the quality and even integrity of the underlying data.


    The authors suggest however sufficient evidence to establish an investigational regimen of doxycycline (200mg daily) to reduce the severity of SARS-CoV-2 if used in combination with ivermectin (200-400 µg/kg daily as part of a well-designed, randomized controlled trial.


    Lead Research/Investigator

    Satish Kumar Sharma, Glocal School of Pharmacy, Glocal University, Saharanpur, U.P., India

    Pankai Bhatt, Department of Pharmaceutics, KIET groups of Institution (KIET School of Pharmacy), Ghaziabad, Uttar Pradesh, India

    Syed Mohammed Basheeruddin Asdaq, Department of Pharmacy Practice, College of Pharmacy, AlMaarefa University, Dariyah, 13713, Riyadh, Saudi Arabia

    Mohammed Kanan Alshammari, Department of Pharmaceutical Care, Rafha Central Hospital, Rafha 91911, Saudi Arabia

    Abeer Alanazi, Department of Pharmaceutical Care, King Fahad specialist Hospital, Dammam 32253, Saudi Arabia

    Naif Saleh Alrasheedi, Department of Pharmaceutical Care, Northern Area Armed Forces Hospital, King Khalid Military City Hospital, Hafer Al-Batin 39745, Saudi Arabia

    Bader Abdullah Alrashdi, Department of Pharmaceutical Care, Northern Area Armed Forces Hospital, King Khalid Military City Hospital, Hafer Al-Batin 39745, Saudi Arabia

    Saad Saleh Alyami, Department of Pharmaceutical Care, King Fahad specialist Hospital, Dammam 32253, Saudi Arabia

    Guru Gobind Singh College of Pharmacy, Yamunanagar, Haryana, India

    Bshayer Hmdan Alhazmi, Department of Pharmaceutical Care, Northern Area Armed Forces Hospital, King Khalid Military City Hospital, Hafer Al-Batin 39745, Saudi Arabia

    Perwaiz Alam, Radiant Institute of Pharmaceutical Sciences, Kishanganj, Bihar, India

    Prerna Sharma , Guru Gobind Singh College of Pharmacy, Yamunanagar, Haryana, India

    Ritu Tomar, School of Pharmaceutical and Population Health Informatics, DIT University, Dehradun, India

    Madeep K Arora, School of Pharmaceutical and Population Health Informatics, DIT University, Dehradun, India

    Mohd Imran, Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Northern Border University, Rafha, Saudi Arabia

    Quote from Fm1

    Indian & Saudi Research: Time to Take Combination Therapy of Ivermectin & Doxycycline Serious as a possible Regimen Targeting SARS-CoV-2 Cytokine Storm

    Big Pharma hates this drug combination as it kills almost all known virus. It also cures at least 3 different types of cancer. Further it kills Helio bacter pyroli (stomach cancer).

    And newest it could help to heal Parkinson/MS as IVR induces re-myelization!


    If you remove all virus then th overall cancer rate will dramatically be reduced. These 2 drugs alone almost can kill Big Pharma!

    Quote from Wyttenbach

    Big Pharma hates this drug combination as it kills almost all known virus. It also cures at least 3 different types of cancer. Further it kills Helio bacter pyroli (stomach cancer).

    And newest it could help to heal Parkinson/MS as IVR induces re-myelization!


    If you remove all virus then th overall cancer rate will dramatically be reduced. These 2 drugs alone almost can kill Big Pharma!

    Agreed but make sure your iron levels are good before taking doxy. It has an adverse effect on iron poor recipients.

    Peginterferon Lambda: The Next Early Outpatient Antiviral?


    Peginterferon Lambda: The Next Early Outpatient Antiviral?
    Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite. by Stephen Ditmore In the
    trialsitenews.com


    In the Opinion section of May 22, 2020, New York Times there appeared an editorial titled:


    Treating Mild Coronavirus Cases Could Help Save Everyone



    Acting before or very soon after an infection is the best way to handle


    Most acute viral diseases. Why aren’t we focusing on that with Covid-19?


    by Harvard Medical School infectious diseases professors Richard Malley and Marc Lipsitch. In it was the sentence:


    “One trial, conducted at various sites worldwide, will test the effectiveness against Covid-19 of peginterferon lambda, a drug also being considered for hepatitis D.”


    Nearly 22 months later on March 18, 2022, Dr. Ed Mills of Canada’s McMaster University opened a Rethinking Clinical Trials Grand Rounds discussion of ivermectin’s performance in the multi-drug TOGETHER trial by remarking:


    “Today we’re supposed to be talking about ivermectin, but what I wish we were talking about is peginterferon lambda, which the results just got released on yesterday. From the same trial, peginterferon lambda is a single dose subcutaneous injection. It showed a 50% reduction in the composite endpoint that we use, it showed a 40% (significant) reduction in hospitalization and about a 70% reduction in deaths. A single dose of something within the same population we’re talking about, I’m super excited about that, but it only got released yesterday, we’re still working on a lot of analytics.”


    Clearly, there’s a story concerning the development of peginterferon lambda as a COVID-19 therapeutic, including all that transpired in the intervening 22 months. At this time, peginterferon lambda remains investigational; it’s up to developer Eiger BioPharmaceuticals to apply to the FDA for emergency use authorization. That has not yet occurred, and a paper concerning the peginterferon lambda-1a leg of the TOGETHER trial has not yet been published as of this writing.


    In a response to a TrialSite News inquiry on April 6, Dr. Mills responded:


    “We have not yet written up the manuscript and are still in the data analysis phase. We do intend on submitting an EUA when the analysis is complete. We have had initial contact with FDA on the EUA.”


    While the TOGETHER trial result is sufficiently impressive to encourage belief that peginterferon lambda might take its place with Paxlovid and Molnupiravir among the first-line antivirals offered as part of President Biden’s Test to Treat program, we’re not there yet.


    Interferons Lambda 1-4, also known as type III interferons, occur naturally in the human body where they are generated by type 2 myeloid dendritic cells. A peginterferon is pegylated, meaning polyethylene glycol is added to make it last longer in the body.


    The Phase 3 TOGETHER study of Lambda is the second largest study to date of a COVID-19 therapeutic, anywhere. Final analyses evaluated data from 1,936 patients, with 84% of patients having received at least a single dose of any COVID-19 vaccine.


    Analyses using a Bayesian analytic framework showed:


    Lambda highly superior compared to placebo on the primary endpoint, with a probability of superiority of 99.91%, surpassing the prespecified superiority threshold of 97.6%

    50% risk reduction was observed [95% Bayesian credible interval (95% BCI): 23–69%] of COVID-19-related hospitalizations or emergency room visits compared to placebo in patients treated ≤7 days of symptom onset

    2.7% of patients (25 / 916) who received Lambda were hospitalized or had ER visits through Day 28, compared to 5.6% of patients (57 / 1020) who received placebo

    Risk reduction of COVID-19-related hospitalizations was observed:

    42% (95% BCI: 5–66%) risk reduction when treated ≤7 days of symptom onset

    60% (95% BCI: 18–82%) risk reduction when treated ≤3 days of symptom onset

    One COVID-19-related death in Lambda group; four in placebo group

    Incidence of any treatment-emergent adverse events was similar between Lambda and placebo groups, which were primarily injection site reactions

    Viral sequencing was conducted on all patients. The primary endpoint was achieved across all variants tested, including omicron. Based on these data, Eiger BioPharmaceuticals believes peginterferon lambda-1a has the potential to be effective against any new variants.


    “These data demonstrate that a single subcutaneous injection of Lambda has the potential to be a convenient, ‘one and done’ treatment to reduce the severity of COVID-19, reducing hospitalizations and death – even in a vaccinated population,” said Eiger President and CEO, David Cory. “With the continued global impact of COVID-19, we are encouraged by this data and look forward to supporting the global public health response. We’re thankful to the patients, investigators, and sites who participated in this clinical trial, and we look forward to discussing these results with FDA and submitting an EUA application to add Lambda to the evolving armamentarium of COVID-19 therapeutics.”


    Lambda stimulates immune responses critical to innate defenses with a mechanism of action potentially agnostic to variants of SARS-CoV-2 and resistance concerns with other treatments. If authorized, Lambda could be prescribed more broadly to help reduce illness severity, hospitalizations, and deaths, as well as reduce the probability of infection following exposure, among adults.


    “Lambda has demonstrated a reduction of risk in COVID-19-related hospitalizations or deaths in this clinical study in a predominantly vaccinated population, something that no other investigational drug has achieved – this is a game-changing event,” said Principal Investigator, Professor of Health Research Methods, Evidence, and Impact at McMaster University, Hamilton, Canada, Edward Mills, Ph.D., who is leading the TOGETHER study with Co-Investigator, Associate Professor of Medicine, Pontifical Catholic University of Minas Gerais, Brazil, Gilmar Reis, MD, Ph.D. “The COVID-19 pandemic continues to be a global public health emergency, and outpatient treatments that can be quickly and efficiently administered to newly diagnosed SARS-CoV-2 patients are desperately needed with a goal of reducing COVID-19 complications.”


    The TOGETHER Study

    TOGETHER is a multi-center, investigator-sponsored, randomized, placebo-controlled adaptive platform Phase 3 study evaluating therapeutics in newly diagnosed, high-risk, non-hospitalized patients with COVID-19. TOGETHER is the largest placebo-controlled study in COVID-19 and has evaluated eleven different therapeutic agents for non-hospitalized COVID-19 patients. This evaluation of Lambda versus placebo was the second largest study to date of a COVID-19 therapeutic. Eligibility criteria required that all patients had laboratory-confirmed mild or moderate COVID-19, and were randomized within 7 days of symptom onset. High-risk criteria were defined by patients having at least one of the following, including but not limited to: > age 50, diabetes, hypertension, CV disease, lung disease, kidney disease, obesity, etc. The study enrolled patients regardless of vaccination status or variant strain of SARS-CoV-2. The primary endpoint was a clinical outcome comparing hospitalizations or emergency room visits greater than six hours after a single subcutaneous injection of Lambda versus placebo. The DSMB provided independent oversight for the trial and had previously discontinued other therapeutics due to observed futility. The TOGETHER study recruited from twelve sites in Brazil. For more information visit http://www.clinicaltrials.gov (NCT04727424) and http://www.togethertrial.com.


    About Peginterferon Lambda

    Lambda is a late-stage, first-in-class, type III interferon (IFN) that stimulates immune responses that are critical for the development of host protection during viral infections and has been well-tolerated in clinical studies.


    Lambda is to be administered as a single subcutaneous injection so that it can be prescribed and administered at the first sign of infection or at first awareness of an exposure, potentially helping patients avoid severe illness that can lead to hospitalization and death.


    IFN lambdas are critical for maintaining a balanced antiviral response in the respiratory tract. They are induced at lower viral burden before type I IFNs to limit the initial infection by inducing viral resistance to cells and helping them deal with the virus load. IFN lambda lacks the strong pro-inflammatory effects of type I IFNs and are tissue-protective and anti-inflammatory. Administration of IFN lambda has been shown to suppress viral replication while stopping ‘cytokine storm’ from developing.


    Eiger BioPharmaceuticals is developing Lambda for the treatment of HDV infection. Peginterferon Lambda has been administered to over 3,000 subjects in 23 clinical trials of HBV, HCV, HDV, and COVID-19. Lambda is an investigational agent and not yet approved for any indication. Eiger has received Orphan Designation by the U.S. Food and Drug Administration (FDA) and European Medicines Agency, and Fast Track and Breakthrough Therapy Designation by FDA for Lambda in HDV.


    Eiger BioPharmaceuticals licensed worldwide rights to Lambda from Bristol-Myers Squibb.

    FDA VRBPAC Meeting Represents Watershed Event in Response to COVID-19

    FDA VRBPAC Meeting Represents Watershed Event in Response to COVID-19
    On April 6, the U.S. Food and Drug Administration (FDA) held its Vaccines and Related Biological Products Advisory Committee (VRBPAC) Meeting to discuss
    trialsitenews.com


    On April 6, the U.S. Food and Drug Administration (FDA) held its Vaccines and Related Biological Products Advisory Committee (VRBPAC) Meeting to discuss ongoing COVID-19 vaccine programs, including the prospect of modifying the COVID-19 vaccine designs to deal with mutating variants. But the experts in the FDA acknowledge they lack sufficient data to comprehend the implications of such change fully. Taking a step back and pondering on the last couple of years, with enormous troves of data and tens if not hundreds of billions spent in pandemic responses, TrialSite suggests the meeting points out not only a major shift in government pandemic response but a profound failure of public health and regulatory oversight of the pandemic.


    Is the American public exhausted by COVID-19 booster campaigns, given the recent authorization of a fourth booster dose for the elderly and select immunocompromised individuals? Can the FDA and industry pivot and develop next-generation vaccines to take on multiple variants? How can the FDA and Centers for Disease Control and Prevention (CDC) model and predict COVID-19 variant surges in the future? Would it be comparable to modeling influenza pathogens?


    Unfortunately, more questions than answers have arisen in this meeting. After two years, hundreds of billions of taxpayer-based dollars and ongoing variant-driven surges lead to disturbing conclusions.


    This VRBPAC meeting included outside experts and other stakeholders, including drug development expert David Wiseman, Ph.D., who reports on profound shifts in how the government is dealing with the COVID-19 pandemic.



    Other attendees included researchers from Israel who presented recent data, including a study published in the New England Journal and reported on today by TrialSite. The recent Israeli data reveals that in regard to stopping infection and thus transmission, Pfizer-BioNTech’s mRNA vaccine’s effectiveness wanes within five weeks.


    Wiseman participated remotely in this watershed event, reporting to TrialSite fundamental changes in outlook among the FDA and the CDC. In addition, TrialSite concurs there is a significant shift in agency outlook moving forward with profound implications.


    Moreover, an undercurrent of friction between the government and industry emerges as it becomes clear that the existing vaccines are not the panacea once hoped for. Wiseman reports that the government participants and committee members acknowledge that herd immunity is unlikely and an unrealistic goal, despite the fact that this was a primary rationale for the mass vaccination campaign in the first place.


    Evidencing these shifts, the FDA’s activities and topics of discussion implicitly demonstrated a materially changing outlook, approach, and failure when revisiting initial public health pandemic response goals.


    The following table summarizes these shifts:


    Paradigm Shifting/Acknowledged Failures Summary of shift/failure

    Herd Immunity This isn’t relevant anymore.

    Immunological Correlate of Protection Nonexistent and not even on the horizon—after two years and billions of dollars of taxpayer money spent, there is still a shocking lack of basic understanding. This type of research should have been prioritized.

    Vaccinate to Eradicate the Pathogen—prevent, shift the curve, achieve herd immunity, etc. There’s now a shift to therapeutics as a higher priority than before.

    Shortcomings with Data We still do not know if someone is hospitalized with COVID or for COVID—we cannot distinguish between the two nor can we assess by variant. This was acknowledged by Dr. Heather Scobie, Ph.D., MPH.

    Industry-driving agenda vs. goal of partnership Industry on the outs? TrialSite notes that Moderna’s VP of COVID Vaccines attended as a member of the public, seemingly trying to educate the members about company direction—this is a marked change.

    Tracking of Natural Immunity data They are not tracking with nearly enough granularity.

    Regarding vaccine exhaustion, Dr. Marks said, “We simply can’t be boosting people as frequently as we are, and I’m the first to acknowledge that this additional fourth booster dose that was authorized was a stopgap measure.” TrialSite’s Dr. Wiseman agreed with growing government sentiment that “the need for therapeutics becomes ever more pressing.”


    While the committee discussed how public health agencies and industry collaborate to model and develop vaccines for influenza, a stunning lack of data and knowledge among government health-related agencies makes it clear, at least to Wiseman, that “trying to handle COVID-19 in the same way that we manage influenza is unrealistic.”


    Moreover, keeping up with SARS-CoV-2, a rapidly mutating pathogen, remains an elusive goal. After this latest VRBPAC meeting, it became apparent that the coronavirus evolves 2.5 times faster than the flu; combine that with a lack of seasonality data, and the road toward a more predictable suite of data and models becomes a long one.


    Acknowledging this challenge, Dr. Marks shared, “We’re going to have to think about this in a way that is less than optimal because we’re not going to have all the data that we’d like to have.”


    TrialSite suggests that the FDA has reached the end of the road as to how to deal with this pandemic under the current set of assumptions and overall paradigm. While industry has been a proactive driver, it became evident from Wednesday’s meeting that the lack of industry (except for Moderna’s VP of COVID Vaccines, Rituparna Das, who presented as a member of the public) represents a significant shift from past practices.


    The hope from this meeting was that a sharpened booster policy would emerge along with a compelling direction to handle new variants. Unfortunately, it appears the government has neither. Two years into this pandemic, the world’s top public health agencies are caught rather flatfooted in advancing to the next pandemic-fighting chapter. However, it’s clear, at least implicitly, that the way the CDC and FDA were responding to COVID-19 over the past couple of years won’t work moving forward

    Quote from Fm1

    TrialSite suggests that the FDA has reached the end of the road

    If you do run a state (FDA/CDC etc..) by picking brainless FM/R/F/B mafia members to run it, you exactly end up where the USA is today.

    Since more than 10 years FDA follows the money and not science.


    Even the simplest prevention treatments (V-D3, zinc) are suppressed as in most western, now mafia run countries too.


    Basically most countries are still run like concentration camps. To enter the USA you must still agree to accept an experimental - damaging treatment.


    RNA "vaccines" 10000% failed if you look at India, that never did use it.


    To many trolls and idiots live on our planet. ;(

    In a recent development, things are not looking very good in England for the double/triple vaccinated. This article unpacks the latest UK data, and breaks it down to per/100,000. Generally, with only a few age group exceptions, the double/triple are getting COVID, hospitalized, and dying from COVID at a higher rate than the unvaccinated:


    Official Government data suggests the Fully Vaccinated are suffering Antibody-Dependent Enhancement; and the newly published Pfizer Documents prove Pfizer & the FDA knew it would happen – The Expose (dailyexpose.uk)

    The British are now officially hiding Covid vaccine data Since last fall, and especially since the Omicron variant hit, the reports have presented an increasingly dismal picture of vaccine efficacy. Last week’s report showed that in March, nearly 90 percent of adults hospitalized for Covid were vaccinated. And OVER 90 percent of deaths were in the vaccinated. As of this week’s report the british government is no longer providing these charts. The British government is offering the nonsensical excuse that it can no longer provide the figures because it has ended free universal testing for Covid. It would make no difference to the hospitalization or death figures, which are far more important.


    Every hospital admission is still Covid-19 tested and vaccination status is universally recorded after all. Apparently every government - no matter of level of democracy claimed - can immediately switch to mendacious Putin's regime once data point at its corruption.


    The existence of these reports have become an embarrassment. They are impossible to spin, and the clearest possible signal of vaccine failure. But hiding the numbers won’t make the vaccines work better. It will just make people less likely to believe anything else public health authorities tell them about Covid and the vaccines - if that’s even possible at this point.

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