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‘Planning for dropouts’: Drugmakers grapple with testing unproven vaccines on seniors – Clearwater Times

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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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B.C. unveils details of mass vaccination plan, approves four-month window between doses – CHEK

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The B.C. government is optimistic that with a longer window between doses and a more storage-friendly vaccine approved for use, everyone in the province 18 years or older will be able to receive a COVID-19 immunization by the end of September or even sooner.

The province provided more concrete details of its sweeping COVID-19 immunization program Monday, giving a glimpse of a potential end to a pandemic entering its second year.

“We can now see the light at the end of what has been a difficult and challenging time for us all. To get us through, we need to continue to work together and support each other,” Dr. Bonnie Henry, provincial health officer, said in a news release.

On Monday, Premier John Horgan revealed that through the end of April, under Phase 2 of the plan, there are more than 415,000 people set to receive their vaccinations including:

  • Seniors over 80
  • Indigenous people over 65
  • Any remaining medical staff and specialists not immunized
  • Vulnerable people in close quarters
  • Those who work in senior community home support and nursing

Those mass vaccinations will begin in the latter half of March, with a call-in system being launched March 8 for those targeted in Phase 2. On the following dates, seniors and Indigenous people can call in to book their appointments:

  • March 8, 2021: Seniors born in or before 1931 (90 years+)/Indigenous peoples born in or
    before 1956 (65 years+)
  • March 15, 2021: Seniors born in or before 1936 (85 years+)
  • March 22, 2021: Seniors born in or before 1941 (80 years+)

Vaccines for that group will begin taking place on March 15. The government is asking people to visit its senior vaccination website for more information on health authority contacts, call-in schedules and step-by-step instructions on how to make an appointment.

The government also revealed that over the weekend, it approved a four-month window between doses one and two of the Pfizer and Moderna vaccines because the first dose has been higher than 90 per cent effective after three weeks, with protection lasting four months.

Because of that, more initial doses will be made available to a broader segment of the population sooner, according to the province.

The province has been operating under Phases 1 and 2 of its immunization plan over winter, with the most at-risk and vulnerable populations receiving the vaccine so far.

Also not included in the government’s rollout plan was the recently approved Astra-Zeneca vaccine, which Henry touted as being more “fridge-stable” compared to the current two vaccines in use. She also said it will speed up delivery plans even further. Canada is expected to get 24-million doses of the vaccine between April and September. The province is not yet sure how much of that it will be getting and when.

Once Phases 3 and 4 begin more of the general population will be able to schedule their vaccination appointments by phone or through a government website.

One such immunization clinic was held at the University of Victoria over the weekend, where front-line health care workers received their first doses of the vaccine.

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Ontario reports fewest number of coronavirus-related deaths in a single day since late October – CP24 Toronto's Breaking News

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Ontario logged just over 1,000 new cases of COVID-19 today and six more virus-related deaths, the lowest single-day death toll reported since late October.

Ontario health officials confirmed 1,023 new cases of the disease caused by the novel coronavirus on Monday, down from 1,062 on Sunday and 1,185 on Saturday. Today’s case count is also lower than the 1,058 infections logged one week ago.

Six new virus-related deaths were confirmed today, the lowest single-day death toll reported since Oct. 28, when just five new deaths were logged in the province.

The rolling seven-day average of new deaths now sits at 16, down from 24 at this point last week.

Just over 35,000 tests were processed over the past 24 hours with the Ministry of Health reporting a provincewide positivity rate of 3.1 per cent today, down from 3.3 per cent last Monday.

The rolling seven-day average of new infections is now 1,099, up from 1,045 last week.

According to the province, there are now 659 patients infected with COVID-19 who are receiving treatment in hospital, up from 646 seven days ago.

The number of patients in intensive care is now 280, down from 289 on Sunday but unchanged from last Monday.

It should be noted that hospitalization data is less reliable early in the week due to gaps in reporting from some hospitals in the province.

The number of active cases of COVID-19 in Ontario is now 10,570, up from 10,335 last Monday. Of the new cases reported today, 280 are in Toronto, 182 are in Peel Region, and 72 are in Ottawa.

New restrictions imposed in 2 Ontario regions

The Thunder Bay and Simcoe-Muskoka public health units are under new restrictions starting today following a surge in COVID-19 infections in both regions. The province activated its so-called “emergency brake” last week to place both public health units into the grey, or “lockdown,” category of its colour-coded reopening framework.

The move forced restaurants to shut down in-person dining once again and close gyms, barbershops, and hair salons.

The rise in cases in those regions has been partially attributed to the circulation of more transmissible COVID-19 variants. The Simcoe-Muskoka District Health Unit is reporting a total of nearly 200 confirmed cases of the B.1.1.7 variant, which was first detected in the United Kingdom. This accounts for more than a third of all confirmed cases involving a variant of concern across Ontario.

The province reported another seven cases of the B.1.1.7 variant on Monday, bringing the total number of confirmed cases to 535. There are a total of 27 confirmed B.1.351 variant cases in Ontario along with three of the P.1 variant of concern.

Thousands of additional cases have screened positive for a variant of concern but have not yet undergone full genome sequencing. The province has said it is only a matter of time before the B.1.1.7 variant becomes the dominant strain in Ontario.

The province’s continues to roll out vaccine doses as part of Phase 1 of its COVID-19 vaccination program and starting today, multiple regions of Ontario, including Hamilton and York Region, began inoculating members of the general population over the age of 80. Ontario has administered a total of 704,695 doses of a COVID-19 vaccine to date and 263,214 people have received two doses for full immunization.

The numbers used in this story are found in the Ontario Ministry of Health’s COVID-19 Daily Epidemiologic Summary. The number of cases for any city or region may differ slightly from what is reported by the province, because local units report figures at different times.

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Coronavirus: Latest developments in the Greater Toronto Area on March 1 – Global News

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Here are the latest developments on the coronavirus pandemic in the Greater Toronto Area for Monday.


Toronto’s Porter Airlines sets new tentative reopening date of May 19

Toronto’s Porter Airlines has set a new tentative reopening date again of May 19 amid the ongoing coronavirus pandemic.

The airline suspended its operations in March 2020 due to COVID-19 and the restart date has since been pushed several times. The last tentative date was March 29.

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Read more:
Coronavirus: Toronto’s Porter Airlines sets new tentative reopening date of May 19


Status of cases in the GTA

Ontario reported a total of 1,023 new coronavirus cases on Monday.

Of those:

  • 280 were in Toronto
  • 182 were in Peel Region
  • 47 were in York Region
  • 34 were in Durham Region
  • 39 were in Halton Region


Ontario reports more than 1,000 new coronavirus cases, 6 more deaths

Ontario is reporting 1,023 new coronavirus cases on Monday, bringing the provincial total to 301,839.

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The death toll in the province has risen to 6,986 as six more virus-related fatalities were reported which is the lowest single-day increase in deaths since the end of October.

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Resolved cases increased by 939 from the previous day. The government said 35,015 tests were processed in the last 24 hours

Read more:
Ontario reports more than 1,000 new coronavirus cases, 6 more deaths


Cases, deaths and outbreaks in Ontario long-term care homes

According to the Ministry of Long-Term Care, there have been 3,744 deaths reported among residents and patients in long-term care homes across Ontario which is unchanged from yesterday. Eleven virus-related deaths in total have been reported among staff.

There are 106 current outbreaks in homes, which is unchanged from the previous day.

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The ministry also indicated there are currently 80 active cases among long-term care residents and 179 active cases among staff — cases for both have stayed the same in the last 24 hours.


Cases among students and staff at Ontario schools, child care centres

Meanwhile, government figures show there have been a total of 8,563 school-related COVID-19 cases in Ontario to date. This is an increase of 116 more cases in the last day — 99 student cases, 15 staff cases and two were not identified.

The COVID-19 cases are currently from 530 out of 4,828 schools in the province. Twenty schools in Ontario are currently closed as a result of positive cases, the government indicated.

There have been a total of 2,675 confirmed cases within child care centres and homes — an increase of 13 (seven new child cases and six staff cases). Out of 5,264 child care centres in Ontario, 139 currently have cases and 21 centres are closed.

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COVID-19 pandemic zaps electricity usage in Ontario as people stay home

Demand for electricity in Ontario last year fell to levels rarely seen in decades amid shifts in usage patterns caused by pandemic measures, new data show.

The decline came despite a hot summer that had people rushing to crank up the air conditioning at home, the province’s power management agency said.

In all, Ontario used 132.2 terawatt-hours of power in 2020, a decline of 2.9 per cent from 2019.

Read more:
COVID-19 pandemic zaps electricity usage in Ontario as people stay home

NOTE: This story will be updated throughout the day.

— With files from The Canadian Press.

© 2021 Global News, a division of Corus Entertainment Inc.

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