The risk to young, healthy participants, the argument goes, is small to start with and offset by the potentially massive benefit to society
It began as a proposal on the fringes of science: deliberately exposing people to COVID-19 to speed up development of vaccines, even though there’s no sure-fire treatment for the potentially lethal bug.
But the controversial idea of so-called challenge trials to test coronavirus shots seems to be picking up steam, with one huge endorsement pushing the concept ahead in recent days.
Scientists at Oxford University, which published promising early results of its would-be vaccine Monday, say they’re actively planning a challenge study.
The Oxford team is working with an unusual grass-roots group, 1DaySooner, that has recruited more than 32,000 volunteers from around the world willing to risk getting COVID-19 by taking part in such a trial.
And the group said Monday it is in talks with other vaccine developers, too, not yet ready to go public with their intentions.
Last week, the organization released an open letter signed by several Nobel laureates and other academic experts promoting the concept, as a separate survey of residents of Canada and other countries found wide support for it.
“Challenge trials are no longer a thought experiment; they may soon become a reality,” Abie Rohrig, a 1DaySooner spokesman, said Monday. “Support is growing from many scientific fields.”
Underlying the movement is the widespread belief that the world will not be free of the virus — and the economic devastation wrought by it — until people can be immunized against SARS-COV-2, the virus that causes COVID-19.
The hope is that challenge trials will get vaccines on the market sooner, as conventional Phase 3 studies depend on subjects being exposed to a germ in everyday life and seeing if they are infected. That can take months or longer.
The risk to young, healthy participants, the argument goes, is small to start with and offset by the potentially massive benefit to society.
Critics respond that the danger is unacceptable because, unlike challenge trials conducted in the past, COVID-19 can kill and there is no life-saving “rescue therapy.” Researchers preparing one of the first human trials of a vaccine in Canada have rejected the idea.
Adrian Hill, head of Oxford’s Jenner Institute, told The Guardian last week that his team developing a COVID-19 shot hopes to begin a challenge trial by the end of the year, in parallel with conventional Phase 3 studies.
Challenge trials are no longer a thought experiment
Using healthy people in their 20s as subjects, “everybody would agree that the risk is extremely low,” Hill told the British newspaper. “It’s so low that it’s very difficult to measure.”
The Oxford vaccine candidate, being developed with pharmaceutical giant AstraZeneca, is one of the furthest advanced in the world. And on Monday, the journal Lancet published results of a combined Phase 1 and 2 trial involving 1,073 people that found it to be safe and to generate an immune response.
Whether it actually prevents infection from the COVID-19 virus is still unknown, and what the Phase 3 or challenge trial would seek to find out.
A vaccine developed by China’s CanSino, which the Canadian government is now helping test, also published results of a 500-person trial showing general safety and a less-promising immune response.
Rohrig said 1DaySooner is in touch with other vaccine developers about conducting their own challenge trials, but they’re “not at a point where they can make a similar announcement.”
Meanwhile, the group is collaborating with the Oxford team in preparing the “challenge doses” — the live coronavirus to which participants will be exposed. That involves finding facilities where the exposure can occur safely, he said.
Ethicist Nir Eyal, who published the first peer-reviewed journal paper advocating COVID-19 challenge trials with colleagues at Rutgers University, said he too has heard from other scientists in the field.
“Some vaccine production teams have been in touch and expressed keen interest (in challenge trials),” he said. “That sometimes included people who publicly expressed no interest.”
Eyal said the concept can satisfy all the basic requirements of ethical research, such as informing subjects of the risk, limiting that danger and providing a commensurate benefit to society.
Rohrig cited recent French research that found the risk of death for COVID-19-infected people between ages 20 and 29 is about one in 14,000, and that includes those with underlying conditions. The risk of dying from donating a kidney — something society considers acceptable — is about one in 3,300. The 1DaySooner spokesman donated a kidney himself last year.
But Francoise Baylis, a bioethicist at Dalhousie University, is among those less than keen on the idea. She has advised the Canadian Centre for Vaccinology at Dalhousie that is readying Canadian trials of the CanSino vaccine.
She said challenge trials can only be ethically justified if there is no alternative with a similar risk-benefit equation. The Dalhousie group is planning to use “adaptive” trial designs, which enable studies to be modified as they move along in response to findings, and which they believe can be just as speedy.
“If you can achieve the same benefit — faster route to a safe and effective vaccine — with less risk to research participants, there is an ethical obligation to take (that) path,” said Baylis.
Source: – The Kingston Whig-Standard
Vaping injuries cause lingering problems for some youth, Canadian data suggests – CBC.ca
Canadian pediatricians are reporting numerous vaping-related injuries, with one third of cases involving ongoing health problems.
Interim data from the Canadian Paediatric Surveillance Program highlight the risks of vaping as well as non-medical cannabis use, particularly accidental ingestion of edibles.
A one-time survey of about 1,100 doctors found 88 cases of vaping illness or injury over a 12-month period, with one quarter of kids hospitalized.
Dr. Nicholas Chadi, a specialist in adolescent and addiction medicine at the University of Montreal, suspects this is just the “tip of the iceberg” since the numbers don’t include kids who turn to their family doctor or a nurse with vaping problems.
Chadi found it “very concerning” that about a third had ongoing issues and says vaping dangers should be raised with kids and teens as they prepare to return to school and reunite with friends.
“If we look at what might be happening in smaller cities where we have emergency room doctors who are not pediatricians receiving these kids, there are probably many, many more cases of these injuries happening in Canada,” says Chadi, also affiliated with Sainte-Justine University Hospital Centre.
Children and youth most often suffered respiratory problems or nicotine toxicity, which can cause a very rapid heart rate, dizziness, headaches, or vomiting.
The data did not reveal what ongoing issues they suffered, but Chadi suspects they included cough or shortness of breath and possibly external wounds or burns that needed time to heal.
WATCH | Smoking or vaping may increase risk of a severe coronavirus infection:
The survey also did not capture how many kids may be addicted to vaping products, something Chadi says he expects to examine in a two-year follow-up study.
Thirteen cases involved kids who drank e-liquids or other vaping substances. Half the time this was by accident, and was more common among toddlers and preschoolers.
But the other half of incidents were on purpose, and typically involved those age 15 and older, says Chadi.
Teens tend towards riskier behaviour because their brains are still developing, but Chadi notes their lungs are still maturing, too, making the impact of dicey decisions more serious.
“They might be using more of it, they might be trying to trick the device or play with it to make it stronger, to make it blow more aerosol or things like that, which will increase the risk of injury,” he says of other teen vaping habits.
“But we also know that the lungs of a teenager can be more fragile to certain chemicals because they’re still growing, they’re still developing.”
Chadi says those findings only point to an association between vaping and a COVID-19 diagnosis, noting the study also suggested young vapers were more likely to be tested for the virus.
He says that might be because respiratory symptoms common to vaping are similar to those of COVID-19, such as coughing.
When it came to cannabis-related injuries, the surveillance program found almost all of the 36 cases reported required hospitalization, with an average patient aged 9 to 10 years old.
Not all cases involved edibles, but a third of them involved kids younger than 12 who accidentally ate cannabis products.
Because edibles have only been legal since December 2019, researchers say it’s worth dedicating more time to examining the impact of legalization on kids.
Eight cases were teens who experienced hyperemesis syndrome — a condition that causes repeated and severe bouts of vomiting.
The Canadian Paediatric Surveillance Program is a joint initiative of the Public Health Agency of Canada and the Canadian Paediatric Society.
The two-year longitudinal study on cannabis is set to wrap in October. The two-year vaping study will begin this fall.
‘A call out to Deadpool’: B.C. premier wants stars to help fight surge in younger coronavirus cases – Global News
Calling Ryan Reynolds and Seth Rogen: B.C. Premier John Horgan wants you.
At a Wednesday press conference announcing the hiring of 500 new contact tracers in the province, Horgan also called on some of B.C.’s best-known celebrities to use their influence to help get younger people on board with coronavirus precautions.
“This is a callout to Deadpool right now. Ryan, we need your help up here. Get in touch with us, my number’s on the internet,” Horgan said. “Seth Rogen, another outstanding British Columbian. We need to communicate with people who aren’t hearing us. The two of you alone could help us in that regard.”
The ask comes as B.C. grapples with a growing number of new cases of the virus, many of them in the younger demographic.
About a third of new cases in July involved people aged between 20 and 29. A recent party in the Vancouver Coastal Health region led to about 400 people being quarantined and up to 46 cases of COVID-19.
Provincial government enlists ‘influencers’ in fight against coronavirus
As of Tuesday, about 42 per cent of B.C.’s cases involved people under the age of 39.
Data shows that younger adults have been less severely affected by the symptoms of the virus, but are just as capable of passing it on to others.
“We’re working as hard as we can to enlist a number of prominent British Columbians and prominent Canadians to help get that message through to the demographic that clearly isn’t hearing our message,” said Horgan, adding that “other options” were also on the table.
The province has already recruited social media influencers such as Jillian Harris to help spread the message following July’s outbreak in Kelowna linked largely to younger people.
Last month, provincial health officer Dr. Bonnie Henry did an “account takeover” on actor Olivia Munn’s Instagram.
And the province has launched a website dubbed Dr. Bonnie Henry’s Good Times Guide with information for young people about how to socialize safely during the pandemic.
© 2020 Global News, a division of Corus Entertainment Inc.
Travel led to 18% of Waterloo region's COVID-19 cases in July – CBC.ca
Travel-related infections made up 18 per cent of the region’s new confirmed COVID-19 cases in July, public health says.
Dr. Ryan Van Meer, one of the region’s associate medical officers of health, said Tuesday 15 of 81 cases were related to out-of-country travel: seven of those were people who had travelled to the United States, five were people who travelled to India and one case each involved trips to the United Kingdom, Nicaragua and Pakistan.
So far in August there have been 25 new cases. Six of those are travel related, the region’s COVID-19 dashboard shows.
“This serves as an important reminder that travel outside of Canada continues to pose a risk,” Van Meer told regional councillors during a committee meeting Tuesday. He noted the federal government continues to advise against unessential travel outside of the country.
Public health officials said they do not record the reason why a person has visited another country, so it’s unknown if those who travelled did so for work, family commitments or a vacation.
Van Meer says the overall status of the novel coronavirus in the region “remains stable.”
The region reported 1,410 cases as of Wednesday morning, a rise of four cases since Tuesday. More than 58,200 tests have been done and 90 per cent of positive cases have been marked as resolved.
There are 28 active cases in the region with two people in hospital. The number of people who have died from COVID-19 since March remains at 119.
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