Covid-19 News

Quote from Curbina

This is a study published by a survey at Luxembourg about the observation of magnetism. TL/DR: 0 of 30 people not vaccinated showed magnet adherence, while 29 of 30 vaccinated did show adherence in at least one, But some on both, Their arms.

https://lilianeheldkhawam.file…xembourg-amar-goudjil.doc

Thank you! According to the study, the magnetism becomes stronger with more time after the dose, and the 7 people who received 2 doses are magnetic in both arms, not just the one injected.

I may enquire further of the study author himself because I would like to know:

- the type of magnet used and how it was applied.

- more details about the EM field readings with the Meterk MK54 device. It described two individuals who had 'abnormal' field emissions, but it would be nice to know what the readings actually showed for all the subjects and whether this correlated to the magnet sticking. All very odd I must say!

Stanford researchers find signs of inflammation in brains of people who died of COVID-19

A detailed molecular analysis of tissue from the brains of individuals who died of COVID-19 reveals extensive signs of inflammation and neurodegeneration, but no sign of the virus that causes the disease.

https://med.stanford.edu/news/…who-died-of-covid-19.html

The most comprehensive molecular study to date of the brains of people who died of COVID-19 turned up unmistakable signs of inflammation and impaired brain circuits.

Investigators at the Stanford School of Medicine and Saarland University in Germany report that what they saw looks a lot like what’s observed in the brains of people who died of neurodegenerative conditions such as Alzheimer’s disease and Parkinson’s disease.

The findings may help explain why many COVID-19 patients report neurological problems. These complaints increase with more severe cases of COVID-19. And they can persist as an aspect of “long COVID,” a long-lasting disorder that sometimes arises following infection with SARS-CoV-2, the virus that causes COVID-19. About one-third of individuals hospitalized for COVID-19 report symptoms of fuzzy thinking, forgetfulness, difficulty concentrating and depression, said Tony Wyss-Coray, PhD, professor of neurology and neurological sciences at Stanford.

Yet the researchers couldn’t find any signs of SARS-CoV-2 in brain tissue they obtained from eight individuals who died of the disease. Brain samples from 14 people who died of other causes were used as controls for the study.

“The brains of patients who died from severe COVID-19 showed profound molecular markers of inflammation, even though those patients didn’t have any reported clinical signs of neurological impairment,” said Wyss-Coray, who is the D. H. Chen Professor II.

Scientists disagree about whether SARS-CoV-2 is present in COVID-19 patients’ brains. “We used the same tools they’ve used — as well as other, more definitive ones — and really looked hard for the virus’s presence,” he said. “And we couldn’t find it.”

A paper describing the study will be published June 21 in Nature. Wyss-Coray shares senior authorship with Andreas Keller, PhD, chair of clinical bioinformatics at Saarland University. The lead authors are Andrew Yang, PhD, a postdoctoral scholar in Wyss-Coray’s group, and Fabian Kern, a graduate student in Keller’s group.

Blood-brain barrier

The blood-brain barrier, which consists in part of blood-vessel cells that are tightly stitched together and blob-like abutments created by brain cells’ projections squishing up against the vessels, has until recently been thought to be exquisitely selective in granting access to cells and molecules produced outside the brain.

But previous work by Wyss-Coray’s group and by others has shown that bloodborne factors outside the brain can signal through the blood-brain barrier to ignite inflammatory responses inside the brain. This could explain why, as Wyss-Coray and his colleagues have discovered, factors in young mice’s blood can rejuvenate older mice’s cognitive performance, whereas blood from old mice can detrimentally affect their younger peers’ mental ability.

On hearing reports of enduring neurological symptoms among some COVID-19 patients, Wyss-Coray became interested in how SARS-CoV-2 infection might cause such problems, which resemble those that occur due to aging as well as to various neurodegenerative diseases. Having also seen conflicting reports of the virus’s presence in brain tissue in other studies, he wanted to know whether the virus does indeed penetrate the brain.

Brain tissue from COVID-19 patients is hard to find, Wyss-Coray said. Neuropathologists are reluctant to take the steps required to excise it because of potential exposure to SARS-CoV-2 and because regulations often prohibit such procedures to prevent viral transmission. But Keller, who has worked in the Wyss-Coray lab as a visiting professor at Stanford, was able to access COVID-19 brain-tissue samples from autopsies conducted at the hospital that’s associated with Saarland University.

Using an approach called single-cell RNA sequencing, the scientists logged the activation levels of thousands of genes in each of 65,309 individual cells taken from brain-tissue samples from the COVID-19 patients and the controls.

In neurons of the cerebral cortex, signs of distress

Activation levels of hundreds of genes in all major cell types in the brain differed in the COVID-19 patients’ brains versus the control group’s brains. Many of these genes are associated with inflammatory processes.

There also were signs of distress in neurons in the cerebral cortex, the brain region that plays a key role in decision-making, memory and mathematical reasoning. These neurons, which are mostly of two types — excitatory and inhibitory — form complex logic circuits that perform those higher brain functions.

The outermost layers of the cerebral cortex of patients who died of COVID-19 showed molecular changes suggesting suppressed signaling by excitatory neurons, along with heightened signaling by inhibitory neurons, which act like brakes on excitatory neurons. This kind of signaling imbalance has been associated with cognitive deficits and neurodegenerative conditions such as Alzheimer’s disease.

An additional finding was that peripheral immune cells called T cells, immune cells that prowl for pathogens, were significantly more abundant in brain tissue from dead COVID-19 patients. In healthy brains, these immune cells are few and far between.

“Viral infection appears to trigger inflammatory responses throughout the body that may cause inflammatory signaling across the blood-brain barrier, which in turn could trip off neuroinflammation in the brain,” Wyss-Coray said.

“It’s likely that many COVID-19 patients, especially those reporting or exhibiting neurological problems or those who are hospitalized, have these neuroinflammatory markers we saw in the people we looked at who had died from the disease,” he added. It may be possible to find out by analyzing these patients’ cerebrospinal fluid, whose contents to some extent mirror those of the living brain.

“Our findings may help explain the brain fog, fatigue, and other neurological and psychiatric symptoms of long COVID,” he said.

Wyss-Coray is co-director of the Paul F. Glenn Center for Biology of Aging Research at Stanford, a member of Stanford Bio-X, Stanford’s Maternal and Child Health Research Institute, and Wu Tsai Neurosciences Institute at Stanford, and a faculty fellow of ChEM-H.

Other Stanford co-authors of the study are postdoctoral scholars Patricia Losada, PhD, Nicholas Schaum, PhD, Ryan Vest, PhD, Nannan Lu, PhD, and Oliver Hahn, PhD; basic life research scientist Daniela Berdnik, PhD; life science research professionals Maayan Agam and Kruti Calcuttawala; former life science research associate Davis Lee; former visiting student researcher Christina Maat; life science research professional Divya Channappa; David Gate, PhD, instructor of neurology and neurological sciences; M. Windy McNerney, PhD, clinical assistant professor of psychiatry and behavioral sciences; and Imma Cobos, MD, PhD, assistant professor of pathology.

In addition to Keller and Kern, other researchers at Saarland University also contributed to the study.

The work was funded by the Nomis Foundation, the National Institutes of Health (grants T32-AG0047126, 1RF1AG059694 and P30AG066515), Nan Fung Life Sciences, the Wu Tsai Neurosciences Institute and the Stanford Alzheimer’s Disease Research Center.

a preview of things to come? 1 in 1,000 is considered rare?

Almost 4,000 fully vaccinated people in Massachusetts have tested positive for COVID-19

https://news.google.com/articl…=en-US&gl=US&ceid=US%3Aen

Nearly 4,000 fully vaccinated people in Massachusetts have tested positive for COVID-19, according to recent data from the state Department of Public Health.

The number of breakthrough cases in the state has been infrequent so far -- accounting for approximately one in 1,000 vaccinated people.

As of June 12, there were 3,791 coronavirus cases among the more than 3.7 million fully vaccinated individuals in Massachusetts, reports said.

"We’re learning that many of the breakthrough infections are asymptomatic or they’re very mild and brief in duration," said Boston University infectious diseases specialist Davidson Hamer, according to the Boston Herald. "The viral load is not very high."

"Breakthroughs are expected, and we need to better understand who’s at risk and whether people who have a breakthrough can transmit the virus to others," he continued. "In some cases, they’ll be shedding such low levels of the virus and won’t be transmitting to others."

According to the Centers for Disease Control and Prevention, large-scale clinical studies have found that COVID-19 vaccination prevented most people from getting the virus. Still, no vaccine is 100% effective at preventing the disease and there will be "a small percentage of fully vaccinated people who still get sick, are hospitalized, or die from COVID-19," the agency said.

CDC PANEL CRITICIZED FOR POSTPONED MEETING ON COVID-19 VACCINES, RARE HEART ISSUES

A recent study from the CDC showed that Pfizer and Moderna are about 90% effective against infection two weeks after the last dose has passed. The one-dose Johnson & Johnson vaccine is about 72% effective against moderate to severe disease, according to U.S. trials.

Testing to identify current infection remains critical to control of COVID-19," a DPH spokeswoman told the paper. "People with current infection can spread the virus to others and isolation of cases and identification of close contacts (individuals who may have been exposed) is a foundation of public health response."

Health officials also warned about the contagious Delta variant, seen in areas in the U.S.

Todd Ellerin, director of infectious diseases at South Shore Health, expressed the need to get as many people vaccinated due to the highly contagious variants.

He made the plea as new virus cases were at record lows in the state last week amid the vaccine rollout.

As of Monday, more than 150 million people in the U.S. have been fully vaccinated, according to the CDC.

Stop vaccinating kids!!!!

The WHO Says Children Should Not Receive COVID-19 Vaccines

https://www.precisionvaccinati…ive-covid-19-vaccines?amp

The World Health Organization (WHO) published revised advice on June 21, 2021, clarifying which populations should receive COVID-19 vaccines. The WHO's website now states, 'Children should not be vaccinated for the moment.'

Furthermore, the WHO says 'There is not yet enough evidence on the use of vaccines against COVID-19 in children to make recommendations for children to be vaccinated against COVID-19. Children and adolescents tend to have milder disease compared to adults.'

'However, children should continue to have the recommended childhood vaccines.'

Additionally, the WHO confirmed 'COVID-19 vaccines are safe for most people 18 years and older, including those with pre-existing conditions of any kind, including auto-immune disorders. These conditions include hypertension, diabetes, asthma, pulmonary, liver, and kidney disease, as well as chronic infections that are stable and controlled.'

'While a COVID-19 vaccine will prevent serious illness and death, we still don’t know the extent to which it keeps you from being infected and passing the virus on to others. The more we allow the virus to spread, the more opportunity the virus has to change.'

This WHO advice conflicts with the U.S. FDA's authorization on May 10, 2021, to include people 12 years old in the Pfizer-BioNTech COVID-19 vaccination program.

Quote from Fm1

Stop vaccinating kids!!!!

The WHO Says Children Should Not Receive COVID-19 Vaccines

https://www.precisionvaccinati…ive-covid-19-vaccines?amp

The World Health Organization (WHO) published revised advice on June 21, 2021, clarifying which populations should receive COVID-19 vaccines. The WHO's website now states, 'Children should not be vaccinated for the moment.'

Furthermore, the WHO says 'There is not yet enough evidence on the use of vaccines against COVID-19 in children to make recommendations for children to be vaccinated against COVID-19. Children and adolescents tend to have milder disease compared to adults.'

'However, children should continue to have the recommended childhood vaccines.'

Additionally, the WHO confirmed 'COVID-19 vaccines are safe for most people 18 years and older, including those with pre-existing conditions of any kind, including auto-immune disorders. These conditions include hypertension, diabetes, asthma, pulmonary, liver, and kidney disease, as well as chronic infections that are stable and controlled.'

'While a COVID-19 vaccine will prevent serious illness and death, we still don’t know the extent to which it keeps you from being infected and passing the virus on to others. The more we allow the virus to spread, the more opportunity the virus has to change.'

This WHO advice conflicts with the U.S. FDA's authorization on May 10, 2021, to include people 12 years old in the Pfizer-BioNTech COVID-19 vaccination program.

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Interesting.

Same with Remedisvir, WHO says no, FDA says yes.

Some here say "follow the science" or "the experts say" this and that. That Ivermectin is not "proven" because studies, i.e. the experts say (they read only the studies by those biased against it) is not to be used.

Well, who follows "the science"? WHO or FDA? Who follows "the experts" ? The WHO or FDA.

The large number of positive studies on Ivermectin ARE done by experts and qualified scientists / doctors. Just because they are not part of WHO or FDA does not disqualify them.

So the arguments againstt Ivermectin are unsubstantiated. There is far, far more reports positive than questioning ivermectin and those questioning have strong bias and conflict of interests. The above proves "it is not a clear cut case" of who to believe. (pun intended?)

And now the WHO states not to vaccinate kids for Covid at this time. I believe a wise decision. However, the US is plunging ahead recklessly with this. So someone here will say "the experts say to vaccinate kids". Well the "WHO experts" say do not! hmmmm... not so clear cut is it.

The whole issue of Ivermectin is solely political / financial. Sorry THH, I usually respect most of your opinions, but on this, I do not believe you have read or studied any Ivermectin reports and trials but are only cherry picking one or two biased "anti-ivermectin" published reports.

I make this strong point because it looking more each week that Ivermectin can make a HUGE difference. The fact it was available a year ago and has been effectively subverted may have resulted in hundreds of thousands of deaths. And why? This is a major, major negligence and possible crime.

Still waiting on the response as to why mRNA vaccine safety is being lumped in with attenuated vaccine safety records.... "vaccines are safe and have a long history of safety" type of comments. Standard vaccines going through standard safety protocols have most often been proven safe....

mRNA vaccines have not went through long term safety trials, are completely different than attenuated vaccines AND have had a very bad safety record in recent past attempts to use.

Why are some here still lumping mRNA safety with attenuated vaccine safety..... and then also push the "follow the science"..... where is the science in lumping these together? Still waiting...

Thanks,

A doctor's take on VAERS

IVERMECTIN saves India!

Cases now down to < 1/10 of peak. Delhi Uttar Pradesh at 100 cases/day...

Switzerland also close to 100/day but 10% are variants.

Ivermectin trial in UK.. a bit late, the BBC banned me from posting for including Ivermectin links, that's the last license fee they'll get out of me.

https://www.bbc.co.uk/news/health-57570377

Quote from jox

the BBC banned me from posting for including Ivermectin links,

The BCC is a cohort of the FM/R/B mafia.

Now it's only about taking out all money from small/medium people and make them 1000% obedient mafia followers.

Look at India. They have the guts to fuck the FM/R/B mafia.

Guillain-Barré Syndrome following ChAdOx1-S/nCoV-19 Vaccine

https://onlinelibrary.wiley.com/doi/10.1002/ana.26143

Abstract

As of April 22, 2021, around 1.5 million individuals in three districts of Kerala, India had been vaccinated with COVID-19 vaccines. Over 80% of these individuals (1.2 million) received the ChAdOx1-S/nCoV-19 vaccine. In this population, during this period of 4 weeks (mid-March to mid-April 2021), we observed seven cases of Guillain-Barre syndrome (GBS) that occurred within 2 weeks of the first dose of vaccination. All seven patients developed severe GBS. The frequency of GBS was 1.4- to 10-fold higher than that expected in this period for a population of this magnitude. In addition, the frequency of bilateral facial weakness, which typically occurs in <20% of GBS cases, suggests a pattern associated with the vaccination. While the benefits of vaccination substantially outweigh the risk of this relatively rare outcome (5.8 per million), clinicians should be alert to this possible adverse event, as six out of seven patients progressed to areflexic quadriplegia and required mechanical ventilatory support. ANN NEUROL 2021

As of April 22, 2021, more than 727 million doses of SARS/nCoV2 vaccines have been administered worldwide. ChAdOx1-S vaccine (Covishield™/Vaxzevria, Astra-Zeneca) has been administered in 116 countries, BNT-162b1 (Pfizer-BioNTech) in 83, mRNA-1273 (Moderna) in 36 and Ad26.COV2.S (Janssen) in two countries. In India, over 104 million doses of the SARS-CoV-2 vaccine have been administered and 13.5 million people have been fully vaccinated (1% of the population). The ChAdOx1-S vaccine (Astra Zeneca) has been used in >80% of the recipients.1 In three districts of Kerala state (Ernakulam, Kottayam & Kannur) in India, approximately 1.2 million individuals had received the ChAdOx1-S vaccine as of April 22, 2021.2

Neurological complications such as cerebral venous sinus thrombosis (CSVT) due to vaccine-induced immune thrombotic thrombocytopenia (now termed thrombosis with thrombocytopenia syndrome [TTS]) following adenovector-based COVID-19 vaccines have recently been reported.3 To date, one case of Guillain Barre Syndrome (GBS) has also been reported after Pfizer BNT-162b1 vaccination in the US.4 Here, we report seven patients who developed GBS in very proximate temporal relationship to the first dose of ChAdOx1-S vaccination in a 4-week period (mid-March to mid-April, 2021).

Cases

The details of the initial four cases are presented here, while the clinical presentations of cases 5–7 are presented in the Table S1.

Case 1.A 43-year-old woman presented 10 days after the first dose of ChAdOx1-S vaccination with upper back pain. She progressed over the next 10 days to areflexic quadriparesis with facial diplegia and respiratory failure and required mechanical ventilation. Nerve conduction study showed a demyelinating neuropathy and cerebrospinal fluid (CSF) had albuminocytological dissociation (protein 72.2g/L, cell count 5/μL). She was treated with intravenous immunoglobulin (IVIg) but required mechanical ventilation on day 11 for respiratory distress (Table S1).

Case 2.A 67-year-old woman presented 14 days after the first dose of vaccination with distal paraesthesia in all four limbs. Over the next 2 days, she developed facial diplegia, dysphagia, and increasing limb weakness (motor strength 1/5). Subsequently, she developed a right abducens palsy and respiratory failure requiring mechanical ventilation, while being treated with IVIg. Plasmapheresis was initiated and she was extubated on day 15.

Case 3.A 53-year-old woman presented 12 days after her first dose of vaccine with bilateral lower limb numbness and weakness, right-sided facial and tongue numbness, and back pain. At the initial examination, her motor strength was grade 3/5 in all four limbs. Over the next 4 days, she developed right trigeminal sensory impairment, bilateral lower motor neuron facial palsy, and areflexic flaccid quadriplegia (MRC sum score 5), requiring mechanical ventilation.

Case 4.A 68-year-old woman presented 14 days after the first dose of vaccination with bilateral upper and lower limb numbness and weakness with dysphagia. Her initial motor strength was grade 4/5 in all four limbs. Over the next 4 days, she developed profound bilateral facial numbness along with bilateral lower motor neuron facial weakness and areflexic flaccid quadriplegia (MRC sum score 7).

In Patients 3 and 4, MRI brain and spine were normal (performed for evaluation of trigeminal sensory loss) and serum ganglioside antibodies were negative.

As of this report, six patients are still bedbound and undergoing rehabilitation (Hughes stage IV), whereas Case 1 has completely recovered.

Discussion

In this report, we describe seven patients who developed GBS within 2 weeks of the first dose of the ChAdOx1-S vaccine during a 4-week period (mid-March to mid-April, 2021.)

A calculated Naranjo adverse reaction scale score of 3 suggested a possible association between vaccination and GBS.5

Our patients were in their 5th to 7th decades of life and predominantly female (Female: Male ratio - 6:1). All patients progressed to areflexic quadriplegia, and six of the seven cases required mechanical ventilation for respiratory failure. All seven cases had bilateral facial paresis, which usually occurs in fewer than 20% of unselected GBS cases.6 Four patients (57%) also developed other cranial neuropathies such as abducens palsy and trigeminal sensory nerve involvement, which are rare (<5%) in reports of GBS from India.7

The incidence of GBS in the community worldwide is approximately 17 cases per million per year. An analysis of previous post-vaccination periods (1976/1977 Swine flu and 2008/2009 H1N1 vaccination programs) has not revealed an increased incidence of post-vaccination GBS.8 An association has also not been established between COVID-19 infection and GBS.9 Therefore, an increase in the incidence of post-COVID vaccination GBS is thought unlikely.10 Nevertheless, it is worth noting that as of March 24, 2021, the Food and Drug Administration (FDA) has updated warnings about GBS with another vaccine [GlaxoSmithKline's SHINGRIX™ (Zoster Vaccine Recombinant, Adjuvanted)] after noting three excess cases of GBS per million within 42 days of administration of the vaccine.11

The incidence of GBS in India is approximately 6–40 cases per million per year, with a seasonal variation, peaking in the rainy season (June–September).12, 13 With a denominator of 1.2 million people, the expected cases of GBS per year are approximately seven to 48 annually or between 0.58 to four cases of GBS every 4 weeks. Thus, with seven cases of GBS in1.2 million people (5.8 per million), a 1.4-to-10-fold rise in the incidence of GBS was observed.

Overall, our experience should prompt all physicians to be vigilant in recognizing GBS in patients who have received the ChAdOx1-S vaccine. While the risk per patient (5.8 per million) may be relatively low, our observations suggest that this clinically distinct GBS variant is more severe than usual and may require mechanical ventilation.

As in the case of the ‘thrombosis with thrombocytopenia syndrome’ (TTS), GBS seems to be associated with the first dose of ChAdOx1-S vaccine and the incidence seems to be higher within 14 days of administration However, the pathogenic mechanisms in post-vaccination GBS remain unclear.

Quote from Fm1

An analysis of previous post-vaccination periods (1976/1977 Swine flu and 2008/2009 H1N1 vaccination programs) has not revealed an increased incidence of post-vaccination GBS.

There is a strong correlation between Influenza/influenza vaccine and a Camphylobacter infection leading to GBS in 1..3% of the cases.

May be here we have a similar cross reaction. At the end of the big chimpanzee test we will know all damaging reactions of the experimental vaccines.

Dr. Peter McCullough Suggests Health Authorities Consider Stopping Vaccines for Those Under Aged 30

https://trialsitenews.com/dr-p…-for-those-under-aged-30/

Is the Delta variant far worse than the original SARS-CoV-2 strain or is it the case that the pathogen is more transmissible but weaker and hence less dangerous as suggested by Fox News host Laura Ingraham representing the phenomena known as Muller’s ratchet? Ms. Ingraham showcased CNN guests warning the network’s viewers that Delta may be a harbinger of the next major pandemic wave as Dr. Anne Rimon, a UCLA Professor of Epidemiology, warned CNN viewers while author Andy Slavitt called the mutant “COVID on Steroids” and Dr. Leana Wen, a CNN Medical Analyst, declared all “cannot let down their guard at all.” Ingraham asks, “is this fear mongering? What about growing reports of vaccine adverse events, especially in children?” asks Ingraham. On the show to help at least address some of these questions was Dr. Peter McCullough, a well-known cardiologist, researcher, and TrialSite Advisory Committee member, to provide a point of view to the listeners that may not be heard on CNN, at least not yet.

Dr. McCullough updated viewers that in America, the names of the COVID-19 variants have changed as the UK variant was renamed alpha, South Africa’s as Beta and Brazil’s as Gamma while again the Indian variant is known as Delta and that Muller’s ratchet has been fulfilled in that the Delta, unlike the prior three, is a triple variant all in the spike protein.

On June 18th the UK presented their 16th report on mutations highlighting that the news is good: that the Delta variant, while more contagious, is far weaker and less worrisome. Dr. McCullough emphasized that the UK’s effort to keep up with these SARS-CoV-2 sequencing studies has been notable as compared to the U.S. CDC, which has fallen short of expectations.

Ingraham suggested that the CDC website is presenting a different picture, one with more danger and concern than perhaps the situation merits. Is the pandemic getting closer to the end or, conversely, getting ready for another major spike? The answer may depend on which newscast one watches.

Ingraham, to her credit, raises the controversial yet important and uncomfortable discussion in America concerning COVID-19 vaccine events. Dr. McCullough shared that the CDC is absolutely overwhelmed with nearly 6,000 VAERS reported deaths and over 300,000 adverse event reports. He mentioned reports of myocarditis in children, where the spike protein replicates and damages the heart, suggesting the health authorities might consider taking a time-out on COVID-19 vaccination for those under the age of 30.

Call to Action: What are your thoughts? TrialSite receives ever more numbers of reports of adverse events that may be associated with the COVID-19 vaccines. There is no censorship at TrialSite, and the platform is open to those that want to have real scientific debates.

Glenmark Pharmaceuticals Reports More Positive Favipiravir Data Associated with COVID-19 Pandemic—Will Western Media Pick up?

https://trialsitenews.com/glen…ll-western-media-pick-up/

Glenmark Pharmaceuticals (Glenmark), a leading generic drug producer in India, actively markets an authorized generic antiviral drug targeting COVID-19 called Favipiravir. This drug was authorized first in Russia for COVID-19 and TrialSite has followed its studies around the world. First developed in Japan by FUJIFILM Toyama Chemical, recently Glenmark announced the interim data of 503 patients from its Post Marketing Surveillance (PMS) study on Favipiravir in India. This study started back in July 2020 with the goal of evaluating the safety and efficacy of the antiviral in mild to moderate COVID-19 patients. The first and largest of post-marketing studies now underway in India involving Favipiravir in mild to moderate SARS-CoV-2 infections, a total of 1083 patients were enrolled in the prospective, open-label, multicenter, single-arm study involving 13 government and private trial sites across Mumbai, Bangalore, Hyderabad, Nashik, Nagpur, and Trivandrum. Thus far, the data is quite promising, revealing no new safety signals or concerns with the use of the study drug (currently authorized on an emergency basis) and known side effects such as weakness, gastritis, diarrhea, vomiting, etc. which were found to be mild. Glenmark reports that the time to fever resolution was reported on day 3, while two-thirds of the patients achieved clinical cure by day 7. TrialSite emphasizes that these antivirals are used in many nations yet in places such as North America and Europe, the press barely mentions the use of this now generic drug. Could that be because of regulatory capture?

Favipiravir Authorized in India for COVID-19

As TrialSite was one of only a few media platforms in North America, or Europe for that matter, to report on this news, on June 19th, 2020, Glenmark became the first industry sponsor in India to receive restricted emergency use approval for their version of Favipiravir called FabiFlu®, making it the first oral Favipiravir-approved medication in the world’s second-most populous nation and seventh-largest economy as measured by GDP. The indication was for mild to moderate COVID-19, representing the vast overwhelming number of cases, about 90% if not more. This approval was granted as part of an accelerated approval process, considering the emergency conditions associated with the pandemic.

Authorized & Used in Many Nations…But

TrialSite has chronicled the study and use of this drug around the world during the pandemic, including the Russian Ministry of Health’s approval of the drug targeting COVID-19 at the start of June 2020. TrialSite reported that the U.S. Department of Defense has spent over $200 million studying this drug just six years ago. In “Favipiravir Follow-up: DOD Led the Way but U.S. Left Out,” TrialSite raised a number of questions about this research and why there’s no mention of it during the pandemic.

Interestingly, there’s one vendor trying to commercialize the product in Noth America as reported by TrialSite. Appili Therapeutics along with Dr. Reddy’s submitted an application to Health Canada to market the drug in that country. To this day, it’s only crickets in the public sphere while the company continues on with a Phase 3 study. When it comes to generic drugs for early COVID-19 care, apparently Canadian regulators weren’t in too much of a rush.

The Study

This study involved those patients categorized in the mild to moderate COVID-19, in line with the approved indication of the drug as mentioned earlier—the drug is authorized for use in India and several other countries including Russia. With a mean age of 40, the most common study age cohort was 30 to 45 years of age. The study included 40% female and 60% male subjects. The two most common comorbidities included hypertension and diabetes. At baseline, the study teams found fever present in all patients along with cough (84.6%), fatigue (55%) and new loss of taste (38.1%).

Mr. Alok Malik serves Glenmark as Group Vice President & Head of India Formulations and commented recently, “It is encouraging to note that our interim data supports the safety and effectiveness of FabiFlu® in real-world settings. Since its launch last year, FabiFlu® has provided immense relief to millions of patients in India and the world, while also reducing the overall burden on healthcare infrastructure. We will soon submit the final study findings to the regulator and continue to deliver Fabiflu’s multiple benefits to patients all over.”

Of course, TrialSite notes that this is interim data and that not until the data is complete and peer-reviewed can the impact of such findings be truly instrumental in influencing regulatory authorities and apex national biomedical research agencies.

Quote from Fm1

Has the United States reached herd immunity? President Biden announces that the us has injected 300 million doses of vaccine and with 33.5 million confirmed cases surely the us has reached herd immunity,

It is not even close! 300 million doses are enough to vaccinate 150 million people. Only 54% of the population has been vaccinated (150 million people):

https://www.washingtonpost.com…tates-distribution-doses/

Add 30 million confirmed cases = 180 million.The population is 330 million. (150+30)/330 = 56%. Herd immunity is estimated somewhere between 70% and 80%. Furthermore, confirmed cases are not a good way to ensure immunity. The vaccines are much better.

FLCCC’s Dr. Pierre Kory Talks Ivermectin & Early COVID-19 Care with Fox’s Maria Bartiromo

https://trialsitenews.com/flcc…ith-foxs-maria-bartiromo/

Fox’s Maria Bartiromo recently introduced TrialSite contributor Dr. Pierre Kory and Sen. Ron Johnson to discuss the use of ivermectin as an early onset antiviral treatment targeting COVID-19 as well as growing concerns of censorship. Bartiromo asked the question, why did 600,000 Americans have to die given it appears treatments for early-onset COVID-19 were in fact available? Like the recent meta-analysis published in American Journal of Therapeutics, Bartiromo learned of mounting data evidencing the generic drug’s efficacy combined while scandalous elements within the U.S. government, Big Tech, and academic medicine promoting severe censorship of anyone trying to counter the dominant narrative that there’s no current treatment for early-onset COVID-19. Bartiromo said the U.S. government will spend $3.2 billion for treatments, including Merck’s proprietary experimental drug, which has already been given a $356 million federal infusion plus now a $1.2 billion contract securing procurement. Bartiromo connected the dots highlighting that Merck also has ivermectin in its generic portfolio. Of course, TrialSite showcased how a great American pharmaceutical company lost its way in pursuit of greenbacks. The Fox host asks, “Is it just money? Is it that it is off-patent and they are not making money?” Dr. Kory retorts it’s a “glaring example of the system we are in.” For-profit medicine reins over nonprofit, generic, repurposed, and in the case of ivermectin, potentially highly effective drugs, suggests the doctor who helped launch the Front Line COVID-19 Critical Care Alliance (FLCCC). The government via Dr. Anthony Fauci’s National Institutes of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), committed nearly $4 billion to pharma to target antivirals with an impact like ivermectin, yet Kory reminds the Fox host such a drug is available now.

The Fox News hosts declared the associated censorship of doctors, scientists, and politicians as completely unacceptable, in a bid to keep the American people away from important information, such as the ongoing ivermectin story. Senator Ron Johnson chimed in that he has been trying to alert Americans that there are treatment options. The Senator went on to mention the potential mass coverup concerning vaccine safety, perhaps one of the biggest such affairs in history, declaring that there are over 5,000 deaths associated with the COVID-19 vaccines as reported in VAERS. Will CNN, MSNBC, and other networks share this point of view at some point?

Dr. Kory shared with the Fox host the important new meta-analysis, authored by Dr. Tess Lawrie, covering dozens of randomized controlled trials, leading to “massive benefit” for early COVID-19 early treatment.

Kory claimed that over a hundred thousand American lives could have been saved had the NIH listened to the FLCCC presentation in January 2021 covered by TrialSite. Johnson suggests the culprit here is Dr. Anthony Fauci, a man that put power, politics, and branded drugs over the health of the people. Bartiromo took on what became the egregious censorship rampant across American society. While “Big Tech” is painted as the villain, TrialSite suggests that some elements within the NIH, CDC, and other government agencies may have been hand-in-hand collaborators behind the scene as committees were formed during the beginning of the pandemic to filter out misinformation online. Probably initially this came from a good place, with decent intentions, but the effort perhaps was commandeered by profit-making forces? But if the government was (and is) directly instructing Big Tech to censor citizens, including journalists with objective stories based on facts, then constitutional rights are under attack. Freedom of speech represents a vital foundation of American democracy

Bavarian Television Highlights Successful Use of Ivermectin

https://trialsitenews.com/bava…essful-use-of-ivermectin/

While vaccines have made up much of the COVID-19 headlines and represent an instrumental strategy in the long-term fight against COVID-19, so do antiviral therapies as the U.S. government recently proclaimed with a $3+ billion announcement to focus on these treatments moving forward. TrialSite’s followed the ivermectin story since April 2020 and has chronicled many of the 60 studies from all over the world. The majority of the studies produced positive data, albeit a couple generated neutral but not negative results. Several locales authorized the use, mostly low-to middle-income countries (LMICs), and the world’s second-most populous country saw some of its states use the therapy effectively in a population-wide scheme. Enormous pressure built up from a combination of a powerful lobby consisting of industry, government, and academia to repress the use of this drug for a confluence of reasons. But the use goes on and grows as a defensive precaution in many locales, such as in the richest state in the world’s fourth-biggest economy as measured by GDP—Germany. While ivermectin not authorized in Germany for the COVID-19 indication, in Bavaria, TrialSite’s community is active and sends updates, including the use of the drug by some physicians at a major academic medical center in Munich.

For example, the chief doctor and anesthesiologist in intensive care, Dr. Franz Brettner at the academic medical center known as the Barmherzige Bruder Hospital in Munich, affiliated with the University of Munich and the German Academy for Nutritional Medicine, reports that the use of ivermectin targeting COVID-19 has made a material difference in the lives of patients.

As the drug isn’t approved for this indication, its use is done via the traditional off-label approach where the physician and the patient both agree on the approach after reviewing risks and benefits. Dr. Brettner shared with Bavaria TV Live that in some cases when their protocol merits, they may treat the hospitalized COVID-19 patient with ivermectin and corticosteroids. Interestingly, the doctor reports that the hospital has seen dramatically better results for moderately to severely ill COVID-19 patients under this protocol.

This German TV entry also shared the perspective of a physician practicing in the upscale Bogenhausen district of Munich. According to the show’s translation, Dr. Peter Schleicher, purports to be an expert in ivermectin that used the drug for three decades. Pointing out the drug’s safety, this German physician suggested that where it’s in use, the incidence of COVID-19 goes down. He emphasized recent meta-analyses, such as the recent one authored by Dr. Tess Lawrie and team in the American Journal of Therapeutics sharing that dozens of randomized controlled trials, not to mention numerous observational studies, indicate positive evidence using rigorous medicinal evidence-focused analytical methodologies.

Driponin

In Germany, ivermectin is known as Driponin. An economical generic drug, its safety profile is compelling on label with multiple billions of doses of evidence across four decades in LMICs, predominantly in Africa.

TrialSite shares a European “Public Assessment Report” covering this German generic form of Merck’s Stromectal registered in the EU since 2003.

In 2019, the decentralized procedure shared the similarity between the branded and generic ivermectin versions, thus earning market authorization. Driponin is produced by Substipharm, a generic pharmaceutical company headquartered in Paris, France.

A Point of View

Around the globe, networks of physicians communicate and collaborate in hospitals, clinics, and medical offices to help patients overcome COVID-19. During the pandemic, groups such as the Front Line COVID-19 Critical Care Alliance (FLCCC) and others helped organize these networks to disseminate important information about treatments such as ivermectin that were censored via the primary communication channels of today—the tech social network giants of Facebook, Google (YouTube) and Twitter. TrialSite has been directly censored by these organizations for no apparent reason. As TrialSite has pointed out, a confluence of forces such as government, public health heads, industry, and media came together to establish what was “truth” versus “misinformation.”

While, undoubtedly, there were good intentions for many behind this mass communication initiative, it became a vehicle for regulatory capture, as even truthful journalism was suppressed. For example, just the word ivermectin could trigger the censorship algorithms. No doubt there has been some collective move to suppress cheap generic approaches despite the mounting evidence of positive data. While the National Institutes of Health (NIH) has finally included an ivermectin study (ACTIV-6), this was quite late given the pandemic’s devastation and the mounting evidence, including a meeting with the FLCCC in January 2021.

In America, a principal investigator and study team strive to complete a study and impact COVID-19 early-onset care via the COVID-Out study. Led by the University of Minnesota’s Carolyn Bramante, the study seeks patients and partnering clinics to participate in a trial that ships the drug same day to patients that fit the inclusion and exclusion criteria. Although there is a placebo, a sizable percentage of participants receive study drugs. This study is backed by UnitedHealthcare. America’s largest payer would benefit if a low-cost therapy addressing COVID-19 were formally authorized by the FDA.

1st International Ivermectin for Covid Summit

https://trialsitenews.com/1st-…rmectin-for-covid-summit/

Indian Randomized Controlled Trial Shows Positive Results for Natural Supplements Targeting COVID-19

https://trialsitenews.com/indi…ments-targeting-covid-19/

In another positive data point for natural supplements in the fight against COVID-19, yet again, researchers, this time in India, reveal that natural substances could be as if not more efficacious as what big pharmaceutical companies spend hundreds of millions of dollars in investments to test on the market. In this case, a component of Turmeric (Curcumin) and Piperine (black pepper) showed impressive results in a double-blind, randomized control trial.

A TrialSite Community member, Paul Elkins, submitted this study summary, which was reviewed by the TrialSite team.

The Study

In this RCT they tracked many important clinical markers of disease progression in Covid-19, symptom resolution, and progression to serious outcomes. They also used subgroup analysis to separate the effects in Mild, Moderate and Severe disease. Many of the well-funded Big Pharma trials should take note of this design in order to elucidate a therapeutics efficacy in specific target subjects. It’s well known that Covid-19 is a disease of two stages. The early viral infection stage and the later pulmonary phase driven by hyperinflammation, coagulation and immune dysregulation. It’s critical to ascertain which of these phases a therapeutics’ Mechanism Of Action (MOA) targets and to measure the results in the target group. One limitation of this study is that the number of subjects is relatively small but that’s typical in a study not funded by Big Pharma looking to capitalize on a lucrative therapeutic.

They call the treatment group C3 and the control group Non-C3. Due to the multiple endpoints the results are a bit complex to sort through. In general, they showed statistically significant improvement in many clinical markers and symptoms. They also showed a reduction in deaths (1 in the C3 group and 5 in the control group).

The Results

“in the mild, moderate, and severe subgroups, compared to the patients of the non-C3 group, patients of the C3 group showed early symptomatic recovery (of fever, cough, sore throat, breathlessness), less deterioration over the period of hospital stay, lower incidence of red flag signs, and better ability to maintain oxygen saturation above 94% on room air throughout the hospital stay. Further, patients of the C3 group could maintain SpO2 above 94% on room air for more days, and fewer patients of the C3 group required oxygen therapy with or without HFNO, failed to maintain SpO2 >88% despite oxygenation, or required intubation and mechanical ventilation to maintain SpO2 above 88%. Although deterioration in laboratory parameters was observed in patients from both groups, the rise in D-Dimer levels was less severe in the C3 Group than in the non-C3 group.

The Neutrophil/lymphocyte ratio was >3.5 in both groups, and differences between the moderate and severe subgroups were not significant. 3/30 patients from the mild C3 subgroup and 7/30 from the non-C3 subgroup showed the development of pneumonitis on chest X-rays during hospitalization. All patients in the moderate and severe subgroups of the C3 and non-C3 groups presented with bilateral pneumonitis, except one patient in the moderate C3 subgroup, who had unilateral pneumonitis.

Fewer patients in the study group required the administration of the COVID awakening protocol, remdesivir, low molecular weight heparin, or unfractionated heparin in addition to oral doxycycline, favipiravir, steroids, and nutritional supplements. None of the patients in the moderate C3 subgroup required tocilizumab injections, while 5/25 patients in the Moderate Non-C3 subgroup did. 2/15 patients from the severe C3 subgroup and 4/15 from the severe Non-C3 subgroup required and received tocilizumab per protocol. Unfortunately, none of these patients survived.

Secondary Outcomes

As shown in , the duration of hospitalization was almost the same in the C3 and non-C3 mild subgroups; however, it was significantly lower in the moderate and severe C3 subgroups than in the corresponding non-C3 subgroups. Fewer patients required mechanical ventilator support and suffered thromboembolic episodes in the C3 group than in the non-C3 group. Oral aspirin was not given to any of these patients.

There were no deaths in the mild and moderate C3 subgroups, while there was 1 death out of 30 in the mild non-C3 subgroup and 5 deaths out of 25 in the moderate non-C3 subgroup. There were fewer deaths (2/15) in the severe C3 subgroup than in the severe non-C3 subgroup (5/15).”

Lead Research/Investigator

Kirti S. Pawar, Giriraj Hospital and Intensive Care unit, Baramati, India

Quote from Fm1

that the Delta variant, while more contagious, is far weaker and less worrisome.

That's what we did hope since long. A mild fast spreading variant will lead to a global immunization free of charge!!

As said before. Geneva had the highest relative count of the India Variant (due to UNO, WHO etc..). Now hospitals are empty almost no more new cases.