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Made-in-Canada COVID-19 vaccine effort slowed by manufacturing delay – CBC.ca

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In early February, a tiny tube of yellow-tinged liquid was packed into a sealed container designed to withstand an airplane crash. 

The sample was from the first Canadian case of COVID-19, and destined for the University of Saskatchewan campus in Saskatoon, where research scientists were mobilizing their efforts to develop a vaccine. 

At the time, the Vaccine and Infectious Disease Organization-International Vaccine Centre (VIDO-InterVac) was one of only a handful of labs around the world working on a potential COVID-19 vaccine. 

The team, which is now one of more than 160 research groups around the world working on a vaccine, set an incredibly tight timeline considering vaccines usually take around a decade to get approval.

VIDO-InterVac’s plan, if trials were successful, was to have a vaccine ready to manufacture for targeted groups — such as front-line workers — by March 2021. 

But now, despite long workdays and promising early results, the team says a lack of manufacturing capacity is slowing down their efforts at a made-in-Canada vaccine — something that matters given concerns over “vaccine nationalism,” which could prevent access to a product that’s not made at home.

Dr. Volker Gerdts says his team could have been much farther along in the vaccine approvals process if it had been funded to finish build a manufacturing facility at the University of Saskatchewan before the pandemic. (VIDO-InterVac/University of Saskatchewan)

 A typical day for director Volker Gerdts could begin with a meeting with the World Health Organization as early as 6:30 a.m. CST and end as late as 10 p.m. with a call to China.

“We all sense the urgency and the importance of our work and so it’s hard to explain to yourself taking time off when people are literally dying in the hospital,” said Gerdts in June. 

“We have a really good team … however burnout is a real thing.”

Early test results were good. Ferrets given the vaccine candidate showed a strong immune response to COVID-19, generating antibodies and having a decreased viral infection. 

Regardless of the encouraging signs, the researchers were always at the mercy of external factors like global politics and manufacturing capacity. Now, Gerdts says the timeline of a VIDO-InterVac vaccine being ready to manufacture, if it’s successful, has been delayed by both.

Before it can proceed to human clinical trials, the facility needs to complete more studies using higher-grade materials than what they needed for their early animal studies. But waiting for busy manufacturers to provide them is holding up the process.  

Had the federal government invested more in a proposed manufacturing facility at VIDO- InterVac before the pandemic, Gerdts said, a Canadian vaccine would be at the front of the race.

“We’ve been telling the government, and I don’t want to use this as a blaming, but we have raised the issue of Canada’s unpreparedness for pandemic diseases for quite a while,” Gerdts said. “You need to have manufacturing capacity. You need to have the ability to quickly respond.”

CBC News asked the federal government  why it didn’t invest more in manufacturing at VIDO-InterVac before 2020, and whether it feels it did enough to prepare for a potential pandemic before COVID-19. 

“The health and safety of Canadians is the Government of Canada’s top priority,” said part of a statement from Innovation, Science and Economic Development Canada in response.

“That’s why the government is mobilizing Canada’s world-class researchers to deliver rapid responses to fight COVID-19.”

Inside the lab

Darryl Falzarano’s work day begins with a series of biosecurity protocols including changing his clothes twice, showering and going through a secure corridor.

He works in the Level 3 high containment lab with SARS-CoV-2 — the virus that causes COVID-19 — and other viruses. His uniform includes a face shield and a head covering that pumps clean air around his face.  He puts duct-tape around his wrists where his gloves meet the sleeves of his suit. 

Research scientist Darryl Falzarano sits in front a biosafety cabinet at the Level 3 containment lab in Saskatoon. The cabinet blows a protective wall of air between him and the virus, which is inside the cabinet. (Matthew Garand/CBC)

Falzarano said people ask him if he is scared about working in containment labs.

“For myself, that’s not the case,” he said.

“Of course you’re working with a pathogen that can infect you and in some cases cause a … high fatality rate, but being fearful, that’s not the right attitude to have.”

Falzarano, who is also working on a vaccine for the MERS coronavirus in camels, needs to prepare samples of SARS-CoV-2 for what the researchers called “challenge” studies. 

The study involves giving ferrets or hamsters two doses of the vaccine over a period of two months. After that, the animals are infected with the virus. The scientists then monitor the infected animals to see how well they are protected by the vaccine. 

The VIDO-InterVac vaccine is made with the spike protein on the outside of SARS-CoV-2. If successful, it would work by using that protein to trick the immune system into thinking it has COVID-19 so it will generate the antibodies and T-cells that fight the virus. 

To make it, the researchers grow the spike protein in human cells then combine it with an ingredient called an “adjuvant,” which kicks the immune system into even higher gear. 

WATCH | See inside the high-security lab in January, as work began on a COVID-19 vaccine

Scientists at a Saskatoon lab are part of a global effort to find a vaccine for the novel coronavirus. 2:34

To test the vaccine, VIDO-InterVac identified ferrets and hamsters as the animals who experience the effects of the virus most like humans.

The researchers said ferrets tend to be infected most strongly in the upper respiratory tract. The vaccinated ferrets had a strong immune response to the virus.

But the researchers wanted their tests to show the vaccine also reduces the amount of virus in the lower respiratory tract: the lungs. Hamsters were better suited to show that effect. 

In late July, the researchers learned the experiment involving the hamsters, which takes two months, would have to be repeated to try a higher dose of the virus. 

The researchers said the vaccine also generated an immune response in the hamsters, but not as consistently as it did in ferrets. 

Falzarano said that, despite the tight timeline, he has to filter out the pressure that comes with working on a vaccine the world is waiting for.

“I don’t feel that so much. I actually think that’s a bad thing that leads you to want to cut corners or, you know, look at potentially your data differently,” he said. 

“I think it’s very important that doesn’t happen.”

Manufacturing creates delays 

In June, Gerdts laid out his ideal timeline for progressing to human clinical trials and then manufacturing, if all went well: begin manufacturing in the new year to have 10-20 million doses by March or April 2021

But now, he expects manufacturing to begin in June 2021 at the earliest. 

The researchers need higher-grade ingredients to prepare the virus for an essential phase of the animal testing process and to proceed to human clinical trials, but have been unable to get those ingredients manufactured by suppliers without delays. 

A vaccine must go through three phases of human clinical testing to be approved. 

The first involves one to 100 volunteers and the second phase involves 20 to 500. The third and final phase traditionally takes years, as up to 30,000 volunteers are vaccinated and the researchers wait to see how the vaccine works in volunteers who happen to get infected. 

Concerns are already being raised by some scientists about demand for the vaccine outweighing the capacity to manufacture it around the world. 

The VIDO-InterVac facility is home to one of Canada’s only research facilities with a Level 3 containment lab. (Matthew Garand/CBC)

VIDO-InterVac is in the process of building a pilot manufacturing facility, but it is not scheduled to be ready until the end of 2021. 

The facility received an initial $3.6 million from the federal government in 2018. Even before the pandemic, VIDO-InterVac leaders were trying to get more funding, but an additional $12 million that allowed the facility to start construction didn’t come until March. The facility also received $23 million to develop the vaccine.

Gerdts said his team could now be as far along the approval process as front-runners like Oxford University/AstraZeneca and Moderna vaccines, neither of which are Canadian, if the funding had come earlier.  

Earlier this month the federal government made a deal to purchase millions of doses of the Pfizer and Moderna vaccines, saying it is still considering similar deals with other developers.  

Gerdts said not having the manufacturing facility has created delays for his team. 

The VIDO-InverVac team has more than 50 scientists, including PhD student Swarali Kulkarni, seen in January working on vaccine development to thwart the transmission of Middle East respiratory syndrome (MERS), another strain of coronavirus, from camels to humans. (Bonnie Allen/CBC)

“It is the unfortunate reality and it is disappointing because we have kind of predicted this to happen,” said Gerdts. 

“We need to have a manufacturing facility and when this thing hits you need to be able to quickly respond, and all in-house so that you don’t have to go outside and hire others.”

He said that manufacturers elsewhere are understandably busy now.

“So you can’t just simply expect that a manufacturing facility stops all what they are doing now to produce your vaccine.” 

Andrew Casey from BIOTECanada, an association that supports the vaccine industry, said Canada’s capacity to manufacture an eventual vaccine will depend on what type of vaccine it is, and how closely it resembles ones that have been gone before. 

The ease of manufacturing, and the time and cost of doing so, could also play a role in which Canadian vaccine, if any, is finally made available to the public, he said.

Emergency fast-tracking seems less likely: Gerdts

A June start-date for manufacturing would only be possible if Health Canada granted an emergency authorization to allow some manufacturing for at-risk groups — like seniors and healthcare workers — before Phase 3 of human clinical testing was complete. 

Gerdts said he originally thought that was a strong possibility, but that it seems less likely now. Russia’s decision to start using a vaccine without completing Phase 3 was not well received by many scientists.  

“We haven’t really seen any of the governments saying under an emergency authorization we want this to be used earlier,” Gerdts said. 

“I think there is a concern in the public that some of these vaccines are maybe not safe enough, because they were developed too quickly.” 

Gerdts said he is not concerned about others getting to make a vaccine first, because the world needs multiple vaccines with different abilities. But losing momentum, he fears, could lead the government to invest in other vaccines that are progressing faster, potentially from international companies outside Canada. 

Gerdts said the team plans to continue pushing forward with its vaccine with as much urgency as it had at the start of the pandemic.

“I think the scientist in me says I have a better vaccine than many of these vaccines that are out there right now and that’s really — our results show that,” said Gerdts, who has tested some other vaccines. 

He said he expects some vaccines to start coming out early next year, but they may not be as effective as people want.

“Then there will be a second round of vaccines coming forward which will be better than the first round,” he said.

“Ours will be one of those.”

LISTEN | CBC’s Alicia Bridges discusses VIDO-InterVac’s hunt for a vaccine on Frontburner

A global race for a safe and effective COVID-19 vaccine is underway. More than 160 of them are in different stages of testing around the world. Canada is in this race too. A group of scientists at the University of Saskatchewan’s VIDO-InterVac – the Vaccine and Infectious Disease Organization in Saskatoon – are trying to get through a decade’s worth of testing and approvals as early as next year. Today on Front Burner, CBC Saskatoon reporter Alicia Bridges takes us inside a lab working on a Canadian COVID vaccine, and inside the lives of the scientists trying to find it. 28:37

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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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