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Why restricting AstraZeneca vaccines in Canada means balancing 'vaccine risk vs. disease risk' – CBC.ca

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This is an excerpt from Second Opinion, a weekly roundup of health and medical science news emailed to subscribers every Saturday morning. If you haven’t subscribed yet, you can do that by clicking here.


Canada’s decision to suspend the use of the AstraZeneca-Oxford vaccine in Canadians under 55 during a surging third wave and a slow vaccination rollout is a calculated risk.

The National Advisory Committee on Immunization (NACI) updated its guidance to provinces and territories against the use of the vaccine for younger Canadians on Monday, following reports of rare but potentially fatal blood clots in Europe connected to the shot.

Health Canada says the benefits of the vaccine to protect against COVID-19 still outweigh the potential risks, with more than 300,000 doses of the shot administered and no cases of the serious clotting condition, known as vaccine-induced prothrombotic immune thrombocytopenia (VIPIT), in Canada. 

But the decision to restrict the use of one of four approved vaccines at a time when COVID-19 levels are rising again in Canada’s hardest hit provinces is a tough pill to swallow for some.

“It can be a very powerful tool when we’re at this stage of the pandemic where we’re talking about, in hotspots at least, the system getting to a point of potential collapse,” said Dr. Susy Hota, an infectious disease specialist at the University Health Network and an associate professor of medicine at the University of Toronto. 

“There are humans behind that story, and when you’re in a hospital where you’re seeing an exponential rise in the number of COVID-positive patients coming in, and your staff to help manage these patients is the same pool of staff — then those numbers aren’t adding up.”

But on an individual level, experts say the lack of data on the risk of VIPIT to Canadians from the AstraZeneca vaccine is concerning and NACI was right to err on the side of caution in order to avoid putting lives unnecessarily at risk. 

Pharmacist Abraam Rafael administers a COVID-19 vaccine to Maureen Doyle at his pharmacy in Toronto on March 14 as Ontario starts administering the AstraZeneca vaccine for COVID-19 to residents aged 60-64. (Cole Burston/The Canadian Press)

Race between vaccines and variants

Ontario has more ICU admissions than at any other point in the pandemic, B.C. has had its highest single-day number of new cases to date, and Quebec saw its biggest one-day spike in almost two months as more transmissible variants are spreading rapidly across Canada.

The good news is that vaccines work; eight provinces and territories reported no new deaths in a single day this week, and the decision to prioritize COVID-19 vaccines in long-term care has led to a dramatic drop in deaths in residents. 

The bad news is that the race between vaccines and variants is taking on new urgency; the majority of vulnerable Canadians are still unvaccinated and the third wave is hitting younger adults harder and showing no signs of slowing down. 

“It’s so complicated, because I look at it as being two things: What is the absolute risk of this potentially related severe side effect versus the absolute risk of the disease?” said Dr. Lynora Saxinger, an infectious diseases physician and an associate professor at the University of Alberta faculty of medicine in Edmonton.

“The other consideration is, what is the public backlash to potential outcomes of any particular course of action?”

WATCH | AstraZeneca now only recommended for Canadians over 55:

Canada’s vaccine advisory committee has changed its advice and now says the AstraZeneca COVID-19 vaccine should only be given to people aged 55 and up following concerns it could be linked to a rare blood clot. 2:21

Health Canada says VIPIT occurs at a rate of about one in 100,000 people vaccinated, with a mortality rate of about 40 per cent, although more research is needed and that risk is reduced if treated early enough. The total number of people in Europe who got the rare blood clots after vaccination is small — as of Thursday, dozens of cases have been reported compared to millions who received the shot.

But crucially, the people who appear to have an elevated risk of the rare blood clots are not the same age group most at risk from COVID-19.

“If you look at the average 30 or 40-year-old Canadian, their risk of getting severely ill from COVID based on our current experience is substantially less,” said Dr. Andrew Morris, a professor of infectious diseases at the University of Toronto.

“You’re asking them for the good of the country to take on a risk that they wouldn’t even get with COVID. So why would you give them a vaccine that is more likely to give them harm then COVID is? It makes no sense.”

Canada has had close to 23,000 COVID-19 deaths in the year since the pandemic began, but fewer than a thousand of those have been in people under 60 and just over 300 in Canadians under 50.

“What happens to NACI if they say that everything is fine, despite the European experience which really brings it into question, and then we have even one death in Canada from this?” said Morris. “NACI would be just absolutely raked over the coals.”

‘Vaccine risk versus disease risk’

Dr. David Fisman, an epidemiologist at the University of Toronto’s Dalla Lana School of Public Health, said the debate over whether suspending the vaccine in younger Canadians was the right decision is due to a miscalculation of risks for that age group.

“I think what you see is a bit of wire crossing around vaccine risk versus disease risk,” he said.

There is also a risk of clots from getting COVID-19, but that’s conditional on getting the disease first, and there are other vaccines to protect against it, he said, rather than using a vaccine linked to adverse events in this age group.

“The adverse effect here is rather devastating,” he said. “[VIPIT] seems to be killing about half the people who suffer these consequences, and is highly likely to cause permanent neurological damage in survivors.”

“Given that these are young people working in healthcare, it is likely that vaccination is conferring damage or death that they would not have suffered otherwise.”

Dr. Menaka Pai, a clinical hematologist at McMaster University and a member of Ontario’s COVID-19 Science Advisory Table, says the risks associated with VIPIT in younger adults are dangerous enough to warrant halting its use in those under 55.

“The clots that we see with VIPIT — they’re serious. If you’re not aware of them they can be hard to diagnose, they can be hard to treat,” she said. 

“If you’re older and likely to experience all the other horrible things that COVID does, including killing you, then your decision about urgency and needing any vaccine frankly is really different from somebody who is younger and probably better able to weather the storms of COVID.” 

WATCH | Should people who’ve had the AstraZeneca vaccine be concerned?

Infectious disease experts take questions about the changing advice for the AstraZeneca COVID-19 vaccine including if those who’ve had a shot should be concerned. 4:22

Pai says critics of NACI’s decision are inaccurately drawing comparisons with the risk of VIPIT to the risk of birth control pills, which also carry an increased risk of blood clots.

“The reality is that every year a little under one in 3,000 women will get a blood clot on the combined oral contraceptive pill and every year one in 300 pregnant women will get a blood clot,” she said. 

“But the clots that you get on those hormones are very different from the clots that we’re seeing related to the AstraZeneca vaccine.” 

Raywat Deonandan, an epidemiologist and associate professor at the University of Ottawa, says if the risk from the AstraZeneca-Oxford vaccine to younger Canadians can be mitigated with another COVID-19 shot, then the decision to halt the use of it makes sense.

“This is not the same as going to a place like Brazil where the disease is rampaging out of control,” he said. 

“Whereas this is the only vaccine you have available to you — take it now or I can’t guarantee you will be alive in a month. It’s a different scenario entirely.” 

But Deonandan says he can sympathize with critics of NACI’s recommendations to suspend the vaccine because of the damage the decision may do to the public perception of COVID-19 vaccine safety overall. 

“If you are saving any lives, you’re saving one or two lives [from VIPIT],” he said.  “On the other hand, you’re creating such distrust of the vaccine you may be causing hundreds, possibly thousands of deaths from people not taking the vaccine.” 

“But given what NACI’s job is, which is to advise how best to deploy vaccines, they used the best evidence and came upon the right decision for their mandate.” 


To read the entire Second Opinion newsletter every Saturday morning, subscribe by clicking here.

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CANADA STOCKS – TSX falls 0.14% to 19,201.28

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* The Toronto Stock Exchange’s TSX falls 0.14 percent to 19,201.28

* Leading the index were Stantec Inc <STN.TO​>, up 3.4%, Imperial Oil Ltd​, up 3.3%, and Corus Entertainment Inc​, higher by 2.9%.

* Lagging shares were Aphria Inc​​, down 14.2%, Village Farms International Inc​, down 9.9%, and Aurora Cannabis Inc​, lower by 9.4%.

* On the TSX 91 issues rose and 134 fell as a 0.7-to-1 ratio favored decliners. There were 24 new highs and no new lows, with total volume of 228.0 million shares.

* The most heavily traded shares by volume were Toronto-dominion Bank, Royal Bank Of Canada and Suncor Energy Inc.

* The TSX’s energy group fell 0.32 points, or 0.3%, while the financials sector climbed 2.46 points, or 0.7%.

* West Texas Intermediate crude futures rose 0.52%, or $0.31, to $59.63 a barrel. Brent crude  rose 0.4%, or $0.25, to $63.2 [O/R]

* The TSX is up 10.1% for the year.

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Air Canada signs C$5.9 billion government aid package, agrees to buy Airbus, Boeing jets

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By David Ljunggren and Allison Lampert

OTTAWA/MONTREAL (Reuters) -Air Canada, struggling with a collapse in traffic due to the COVID-19 pandemic, reached a deal on Monday on a long-awaited aid package with the federal government that would allow it to access up to C$5.9 billion ($4.69 billion) in funds.

The agreement – the largest individual coronavirus-related loan that Ottawa has arranged with a company – was announced after the airline industry criticized Prime Minister Justin Trudeau’s Liberal government for dawdling. The United States and France acted much more quickly to help major carriers.

Canada‘s largest carrier, which last year cut over half its workforce, or 20,000 jobs, and other airlines have been negotiating with the government for months on a coronavirus aid package.

In February, Air Canada reported a net loss for 2020 of C$4.65 billion, compared with a 2019 profit of C$1.48 billion.

As part of the deal, Air Canada agreed to ban share buybacks and dividends, cap annual compensation for senior executives at C$1 million a year and preserve jobs at the current level, which is 14,859.

It will also proceed with planned purchases of 33 Airbus SE 220 airliners and 40 Boeing Co 737 MAX airliners.

Chris Murray, managing director, equity research at ATB Capital Markets, said the deal took into account the “specific needs of Air Canada in the short and medium term without being overly onerous.”

He added: “It gives them some flexibility in drawing down additional liquidity as needed.”

Transport Minister Omar Alghabra said the government was still in negotiations with other airlines about possible aid.

Canada, the world’s second-largest nation by area, depends heavily on civil aviation to keep remote communities connected.

Opposition politicians fretted that further delays in announcing aid could result in permanent damage to the country.

Air Canada said it would resume services on nearly all of the routes it had suspended because of COVID-19.

‘SIGNIFICANT LAYER OF INSURANCE’

The deal removes a potential political challenge for the Liberals, who insiders say are set to trigger an election later this year.

The government has agreed to buy C$500 million worth of shares in the airline, at C$23.1793 each, or a 14.2% discount to Monday’s close, a roughly 6% stake.

“Maintaining a competitive airline sector and good jobs is crucially important,” Finance Minister Chrystia Freeland told reporters, adding the equity stake would allow taxpayers to benefit when the airline’s fortunes recovered.

The Canadian government previously approved similar loans for four other companies worth up to C$1.billion, including up to C$375 million to low-cost airline Sunwing Vacations Inc. The government has paid out C$73.47 billion under its wage subsidy program and C$46.11 billion in loans to hard-hit small businesses.

Michael Rousseau, Air Canada‘s president and chief executive officer, said the liquidity “provides a significant layer of insurance for Air Canada.”

Jerry Dias, head of the Unifor private-sector union, described the announcement as “a good deal for everybody.”

Unifor represents more than 16,000 members working in the air transportation sector.

But the Canadian Union of Public Employees, which represents roughly 10,000 Air Canada flight attendants, said the package protected the jobs of current workers rather than the 7,500 members of its union who had been let go by the carrier.

($1=1.2567 Canadian dollars)

(Reporting by David Ljunggren in Ottawa and Allison Lampert in Montreal; Additional reporting by Julie Gordon in Ottawa and Munsif Vengattil in Bengaluru; Editing by Dan Grebler and Peter Cooney)

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U.K. advises limiting AstraZeneca in under-30s amid clot worry

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LONDON —
British authorities recommended Wednesday that the AstraZeneca COVID-19 vaccine not be given to adults under 30 where possible because of strengthening evidence that the shot may be linked to rare blood clots.

The recommendation came as regulators both in the United Kingdom and the European Union emphasized that the benefits of receiving the vaccine continue to outweigh the risks for most people — even though the European Medicines Agency said it had found a “possible link” between the shot and the rare clots. British authorities recommended that people under 30 be offered alternatives to AstraZeneca. But the EMA advised no such age restrictions, leaving it up to its member-countries to decide whether to limit its use.

Several countries have already imposed limits on who can receive the vaccine, and any restrictions are closely watched since the vaccine, which is cheaper and easier to store than many others, is critical to global immunization campaigns and is a pillar of the UN-backed program known as COVAX that aims to get vaccines to some of the world’s poorest countries.

“This is a course correction, there’s no question about that,” Jonathan Van-Tam, England’s deputy chief medical officer, said during a press briefing. “But it is, in a sense, in medicine quite normal for physicians to alter their preferences for how patients are treated over time.”

Van-Tam said the effect on Britain’s vaccination timetable — one of the speediest in the world — should be “zero or negligible,” assuming the National Health Service receives expected deliveries of other vaccines, including those produced by Pfizer and Moderna.

EU and U.K. regulators held simultaneous press conferences Wednesday afternoon to announce the results of investigations into reports of blood clots that sparked concern about the rollout of the AstraZeneca vaccine.

The EU agency described the clots as “very rare” side effects. Dr Sabine Straus, chair of EMA’s Safety Committee, said the best data is coming from Germany where there is one report of the rare clots for every 100,000 doses given, although she noted far fewer reports in the U.K. Still, that’s less than the clot risk that healthy women face from birth control pills, noted another expert, Dr. Peter Arlett.

The agency said most of the cases reported have occurred in women under 60 within two weeks of vaccination — but based on the currently available evidence, it was not able to identify specific risk factors. Experts reviewed several dozen cases that came mainly from Europe and the U.K., where around 25 million people have received the AstraZeneca vaccine.

“The reported cases of unusual blood clotting following vaccination with the AstraZeneca vaccine should be listed as possible side effects of the vaccine,” said Emer Cooke, the agency’s executive director. “The risk of mortality from COVID is much greater than the risk of mortality from these side effects.”

Arlett said there is no information suggesting an increased risk from the other major COVID-19 vaccines.

The EMA’s investigation focused on unusual types of blood clots that are occurring along with low blood platelets. One rare clot type appears in multiple blood vessels and the other in veins that drain blood from the brain.

While the benefits of the vaccine still outweigh the risks, that assessment is “more finely balanced” among younger people who are less likely to become seriously ill with COVID-19, the U.K’s Van-Tam said.

“We are not advising a stop to any vaccination for any individual in any age group,” said Wei Shen Lim, who chairs Britain’s Joint Committee on Vaccination and Immunization. “We are advising a preference for one vaccine over another vaccine for a particular age group, really out of the utmost caution rather than because we have any serious safety concerns.”

In March, more than a dozen countries, mostly in Europe, suspended their use of AstraZeneca over the blood clot issue. Most restarted — some with age restrictions — after the EMA said countries should continue using the potentially life-saving vaccine.

Britain, which relies heavily on AstraZeneca, however, continued to use it.

The suspensions were seen as particularly damaging for AstraZeneca because they came after repeated missteps in how the company reported data on the vaccine’s effectiveness and concerns over how well its shot worked in older people. That has led to frequently changing advice in some countries on who can take the vaccine, raising worries that AstraZeneca’s credibility could be permanently damaged, spurring more vaccine hesitancy and prolonging the pandemic.

Dr. Peter English, who formerly chaired the British Medical Association’s Public Health Medicine Committee, said the back-and-forth over the AstraZeneca vaccine globally could have serious consequences.

“We can’t afford not to use this vaccine if we are going to end the pandemic,” he said.

In some countries, authorities have already noted hesitance toward the AstraZeneca shot.

“People come and they are reluctant to take the AstraZeneca vaccine, they ask us if we also use anything else,” said Florentina Nastase, a doctor and co-ordinator at a vaccination centre in Bucharest, Romania. “There were cases in which people (scheduled for the AstraZeneca) didn’t show up, there were cases when people came to the centre and saw that we use only AstraZeneca and refused (to be inoculated).”

Meanwhile, the governor of Italy’s northern Veneto region had said earlier Wednesday that any decision to change the guidance on AstraZeneca would cause major disruptions to immunizations — at a time when Europe is already struggling to ramp them up — and could create more confusion about the shot.

“If they do like Germany, and allow Astra Zeneca only to people over 65, that would be absurd. Before it was only for people under 55. Put yourself in the place of citizens, it is hard to understand anything,” Luca Zaia told reporters.

The latest suspension of AstraZeneca came in Spain’s Castilla y Leon region, where health chief Veronica Casado said Wednesday that “the principle of prudence” drove her to put a temporary hold on the vaccine that she still backed as being both effective and necessary.

French health authorities had said they, too, were awaiting EMA’s conclusions, as were some officials in Asia.

On Wednesday, South Korea said it would temporarily suspend the use of AstraZeneca’s vaccine in people 60 and younger. In that age group, the country is only currently vaccinating health workers and people in long-term care settings.

The Korea Disease Control and Prevention Agency said it would also pause a vaccine rollout to school nurses and teachers that was to begin on Thursday, while awaiting the outcome of the EMA’s review.

But some experts urged perspective. Prof Anthony Harnden, the deputy chair of Britain’s vaccination committee, said that the program has saved at least 6,000 lives in the first three months and will help pave the way back to normal life.

“What is clear it that for the vast majority of people the benefits of the Oxford AZ vaccine far outweigh any extremely small risk,” he said. “And the Oxford AZ vaccine will continue to save many from suffering the devastating effects that can result from a COVID infection.”

Source: – CTV News

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