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1st Canadian human trial for coronavirus vaccine is underway. Here's what that means – thepeakfm.com

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Canadian trials have just begun for a prospective COVID-19 vaccine but its Quebec-based manufacturer is already tempering expectations.

Bruce Clark, president and CEO of the biopharmaceutical company Medicago, cautions observers against holding unrealistic assumptions that his product — or any of the numerous vaccine hopefuls in development globally — can bring the pandemic to a screeching halt if proven viable.

Clark notes more than 120 companies are trying to come up with a COVID-19 vaccine, many of which have never been in the vaccine space before.

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He doesn’t doubt that “something’s going to come out of this,” but he questions how effective it may be.

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“Whatever vaccine we get in this first round — unless it’s a miracle — it’s not going to be perfect,” says Clark, whose company began trials for its proposed vaccine Monday in Quebec City.

“It’s going to have to undergo development, it’s going to take probably years to come up with an understanding of the right vaccine, the right approach. It’s not the panacea.

“To assume that we can have, in 18 months, the solution to a pandemic that comes around once in a generation, is naive.”

Canada’s deputy public health officer Dr. Howard Njoo expressed similar cautions Tuesday, while acknowledging the need to develop viable vaccines and therapies.

“Lots of different steps are still ahead of us before we might even anticipate that there might be a safe, effective vaccine that would be available for use in the general population,” said Njoo.

So much is still unknown about COVID-19, notes Clark, including how it may manifest during the flu season later this year.

He suspects a more likely scenario is that a vaccine will offer only part of the solution, along with new therapeutics and ongoing public health interventions.

Plant-based product to be tested on 180 people

Medicago’s first phase of clinical trials will test the safety of a plant-based product on 180 healthy men and women, aged 18 to 55.

The randomized, partially blinded study uses technology that does not involve animal products or live viruses like traditional methods.

Clark notes that vaccine developers typically use chicken eggs to propagate a virus, but Medicago uses recombinant technology involving the genetic sequence of a virus, with living plants as the host.

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The resulting virus-like particles mimic the shape and dimensions of a virus, which allows the body to recognize them and spark an immune response.

Clark says the plant-based approach is significantly faster and offers more consistent results than egg-based or cell-based methods.

It’s the same method Medicago has used for a proposed seasonal flu vaccine that Clark says is currently being reviewed by Health Canada. If approved, Clark says it would be the first plant-based vaccine in the world.

While it takes five to six months to propagate a virus in eggs, the plant-based technique requires just five to six weeks, he says.

“In a pandemic, something like COVID, if you’re able to cut that much time off development, you have a substantial impact on public health.”

Meanwhile, Clark says viruses are prone to mutations as they adapt and grow in an egg, which could result in a vaccine that doesn’t exactly match the circulating virus. In contrast, “a plant is a plant,” and that makes production easily scalable.

“One plant behaves like 100,000 plants,” he says.

The trial will evaluate three different dosages alone, or with one of two adjuvants provided by GlaxoSmithKline and Dynavax. An adjuvant can boost the effectiveness of a vaccine for a better immunological response, thereby reducing the required dose, Clark adds.

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He hopes to know the safety of the product, as well as effectiveness of the adjuvants and dosing by October. Based on that, researchers would kick off a second, more targeted trial phase involving about 1,000 participants.

If that’s successful, Clark says a third phase would involve about 15,000 to 20,000 subjects, include older cohorts, and may be a global study, depending on circumstances of the pandemic by then.

Border issues complicate supply chains

If the vaccine proves effective, Clark points to another uncertainty.

Because the company’s commercial plant is across the border in Durham, N.C., he says there’s no guarantee of a Canadian supply.

“‘Guarantee’ is a strong word,” says Clark. “Strange things happen to borders in the context of a pandemic.”

Such border complications were made clear to Canadians in April when Prime Minister Justin Trudeau complained about problems with incomplete or non-existent deliveries of critical COVID-19 supplies. At the time, U.S. President Donald Trump ordered U.S. producers to prioritize the domestic market.

Clark suggests similar hurdles could impact vaccine distribution, putting immediate pressure on Medicago to complete construction of a large-scale manufacturing facility in its home base of Quebec City.

“Certainly, we need a facility in Canada,” Clark says.

“There’s no guarantee on the easy flow of materials back and forth across the border should we have a successful vaccine. We have to keep the focus on completing the Canadian facility so that we have domestic capacity. I think this is what most countries are concerned about.”

By the end of 2023, the Quebec City plant is expected to be able to produce up to one billion doses of a COVID-19 vaccine annually.

Until then, Medicago says it expects to be able to make approximately 100 million doses by the end of 2021, assuming its trials are successful.

Clark says countries must temper any nationalist agendas that might emerge with a viable vaccine and acknowledge that the fight against COVID-19 is global.

Commentary:
‘Vaccine nationalism’ could threaten Canada’s access to a COVID-19 vaccine

Meeting that demand would require multiple manufacturers, multiple distribution routes, and lots of co-operation, he says, possibly through the World Health Organization.

“There has to be some ability to share those around and distribute, whether that’s through an entity like the WHO, or something equivalent.”

© 2020 The Canadian Press

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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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