Covid-19 News

  • Why is the Major Ivermectin Study in the Philippines in Continuous Delay?


    Why is the Major Ivermectin Study in the Philippines in Continuous Delay?
    In May 2021 TrialSite reported that a major ivermectin study was to start in the Philippines. Numerous announcements in various press in the
    trialsitenews.com


    In May 2021 TrialSite reported that a major ivermectin study was to start in the Philippines. Numerous announcements in various press in the Southeast Asian nation of approximately 112 million people declared the start of the vitally important study. The demand was pressing given there were spikes in SARS-CoV-2 cases in the spring and then again in the summer with the Delta variant. However, the study never started. Even the nation’s strong man president Rodrigo Duterte ordered the May to June launch of a large ivermectin study. Interestingly, by June an investigational study of Merck’s molnupiravir was off to the races finishing up this month. While TrialSite reported Merck executives were crossing Asia already selling orders to neighboring nations, the Philippines was preparing to do the same. Even the Gates Foundation was ready to make a $120 million purchase for low-and middle-income countries (LMICs). But what about that low-cost, readily available, and highly used product over the last four decades? Stuck in quicksand apparently, and conveniently so while Merck wraps up its molnupiravir study. Now the media suggests that the ivermectin study will finally start in November, but Merck was given the buffer time needed to prepare for monetization. What about Roberto Duterte’s call to action to commence the large-scale ivermectin trial in his country back in May? Apparently, more talk than action.


    CNN Philippines recently reported that enrollment for the large-scale clinical trial testing ivermectin finally commences in November—November? TrialSite’s Southeast Asia correspondents have monitored this situation for about half a year. Horrible spikes occurred in April/May and then again in August/September. At this time, plenty of ivermectin was used off-label causing growing tensions between medical factions and the majority establishment who very much aligned with the World Health Organization’s (WHO) disapproval of the use of ivermectin for anything but clinical trials.


    While Science and Technology Undersecretary Rowena Guevara seemingly exhibits a genuinely positive intent, recently declaring they will need 1,463 asymptomatic and non-severe COVID-19 patients to participate in the study, she has declared this over and over analogous to scenes in the movie Groundhog Day.


    Confusing matters more, back in June Dr. Aileen Wang with the University of the Philippines-Philippines General Hospital reported there was no need to conduct an ivermectin study as they would simply await results from other studies. This of course contradicted President Duterte’s mandate to conduct an ivermectin trial around the same time!


    Now Dr. Aileen Wang commences the ivermectin study at trial sites including quarantine facilities at Ateneo de Manila University, De La Salle University, University of the Philippines, and Makati Science High School reports CNN Philippines. CNN Philippines stated it is part of an international study led by the University of Liverpool —but the actual name of the study was omitted. Dr. Wang declared that preliminary findings could be available by the end of the year, although that seems odd given the fact that patient recruitment doesn’t start until November.


    COVID-19 Vaccination & Declining Cases

    According to Our World in Data, only 22% of the entire nation of 112 million people have been fully vaccinated. The country experienced a huge Delta variant-driven surge of SARS-CoV-2 cases starting in late July which spiked by mid-September. Much like many other Southeast Asia countries, the cases have fallen dramatically (although there are exceptions such as heavily vaccinated Singapore).


    CNN Philippines reports that a total of eight pharmaceutical companies were authorized to conduct COVID-19 vaccine studies in the nation, and all of them have completed studies. Meanwhile, the Philippines Department of Science and Technology (DOST) continues a study concerning the safety and efficacy of mixing and matching COVID-19 vaccine products to be conducted in trial sites in the cities of Muntinlupa, Marikina, and Davao.


    For example, by September 15, 2021, the country reported a 7-day average daily new cases of 21,287; as of October 23, the case count average dropped to 5,451.


    Philippines COVID-19 Case & Death Rates

    How does the Philippines compare to some other countries in terms of infection rate and deaths due to COVID-19? We included some of the world’s largest nations including Indonesia as well as Southeast Asian neighbor Malaysia. The findings are quite striking.


    Nation Pop Cases Case/Pop Death/Pop Death/Case

    India 1.4 b 34.2m 2% 0.03% 1%

    USA 333.5m 46.3m 14% 0.23% 2%

    Indonesia 277.3m 4.2m 2% 0.05% 3%

    Brazil 213.3m 21.7m 10% 0.28% 3%

    Russia 146.1m 8.2m 6% 0.16% 3%

    Philippines 112m 2.8m 2% .04% 2%

    Malaysia 32.7m 2.4m 7% .09% 1%

    As indicated by the data, the Philippines has a markedly lower-case rate as compared to its population—the lowest out of the sample along with Indonesia. Of course, this number could be influenced by less than comprehensive public health reporting. Meanwhile, the Philippines also fares better when looking at total COVID-19 deaths to the entire population. In this category, Russia fared the worst followed by America. Finally, death to case rates range between 1% to 3% with the Philippines at 2%.


    Other Studies

    CNN Philippines reported on other studies involving local herbs and treatments including the following:


    Can virgin coconut oil help treat COVID-19? According to a small study conducted last year at Laguna’s Food and Nutrition Institute, VCO may ease symptoms of suspected COVID-19 patients.

    Another study investigating the use of “tawa-tawa” found 172 COVID-19 patients reported improved symptoms within three to five days.

    In other news the country still awaits the launch of the Solidarity study sponsored by the World Health Organization


    Patient recruitment for ivermectin trial vs COVID-19 to begin in November
    The enrollment of participants for the clinical trial that seeks to determine if the anti-parasitic drug ivermectin works against COVID-19 is set to begin next…
    cnnphilippines.com

  • Undeclared Hazardous Components in Nasopharyngeal Test Swabs Used in COVID-19 PCR Tests


    Undeclared Hazardous Components in Nasopharyngeal Test Swabs Used in COVID-19 PCR Tests
    Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite. By Peter Grandics A-D Research
    trialsitenews.com


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


    By Peter Grandics


    A-D Research Foundation


    Carlsbad, CA 92013 USA


    e-mail: [email protected]


    We tested two widely used nasopharyngeal test swabs used for COVID-19 PCR test sample collection by the SEM-EDS method. Scanning electron microscopic (SEM) analysis demonstrated fairly uniform artificial fibers that showed a great degree of heterogeneity in their internal composition. Elemental analysis by electron dispersion spectroscopy (EDS) revealed carbon, oxygen, nitrogen, aluminum, and silicon as main components at highly variable concentrations within the cross-sections of the fibers. In some spots, the concentrations of aluminum and silicon were as high as 7.25% and 14.06%, respectively. The base matrix appeared to be nylon with inorganic ingredients mixed in. Aluminum and silicon can both present health hazards, and this can explain the rapid-onset nasal bleed and strong and lasting adverse reactions reported by the tested individuals.


    Introduction

    Respiratory specimen collection techniques for the detection of SARS-CoV-2 were defined by the WHO and CDC (1,2) in March 2020, and these have become standard methods worldwide. The most widely used technique is the nasopharyngeal test swab, (3) even though a more effective and less irritating method is available (4).


    The swab has a long shaft with a fiber tip made of nylon, rayon or polyester. It was reported that the specimen collection may cause a mild discomfort (3). However, numerous tested persons have reported epistaxis (4) and/or a rapid-onset irritation reaction that may even require medical attention. In one study, 28% of the swabbed individuals reported significant side-effects (5). Unfortunately, such observations are typically not followed up and often dismissed as insignificant.


    However, the rapid onset of these adverse reactions suggest mechanical and/or chemical damage to the nasopharyngeal mucosa. Since the swabbing procedure is administered by trained professionals, we wanted to check out if the swabs themselves could be responsible for the observed reactions. Our test method was SEM-EDS, which allows morphological examination of the fibers and a determination of the main elements present in them. This also allows for the discovery of material heterogeneities in test samples.


    Results and discussion

    We tested two specimen collection swabs widely used in COVID-19 PCR diagnostic tests. Swab “K” (Figure 1A) was manufactured by Noble Bio Clinical Diagnostics Products, Republic of Korea, lot number NFS-12011-02. This is a sterile flocked nylon swab. The other sterile swab “M” (Figure 1B) provides lot number 20201130 on its packaging, but no manufacturer information is listed. This is in violation of both U.S. and European labeling requirements for diagnostic products.



    Figure 1A. Swab “K” packaging



    Figure 1B. Swab “M” packaging


    The fiber tips of the two swabs were placed into the sample holder of a Zeiss Quant SEM-EDS system, and the fibers analyzed for morphology and elemental composition. Specifically, we were interested in finding out if the fibers have sharp surface features that could account for the reported injuries of the nasal microvasculature. Figure 2 exhibits the images of sample “M” and subsequently the EDS analysis results.




    Figure 2. Fibers of sample “M”.


    The endpoint of a fiber was analysed at three spots by EDS and the bulk elemental composition and concentrations were recorded. The X-ray spectra are shown in Figure 3.



    .Figure 3. Elemental composition of the sample “M” swab nylon fiber.



    Table 1. Elemental composition of fibers in sample “M”.


    The spectra and tabulated data reveal that the fibers were not in fact made of nylon exclusively, but contained unreported bulk components of aluminum and silicon. This is in violation of prevailing regulations that require the identification of all constituents in diagnostic products. The concentrations of aluminum and silicon were variable, at some spots as high as 1.68% and 14.06%, respectively. The distribution of these inorganic components across the fibers was highly uneven, a factor that could be caused by an uncontrolled manufacturing process.


    Swab “K” was tested under the same conditions and the morphology of the fibers was comparable, suggesting that both manufacturers use similar technology. However, the elemental compositions were different, with aluminum being the dominant inorganic component.




    Figure 4. Fibers of sample “K”.



    Figure 5. Elemental composition of the swab “K” nylon fiber.


    Considering the strict manufacturing and quality procedures embodied in Current Good Manufacturing Practices, it is reasonable to suggest that this heterogeneity of the fibers is by design. Silicon is likely present as silicon dioxide (quartz) microparticles, an abrasive that can have sharp edges randomly distributed inside and on the surface of the fibers. Rotating such a fiber tip inside the nasal cavity may injure the microvasculature of the nasal mucosa, leading to the observed nose bleeds.



    Table 2. Elemental composition of fibers in sample “K”.


    The presence of high levels of aluminum in the fibers is another disturbing finding, particularly in sample “K” (as high as 7.25% aluminum), which is hard to rationalize. These swab fibers contain ingredients that are known health hazards to humans, but this fact is undisclosed by the manufacturers, and apparently missed by the regulatory agencies.


    Aluminum is a neurotoxin and can enter the brain viathe nasal cavity. Accumulation of aluminum in the brain leads to encephalopathy-related dementia. Considering the mass (and repeated) COVID-19 PCR testing of healthy individuals, aluminum exposure of the population via swabbing could constitute a health hazard and should be discontinued. Nasal uptake of aluminum is facilitated by mucosal injury, which can be another factor involved in the reported adverse reactions. It is likely that testing more fibers at more spots could reveal even more heterogeneities in the fibers’ compositions.


    There is an alternative to swabbing: The nasal rinse procedure, which is more effective in recovering respiratory pathogens and is far less intrusive to the tested individuals (6). In this study, 91% of the test subjects opted for the nasal rinse because it is easier to tolerate. Apparently, the well being of patients is of little concern for the medical industry currently; this is just one more iatrogen effect that is accepted as “normal.”


    Our results revealed a disturbing pattern of noncompliance with regulatory requirements, combined with the lack of concern for the well-being of test subjects. It is ironic that the medical establishment that now strives to control human health is incapable of producing a safe and simple product in conformance with current regulatory standards.


    Since the COVID-19 PCR technique is standardized, these commonly used test swabs should be reevaluated for regulatory and manufacturing compliance. We have contacted Noble Bio Clinical Diagnostics Products for further safety information on their product, but our inquires have so far gone unanswered. This is unacceptable corporate behavior, and should prompt the regulatory agencies to take action to protect patient health.


    The optimal decision would be to promote nasal rinse or oral saliva sampling and discontinue the use of swabs. If viral RNA can be detected from wastewater (7), why can’t COVID-19 diagnostics tests use other sources, e.g., urine samples? These are logical questions that need an answer, and the continued proliferation of COVID-19 testing argues for improved testing protocols. Hopefully, protecting the profits of healthcare providers will not become the overarching issue here. The current atmosphere, in which essential scientific debate about COVID-related issues is discouraged, unfortunately leads to the situation we are reporting in this communication. We urge researchers to be courageous enough to scrutinize the fundamental risks and benefits of COVID-19 testing protocols, and be forthright about bringing these to light.


    Acknowledgement

    We are indebted to Gregory M. Vogel for his valuable comments and suggestions on the manuscript.


    Competing interests

    None.


    References

    1. World Health Organization. Laboratory testing for coronavirus disease 2019 (COVID-19) in suspected human cases: interim guidance. March 2, 2020.


    2. Centers for Disease Control and Prevention. Interim guidelines for collecting, handling, and testing clinical specimens from persons for coronavirus disease 2019 (COVID-19). April 14, 2020, accessed on 08/15/2021.


    3. Marty FM, Chen K, and Verrill, KA. How to obtain a nasopharyngeal swab specimen. N Engl J Med 2020; 382:e76


    4. Gritzfeld JF, Roberts P, Roche L, El Batrawy S, and Gordon SB. Comparison between nasopharyngeal swab and nasal wash, using culture and PCR, in the detection of potential respiratory pathogens. BMC Res Notes 2011; 4:122-122.


    5. Healthline, accessed on 08/15/2021.


    6. Gupta, K, Bellino, PM and Charness, ME. Adverse effects of nasopharyngeal swabs: Three-dimensional printed versus commercial swabs. Infect Control Hosp Epidemiol. 2020 Jun 11:1.


    7. Aizza Corpus MV, Buonerba A, Vigliotta G, et al. Viruses in wastewater: occurrence, abundance and detection methods. Sci Total Environ. 2020; 745:140910

  • Reports out of India share a disturbing and purportedly rare example of vaccinated health care workers getting infected not once or twice but three times! Apparently, a 28-year-old male working in a Pune-based hospital was first infected with the SARS-CoV-2 wildtype, and then re-infected with the Delta variant. Then, after full immunization, he was infected yet again. The Pune health care worker was infected for the third time a month after receiving the second dose of Covishield, the brand name for the Oxford/AstraZeneca vaccine product developed domestically by Serum Institute of India. Apparently, at least two other doctors in India have been infected three times.

    This is indeed worrying.


    it shows that, for some people, natural immunity just does not work to prevent future infection! And for some of them, also, vaccination after natural immunity does not work.


    I'd just point out that in medicine everything is variable, and while it is a personal tragedy if you keep cathcing COVID (maybe) for society as a whole what matters is the average protection which I hope and expect would be better than this.


    THH

  • It looks like the international FM/R/ ;) /B mafia desperately tries to discredit Ivermectin with made up fake facts.


    According to a Swiss background news site Elgazzar said that he never uploaded any data to any internet accessible portal. He also said that the presented data has been manipulated.


    The guy(s) doing this manipulation are well known and paid anti-anitvaxx propagandists.


    So basically we can note:: All real Ivermectin studies shows extremely high benefits. > 3/4 of India is free of COV-19 without any vaccination thanks to Ivermectin. The use of early Ivermectin gives you a close to 100% survival guarantee.


    The FM/R/ :whistling: /B mafia fake studies all did not use any add-ons(zinc, V-D, doxy) to Ivermectin. This shows the average mediocre brain of international FM/R/ :* /B mafia members.


    200 years ago free masons attracted the most brilliant people today is 100% opposite... Just a bunch of mental cripples.

  • According to a Swiss background news site Elgazzar said that he never uploaded any data to any internet accessible portal. He also said that the presented data has been manipulated.

    Ummm....


    Well:

    (1) strictly speaking the data was password protected

    (2) given that he is being accused, seriously, of fraud, based on anlysis of that data, you'd hardly expect him to admit it

    (3) Mafia?


    Data detectives dig into ivermectin studies
    How do we protect COVID science from fishy data?
    cosmosmagazine.com


    That’s where the data detectives come in. The fabulous five – including three irreverent Aussies – do not hail from a single institution and have no formal collaboration. Three don’t even have a PhD yet. What unites them is their hobby of sleuthing startling papers. That’s how they all met on Twitter.

    “We’re five inherently suspicious people,” explains Kyle Sheldrick – a medical doctor currently doing a PhD on back pain at the University of New South Wales, Australia, and the senior author of the paper.

    The two that do have PhDs – Nick Brown, a Brit now based at Linnaeus University in Sweden; and Australian James Heathers, now chief scientific officer at a biotech company called Cipher Skin in Colorado – already enjoyed a reputation as “data thugs” for exposing fraud in psychology papers. One of their sleuthing successes resulted in the retraction of 15 papers.

    The other three authors were galvanised by the pandemic: Jack Lawrence, a medical student at the University of London who also moonlights as a “journalist and disinformation researcher”; Gideon Meyerowitz-Katz, an experienced epidemiologist with a master’s degree in Public Health who is now carrying out a PhD in the use of electronic devices in diabetes at the University of Wollongong in Australia; and Sheldrick.

    Last November they were mesmerised by a paper uploaded onto the preprint server Research Square. It was by Ahmed Elgazzar, a Professor Emeritus at the University of Benha, in Egypt.

    The paper was dazzling for two reasons. It reported that ivermectin reduced mortality by 90%! And with 600 people, it was the largest randomised controlled trial to date.

    Other meta-analyses did use the Elgazzar paper. One was led by statistician Andrew Bryant at Newcastle University, UK, and published in the American Journal of Therapeutics. Their meta-analysis claimed ivermectin reduced the risk of dying of COVID-19 by 62%. One of the co-authors was Tess Lawrie, a doctor and founder of the British Ivermectin Recommendation Development Group (BIRD). While the authors of the meta-analysis claim they have no conflict of interest, Lawrie has a large online following of vaccine sceptics to whom she spruiks the dangers of vaccines while holding up ivermectin as an effective treatment. Indeed, she’s weaponised the meta-analysis as part of her pro-ivermectin, anti-vaccine campaign – views that are at odds with the impartiality expected of someone carrying out a meta-analysis. As Garner put it: “Cochrane has checks and balances to prevent using authors with a particular positionality.”


    I know this thread has many people who believe strongly that scientists with science jobs are all corrupt. If you don't hold that position - the evidence for Elgazar fradulent, and for FLCC being a high spin PR group pushing an unproven claim with an agenda (antivaxxers want everyone to belive there is an alternative to vaccines) is compelling.


    The above does not mean ivermectin will not prove to be useful. Even 10% reduction in mortality would be great, and ivermectin has not yte had large enough testing to know whether it might deliver that. Mainstream science has enough curiosity in it to be investing such testing time. We can hope for something.


    THH

  • Ivermectin saves India!


    And not Kerala!

    25.10.2021:: Kerala - the vaccine terror state - today presented a very high number of deaths possible a backlog and correction.


    They still contribute > 50% of all India cases with less than 1/40 the India population...


    The states (like Tamil Nadu) that initially followed WHO and killed some 10'000 Indians by no treatment now fully catch up too. Only a few small mafia states (Kerala, Mitoram are still completely dysfunctional.

  • Excess deaths in UK.

    You have to compare the two tables in::

    Excess deaths in England and Wales 2021 | Statista
    There were 536 weekly excess deaths recorded in England and Wales for the week ending September 3, 2021.
    www.statista.com


    and: https://www.worldometers.info/coronavirus/country/uk/


    What we see:: The first "Alpha" wave with 4000 cases peek produced most excess deaths. 10 x more cases during gamma did produce only a 50% excess death peek (effect 20x less in total), what clearly indicates that COV-19 is just a predating illness.

    This is definitely clear when you look at the Delta figures starting week 11. No more excess deaths can bee seen.


    Geneva in Switzerland did show the same: Delta did strongly reduce random COV-19 deaths.

  • Merck and Ridgeback Announce Initiation of a Rolling Review by the European Medicines Agency for Molnupiravir, an Investigational Oral Antiviral Medicine, for the Treatment of COVID-19 in Adults

    If Granted Marketing Authorization by the European Commission, Molnupiravir Could Be the First Oral Antiviral Medicine for the Treatment of COVID-19 in the European Union


    https://www.businesswire.com/news/home/20211025005204/en/


    KENILWORTH, N.J. & MIAMI--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that the European Medicines Agency (EMA) has initiated a rolling review for molnupiravir, an investigational oral antiviral medicine, for the treatment of COVID-19 in adults. Merck plans to work with the EMA’s Committee for Medicinal Products for Human Use (CHMP) to complete the rolling review process to facilitate initiating the formal review of the Marketing Authorization Application. As previously announced, Merck has submitted an application for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA), and is actively working to submit applications to other regulatory agencies worldwide.


    “This application to the EMA is another step in our efforts to bring molnupiravir forward to patients globally,” said Dr. Dean Y. Li, executive vice president and president, Merck Research Laboratories. “We believe that molnupiravir will be an important addition to the range of public health tools to fight COVID-19 – including the vaccines developed by the research-based pharmaceutical industry, which remain essential and are the first-line of defense against this pandemic.”


    The submission is based on positive results from a planned interim analysis from the Phase 3 MOVe-OUT clinical trial, which evaluated molnupiravir in non-hospitalized adult patients with mild-to-moderate COVID-19 who were at increased risk for progressing to severe COVID-19 and/or hospitalization. At the interim analysis, molnupiravir 800 mg twice-daily reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were hospitalized through Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377) that were either hospitalized or died; p=0.0012. Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo. The incidence of any adverse event was comparable in the molnupiravir and placebo groups (35% and 40%, respectively). The incidence of drug-related adverse events was also comparable (12% and 11%, respectively), and fewer patients in the molnupiravir group discontinued therapy due to an adverse event compared to the placebo group (1.3% and 3.4%, respectively).


    “In the nearly two years since COVID-19 emerged, the global scientific community has made extraordinary strides in developing several critical vaccines and treatments, but we still have a need for an oral antiviral medicine that can be taken at home,” said Wendy Holman, chief executive officer, Ridgeback Biotherapeutics. “We believe that molnupiravir, with the exciting finding of reduction in hospitalization and death in the MOVe-OUT study, may help fill that need and look forward to working with the EMA on its review.”


    About Merck’s Efforts to Enable Global Access to Molnupiravir, if it is Granted Authorization or Approval


    In anticipation of the results from MOVe-OUT and the potential for regulatory authorization or approval, Merck has been producing molnupiravir at risk and expects to produce 10 million courses of treatment by the end of 2021, with even more courses expected to be produced in 2022.


    On October 11, Merck and Ridgeback announced that Merck had submitted an application for EUA to the U.S. FDA for molnupiravir for the treatment of at-risk adults with mild-to-moderate COVID-19. Additional submissions to global regulatory agencies are underway.


    Earlier this year, Merck entered into a procurement agreement with the U.S. Government under which the company will supply approximately 1.7 million courses of molnupiravir to the U.S. Government following EUA or approval from the U.S. FDA. Additionally, Merck has entered into supply and advance purchase agreements for molnupiravir with other governments worldwide, pending regulatory authorization, and is currently in discussions with additional governments.


    Merck is committed to providing timely access to molnupiravir globally, if it is authorized or approved, and plans to implement a tiered pricing approach based on World Bank country income criteria that reflect countries’ relative ability to finance their health response to the pandemic.


    As part of its commitment to widespread global access, Merck previously announced that the company has entered into non-exclusive voluntary licensing agreements for molnupiravir with established Indian generic manufacturers to accelerate availability of molnupiravir in more than 100 low- and middle-income countries (LMICs) following approvals or emergency authorization by local regulatory agencies. Merck continues to discuss additional measures and collaborations to accelerate broad, global access to molnupiravir.


    About Molnupiravir


    Molnupiravir (MK-4482 and EIDD-2801) is an investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19. Molnupiravir has been shown to be active in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and prevention of transmission. Additionally, pre-clinical and clinical data have shown molnupiravir to be active against the most common SARS-CoV-2 variants.


    Molnupiravir was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University; Emory/DRIVE received some research funding from the U.S. Department of Defense and the U.S. National Institutes of Health. Molnupiravir is being developed by Merck & Co., Inc. in collaboration with Ridgeback Biotherapeutics. Ridgeback received an upfront payment from Merck and also is eligible to receive contingent payments dependent upon the achievement of certain developmental and regulatory approval milestones. Any profits from the collaboration will be split between the partners equally. Since licensed by Ridgeback, all funds used for the development of molnupiravir have been provided by Merck and by Wayne and Wendy Holman of Ridgeback.


    Molnupiravir is also being evaluated for post-exposure prophylaxis in MOVe-AHEAD, a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study, which is evaluating the efficacy and safety of molnupiravir in preventing the spread of COVID-19 within households. For more information, please visit http://merckcovidresearch.com.


    About the MOVe-OUT Study


    The MOVe-OUT trial (MK-4482-002) (NCT04575597) is a global Phase 3, randomized, placebo-controlled, double-blind, multi-site study of non-hospitalized adult patients with laboratory-confirmed mild-to-moderate COVID-19. Patients enrolled in the study were unvaccinated against SARS-CoV-2, had at least one risk factor associated with poor disease outcomes, and symptom onset within five days prior to randomization. The primary efficacy objective of MOVe-OUT is to evaluate the efficacy of molnupiravir 800 mg twice daily for five days compared to placebo as assessed by the percentage of participants who are hospitalized and/or die from the time of randomization through Day 29.


    The Phase 3 portion of the MOVe-OUT trial was conducted globally, including in more than 170 planned sites in countries including Argentina, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Guatemala, Israel, Italy, Japan, Mexico, Philippines, Poland, Russia, South Africa, Spain, Sweden, Taiwan, Ukraine, the United Kingdom and the United States. For further information about the MOVe-OUT trial, please visit clinicaltrials.gov.


    The most common risk factors for poor disease outcome included obesity, older age (>60 years), diabetes mellitus and heart disease. Delta, Gamma and Mu variants accounted for nearly 80% of the baseline viral variants that had been sequenced at the time of the interim analysis. Recruitment in Latin America, Europe, and Africa accounted for 56%, 23% and 15% of the study population, respectively.


    About Ridgeback Biotherapeutics


    Headquartered in Miami, Florida, Ridgeback Biotherapeutics LP is a biotechnology company focused on emerging infectious diseases. Ridgeback markets EbangaTM for the treatment of Ebola and has a late-stage development pipeline which includes molnupiravir for the treatment of COVID-19. Development of molnupiravir is entirely funded by Ridgeback Biotherapeutics and Merck & Co., Inc. All equity capital in Ridgeback Biotherapeutics, LP originated from Wayne and Wendy Holman, who are committed to investing in and supporting medical technologies that will save lives. The team at Ridgeback is dedicated to working toward finding life-saving and life-changing solutions for patients and diseases that need champions.


    About Merck


    For over 130 years, Merck, known as MSD outside the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit http://www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.


    Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA.


    This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.


    Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.


    The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2020 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (http://www.sec.gov).




    Contacts

    Media Contacts:


    Melissa Moody

    (215) 407-3536


    Patrick Ryan

    (973) 275-7075


    Investor Contacts:


    Peter Dannenbaum

    (908) 740-1037


    Raychel Kruper

    (908) 740-2107


    Ridgeback Media Contact:


    Chrissy Carvalho

    [email protected]

  • This is it’ is the consensus among some COVID experts. So how should you assess risk for the long term?


    ‘This is it’ is the consensus among some COVID experts. So how should you assess risk for the long term?


    Last week, Dr. Bob Wachter — one of the Bay Area’s leading experts on COVID-19, who is known to be cautious — did something potentially surprising: He hosted a 300-person medical conference in downtown San Francisco, with people traveling in from different places, despite the ongoing pandemic.


    Of course, those who attended the conference all had their vaccine cards checked and wore masks indoors, and there was a virtual option for those not quite ready to attend something in person. But for many, going to the conference was a big step — and one of their first forays back into regular life, said Wachter, the chair of UCSF’s Department of Medicine.

    That slow shift back, with pandemic calculus still running in the background, is how Bay Area public health and infectious disease experts see the upcoming months and years of the coronavirus crisis, as cases remain relatively low but risk persists.


    “Seeing (the pandemic) through the lens of ‘this may be a pretty stable state,’ creates a different risk-benefit analysis, at least for me,” Wachter said.

    And with that new approach, Wachter said he has recently decided to loosen up on his own COVID-19 precaution-taking. He’s more open to things like eating inside restaurants, flying for vacations or to visit family — or even holding a 300-person conference in San Francisco.

    I’m still going to be thoughtful and careful,” he said, but “if I’m not going to do it now, I’m probably saying that I’m not going to do it for the next couple of years, and I might be saying I’m not doing it forever. I hate to say that, but it’s possible that this is it.”


    While not every infectious disease expert is willing to loosen up quite yet, with many emphasizing that people must continue to take into account their individual risk and the context of immunity and illness levels where they live, “this is it” is a consensus that many doctors and disease experts are starting to come to.


    It means that COVID-19 will continue to be around for at least the next few years, but we’re going to co-exist with it.


    “Eradication, meaning complete elimination of this virus from the world, is not going to happen,” said Dr. John Swartzberg, a UC Berkeley infectious disease expert. “We’re going to be living with COVID.”


    He added that pandemics are defined by humans, so when, exactly, COVID-19 will no longer be considered a pandemic — becoming endemic instead, or always “in the background,” like influenza — isn’t clear cut. He thinks the time will come when surges in case numbers slow, and the reproduction number, or how many people an infected person passes the virus to, remains consistently below one.


    While that might still necissitate changes in our behavior, he added, he’s optimistic — “we’ll adapt to it, we’ll live with it, and life is going to be fun again.”


    Dr. George Rutherford, an infectious disease expert at UCSF, said the endemic phase will probably include a lower everyday risk as well as a much lower mortality rate for the virus. To him, getting there is “a race between booster shots and waning immunity,” with the next few months being critical, during which he recommends people stay careful.


    Experts agree that with booster shots and increasing vaccinations overall, the endemic phase will settle in over the next few years.


    Dr. Monica Gandhi, an infectious disease expert at UCSF, said that especially with children between 5 and 11 set to become eligible for vaccines soon — a milestone nearly every expert is looking forward to — she believes the “end is in sight” as rates of immunity in the community continue to rise.


    “I think we are getting to control of COVID-19 in this country,” she wrote in an email. “However, the state of control for communicable diseases (which means that a disease is brought to low circulating levels and impact) takes constant vigilance, and that vigilance is in vaccinating those who are still without immunity (e.g. children) and using treatment for those who decline vaccination.”


    Gandhi is not alone in her optimism about better treatments for the virus coming. Experts agree it’s another key piece of the post-pandemic puzzle. Swartzberg said that better vaccines and treatments “could be a game-changer.”


    While experts still aren’t sure about the exact timeline for post-pandemic life — waiting on higher immunity levels and wary of another surprise like the delta variant — one thing is for sure: risk will never be zero, and decision-making is fuzzy.


    Living in the pandemic is like playing “multi-dimensional chess,” Wachter said. “All of us are having to navigate our lives and make decisions under conditions of substantial uncertainty, and the ground is shifting under us all the time.”

  • Pastors Across Nation Issuing a “Hail-Mary” to the Vaccine-Mandate Critics


    Pastors Across Nation Issuing a “Hail-Mary” to the Vaccine-Mandate Critics
    For every worker that is given the ultimatum to become vaccinated or face termination, another unvaccinated individual is watching from the shadows and
    trialsitenews.com



    For every worker that is given the ultimatum to become vaccinated or face termination, another unvaccinated individual is watching from the shadows and wondering when the time will come where, they too, will be forced to make the same near-impossible decision. We see the conversations swirling on social media that go a little something like this: Those who are against the mandates are appalled with what’s happening and say that no one should be forced to choose between their job or a jab. Pro-vaxxers then clap back with a response that usually runs along the lines of, “Well, no one is forcing you to take it.” But it’s hardly a “choice” when earning money to put food on the table is critical. As the number of workers being ordered to vaccinate grows, many are turning to possible religious exemptions as their last saving grace, and although religious leaders traditionally opt-out of discussing politics with their congregation, many are now starting to rise and join in on the resistance.


    Religious exemptions originated during the Civil Rights Act of 1964 and although employee requests for them have long been minuscule, they are now being requested in mass numbers, according to Reuters. Of course, the concept of religious preference and freedom goes way back in America to its founding.


    The National Conference of State Legislatures reports that a religious exemption may be valid for those who have a “sincere religious belief,” which stimulated pastors like Shane Vaughn of First Harvest Ministries in Waveland, Mississippi, to approve such requests.


    Vaughn is the leader in an online development that elevates personal faith as an alternative to following a vaccine mandate. According to Reuters, the preacher posts letters on his website that have been printed over 40,000 times from workers who are seeking a religious exemption and pleads, “this is the only way out.”


    Vaughn, a conservative-leaning religious figure puts his future not as much in science but in his faith. But a growing so-called “medical freedom” movement brings together an odd assortment of at least temporary allies, from civil libertarian types to deeply religious people.


    The preacher shared in the Georgia Voice “If you’re one of those that (are) trusting in anything besides God, let me tell you something…” He continued “They’ve got variants coming that ain’t no vaccine going to work for. This nation is under the judgment of God. And I want to tell you something right now: They’re already admitting that the vaccine is alarmingly not working. Alarmingly! They’re alarmed at what they’re seeing.”


    Tulsa Oklahoma Pastor Jackson Lahmeyer is joining in on the effort and offering a religious exemption letter in exchange for church donations, with over 30,000 letters already issued by Lahmeyer, according to The Washington Post.


    Lahmeyer, a 29-year-old entrepreneur and pastor of Sheridan Church, is running as a Republican against Sen. James Lankford (R-OK) to take his Senate seat in 2022.


    Lahmeyer told the Washington Post that he wanted to provide an opportunity for people to get a signed exemption letter since most pastors across the nation have decided to not get involved.


    Lead Pastor of Cornerstone Church in San Antonio, Texas, Matt Hagee is pointing his congregation to a non-profit legal organization called First Liberty that advocates for religious rights, according to Insider.


    “We have received a number of phone calls here at the ministry for individuals who are concerned about vaccine mandates, and they’re concerned that it’s going to cost them their career because some of the places that they work are saying, ‘You will be vaccinated or you will be terminated,’” Hagee said in an August 22 service, told by Insider. “Believe me, our religious liberty is something that’s under attack in the United States today.”


    Director of Litigation at First Liberty, David Hacker, said the brochure the non-profit provides is a guide on how to ask for religious accommodations through school or their employer.


    “We’re not calling those balls and strikes on whether someone has a sincere belief or not,” Hacker told Insider. “What we’re doing is we’re providing them with a legal analysis of the protections that they have available to them, giving them samples and telling them: ‘You need to put this in your own words. You need to craft this according to your own religious beliefs.'”


    According to ABC News, although religious exemptions have been around since the 60s, there have been times like the measles outbreak of 2019 where states like New York and Washington eliminated such exemptions.


    It’s too early to tell what the outcome will be regarding mandates, religious exemptions, and the possibility of such exemptions being eliminated, but one thing is for certain: Regardless of what side of the aisle you might be on in terms of vaccine mandates, we are all riding on a very slippery slope. Will pastors continue to champion the medical freedom cause or will organize efforts at the federal and state level convince them to embrace at least the official interpretation of the science of COVID-19 vaccination? Will the federal government somehow turn this into a political issue, threatening the religious non-profit status of those church leaders that continue organizing and resisting

  • Question, we have all read the headlines concerning ivermectin, from horse dewormer to overdosing. Why have we not read a headline of someone treated with ivermectin that developed long covid or relapsed or even a reinfection? Now that would be worldwide breaking news! No headlines relating to that. Hummmmmmmmm!

  • New Zealand Prime Minister Embraces Authoritarian Two-Class Human System—the Unvaccinated are Second-Class Citizens


    New Zealand Prime Minister Embraces Authoritarian Two-Class Human System—the Unvaccinated are Second-Class Citizens
    New Zealand, perhaps one of the most democratic, and egalitarian places on the planet, has transformed into something very different during the era of
    trialsitenews.com


    New Zealand, perhaps one of the most democratic, and egalitarian places on the planet, has transformed into something very different during the era of COVID-19 under Prime Minister Jacinda Ardern. With a new traffic light warning system planned to manage the pandemic, the government seeks to avoid national level lockdowns by achieving a 90% vaccination rate in places like Auckland and its eligible population. The government under Prime Minister Jacinda Ardern will apply the same approach across the country. But freedom is only restored to those who are vaccinated. This is similar to what we reported on in Austria where 1930s-style individual identification, classification, and discrimination are planned for the unvaccinated (e.g., they cannot leave their homes unless they have certain approved reasons). What was once a fully liberalized democracy, now seamlessly moves to shockingly discriminatory practices given all the biased elements involved in COVID-19 including improper attacks on early-use treatments to coverups of vaccine safety.


    On Friday during an interview with NZ Herald Prime Minister Ardern explicitly revealed her views on the emerging traffic light rules and the implications for personal freedoms and liberty in this age of COVID-19.


    Derek Cheng, a deputy political editor for New Zealand’s NZ Herald asked Ardern “So you’ve basically said, you probably don’t see it like this, but there will be two different classes of people—if you’re vaccinated or unvaccinated. You have all these rights if you are vaccinated…” The Prime Minister immediately responded, “That is what it is, yep.”


    Economics vs. Human Rights?

    What is emerging is a whole new way to manage an ongoing COVID-19 pandemic, as it moves to the endemic stage. That is, the virus will persist—a point this media has declared a reality from just about day one. We were clear that it was impossible to eradicate this novel pathogen with mass vaccination, particularly with version 1.0 vaccine products rushed to market.


    But given the dynamics behind the scenes, if distinct classes of human rights are to be established in Western liberal democratic society shouldn’t these types of “rules” become codified in laws? That is, if the government deems that the unvaccinated pose a threat to society, that should be taken up by national legislatures, who can investigate and debate the science and incorporate that dynamic into the democratic process. When executive branch agencies start making unilateral decisions based on questionable science—what’s the “in” thing to do among the global public health authority profession, all sorts of problems ensue.


    Step-Back & Rethink

    That a liberal democratic society such as New Zealand so quickly embraces a two-tiered system based entirely on vaccination shows the rapidly unfolding pressures the political class faces during the pandemic. What is most expedient to rev up an economy and ensure political success isn’t necessarily the right course for a healthy, thriving dynamic democracy. The suppression of freedom and economic mobility based on vaccination status moving forward shouldn’t be an option until the following points are addressed:


    We must demand to understand what the origin of this pathogen is—if human societies are to give up their liberties based on a vaccination it become imperative that the obvious cover-ups are uncovered—and if it is determined that it was human-made, those who were doing the covering up must be brought into the legal process.

    Rampant conflict of interests now entangled in health systems, regulatory bodies, and influential agencies such as the WHO must be understood and addressed. No industry or company should profiteer at the expense of an entire class of citizen or resident.

    An unprecedented centralization of the practice of medicine must be better understood and addressed. For example, physicians have the right to treat patients with off-label treatments should the physician and patient discuss and agree on an approach without federal/national government meddling.

    Transparency will be paramount with vaccines that are at the core of a two-tier human class system—full investigations into deaths and adverse events with accountability are foundational.

    Classifying and discriminating against humans based on early-stage, version 1.0 vaccine products are unprecedented moves that should be checked by a requirement for product maturity. Right now, Prime Minister Ardern cannot assure COVID-19 vaccine durability—once this system is implemented and part of the societal fabric there could be one booster after another (say every 6 months) raising health issues and conflict of interest with industry.

    While this media is pro-biopharma, the industry’s interests cannot supersede those of national interests whether in contracts or in other preferences and no industry should benefit from the suppression of one class of people over another—too fertile a ground for conflicts of interest.

    TrialSite certainly has some influential readers in New Zealand. Prime Minister Ardern will hopefully come to her senses and ponder some of these important points. Or, Kiwis perhaps may consider electing someone else


    New Zealand PM Admits to Treating Unvaxxed as Second-Class Citizens

    New Zealand PM Admits to Treating Unvaxxed as Second-Class Citizens - newsbinding
    New Zealand Prime Minister Jacinda Ardern admitted she wants to create two classes of citizens based on Chinese coronavirus vaccination status.
    newsbinding.com

  • What we see:: The first "Alpha" wave with 4000 cases peek produced most excess deaths. 10 x more cases during gamma did produce only a 50% excess death peek (effect 20x less in total), what clearly indicates that COV-19 is just a predating illness.


    This is definitely clear when you look at the Delta figures starting week 11. No more excess deaths can bee seen.


    Geneva in Switzerland did show the same: Delta did strongly reduce random COV-19 deaths.

    WyttenInference


    Only an antivaxxer could ignore all other evidence and attribute lower deaths during delta to delta, rather than vaccine!


    Of course only an antivaxxer would ignore infection rates as well.

  • It means that COVID-19 will continue to be around for at least the next few years, but we’re going to co-exist with it.


    “Eradication, meaning complete elimination of this virus from the world, is not going to happen,” said Dr. John Swartzberg, a UC Berkeley infectious disease expert. “We’re going to be living with COVID.”

    That has been obvious ever since delta emerged, and was always on the cards.

  • I think the better question is why this rush to vaccinate the children? The (short term) risks appear at this time very small getting vaxxed

    The short and long term risks are gigantic compared to most other childhood diseases we vaccinate for, such as chickenpox, mumps and measles. Again, why do you have one standard for all these other diseases, and another for COVID?

  • Question, we have all read the headlines concerning ivermectin, from horse dewormer to overdosing. Why have we not read a headline of someone treated with ivermectin that developed long covid or relapsed or even a reinfection? Now that would be worldwide breaking news! No headlines relating to that. Hummmmmmmmm!

    sorryantivaxxer.com -> search "ivermectin"


    sorryantivaxxer.com | A repository of stories of anti-vaxxers who died or came close to dying of COVID.
    A repository of stories of anti-vaxxers who died or came close to dying of COVID.
    www.sorryantivaxxer.com


    There you go. But that deals only in deaths.

  • Those vaccines actually work, most for a lifetime, not so with Covid vax. Protection begins waning at 2 months.

    Protection may wane, but a booster returns it to full strength. Furthermore, if 80% of people were vaccinated in the near term, the pandemic would end, and there would be no need for protection. Japan, Chile and other countries are rapidly approaching this level. Even it COVID does not go extinct, it may become so rare there would be no significant risk of being infected by it. It would be similar to the bubonic plague (Yersinia pestis) which still exists in the U.S., but it is so rare there is no need to vaccinate against it.