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Origins of SARS-CoV-2: Why the lab-leak idea is being considered again

Gain-of-function studies make a natural virus more dangerous or transmissible to humans. Could the Wuhan Institute of Virology be the source of SARS-CoV-2?

A security guard leads reporters away from the Wuhan Institute of Virology after a WHO team arrived for a field visit in Wuhan, Hubei province of China, Feb. 3, 2021. The team came to no conclusions about the origins of the pandemic. (AP Photo/Ng Han Guan)

Since the beginning of the COVID-19 pandemic, there are been various hypotheses to explain the origin of SARS-CoV-2.

So far, none of these hypotheses have shown the origins of the virus. One of the first scenarios put forward — that the Wuhan seafood market allowed for a rapid dispersion of the virus — seems less certain now. After a year of intensive research, the virus has still not been identified in any animals.

Animal-human transmission, however, remains one of the strongest hypotheses explaining the appearance of the new coronavirus: the coronavirus was transmitted from bats to humans through an intermediate host. It would not be the first time this happened.

In the case of MERS-CoV (Middle East Respiratory Syndrome), camels likely served as the intermediate host. For SARS-CoV-2, pangolins, scaly anteaters sold illegally in the Wuhan market, may be the host, although this hypothesis requires more convincing evidence.

I am a professor in the department of biological sciences at Université du Québec in Montréal, an expert in virology, particularly in human retroviruses, and in human coronaviruses.

‘Gain-of-function’ research

The idea that SARS-CoV-2 had accidentally leaked from a maximum-security biological laboratory — biosafety level-4 (BSL-4) — at the Wuhan Institute of Virology (WIV) began to circulate soon after the onset of the pandemic.

The possibility resurfaced in recent weeks, placing Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), in an embarrassing situation. Some newspapers assert that the United States was funding this research laboratory and claim that the projects being funded there focused on gain-of-function studies. An opinion piece published in the Wall Street Journal claims that NIAID may have supported some of these experiments that were underway at WIV.

Although there may be benefits to gain-of-function experiments, there are also risks.

So, what are gain-of-function studies? Although the term is sometimes used broadly to refer to “gain-of-function” studies of proteins, in medical terms, it is associated with research on viruses. The goal of gain-of-function research is to create a virus with new properties that make it more pathogenic or more transmissible to humans.

Traditionally, this type of change focused on the growing the virus in animal or human cells. Recently, there have been important advances in animal models and in molecular biology techniques to make precise, targeted changes to viral genes. This process can lead to the rapid generation of new viruses (as opposed to the natural evolution of viruses, which takes several years) that are better adapted to humans, possibly changing their virulence and their ability to be transmitted between humans.

illustration of a coronavirus
Gain-of-function studies allow scientists to change the viral genome to make a natural virus more dangerous to humans. (Shutterstock)

The rationale for this type of research is that by isolating these new viruses, researchers will be able to identify the specific changes in the genome that are responsible for the new characteristics. This knowledge could make it possible for scientists to better predict the arrival of new pandemics. It could help scientists develop vaccines and treatments adapted to new infectious agents.

Research that is too dangerous?

However, the principle underlying gain-of-function research has been widely challenged over the past decade.

A classic and oft-cited example, which concerns many scientists, is Ron Fouchier and Yoshihiro Kawaoka’s research on the highly dangerous avian H5N1 influenza virus. Using a technique that passed the virus from one ferret to another many times over, these researchers were able to create an H5N1 influenza virus that could be transmitted to the species by aerosols.

The study was widely debated and the research was eventually put on hold. The U.S. government even urged scientific journals not to publish its full results, arguing that the information could be used by bioterrorists. The research was resumed in 2013.

Gain-of-function research has the potential to help prevent animal-to-human transmission of a virus with pandemic potential. However, this type of research must be carried out in highly secure laboratory, such as those known as BSL-4.

A view of the BSL-4 laboratory inside the Wuhan Institute of Virology in China's Hubei province
A view of the BSL-4 laboratory inside the Wuhan Institute of Virology after a visit by the WHO team, Feb. 3, 2021. (AP Photo/Ng Han Guan)

These laboratories are built to protect staff and researchers from becoming infected, and to prevent organisms from escaping. However, documents from U.S. Embassy officials have revealed that the biosafety standards at the BSL-4 laboratory at the WIV were not sufficiently rigorous. In addition, a number of researchers have suggested that the institute’s gain-of-function studies on bat coronaviruses were risky and might be harmful to humans if it escaped.

The Wuhan lab-leak hypothesis is revived

So, the hypothesis that SARS-CoV-2 originated in a leak from the Wuhan lab is now being taken seriously.

Although a WHO-formed committee that visited the Wuhan facility concluded that no evidence appeared to support a human-made origin of the SARS-CoV-2 virus, several prominent scientists questioned whether China was being fully transparent during that visit. In an open letter published in May in Science, these scientists called for further investigation.

People dressed in security gear standing outside a building
Security personnel gather near the entrance of the Wuhan Institute of Virology during a visit by the WHO team, Feb. 3, 2021. (AP Photo/Ng Han Guan)

In a May 11 interview, Fauci called for a more thorough investigation into the origins of SARS-CoV-2. On May 26, U.S. President Joe Biden instructed his intelligence agencies to double-down on their investigation into a possible laboratory leak of the virus responsible for the current pandemic.

New evidence has also been put forward by different media outlets: the Wall Street Journal recently revealed that several WIV researchers became sick in the fall of 2019 with symptoms similar to “both COVID-19 and common seasonal illnesses,” and that at least three were hospitalized, adding support to the need to investigate whether the COVID-19 virus escaped from the Wuhan lab.

The WHO, Biden and Fauci, among others, are calling for further investigation of the hypothesis, and the gain-of-function studies on animal coronaviruses at WIV is central to these inquiries.

Although a conclusive evidence on the origins of SARS-CoV-2 may never be obtained, the latest developments raise new concerns about gain-of-function experiments in general, and may lead to a re-evaluation of both the experimental approach and the safety regulations of the laboratories that use it.

Benoit Barbeau does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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Monkeypox cases are rising. Should we be worried?

The World Health Organization has said the current outbreak of monkeypox is the largest ever recorded outside sub-Saharan
The post Monkeypox cases are…

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The World Health Organization has said the current outbreak of monkeypox is the largest ever recorded outside sub-Saharan Africa, with cases rising above the 100-mark a few days ago and the UK top of the table with 56 as of yesterday.

Top of the list of concerns is how the virus – which does not spread easily between humans and requires skin-to-skin contact – is spreading so quickly in so many countries in Europe, the Americas and Australia where the disease is not endemic.

There is speculation that monkeypox may be being spread between sexual partners, even though it is not normally considered a sexually-transmitted infection. Thankfully, there have been no deaths reported so far, although the WHO notes monkeypox has a fatality rate of between 3% and 6%.

While health authorities are on alert, the WHO said it thinks the outbreak can be contained and that the overall risk to the population remains low. It also stressed there is no evidence that a viral mutation is responsible for the unusual pattern of infections.

Monkeypox is considered less likely to mutate quickly because it is a DNA virus rather than an RNA virus like influenza or COVID-19.

Several countries including Belgium and the UK are already advising a three-week quarantine period for anyone who contracts the virus and their close contacts.

The increasing case numbers in the current monkeypox outbreak are certainly concerning,” commented Dr Charlotte Hammer, an expert in emerging infectious diseases based at the University of Cambridge in the UK.

“It is very unusual to see community transmission in Europe – previous monkeypox cases have been in returning travellers with limited ongoing spread. However, based on the number of cases that were already discovered across Europe and the UK in the previous days, it is not unexpected that additional cases are now being and will be found, especially with the contact tracing that is now happening.”

Vaccines and drugs are available

Meanwhile, attention is now being turned to other measures to control the outbreak, including the use of vaccines against smallpox – a related virus – in a ‘ring vaccination’ approach designed to control the spread among contacts.

Vaccines used during the smallpox eradication programme can provide around 85% protection against monkeypox, according to the WHO, which notes that one newer vaccine – Bavarian Nordic’s Jyneos – has been approved by the FDA for prevention against both viruses.

There’s also a licensed antiviral drug for monkeypox. SIGA Technologies’ oral drug Tpoxx (tecovirimat) is approved for smallpox, monkeypox and cowpox in Europe, and in the US and Canada for smallpox, although it can be used off-label for the other disease. The US FDA also approved a new intravenous form of the drug last week.

The WHO says there is no need for widespread vaccination, as other control measures like isolation of patients should be enough to curb the spread and in any case supplies of vaccines are limited.

Monkeypox causes symptoms similar to but milder than smallpox, typically beginning with fever, headache, muscle aches and exhaustion. It is transmitted to people from various wild animals, such as rodents and primates, and is usually a self-limited disease with symptoms lasting from two to four weeks.

In 2003, the US experienced an outbreak of monkeypox, which was the first time human monkeypox was reported outside of Africa. The Centers for Disease Control and Prevention (CDC) is making some Jyneos vaccine reserves available for close contact inoculations, including healthcare workers tending to patients.

The UK Health Security Agency (UKHSA) said yesterday it had identified 36 additional cases of monkeypox in England, and that vaccination of high-risk contacts of cases is already underway.

“A notable proportion of recent cases in the UK and Europe have been found in gay and bisexual men so we are particularly encouraging these men to be alert to the symptoms,” said the agency’s chief medical advisor Dr Susan Hopkins.

“Because the virus spreads through close contact, we are urging everyone to be aware of any unusual rashes or lesions and to contact a sexual health service if they have any symptoms.”

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UK’s Johnson Urges Talks As Unions Threaten “Biggest Rail Strike In Modern History”

UK’s Johnson Urges Talks As Unions Threaten "Biggest Rail Strike In Modern History"

Authored by Alexander Zhang via The Epoch Times,

British…

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UK's Johnson Urges Talks As Unions Threaten "Biggest Rail Strike In Modern History"

Authored by Alexander Zhang via The Epoch Times,

British Prime Minister Boris Johnson has urged rail unions to talk to the government before causing “irreparable damage” with strike action.

The National Union of Rail, Maritime, and Transport Workers (RMT) is holding a ballot of its 40,000 members on plans to strike over jobs, pay, and conditions. The ballot is set to close on Tuesday, and the union has claimed that a yes vote could lead to “the biggest rail strike in modern history.”

Another union, the Transport Salaried Staffs’ Association (TSSA), has also warned of a “summer of discontent” with similar action on the way unless pay disputes are resolved.

The prime minister’s official spokesman said on Monday:

“Railways are going through difficult times with passenger numbers down. We need to make sure they’re fit for the future.”

He said the government wants “a fair deal for staff, for passengers, and taxpayers” so that “money isn’t taken away from other essential services” such as the National Health Service.

“The prime minister is firmly of the view that unions should talk to the government before causing irreparable damage to our railways—strikes should be the last resort not the first,” he added.

Transport Secretary Grant Shapps told The Sunday Telegraph that ministers are looking at drawing up laws which would make industrial action illegal unless a certain number of staff are working.

Shapps said the government hopes the unions will “wake up and smell the coffee” and suggested that strikes could put more people off rail travel.

He also accused unions of going straight to industrial action rather than using it as a last resort, adding that railways were already on “financial life support” because of the CCP (Chinese Communist Party) virus pandemic.

Referring to a pledge in the Conservative Party’s 2019 election manifesto, which promised minimum services during rail strikes, he said:

“We had a pledge in there about minimum service levels. If they really got to that point then minimum service levels would be a way to work towards protecting those freight routes and those sorts of things.”

Unions have reacted to the threat with anger.

RMT General Secretary Mick Lynch said, “Any attempt by Grant Shapps to make effective strike action illegal on the railways will be met with the fiercest resistance from RMT and the wider trade union movement.”

He said the government needs to “focus all their efforts on finding a just settlement” to the rail dispute rather than “attack the democratic rights of working people.”

Tyler Durden Tue, 05/24/2022 - 02:00

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CytoDyn Inc (OTCMKTS: CYDY) On the Comeback Trail (HIV Leronlimab Update)

CytoDyn Inc (OTCMKTS: CYDY) continues to move steadily higher in recent trading since hitting lows of $0.231 after the FDA placed a partial clinical hold…

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CytoDyn Inc (OTCMKTS: CYDY) continues to move steadily higher in recent trading since hitting lows of $0.231 after the FDA placed a partial clinical hold on the Company’s HIV program and a full clinical hold on its COVID-19 program in the United States. CYDY was one of the biggest runners of 2020 skyrocketing from pennies to $10 per share and MIcrocapdaily covered the stock regularly back in those exciting times. Since than CYDY has been downward bound, first suffering from the Citron short attack and more recently the March 30 drop after the FDA hold. Further, CytoDyn elected to pause its Brazil COVID-19 trials pending results from its previously scheduled data safety monitoring committee meeting and is in the process of reevaluating the timing of its HIV BLA resubmission. CYDY saw further declines after the Company’s CEO and registered public accounting firm, Warren Averett LLC, both resigned. 

On May 23 CYDY reached a non-cash settlement with its former Chief Medical Officer, Dr. Richard Pestell. The Company will release to Dr. Pestell 8.3 million shares of CYDY held in escrow, transfer to Dr. Pestell the assets acquired from ProstaGene LLC and subsequently written-off by the Company and issue a warrant at an exercise price of $0.37 per share to Dr. Pestell for seven million shares of the Company’s common stock. Dr. Pestell and the Company are also exploring ways in which Dr. Pestell can reengage with the Company to help realize Leronlimab’s full potential in oncology. This is an important step forward for CytoDyn as any potential suitor would want the current management to clear the deck of lawsuits before initiating a buyout or partnership. Also, an all-stock settlement shows a lot of faith in the Company from Dr. Pestell who make come back. At this point Cytodyn must find a sponsor or partner to get Leronmilab back on track for HIV. 

The underlying science of Leronmilab has not changed; leronlimab has demonstrated significant potential to attack a number of diseases including cancer, and HIV.  Considering how fast CYDY dropped the bounce potential here is significant and when CYDY does make a definitive move northbound the stock could make rapid gains in a very shorty time period. Management remains hopeful the FDA will review the case and stop the hold of Leronlimab. 

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CytoDyn Inc (OTCMKTS: CYDY) is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes. CytoDyn is studying leronlimab in multiple therapeutic areas, including infectious disease, cancer, and autoimmune conditions. 

In January Cytodyn reported positive results from the 350 mg weekly dose of its Phase 2 NASH clinical trial. The trial was conducted in two parts. Part 1 compared a 700 mg weekly dose and placebo in a double-blind randomized manner and Part 2 evaluated a 350 mg weekly dose as an open label study compared to the same placebo blinded arm. Results of the topline report will be announced when available.  

The pre-clinical and clinical development of PRO 140 was led by Progenics Pharmaceuticals, Inc. through 2011. The Company acquired the asset from Progenics in October 2012. In February 2018, CYDY announced it had met the primary endpoint in its Phase 3 trial for leronlimab as a combination therapy with HAART for highly treatment-experienced HIV patients and first submitted the non-clinical portion of the Company’s Biologics License Application (“BLA”) to the FDA in March 2019.  

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CYDY

Cytodyns current business strategy is to resubmit its BLA to the FDA as soon as possible, to finalize with the FDA our submitted protocol for a pivotal Phase 3 clinical trial with leronlimab as a monotherapy for HIV patients, to seek emergency use authorization and approval for leronlimab as a potential therapeutic benefit for COVID-19 patients with mild-to-moderate, severe-to-critical, and long-haulers indications in the U.S., Brazil, and other countries, to advance the Company’s clinical trials with leronlimab for various forms of cancer, including, among others, the Phase 2 clinical trial for metastatic triple-negative breast cancer and Phase 2 basket trial for 22 solid tumor cancers, to complete the Phase 2 trial for liver fibrosis associated with nonalcoholic steatohepatitis (“NASH”), and to explore other cancer and immunologic indications for leronlimab.  

On May 23 CYDY announced it has reached a non-cash settlement with its former Chief Medical Officer, Dr. Richard Pestell, concerning an ongoing legal dispute related to his former employment with the Company. 

Under the terms of the agreement, the parties will release each other of all claims, and the Company will release to Dr. Pestell 8.3 million shares of the Company’s common stock held in escrow, transfer to Dr. Pestell the assets acquired from ProstaGene LLC and subsequently written-off by the Company and issue a warrant at an exercise price of $0.37 per share to Dr. Pestell for seven million shares of the Company’s common stock. Dr. Pestell and the Company are also exploring ways in which Dr. Pestell can reengage with the Company to help realize leronlimab’s full potential in oncology. CytoDyn regrets Dr. Pestell’s departure from the Company and the subsequent public statements made by its former CEO about Dr. Pestell. 

Dr. Pestell has published more than 600 works, is the most frequently cited scientist in the field of cell-cycle control and was appointed an Officer of the Order of Australia in the 2019 Queen’s Birthday Honours for distinguished service to medicine and medical education. He has served on editorial boards of six journals, was the Director of two NCI-designated Cancer Centers and has founded several biotechnology companies. He serves as an advisor and reviewer for a number of domestic and international research centers, including NCI cancer centers. 

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Currently trading at a $226 million market valuation CYDY is an SEC filer and is fully reporting OTCQB. The Company has close to $100 million in assets and about that in debt. At current price levels CYDY is worth a close look; CYDY was one of the biggest runners of 2020 skyrocketing from pennies to $10 per share. While there are plenty of ricks not to mention the CEO and accounting firm resigning CYDY is moving northbound now and looks to be coming back. The underlying science has not changed; Leronlimab has demonstrated significant potential to attack a number of diseases including cancer and HIV.  Considering how fast CYDY dropped the bounce potential here is significant and when CYDY does make a definitive move northbound the stock could make rapid gains in a very shorty time period. Management remains hopeful the FDA will review the case and stop the hold of Leronlimab. We will be updating on CYDY when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with CYDY.

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Disclosure: we hold no position in CYDY either long or short and we have not been compensated for this article.

The post CytoDyn Inc (OTCMKTS: CYDY) On the Comeback Trail (HIV Leronlimab Update) first appeared on Micro Cap Daily.

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