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Why a pause on AstraZeneca’s coronavirus vaccine trial isn’t entirely bad news

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The world is waiting with bated breath for a coronavirus vaccine.

So when AstraZeneca, a frontrunner in Phase 3 of global trials, unexpectedly hit pause on its study due to a participant becoming ill, prospects for an early rollout dimmed.

While it might be disappointing, experts say it’s far from uncommon.

In fact, there’s some comfort to be found in the temporary hold, according to Craig Jenne, an associate professor in microbiology, immunology and infectious diseases at the University of Calgary.

“This is proof that the safety checks in place are robust and non-negotiable,” he said. “They didn’t wait for 10 patients to pause the study… We’re not willing to compromise safety to get a vaccine faster.”

AstraZeneca announced it would halt its trial Tuesday after a participant came down with a “potentially unexplained” illness. In a statement, the company said it would conduct an investigation and “review of safety data” to determine if the illness is a side effect of the vaccine or a coincidence.

The U.K.-based company began recruiting 30,000 people in the U.S. for its largest part of the study in late August. The vaccine is also being tested in thousands of people in Britain — as it’s being developed by Oxford University — as well as in Brazil and South Africa.

It’s been described by the World Health Organization as likely the world’s leading candidate and the most advanced in terms of development.

While the pause might be a setback, the researchers are ultimately being “very careful,” said Dr. Isaac Bogoch, an infectious disease specialist based out of Toronto General Hospital.

“This is exactly why you do Phase 3 clinical trials. You’re looking out for safety and efficacy,” he said. “There are certain things you can only find out if you give this drug or vaccine to thousands of thousands of people.”

AstraZeneca did not reveal any information about the possible side effect except to call it a “potentially unexplained illness.” However, a New York Times report citing an anonymous source “familiar with the situation” suggested that the participant in the U.K. trial was diagnosed with transverse myelitis — an inflammatory syndrome that affects the spinal cord and is often triggered by viral infections.

Bogoch emphasized that this is “still speculation” since the investigation has not been completed in full. The timing of the diagnosis, and whether it is linked to the AstraZeneca vaccine, remains unknown.

“It might be real. It might not be real. Let’s just wait until we hear from the people actually following this closely.”

AstraZeneca did not elaborate on how it will conduct the investigation, nor the procedural methods it undertook in the process of the third-stage study.

Jenne suspects the researchers and doctors will go through a litany of potential interactions and potential causes of the reaction of the patient, “keeping in mind that this may still be completely coincidental.”

“What exactly was the response? Is it attributable to the vaccine formulation? Was it something to do with the administration of the vaccine? How was it administered? Who administered it? Was there an underlying medical condition?” he said.

Alasdair Munro, a clinical researcher of pediatric infectious diseases in Britain who is working on the Oxford vaccine trials, provided a snapshot of what that investigation might look like in a human vaccine trial.

Munro said on Twitter that participants in Oxford studies have 24-hour-a-day access to a study doctor and complete “symptom diaries” following the vaccination. The researchers are alerted “if any serious symptoms are recorded,” which are followed up on and reviewed to see if they are related to the vaccine.

“Everything gets recorded,” he wrote, from mild to serious, and the unrelated. “If they took paracetamol for a headache, it gets recorded. Antihistamine for sneezing, gets recorded.”

The moment there are concerns a serious symptom “could” be related, “the studies stop until their dedicated safety monitoring team can collect and review all the relevant information to ensure they are happy the study is safe to continue,” he wrote.

“These reviews are extremely rigorous.”

Other vaccines on the table

Depending on what’s determined, the trial could very well go back to a second stage or even have the third stage “retooled,” Jenne said.

All parties involved in the trials also have to come to a cohesive conclusion and agree on whether it’s safe to continue, he added.

One report from the Financial Times claims AstraZeneca’s trials may resume as early as next week.

“One thing Canadians have to remember is that not all vaccines are going to be approved. That’s the whole reason we have a Phase 3,” Jenne continued.

More than 150 potential vaccines are being developed and tested globally to stop the COVID-19 pandemic, with 34 in human trials.

“This is also why Canada has invested in four different vaccine platforms. In the case one isn’t approved for whatever reason, we’re not relying on that. We have backup plans.”

Bogoch took it one step further. As pressure on researchers and pharmaceutical companies has grown, so, too, have concerns about fast-tracking trials.

The WHO has warned that “if you move too quickly to vaccinate… millions of people, you may miss certain adverse effects.”

“We hear these narratives. ‘We can’t rush this process,’ and ‘Is it going to be safe?’” Bogoch said.

“Well, here’s your safety mechanisms at work.”

— with files from the Associated Press and Reuters

 

Source: – Global News

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Lufthansa sets 2024 goal, eyes capital increase

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Germany’s flagship carrier Deutsche Lufthansa said it aims to boost its return on capital employed (ROCE) and laid out plans for a capital increase as it prepares for a business recovery amid an easing coronavirus pandemic.

The largest German airline aims to have an adjusted EBIT margin of at least 8% and an adjusted ROCE of at least 10% in 2024, it said late on Monday.

Adjusted ROCE was –16.7% in 2020 and 6.6% in 2019.

The group added it had mandated banks to prepare a possible capital increase, though size and timing have not yet been determined and the German state, which has bailed out the airline during the pandemic, has not yet given its approval.

 

(Reporting by Ludwig Burger; editing by Jonathan Oatis)

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Virtual Law Firms Are on the Rise in Canada

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Virtual law firms have been on the rise for a while. In a 2019 roundtable discussion conducted by the American Bar Association, several firm leaders met to discuss the growing presence of online legal services. The consensus was clear: virtual is the new reality.

That was 2019. In the intervening two years, the world was gripped by a global pandemic that forced most people to conduct their business indoors. As you might have guessed, demand for contactless, remote legal services has only ballooned since that roundtable discussion.

While the roundtable primarily focused on the legal industry in the US, you can witness similar trends here in Canada. Like the taxi industry and entertainment distribution industry before it, law is increasingly moving toward digital spaces.

This article explores what virtual law firms are, what benefits they present for Canadian clients, and what kind of clients are driving the virtual law boom.

Not a Change but an Addition

At its best, the shift from brick-and-mortar law firms to virtual isn’t an alteration of legal services as much as it is an addition.

The best virtual law firms do not compromise on service – they still offer traditional legal services with the expertise of real lawyers. The only difference is that they have added a new medium: a more accessible, transparent means of communication and billing.

Why Canadians Choose Online Law Firms

For some clients, the traditional brick-and-mortar firm was hard to give up. They viewed their lawyer like they viewed their doctor: a professional whose in-person expertise couldn’t be replicated in a digital space. Then, the pandemic hit. As millions more Canadians acclimatized to working online, they also habituated to the idea of doing business online.

 

Credit: Ketut Subiyanto Via Pexels

The benefits were immediately apparent. Virtual law firms feature streamlined communication, available seven days a week. They eliminate the need to go to a physical office. They offer all the same legal expertise and services as a brick-and-mortar lawyer. And, crucially, they often leverage transparent pricing: flat, predetermined legal fees with no hidden costs. A client looking for affordable legal services in Mississauga or Toronto, for instance, can simply click a few buttons and hire a lawyer on the spot.

Who Is Using These New Services?

You might be wondering: do they wheel a computer into the courtroom when someone avails themselves of a virtual lawyer? No, that isn’t quite the case.

Clients tend to use virtual law firms for everyday legal services – not necessarily courtroom representation. A client looking to create a will or name a power of attorney might choose a virtual lawyer for the sake of simplicity. A homebuyer, looking to keep costs manageable might hire a virtual lawyer for closing since their prices are both more transparent and affordable. A couple seeking to draft a cohabitation agreement may find similar benefits in an online lawyer.

The fact is that virtual legal services are not only here to stay – they are on the rise. Fortunately, the future is friendly; online law firms offer the same legal expertise as their physically housed counterparts, with the added benefits of being accessible and affordable.

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Tourmaline to expand in Montney with C$1.1 billion deal for Black Swan

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Canada‘s Tourmaline Oil Corp said on Friday it would buy privately owned Black Swan Energy Ltd in a C$1.1 billion ($908.79 million) deal, as the oil and gas producer looks to expand in the Montney region, one of North America’s top shale plays.

Canada‘s Montney, which straddles Alberta and British Columbia, has seen a wave of consolidation as companies buckled under collapsing oil prices amid the COVID-19 pandemic.

Tourmaline said the deal represents a key part of its ongoing North Montney consolidation strategy and the company sees the area as a key sub-basin for supplying Canadian liquefied natural gas.

The company in April acquired 50% of Saguaro Resources Ltd’s assets in the Laprise-Conroy North Montney play for $205 million and entered into a joint-venture agreement to develop these assets.

Analysts at brokerage ATB Capital Markets called the Black Swan assets a “hand in glove” fit with its recent acquisitions.

Tourmaline stock rose 4.5% to C$32.1.

The deal value consists of 26 million Tourmaline shares and a net debt of up to $350 million, including deal costs.

Tourmaline will acquire an expected average production capacity of over 50,000 boepd when the deal closes, likely in the second half of July.

The company, which also raised its dividend by 1 Canadian cent per share, expects the Black Swan assets to generate free cash flow of $150 million to $200 million in 2022 and beyond.

The Canadian energy sector has seen a flurry of deals with companies expecting to benefit from the rebound in oil prices as global fuel demand picks up.

ARC Resources Ltd in April bought Seven Generations Energy Ltd for C$2.7 billion to create Montney’s largest oil and gas producer.

($1 = 1.2104 Canadian dollars)

 

(Reporting by Rithika Krishna in Bengaluru; Editing by Vinay Dwivedi)

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