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Gain-Of-Function Experiments At Boston University Create A Deadly New Covid-19 Virus. Who Thought This Was A Good Idea? – Forbes

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After all the controversy over the past few years about gain-of-function research on viruses, especially the Covid-19 virus, I thought this kind of work was on hold, at least in the U.S. Indeed, the controversy grew so hot that NIH issued a statement in May of 2021 declaring that it wouldn’t support such work.

Nonetheless, some scientists continue to pursue gain-of-function work. In a new study, just released on the preprint server bioRxiv, a group of virologists at Boston University did the following. They took the Spike protein from the Omicron BA.1 strain of SARS-CoV-2 (that’s the strain that spread throughout the world last winter, often slipping past the protection offered by vaccines) and combined it with an early 2020 strain of the Covid-19 virus.

This experiment gave them a brand-new, never-before-seen strain of Covid-19. Was it more deadly? You bet!

In their experiments, the BU scientists infected laboratory mice with the original Omicron virus, which caused “mild, non-fatal infection.” But when they infected mice with their new, recombinant virus, which they called Omi-S, 80% of the mice died. To quote from their article:


“the Omicron S-carrying virus inflicts severe disease with a mortality rate of 80%.”


Well, that’s just great. Making matters worse, the researchers found that the new recombinant virus also replicated much faster in mice: “Omi-S-infected mice produced 30-fold more infectious virus particles compared with Omicron-infected mice.” Yes, you read that right: Omi-S might grow 30 times faster than the garden-variety Omicron strain.

This, dear readers, is what we mean by “gain of function” research. The scientists took sequences from two different strains of the Covid-19 virus, one of which was relatively mild, and created a new strain that is far more infectious and far more deadly. As many scientists (and others) have pointed out, research like this carries great risks, foremost among them the chance that an accidental lab leak could create a new pandemic, killing millions of people.

And the benefits? There must some pretty major benefits to offset this risk, right? Well, not exactly. The researchers say that these experiments show that the pathogenicity of the Covid virus is determined primarily by something other than the Spike protein. That’s a pretty narrow finding, and the authors don’t seem to consider that they might have learned this without creating an entirely new, more-lethal virus.

Does this work violate NIH policies? The NIH director has stated that “neither NIH nor NIAID have ever approved any grant that would have supported ‘gain-of-function’ research on coronaviruses that would have increased their transmissibility or lethality for humans.” First, let me point out that this is a very narrow statement: the NIH doesn’t deny that it funds gain-of-function work on viruses, because it does. They even put a “pause” on such work for 3 years, but they lifted it (regrettably) in 2017. I wrote about that at the time (“NIH Re-opens the Door to Creation of Super-Viruses,” December 2017).

Second, the NIH policy carefully says they don’t support work that would make viruses more deadly for humans. The BU study only looked at mice, so one might argue that it wasn’t making the viruses more deadly in humans–but there’s simply no way we can tell that, not unless we intentionally infect someone. Having read the paper, this work seems to me to be a clear violation of NIH rules.

Boston University and the researchers who led the study disagree. In a statement issued last week, BU officials wrote: “First, this research is not gain-of-function research, meaning it did not amplify the Washington state SARS-CoV-2 virus strain or make it more dangerous.”

Let’s take a look at this denial, shall we? First, let me reiterate that the new experiments combined 2 strains of the Covid-19 virus: the Omicron strain, which has been the main strain infecting humans since last winter, and an earlier strain that was collected from a patient in Washington state in 2020. The Omicron strain causes only mild infections in mice, but the new Omi-S strain–the one that Boston University scientists created in their lab–kills 80% of them. The Washington state strain, which is no longer circulating in people and thus isn’t a current threat, kills 100% of mice.

So that is the BU argument: because Omi-S is less deadly than one of its parental strains, the research doesn’t meet the definition of gain-of-function.

Sorry, but this argument is just nonsense. You don’t get to redefine gain-of-function in the same sentence where you’re denying you’ve done it. These experiments created a brand-new, recombinant strain of Covid-19, and that strain was much more infectious and much more deadly than Omicron, which is one of the strains it was created from. This is precisely what most scientists mean when they describe gain-of-function research and the risks that it carries.

Furthermore, we have no idea how this virus will behave in humans. It might be far more deadly than Omicron in people. Let’s hope we never find out.

And what about that 80% mortality rate? According to Prof. Ronald Corley, Director of BU’s National Emerging Infectious Diseases Laboratories (NEIDL), “This was a statement taken out of context for the purposes of sensationalism, and it totally misrepresents not only the findings, but [also] the purpose of the study.”

Out of context? Well, here’s what the scientists themselves wrote in the very first paragraph (the abstract) of their paper: “We generated chimeric recombinant SARS-CoV-2 encoding the S gene of Omicron in the backbone of an ancestral SARS-CoV-2 isolate and compared this virus with the naturally circulating Omicron variant…. In K18-hACE2 mice, while Omicron causes mild, non-fatal infection, the Omicron S-carrying virus inflicts severe disease with a mortality rate of 80%.”

That’s the scientists’ own statement, and it’s not out of context. The authors themselves were emphasizing this dramatic mortality rate.

The experiments also present another problem for BU. Despite being funded by multiple NIH grants, neither the scientists themselves nor Boston University appears to have informed NIH about this work, which is a requirement for gain-of-function research.

BU officials addressed this problem by stating, first, that the NIH funds only supported some of the underlying “tools and platforms,” and that NIH funds did not directly support the research. Really, BU? How stupid do you think we are? Money, as we all know, is fungible.

Second, according to BU, “there was no gain of function with this research. If at any point there was evidence that the research was gaining function, under both NIAID and our own protocols we would immediately stop and report.” (Read the full BU statement here.)

Well, I would say that when those mice started dying, you had some pretty good evidence that “the research was gaining function.”

I’ve been in touch with multiple virologists who take a similar view. Simon Wain-Hobson, an Emeritus Professor at the Pasteur Institute, wrote to tell me that the BU research “is a GOF outcome in that the recovered virus is more pathogenic than the parental (backbone) virus, albeit in a transgenic mouse setting.” Prof. Wain-Hobson also pointed out that this work “provides a road map to [creating] a virus that might be dangerous to man. By posting this, these authors are making life easier for the next person or copycat.”

Another virologist, Dr. Valentin Bruttel of the University of Würzburg, pointed out the same problems and more, writing that:

  • [the experiments] could have produced a virus that is “way more lethal” than the original SARS-CoV-2 strain
  • “the study is useless for the general population, because the chance that exactly this Omi-Spike [would] recombine with an extinct variant [the Washington state strain] are zero,”
  • “the chimeric virus could cause more severe disease in humans than estimated from mouse data.”

Like Prof. Wain-Hobson, Dr. Bruttel also pointed out that “any terrorist group could copy the BU group’s protocols.”

What does NIH think? They don’t appear convinced by the BU denials. According to an article in The Hill, “NIH is examining the matter to determine whether the research” fits the definition of gain-of-function. And as reported by Helen Branswell in Stat last week, an NIAID official said that NIH should have been informed, at a minimum so that they could determine whether or not the research was permitted under NIH’s gain-of-function rules.

I contacted the lead author of the study to get his response, but he did not reply.

The bottom line here is that some virologists (by no means a majority) believe that conducting gain-of-function research on the Covid-19 virus is just fine. Many other scientists disagree, and strongly. Some have pointed out that this work is qualitatively no different from biowarfare research. I’ve been warning about the risks for years, and I’m certainly not the only one.

Merely requiring scientists to inform the government, which is the current NIH policy, is not enough. We need to shut this research down and take a long, hard look at it before any such experiments can go forward again.

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Health Canada approves updated Moderna COVID-19 vaccine

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TORONTO – Health Canada has authorized Moderna’s updated COVID-19 vaccine that protects against currently circulating variants of the virus.

The mRNA vaccine, called Spikevax, has been reformulated to target the KP.2 subvariant of Omicron.

It will replace the previous version of the vaccine that was released a year ago, which targeted the XBB.1.5 subvariant of Omicron.

Health Canada recently asked provinces and territories to get rid of their older COVID-19 vaccines to ensure the most current vaccine will be used during this fall’s respiratory virus season.

Health Canada is also reviewing two other updated COVID-19 vaccines but has not yet authorized them.

They are Pfizer’s Comirnaty, which is also an mRNA vaccine, as well as Novavax’s protein-based vaccine.

This report by The Canadian Press was first published Sept. 17, 2024.

Canadian Press health coverage receives support through a partnership with the Canadian Medical Association. CP is solely responsible for this content.

The Canadian Press. All rights reserved.

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These people say they got listeria after drinking recalled plant-based milks

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TORONTO – Sanniah Jabeen holds a sonogram of the unborn baby she lost after contracting listeria last December. Beneath, it says “love at first sight.”

Jabeen says she believes she and her baby were poisoned by a listeria outbreak linked to some plant-based milks and wants answers. An investigation continues into the recall declared July 8 of several Silk and Great Value plant-based beverages.

“I don’t even have the words. I’m still processing that,” Jabeen says of her loss. She was 18 weeks pregnant when she went into preterm labour.

The first infection linked to the recall was traced back to August 2023. One year later on Aug. 12, 2024, the Public Health Agency of Canada said three people had died and 20 were infected.

The number of cases is likely much higher, says Lawrence Goodridge, Canada Research Chair in foodborne pathogen dynamics at the University of Guelph: “For every person known, generally speaking, there’s typically 20 to 25 or maybe 30 people that are unknown.”

The case count has remained unchanged over the last month, but the Public Health Agency of Canada says it won’t declare the outbreak over until early October because of listeria’s 70-day incubation period and the reporting delays that accompany it.

Danone Canada’s head of communications said in an email Wednesday that the company is still investigating the “root cause” of the outbreak, which has been linked to a production line at a Pickering, Ont., packaging facility.

Pregnant people, adults over 60, and those with weakened immune systems are most at risk of becoming sick with severe listeriosis. If the infection spreads to an unborn baby, Health Canada says it can cause miscarriage, stillbirth, premature birth or life-threatening illness in a newborn.

The Canadian Press spoke to 10 people, from the parents of a toddler to an 89-year-old senior, who say they became sick with listeria after drinking from cartons of plant-based milk stamped with the recalled product code. Here’s a look at some of their experiences.

Sanniah Jabeen, 32, Toronto

Jabeen says she regularly drank Silk oat and almond milk in smoothies while pregnant, and began vomiting seven times a day and shivering at night in December 2023. She had “the worst headache of (her) life” when she went to the emergency room on Dec. 15.

“I just wasn’t functioning like a normal human being,” Jabeen says.

Told she was dehydrated, Jabeen was given fluids and a blood test and sent home. Four days later, she returned to hospital.

“They told me that since you’re 18 weeks, there’s nothing you can do to save your baby,” says Jabeen, who moved to Toronto from Pakistan five years ago.

Jabeen later learned she had listeriosis and an autopsy revealed her baby was infected, too.

“It broke my heart to read that report because I was just imagining my baby drinking poisoned amniotic fluid inside of me. The womb is a place where your baby is supposed to be the safest,” Jabeen said.

Jabeen’s case is likely not included in PHAC’s count. Jabeen says she was called by Health Canada and asked what dairy and fresh produce she ate – foods more commonly associated with listeria – but not asked about plant-based beverages.

She’s pregnant again, and is due in several months. At first, she was scared to eat, not knowing what caused the infection during her last pregnancy.

“Ever since I learned about the almond, oat milk situation, I’ve been feeling a bit better knowing that it wasn’t something that I did. It was something else that caused it. It wasn’t my fault,” Jabeen said.

She’s since joined a proposed class action lawsuit launched by LPC Avocates against the manufacturers and sellers of Silk and Great Value plant-based beverages. The lawsuit has not yet been certified by a judge.

Natalie Grant and her seven year-old daughter, Bowmanville, Ont.

Natalie Grant says she was in a hospital waiting room when she saw a television news report about the recall. She wondered if the dark chocolate almond milk her daughter drank daily was contaminated.

She had brought the girl to hospital because she was vomiting every half hour, constantly on the toilet with diarrhea, and had severe pain in her abdomen.

“I’m definitely thinking that this is a pretty solid chance that she’s got listeria at this point because I knew she had all the symptoms,” Grant says of seeing the news report.

Once her daughter could hold fluids, they went home and Grant cross-checked the recalled product code – 7825 – with the one on her carton. They matched.

“I called the emerg and I said I’m pretty confident she’s been exposed,” Grant said. She was told to return to the hospital if her daughter’s symptoms worsened. An hour and a half later, her fever spiked, the vomiting returned, her face flushed and her energy plummeted.

Grant says they were sent to a hospital in Ajax, Ont. and stayed two weeks while her daughter received antibiotics four times a day until she was discharged July 23.

“Knowing that my little one was just so affected and how it affected us as a family alone, there’s a bitterness left behind,” Grant said. She’s also joined the proposed class action.

Thelma Feldman, 89, Toronto

Thelma Feldman says she regularly taught yoga to friends in her condo building before getting sickened by listeria on July 2. Now, she has a walker and her body aches. She has headaches and digestive problems.

“I’m kind of depressed,” she says.

“It’s caused me a lot of physical and emotional pain.”

Much of the early days of her illness are a blur. She knows she boarded an ambulance with profuse diarrhea on July 2 and spent five days at North York General Hospital. Afterwards, she remembers Health Canada officials entering her apartment and removing Silk almond milk from her fridge, and volunteers from a community organization giving her sponge baths.

“At my age, 89, I’m not a kid anymore and healing takes longer,” Feldman says.

“I don’t even feel like being with people. I just sit at home.”

Jasmine Jiles and three-year-old Max, Kahnawake Mohawk Territory, Que.

Jasmine Jiles says her three-year-old son Max came down with flu-like symptoms and cradled his ears in what she interpreted as a sign of pain, like the one pounding in her own head, around early July.

When Jiles heard about the recall soon after, she called Danone Canada, the plant-based milk manufacturer, to find out if their Silk coconut milk was in the contaminated batch. It was, she says.

“My son is very small, he’s very young, so I asked what we do in terms of overall monitoring and she said someone from the company would get in touch within 24 to 48 hours,” Jiles says from a First Nations reserve near Montreal.

“I never got a call back. I never got an email”

At home, her son’s fever broke after three days, but gas pains stuck with him, she says. It took a couple weeks for him to get back to normal.

“In hindsight, I should have taken him (to the hospital) but we just tried to see if we could nurse him at home because wait times are pretty extreme,” Jiles says, “and I don’t have child care at the moment.”

Joseph Desmond, 50, Sydney, N.S.

Joseph Desmond says he suffered a seizure and fell off his sofa on July 9. He went to the emergency room, where they ran an electroencephalogram (EEG) test, and then returned home. Within hours, he had a second seizure and went back to hospital.

His third seizure happened the next morning while walking to the nurse’s station.

In severe cases of listeriosis, bacteria can spread to the central nervous system and cause seizures, according to Health Canada.

“The last two months have really been a nightmare,” says Desmond, who has joined the proposed lawsuit.

When he returned home from the hospital, his daughter took a carton of Silk dark chocolate almond milk out of the fridge and asked if he had heard about the recall. By that point, Desmond says he was on his second two-litre carton after finishing the first in June.

“It was pretty scary. Terrifying. I honestly thought I was going to die.”

Cheryl McCombe, 63, Haliburton, Ont.

The morning after suffering a second episode of vomiting, feverish sweats and diarrhea in the middle of the night in early July, Cheryl McCombe scrolled through the news on her phone and came across the recall.

A few years earlier, McCombe says she started drinking plant-based milks because it seemed like a healthier choice to splash in her morning coffee. On June 30, she bought two cartons of Silk cashew almond milk.

“It was on the (recall) list. I thought, ‘Oh my God, I got listeria,’” McCombe says. She called her doctor’s office and visited an urgent care clinic hoping to get tested and confirm her suspicion, but she says, “I was basically shut down at the door.”

Public Health Ontario does not recommend listeria testing for infected individuals with mild symptoms unless they are at risk of developing severe illness, such as people who are immunocompromised, elderly, pregnant or newborn.

“No wonder they couldn’t connect the dots,” she adds, referencing that it took close to a year for public health officials to find the source of the outbreak.

“I am a woman in my 60s and sometimes these signs are of, you know, when you’re vomiting and things like that, it can be a sign in women of a bigger issue,” McCombe says. She was seeking confirmation that wasn’t the case.

Disappointed, with her stomach still feeling off, she says she decided to boost her gut health with probiotics. After a couple weeks she started to feel like herself.

But since then, McCombe says, “I’m back on Kawartha Dairy cream in my coffee.”

This report by The Canadian Press was first published Sept. 16, 2024.

Canadian Press health coverage receives support through a partnership with the Canadian Medical Association. CP is solely responsible for this content.

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B.C. mayors seek ‘immediate action’ from federal government on mental health crisis

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VANCOUVER – Mayors and other leaders from several British Columbia communities say the provincial and federal governments need to take “immediate action” to tackle mental health and public safety issues that have reached crisis levels.

Vancouver Mayor Ken Sim says it’s become “abundantly clear” that mental health and addiction issues and public safety have caused crises that are “gripping” Vancouver, and he and other politicians, First Nations leaders and law enforcement officials are pleading for federal and provincial help.

In a letter to Prime Minister Justin Trudeau and Premier David Eby, mayors say there are “three critical fronts” that require action including “mandatory care” for people with severe mental health and addiction issues.

The letter says senior governments also need to bring in “meaningful bail reform” for repeat offenders, and the federal government must improve policing at Metro Vancouver ports to stop illicit drugs from coming in and stolen vehicles from being exported.

Sim says the “current system” has failed British Columbians, and the number of people dealing with severe mental health and addiction issues due to lack of proper care has “reached a critical point.”

Vancouver Police Chief Adam Palmer says repeat violent offenders are too often released on bail due to a “revolving door of justice,” and a new approach is needed to deal with mentally ill people who “pose a serious and immediate danger to themselves and others.”

This report by The Canadian Press was first published Sept. 16, 2024

The Canadian Press. All rights reserved.

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