Covid-19 News

Quote from Wyttenbach

You are obviously sponsored by some big pharma. Did you notice that I did exclude Moderna? Israel data clearly says

there is no (=15..30%) infection protection after 6 months.

As said you have to divide all UK figures for vaccinated by at least 2 because 50% are protected by an infection not by the vaccine they got later...

There is no vendetta: I just tell people that Pfizer and Oxford/Astra are crap vaccines.

Warning: WyttenSpin repetition

I point out that ignoring the protection from serious infection offered by vaccines is WyttenSpin.

The quoted post above then quotes part of my post and replies to it with exactly the same WyttenSpin.

Warning: WyttenFact repetition

And, in a previous post I showed why < 50% of the UK population has been infected by COVID, but even if it had this would cancel out, because both vaccinated and unvaccinated are so affected, and protection is defined as:

1 - vaccinated infection rate / unvaccinated infection rate.

I expect Wyttenfacts to be repeated - but it is pretty extreme when i directly show why they are false, and they get repeated again immediately after without reference to my correction.

Quote from Fm1

Idaho doctor reports a ‘20 times increase’ of cancer in vaccinated patients

https://www.lifesitenews.com/n…r-in-vaccinated-patients/

BOISE, Idaho (LifeSiteNews) — A doctor has found an increase in cancers since the COVID-19 inoculation rollout.

On March 18, Dr. Ryan Cole, a board-certified pathologist and owner and operator of a diagnostics lab, reported to the public in a video produced by Idaho state government’s “Capitol Clarity” project, that he is seeing a massive ‘uptick’ in various autoimmune diseases and cancers in patients who have been vaccinated.

Since January 1, in the laboratory, I’m seeing a 20 times increase of endometrial cancers over what I see on an annual basis,” reported Dr. Cole in the video clip shared on Twitter.

“I’m not exaggerating at all because I look at my numbers year over year, I’m like ‘Gosh, I’ve never seen this many endometrial cancers before’,” he continued.

Explaining his findings at the March 18 event, Cole told Idahoans that the vaccines seem to be causing serious autoimmune issues, in a way he described as a “reverse HIV” response.

Cole explained that two types of cells are required for adequate immune system function: “Helper T-cells,” also called “CD4 cells,” and “killer T-cells,” often known as “CD8 cells.”

According to Cole, in patients with HIV, there is a massive suppression of “helper T-cells” which cause immune system functions to plummet, and leave the patient susceptible to a variety of illnesses.

Similarly, Cole describes, “post-vaccine, what we are seeing is a drop in your killer T-cells, in your CD8 cells,”

“And what do CD8 cells do? They keep all other viruses in check,” he continued

Much like HIV causes immune system disruption by suppressing CD4 “helper” cells, the same thing happens when CD8 “killer” cells are suppressed. In Dr. Cole’s expert view, this is what seems to be the case with the COVID-19 jabs.

Cole goes on to state that as a result of this vaccine-induced “killer T-cell” suppression, he is seeing an “uptick” of not only endometrial cancer, but also melanomas, as well as herpes, shingles, mono, and a “huge uptick” in HPV when “looking at the cervical biopsies of women.”

This is not the first time the COVID-19 vaccines have been linked to serious issues regarding women’s health.

According to a German research study, polyethylene glycol, an ingredient found in the Pfizer and Moderna jabs, has been found to pose a “potential toxicity risk” to women’s ovaries.

Dr. Michael Yeadon, a former vice president at Pfizer, has cited the German study as a possible explanation for the large number of menstrual irregularities and miscarriages being reported by vaccinated women.

Yeadon warns young women to avoid the vaccine for, in his expert opinion as a toxicologist, the shots will likely impede a woman’s ability to get pregnant and carry a baby to term.

Dr. Cole states in his video that, not only are melanomas showing up more frequently, like endometrial cancers, the melanomas are also developing more rapidly, and are more severe in younger people, than he has ever previously witnessed.

“Most concerning of all, there is a pattern of these types of immune cells in the body keeping cancer in check,” stated the doctor.

“I’m seeing invasive melanomas in younger patients; normally we catch those early, and they are thin melanomas, [but] I’m seeing thick melanomas skyrocketing in the last month or two,” he added.

Cole came into prominence in January of 2021 when the Idaho government put in place an effort called “Capitol Clarity,” with the stated goal of keeping Idahoans informed about the facts surrounding COVID-19.

Capitol Clarity has since hosted Dr. Ryan Cole multiple times to provide information to the public about vaccine safety and COVID-19 measures more broadly.

The videos of Dr. Cole at these events, which were originally posted on YouTube, have since been deleted by the Google owned video platform in a continual effort of censorship by Big Tech.

“You’re not being told the truth,” said Yeadon “Thinking about this, I try to imagine that I was speaking to my own young adult daughters, for whom I would be very concerned if they got these vaccines.”

LifeSiteNews has produced an extensive COVID-19 vaccines resources page. View it here

https://lifefacts.lifesitenews.com/covid-19/

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This is TSN showing its true colors and repeating baseless full-blown antivax propaganda. And those people here who claim to be antivax-lite might want to repudiate it.

This guy is a political anti-vax nasty. He calls the vaccines needle rape.

He has not a clue about science: for a TikTok (!) rebuttal of his previous claims that the vaccine were fake from Tracy Ruscetti:

https://www.idahostatesman.com/news/coronavirus/article253737863.html

Looks like he is now going one further, and claiming the vaccines cause cancer (though he has run with this one before).

Comprehensive Cole fact check - if you can bear a closer look at the slimy political anti-science that surrounds him:

Idaho Doctor Makes Baseless Claims About Safety of COVID-19 Vaccines - FactCheck.org

A viral video features a doctor making dubious claims about COVID-19 vaccines and treatments at a forum hosted by Idaho's lieutenant governor. Dr. Ryan Cole…

www.factcheck.org

What has happened to this site that it uncritically publicises anti-science anti-vax propaganda from TrialSiteNews?

Quote from THHuxleynew

The quoted post above then quotes part of my post and replies to it with exactly the same WyttenSpin.

This is a regular strategy of wyttenbach, instead of offering evidence, the statement is repeated over and over, as if it is some kind of self-evident truth.

It relies on the fact that a normal person will at some point stop replying to the same nonsense repeated over and over.

Then perhaps he then hopes it will become canon for the more simple-minded readers that he seeks to to influence and receive adulation from.

Weird, eh?

Quote from THHuxleynew

What has happened to this site that it uncritically publicises anti-science anti-vax propaganda from TrialSiteNews?

"This site" meaning lenr-forum.com? Or lifefacts?

For lenr-forum.com, this is business as usual. It is a little annoying that FM1 and others have no bullshit filter, and they will repost anything. On the other hand I suppose it is useful for the rest of us to know what the lunatic fringe is saying. I could find out from original sources but FM1 wades through this garbage so I don't have to.

Re Dr. Cole:

Isn't it interesting the the only doctor in the world who has noticed a "x20 increase in the number of cancers" is political appointee with a history of unique anti-vax views.

Who would have predicted it?

Quote from Zeus46

Re Dr. Cole:

Isn't it interesting the the only doctor in the world who has noticed a "x20 increase in the number of cancers" is political appointee with a history of unique anti-vax views.

Who would have predicted it?

Interestingly, it is likely there will be (in the UK at least) an increase in cancers presenting for treatment, with severity worse than typical. That is because a whole load of people have been avoiding hospitals and doctors for fear of getting COVID. Slightly worrying symptoms are then not seen by doctors and early-stage cancers not detected. You would expect an increase in diagnosed cancer corresponding to the decrease in diagnosed cancer over the last 18 months as the unseen cancers get picked up.

And that will be real numbers, not a political appointee (who lied about his politics when asked) with anecdotes.

Expect a whole load of new anti-vax info in your inboxes based on this...

The famous UK vaccination report: https://assets.publishing.serv…e_report_-_week_37_v2.pdf

Go to page 13!? Table 2. It looks like the vaccinated in the segment above age > 40 had 30% more CoV-19 cases than unvaccinated. Only age 80+ is 1:1 again...

Strange....

Quote from THHuxleynew

What has happened to this site that it uncritically publicises anti-science anti-vax propaganda from TrialSiteNews?

While you disagree with the Pathologists theory for the increase he is seeing in cancers, you later on agree that he may very well be seeing such an increase:

Quote from THHuxleynew

Interestingly, it is likely there will be (in the UK at least) an increase in cancers presenting for treatment, with severity worse than typical. That is because a whole load of people have been avoiding hospitals and doctors for fear of getting COVID.

Sounds like an honest difference of opinion about causation between two experts IMO. I agree your theory sounds much more plausible than his. In fact, in the early days of the lockdowns, many doctors were warning the same thing; that patients were avoiding hospitals, and to expect an increase in cancers, heart attacks, etc as a result.

His theory that the vaccine is killing off the protective T-cells could have been influenced by his politics. In this pandemic, we have learned to "trust but verify"...everyone. No exceptions.

Page 3 of 14 https://www.ons.gov.uk/peoplep…atafortheuk/13may2021/pdf

1 . Main points

In England, an estimated 7 in 10 adults or 69.3% of the adult population (95% credible interval: 65.6% to
73.9%) would have tested positive for antibodies against the coronavirus – SARS-CoV-2 – on a blood test
in the week beginning 19 April 2021, suggesting they had the infection in the past or have been vaccinated.

Vaccination status April 19. among age < 45 first dose < 20% This is > 50% of the UK population.

The problem is this paragraph:

Page 6 of 14
In the same week, our estimates suggest the percentage of adults who reported they had received at least one dose of a coronavirus (COVID-19) vaccine continued to increase – estimates ranged from 61.9% to 73.0% of adults across the UK. The estimated percentage of adults who are fully vaccinated against COVID-19 varied between 23.8% to 35.3% of adults across the UK in the week beginning 19 April 2021. These vaccination estimates for the community population will differ from official figures.

That totally contradicts: https://assets.publishing.serv…e_report_-_week_37_v2.pdf

Week 14-15. Please keep in mind that it takes 2(-4) weeks for antibodies to show up after a vaccination so week 13-14 is a better fit. At best 38..40% (all popolation !!!) had a first vaccine dose at the point of 19 April. But 70% had antibodies. (see link above)

This gives net antibodies for about 30% among unvaccinated if 40% have been vaccinated then 12% (of total population) of the vaccinated had antibodies too. So we in total have been at about 42% antibodies due to infection April 19th.

Since then about 3 mio new CoV-19 cases have been added with a shadow factor of 5 (from first figure). So we have well above 50% of UK people that had a corona infection so far.

I understand that some people have problems to follow the tricky logic (bias) of the reports once using adults for vaccines, but all population for cases...and forgetting 2 week adjustments for antibodies and using (at that time) guessed data from interviews - not facts.

I like this Dr Cole

Our greatest weapon against the coronavirus is Vitamin D: Board-certified pathologist

‘We don't just have a viral pandemic, we have an international Vitamin D deficiency pandemic – 70 percent of the world is immune-suppressed,' Dr. Ryan Cole says

Our greatest weapon against the coronavirus is Vitamin D: Board-certified pathologist - LifeSite

‘We don't just have a viral pandemic, we have an international Vitamin D deficiency pandemic – 70 percent of the world is immune-suppressed,' Dr. Ryan Cole…

www.lifesitenews.com

March 29, 2021 (LifeSiteNews) –A founder of one of the largest independent laboratories in Idaho is declaring loud and clear that the greatest weapon against the coronavirus is Vitamin D.

(The) biggest lost message in this entire pandemic is Vitamin D. It is the master key to your immune system, the master key. So we don't just have a viral pandemic, we have an international Vitamin D deficiency pandemic – i.e., 70 percent of the world is immune-suppressed,” Dr. Ryan Cole, founder of Cole Diagnostics, said during a March Capitol Clarity talk hosted by the Idaho Freedom Foundation.

Dr. Cole introduced himself as a “Mayo clinic trained, board-certified pathologist, board certified anatomic and clinical pathology,” who had seen about 350,000 patients in his career, and had done about 100,000 COVID tests and read about 6,000 articles in the past year.

“It is right up my alley, and so I’m not just blowing smoke today,” he explained.

“Normal D levels decrease your COVID symptom severity risk for hospitalization by 90 percent. There have been a lot of placebo controlled trials that show this all around the world. It is scientific fact, not just a correlation,” said Dr. Cole.

Dr. Cole explained why Vitamin D deficiency is the biggest contributor to both Wuhan coronavirus hospitalizations and deaths: “Data shows what kills people. Cytokine storm. If you are in (Vitamin D) mid-level range, you will not die from COVID because you cannot get a cytokine storm.”

According to Dr. Cole, widespread Vitamin D deficiency makes this a big problem. “Seventy to 80 percent of all Americans are immune suppressed because they are D deficient.” He further noted that “96 percent of people in the ICU are Vitamin D deficient.”

Dr. Cole cited statistics showing lower levels of Vitamin D in darker skinned populations, which he says is due to biology, and not “social disparity.”

“Eighty-three percent of African Americans, 70 percent of Latinos, 72 percent of Native Americans, 47 percent of Caucasians are deficient,” Dr. Cole said. “The darker your skin, the further north you live, the harder it is to synthesize Vitamin D.”

Along with low Vitamin D levels, Dr. Cole discussed what he called the other “highest risk factors” for COVID-19: obesity and advanced age.

“Ninety percent of deaths in the state have been over 70 years of age. That’s the at-risk population. We have stopped our society for something that's taking people that are already at that death risk age anyway,” said Dr. Cole.

Dr. Cole explained that obesity contributes to higher risk of symptoms and death at least in part because it “drastically reduces your ability to get Vitamin D into your circulation.”

“D is a fat soluble vitamin. The heavier set you are, the more it goes into your fat and not into your circulation to stimulate your immune system,” Dr. Cole explained.

“If you don't have D in normal range, how do we get D? Sunshine,” he continued.

“There's only about a three-hour window a day, without your sunscreen. You need to be outside for 20 to 30 minutes during the spring and summer to get natural Vitamin D. In the fall, in the winter, you need to supplement to boost your immune system.”

To help guide the best use of time spent outdoors, Dr. Cole recommended an app called D Minder that “shows you when you can synthesize your vitamin D.”

Dr. Joseph Mercola stresses the importance of taking vitamin K2 while supplementing with vitamin D, to prevent any potential vitamin D toxicity symptoms. He recommends supplementing with vitamin D3, instead of vitamin D2, at 5,000 units per day for adults.

Dr. Cole noted that Dr. Fauci revealed in an interview in November that he takes 8,000 to 9,000 IU of vitamin D a day in the winter. “Yet inexplicably, that’s not a public health message,” Dr. Cole continued.

While Dr. Cole focused on the preventative power of vitamin D, he also emphasized the importance of early treatment of COVID-19, if and when the disease is contracted, through the use of Ivermectin.

“This medication won the Nobel prize for the discoverer. It is on the world’s safest and most essential drugs list,” Dr. Cole explained.

“Ivermectin, if that’s added to the mix, it decreases the death rate by 75 percent. If given early, by 86 percent. What does that mean? Of the half-million deaths we have in North America we would have 375,000 less deaths. There is blood on the hands of the bureaucrats in Washington who have suppressed this life-saving medication,” he continued.

“Wherever it has been given in the world, they’re back to normal life. 100 percent of the world trials have shown benefit. In Argentina, in a hospital trial it prevented 100% of acquisition in health care workers. In the placebo group, 57% got Covid that were not on Ivermectin. To a ‘T,’ every person that’s had Covid I’ve treated with this has been better in 12 to 48 hours. 42 people. I know it works.”

“The beauty of it: It can cover all the variants because of its mechanism,” he continued.

Dr. Cole didn’t stop at promoting prevention and treatment of Covid. During his talk, he warned about the potential dangers of the mRNA so-called “vaccines.”

He first pointed out, “If there’s a treatment for a disease, the federal government cannot approve a vaccine. By law. The NIH who is involved in approving medications, they co-hold the patent on the “vaccine” with Moderna. That is insanity, to have the government in bed with a private company vending a product that they want to give to everybody.”

He further explained that the mRNA injections don’t fall under the definition of vaccines, but are rather “experimental biological gene therapy.”

“Long-term safety data is not there. MRNA trials in mammals have led to odd cancers. mRNA trials on mammals have led to auto-immune diseases, not right away — six, nine, twelve months later,” said Dr. Cole.

“The companies did their own data. There were no independent observer groups looking at the data. They don't fall under the definition of creating peer immunity and preventing transmission. If you are immune after injection, why in the world would you have to mask and social distance. That is an admission that they don't know that it’s a vaccine. That’s an absurdity,” he continued.

“My biggest concern is antibody-dependent enhancement reaction. If you get a coronavirus shot, historically SARS, MERS, animal coronaviruses, when you are exposed to a wild type variant of the virus, six, nine, twelve months later the immune system can go haywire.”

“In the SARS vaccine trials, in the ferrets and the monkeys, 100 percent of the animals, when exposed to wild type virus, ended up with immune reaction.”

Dr. Cole also explained that COVID, like other coronaviruses, must be allowed to run its course, and slammed some of the measures being currently used to keep it in check.

“Coronaviruses are seasonal. They follow a 6-9 month life cycle – no matter what we do, they’re going to do what they do, and then they’re going to fade. What happened to SARS? What happened to MERS? What did we do to stop them? Nothing. They did their thing.”

He showed a graph of Idaho daily cases over the past year and explained that Idaho is no longer in a state of pandemic, but in an endemic. “Statistically, once we are below a certain percentage we are not in a pandemic. Is the disease present? Sure it is. Is it widespread? No. At most we are seeing 2% (positives) per day now and so the numbers are going way down.”

Dr. Cole also explained why wearing masks outside is “insanity.”

“The virus is fragile. It doesn’t live outside. UV light fractionates it, kills it, blows it apart. Ventilation and the wind blows it away. It is insanity to wear a mask outside. Absolute insanity. There is not one study that has shown any superspreader to have occurred outside. They have all happened indoors with poor ventilation.”

Post Approval Real-World Study of Favipiravir in India: Antiviral Helping in India’s War Against COVID-19

Post Approval Real-World Study of Favipiravir in India: Antiviral Helping in India’s War Against COVID-19

Glenmark Pharmaceuticals (Glenmark), one of the Indian generic pharmaceutical companies commercializing Favipiravir as a treatment for early-onset

trialsitenews.com

Glenmark Pharmaceuticals (Glenmark), one of the Indian generic pharmaceutical companies commercializing Favipiravir as a treatment for early-onset mild-to-moderate COVID-19, reports positive results in a post-market surveillance involving 1,083 patients with mild-to-moderate COVID-19. In India, Favipiravir competes against Ivermectin in the world’s second-most populous nation as well as the indigenously developed 2-DG and possibly new entrants such as Merck’s Molnupiravir, presently in clinical trials. Glenmark reports positive results from its “Post-Marketing Surveillance” (PMS) activity over real-world outcomes for the antiviral drug developed originally in Japan by FUJIFILM Toyama Chemical. In use in dozens of countries to treat COVID-19, from Russia and Turkey to China and India, Favipiravir was also extensively studied by the U.S. Department of Defense just six years ago in 2015—over $200 million in taxpayer money went into Phase 3 clinical trials. The Mumbai-based generic pharmaceutical producer’s version of the drug, known as “Fabiflu®,” is at the center of attention in the first and largest PMS conducted in India in mild to moderate COVID-19 patients. This PMS study was part of a deal with Indian regulators: in exchange for a restricted emergency use approval for Favipiravir. The results indicate no new safety signals or concerns to date, while side effects are in line with the drug’s known safety profile.

American Media: Pathetic

While Favipiravir is now used in dozens of countries as a treatment for early-onset, mild-to-moderate COVID-19, the U.S. media market all but blacks out this topic—much like Ivermectin (unless, of course in the latter, they take pot-shots calling it the horse deworm medication), if the average American health consumer simply relies on CNN, MSNBC, Fox, and even PBS they actually are kept completely in the dark as to what’s going on in the world when it comes to various early care treatments for COVID-19.

More than likely, that’s because the U.S. economy and society have been usurped by special interests leading to regulatory capture and a particular brand of market political economy called “Crony Capitalism.” Now with COVID-19, a medical-industrial complex emerges through the use of regulators and other purportedly “independent” agencies, influencing what can, and what cannot be broadcast or shared on social media.

Consequently, at this stage in the United States, thought control is not needed due to “thought contraception.” Meaning a combination of mass media, social networking, and complicit government bodies support a joint narrative that essentially keeps competition out. Thankfully TrialSite is an independent media platform that delivers the latest news, information, and analysis about biomedical research around the world.

Indian Competition

Generally, TrialSite reports the Indian pharmaceutical market is a dynamic, robust, and competitive space—far more than America- and for this early stage, mild-to-moderate COVID-19 treatment, a number of generic producers possess Favipiravir licenses, including Sun Pharma, Hetero, Cipla, Dr. Reddy’s Laboratories and others.

The PMS Study

Starting back in July 2020, the company initiated the post-marketing surveillance (PMS) study to investigate the safety and efficacy of Favipiravir in mild-to-moderate COVID-19 patients. With 1,083 patients enrolled in the prospective, open-label, multicenter, single-arm study, 13 trial site organizations—both from the government and private sector—evaluated the drug across Mumbai, Bengaluru, Hyderabad, Nashik, Nagpur, and Thiruvananthapuram.

Glenmark reports in their press release that in this PMS study, the average age of patients was 40 years, with women comprising 40%, while men 60% of the study population. Hypertension (11%) and diabetes (8%) were the two most common comorbidities noted in these patients. Fever was present in all patients at baseline, followed by cough (81%), fatigue (46.2%), and new loss of taste (41%).

The Results

The sponsor, Glenmark, reports no new safety signals or concerns with the use of Favipiravir, although known side-effects were chronicled from weakness to gastritis and diarrhea, and vomiting. However, these effects were overwhelmingly mild in nature. Glenmark reports that the Favipiravir (FabiFlu) cohort experienced fever resolution in four (4) days, with an average clinical cure in seven (7) days.

Executive Comments

Alok Malik, Glenmark Vice President & Head (India Formulations), went on the record “This study was crucial as it examined the safety and efficacy of FabiFlu® in real-world settings, where multiple variables can impact the results. Despite these factors, the PMS study demonstrated FabiFlu’s consistent ability to provide symptomatic relief and improve clinical outcomes in patients with mild to moderate COVID19. It is a step forward both for Glenmark and the medical community, as it reinforces the multiple benefits in tackling the pandemic.”

Peer-Review Published Results

The study results come by way of a company press release. While informative, the company will need to write up the results, secure peer-review journal entry, and thus have the outcomes validated by the wider biomedical community.

Welcome to Glenmark | Glenmark

This came out the other day. Don't remember if it has been posted here already: https://www.thelancet.com/jour…twitter&utm_medium=social

I imagine these 16 scientists will be blacklisted by the Chinese, but at least they will be able to sleep well at night:

On July 5, 2021, a Correspondence was published in The Lancet called “Science, not speculation, is essential to determine how SARS-CoV-2 reached humans”.¹ The letter recapitulates the arguments of an earlier letter (published in February, 2020) by the same authors,² which claimed overwhelming support for the hypothesis that the novel coronavirus causing the COVID-19 pandemic originated in wildlife. The authors associated any alternative view with conspiracy theories by stating: “We stand together to strongly condemn conspiracy theories suggesting that COVID-19 does not have a natural origin”. The statement has imparted a silencing effect on the wider scientific debate, including among science journalists.³

The 2021 letter did not repeat the proposition that scientists open to alternative hypotheses were conspiracy theorists, but did state: “We believe the strongest clue from new, credible, and peer-reviewed evidence in the scientific literature is that the virus evolved in nature, while suggestions of a laboratory leak source of the pandemic remain without scientifically validated evidence that directly supports it in peer-reviewed scientific journals”. In fact, this argument could literally be reversed. As will be shown below, there is no direct support for the natural origin of SARS-CoV-2, and a laboratory-related accident is plausible.

There is so far no scientifically validated evidence that directly supports a natural origin. Among the references cited in the two letters by Calisher and colleagues,¹all but one simply show that SARS-CoV-2 is phylogenetically related to other betacoronaviruses. The fact that the causative agent of COVID-19 descends from a natural virus is widely accepted, but this does not explain how it came to infect humans. The question of the proximal origin of SARS-CoV-2—ie, the final virus and host before passage to humans—was expressly addressed in only one highly cited opinion piece, which supports the natural origin hypothesis,⁴ but suffers from a logical fallacy: it opposes two hypotheses—laboratory engineering versus zoonosis—wrongly implying that there are no other possible scenarios. The article then provides arguments against the laboratory engineering hypothesis, which are not conclusive for the following reasons. First, it assumes that the optimisation of the receptor binding domain for human ACE2 requires prior knowledge of the adaptive mutations, whereas selection in cell culture or animal models would lead to the same effect. Second, the absence of traces of reverse-engineering systems does not preclude genome editing, which is performed with so-called seamless techniques.⁶

Finally, the absence of a previously known backbone is not a proof, since researchers can work for several years on viruses before publishing their full genome (this was the case for RaTG13, the closest known virus, which was collected in 2013 and published in 2020).⁸

Based on these indirect and questionable arguments, the authors conclude in favour of a natural proximal origin. In the last part of the article, they briefly evoke selection during passage (ie, experiments aiming to test the capacity of a virus to infect cell cultures or model animals) and acknowledge the documented cases of laboratory escapes of SARS-CoV, but they dismiss this scenario, based on the argument that the strong similarity between receptor binding domains of SARS-CoV-2 and pangolins provides a more parsimonious explanation of the specific mutations. However, the pangolin hypothesis has since been abandoned, so the whole reasoning should be re-evaluated.

Although considerable evidence supports the natural origins of other outbreaks (eg, Nipah, MERS, and the 2002–04 SARS outbreak) direct evidence for a natural origin for SARS-CoV-2 is missing. After 19 months of investigations, the proximal progenitor of SARS-CoV-2 is still lacking. Neither the host pathway from bats to humans, nor the geographical route from Yunnan (where the viruses most closely related to SARS-CoV-2 have been sampled) to Wuhan (where the pandemic emerged) have been identified. More than 80 000 samples collected from Chinese wildlife sites and animal farms all proved negative.¹³

In addition, the international research community has no access to the sites, samples, or raw data. Although the Joint WHO-China Study concluded that the laboratory origin was “extremely unlikely”,¹³
WHO Director-General Tedros Adhanom Ghebreyesus declared that all hypotheses remained on the table including that of a laboratory leak.¹⁴

A research-related origin is plausible. Two questions need to be addressed: virus evolution and introduction into the human population. Since July, 2020, several peer-reviewed scientific papers have discussed the likelihood of a research-related origin of the virus. Some unusual features of the SARS-CoV-2 genome sequence suggest that they may have resulted from genetic engineering,an approach widely used in some virology labs.¹⁷

Alternatively, adaptation to humans might result from undirected laboratory selection during serial passage in cell cultures or laboratory animals, including humanised mice. Mice genetically modified to display the human receptor for entry of SARS-CoV-2 (ACE2) were used in research projects funded before the pandemic, to test the infectivity of different virus strains.²¹
Laboratory research also includes more targeted approaches such as gain-of-function experiments relying on chimeric viruses to test their potential to cross species barriers.

A research-related contamination could result from contact with a natural virus during field collection, transportation from the field to a laboratory, characterisation of bats and bat viruses in a laboratory, or from a non-natural virus modified in a laboratory. There are well-documented cases of pathogen escapes from laboratories. Field collection, field survey, and in-laboratory research on potential pandemic pathogens require high-safety protections and a strong and transparent safety culture. However, experiments on SARS-related coronaviruses are routinely performed at biosafety level 2^, which complies with the recommendations for viruses infecting non-human animals, but is inappropriate for experiments that might produce human-adapted viruses by effects of selection or oriented mutations.

Overwhelming evidence for either a zoonotic or research-related origin is lacking: the jury is still out. On the basis of the current scientific literature, complemented by our own analyses of coronavirus genomes and proteins, we hold that there is currently no compelling evidence to choose between a natural origin (ie, a virus that has evolved and been transmitted to humans solely via contact with wild or farmed animals) and a research-related origin (which might have occurred at sampling sites, during transportation or within the laboratory, and might have involved natural, selected, or engineered viruses).

An evidence-based, independent, and prejudice-free evaluation will require an international consultation of high-level experts with no conflicts of interest, from various disciplines and countries; the mandate will be to establish the different scenarios, and the associated hypotheses, and then to propose protocols, methods, and required data in order to elucidate the question of SARS-CoV-2's origin. Beyond this issue, it is important to continue debating about the risk–benefit balance of current practices of field and laboratory research, including gain-of-function experiments, as well as the human activities contributing to zoonotic events.

Scientific journals should open their columns to in-depth analyses of all hypotheses. As scientists, we need to evaluate all hypotheses on a rational basis, and to weigh their likelihood based on facts and evidence, devoid of speculation concerning possible political impacts. Contrary to the first letter published in The Lancet by Calisher and colleagues,²
we do not think that scientists should promote “unity” (“We support the call from the Director-General of WHO to promote scientific evidence and unity over misinformation and conjecture”). As shown above, research-related hypotheses are not misinformation and conjecture. More importantly, science embraces alternative hypotheses, contradictory arguments, verification, refutability, and controversy. Departing from this principle risks establishing dogmas, abandoning the essence of science, and, even worse, paving the way for conspiracy theories. Instead, the scientific community should bring this debate to a place where it belongs: the columns of scientific journals.

FDA Grants EUA for Post-Exposure Prophylaxis to High-Risk COVID-19 Outpatient Care: Lilly’s Bamlanivimab & Junshi Bioscience’s Etesevimab

FDA Grants EUA for Post-Exposure Prophylaxis to High-Risk COVID-19 Outpatient Care: Lilly’s Bamlanivimab & Junshi Bioscience’s Etesevimab

Eli Lilly is back in business with their experimental monoclonal antibody (mAb) product as U.S. demand for monoclonal antibody treatments spike during the

trialsitenews.com

Eli Lilly is back in business with their experimental monoclonal antibody (mAb) product as U.S. demand for monoclonal antibody treatments spike during the Delta-variant has driven surge. In this case, a significant breakthrough as the combination experimental monoclonal antibody (mAb) therapy—including a licensed mAb from a Chinese biotech called Junshi Biosciences (HKEX: 1877; SSE: 688180) secures post-exposure prophylaxis status for certain high-risk people. This is a big deal. The U.S. Food and Drug Administration (FDA) expanded the Emergency Use Authorization (EUA) for the combined monoclonal antibody product (bamlanivimab (LY-CoV555) 700 mg and etesevimab (JSo16/LY-CoV016) 1400 mg) administered together to include post-exposure prophylaxis (PEP) in select individuals for the prevention of SARS-CoV-2 infection. Moving forward, select infusion centers will be able to use these neutralizing antibodies together to treat high-risk individuals 12 years of age and up who have not been fully vaccinated against COVID-19 or are not expected to mount an adequate immune response to complete vaccination, and have been exposed to someone infected with SARS-CoV-2 or who are at a high risk of exposure in an institutional setting, including a nursing home or prison. This authorization follows the national reopening of distribution earlier this month. Positive news indeed that a PEP therapy, albeit still investigational, is available now to treat patients that meet inclusion criteria.

Delta-Surge Required Action for Prophylactic Care

With an ongoing surge in COVID-19 cases, the U.S. political economy faces deep trouble if the contagion isn’t contained relatively soon. U.S. authorities and medical societies have grown increasingly aggressive in inhibiting the use of approved yet off-label treatments such as Ivermectin (monthly prescriptions have skyrocketed over 2,000%) while there are currently no approved early-stage treatments for COVID-19.

The government now makes a move to offer treatments for high-risk demographic cohorts, and in this case, now introduce the use of the Lilly and Junshi Bioscience combined mAb investigational product as a post-exposure prophylaxis, meaning a way to prevent the disease once someone has experienced contact with a SARS-CoV-2 infected person.

Eradication by Vaccination Won’t Work by Itself

The government increasingly acknowledges to American society that vaccination won’t be enough to transcend the public health crisis. Due to the early maturity of existing COVID-19 vaccines, for example, vaccine hesitancy is pervasive around the country, with over 80 million people not comfortable with the jab—at least not yet—despite POTUS recent move to force up to 100 million people to succumb to vaccination.

Myron Cohen, MD, director of University of North Carolina’s Global Health and Infectious Diseases, shared in the recent Lilly press release that “Recent reports suggest that fully vaccinated residents of nursing homes have contracted COVID-19, some of whom became quite ill.” Dr. Cohen continued, “This additional emergency use authorization of monoclonal antibodies for post-exposure prophylaxis in addition to the treatment of COVID-19 offers an achievement in the fight against the pandemic.”

Bring on the Care— TrialSite’s Founder on the Record

TrialSite’s Founder, Daniel O’Connor, suggested that the EUA was important—a positive move by the FDA to get care options out to the people declaring “front line doctors have lamented for nearly 1.5 years that early access treatments, including critically important pre-and post-exposure prophylaxis, are necessary for addition to safe and effective vaccines.”

O’Connor continued, “What is needed to manage and eventually overcome this crisis are a portfolio of options from safe and effective vaccines to a spectrum of affordable early-care treatments, specialized monoclonal antibody options like the Lilly and Junshi combination, in addition to the Regeneron and GSK/Vir products and importantly, data-driven, risk-based targeted public health initiatives that are not politicized.”

TrialSite provides a breakdown of this overall good news in a question and answer format.

Does this move indicate the government’s recognition that a vaccine-centric strategy is not sufficient to overcome SARS-CoV-2?

Yes. Despite widespread vaccination in nations such as Israel, Iceland, and many other places, breakthrough infections rage due to a confluence of factors, including the early maturity of the existing COVID-19 vaccines (first generation) and the overpowering SARS-CoV-2 mutant strains such as the Delta variant.

Hence Daniel Skovronsky, MD, Ph.D., Lilly’s chief scientific and medical office and president of Lilly Research Laboratories, went on the record that although COVID-19 vaccination is improving public health, unfortunately, “with the rise of the highly contagious Delta variant, the virus continues to have a devastating impact on the most vulnerable individuals, including nursing home residents and individuals with medical conditions that put them at high risk for the most severe conditions.”

What is the basis for the expanded EUA?

The FDA reviewed the data from the BLAZE-2 study conducted in partnership with the National Institutes of Allergy and Infectious Disease (NIAID), part of the National Institutes of Health (NIH), and the COVID-19 Prevention Network (CoVPN), that enrolled residents and staff at long-term care facilities, commonly referred to as nursing homes, across the U.S. In this placebo-controlled Phase 3 study, bamlanivimab 4200 mg reduced the risk of contracting symptomatic COVID-19 by up to 80 percent in nursing home residents and up to 57 percent among residents and staff of long-term care facilities.

What is Lilly’s Bamlanivimab?

Also known as LY-CoV555, this monoclonal antibody was actually developed by a partnership between AbCellera Biologics (a University of British Columbia spin-off) and some sharp scientists at Lilly as a treatment for COVID-19. The investigational therapy was first granted EUA by the FDA in November 2020, and 950,000 doses were acquired by the U.S. government as of December 2020. By April 2021, the EUA was revoked.

An IgG1 monoclonal antibody directed against the spike protein of SARS-CoV-2 the drug serves to block viral attachment and entry into human cells, thus neutralizing the pathogen. Of course, the combination with Junshi Biosciences etesevimab was granted a EUA by the FDA just recently. See that fact sheet.

Were shipments halted in June?

Yes. By June 25, 2021, the U.S. government (Office of the Assistant Secretary for Preparedness and Response or ASPR) issued a pause in the distribution of the combination mAbs as well as etesevimab alone (to pair with existing supply of bamlanivimab at a facility for use under the UEA) due to intensifying circulation of SARS-CoV-2 variants.

The government informed that other mAbs were available, including Regeneron’s REGEN-COV and GSK/Vir Biotech’s sotrovimab.

When were shipments allowed again?

On September 2, ASPR, alongside the FDA, resumed the shipment and distribution of bamlanivimab and etesevimab administered together.

Why were they given the greenlight?

Because pseudovirus and authentic virus studies demonstrate that bamlanivimab and etesevimab work together to retain neutralization activity against the Alpha and Delta variants.

Is the mAb combo of bamlanivimab and etesevimab the only way to access these products?

Yes.

What is the track record of bamlanivimab and etesevimab to date?

Bamlanivimab alone or in combination with etesevimab to date has been used in over 535,000 treatment courses, and the government suggests that the treatment could have prevented over 25,000 hospitalizations and 10,000 deaths.

Where can care providers & patients find more information about the use of the combination mAbs under expanded EUA?

The FDA EUA includes a Fact Sheet for Healthcare Providers as well as Fact Sheet for Patients, Parents, and Caregivers in both English and Spanish. Lilly also provides a 24-hour support line at 1-855-LillyC19 (1-855-545-5921). Lilly’s media kit can be found here.

Where can patients find infusion centers?

Patients can check out the NICA Infusion Center Locator or the HHS Therapeutics Distribution Locator to find a potential therapy location.

What is the authority for EUA?

Bamlanivimab and etesevimab together are authorized under Emergency Use Authorization only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under Section 564(b)(1) of the Act, 21 U.S.C § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.

What’s the fine print on investigational products authorized under FDA EUA?

These are not approved drugs—rather, they are still experimental. Lilly must declare that it is not known if bamlanivimab and etesevimab together are safe and effective for the treatment of post-exposure prophylaxis of COVID-19.

What is the treatment patient demographic?

Bamlanivimab and etesevimab together are authorized for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death.

Are there other limitations of use?

Yes. For example, the mAb combo therapy can’t be used in states, territories, and U.S. jurisdictions in which the combined frequency of variants resistant to each mAb exceeds 5%. The FDA provides a list of such places here.

Also, the mAb combo cannot be administered to patients who are A) hospitalized due to COVID-19, B) require oxygen therapy due to COVID-19, or C) require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19-related comorbidity.

Note that this mAb combo hasn’t been studied in hospitalized patients, and use there may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.

What are FDA’s instructions around Post-Exposure Prophylaxis use?

The mAb combo can be used for PEP of COVID-19 adults and pediatric individuals (12+ a weighing at least 40kg) who are at high risk for progression to severe COVID-19, including hospitalization or death, including A) those who are not fully vaccinated or are not expected to

Bamlanivimab and etesevimab administered together are authorized for post-exposure prophylaxis of COVID-19 in adults and pediatric individuals (12 years of age or older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death, and are to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, individuals with immunocompromising conditions including those taking immunosuppressive medications and A) have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC) or B) who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes, prisons).

What are Limitations of Authorized Use: Post-Exposure Prophylaxis

Bamlanivimab and etesevimab are not authorized for use in states, territories, and US jurisdictions in which the combined frequency of variants resistant to bamlanivimab and etesevimab exceeds 5%.

A list of states, territories, and US jurisdictions in which bamlanivimab and etesevimab are and are not currently authorized is available on the following FDA website.

Post-exposure prophylaxis with bamlanivimab and etesevimab is not a substitute for vaccination against COVID-19.

Bamlanivimab and etesevimab together are not authorized for pre-exposure prophylaxis for prevention of COVID-19.

What are safety risks?

Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions

Serious hypersensitivity reactions, including anaphylaxis, have been observed with the administration of bamlanivimab and etesevimab. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive care.

Infusion-related reactions, occurring during or up to 24 hours after infusion, have been observed with the administration of bamlanivimab and etesevimab together. These reactions may be severe or life-threatening. Signs and symptoms of infusion-related reactions may include:

fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vasovagal reactions (e.g. presyncope, syncope), dizziness, and diaphoresis.

Consider slowing or stopping the infusion and administer appropriate medications and/or supportive care if an infusion-related reaction occurs.

Hypersensitivity reactions occurring more than 24 hours after the infusion have also been reported with the use of bamlanivimab and etesevimab under Emergency Use Authorization.

Clinical Worsening After Receiving Bamlanivimab and Etesevimab Administration

Clinical worsening of COVID-19 after administration of bamlanivimab and etesevimab together has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (e.g., atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and altered mental status. Some of these events required hospitalization. It is not known if these events were related to bamlanivimab and etesevimab use or were due to progression of COVID-19.

Limitations of Benefit and Potential Risk in Patients with Severe COVID-19

Treatment with bamlanivimab and etesevimab has not been studied in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab and etesevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation. See Limitations of Authorized Use.

Adverse Reactions

Adverse reactions observed in those who have received bamlanivimab and etesevimab are anaphylaxis (n=1, 0.07%) and infusion-related reactions (n=16, 1.1%). The most common treatment-emergent adverse events included nausea, dizziness, and pruritus. No treatment-emergent events occurred in more than 1% of participants, and rates were comparable to placebo.

Use in Specific Populations

Pregnancy

There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Bamlanivimab and etesevimab together should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus.

Breastfeeding

There are no available data on the presence of bamlanivimab or etesevimab in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.

Investigational mAb Combo Therapy Description

Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It was designed to block viral attachment and entry into human cells, thus neutralizing the virus. Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. Bamlanivimab was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.

Etesevimab (LY-CoV016, also known as JS016) is a recombinant fully human monoclonal neutralizing antibody, which specifically binds to the SARS-CoV-2 surface spike protein receptor-binding domain with high affinity and can block the binding of the virus to the ACE2 host cell surface receptor. Point mutations were introduced into the native human IgG1 antibody to mitigate effector function. Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and the Institute of Microbiology, Chinese Academy of Science (IMCAS). Junshi Biosciences leads development in Greater China, while Lilly leads development in the rest of the world.

Results from a Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) were published in the New England Journal of Medicine. Results from a Phase 3 study of bamlanivimab in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) were published in the Journal of American Medical Association (JAMA). A Phase 2 study assessing the efficacy and safety of bamlanivimab alone and bamlanivimab with other neutralizing antibodies versus placebo for the treatment of symptomatic low-risk COVID-19 in the outpatient setting (BLAZE-4. NCT04634409) has completed enrollment.

For more information, follow up and read Lilly’s press release.

Emergency Use Authorization for Lilly's bamlanivimab and etesevimab administered together expanded to include post-exposure prophylaxis for COVID-19 | Eli Lilly and Company

The Investor Relations website contains information about Eli Lilly and Company's business for stockholders, potential investors, and financial analysts.

investor.lilly.com

Quote from Fm1

Glenmark reports positive results from its “Post-Marketing Surveillance” (PMS) activity over real-world outcomes for the antiviral drug developed originally in Japan by FUJIFILM Toyama Chemical.

There have been positive result in Japan too but also to many neutral ones. So it is still not recommended. It's teratogenic too for about 6 months in men's sperm...Not very ideal.

Quote from Fm1

The government now makes a move to offer treatments for high-risk demographic cohorts, and in this case, now introduce the use of the Lilly and Junshi Bioscience combined mAb investigational product as a post-exposure prophylaxis, meaning a way to prevent the disease once someone has experienced contact with a SARS-CoV-2 infected person.

This is silly and a waste of $$$$$$$$ if you have a drug that does the same for 10 cents....

Dr. Fareed addresses Italian Senate at COVID summit

The following is Dr. Fareed's speech to the Italian Senate, Rome, and Italy at the International COVID Summit Monday, Sept. 13.

www.thedesertreview.com

Sept 13 testimony of a doctor on the US/Mexican border to the Italian Senate:

Distinguished Senators and Dear colleagues, friends, ladies and gentlemen, it’s a great honor for me to address you today.

My name is Dr. George Fareed. I practice medicine in a rural town called Brawley California that sits on the Mexican border.

This small community became the epicenter of COVID 19 in California, and I, who continue to treat patients in both the outpatient and hospital setting, found myself in the “eye of the storm,” treating very sick and contagious patients----not a place I thought I would be at age 76.

However, my training in biochemistry and virology, along with my degree from Harvard Medical School, prepared me well for the battle ahead, a battle that I have been fighting now for the past 18 months.

I, along with my colleague Dr. Brian Tyson, are winning the battle against COVID-19 for one simple reason: we follow the science!

COVID-19 is a disease that can be easily treated in its early stage, but comes very difficult to treat as the disease progresses.

As scientists such as Drs. Didier Raoult, Vladimir Zelenko, and Peter McCullough have taught us, the first stage of COVID involves viral replication resulting in symptoms such as flu-like symptoms of cough, fever, malaise, headache, and perhaps loss of taste and smell---if a patient is left untreated, this may progress into “cytokine storm” where oxygen saturation drops, and then into the thromboembolic stage where blood clots occur that can be fatal.

I’ve treated patients in all three stages--- delaying treatment in an elderly or high-risk patient, those with co-morbidities such as asthma or diabetes, is nothing short of cruel as the disease predictably progresses—many then die. The standard “wait and see” approach to COVID-19 has been the greatest medical failure I have seen in my long career because deaths are preventable- but you must treat early!

NO ONE NEEDS TO DIE FROM COVID-19

Eighteen months ago, in March 2020, I, along with my colleague Dr. Brian Tyson, began treating COVID-19 patients early in the course of the disease with a combination of medications, initially primarily hydroxychloroquine and azithromycin or doxycylcine, and nutraceuticals including zinc, vitamin D and C.

As Dr. McCullough explains, medications such as hydroxychloroquine act as ionophores to allow zinc into the cell to interfere with viral replication.

As time progressed, so did our treatment, and we added drugs such as ivermectin, fluvoxamine, and monoclonal antibodies, as well as aspirin and budesonide (steroid) to treat the other aspects of the disease.

We became part of an international network of physicians, including groups such as the American Association of Physicians and Surgeons led by Dr. McCullough and leaders such as Dr. Jean-Pierre Kiekens from Covexit.com---all engaged in one singular goal- saving lives through early treatment.

I developed my own protocols which vary slightly from patient to patient- depending on their clinical situation.

So- what do our results look like?

We have now treated over 7,000 patients, and there has not been a single death in patients treated within the first 5 to 7 days of the onset of symptoms. NOT A SINGLE DEATH. This includes patients with multiple co-morbidities as well as patients in their 90s!

As a medical director at a nursing home, while other nursing homes in the area suffered major losses, we saw very few deaths from COVID in our residents because of early treatment.

To put this in perspective, our County has seen around 30,000 COVID cases and there has been 750 deaths. We have treated over 20% of the patients, and have seen just a few deaths, and NONE when we have treated early.

Moreover—we are called on a daily basis from patients all over the US who are desperately seeking early treatment, and we have helped hundreds-the letters we receive from thankful patients are incredibly gratifying.

What is the proof that our treatment is “scientific”? Our results have been duplicated all around the world, and there are now hundreds of peer reviewed publications on early treatment. I have been honored to be on a few of these publications, including on Dr. McCullough’s seminal paper on early treatment.

What is going on that COVID patients cannot get the treatment they need from their own physicians?

Perhaps the major reason is that our own health agencies such as the FDA and CDC have come out against these medications—even making false claims that they are dangerous.

First, we were told that HCQ was cardiotoxic based on sham study in the Lancet that was eventually retracted. Now we hear that Ivermectin is a “horse medication”—ignoring the fact that it is recommended by the CDC and WHO and millions of doses have been given to humans to treat parasitic infections - the propaganda against early treatment is then echoed in the media.

I and other doctors who treat COVID early have come under attack by our local health departments, hospitals, and even state licensing boards. With increasing frequency, my prescriptions are now being denied by pharmacies. Even as it becomes more evident that vaccines by themselves are not the answer, patients are finding it increasingly difficult to get treatment.

Moreover, there is censorship…my own you-tube videos regarding early treatment have been taken down and labeled misinformation…in the US, we say it is like the book “1984” or McCarthyism.

Censorship is never good in a free society, but especially damaging in medicine where patients benefit when physicians exchanging ideas. Rather, we depend on a few “experts” who don’t even treat COVID patients.

The results, as we have seen, have been tragic!

CONCLUSION

When I began working in my rural community in 1990, I never dreamed that I would one day be speaking in the United States Senate and then in an international conference…but because I have seen first-hand how early treatment of COVID-19 saves lives, I feel an ethical and moral obligation to speak out and fight for not only my patients, but for the many around the world who continue to die unnecessarily.

This is a time that calls on the greatest of human attributes- courage. Everyone here must understand that we are in the greatest fight of our lives---when doctors are prevented from treating their patients with life-saving medicine, we know that something sinister is going on.

I thank you all for being here, and applaud your courage for standing up for your patients and the rest of humanity.

Egypt’s Ministry of Health Moves To Merck’s Molnupiravir

Egypt’s Ministry of Health Moves To Merck’s Molnupiravir

Merck has been quietly making moves worldwide to position molnupiravir as the standard early-onset, orally-administered antiviral treatment for COVID-19.

trialsitenews.com

Merck has been quietly making moves worldwide to position molnupiravir as the standard early-onset, orally-administered antiviral treatment for COVID-19. TrialSite has reported that Merck’s teams are crisscrossing the globe, inking deals with governments and generic drug companies. In Vietnam, the drug is even being administered as part of a home care program in Ho Chi Minh City, similar to how ivermectin has been used in Uttar Pradesh, India, and other places. Controversially this is outside of a controlled trial. Now the Egypt Independent reports, “Egypt’s Ministry of Health and Population has started working to provide new drugs that will change coronavirus resistance by reducing the viral load.” In a statement on Friday, the ministry said that the “molnupiravir” drug reduces the viral load of the disease and that Egypt is participating in two studies by the company producing the drug.

Egypt’s existing national COVID-19 protocol includes Hydroxychloroquine, Budesonide, and several other treatments depending on the stage of infection. By last year, an Egyptian pharmaceutical company, Eva Pharma, was also producing both remdesivir and favipiravir.

The ministry noted that the new drugs it is providing include medicines to people in contact with infected cases, which means that Egypt is positioning the drug molnupiravir not only to those infected with SARS-CoV-2 but also potentially household contacts.

COVID-19 in Egypt

With about 105 million people, approximately 297,000 COVID-19 cases have been reported in the country over four waves of infections during the pandemic. Approximately 16,970 deaths associated with SARS-CoV-2 have been reported. Overall, the number of deaths and reported infections declined—the most deadly pandemic wave was the first surge in late May through July 2020.

A Delta variant-driven spike now unfolds as the cases have steadily risen since mid-August 2021.

Current Vaccination Rates

Egypt’s vaccination rate is considerably lower than much of the wealthy nations of Europe or North America, or for that matter, Israel. Presently, only about 4.2% of the population has received both COVID-19 vaccine doses, while about 7.7% have received one dose.

The ministry announced the vaccination of 2.4 million people working in the state’s administrative apparatus, and about one million others will be vaccinated within days, in addition to workers of the Education Ministry.

The ministry said it has provided two million doses to vaccinate university students and workers in the Ministry of Higher Education before October 9. In late August, the prime minister shared with the nation that the government planned to inoculate 40% of the population by the end of 2021. Based on the progress thus far, that target looks nearly out of reach.

The nation has received millions of COVID-19 vaccine doses from several suppliers, including AstraZeneca, Sinopharm, Sinovac, Sputnik, and Johnson & Johnson. Moreover, the country set up a localized production partnership with Sinovac—15 million doses of that Chinese vaccine can be produced locally. And in August, Reuters reported the country was scheduled to receive 5.2 million doses produced by Pfizer-BioNTech and Moderna.

Some of those shipments arrive soon, including 1.6 million doses of the Pfizer vaccine on September 24. More than 1,000 refrigerators will be contracted to store the vaccines as a gift from the United Nations Children’s Fund (UNICEF). Also, during the next week, Egypt will receive more than 3.5 million doses of the AstraZeneca vaccine.

Egypt changes rules for fighting COVID-19 - Egypt Independent

Egypt’s Ministry of Health and Population has started working to provide new drugs that will change coronavirus resistance by reducing the viral load. In a…

www.egyptindependent.com

Quote from THHuxleynew

Interestingly, it is likely there will be (in the UK at least) an increase in cancers presenting for treatment, with severity worse than typical. That is because a whole load of people have been avoiding hospitals and doctors for fear of getting COVID. Slightly worrying symptoms are then not seen by doctors and early-stage cancers not detected.

For sure. Although I doubt this could ever show a 20x increase using yearly figures, as he claims to have seen. Maybe its possible with extreme cherry-picking of data, say comparing a lockdown month to a pent-up non-lockdown month a year later, but again he implies he has not done this.

I guess this type of cynical misrepresentation is why only lifesitenews published the story. They are pretty much the opposite of science journalists. They seem to dwell at the crazier end of catholicism, running a story every couple of weeks that amalgamates vaccines and abortions. Even other catholic media say they are bullshiters.

Study Spots People at High Risk for Severe Breakthrough COVID

https://www.newsmax.com/amp/health/health-news/covid-high-risk-breakthrough-vaccinated/2021/09/20/id/1037153/

A study of millions of people vaccinated against COVID-19 has identified those at greatest risk of hospitalization and death after breakthrough infection.

The most vulnerable are those who are immunosuppressed from chemotherapy, a recent bone marrow or solid organ transplant, or HIV/AIDS. Also at risk are people with neurological disorders (such as dementia and Parkinson's disease), nursing home residents, and those with chronic disorders (including Down syndrome).

For the report, British researchers updated a tool called QCovid, using datasets from general practice, national COVID-19 vaccination and testing, death registry and hospital data in the United Kingdom. In all, a sample of nearly 7 million vaccinated adults was included, of whom more than 5 million had received both vaccines doses.

The report was published Sept. 17 in the journal BMJ.

This enormous national study of over 5 million people vaccinated with two doses across the U.K. has found that a small minority of people remain at risk of COVID-19 hospitalization and death. Our risk calculator helps to identify those who remain most at risk post-vaccination," according to researcher Aziz Sheikh. He is a professor of primary care research and development at the University of Edinburgh.

Within the vaccinated group, there were more than 2,000 COVID-19 deaths and nearly 2,000 COVID-19-related hospital admissions, the investigators found. Eighty-one of the deaths and 71 admissions occurred 14 or more days after the second vaccine dose, when substantial immunity is expected.

The researchers also took into account factors such as age, sex, ethnicity and the rate of COVID-19 infections, they noted in a news release from the University of Oxford.

Relatively few COVID-19-related hospitalizations or deaths occurred among those who received a second dose of the vaccine. This means the study lacked the statistical power to determine if the at-risk groups are more, or less, vulnerable after a second vaccine dose, compared with post-first dose.

According to study co-author Julia Hippisley-Cox, a professor of clinical epidemiology and general practice at the University of Oxford, "Individual risk will always depend on individual choices as well as the current prevalence of the disease, however we hope that this new tool will help shared decision making and more personalized risk assessment."