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Lancet Commission Report: 6 Reasons COVID Response “A Massive Global Failure”

Lancet Commission Report: 6 Reasons COVID Response "A Massive Global Failure"

Authored by Dr. Yuhong Dong and Health 1+1 via The Epoch Times,

The…

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Lancet Commission Report: 6 Reasons COVID Response "A Massive Global Failure"

Authored by Dr. Yuhong Dong and Health 1+1 via The Epoch Times,

The Lancet COVID-19 Commission published an article on Sept. 14, 2022 about the lessons learned from the COVID-19 pandemic. As of May 31, 2022, 6.9 million deaths from COVID-19 were reported, but the estimated excess death toll is 17.2 million, based on data from the Institute for Health Metrics and Evaluation (IHME) at the University of Washington. The report states that “this staggering death toll is both a profound tragedy and a massive global failure at multiple levels.”

The Commission identified six major areas of failures, namely failures of prevention, failures of rationality, failures of transparency, failures to follow normal public health practice, failures of operational cooperation, and failures of international solidarity.

Due to these failures, social sustainability goals were set back a few years and 17.2 million lives were lost.

What can we learn from these failures? I’d like to share my thoughts based on the six failure reasons raised by Lancet.

First Lesson Learned: Failure of Prevention

Many countries adopted aggressive methods to stop the spread of the virus, such as social distancing, lockdowns, vaccines, etc. But none of the methods hit the nail in the head, so to speak.

A SARS-CoV-2 human challenge experiment was done among young adults by researchers in the UK. Their paper was published in the March 2022 issue of Nature.

The study involved 36 healthy volunteers aged 18–29 without history of SARS-CoV-2 infection or vaccination. They were inoculated with the SARS-CoV-2 virus intranasally. During the experiment, two were excluded from the Per-Protocol analysis because baseline antibodies were detected. The results of 34 subjects were: 16 participants were infected (confirmed with PCR tests) with mild symptoms, 3 were infected (confirmed with PCR tests) but were asymptomatic, and 15 participants remained uninfected.

The reason why the 15 participants were not infected should be the key to prevention. In my view, this key is to strengthen people’s immune systems.

Humans have an intricate immune system, a comprehensive defense network against external invading substances. The first line of defense is the physical barriers such as skin, nose hair, tears, etc. They can block most pathogens from entering the body.

The second line of defense is the epithelial interferon barrier. When a virus enters an epithelial cell, the cell automatically activates its antiviral mechanism and produces interferon. Interferon is a natural enemy of viruses and sends instructions to coordinate cells to fight the virus and prevent it from replicating.

Even if the virus enters the blood, there are the innate and adaptive immune cells to protect us. These include the macrophages, dendritic cells, and natural killer cells in the blood, all of which play an important role in antiviral immunity.

No matter what type of disease we are facing, it is important to know that the pathogens are external factors, and it is the human body itself that determines whether we fall ill or not. After we identify and correct the problems in our immune system, those external factors won’t matter much.

Therefore, strengthening our innate immune functions is the key to prevent pandemic spread.

Second Lesson Learned: Failure of Rationality

Rationality refers to the ability to make decisions based on facts. In the process of vaccine development, irrationalities included blindly pushing the vaccine among the masses without a complete evaluation of its efficacy and safety.

There are many limitations with the vaccines.

  1. Inability to prevent infection: Neutralizing antibodies are mainly produced in the human bloodstream, but not in the epithelial cells. Therefore, if the first two lines of defense were weakened, the virus could still enter the blood and cause infection. That is why the vaccine and antibody strategy is unable to prevent infection.
  2. Needs to be renewed: Vaccines need to be renewed along with the virus variation, and the current vaccine is designed based on the genetic code of the old strain in 2020.
  3. Needs time to develop: On average, it takes five to 10 years to develop a vaccine. It requires a significant amount of animal trials and human trials to ensure the vaccine’s safety and prove its efficacy. Viruses mutate quickly. The speed of vaccine development can never match that of the viral mutation. If the vaccine is injected frequently for different variants of the virus, it will generate the antibody-dependent enhancement effect (ADE effect), which makes the vaccine ineffective.
  4. Inferior to our natural immunity: Numerous studies have shown that the immunity produced by the human body against viruses after natural infection is much longer lasting and stronger than the antibodies produced by simply stimulating T cells with vaccines.

Additionally, a growing body of basic research has found that the spike protein on the surface of the SARS-CoV-2 virus, which is a component of the vaccine, not only binds to cell surface receptors, but also causes cardiac cell damage, vascular damage, mitochondrial damage, and induces chronic inflammatory states. It is a toxic protein.

Under these circumstances, it is irrational and potentially damaging to use spike protein to stimulate the body.

Moreover, the rocket-like speed of vaccine development and uncertainty of vaccine safety issues has brought stress and tension among people, which can cause excessive release of stress hormones and reduce the human body’s immune resistance to the virus further.

It is good to be proactive, but we should follow the nature of the epidemic, and treat people as fellow humans rather than “living beings.” With a pandemic response, we should first ensure that people eat, drink, and rest well, and are emotionally stable. We shouldn’t over-medicate and over-react.

The Third Lesson Learned: Failure of Transparency

The September 2021 issue of the New England Journal of Medicine published a study of Pfizer’s BNT162b2 mRNA COVID-19 vaccine over six months. There was one case of cardiac arrest in the placebo group, but 4 cases in those who received the vaccine. But this data was not transparently discussed in the main article, but in the supplementary appendix.

Although the numbers are too small to be statistically significant, from a pharmacovigilance perspective, this is an unusual safety signal and due diligence should be further made.

As of Sept. 23, 2022, the VAERS COVID Vaccine Adverse Event Reports database has recorded 1,424,789 cases of adverse events with 31,214 deaths, most of which occurred within one to seven days of vaccination. The unusual short time to death strongly indicates the causal role of vaccines in those death cases.

A Nordic study published in April 2022 showed that the mRNA vaccine was associated with an increased risk of myocarditis, with the highest risk in young men aged 16 to 24. The number of myocarditis episodes increased 4 to 7 cases per 100,000 young men within 28 days of the second Pfizer vaccination and increased 9 to 28 cases per 100,000 young men within 28 days of the second Modena vaccination.

A study published in the July 2022 issue of JAMA Internal Medicine reported that the leading cause of death in the United States during the pandemic period of March 2020 to October 2021 was heart disease.

A report published in April 2022 in Nature found a 25 percent increase in cardiac arrest and acute coronary syndrome among young people aged 16 to 39. This phenomenon is closely related to the mRNA vaccines but not the COVID-19 infection.

Renowned British cardiologist Dr. Aseem Malhotra, who used to support the mRNA vaccine, published two articles in the Journal of Insulin Resistance calling for a halt on mRNA vaccine. What changed his mind?

As a supporter of the mRNA vaccine, Dr. Malhotra volunteered at vaccine centers and was one of the first people to receive two doses of the Pfizer mRNA vaccine. He also advised his patients and those around him to get the shot.

His father, Dr. Kailand Chand, former Vice President of the British Medical Association (BMA) and a general practitioner, suffered a cardiac arrest at home on July 26, 2021, six months after he received two doses of Pfizer mRNA vaccine.

The autopsy revealed that two of his father’s three major coronary arteries were severely obstructed, with the left anterior descending branch 90 percent obstructed and the right coronary artery 75 percent obstructed.

His father led an active lifestyle and was healthier than most men of his age. Even during the pandemic lockdown, he meditated regularly and walked an average of 10,000 to 15,000 steps a day.

Malhotra suspected that his father’s death was related to the vaccination and subsequently discovered the problem with the vaccine. He called for an end to the vaccination, but it was already too late.

The Truth About ‘95% Effectiveness’: 95 out of 100 Protected?

In terms of the vaccine’s effectiveness, news reports around the world claim that the vaccine is “95 percent effective.” Most doctors explain to the public that “if 100 people are vaccinated, then 95 will be protected from infection.”

But that is not the case at all.

According to the paper published on Dec. 10, 2020 in the New England Journal of Medicine studied the safety and efficacy of Pfizer’s BNT162b2 mRNA Covid-19 vaccine. Of the 18,325 unvaccinated people, there were 162 symptomatic infections. The infection rate was 0.88 percent. Among the 18,198 vaccinated people, there were 8 infections. The infection rate was 0.04 percent. Then it concluded that “the vaccine was 95% effective in preventing Covid-19.”

However, most people overlooked the fact that 99.12 percent of the population was not infected despite being unvaccinated.

For the total population, the vaccine actually protects only 0.84 percent of the population, which is the real absolute protection rate.

So the real “absolute protection” is out of 10000 people vaccinated, only 84 people (0.84%) will be protected, but not the 95 out of 100 people will be protected, which is a relative protection.

Had we known the facts of absolute protection, would we have worried about creating a vaccine so much? We would not have such high hopes that a vaccine would resolve the pandemic. The vaccine mandate would not be so solid at the beginning.

Instead, we would be more rational to seek natural ways to boost immunities so as to prevent the virus in a more feasible and easy way.

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Tyler Durden Thu, 10/13/2022 - 09:55

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Four burning questions about the future of the $16.5B Novo-Catalent deal

To build or to buy? That’s a classic question for pharma boardrooms, and Novo Nordisk is going with both.
Beyond spending billions of dollars to expand…

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To build or to buy? That’s a classic question for pharma boardrooms, and Novo Nordisk is going with both.

Beyond spending billions of dollars to expand its own production capacity for its weight loss drugs, the Danish drugmaker said Monday it will pay $11 billion to acquire three manufacturing plants from Catalent. It’s part of a broader $16.5 billion deal with Novo Holdings, the investment arm of the pharma’s parent group, which agreed to acquire the contract manufacturer and take it private.

It’s a big deal for all parties, with potential ripple effects across the biotech ecosystem. Here’s a look at some of the most pressing questions to watch after Monday’s announcement.

Why did Novo do this?

Novo Holdings isn’t the most obvious buyer for Catalent, particularly after last year’s on-and-off M&A interest from the serial acquirer Danaher. But the deal could benefit both Novo Holdings and Novo Nordisk.

Novo Nordisk’s biggest challenge has been simply making enough of the weight loss drug Wegovy and diabetes therapy Ozempic. On last week’s earnings call, Novo Nordisk CEO Lars Fruergaard Jørgensen said the company isn’t constrained by capital in its efforts to boost manufacturing. Rather, the main challenge is the limited amount of capabilities out there, he said.

“Most pharmaceutical companies in the world would be shopping among the same manufacturers,” he said. “There’s not an unlimited amount of machinery and people to build it.”

While Novo was already one of Catalent’s major customers, the manufacturer has been hamstrung by its own balance sheet. With roughly $5 billion in debt on its books, it’s had to juggle paying down debt with sufficiently investing in its facilities. That’s been particularly challenging in keeping pace with soaring demand for GLP-1 drugs.

Novo, on the other hand, has the balance sheet to funnel as much money as needed into the plants in Italy, Belgium, and Indiana. It’s also struggled to make enough of its popular GLP-1 drugs to meet their soaring demand, with documented shortages of both Ozempic and Wegovy.

The impact won’t be immediate. The parties expect the deal to close near the end of 2024. Novo Nordisk said it expects the three new sites to “gradually increase Novo Nordisk’s filling capacity from 2026 and onwards.”

As for the rest of Catalent — nearly 50 other sites employing thousands of workers — Novo Holdings will take control. The group previously acquired Altasciences in 2021 and Ritedose in 2022, so the Catalent deal builds on a core investing interest in biopharma services, Novo Holdings CEO Kasim Kutay told Endpoints News.

Kasim Kutay

When asked about possible site closures or layoffs, Kutay said the team hasn’t thought about that.

“That’s not our track record. Our track record is to invest in quality businesses and help them grow,” he said. “There’s always stuff to do with any asset you own, but we haven’t bought this company to do some of the stuff you’re talking about.”

What does it mean for Catalent’s customers? 

Until the deal closes, Catalent will operate as a standalone business. After it closes, Novo Nordisk said it will honor its customer obligations at the three sites, a spokesperson said. But they didn’t answer a question about what happens when those contracts expire.

The wrinkle is the long-term future of the three plants that Novo Nordisk is paying for. Those sites don’t exclusively pump out Wegovy, but that could be the logical long-term aim for the Danish drugmaker.

The ideal scenario is that pricing and timelines remain the same for customers, said Nicole Paulk, CEO of the gene therapy startup Siren Biotechnology.

Nicole Paulk

“The name of the group that you’re going to send your check to is now going to be Novo Holdings instead of Catalent, but otherwise everything remains the same,” Paulk told Endpoints. “That’s the best-case scenario.”

In a worst case, Paulk said she feared the new owners could wind up closing sites or laying off Catalent groups. That could create some uncertainty for customers looking for a long-term manufacturing partner.

Are shareholders and regulators happy? 

The pandemic was a wild ride for Catalent’s stock, with shares surging from about $40 to $140 and then crashing back to earth. The $63.50 share price for the takeover is a happy ending depending on the investor.

On that point, the investing giant Elliott Investment Management is satisfied. Marc Steinberg, a partner at Elliott, called the agreement “an outstanding outcome” that “clearly maximizes value for Catalent stockholders” in a statement.

Elliott helped kick off a strategic review last August that culminated in the sale agreement. Compared to Catalent’s stock price before that review started, the deal pays a nearly 40% premium.

Alessandro Maselli

But this is hardly a victory lap for CEO Alessandro Maselli, who took over in July 2022 when Catalent’s stock price was north of $100. Novo’s takeover is a tacit acknowledgment that Maselli could never fully right the ship, as operational problems plagued the company throughout 2023 while it was limited by its debt.

Additional regulatory filings in the next few weeks could give insight into just how competitive the sale process was. William Blair analysts said they don’t expect a competing bidder “given the organic investments already being pursued at other leading CDMOs and the breadth and scale of Catalent’s operations.”

The Blair analysts also noted the companies likely “expect to spend some time educating relevant government agencies” about the deal, given the lengthy closing timeline. Given Novo Nordisk’s ascent — it’s now one of Europe’s most valuable companies — paired with the limited number of large contract manufacturers, antitrust regulators could be interested in taking a close look.

Are Catalent’s problems finally a thing of the past?

Catalent ran into a mix of financial and operational problems over the past year that played no small part in attracting the interest of an activist like Elliott.

Now with a deal in place, how quickly can Novo rectify those problems? Some of the challenges were driven by the demands of being a publicly traded company, like failing to meet investors’ revenue expectations or even filing earnings reports on time.

But Catalent also struggled with its business at times, with a range of manufacturing delays, inspection reports and occasionally writing down acquisitions that didn’t pan out. Novo’s deep pockets will go a long way to a turnaround, but only the future will tell if all these issues are fixed.

Kutay said his team is excited by the opportunity and was satisfied with the due diligence it did on the company.

“We believe we’re buying a strong company with a good management team and good prospects,” Kutay said. “If that wasn’t the case, I don’t think we’d be here.”

Amber Tong and Reynald Castañeda contributed reporting.

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Petrina Kamya, Ph.D., Head of AI Platforms at Insilico Medicine, presents at BIO CEO & Investor Conference

Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb….

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Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb. 26-27 at the New York Marriott Marquis in New York City. Dr. Kamya will speak as part of the panel “AI within Biopharma: Separating Value from Hype,” on Feb. 27, 1pm ET along with Michael Nally, CEO of Generate: Biomedicines and Liz Schwarzbach, PhD, CBO of BigHat Biosciences.

Credit: Insilico Medicine

Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb. 26-27 at the New York Marriott Marquis in New York City. Dr. Kamya will speak as part of the panel “AI within Biopharma: Separating Value from Hype,” on Feb. 27, 1pm ET along with Michael Nally, CEO of Generate: Biomedicines and Liz Schwarzbach, PhD, CBO of BigHat Biosciences.

The session will look at how the latest artificial intelligence (AI) tools – including generative AI and large language models – are currently being used to advance the discovery and design of new drugs, and which technologies are still in development. 

The BIO CEO & Investor Conference brings together over 1,000 attendees and more than 700 companies across industry and institutional investment to discuss the future investment landscape of biotechnology. Sessions focus on topics such as therapeutic advancements, market outlook, and policy priorities.

Insilico Medicine is a leading, clinical stage AI-driven drug discovery company that has raised over $400m in investments since it was founded in 2014. Dr. Kamya leads the development of the Company’s end-to-end generative AI platform, Pharma.AI from Insilico’s AI R&D Center in Montreal. Using modern machine learning techniques in the context of chemistry and biology, the platform has driven the discovery and design of 30+ new therapies, with five in clinical stages – for cancer, fibrosis, inflammatory bowel disease (IBD), and COVID-19. The Company’s lead drug, for the chronic, rare lung condition idiopathic pulmonary fibrosis, is the first AI-designed drug for an AI-discovered target to reach Phase II clinical trials with patients. Nine of the top 20 pharmaceutical companies have used Insilico’s AI platform to advance their programs, and the Company has a number of major strategic licensing deals around its AI-designed therapeutic assets, including with Sanofi, Exelixis and Menarini. 

 

About Insilico Medicine

Insilico Medicine, a global clinical stage biotechnology company powered by generative AI, is connecting biology, chemistry, and clinical trials analysis using next-generation AI systems. The company has developed AI platforms that utilize deep generative models, reinforcement learning, transformers, and other modern machine learning techniques for novel target discovery and the generation of novel molecular structures with desired properties. Insilico Medicine is developing breakthrough solutions to discover and develop innovative drugs for cancer, fibrosis, immunity, central nervous system diseases, infectious diseases, autoimmune diseases, and aging-related diseases. www.insilico.com 


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Another country is getting ready to launch a visa for digital nomads

Early reports are saying Japan will soon have a digital nomad visa for high-earning foreigners.

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Over the last decade, the explosion of remote work that came as a result of improved technology and the pandemic has allowed an increasing number of people to become digital nomads. 

When looked at more broadly as anyone not required to come into a fixed office but instead moves between different locations such as the home and the coffee shop, the latest estimate shows that there were more than 35 million such workers in the world by the end of 2023 while over half of those come from the United States.

Related: There is a new list of cities that are best for digital nomads

While remote work has also allowed many to move to cheaper places and travel around the world while still bringing in income, working outside of one's home country requires either dual citizenship or work authorization — the global shift toward remote work has pushed many countries to launch specific digital nomad visas to boost their economies and bring in new residents.

Japan is a very popular destination for U.S. tourists. 

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This popular vacation destination will soon have a nomad visa

Spain, Portugal, Indonesia, Malaysia, Costa Rica, Brazil, Latvia and Malta are some of the countries currently offering specific visas for foreigners who want to live there while bringing in income from abroad.

More Travel:

With the exception of a few, Asian countries generally have stricter immigration laws and were much slower to launch these types of visas that some of the countries with weaker economies had as far back as 2015. As first reported by the Japan Times, the country's Immigration Services Agency ended up making the leap toward a visa for those who can earn more than ¥10 million ($68,300 USD) with income from another country.

The Japanese government has not yet worked out the specifics of how long the visa will be valid for or how much it will cost — public comment on the proposal is being accepted throughout next week. 

That said, early reports say the visa will be shorter than the typical digital nomad option that allows foreigners to live in a country for several years. The visa will reportedly be valid for six months or slightly longer but still no more than a year — along with the ability to work, this allows some to stay beyond the 90-day tourist period typically afforded to those from countries with visa-free agreements.

'Not be given a residence card of residence certificate'

While one will be able to reapply for the visa after the time runs out, this can only be done by exiting the country and being away for six months before coming back again — becoming a permanent resident on the pathway to citizenship is an entirely different process with much more strict requirements.

"Those living in Japan with the digital nomad visa will not be given a residence card or a residence certificate, which provide access to certain government benefits," reports the news outlet. "The visa cannot be renewed and must be reapplied for, with this only possible six months after leaving the countr

The visa will reportedly start in March and also allow holders to bring their spouses and families with them. To start using the visa, holders will also need to purchase private health insurance from their home country while taxes on any money one earns will also need to be paid through one's home country.

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