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'Planning for dropouts': Drugmakers grapple with testing unproven vaccines on seniors – SaultOnline.com

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TORONTO — 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 biopharmaceutical Medicago 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.”

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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Coronavirus: Toronto still waiting on vaccine supply boost from province – Global News

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While thousands of Ontario seniors 80 years of age and older were recently inoculated against COVID-19, many have not yet received their first vaccine dose.

Peel and York Regions launched their own online portals two weeks ahead of the provincial government’s website.

Online booking for appointments in York opened at 8 a.m. on Monday. Within an hour and a half, all 20,000 available spots had been claimed.

The region announced late Wednesday evening it would be opening an additional 2,000 appointments.

Read more:
Toronto officials recommend city move into grey-lockdown level next week

In Peel, public health is working in collaboration with Trillium Health Partners and William Osler Health System to provide the shots for eligible residents.

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Meanwhile, in Canada’s largest city, officials continue to wait for a badly needed boost to its vaccine rollout.

“We are vaccine availability limited,” said Toronto Fire Chief Matthew Pegg.

Pegg, who is the general manager of Toronto’s Office of Emergency Management, faced several questions about when residents in that age group would be able to receive vaccinations at city-run sites.

“There are a number of hospitals and there are a number of health care partners who are moving forward, and who are vaccinating a number of people, and residents who are over the age of 80, from the supply of vaccine that they have,” he said during a news conference on Wednesday.

Read more:
Ontario to extend COVID-19 vaccine intervals after change in federal guidance

Sunnybrook Health Sciences Centre, Michael Garron Hospital and North York General Hospital are all offering pre-registration. Their portals were also launched in advance of the provincial government site.

When asked on Monday during a news conference about why Toronto was unable to launch its own targeted vaccination effort, Dr. Eileen de Villa pointed to the considerable number of people required to be inoculated under the provincial prioritization framework.

“We have roughly, I believe, about 100,000 people working within the health-care system here, and that just doesn’t exist in other jurisdictions,” she said.

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“That’s just one example of the scale or the size and scope of the vaccination campaign that we need to undertake here in Toronto that differentiates us from other jurisdictions.”


Click to play video 'Coronavirus: Toronto and Peel Region request a return to the grey zone'



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Coronavirus: Toronto and Peel Region request a return to the grey zone


Coronavirus: Toronto and Peel Region request a return to the grey zone

Global News reached out to the Ministry of Health for comment on Wednesday afternoon, and did not receive a response in time for publication.

As of the week of February 22, Toronto received 137,670 doses of the Pfizer vaccine and 57,700 doses of the Moderna vaccine.

Toronto Public Health says this was enough to cover 97,685 people as part of the two-dose regimen. The estimated number of people to be vaccinated in phase one is 325,000.

Public Health officials in Peel Region tell Global News as of the end of last month, 65,000 doses have been received across sites that obtain doses directly from province.

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Nearly 52,000 doses have been administered to those eligible to receive one.

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

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Ontario to launch coronavirus vaccine pilot project in selected pharmacies – CP24 Toronto's Breaking News

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As vaccine supply starts to ramp up in Ontario, residents could soon get their COVID-19 vaccine in pharmacies.

The Ford government and the Ontario Pharmacists Association have reached a deal that will allow the administration of vaccines in 4,600 pharmacy locations across the province.

“We have signed agreements now with the pharmacy association to allow them to vaccinate. As you know, the minister of health has expanded the number of health care practitioners who can provide vaccines,” Solicitor General Sylvia Jones said Wednesday.

“So, we’re ready. We have put in the bricks if you may to make sure that no matter how much vaccine we have, we’re ready and able to ramp up quickly.”

Justin Bates, the president of the association, told CTV News Toronto Wednesday that a pilot project will be launched in a number of pharmacies next week in three health units – Toronto Public Health, Kingston, Frontenac, Lennos and Addington Public Health, and Windsor-Essex County Health Unit.

“I think that’s a great milestone to increase access and convenience for residents of Ontario,” Bates said.

“We’re going to start there with the limited amount of vaccine that’s available and then scale up.”

Bates added that details of the pilot project are still being finalized, including who is eligible to go to a pharmacy and what vaccine will be distributed.

The province could see 46 vaccinations in a day per pharmacy, which amounts to about one million per week, he said.

“We have the resources and infrastructure to be able to add quite a few vaccinations and give ultimately, a choice and a complementary system to both public health mass immunization clinics, as well as what the role for primary care physicians are going to going to ultimately be,” Bates said.

“This is going to be an all-hands-on-deck scenario. And pharmacies are certainly an important part of that.”

When asked if pharmacists will be involved in the rollout of therecently approved Oxford/AstraZeneca vaccine, Bates said that it is under consideration, but no final decision has been made.

The provincial government indicated that it will be using ‘a different pathway’ in delivering the AstraZeneca vaccine into people’s arms. Ontario is expected to receive approximately 190,000 doses of the vaccine this month, including 114,000 shots with an expiration date of April 2.

The province said those between the ages of 60 and 64 will have access to the AstraZeneca vaccine.

“I think because of the supply challenges, and also because we don’t want to take away from what’s available in the public health clinics, whether it’s the mass immunization clinics or the mobile pop-up clinics, I think they’re going to look for a separate supply for pharmacy, whether that’s AstraZeneca or what have you,” Bates said.

“But we want to make sure what we’re doing is complimentary. That we’re offering choice for patients, residents in the province lots of access points. We don’t want to take away from the efforts that are underway for the priority populations within the other parts of the system.”

– with files from CTV News Toronto’s Colin D’Mello

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7 additional deaths and 542 new COVID-19 cases in BC – Trail Daily Times – Trail Times

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B.C. announced 542 new COVID-19 cases and seven deaths as of Wednesday (March 3), said provincial health officer Dr. Bonnie Henry.

It breaks down to 131 new cases in the Vancouver Coastal Health authority region, 292 in Fraser Health, 31 in Island Health, 43 in Interior Health and 44 in Northern Health.

There are now a total of 4,654 active cases in the province, this includes three more people are being treated in hospital for the virus, for a total of 246. Of them, 64 are in intensive care.

In a joint statement, Henry and health minister Adrian Dix reported 18 new COVID-19 cases linked to variants of concern for a total of 200 in the province:

“Our goal is to protect as many people as possible, as quickly as possible, through the available COVID-19 vaccines. With a single primer dose, these vaccines are helping to stop outbreaks and reduce serious illness and death.”

RELATED: Federal panel recommends 4-month gap between COVID vaccine doses due to limited supply

So far, 289,809 doses of a COVID-19 vaccine have been administered in B.C., of which 86,616 were second doses.

A total of 1,372 people in B.C. have lost their lives to COVID-19 since the pandemic began. There have been a total of 81,909 cases, of which 75,819 have recovered.

There were no new reported health care facility outbreaks as a result of the virus.


@sarahgrowch
sarah.grochowski@bpdigital.ca

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