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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.

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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EU to extend vaccine export control measures to end of June, sources say – Global News

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The European Union is planning to extend its export authorization scheme for COVID-19 vaccines to the end of June, two EU sources told Reuters on Thursday, in a move that could reignite tensions with countries who rely on shots made in the EU.

The mechanism was set up at the end of January as a reaction to vaccine makers’ announcements of delays in the deliveries of COVID-19 vaccines to the EU.

Read more:
EU to propose ‘digital green pass’ as proof a person has been vaccinated

It is due to expire at the end of March, but the European Commission wants to extend it through June, the two officials said.

“The Commission will propose its extension into June. And that was greeted by the member states with approval, not necessarily enthusiasm, but there is a feeling that we still need that mechanism,” one senior EU diplomat said.

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The second official added that at a meeting with EU diplomats on Wednesday, many countries supported the measure, including heavyweights Germany and France.

The EU Commission was not immediately available for comment.






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Coronavirus: Canada received ‘strong assurances’ from EU leadership on vaccine deliveries, Trudeau says


Coronavirus: Canada received ‘strong assurances’ from EU leadership on vaccine deliveries, Trudeau says – Feb 2, 2021

Italian Prime Minister Mario Draghi has also called for sanctions on companies that do not respect their contractual obligations with the EU.

When the EU’s export control mechanism was introduced in late January it triggered an outcry from importing countries who feared their vaccine supplies might have been hampered.

Under the scheme, companies must get authorization before exporting COVID-19 shots and may have export requests denied if they do not respect their supply commitments with the EU.

However, the EU has authorized all requests for export since the scheme’s debut on Jan. 30 to Feb. 26, which amounted to 150 requests for millions of shots to 29 countries, including Britain, the United Arab Emirates and Canada, an EU Commission spokeswoman said.

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Read more:
AstraZeneca backtracks, says it will meet EU supply for Q2 after reporting shortfall

She added, however, that at least one request was withdrawn by an exporting company. She declined to elaborate.

Export requests mostly concern the Pfizer-BioNTech vaccine which is manufactured in Belgium. AstraZeneca and Moderna shots have also been exported from the EU.

Since Jan. 30 more than eight million vaccines were shipped from the EU to Britain, a third EU source said.


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Coronavirus: Trudeau questioned on EU export controls over vaccine production


Coronavirus: Trudeau questioned on EU export controls over vaccine production – Feb 2, 2021

Britain has so far prevented the export of AstraZeneca vaccines to the EU, using a U.K.-first clause in its supply contract with the Anglo-Swedish firm, EU officials have said.

The United States also has regulations that effectively ban vaccine exports, the head of the European Commission Ursula von der Leyen told a news conference last week.

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A look at COVID-19 vaccinations in Canada on Thursday, March 4, 2021 – Yahoo News Canada

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The latest numbers on COVID-19 vaccinations in Canada as of 4 a.m. ET on Thursday, March 4, 2021.

In Canada, the provinces are reporting 77,572 new vaccinations administered for a total of 2,091,700 doses given. The provinces have administered doses at a rate of 5,519.103 per 100,000.

There were 129,330 new vaccines delivered to the provinces and territories for a total of 2,611,680 doses delivered so far. The provinces and territories have used 80.09 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. There were 1,800 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 966 new vaccinations administered over the past seven days for a total of 12,596 doses given. The province has administered doses at a rate of 79.405 per 1,000. 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 85.6 per cent of its available vaccine supply.

Nova Scotia is reporting 6,054 new vaccinations administered over the past seven days for a total of 35,291 doses given. The province has administered doses at a rate of 36.163 per 1,000. 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 56.94 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. 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 17,382 new vaccinations administered for a total of 472,710 doses given. The province has administered doses at a rate of 55.245 per 1,000. There were 100,620 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 74.04 per cent of its available vaccine supply.

Ontario is reporting 27,398 new vaccinations administered for a total of 754,419 doses given. The province has administered doses at a rate of 51.359 per 1,000. 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 83.52 per cent of its available vaccine supply.

Manitoba is reporting 1,966 new vaccinations administered for a total of 80,171 doses given. The province has administered doses at a rate of 58.221 per 1,000. There were 8,190 new vaccines delivered to Manitoba for a total of 116,650 doses delivered so far. The province has received enough of the vaccine to give 8.5 per cent of its population a single dose. The province has used 68.73 per cent of its available vaccine supply.

Saskatchewan is reporting 1,361 new vaccinations administered for a total of 81,597 doses given. The province has administered doses at a rate of 69.20 per 1,000. 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 109.4 per cent of its available vaccine supply.

Alberta is reporting 10,229 new vaccinations administered for a total of 255,283 doses given. The province has administered doses at a rate of 57.992 per 1,000. 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 92.84 per cent of its available vaccine supply.

British Columbia is reporting 6,627 new vaccinations administered for a total of 289,809 doses given. The province has administered doses at a rate of 56.476 per 1,000. There were 18,720 new vaccines delivered to British Columbia for a total of 382,740 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 75.72 per cent of its available vaccine supply.

Yukon is reporting 990 new vaccinations administered for a total of 18,158 doses given. The territory has administered doses at a rate of 435.12 per 1,000. 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 96.07 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. 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 5,327 new vaccinations administered for a total of 13,393 doses given. The territory has administered doses at a rate of 345.84 per 1,000. 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 56.04 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 4, 2021.

The Canadian Press

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B.C. reports 438 new COVID cases, 2 deaths; Dr. Henry defends vaccine plan – Pentiction Western News

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B.C. is reporting 438 new COVID-19 cases and two deaths as of Tuesday (March 2), provincial health officer Dr. Bonnie Henry said.

By health authority, it breaks down to 137 new cases in Vancouver Coastal Health, 249 in Fraser Health, 19 in Island Health, 16 in Interior Health and 17 in Northern Health. There are now a total of 4,679 active cases and 8,445 people in isolation.

There are 243 people in hospital, of whom 62 are in ICU with the virus. There have been a total of 81,367 cases in B.C. since the pandemic began, of which 72,255 have recovered. B.C.’s death toll from the virus has reached 1,365.

Henry on Tuesday defended delaying the second dose of COVID vaccines for up to four months. Health officials announced Monday that choosing to delay the booster shot would allow all B.C. adults to receive their first dose by mid-July.

“If you give it too soon, your body’s immune system doesn’t recognize it as something news,” she said. “If you extend it a period of time as long as six months… you can get a more durable and long-lasting protection.”

Henry said that last week’s approval of AstraZeneca allows B.C. to be “more agile” in targeting areas of outbreaks and transmission. However, she noted that people will by and large not have a choice in which vaccine they get, but that the AstraZeneca could be offered to some front line and essential workers earlier than they may get the Pfizer and Moderna vaccines.

“The vaccine you are offered is the best vaccine,” she said. “I would not suggest people wait.”

However, upcoming mass vaccinations of seniors are expected to continue using the Pfizer and Moderna.

B.C. also extended its state of emergency for the COVID pandemic to March 16, marking nearly one full year.

READ MORE: Most B.C. adults could get their first COVID vaccine shot by July: health officials


@katslepian

katya.slepian@bpdigital.ca

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