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‘Planning for dropouts’: Drugmakers grapple with testing unproven vaccines on seniors – Fernie Free Press

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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.

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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COVID-19 vaccines could be available to the general public in Kingston in May, top doctor predicts – CTV Edmonton

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KINGSTON —
As new COVID-19 vaccines arrive in Kingston, the city’s top doctor is hopeful everyone in the region will have access to the vaccine by May.

Medical officer of health Dr. Kieran Moore confirmed to CTV News Ottawa on Saturday, that with Canada now being the first country to approve a fourth vaccine, he believes inoculation of the general public could begin in two months.

With vaccinations in the city’s long-term care homes beginning only in mid-January, it was a slow start to Kingston’s vaccination campaign, but Moore says the effort will ramp-up now.

“We’ve reached 10,000 individuals with doses given of vaccine,” he says. “We‘ve had a very aggressive week this week of trying to get doses into arms.”

Kingston, Frontenac, Lennox and Addington’s Public Health remains in phase one of the COVID-19 vaccine rollout, with immunization still under way for long-term care home residents and frontline healthcare workers. 

Starting next week, hundreds more a day will be vaccinated in a pilot project that will see pharmacists administering doses.

“I do think anyone who wants access will be offered the vaccine will be offered it very, very quickly and I think we’ll have robust heard immunity over the next several months,” said Moore of the roll out during a press conference on Thursday.

Demand for the vaccine in the region is high, and public health has been flooded with calls asking to book an appointment for the shot. Health officials warn they can’t book appointments for those who aren’t yet eligible, and there is no waiting list.

They advise waiting to be contacted when it’s your turn.

Andrew Vanoverbeke says getting the vaccine will mean his two-year-old daughter will be able to see her grandparents.

“We’re doing the Zoom and stuff but it’s not the same as being able to give hugs and just play. It’s really hard,” Vanoverbeke says. “I’m excited about it. And the sooner the better for us.”

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Regina police issue second COVID ticket in less than 24 hours – News Talk 980 CJME

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For the second time in less than 24 hours, Regina police have issued a ticket for breaking COVID rules.

Officers gave one woman a $2,800 fine for participating in an outdoor gathering Saturday at about 2 p.m.

She and about 18 other people were protesting the province’s public health orders in Victoria Park.

Current COVID measures ban outdoor gatherings of more than 10 people.

This follows a ticket issued Friday night, when a Regina man was fined for gathering nine people in his home.

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A look at COVID-19 vaccinations in Canada on March 5, 2021 – The Record (New Westminster)

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The latest numbers on COVID-19 vaccinations in Canada as of 10:00 p.m. ET on Friday, March 5, 2021.

In Canada, the provinces are reporting 85,376 new vaccinations administered for a total of 2,253,514 doses given. Nationwide, 561,238 people or 1.5 per cent of the population has been fully vaccinated. The provinces have administered doses at a rate of 5,946.061 per 100,000.

There were 8,190 new vaccines delivered to the provinces and territories for a total of 2,622,210 doses delivered so far. The provinces and territories have used 85.94 per cent of their available vaccine supply.

Please note that Newfoundland, P.E.I., Nova Scotia, New Brunswick and the territories typically do not report on a daily basis.

Newfoundland is reporting 4,472 new vaccinations administered over the past seven days for a total of 24,757 doses given. The province has administered doses at a rate of 47.279 per 1,000. In the province, 1.61 per cent (8,427) of the population has been fully vaccinated. There were zero new vaccines delivered to Newfoundland for a total of 35,620 doses delivered so far. The province has received enough of the vaccine to give 6.8 per cent of its population a single dose. The province has used 69.5 per cent of its available vaccine supply.

P.E.I. is reporting 1,105 new vaccinations administered over the past seven days for a total of 13,281 doses given. The province has administered doses at a rate of 83.724 per 1,000. In the province, 3.32 per cent (5,273) of the population has been fully vaccinated. There were zero new vaccines delivered to P.E.I. for a total of 14,715 doses delivered so far. The province has received enough of the vaccine to give 9.3 per cent of its population a single dose. The province has used 90.25 per cent of its available vaccine supply.

Nova Scotia is reporting 6,657 new vaccinations administered over the past seven days for a total of 38,676 doses given. The province has administered doses at a rate of 39.631 per 1,000. In the province, 1.48 per cent (14,395) of the population has been fully vaccinated. There were zero new vaccines delivered to Nova Scotia for a total of 61,980 doses delivered so far. The province has received enough of the vaccine to give 6.4 per cent of its population a single dose. The province has used 62.4 per cent of its available vaccine supply.

New Brunswick is reporting 7,424 new vaccinations administered over the past seven days for a total of 33,741 doses given. The province has administered doses at a rate of 43.255 per 1,000. In the province, 1.56 per cent (12,142) of the population has been fully vaccinated. There were zero new vaccines delivered to New Brunswick for a total of 46,775 doses delivered so far. The province has received enough of the vaccine to give 6.0 per cent of its population a single dose. The province has used 72.13 per cent of its available vaccine supply.

Quebec is reporting 19,975 new vaccinations administered for a total of 510,479 doses given. The province has administered doses at a rate of 59.659 per 1,000. There were zero new vaccines delivered to Quebec for a total of 638,445 doses delivered so far. The province has received enough of the vaccine to give 7.5 per cent of its population a single dose. The province has used 79.96 per cent of its available vaccine supply.

Ontario is reporting 35,886 new vaccinations administered for a total of 820,714 doses given. The province has administered doses at a rate of 55.872 per 1,000. In the province, 1.83 per cent (269,063) of the population has been fully vaccinated. There were zero new vaccines delivered to Ontario for a total of 903,285 doses delivered so far. The province has received enough of the vaccine to give 6.1 per cent of its population a single dose. The province has used 90.86 per cent of its available vaccine supply.

Manitoba is reporting 2,358 new vaccinations administered for a total of 84,937 doses given. The province has administered doses at a rate of 61.682 per 1,000. In the province, 2.17 per cent (29,847) of the population has been fully vaccinated. There were 8,190 new vaccines delivered to Manitoba for a total of 124,840 doses delivered so far. The province has received enough of the vaccine to give 9.1 per cent of its population a single dose. The province has used 68.04 per cent of its available vaccine supply.

Saskatchewan is reporting 2,789 new vaccinations administered for a total of 86,879 doses given. The province has administered doses at a rate of 73.679 per 1,000. In the province, 2.37 per cent (27,945) of the population has been fully vaccinated. There were zero new vaccines delivered to Saskatchewan for a total of 74,605 doses delivered so far. The province has received enough of the vaccine to give 6.3 per cent of its population a single dose. The province has used 116.5 per cent of its available vaccine supply.

Alberta is reporting 9,488 new vaccinations administered for a total of 275,719 doses given. The province has administered doses at a rate of 62.634 per 1,000. In the province, 2.06 per cent (90,486) of the population has been fully vaccinated. There were zero new vaccines delivered to Alberta for a total of 274,965 doses delivered so far. The province has received enough of the vaccine to give 6.2 per cent of its population a single dose. The province has used 100.3 per cent of its available vaccine supply.

British Columbia is reporting 12,357 new vaccinations administered for a total of 311,208 doses given. The province has administered doses at a rate of 60.646 per 1,000. In the province, 1.69 per cent (86,865) of the population has been fully vaccinated. There were zero new vaccines delivered to British Columbia for a total of 385,080 doses delivered so far. The province has received enough of the vaccine to give 7.5 per cent of its population a single dose. The province has used 80.82 per cent of its available vaccine supply.

Yukon is reporting 1,279 new vaccinations administered for a total of 19,437 doses given. The territory has administered doses at a rate of 465.769 per 1,000. In the territory, 17.00 per cent (7,093) of the population has been fully vaccinated. There were zero new vaccines delivered to Yukon for a total of 18,900 doses delivered so far. The territory has received enough of the vaccine to give 45 per cent of its population a single dose. The territory has used 102.8 per cent of its available vaccine supply.

The Northwest Territories are reporting zero new vaccinations administered for a total of 19,775 doses given. The territory has administered doses at a rate of 438.285 per 1,000. In the territory, 10.10 per cent (4,558) of the population has been fully vaccinated. There were zero new vaccines delivered to the Northwest Territories for a total of 19,100 doses delivered so far. The territory has received enough of the vaccine to give 42 per cent of its population a single dose. The territory has used 103.5 per cent of its available vaccine supply.

Nunavut is reporting 158 new vaccinations administered for a total of 13,911 doses given. The territory has administered doses at a rate of 359.216 per 1,000. In the territory, 13.28 per cent (5,144) of the population has been fully vaccinated. There were zero new vaccines delivered to Nunavut for a total of 23,900 doses delivered so far. The territory has received enough of the vaccine to give 62 per cent of its population a single dose. The territory has used 58.21 per cent of its available vaccine supply.

*Notes on data: The figures are compiled by the COVID-19 Open Data Working Group based on the latest publicly available data and are subject to change. Note that some provinces report weekly, while others report same-day or figures from the previous day. Vaccine doses administered is not equivalent to the number of people inoculated as the approved vaccines require two doses per person. The vaccines are currently not being administered to children under 18 and those with certain health conditions. In some cases the number of doses administered may appear to exceed the number of doses distributed as some provinces have been drawing extra doses per vial.

This report was automatically generated by The Canadian Press Digital Data Desk and was first published March 5, 2021.

The Canadian Press

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