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Why Canada's decision to delay 2nd doses of COVID-19 vaccines may not work for everyone – CBC.ca

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New research from two small pre-print studies suggests delaying second doses of COVID-19 vaccines by up to four months may not be the best approach for some older Canadians.

The research comes as some experts are also questioning whether Canada’s vaccination advisers, who recommended the delay, can keep up with rapidly evolving science during the pandemic.

Prior to the pandemic, the National Advisory Committee on Immunization (NACI), which has provided guidance to the federal government on vaccinations since 1964, met just three times a year to discuss issues related to vaccines for influenza, mumps, measles and other viruses.

But a year after the pandemic was declared, with new data emerging daily, NACI has been thrust into the spotlight and forced to evaluate new vaccines for a novel virus faster than ever before.

“NACI’s committees are basically made up of volunteers, many with heavy daily responsibilities during the pandemic,” said Dr. David Naylor, co-chair of Canada’s COVID-19 Immunity Task Force.

“There’s no precedent for NACI to operate at this pace, and everyone is adapting on the fly.”

NACI has met nine times since Canada approved its first COVID-19 vaccine on Dec. 10, but it has plans to ramp up in the coming months with another 13 meetings scheduled between now and the end of June.

Guido Armellin, 86, receives the COVID-19 vaccine during a clinic at a church in Toronto on March 17. A team was on-site administering the Pfizer-BioNTech vaccine to parishioners as part of a community outreach program to get seniors vaccinated at their place of worship. (Evan Mitsui/CBC)

The committee has previously overturned its initial guidance against immunocompromised individuals and pregnant women receiving COVID-19 vaccinations, as well as a controversial decision against the AstraZeneca-Oxford vaccine for those over 65.

Delay could leave cancer patients less protected, U.K. study suggests

Perhaps one of NACI’s most impactful recommendations on Canada’s vaccine rollout was the decision to delay second doses beyond manufacturing guidelines by up to four months, but emerging research signals it may not be the best approach for vulnerable Canadians.

A new pre-print study, which has not yet been peer reviewed, analyzed 151 older cancer patients and compared their immune response with 54 healthy adults after receiving the first and second doses of the Pfizer-BioNTech COVID-19 vaccine in the U.K.

The researchers concluded that delaying second doses to between eight and 12 weeks for most cancer patients left them “wholly or partially unprotected” and had implications on their health and the potential emergence of coronavirus variants. 

WATCH | Delaying some 2nd COVID-19 vaccine doses challenged by new data:

New early data suggests that Canada’s recommendation of delaying the second dose of COVID-19 vaccines to up to four months may not be effective in some older, more vulnerable patients, causing the vaccine advisory committee to re-examine its guidance. 2:36

“Our data advocates that bringing forward the second dose of the vaccine for patients who have cancer may benefit them,” said Leticia Monin-Aldama, lead author of the study and a researcher at the Francis Crick Institute in London.

“And that perhaps a sort of one-size-fits-all approach may not be ideal when delivering these vaccines to the population.”

NACI advocated for that universal approach to delay second doses by up to four months for all Canadians — the longest interval recommended by a country so far — based on limited real-world evidence and the reality of Canada’s vaccine supply.

The decision was also informed by findings from Dr. Danuta Skowronski, epidemiology lead at the British Columbia Centre for Disease Control (BCCDC), who determined that one dose of the vaccine was actually more effective than clinical trials had initially shown.

NACI said if second doses were stretched to four months across the country, close to 80 per cent of Canadians over the age of 16 could get at least one shot by the end of June.

But Canada’s chief science adviser, Mona Nemer, has said the decision to delay second doses amounted to a “population level experiment” and advised against the delay in older Canadians on CTV’s Power Play this week, citing a lack of data to back up the decision.

Darryl Falzarano, a research scientist with the Vaccine and Infectious Disease Organization (VIDO) lab in Saskatoon, is also against the decision to increase the time between doses and said there is a growing body of research that suggests it’s not the safest approach for immunocompromised and older adults.

“The initial data look like delaying the dose of the mRNA vaccines would still provide reasonable protection to the population from severe or moderate disease, and so vaccinating more people was looked at as the greater good,” he said.

“Now, in certain populations — older people, people with comorbidities and cancers — likely delayed boosting for them is sub-optimal and possibly will lead to revised recommendations for those groups.”

Darryl Falzarano, a research scientist with the Vaccine and Infectious Disease Organization lab in Saskatoon, is opposed to increasing the time between doses and says there is a growing body of research that suggests it’s not the safest approach for immunocompromised and older adults. (Debra Marshall)

B.C. study analyzed long-term care residents

A second pre-print study released this week from researchers in British Columbia, which has also not been peer reviewed, cast further doubt on the dose delay for seniors and found that their immune response may not be as strong as in younger, healthier people.

The study analyzed antibody levels in a dozen long-term care residents in Vancouver a month after receiving their first dose of a COVID-19 vaccine, compared with 22 younger health-care workers — 18 of whom had not previously been infected by COVID-19 and four who had.

“The level of antibodies in older residents was fourfold lower, so significantly decreased,” said Dr. Marc Romney, a clinical associate professor at the University of British Columbia in Vancouver and one of the authors of the study. “The function of those antibodies in older people was also compromised.”

Romney said antibodies are just part of the picture, and he also plans to look at the immune system’s full response in future research. But he said the fact that antibodies in the elderly didn’t neutralize the virus as well as in the younger health-care workers suggests the dose delay may need to be revised for them.

“There is emerging evidence that demonstrates that there are some populations that will probably not fare as well and have the same degree of protection following single doses of a vaccine,” said Dr. Isaac Bogoch, an infectious diseases physician and member of Ontario’s COVID-19 Vaccine Distribution Task Force.

“These are groups you would want to shorten the time between dose one and two.”

WATCH | The science behind delaying the 2nd dose of COVID-19 vaccines:

Federal government scientists have put their support behind delayed second doses of COVID-19 vaccines — which several provinces were already doing — and ongoing research shows some of the benefits of the adapted strategy. 2:04

‘This isn’t a regular vaccine’

The speed with which NACI members are able to make these decisions has come under fire.

Falzarano said NACI is typically used to working under a “slow-moving” vaccine regulatory process where vaccines can take up to a decade to go from research to rollout.

“Their job is to review vaccines, but their experience is reviewing them under a much different scenario,” he said.

“They are normally looking at a full data set when they have to make decisions. They would normally make very conservative decisions, and now, they find themselves in a much different scenario than what they’re used to — and I think that’s highly challenging for them.”

Visitors to a mass vaccination clinic in Toronto on Tuesday fill in paperwork as they wait in line. The National Advisory Committee on Immunization initially recommended against giving the AstraZeneca-Oxford vaccine to seniors, but that guidance changed on March 16 after it reviewed data. (Frank Gunn/The Canadian Press)

NACI’s decision to recommend against the AstraZeneca-Oxford shot for seniors on March 1 came despite emerging evidence from around the world demonstrating its ability to prevent severe COVID-19 in older adults.

But that guidance changed on March 16 after more real-world data on the vaccine’s effectiveness was reviewed by NACI, and CBC News broke the story revealing documents on the federal government’s plans to allow those 65 and older to receive it.

Alyson Kelvin, an assistant professor at Dalhousie University and a virologist at the IWK Health Centre and the Canadian Centre for Vaccinology, all in Halifax, said NACI should include more experts in emerging viruses and vaccine development to help navigate the research in the pandemic.

“This isn’t a regular vaccine that’s gone through the typical workflow for vaccine approval and vaccine development because it’s an emerging virus,” said Kelvin, who is also evaluating Canadian vaccines at the VIDO lab in Saskatoon.

“You need somebody who understands that dynamic, instead of what we would normally depend on for our medicines or vaccines.”

Dr. Caroline Quach-Thanh, who chairs NACI, responded to criticism during a news conference on March 16, saying that as new evidence emerged on the efficacy of the AstraZeneca-Oxford vaccine in older adults, NACI was “busy with other files” that delayed its guidance.

“The committee is very busy, obviously, meeting weekly to discuss the emerging data on these important topics,” said Matthew Tunis, executive secretary to the committee.

“So there’s always inevitably going to be a bit of a lag between when a committee deliberates and when the advice is made public.”

Decisions take time, NACI chair says

Quach-Thanh responded to further questions about the delay in revising recommendations on CBC’s Power and Politics on Wednesday, noting that NACI isn’t equipped to review new evidence one day and make recommendations the next.

“It’s not possible, we can’t be that reactive,” she said. “I don’t think any advisory committee can be that reactive because it would mean that every time something changes, you move the needle one way or the next.

Dr. Caroline Quach-Thanh, who chairs the National Advisory Committee on Immunization, says NACI is currently re-examining its guidance based on new research, and new guidelines on the timing of second doses for seniors and the immunocompromised could come as early as next week. (Skype)

“Then it just means that you’re changing your recommendation every other day. So you need to gather that base of evidence before you change something.”

But even after NACI has finalized its recommendations, Quach-Thanh said, it takes an entire week to translate and upload them to the Public Health Agency of Canada’s website — precious time in a pandemic where new data emerges daily.

Quach-Thanh said the committee is currently re-examining its guidance based on new research, and new guidelines on the timing of second doses for seniors and the immunocompromised could come as early as next week. But Skowronski, with the BCCDC, said it’s too early to make that call definitively.

“This is a kind of a signal that we might want to follow, it’s of interest, but we cannot change or make policy on the basis of this sort of small study,” she said.

“It may come to pass that we will want to adjust depending upon how far we have come in achieving that goal of getting at least one dose into these individuals at highest risk.”

Skowronski defended the decision to delay second doses by up to four months in Canada and stressed that the benefits of vaccinating more vulnerable groups with an initial shot outweigh the risks of delaying a second.

“My preoccupation is in at least getting a first dose into those at high risk of severe complications, and we’ve not achieved that yet,” she said, adding that age was by far the biggest risk factor for severe outcomes from COVID-19.

“That’s job one. Let’s get that job one done, and then let’s debate the timing of the second dose.”

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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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