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Made-in-Canada COVID-19 vaccine effort slowed by manufacturing delay – Yahoo News Canada

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Made-in-Canada COVID-19 vaccine effort slowed by manufacturing delay

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. 

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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. 

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="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&nbsp;over "vaccine nationalism," which could prevent access to a product that’s not made at home.” data-reactid=”37″>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.

VIDO-InterVac/University of SaskatchewanVIDO-InterVac/University of Saskatchewan

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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.”

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Inside the lab” data-reactid=”74″>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. 

Matthew Garand/CBCMatthew Garand/CBC

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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. 

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="WATCH | See inside the high-security lab in January, as work began on a COVID-19 vaccine” data-reactid=”106″>WATCH | See inside the high-security lab in January, as work began on a COVID-19 vaccine

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.”

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Manufacturing creates delays&nbsp;” data-reactid=”115″>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. 

Matthew Garand/CBCMatthew Garand/CBC

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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. 

Bonnie Allen/CBCBonnie Allen/CBC

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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.

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Emergency fast-tracking seems less likely: Gerdts” data-reactid=”173″>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. 

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Gerdts said he originally thought that&nbsp;was a strong possibility, but that it seems less likely now.&nbsp;Russia’s decision to start using a vaccine without completing Phase 3 was not well received by many scientists.&nbsp;&nbsp;” data-reactid=”175″>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.”

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="LISTEN | CBC’s Alicia Bridges discusses VIDO-InterVac’s hunt for a vaccine on Frontburner” data-reactid=”184″>LISTEN | CBC’s Alicia Bridges discusses VIDO-InterVac’s hunt for a vaccine on Frontburner

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Measles case reported locally turns out to be negative: health unit

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NEWS RELEASE
SIMCOE MUSKOKA DISTRICT HEALTH UNIT
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On March 26, the Simcoe Muskoka District Health Unit (SMDHU) was notified by Public Health Ontario’s (PHO) laboratory that due to laboratory error, the case of measles that had been lab-confirmed positive on March 12, based on symptoms and a positive urine measles laboratory result by PHO’s laboratory, is in fact negative for the measles virus.

“With this new information of the negative lab result, we believe that that individual was not infected with measles and that there has not been any public exposure to measles resulting from this individual’s illness,” said Dr. Charles Gardner, medical officer of health. “We recognize that notifying the public of what we believed to be a positive measles case in our area created worry, anxiety and disruption for some, and we regret this.

“We do know that, despite best efforts, on rare occasions laboratory errors can occur. We are working closely with the PHO’s laboratory to do all that we can to ensure that such an incident does not occur again.”

Measles is a highly contagious viral infection that spreads very easily through airborne transmission. The measles virus can live in the air or on surfaces for up to two hours.

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Symptoms of measles begin seven to 21 days after exposure and include fever, runny nose, cough, drowsiness, and red eyes. Small white spots appear on the inside of the mouth and throat but are not always present. Three to seven days after symptoms begin, a red, blotchy rash appears on the face and then progresses down the body.

The risk of transmission to those vaccinated with two doses is low, and when it does occur tends to show a reduction in the severity of these symptoms.

“Although we are relieved for the individual involved, and for all Simcoe-Muskoka residents, that this case has now been confirmed as negative, we know that measles is still active in Ontario at this time and the potential remains for new cases to arise, especially given the increase in Ontarians travelling to areas in the world that have higher numbers of measles cases,” said Dr. Gardner. “This is why we continue to advise individuals to keep up to date with their routine immunizations, including measles, mumps and rubella (MMR) vaccination.”

The risk of measles is low for people who have been fully immunized with two doses of measles vaccine or those born before 1970; however, many children have been delayed in receiving their routine childhood immunizations and people who have not had two doses of measles vaccine are at higher risk of contracting the disease.

People who do get sick usually recover without treatment, but measles can be more severe for infants, pregnant women, and those with compromised immune systems. Possible complications include middle-ear infections, pneumonia, diarrhea, or encephalitis (swelling of the brain) and occasionally death in the very young. Even individuals who are up to date with the measles vaccine should watch for symptoms of measles for 21 days after exposure.

For more information about measles, please visit smdhu.org or call Health Connection at 705-721-7520 or 1-877-721-7520, Monday to Friday between 8:30 a.m. and 4:30 p.m. to speak with a public health professional.

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Kate Middleton Not Alone. Cancer On Rise For People Under 50, Say Experts

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Kate Middleton revealed on Friday that her cancer was discovered after she received abdominal surgery

London:

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When Catherine, Princess of Wales, revealed she was being treated for cancer last week, part of the shock was that an otherwise healthy 42-year-old has a disease that mostly plagues older people.

However, researchers have been increasingly sounding the alarm that more and more people under 50 are getting cancer — and no one knows why.

Across the world, the rate of under-50s diagnosed with 29 common cancers surged by nearly 80 percent between 1990 and 2019, a large study in BMJ Oncology found last year.

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The researchers predicted the number of new cancer cases among younger adults will rise another 30 percent by the end of this decade, with wealthy countries particularly affected.

The increase in cases — and soaring global population — means that the number of deaths among under 50s from cancer has risen by nearly 28 percent over the last 30 years.

This occurred even as the odds of people of all ages surviving cancer have roughly doubled over the last half century.

Shivan Sivakumar, a cancer researcher at the UK’s University of Birmingham, called it an “epidemic” of young adult cancer.

Since Kate Middleton revealed on Friday that her cancer was discovered after she received abdominal surgery earlier this year, Sivakumar and other doctors have spoken out about the uptick in younger cancer patients they have been seeing at their clinics.

While breast cancer remains the most common for people under 50, the researchers expressed particular concern about the rise of gastrointestinal cancers — such as of the colon, pancreas, liver and oesophagus — in younger adults.

Colon cancer is now the leading cause of cancer deaths in men under 50 in the United States, according to the American Cancer Society. For women, it is number two — behind only breast cancer.

One high profile case of colorectal cancer was “Black Panther” actor Chadwick Boseman, who died at the age of 43 in 2020.

Why is this happening?

“We just don’t have the evidence yet” to say exactly what is causing this rise, Sivakumar told AFP, adding it was likely a combination of factors.

Helen Coleman, a cancer epidemiology professor at Queen’s University Belfast who has studied early onset cancer in Northern Ireland, told AFP there were two potential explanations.

One is that people in their 40s were exposed to factors known to cause cancer — such tobacco smoke, alcohol or being obese — at an earlier age than previous generations.

She pointed out that the “obesity epidemic” did not start until the 1980s.

Sivakumar felt that at least part of the puzzle could be explained by obesity.

However, there is “another wave” of under-50 patients who are neither obese nor genetically predisposed still getting cancer, he emphasised, adding that this could not be put down to “statistical chance”.

The other theory, Coleman said, is that “something different” has been going on with her generation.

Fingers have been pointed out a range of possible culprits — including chemicals, new drugs and microplastics — but none have been proven.

Some have suggested that so-called ultra-processed foods could be to blame. “But there’s very little data to back any of that up,” Coleman said.

Another theory is that the food we eat could be changing our gut microbiome.

While there is nothing conclusive yet, Coleman said her own research suggested that cancer causes changes to the microbiome, not the other way around.

Anti-vaxx conspiracy theorists have even tried to blame Covid-19 vaccines.

This is easily disproven, because the rise in young adult cancer has taken place over decades, but the vaccines have only been around for a few years.

What can be done?

To address the rise in younger colorectal cancer, in 2021 the US lowered the recommended age for screening to 45. Other countries have yet to follow suit.

But the researchers hoped that Catherine’s experience would remind people at home that they should consult their doctor if they sense anything is wrong.

“People know their bodies really well,” Sivakumar said.

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“If you really feel that something isn’t right, don’t delay — just get yourself checked out.”

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Almost 3,000 students suspended in Waterloo Region over immunization issues

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Close to 3,000 children attending elementary school across Waterloo Region were suspended from school on Wednesday morning for not having up-to-date immunization records.

The region says Waterloo Public Health suspended 2,969 students under the Immunization of School Pupils Act (ISPA).

For several months, the region has been campaigning for people to get their children’s vaccinations up to date, including sending letters home to parents on a couple of occasions, warning that students’ records needed to be up to date or they would be suspended.

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It announced in January that 32,000 students did not have up-to-date records: 22,000 elementary students and 10,000 high school students.


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“We have made remarkable progress from the original 27,567 immunization notices we sent to parents in November and December 2023,” Dr. Hsiu-Li Wang, medical officer of health, stated.

“Since that time, we have resolved more than 24,500 outdated vaccination records, providing students with valuable protection against these serious and preventable diseases.”

The high school students still have a few weeks to get their records up to date or else face suspension.

The ISPA requires students to have proof-of-vaccination records for diphtheria, polio, tetanus, pertussis, measles, mumps, rubella, varicella (chickenpox) and meningitis, which must be on file with public health.

Public health says caregivers whose children are suspended will need to book an appointment at regionofwaterloo.ca/vaccines for clinics, which will be held in Cambridge and Waterloo on weekdays.

“Given the high number of suspensions, it may take several days before you can be seen at an appointment and return your child to school,” a release from the region warns.

“Record submission and questions must be done in person to ensure immediate resolution.”

The last time suspensions over immunizations were issued was in 2019, when 1,032 students were suspended.

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