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3 more deaths, as Alberta adds 359 new cases of COVID-19 over the weekend – CTV Edmonton

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EDMONTON —
Another three Albertans have died of COVID-19 over the weekend as the province added 359 new cases, according to an Alberta Health spokesperson.

The province initially released data for Friday, Saturday and Sunday’s case count but later retracted it, citing an error and updated it again later on Monday afternoon.

The three reported deaths were all men, two of them in their 60s and one in his 80s. One of the deaths was attributed to each of the north, south and Calgary zones.

There are now 12,412 total cases of COVID-19 in Alberta, including 1,132 active cases and 224 deaths. 

A majority of the province’s 1,132 active cases are in the Edmonton zone, which covers an area bigger than the city itself. 

The city of Edmonton saw an increase of 172 new cases over the weekend, and saw its active case count rise by 84. 

Those increases put the city on the province’s watch list, after exceeding an 50 active cases per 100,000 residents. 

“The province is monitoring the risk and discussing with local government(s) and other community leaders the possible need for additional health measures,” reads the province’s website.

Dr. Deena Hinshaw, the province’s chief medical officer of health, will return on Tuesday for an in-person update.

 

 

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China pushes emergency use of COVID vaccine despite concerns – CTV News

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BEIJING —
After the first shot, he had no reaction. But Kan Chai felt woozy following the second dose of a COVID-19 vaccine approved for emergency use in China.

“When I was driving on the road, I suddenly felt a bit dizzy, as if I was driving drunk,” the popular writer and columnist recounted in a webinar earlier this month. “So I specially found a place to stop the car, rest a bit and then I felt better.”

His is a rare account from the hundreds of thousands of people who have been given Chinese vaccines, before final regulatory approval for general use. It’s an unusual move that raises ethical and safety questions, as companies and governments worldwide race to develop a vaccine that will stop the spread of the coronavirus.

Chinese companies earlier drew attention for giving the vaccine to their top executives and leading researchers before human trials to test their safety and efficacy had even begun. In recent months, they have injected a far larger number under an emergency use designation approved in June, and that number appears poised to rise.

A Chinese health official said Friday that China, which has largely eradicated the disease, needs to take steps to prevent it from coming back. But one outside expert questioned the need for emergency use when the virus is no longer spreading in the country where it was first detected.

It’s unclear exactly who and how many people have been injected so far, but Chinese vaccine makers have offered some clues. State-owned Sinopharm subsidiary CNBG has given the vaccine to 350,000 people outside its clinical trials, which have about 40,000 people enrolled, a top CNBG executive said recently.

Another company, Sinovac Biotech Ltd., has injected 90% of its employees and family members, or about 3,000 people, most under the emergency-use provision, CEO Yin Weidong said. It has also provided tens of thousands of rounds of its CoronaVac to the Beijing city government.

Separately, the Chinese military has approved the use of a vaccine it developed with CanSino Biologics Inc., a biopharmaceutical company, in military personnel.

“The first people to have priority in emergency use are the vaccine researchers and the vaccine manufacturers because when the pandemic comes, if these people are infected then there’s no way to produce the vaccine,” Yin said.

Now, large Chinese firms including telecom giant Huawei and broadcaster Phoenix TV have announced they’re working with Sinopharm to get the vaccine for their employees.

Several people who say they work in “front-line” organizations have said on social media that their workplaces have offered vaccinations for about 1,000 yuan ($150). They declined to comment, saying they would need permission from their organizations.

In an established but limited practice, experimental medications have been approved historically for use when they are still in the third and last phase of human trials. Chinese companies have four vaccines in phase 3 — two from Sinopharm, and one each from Sinovac and CanSino.

The Chinese government referenced the World Health Organization’s emergency-use principles to create its own through a strict process, National Health Commission official Zheng Zhongwei said at a news conference Friday.

He said there have been no serious side effects in the clinical trials.

“We’ve made it very clear that the COVID-19 vaccine we put into emergency use are safe,” Zheng said. “Their safety can be ensured but their efficacy is yet to be determined.”

Under the emergency rule, high-risk personnel such as medical and customs workers and those who have to work overseas are given priority access, he said. He declined to provide exact numbers.

“In China’s case, the pressure in preventing imported infections and domestic resurgence is still huge,” Zheng said.

But Diego Silva, a lecturer in bioethics at the University of Sydney, said that giving vaccines to hundreds of thousands outside of clinical trials doesn’t have “scientific merit” in China, where there are currently very few locally transmitted cases, and incoming arrivals are quarantined centrally.

“If it’s in the U.S. where the virus is still raging that’s a bit different, but in a country like China it doesn’t seem to make sense to me,” he said. “Because there’s not enough of the virus in China locally to deduce anything, you’re introducing a whole host of others factors” by injecting people outside of trials.

Zheng said that all those injected under emergency use are being closely tracked for any adverse health effects.

Kan Chai, the columnist, wrote in an article posted online in September that despite initial hesitation, he decided to sign up after he heard a state-owned company was looking for volunteers.

He didn’t say whether his was an emergency-use case, but the timing of his vaccination suggests it was. He took the first dose in late July, when the emergency inoculations were getting started and the trials were all but over.

“I’m willing to be a little white mouse, and the biggest reason is because I have trust in our country’s vaccination technology,” he said.

His real name is Li Yong, but his 1.65 million followers on the Twitter-like social platform Weibo know him better by his pen name, which means “10 years of chopping wood.” He declined an interview request.

He described taking the vaccine in a public webinar hosted by 8am HealthInsight, a popular health media outlet. It’s unclear why he qualified to receive it.

Scant information is publicly available about the program’s scope, size, and scientific merit. CNBG and parent Sinopharm declined to comment. Zheng, the National Health Commission official, did not know about the Kan Chai case.

While emergency use may be the right path, Chinese companies are not being transparent about issues such as informed consent, said Joy Zhang, a professor who researches the ethical governance of emerging science at University of Kent in Britain.

Zhang said that she could not find any relevant information on the Sinopharm website, and aside from reports published in international medical journals, there is little else made public.

She said relatively more information is publicly available about other trials such as one run by Oxford University and AstraZeneca. The trial was halted after a participant developed severe neurological side effects, and only resumed after clinical data was submitted to an independent review board.

China has a troubled past with vaccines, with various scandals over the past two decades.

The most recent case was in 2018, when Changsheng Biotechnology Co. came under investigation for falsifying records and making ineffective rabies vaccines for children.

In 2017, Wuhan Institute of Biological Products Co., a CNBG subsidiary behind one of the vaccines in phase 3 trials, was found to have made defective diphtheria vaccines that were ineffective.

Public anger over the case prompted an overhaul of a vaccine punishment law in 2019. The country tightened supervision over the vaccine development and distribution process, and increased penalties for fabricating data.

Those concerns seem to be of the past. Guizhen Wu, the chief biosafety expert for China’s Center for Disease Control, said a vaccine could be ready for the general public in China as early as November. She said she took an experimental vaccine back in April.

An overseas employee at a Chinese state-owned company, who spoke on condition of anonymity because she wasn’t authorized to speak with the media, said she decided to sign up last week.

She said she isn’t worried because a vaccine is a government priority, so authorities will keep a close watch on the process.

——

Wu reported from Taipei, Taiwan. Associated Press producer Olivia Zhang and videojournalist Dake Kang contributed to this report.

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Alberta reports 153 new COVID-19 cases, no additional deaths – Edmonton Journal

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Edmonton Public Schools reported another student at Vimy Ridge Academy tested positive, bringing the total to seven. About seven other students and two staff members have to self-isolate.

Vimy, along with Centre High, Highlands School and Austin O’Brien remain on the province’s watch list for having more than five cases. The province is also watching 10 other schools that have reported from two to four cases.

These include Ross Sheppard High School, Holy Trinity, Parkview, McNally, Ecole Pere-Lacombe, Waverly, Riverbend, Harry Ainlay, Bishop Savaryn and Louis St. Laurent.

Alberta Health Services considers a school to have an outbreak when there are two or more cases at one site within 14 days.

Meanwhile, Loblaws reported two staff members testing positive at Shoppers Drug Mart stores at Woodview Drive and Falsbridge Drive. The company said the employee at the Woodview location last worked on Sept. 23 while the Falsbridge location employee last worked on Sept. 19.

A total of 105,358 cases of COVID-19 and 9,254 fatalities have been reported across the country, according to the Canadian Press. More than 6.9 million tests have been run.

Globally, there are more than 31 million cases and more than 973,600 deaths from COVID-19, according to the World Health Organization.

Alberta’s chief medical officer of health Dr. Deena Hinshaw said Thursday a second wave of COVID-19 has not hit Alberta despite the prime minister’s declaration on Wednesday of its arrival in the country’s four biggest provinces.

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Drugmaker Novavax begins late-stage vaccine trial in U.K. – CTV News

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LONDON —
U.S.-based Novavax has begun a late stage trial of its potential COVID-19 vaccine in the United Kingdom because the high-level of the coronavirus circulating in the country is likely to produce quick results, the pharmaceutical company said.

Novavax plans to test the effectiveness of its vaccine in a trial involving 10,000 people between the ages of 18 and 84, according to a statement issued late Thursday. At least 25% of the subjects will be over the age of 65, and 400 participants will also receive a licensed flu vaccine.

The trial is being conducted in partnership with the U.K. government’s Vaccine Taskforce, which was created in April to help speed the development of a COVID-19 vaccine.

“With a high level of SARS-CoV-2 transmission observed and expected to continue in the U.K., we are optimistic that this pivotal phase 3 clinical trial will enrol quickly and provide a near-term view of (the vaccine’s) efficacy,” Dr. Gregory M. Glenn, head of research and development for Novavax, said in the statement.

The announcement comes as COVID-19 cases continue to rise across the U.K. The government reported 6,634 new positive test results on Thursday — the U.K.’s highest daily number since the pandemic began. Britain has the deadliest outbreak in Europe, with nearly 42,000 confirmed COVID-19 deaths.

Drugmakers are rushing to develop COVID-19 vaccines with the backing of governments desperate to find a way of easing restrictions that have hammered the world economy.

The U.K. has already agreed to buy 60 million doses of the Novavax vaccine to ensure it can be distributed as quickly as possible if it is approved by regulators.

The government said Friday that participants in the Novavax trial will be drawn from the 250,000 people who have volunteered to take part in COVID-19 vaccine testing through the National Health Service’s Vaccine Registry.

“Finding a safe and effective vaccine that works for the majority of the U.K. population is the best way to tackle this devastating disease,” said Kate Bingham, chair of the government’s Vaccines Taskforce. “Whilst social distancing, testing and other measures can help reduce the impact of coronavirus, the only long-term solution to beating it will be finding a vaccine.”

Novavax also pledged to publish details of its vaccine testing protocol “to enhance information-sharing during the worldwide pandemic.”

Drugmakers are under pressure to release more information about the progress of their vaccine trials — information they normally wouldn’t release until the trials are complete — to increase public confidence in their work.

Several other big pharmaceutical firms, including AstraZeneca, Moderna and Pfizer, have already released the protocols for their trials.

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