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
Spahn wants to offer supplementary vaccinations – The Germany Eye
Federal Health Minister Jens Spahn (CDU) wants to enable booster vaccinations for groups particularly at risk from the coronavirus from September onwards. In addition, all those who have been fully vaccinated and have received vaccines from Astra Zeneca or Johnson&Johnson in recent months will also be able to receive a booster with an mRNA vaccine from Biontech or Moderna from September. This is provided for in a draft resolution of the Federal Ministry of Health for the conference with the health ministers of the states, which will take place this Monday. The paper has been made available to the South German Newspaper.
Study results indicated “that there may be an increased incidence of a reduced or rapidly declining immune response in certain groups of people after a full COVID-19 vaccination,” the health ministry’s draft states. This applies in particular to the group of relevantly immunocompromised patients as well as the very elderly and those in need of long-term care. For this reason, the states are to send mobile teams to nursing homes, institutions providing integration assistance and other facilities with so-called vulnerable groups. For vulnerable persons still living at home, family physicians should offer appropriate vaccinations.
The health ministers also want to pass a resolution on the vaccination of adolescents between the ages of 12 and 17. This issue has recently been the subject of intense debate between politicians and the Standing Commission on Vaccination (Stiko). It is true that the mRNA vaccines from Biontech and Moderna have now been approved in the European Union for this age group. However, the Stiko has so far refused to issue a general recommendation for immunization of adolescents aged 12 years and older due to insufficient data. Recently, Health Minister Jens Spahn and Bavaria’s Minister-President Markus Söder (CSU) had clashed with the Stiko because they feared an unnecessary delay in the vaccination campaign. The Stiko, in turn, had defended itself against political pressure.
In the draft resolution for the conference with the states, the Ministry of Health now refrains from making a clear recommendation for the vaccination of adolescents and thus opposes the Stiko. Instead, it simply states, “All states will now offer vaccinations for 12- to 17-year-olds at vaccination centers.” Medical information, as well as a necessary agreement of the custodial parents, would be ensured thereby. In addition, children and adolescents could also be vaccinated by pediatricians and family doctors in private practice, as well as by company physicians.
Anyway, the inoculations of young people come in the meantime apparently well forward. As Spahn announced on Twitter over the weekend, 900,000 of the 4.5 million young people in this age group, i.e. around 20 percent, have already received at least one initial vaccination since the Biontech vaccine was released for young people exactly two months ago.New entry regulations have also been in place at German borders since Sunday. Drivers and train passengers must now also show proof of vaccination or testing. However, these are only checked on a random basis.
Image by Gerd Altmann
Canada to receive 2.3 million COVID-19 vaccine doses this week – paNOW
Speaking to reporters on Friday, Dr. Theresa Tam said an updated national modelling for the pandemic trajectory suggests that the highly contagious Delta variant of COVID-19 could drive a fourth wave of infections.
“The trajectory will depend on ongoing increase in fully vaccinated coverage and the timing, pace and extent of reopening,” Tam said.
“While some resurgence is expected as measures are eased, this updated model shows that if we maintain current levels of community-wide contacts, we would expect to see a modest increase in cases.”
Tam said the country could see a high increase of COVID-19 infections if reopening continues quickly before enough people are fully immunized.
“We could expect to see a sharp resurgence by the end of the summer,” she said.
She said the new forecast “reaffirms the need to take a cautious approach to relaxing public health measures to remain vigilant and responsive to signs of resurgence and to continue to increase first and second dose vaccine coverage.”
Canada reported an average of 640 new cases over the past seven days, she said, which is still 93 per cent lower than the peak of the third wave.
As of Friday, 80.3 per cent of those eligible had received a first dose, while 63.7 per cent are now fully vaccinated.
Tam said the country has made “great progress” on vaccinating those who are eligible over the last month, but there is a need to increase numbers of vaccinated even more.
“This means increasing fully vaccinated coverage above 80 per cent across all age groups and particularly in younger age groups where most of the transmission is occurring.”
This report by The Canadian Press was first published Aug. 2, 2021.
This story was produced with the financial assistance of the Facebook and Canadian Press News Fellowship.
Maan Alhmidi, The Canadian Press
Quebec's test positivity rate highest since May as COVID-19 infections climb – CBC.ca
While the number of new COVID-19 cases in Quebec remains low when compared to the peak of the third wave, the test positivity rate hit 1.4 per cent on Sunday.
That’s the highest it’s been since late May, and new public health data shows infections are on the rise.
Quebec has reported an average of 139 new cases a day over the past seven days, up from an average of 57 a week prior.
Quebec Public Health reported 154 new cases of COVID-19 on Monday and 347 new infections were identified on Friday and Saturday.
There have been no new deaths attributed to the disease since Thursday but there are 61 COVID-19 patients in hospital — of those, 17 are in intensive care.
Dr. Donald Vinh, an infectious diseases specialist at the McGill University Health Centre, told The Canadian Press that the current trends are concerning as they show “there is still ongoing community transmission.”
The increased rate is based on fewer tests, he said.
On May 31, Quebec recorded a test-positivity rate of 1.5 per cent based on 15,783 tests. While on Sunday, Quebec analyzed only 11,202 tests.
With that data in mind, Vinh said the concern lies in the future, as schools and university classes resume in late August and September.
“If it’s already increased when we are in the ‘safe’ outdoors,” he said, “what’s going to happen when we’re in the indoors?”
Quebec’s public health institute reported that 84.6 per cent of residents 12 and up have received at least one dose of vaccine while 68 per cent are adequately vaccinated.
Delta variant stirs worldwide worry
Meanwhile, health officials in the United States are sounding the alarm over the rapid spread of the delta variant which is described as extremely contagious, even among vaccinated people. It may also cause more serious disease than earlier coronavirus strains.
“High viral loads suggest an increased risk of transmission and raised concern that, unlike with other variants, vaccinated people infected with delta can transmit the virus,” said Rochelle Walensky, head of the U.S. Centers for Disease Control (CDC) in a statement last week.
On Friday, the CDC released data from a study of an outbreak in Massachusetts in which it said three-quarters of those infected had been fully vaccinated.
The CDC recommends that Americans wear masks in areas with substantial transmission “regardless of vaccination status.”
The highly contagious variant, which was first discovered in India in late 2020, has spread around the world and now accounts for the majority of cases in Canada and various other countries.
As of late July, the delta variant accounted for about five per cent of new cases in Quebec, compared to nearly 90 per cent of new cases in Ontario.
For now, Quebec is continuing to scale back restrictions. For example, bars and restaurants are now officially allowed to serve alcohol until 1 a.m.— one hour longer than what was previously allowed.
Stadiums, venues and festivals can welcome 15,000 spectators outdoors, up from 5,000.
The details on all changes can be found here.
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