Connect with us


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. 

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

Let’s block ads! (Why?)

Source link

Continue Reading


Toronto ties four COVID cases to local club – Caledon Enterprise



Top Stories

Top Stories

Let’s block ads! (Why?)

Source link

Continue Reading


Nearly 20 per cent of COVID-19 infections among health-care workers by late July – Powell River Peak



VANCOUVER — Health care workers in Canada made up about 20 per cent of COVID-19 infections as of late July, a figure that was higher than the global average.

In a report released earlier this month, the Canadian Institute for Health Information said 19.4 per cent of those who tested positive for the virus as of July 23 were health-care workers. Twelve health care workers, nine from Ontario and three from Quebec, died from COVID-19, it said.

article continues below

The World Health Organization said in July that health-care workers made up 10 per cent of global COVID-19 infections.

A national federation of nurses’ unions blames the infection rate on a slow response to the pandemic, a shortage of labour and a lack of personal protective equipment.

Mahi Etminan, a registered oncology nurse who was working at a hospital in Vancouver in mid-March, says she doesn’t know how she was infected by COVID-19.

“It could have been anywhere in the hospital,” she said.

“In March, we weren’t required to really wear any masks or anything.”

Etminan said she has tested negative for the virus twice but still feels the after-effects of her illness. She tires easily, has lost her sense of taste — even salt — and is losing chunks of her hair.

She agrees with the Canadian Federation of Nurses Unions that proper precautions weren’t put in place to deal with COVID-19.

“I think we were behind in putting a proper protocol in place,” Etminan said.

Linda Silas, president of the 200,000-member nurses’ federation, said Canadian hospitals approached COVID-19 based on the findings of a 2003 Ontario government commission into SARS.

“I thought we were ready,” Silas said in an interview.

“And then mid-March, early March, we realized how unready we were. And that’s one of the reasons that we have one of the highest levels of health-care workers getting infected.”

She said with the routes of transmission for the virus being uncertain — and later research showing it was possible the virus could be airborne — it was critical that health care workers get full protection.

The Ontario government convened the commission to investigate the origin, spread and response to SARS. One of the key recommendations of the report was improving the safety of health-care workers.

Ontario Health Ministry spokesman David Jensen said lessons learned from SARS have been implemented, including giving more powers to the chief medical officer of health to issue directives to workers and organizations.

The province recommends health-care workers use appropriate precautions when conducting clinical assessments, testing and caring for patients who are suspected or confirmed to have COVID-19, he said.

The approach to the novel coronavirus was taken on a precautionary basis because little information was available about its transmission and clinical severity, Jensen said in an email response to questions.

“The majority of cases are linked to person-to-person transmission through close direct contact with someone who has COVID-19. There is no evidence that COVID-19 is transmitted through the airborne route.”

The World Health Organization acknowledged in July the possibility that COVID-19 might be spread in the air under certain conditions.

It said those most at risk from airborne spread are doctors and nurses who perform specialized procedures, such as inserting a breathing tube or putting patients on a ventilator.

Michael Brauer, a professor at the University of British Columbia’s school of population and public health, said COVID-19 doesn’t fit the traditional airborne model where viruses remain infectious over long distances and time periods.

“There’s been a little bit of an evolution in our understanding of the transmission,” he said, adding there was evidence as early as March that showed the virus can be transmitted via air.

While early on more attention was paid to surface transmission, it now seems as though the airborne route is more prominent, he said.

Health Canada spokeswoman Tammy Jarbeau said long-term care facilities and retirement homes were among the hardest hit during the peak of COVID-19 in the spring, likely affecting health-care workers.

The federal government is working with the Canadian Institute for Health Information to better understand the virus, including expanding case data for health-care workers.

The Quebec government said the high rate of community contamination in the province coupled with a labour shortage at the beginning of the pandemic affected health-care workers who were working in several long-term care homes to maintain essential services.

“In recent months, Quebec has gone through an unprecedented health crisis,” said Robert Maranda, a spokesman for the ministry of health and social services.

The plan to deal with COVID-19 was based mainly on the experience gleaned from the 2009 swine flu pandemic, he said.

“However, H1N1 influenza is not the same virus that we are currently fighting against,” Maranda said.

“A person with COVID-19 can transmit the virus without having any symptoms, which is not the case with the flu.”

But as more is known about the new coronavirus, he said the province’s response has changed, including no longer allowing health-care workers to work in different places.

Silas said the nurses’ federation has started an investigation led by a former senior adviser to the SARS commission into why Canada didn’t better protect health-care workers from COVID-19. The report is expected later this year.

The Public Health Agency has done a poor job of gathering data about health-care workers infected with COVID-19, she said, adding that the federation has relied on data collected by Statistics Canada.

“There’s this lack of information flowing,” Silas said.

Natalie Mohamed, a spokeswoman for the Public Health Agency, said 25 per cent of all reported cases were among people who describe themselves as working in health care and it has been collecting data from the provinces and territories since March.

Those who identify themselves as health-care workers include physicians, nurses, dentists, physiotherapists, residential home workers, cleaners, janitorial staff and volunteers.

Some health-care workers may also be getting infected outside work, Mohamed said, although exposure data is incomplete.

The associate executive director of the Canadian Medical Protective Association, which provides advice and assistance in medical-legal matters to doctors, said it began fielding concerns from members about a lack of protective equipment when the virus started spreading.

Dr. Todd Watkins said the questions have shifted to how things will be handled in the future.

“Will there be a second wave and how am I going to respond to that? Is my clinic prepared for that? Will there be appropriate protective gear?”

Christine Nielsen, chief executive officer of the Canadian Society for Medical Laboratory Science, said the flow of information is affected by the fact the provinces and territories deliver health care and they could collect data differently.

“There’s room for improvement with how public health has responded,” she said. “Just the scale of the pandemic has really caught everyone off guard.”

This report by The Canadian Press was first published on Sept. 19, 2020.

Let’s block ads! (Why?)

Source link

Continue Reading


B.C. to publish a list of school COVID-19 exposures, outbreaks – Prince George Citizen



The B.C. government intends to publish online all COVID-19 school exposure and outbreak events.

The move follows the first of five health authorities to provide its own online list of exposures or outbreaks, a ministry spokesperson confirmed.

article continues below

Fraser Health announced Wednesday a web page that will list all such events by school district.

The website does not provide any details of a so-called exposure and it’s not yet clear if more details will be provided for an outbreak and whether such details will be updated as cases are confirmed.

An exposure is when someone who attended the school tested positive for COVID-19 and does not mean the disease was transmitted. Only an outbreak notice is an indication public health authorities have determined transmission in a school setting.

Parents do not need to take action if there is an exposure event, unless contacted by a health official (contact tracer) or school official, states Fraser Health.

“We have a responsibility to be transparent, clear, and current in our communication to parents, teachers, and students about COVID-19 exposures in schools in our region, and the launch of our COVID-19 school exposures webpage provides us with an opportunity to do just that,” said Dr. Victoria Lee, Fraser Health president and CEO, via a media statement. “This new page is a tool for us to help keep the lines of communication open and give schools and families the resources they need to feel safe and reassured.”

Fraser Health oversees 11 school districts between Burnaby and Hope, including Delta and Surrey.

The list shows six exposure events, to date. One at Delta secondary school and five others in Surrey.

More details appear to be provided specifically to parents via the school districts, who are in cross communications with the health authority.

In a letter to parents Wednesday, Delta district superintendent Doug Sheppard noted a key point for families to remember is that Fraser Health will connect directly with any individuals who may have been exposed with further instructions via phone call or letter. If someone is contacted by Fraser Health, they’re asked to follow the health authority’s advice carefully.

Sheppard said the protocol in such circumstances includes:

  • Fraser Health Authority will initiate contact tracing
  • FHA will determine how the individual was infected and who they were in close contact with
  • The heath authority will determine if close contacts will be asked to self-isolate for 14 days
  • Only public health can determine who is a close contact.

With files from Delta-Optimist

Let’s block ads! (Why?)

Source link

Continue Reading