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Human challenge trials are a fast way to see if a coronavirus vaccine works. But are they ethical? – Globalnews.ca

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Across the world, there are well over 100 possible vaccines, in one stage of development or other, that makers hope will work on the novel coronavirus.

The first question about any vaccine is: is it safe? The second: does it work?

Recently, a large group of scientists, including 33 Nobel laureates, proposed a simple, but ethically fraught way of answering the second question: give healthy volunteers the trial vaccine, then deliberately try to infect them with coronavirus.

It’s called a “human challenge trial,” and while the logic is obvious, the ethical challenges seem equally obvious.

The practice “may seem intuitively unethical,” and there is a dark history of “unethical research involving deliberate infection of research subjects,” a World Health Organization paper published in May conceded.

“However, there is a consensus among ethicists who have reflected upon human challenge studies that the intentional infection of research participants can be ethically acceptable under certain conditions.”

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Coronavirus: Dr. Njoo ‘encouraged’ by start of Canadian COVID-19 vaccine trials, but urges patience


Coronavirus: Dr. Njoo ‘encouraged’ by start of Canadian COVID-19 vaccine trials, but urges patience

The scientists’ petition argued for human challenge trials on the grounds that they would lead to a working vaccine being available much faster.

“If challenge trials can safely and effectively speed the vaccine development process, there is a formidable presumption in favor of their use, which would require a very compelling ethical justification to overcome,” they wrote.

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University of Toronto epidemiologist David Fisman disagrees. He called it “unethical” in an exchange of Twitter messages.

“Why would anyone do human challenge with a virulent pathogen?”

“(There are) lots of names there that I respect but no, I don’t think that’s right. There’s a rip-roaring COVID epidemic in the U.S. There is plenty of COVID exposure happening without human experimentation with a virulent pathogen.”

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Under the model proposed in the petition, the trials would have to meet a number of requirements:

  • The people involved should be “relatively young and in good health,” and those with pre-existing conditions should be excluded. The petition argues that people aged 20-29 have a similar death rate from coronavirus as that suffered by living kidney donors.
  • They should be given the “highest quality medical care with frequent monitoring.”
  • They should be true volunteers, with children and prisoners excluded. “A large … fraction of the general population is willing to undergo meaningful risks to benefit others due to genuinely altruistic motivation,” it argues.





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When will a COVID-19 vaccine be ready?


When will a COVID-19 vaccine be ready?

Oxford University’s Jenner Institute said this week that it planned to start human challenge trials for coronavirus, the kind of tests recommended in the petition, by the end of the year. It said that this approach could see testing completed in a matter of weeks.

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More traditionally, a vaccine’s effectiveness would be tested on a large number of people in an area where the disease is widespread, explains the University of Toronto’s Colin Furness.

“There are a bunch of different strategies you can use to try to build immunity, or provoke immunity,” he says.

“Normally, what you do is you find a population where the disease is rampant, and you can see what proportion of the population is getting sick.”

But that approach would take too long, the petition argues:

“The rationale for human challenge trials is that they can greatly accelerate the development of a COVID-19 vaccine,” it says.

Human challenge trials can provide information much faster than conventional efficacy trials, which take months longer.”






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Coronavirus: ‘No guarantee’ safe COVID-19 vaccine will be made, Fauci says


Coronavirus: ‘No guarantee’ safe COVID-19 vaccine will be made, Fauci says

Furness worries that human challenge testing could happen in parts of the world where there is less accountability about medical ethics.

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“Unfortunately, of course, humans have a very weak track record of ethical behaviour in medical research,” he says.

“You can speed up your testing by behaving less carefully and less ethically. So if you have a situation where you’re not worried about ethics, then you can tie people down and expose them and find out in a matter of days, rather than weeks or months, whether the vaccine is working.”

In late June, the Chinese army said it planned to test a coronavirus vaccine on soldiers. It would not say whether they were allowed to opt out of the experiment. China’s army inducts about 460,000 conscripts a year.

© 2020 Global News, a division of Corus Entertainment Inc.

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Ontario reports 1,708 new coronavirus cases; 24 new deaths – CP24 Toronto's Breaking News

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Ontario reported 1,708 new cases of COVID-19 on Sunday and 24 new deaths, as hospitalizations broke the 600-mark for the first time since the start of the second wave of the pandemic in September.

“Locally, there are 503 new cases in Peel, 463 in Toronto and 185 in York Region,” Health Minister Christine Elliott wrote on Twitter.

Ontario reported 1,822 new cases of COVID-19 on Saturday and 1,855 on Friday.

Provincial labs processed nearly 54,000 specimens in the past 24 hours, the third day in a row more than 50,000 results were processed.

Sunday’s tests generated a positivity rate of 3.7 per cent, higher than Saturday’s 3.4 per cent and the same as on Friday.

There are now 13,779 active cases of novel coronavirus infection in Ontario, up from 12,918 one week ago.

A total of 3,648 people have died of infection since early March, and 97,319 people have recovered from illness.

One-hundred and sixty-two people have died of infection in the past week.

Seven of the 24 people who died on Sunday were residents of the long-term care system.

The province said 586 people were in hospital due to COVID-19 symptoms on Sunday, down 11 from Saturday, but could not provide a breakdown of intensive care and ventilated patients.

A count of data from local public health units and hospital networks found 601 people in hospital for treatment of COVID-19 symptoms on Sunday, the highest number found since the start of the second wave.

Elsewhere in the GTA, Durham Region reported 73 new cases, Halton Region reported 31 new cases and Hamilton reported 60 new cases.

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A look at what provinces and territories have said about COVID-19 vaccine plans – Preeceville Progress

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The federal government is laying plans for the procurement and distribution of COVID-19 vaccines, inking contracts with seven potential manufacturers and saying six million doses could arrive in the country in the first quarter of 2021. The most recent development from Ottawa came Friday when Prime Minister Justin Trudeau tapped former NATO commander Maj.-Gen. Dany Fortin to lead the national distribution effort. But various provinces have started spelling out their plans as well. Here’s a look at what they’ve said so far:

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Nova Scotia

The province’s chief medical officer of health says he will release a detailed plan for the distribution of a COVID-19 vaccine once Ottawa shares more information.

Dr. Robert Strang said Friday there is no certainty yet about the availability of a vaccine, but expressed hopes an initial supply will trickle into Nova Scotia early in the new year.

Strang said a detailed provincial plan, to be released once the federal government has shared more specifics on its end, will include tight control of the supply and clear rules dictating who can be first in line for immunization.

He said he’s waiting for more federal guidance on issues ranging from priority groups to transportation and storage logistics.

Quebec

The province will be ready to start rolling out its vaccine plan as of Jan. 1, say senior politicians.

Premier Francois Legault said Thursday that public health officials have already settled on the list of priority vaccine recipients, but did not release details.

Legault said the province is also working to put the necessary infrastructure in place to support a vaccine rollout. That includes obtaining fridges capable of maintaining the extremely low temperatures needed by one of the most promising potential vaccine options, currently in development through pharmaceutical giant Pfizer.

Quebec has also tasked assistant deputy health minister Jerome Gagnon, and former provincial public health director Dr. Richard Masse to oversee the province’s vaccination effort.

Ontario

Premier Doug Ford is among those leaders calling on Ottawa to provide more clarity as officials scramble to develop a provincewide vaccination strategy.

Early speculation on the number of doses the province could receive was put to rest earlier this week when federal Health Minister Patty Hajdu said such details were still in the works.

But Ford has forged ahead, naming former chief of national defence Gen. Rick Hillier to oversee the province’s vaccine rollout.

Hillier said on Friday he hopes to have a plan developed by year’s end, while Ford urged Ottawa to provide detailed information on potential vaccine delivery.

“We need a clear line of sight into the timelines of the shipments,” Ford said.

Alberta

The province’s top medical official has said she expects to receive 680,000 doses of COVID-19 vaccine early in the new year, a figure not yet confirmed by the federal government.

Dr. Deena Hinshaw has also said a number of hurdles and unknowns remain as the province works to devise its vaccination scheme.

“These (vaccine) numbers, of course, depend on many factors,” Hinshaw said on Nov. 18. “They depend on the final pieces of the trials that are underway going well. They depend on ensuring that the safety and the effectiveness of the early vaccines can be assured. All of those checks and balances must be cleared.”

On Friday, Hinshaw said the province is working with Ottawa to get vaccine, but it is “a bit of a moving target” on when vaccines might be available.

“But our goal is that whenever vaccine is available, we will be ready to start immunizing individuals on that highest priority list.”

British Columbia

Provincial health officials announced on Wednesday that a vaccine strategy for the province is already in the works.

Dr. Bonnie Henry, the province’s top doctor, said Dr. Ross Brown of Vancouver Coastal Health will join the group working to organize the logistics around the distribution of vaccines.

Henry said front-line workers as well as those in long-term care homes will likely have priority for vaccinations.

She cautioned that while the province has contracts with vaccine makers, there can be challenges with offshore manufacturing.

“It’s very much focused on who is most at risk and how do we protect them best,” Henry said. “There’s a lot of discussion that needs to happen.”

Henry said the province hopes to have vaccines in hand by January.

Yukon

Premier Sandy Silver told the legislature on Wednesday that the territory has been in discussions with various levels of government on a vaccine rollout plan.

He said the goal will be to provide vaccines to elderly people and health-care providers.

Silver said rural and remote communities should also get priority status in northern regions, a fact he said he’s emphasized with federal authorities.

The premier said he has joined the other provincial and territorial leaders in pushing for a national strategy to distribute the vaccine.

“How confusing would it be for 13 different strategies right across the nation?” he said.

Silver said the Pfizer vaccine could cause logistical problems for remote communities because of its cold-storage requirements, but those issues may not apply to other vaccines under development.

This report by The Canadian Press was first published Nov. 29, 2020.

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COVID-19 cases in Canada remain on troubling course, Tam says, amid rising numbers – CFJC Today Kamloops

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Her assessment comes as case counts continued to soar in numerous provinces.

Quebec set a new single-day record with 1,480 new infections today as the provincial death toll crossed the 7,000 threshold.

Ontario, meanwhile, logged case numbers just shy of Friday’s one-day record as it reported 1,822 new diagnoses in the past 24 hours.

Case numbers also jumped sharply in Manitoba where officials recorded 487 new infections and 10 new deaths.

Among those who died was a boy under the age of 10, officials said, though they offered no other details.

Figures from New Brunswick and Newfoundland and Labrador show more modest increases of four and two cases, respectively.

“If we continue on the current pace, our longer range models continue to forecast significant increases in daily case counts and estimate that there could be up to 10,000 cases reported daily by mid-December,” Tam said in a statement. “Right now, we have a window of opportunity to act collectively together with public health authorities to bring the infection rate down to a safer trajectory.”

Tam redoubled her calls for Canadians to heed public health advice, limit their social interactions and practice physical distancing in a bid to bring surging case counts under control.

This report by The Canadian Press was first published Nov. 28, 2020.

The Canadian Press

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