Connect with us

Health

‘Planning for dropouts’: Drugmakers grapple with testing unproven vaccines on seniors – Salmon Arm Observer

Published

 on


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


Like us on Facebook and follow us on Twitter.

Want to support local journalism during the pandemic? Make a donation here.

CoronavirusSeniorsvaccines

Get local stories you won’t find anywhere else right to your inbox.
Sign up here

Let’s block ads! (Why?)



Source link

Continue Reading

Health

As BC COVID Cases Rise, Health Officials Say Better Days Are Ahead – Toronto Star

Published

 on


Despite rising COVID-19 cases, especially in Metro Vancouver, provincial health officer Dr. Bonnie Henry didn’t announce new measures to curb the spread of the virus in a briefing today.

Henry urged British Columbians to continue to stay home when sick, wear a mask in public spaces and not socialize outside their households — public health orders that have been in place for nearly five months.

“It is concerning that we’re seeing an increase in our per-cent positivity and in our weekly average, particularly in the Lower Mainland,” she said.

“We know what to do to manage.”

The province need only stay the course to lower transmission as it continues to roll out vaccines to the most vulnerable to serious illness, she said.

But recent data shows the number of people infected is beginning to climb again after a slow decline. Earlier this month, the province was reporting about 450 new COVID-19 cases each day.

On Thursday, the province reported 617 new cases. Today, Henry said 559 new cases had been identified.

And the rolling seven-day average of new daily cases has surpassed 500 for the first time since early January.

Recent polling also suggests British Columbians are less likely to consistently follow COVID-19 guidelines than people in other provinces.

Concerns have also increased after seven schools reported students and staff had been exposed to COVID-19 variants that are believed to be more easily transmitted and potentially more likely to cause serious illness.

Education Minister Jennifer Whiteside acknowledged the issue in a briefing Monday.

“I can appreciate the anxiety,” she said. But she added that testing has shown the variants are not being spread within schools.

Henry said the province is testing all positive cases for evidence of a variant, and genomic sequencing has been ramped up to confirm the extent of variants in the community.

“We are paying extra attention, so we better understand how and where these are spreading,” she said.

“We’re learning about the impacts of these variants of concern,” Henry said. “But we know what we have to do to manage it.”

Henry said there are signs the province’s vaccination effort has saved lives, particularly in long-term care.

More than 220,000 people have been vaccinated, and at least 55,057 of those have had two doses.

The province reported one death due to COVID-19 today, an individual in assisted living.

There have been no new cases or deaths in long-term care in the last 24 hours, and 92 per cent of residents have had their first dose of the vaccine, Henry said.

Loading…

Loading…Loading…Loading…Loading…Loading…

Outbreaks in long-term care have also dropped from almost 60 in December to 12. There are five outbreaks in assisted living facilities.

On Monday the province will announce the plan for vaccinating seniors over 80 living in the community, Henry said, which will begin shortly.

“We are in a period of vaccine hope and pandemic reality,” she said.

Let’s block ads! (Why?)



Source link

Continue Reading

Health

21K vaccinations booked, thousands left frustrated by technical issues around Alberta's rollout – CTV Toronto

Published

 on


CALGARY —
Registration opened Wednesday morning for Alberta seniors to book vaccination appointments, but the system crashed within minutes, leaving many frustrated.

“As anticipated, we are experiencing very high volumes with the AHS COVID-19 immunization booking tool,” officials wrote on social media.

“The tool remains live. If you are having trouble accessing the site, please try again shortly. Thank you for your patience.”

Health Minister Tyler Shandro said on social media he was “disappointed that the launch of the vaccine booking tool today did not go more smoothly.”

“At launch, more than 150,000 users attempted to visit the site, causing a number of technical issues,” he wrote.

To fix the problems, Shandro said network capacity had been added to 10 servers and additional staff has been brought in to answer Health Link calls.

As of 1 p.m. Wednesday, Shandro said 21,000 appointments had been booked.

All Albertans age 75 and older — including those who will turn 75 this year — can book appointments by calling Health Link (811) or using and an online portal to receive the COVID-19 vaccine.

Anyone born in 1946 or earlier is eligible as part of Phase 1B of the province’s vaccination plan rollout. First Nations and Metis who are age 65 or older are also eligible. Vaccines will be provided in two doses, given five to six weeks apart.

There will be 58 sites set up to deliver vaccinations, Chief Medical Officer of Health Dr. Deena Hinshaw said on Tuesday.

Officials have said the first appointments will be available as early as 11 a.m. on Wednesday.

Let’s block ads! (Why?)



Source link

Continue Reading

Health

Only Two New COVID-19 Cases In N.B. – 91.9 The Bend

Published

 on


New Brunswick is reporting only two new cases of COVID-19 today (February 24).

Public Health says one case in the Moncton Zone 1 region involves someone in their 50s.

The case is under investigation and the individual is said to be self-isolating.

The other case is someone in their 70s in the Edmundston Zone 4 region.

The individual is a staff member at Manoir Belle Vue and is reportedly self-isolating.

Public Health says 13 people have recovered from the virus since Tuesday which has lowered the number of active cases to 64.

Two patients are in hospital and one is in the ICU.

There have been 26 COVID-related deaths in the province.

On Tuesday, 797 tests were conducted.

All zones remain in the Orange level under the province’s mandatory order.

Let’s block ads! (Why?)



Source link

Continue Reading

Trending