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‘Planning for dropouts’: Drugmakers grapple with testing unproven vaccines on seniors – Vernon Morning Star

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At age 70, retired nurse Donna Lessard can expect to be towards the front of the line for a COVID-19 vaccine when supply and distribution expands in coming months.

But instead, she’s opted for an unproven vaccine candidate she can have now – a two-dose product by the Quebec City-based biopharmaceuticalMedicago currently running Phase 2 clinical trials.

Because the trials are blinded, the Montrealer doesn’t know if last month she received a second dose of the prospective vaccine or a placebo, and may not know for a year – well after most Canadians are expected to receive one of several licensed vaccines.

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Lessard admits her decision could put her at risk of COVID-19 infection much longer than other seniors, but says there are many people who need approved vaccines more urgently than she does.

“I’m not in a nursing home, I’m in excellent health,” says Lessard, who was a nurse for 50 years before retiring in 2020. “There are a lot of other people, rightly so, that would go before me.”

Despite the willingness of senior trial participants like Lessard, whether and how to include seniors in COVID-19 vaccine trials poses thorny ethical questions now that effective vaccines are available and more are soon to come, says University of Toronto bioethicist Kerry Bowman.

Seniors, by far, have been hardest hit by the novel coronavirus, with about 70 per cent of Canada’s COVID-19 deaths involving people aged 80 and older, and nearly 20 per cent between the ages of 70 and 80.

The emergence of more infectious variants adds even more uncertainty to the pandemic, especially after one version was linked to a devastating outbreak that engulfed a Barrie, Ont., long-term care facility and killed dozens of residents.

“I generally don’t think it’s justifiable right now having senior citizens in completely blinded trials,” says Bowman.

“We can’t fully quantify risks, which I think is significant…. The variants are the wild card now. We don’t even know which way this is going and the whole situation could get a lot worse very quickly.”

Still, there can be exceptions for healthy volunteers such as Lessard, especially if the trial is designed to minimize potential harms, Bowman allows.

The Medicago trial limits its use of placebos as one way to do that – the company says that for every volunteer who gets a saline injection, five participants receive the proposed vaccine.

That’s instead of splitting volunteers equally between the placebo and treatment groups, more typical in double-blinded trials trying to assess how effective a proposed drug really is.

Given the risks posed by the ongoing pandemic, infectious disease physician Zain Chagla suggests it would more appropriate to compare vaccine hopefuls to already proven options, which in Canada are by Pfizer-BioNTech and Moderna.

It’s hard for researchers to say they’re not causing harm if they effectively deny someone a proven drug, says Chagla, an associate professor of medicine at McMaster University in Hamilton.

“Many of these trials will have to eventually have some implementation of a standard-of-care drug, which might be Pfizer,” Chagla says of placebo arms.

“And then at the end, make sure that everyone who got the (tested) drug also gets Pfizer,” says Chagla, adding the caveat that there are still uncertainties about what happens when someone takes two different COVID-19 vaccines.

All clinical trials undergo multiple ethics and protocol reviews by the drug developer and Health Canada to ensure patient safety remains paramount, says Karri Venn, president of research at LMC Manna Research, which is running multiple trials for various biotechs, including Medicago’s vaccine trial.

And trials don’t typically start with seniors or other vulnerable groups. Only if Phase 1 establishes safety among healthy adults would studies expand to older volunteers, with later trials adding in adolescents, children and pregnant women.

Venn says COVID-19 has added novel complications to scientific research, and suspects it could soon become difficult to recruit and keep seniors committed to clinical trials if they know an approved vaccine is imminent.

“This is for the first time posing a lot of challenges for the traditional way in how you would do research, to be honest with you,” says Venn, expecting some volunteers sign up planning to quit as soon as they’re eligible for other, approved options.

“They may say, ‘I’m going to take (this proposed vaccine) and in nine months I’m going to say, “You know what? Unblind me.”’ … There’s all of that happening, too. It’s a very unusual time.”

It’s very rare to unblind a participant partway through a trial, Venn adds, and if it does happen, it’s almost always for a medical or safety reason.

But all trials must release any participant who wants to quit, no matter the reason, she says, and their data wouldn’t be included in the final results.

Giving seniors a placebo is out of the question for Providence Therapeutics CEO Brad Sorenson, who is planning Phase 2 trials for his COVID-19 vaccine hopeful.

The head of the Calgary-based biotech says his recently launched Phase 1 safety trials include a placebo group, but no seniors. Phase 2 will likely include seniors but no placebos.

“We don’t want to include a placebo group for people that are older and at a higher risk. Not when there’s a vaccine that would be available to them,” says Sorenson, musing on a possible workaround.

“We can do a comparative study where they get either our vaccine or a Moderna vaccine.”

Assuming the trial can get its hands on these approved vaccines – allotments from Moderna and Pfizer are both facing significant distribution delays in Canada.

Bowman sympathizes with volunteers who consider unknown protections of a trial vaccine to be better than nothing. He suggests those who consent to the terms of clinical trials do so “under duress.”

“Before Christmas, we were told we’d be swimming in vaccines by now, and we’re really, really not,” says Bowman.

“People have to protect their own lives and well-being.”

READ MORE: Trudeau says government foresaw short-term delays in vaccine deliveries to Canada, planned accordingly

Still, concrete data on how seniors respond to prospective COVID-19 vaccines is crucial, especially with relatively few therapies and so much still uncertain about the disease, says Medicago’s senior director of scientific and medical affairs.

“I know it’s a big request, but it’s part of science and that’s how it works and that’s how we make sure the product is good, that the people receiving it are safe,” says Nathalie Charland.

“There are constraints related to the trial, we are aware of that, and that’s why we say a big thank you to all those who are involved in our trials.”

Charland says Medicago’s Phase 2 trial has already collected the data it needs from hundreds of senior volunteers in Canada and the United States, but recruiting the thousands more needed in Phase 3 will be tougher.

Half of the 30,000 participants needed are seniors, and half of all volunteers would get a placebo, she says.

“We are already planning for dropouts. We are very conscious that this might – and probably will – happen but Phase 3 is an efficacy trial so we have to go in regions of the world where the virus is circulating a lot,” she says, noting prospective sites include Latin America and Europe.

“It will be in countries where there’s not that many vaccines distributed yet. So that should help recruit subjects.”

Lessard suspects she got Medicago’s vaccine candidate, citing a slight headache and sore arm after the first dose and another sore arm after the second dose.

But she says that was not her primary reason for joining the trial, expressing hope her involvement will serve a greater public good.

“There’s a lot of fear around the COVID vaccines and we still hear people saying, ‘Oh, I’m not going to take the vaccine until it’s perfect,’” says Lessard.

“And my attitude is: Well, how are we going to get it perfect if nobody volunteers? And if not now, when? It’s got to be done now.”

Cassandra Szklarski, The Canadian Press


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Kevin Neil Friesen Obituary 2024 – Crossings Funeral Care

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It is with heavy hearts that we announce the peaceful passing of Kevin Neil Friesen age 53 on Thursday, March 28, 2024 at the Bethesda Regional Health Centre.

A funeral service will be held at 2:00 pm on Thursday, April 4, 2024 at the Bothwell Christian Fellowship Church, with viewing one hour prior to the service.

A longer notice to follow.  

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Spring allergies: Where is it worse in Canada? – CTV News

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The spring allergy season has started early in many parts of Canada, with high levels of pollen in some cities such as Toronto, Ottawa and Montreal.

Daniel Coates, director of Aerobiology Research Laboratories in Ottawa, expects the elevated amounts to continue next week for places, such as most of Ontario, if the temperature continues to rise. Aerobiology creates allergen forecasts based on data it collects from the air on various pollens and mould spores.

Pollens are fertilizing fine powder from certain plants such as trees, grass and weeds. They contain a protein that irritates allergy sufferers.

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Although pollen levels declined after a cold spell in some places, he said they are soaring again across parts of Canada.

“So the worst is definitely British Columbia right now, followed by Ontario and Quebec and then the Prairies and Atlantic Canada for the upcoming weeks,” said Coates in a video interview with CTVNews.ca. “We are seeing pollen pretty much everywhere, including the Maritimes.”

He said pollen has increased over the past 20 years largely due to longer periods of warm weather in Canada.

Meanwhile, the Maritimes is one of the best places to live in Canada if you have seasonal allergies, in part because of its rocky territory, Coates said.

With high levels of cedar and birch pollen, British Columbia is the worst place for allergy sufferers in Canada, he added.

“British Columbia is going strong,” Coates explained, noting the allergy season started “very early” in the province in late January. “It has been going strong since late January, early February and it’s progressing with high levels of pollen, mostly cedar, but birch as well, and birch is highly allergenic.”

Causes of high pollen levels

Coates expects a longer allergy season if the warm weather persists. He notes pollen is increasing in Canada and worldwide, adding that in some cases the allergy season is starting earlier and lasting longer than 15 years ago.

He says tree pollen produced last year is now being released into the air because of warmer weather.

“Mother nature acts like a business,” he said. “So you have cyclical periods where things go up and down. … So when it cooled down a little bit, we saw (pollen) reduce in its levels, but now it’s going to start spiking.”

Along with warmer weather, another factor in higher pollen levels is people planting more male trees in urban areas because they don’t produce flowers and fruits and are less messy as a result, he said. But male trees produce pollen while female ones mostly do not.

Moulds

Coates said moulds aren’t as much of a problem.

“They’ve been mainly at lower levels so far this season,” he explained. “Moulds aren’t as bad in many areas of Canada, but they’re really, really bad in British Columbia.”

In B.C., moulds are worse because of its wet climate and many forested areas, he said.

Coping with allergies

Dr. Blossom Bitting, a naturopathic doctor and herbal medicine expert who works for St. Francis Herb Farm, says a healthy immune system is important to deal with seasonal allergies.

“More from a holistic point of view, we want to keep our immune system strong,” she said in a video interview with CTVNews.ca from Shediac, N.B. “Some would argue allergies are an overactive immune system.”

Bitting said ways to balance and strengthen the immune system include managing stress levels and getting seven to nine hours of restful sleep. “There is some research that shows that higher amounts of emotional stress can also contribute to how much your allergies react to the pollen triggers,” Bitting said.

Eating well by eating more whole foods and less processed foods along with exercising are also important, she added. She recommends foods high in Omega-3 Fatty Acids such as flaxseeds, flaxseed oil, walnuts and fish. Fermented foods with probiotics such as yogurt, kimchi and miso, rather than pasteurized ones, can keep the gut healthy, she added. Plant medicines or herbs such as astragalus, reishi mushrooms, stinging nettle and schisandra can help bodies adapt to stressors, help balance immune systems or stabilize allergic reactions, she said.

To cope with allergies, she recommends doing the following to reduce exposure to pollen:

  • Wear sunglasses to get less pollen into the eyes;
  • Wash outdoor clothes frequently, use outer layers for outside and remove them when you go inside the house;
  • Use air purifiers such as with HEPA (high efficiency particulate air) filters;
  • Wash pets and children after they go outside;
  • Keep the window closed on days with high pollen counts.

Mariam Hanna, a pediatric allergist, clinical immunologist and associate professor with McMaster University in Hamilton, Ont., says immunotherapy can help patients retrain their bodies by working with an allergist so they become more tolerant to pollens and have fewer symptoms.

“Some patients will need medications like over-the-counter antihistamines or speaking with their doctor about the right types of medications to help with symptom control,” she said in a video interview with CTVNews.ca.

Coates recommends people check pollen forecasts and decrease their exposure to pollen since no cure exists for allergies. “The best is knowing what’s in the air so that you can adjust your schedules, or whatever you’re doing, around the pollen levels.”

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Do you need a spring COVID-19 vaccine? Research backs extra round for high-risk groups

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Recent studies suggest staying up-to-date on COVID shots helps protect high-risk groups from severe illness

New guidelines suggest certain high-risk groups could benefit from having another dose of a COVID-19 vaccine this spring — and more frequent shots in general — while the broader population could be entering once-a-year territory, much like an annual flu shot.

Medical experts told CBC News that falling behind on the latest shots can come with health risks, particularly for individuals who are older or immunocompromised.

Even when the risk of infection starts to increase, the vaccines still do a really good job at decreasing risk of severe disease, said McMaster University researcher and immunologist Matthew Miller.

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Who needs another COVID shot?

Back in January, Canada’s national vaccine advisory body set the stage for another round of spring vaccinations. In a statement (new window), the National Advisory Committee on Immunization (NACI) stated that starting in spring 2024, individuals at an increased risk of severe COVID may get an extra dose of the latest XBB.1.5-based vaccines, which better protect against circulating virus variants.

That means:

  • Adults aged 65 and up.
  • Adult residents of long-term care homes and other congregate living settings for seniors.
  • Anyone six months of age or older who is moderately to severely immunocompromised.

The various spring recommendations don’t focus on pregnancy, despite research (new window) showing clear links between a COVID infection while pregnant, and increased health risks. However, federal guidance does note that getting vaccinated during pregnancy can protect against serious outcomes.

Vaccinated people can also pass antibodies to their baby through the placenta and through breastmilk, that guidance states (new window).

What do the provinces now recommend?

Multiple provinces have started rolling out their own regional guidance based on those early recommendations — with a focus on allowing similar high-risk groups to get another round of vaccinations.

B.C. is set to announce guidance on spring COVID vaccines in early April, officials told CBC News, and those recommendations are expected to align with NACI’s guidance.

In Manitoba (new window), high-risk individuals are already eligible for another dose, provided it’s been at least three months since their latest COVID vaccine.

Meanwhile Ontario’s latest guidance (new window), released on March 21, stresses that high-risk individuals may get an extra dose during a vaccine campaign set to run between April and June. Eligibility will involve waiting six months after someone’s last dose or COVID infection.

Having a spring dose is particularly important for individuals at increased risk of severe illness from COVID-19 who did not receive a dose during the Fall 2023 program, the guidance notes.

And in Nova Scotia (new window), the spring campaign will run from March 25 to May 31, also allowing high-risk individuals to get another dose.

Specific eligibility criteria vary slightly from province-to-province, so Canadians should check with their primary care provider, pharmacist or local public health team for exact guidelines in each area.

WATCH: Age still best determines when to get next COVID vaccine dose, research suggests:

 

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Age still best determines when to get COVID vaccines, new research suggests

It’s been four years since COVID-19 was declared a pandemic, and new research suggests your age may determine how often you should get a booster shot.

Why do the guidelines focus so much on age?

The rationale behind the latest spring guidelines, Miller said, is that someone’s age remains one of the greatest risk factors associated with severe COVID outcomes, including hospitalization, intensive care admission and death.

So that risk starts to shoot up at about 50, but really takes off in individuals over the age of 75, he noted.

Canadian data (new window) suggests the overwhelming majority of COVID deaths have been among older adults, with nearly 60 per cent of deaths among those aged 80 or older, and roughly 20 per cent among those aged 70 to 79.

People with compromised immune systems or serious medical conditions are also more vulnerable, Miller added.

Will people always need regular COVID shots?

While the general population may not require shots as frequently as higher-risk groups, Miller said it’s unlikely there will be recommendations any time soon to have a COVID shot less than once a year, given ongoing uncertainty about COVID’s trajectory.

Going forward, I suspect for pragmatic reasons, [COVID vaccinations] will dovetail with seasonal flu vaccine campaigns, just because it makes the implementation much more straightforward, Miller said.

And although we haven’t seen really strong seasonal trends with SARS-CoV-2 now, I suspect we’ll get to a place where it’s more seasonal than it has been.

In the meantime, the guidance around COVID shots remains simple at its core: Whenever you’re eligible to get another dose — whether that’s once or twice a year — you might as well do it.

What does research say?

One analysis, published in early March in the medical journal Lancet Infectious Diseases (new window), studied more than 27,000 U.S. patients who tested positive for SARS-CoV-2, the virus behind COVID, between September and December 2023.

The team found individuals who had an updated vaccine reduced their risk of severe illness by close to a third — and the difference was more noticeable in older and immunocompromised individuals.

Another American research team from Stanford University recently shared the results from a modelling simulation looking at the ideal frequency for COVID vaccines.

The study in Nature Communications (new window) suggests that for individuals aged 75 and up, having an annual COVID shot could reduce severe infections from an estimated 1,400 cases per 100,000 people to around 1,200 cases — while bumping to twice a year could cut those cases even further, down to 1,000.

For younger, healthier populations, however, the benefit of regular shots against severe illness was more modest.

The outcome wasn’t a surprise to Stanford researcher Dr. Nathan Lo, an infectious diseases specialist, since old age has consistently been a risk factor for severe COVID.

It’s almost the same pattern that’s been present the entire pandemic, he said. And I think that’s quite striking.

More frequent vaccination won’t prevent all serious infections, he added, or perhaps even a majority of those infections, which highlights the need for ongoing mitigation efforts.

Lauren Pelley (new window) · CBC News

 

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