Tag Archives: vaccine

Why Canadians have reason to be more optimistic about the COVID-19 vaccine rollout

Comparing apples to oranges isn’t necessarily useful if you’re trying to learn more about apples. And that is exactly what some experts say is happening in recent discussions of Canada’s vaccine rollout performance on the world stage.

This country’s vaccination record can seem disappointing when compared to the quick progress in some other countries, but that may not be a fair comparison, some experts say. The fact is certain key metrics suggest Canada’s rollout performance is actually on the rise compared to those of many other countries.

“It really does matter who you compare Canada to,” said Trevor Tombe, an associate professor of economics at the University of Calgary and a research fellow at its school of public policy. 

How we evaluate Canada’s performance, he said, is by comparing ourselves to other major countries and by “using realistic metrics based on Canada’s current rollout strategy.”

At the beginning of March, the National Advisory Committee on Immunization (NACI) recommended that the interval time between first and second doses for the Moderna, Pfizer-BioNTech and AstraZeneca-Oxford COVID-19 vaccines be extended to a maximum of four months.

The group doubled down on that recommendation this week, saying the extension will allow more people to receive a first dose more quickly. And the Council of Chief Medical Officers of Health publicly announced its support of the interval recommendation the same day.

Tombe said that extension is the reason why Canadians should be sure they are really comparing apples to apples, so to speak, when we look at our numbers internationally.

Comparing Canada to the world based on the metric of how many people have received at least one dose of vaccine paints the most accurate comparative picture right now, he said, given the country has focused its efforts on administering first doses.

By those markers — measuring the Canadian vaccine rollout to other major economies and looking at the percentage of the population that has received at least one dose — this country is doing better than average.

Canada is third in the G7, behind only the United States and United Kingdom. Canada also ranks third when compared to members of the G20 (with data not available for Saudi Arabia and China). And those same metrics put us in the top 10 out of 37 members of the Organisation for Economic Co-operation and Development (OECD). 

Scott Halperin, the director of the Canadian Center for Vaccinology in Halifax, agrees that comparing Canada’s “fully vaccinated” rate with the rest of the world is not the best measure of the country’s immunization progress right now. 

“When you have a policy of first dose completion, that’s the metric you want to use — because it’s a conscious policy,” he said. 

“When you make a conscious decision not to give the second dose for another three or four months, then your two-dose completion rate is going to stall for that three or four months.”

Halperin and other experts have pointed out the dearth of vaccine supply in February and early March was caused mostly by a lack of capacity in Canada to manufacture vaccines on a mass scale, a situation created by decades of policy-making decisions. 

“You can only do as well in rolling out the vaccine in terms of how many vaccine doses you have,” he said. “And the leaders in rolling out the vaccines, except for a small number of exceptions, are countries who already had manufacturing capacity and invested very heavily in those vaccines.”

But in the here and now, he said, working with what Canada has to work with, the rollout is ramping up at a pace that matches supply.

The rationale behind the strategy

Dr. Caroline Quach-Thanh, the head of NACI, says she responds to criticisms of Canada’s vaccination record with a similar recounting of facts. She says the lack of vaccine supply is a factor that influenced her group’s decision to recommend extending the time gap between first and second doses, which is part of what led to Canada’s seemingly poor performance on the world stage when comparing “fully vaccinated” numbers.  

“What we’ve decided to do in Canada is to give one dose to as many people as possible,” she said. “I know that that decision, that was taken by Canada and the provinces, has led to a lot of anger and anxiety in some people.

“It’s very complicated for some people to understand that better protection for all is eventually going to be better protection for them as well.”

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CBC | Health News

EU regulator places no new restrictions on AstraZeneca vaccine due to ‘possible’ blood clot link

The European Union’s drug regulator says it has found a “possible link” between the AstraZeneca-Oxford coronavirus vaccine and a rare blood-clotting disorder, but the benefits of the shot and the potential health consequences of suffering from COVID-19 still outweigh any risks.

The European Medicines Agency (EMA) said it would place no new restrictions on using the vaccine in people 18 and over, in both a statement and a subsequent news conference on Wednesday.

The EMA said most of the cases reported have occurred in women under 60 within two weeks of vaccination. The agency said based on the currently available evidence, it was not able to identify specific risk factors.

“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.

Experts reviewed several dozen cases that came mainly from Europe and the United Kingdom, where around 25 million people have received the AstraZeneca-Oxford vaccine.

At a news conference from Brussels, Cooke said “the risk of mortality from COVID is much greater than the risk of mortality from these side-effects.”

Britain adjusts vaccine advice

The head of Britain’s drug regulator echoed that sentiment, but said on Wednesday people under 30 will be offered another product due to a rare blood clot risk.

The Pfizer-BioNTech and Moderna vaccines should be offered to people in that age group instead, the Medicines and Healthcare Products Regulatory Agency (MHRA) advised.

Dr. June Raine, the head of the MHRA, said the risk “remains extremely low” at “about four people in a million” who receive the shot.

WATCH | Britain’s Raine breaks down the number of cases:

The U.K.’s drug regulator says a rare side-effect from the AstraZeneca-Oxford COVID-19 vaccine has led to a change in its advice for what age groups should receive the shot. 1:33

Raine said that as of the end of March, there had been 79 reports, all after the first dose, out of approximately 20 million doses given within the U.K. Of the adverse reports, 51 came from women.

Raine said the British regulator had tracked 19 deaths among those reports, three of them in people under the age of 30. The regulator said the reports did not constitute proof that the inoculation had caused the clots.

Jonathan Van Tam, Britain’s deputy chief medical officer, characterized the new recommendation as a “course correction” not uncommon for the rollout of vaccines used in treating other illnesses.

“You can’t pick these kinds of things up until you’ve literally deployed tens of millions of vaccines,” he said.

According to reports in Britain, the majority of those under 30 have yet to be vaccinated.

In light of the follow up in Europe, the World Health Organization’s vaccine advisory committee said more specialized studies were needed into the blood clots.

“Based on current information, a causal relationship between the vaccine and the occurrence of blood clots with low platelets is considered plausible but is not confirmed,” the WHO committee said in a statement.

Canada already recommended shot for those 55 and over

The vaccine is one of five separate approvals so far during the pandemic from Health Canada, comprising two different sources.

Canada approved AstraZeneca-Oxford doses being manufactured in both Europe and in India, where it has been branded as Covishield. The vaccine first arrived in Canada in early March, and later that month, Ottawa announced it had received a loan from the United States of 1.5 million additional doses, as a hearing on the vaccine’s approval has yet to be held by American regulators.

Canada’s National Advisory Committee on Immunization (NACI) updated its recommendations in late March regarding the use of the AstraZeneca-Oxford vaccine in light of the blood clot reports seen in Europe. The committee recommended a pause in inoculating Canadians under 55 with that vaccine.

In its tracking of potential adverse events following vaccination, Health Canada has received no reports of the rare blood clotting in this country.

WATCH | Canada’s vaccine advisory committee adjusts AstraZeneca guidelines:

The European Medicines Agency says rare blood clots are a potential side effect of the AstraZeneca-Oxford COVID-19 vaccine, but it still says the benefits of the vaccine far outweigh the risks. 1:39

Dr. Shelley Deeks, co-chair of NACI, said at a virtual briefing on Tuesday that Canadian officials will study the updated data from their European counterparts to see if any advice needs to be updated.

She said it would be “premature” to say if the latest development in Europe will have any effect on confidence in the AstraZeneca-Oxford vaccine.

“What we’ve tried to be doing at NACI is actually being quite transparent about the evolution of the data so Canadians will have confidence that we are communicating what we know about safety, when we know it,” said Deeks.

The EMA is particularly focused on two types of rare blood clots: one that appears in multiple blood vessels and another that occurs in a vein that drains blood from the brain. It also evaluated reports of people who had low levels of blood platelets, which puts them at risk of severe bleeding.

Raine said 14 of the 19 fatalities noted were cases where cerebral venous sinus thrombosis with low platelets was present, while the other cases were associated with other kinds of thrombosis in major veins.

As recently as last week, the EMA said “there is no evidence that would support restricting the use of this vaccine in any population” — a response to several countries doing just that — though an expert said more brain clots were being reported than would be expected.

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

WATCH | European Union regulator says blood clot risk extremely rare:

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

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.

Cooke characterized the reports as evidence that caution and transparency have been guiding decisions.

“These very rare and unusual events were picked up, identified, analyzed and we have made a clear science-based recommendation to allow the safe and effective use of the vaccine,” she said.

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.

That’s because the vaccine is cheaper and easier to store than many others, is critical to Europe’s immunization campaign and a pillar of the United Nations-backed program known as COVAX that aims to get vaccines to some of the world’s poorest countries.

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CBC | World News

Britain says to ease lockdown next week, will test vaccine passports

Britain’s slow but steady march out of a three-month lockdown remains on track even as coronavirus cases surge elsewhere in Europe, Prime Minister Boris Johnson announced Monday, as he confirmed that businesses from barbers to bookstores will be allowed to reopen next week

Johnson said it’s too soon to decide, however, whether U.K. residents will be able to have summer trips abroad. He confirmed that the government will test out a “vaccine passport” system — a way for people to offer proof they have protection from COVID-19 — as a tool to help travel and large events return safely.

Four weeks after England took its first step out of lockdown by reopening schools, Johnson said Britain’s vaccination program was proceeding well and infections were falling. He said the next step would come as planned on April 12, with the reopening of hairdressers, beauty salons, gyms, non-essential shops and bar and restaurant patios. 

“We set out our road map and we’re sticking to it,” Johnson said during a news conference.

But, he added: “We can’t be complacent. We can see the waves of sickness afflicting other countries, and we’ve seen how this story goes.”

A ban on overnight stays away from home in England will also be lifted April 12, and outdoor venues such as zoos and drive-in cinemas can operate again.

Scotland, Wales and Northern Ireland are following similar but slightly different paths out of lockdown.

Highest death toll in Europe

Britain has recorded almost 127,000 coronavirus deaths, the highest toll in Europe. But infections and deaths both have fallen sharply during the current lockdown and since the start of a vaccination campaign that has given a first dose to more than 31 million people, or six in 10 adults.


People paint red hearts onto the COVID-19 Memorial Wall mourning those who have died, on the Embankment in London on April 5, 2021. (Frank Augstein/The Associated Press)

The government aims to give all adults at least one shot of vaccine by July, and hopes that a combination of vaccination and mass testing will allow indoor socializing and large-scale events to return.

It says all adults and children in England will be encouraged to have routine coronavirus tests twice a week as a way to stamp out new outbreaks. The government said free lateral flow tests will be available free starting Friday by mail, from pharmacies and in workplaces. 

Lateral flow tests give results in minutes but are less accurate than the PCR swab tests used to officially confirm cases of COVID-19. But the government insists they are reliable and will help find people who contract the virus but don’t have symptoms.

Britons are currently banned by law from going on holiday abroad under the extraordinary powers Parliament has given the government to fight the pandemic. The government said Monday it won’t lift the travel ban before May 17 — and maybe later.

“The government hopes people will be able to travel to and from the U.K. to take a summer holiday this year, but it is still too soon to know what is possible,” it said in an official update.

Once travel resumes, Britain will rank countries on a traffic-light system as green, yellow or red based on their level of vaccinations, infections and worrying new virus variants. People arriving from “green” countries will have to be tested but won’t face quarantine.

The government also is testing a system of “COVID-status certification” — often dubbed “vaccine passports” — that would allow people seeking to travel or attend events to show they either have received a coronavirus vaccine, tested negative for the virus, or recently had COVID-19 and therefore have some immunity. 

The return of football

A series of events will start this month, including soccer matches, comedy shows and marathon races. The government said the first events will rely only on testing, “but in later pilots vaccination and acquired immunity are expected to be alternative ways to demonstrate status.”


A vial of of the AstraZeneca COVID-19 vaccine is seen at the Guru Nanak Gurdwara Sikh temple, on the day the first Vaisakhi Vaccine Clinic is launched, in Luton, England, on March 21, 2021. (Alberto Pezzali/The Associated Press)

The issue of vaccine passports has been hotly debated around the world, raising questions about how much governments, employers and venues have a right to know about a person’s virus status. The idea is opposed by a wide swath of British lawmakers, from left-of-center opposition politicians to members of Johnson’s Conservative Party, and the policy could face stiff opposition when it is put before Parliament later this month.

Conservative legislator Graham Brady said vaccine passports would be “intrusive, costly and unnecessary.” The leader of the opposition Labour Party, Keir Starmer, called the idea “un-British.”

The government said vaccine passports were all but unavoidable, since many countries were certain to demand proof of COVID-19 status for entry.

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Why restricting AstraZeneca vaccines in Canada means balancing ‘vaccine risk vs. disease risk’

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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British regulators increase number of blood clot cases after AstraZeneca vaccine to 30

British regulators on Thursday said they have identified 30 cases of rare blood clot events after the use of the AstraZeneca-Oxford COVID-19 vaccine, 25 more than the agency previously reported.

The Medicines and Healthcare products Regulatory Agency said it had received no such reports of clotting events following use of the vaccine made by BioNTech SE and Pfizer Inc.

The health officials said they still believe the benefits of the vaccine in the prevention of COVID-19 far outweigh any possible risk of blood clots.

Some countries are restricting use of the AstraZeneca vaccine while others have resumed inoculations, as investigations into reports of rare, and sometimes severe, blood clots continue.

On March 18, the U.K.’s medicines regulator said that there had been five cases of a rare brain blood clot among 11 million administered shots.

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

On Thursday, it put the count at 22 reports of cerebral venous sinus thrombosis, an extremely rare brain clotting ailment, and eight reports of other clotting events associated with low blood platelets out of a total of 18.1 million doses given.

In Canada, the National Advisory Committee on Immunization recommended on Monday that the use of the AstraZeneca vaccine for Canadians under 55 be immediately suspended.

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Pfizer study suggests COVID-19 vaccine is safe, protective in younger teens

Pfizer announced Wednesday that its COVID-19 vaccine is safe and strongly protective in kids as young as 12, a step toward possibly beginning shots in this age group before they head back to school in the fall.

Most COVID-19 vaccines being rolled out worldwide are for adults, who are at higher risk from the novel coronavirus. Pfizer’s vaccine is authorized for ages 16 and older. 

In a study of 2,260 U.S. volunteers ages 12 to 15, preliminary data showed there were no cases of COVID-19 among fully vaccinated adolescents compared to 18 among those given dummy shots, Pfizer reported in a press release on Wednesday.

It’s a small study, that hasn’t yet been published, so another important piece of evidence is how well the shots revved up the kids’ immune systems. Researchers reported “robust antibody responses,” the release said. 

Kids had side effects similar to young adults, the company said. The main side effects are pain, fever, chills and fatigue, particularly after the second dose. The study will continue to track participants for two years for more information about long-term protection and safety.

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Pediatric studies underway for other vaccines 

Pfizer and its German partner BioNTech in the coming weeks plan to ask the U.S. Food and Drug Administration and European regulators to allow emergency use of the shots starting at age 12.

“We share the urgency to expand the use of our vaccine,” Pfizer CEO Albert Bourla said in a statement. He expressed “the hope of starting to vaccinate this age group before the start of the next school year” in the United States.

Pfizer isn’t the only company seeking to lower the age limit for its vaccine. Results also are expected soon from a U.S. study of Moderna’s vaccine in 12- to 17-year-olds.

But in a sign that the findings were promising, the FDA already allowed both companies to begin U.S. studies in children 11 and younger, working their way to as young as six months old.

AstraZeneca last month began a study of its vaccine among 6- to 17-year-olds in Britain. Johnson & Johnson is planning its own pediatric studies. And in China, Sinovac recently announced it has submitted preliminary data to Chinese regulators showing its vaccine is safe in children as young as three.

While most COVID-19 vaccines being used globally were first tested in tens of thousands of adults, pediatric studies won’t need to be nearly as large. Scientists have safety information from those studies and from subsequent vaccinations in millions more adults.

One key question is the dosage: Pfizer gave the 12-and-older participants the same dose adults receive, while testing different doses in younger children.

U.S. FDA timeline not clear

It’s not clear how quickly the FDA would act on Pfizer’s request to allow vaccination starting at age 12. Another question is when the country would have enough supply of shots — and people to get them into adolescents’ arms — to let kids start getting in line.

Supplies are set to steadily increase over the spring and summer, at the same time states are opening vaccinations to younger, healthier adults who until now haven’t had a turn.

Children represent about 13 per cent of COVID-19 cases documented in the U.S. And while children are far less likely than adults to get seriously ill, at least 268 have died from COVID-19 in the U.S. alone and more than 13,500 have been hospitalized, according to a tally by the American Academy of Pediatrics. That’s more than die from the flu in an average year. Additionally, a small number have developed a serious inflammatory condition linked to the coronavirus.


Caleb Chung, seen in this December 2020 photo as he gets his first dose of either the Pfizer vaccine or a placebo, says the study was, ‘was really somewhere that I could actually help out.’ (Richard Chung/The Associated Press)

Caleb Chung, who turns 13 later this week, agreed to volunteer after his father, a Duke University pediatrician, presented the option. He doesn’t know if he received the vaccine or a placebo.

“Usually I’m just at home doing online school and there’s not much I can really do to fight back against the virus,” Caleb said in a recent interview. The study “was really somewhere that I could actually help out.”

His father, Dr. Richard Chung, said he’s proud of his son and all the other children volunteering for the needle pricks, blood tests and other tasks a study entails.

“We need kids to do these trials so that kids can get protected. Adults can’t do that for them,” Chung said.


Have questions about this story? We’re answering as many as we can in the comments.


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CBC | Health News

What’s happening with the AstraZeneca COVID-19 vaccine around the world

Canada’s vaccine advisory committee on Monday recommended suspending the use of the AstraZeneca-Oxford COVID-19 vaccine in people under 55 because of safety concerns, the latest setback for a vaccine seen as crucial in tackling the coronavirus pandemic across the globe.

The National Advisory Committee on Immunization (NACI) updated its guidelines to provinces and territories following reports out of Europe of very rare instances of blood clots in some immunized patients — notably among younger women.

Clinical and real-world data have suggested the vaccine, which is easier and cheaper to transport than rival shots, is highly successful in reducing serious illness and death connected to COVID-19. But it has been dogged by poor communications and questions about possible side-effects.

Here’s the latest on the vaccine’s status in other countries:

Germany

German health officials agreed Tuesday to only give the AstraZeneca vaccine to people aged 60 or older, unless they belong to a high-risk category for serious illness from COVID-19 and have agreed with their doctor to take the vaccine despite the small risk of a serious side-effect.

The move follows the recommendations of Germany’s independent vaccine expert panel and comes after the country’s medical regulator released new data showing a rise in reported cases of an unusual form of blood clot in the head — known as sinus vein thrombosis — in recent recipients of the vaccine.

The Paul Ehrlich Institute said its tally of the rare blood clots reported by March 29 had increased to 31, out of some 2.7 million doses of AstraZeneca administered in Germany so far. Nine of the people died and all but two of the cases involved women, who were aged 20 to 63, the regulator said.


A man gets an injection of the AstraZeneca vaccine in Ebersberg near Munich on March 22. (Matthias Schrader/The Associated Press)

Spain

Spain has decided to remove an upper age limit of 65 years on the AstraZeneca vaccine, Cadena Ser radio reported on Tuesday.

A public health commission approved the change at a meeting on Tuesday, the broadcaster said, citing a document it had seen. That comes a week after Spain decided to reintroduce the AstraZeneca shot for people aged 18 to 65.

Like Germany and several other European countries, Spain had suspended administering the shot over blood clot concerns but resumed its use after the EU’s drug regulator deemed the vaccine “safe and effective.”

Italy

Italy resumed using the AstraZeneca vaccine on all age groups on March 19 after briefly pausing usage earlier this month.

On Tuesday, Prime Minister Mario Draghi and his wife Maria Serenella Cappello, who are both 73, received their first doses of the vaccine at a large vaccination centre set up at Rome’s main railway station, the prime minister’s office said.

The head of the health panel advising the government has said that Italians who decline to be inoculated with the AstraZeneca vaccine will be “reconsidered later for another type of vaccine.”


People wait to receive the AstraZeneca vaccine at the Clinique de l’Estree-ELSAN private hospital in Stains, France, on March 5. (Benoit Tessier/Reuters)

France

France’s medical regulator approved the resumed use of AstraZeneca’s vaccine on March 19 but said it should only be given to people aged 55 and older, breaking with guidance from the European Medicines Agency (EMA).

France said the decision was based on evidence that the clotting affected younger people.

Denmark

Denmark was among the first countries in Europe to suspend the use of the AstraZeneca vaccine this month over concerns about the rare cases of blood clots. On March 25, it extended its suspension for another three weeks, pending further investigation.

Authorities said they still could not rule out a connection between the vaccine and the very unusual illness in two local cases, which are still being analyzed, and cases elsewhere in Europe.

Approximately 150,000 people in Denmark had received AstraZeneca’s shot before it was suspended.

WATCH | Why Canada’s vaccine committee recommended pausing AstraZeneca:

‘It has been very challenging as a committee to make recommendations on these vaccines and to be nimble and change recommendations when the data merits it,’ says Dr. Shelley Deeks, vice-chair of the National Advisory Committee on Immunization. 7:03

Norway 

Like neighbouring Denmark, Norway suspended the rollout of the AstraZeneca vaccine on March 11. On March 26, health officials said they would delay a decision on whether to resume its use until April 15.

Norway had reported five cases in which healthy recipients of the vaccine were admitted to hospital with a combination of blood clots, bleedings and low platelets, three of whom died.

Sweden

The country’s health agency said on March 25 it will resume use of the vaccine for people aged 65 and older, but keep the pause in place for younger Swedes.

Thailand

Thailand began using the AstraZeneca vaccine on March 16, after it delayed rollout the week before over safety concerns.

Prime Minister Prayuth Chan-ocha was the first in the country to be inoculated with the vaccine.

“Today I’m boosting confidence for the general public,” Prayuth, who was soon to turn 67, told reporters at Government House before he received the shot.

South Korea

South Korea authorized the AstraZeneca vaccine for people 65 and older earlier this month after delaying its use for that age group, citing a lack of clinical data.

President Moon Jae-in received the vaccine at a community clinic on March 23, a day after authorities reaffirmed they had found no evidence of health risk.

Cameroon

Cameroon’s Health Ministry suspended administration of the batch of AstraZeneca vaccines it was scheduled to receive on March 20 as part of the global vaccines-sharing initiative COVAX.

The ministry said in a statement March 18 that the suspension was due to precaution and prudence. It gave no further reasons for the decision or say if it will go ahead and take delivery of its share of the vaccine.

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

United Kingdom

The U.K. was the first country in the world to approve the AstraZeneca vaccine, on Dec. 30. On March 18, Britain’s medicines regulator gave its continued backing to the vaccine, saying the benefits outweighed the risks after finding there had been five cases of a rare brain blood clot among 11 million administered shots.

Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA) said that use of the vaccine should continue while the five reports were investigated.

At a new conference that day, Prime Minister Boris Johnson said he was receiving a first dose of the AstraZeneca vaccine himself the following day.

“The Oxford jab is safe and the Pfizer jab is safe,” he said. “The thing that isn’t safe is catching COVID, which is why it’s so important that we all get our jabs as soon as our turn comes.”


British Prime Minister Boris Johnson reacts after receiving a dose of the AstraZeneca vaccine in London on March 19. (Frank Augstein/Reuters)

United States

While the AstraZeneca vaccine has been authorized for use in more than 50 countries, it has not yet been given the green light in the U.S.

U.S. health officials had publicly rebuked the drugmaker for not using the most up-to-date information when it published an interim analysis of its major U.S. trial on March 22 that said the vaccine had a 79 per cent efficacy rate at preventing symptomatic illness. An updated analysis showed a 76 per cent efficacy rate, AstraZeneca said a few days later.

AstraZeneca said it plans to seek U.S. emergency use authorization in the coming weeks and that the latest data has been presented to the independent trial oversight committee, the Data Safety Monitoring Board.

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Trudeau urges Canadians to ‘stay strong’ as vaccine deliveries accelerate

Canadians should be able to receive their vaccinations against COVID-19 sooner now that deliveries of vaccine doses ordered by the federal government are speeding up.

Ottawa announced today that millions of additional vaccine doses are expected to arrive from three approved vaccine makers over the spring.

Pfizer-BioNTech agreed to move up delivery of five million vaccine doses to Canada from late summer to June following negotiations with the federal government, Prime Minister Justin Trudeau told a press conference in Ottawa today.

The accelerated timeline means the pharmaceutical giant now plans to ship 17.8 million doses between April and June — more than a million doses each week in April and May and another two million per week in June.

Procurement Minister Anita Anand also said the first doses of Johnson & Johnson’s one-shot vaccine will arrive at the end of April. While the exact amounts and dates for the Johnson & Johnson product remain in flux, it’s the first indication of a delivery schedule since that vaccine was approved by Health Canada over three weeks ago.

Canada also will receive an additional 4.4 million additional doses of the AstraZeneca-Oxford vaccine by the end of June, Anand said. Those doses will come from the manufacturer itself, the Serum Institute of India and the COVAX global vaccine initiative.

“As we’ve been saying for months, and as we’ve been planning with provinces and territories since last year, the end of March will be followed by an increase in vaccine supply,” Trudeau said.

“We now have handily exceeded our promised target of six million doses delivered before April. And this week, we begin our ramp-up phase.”

WATCH: Procurement minister says Johnson & Johnson COVID-19 vaccines are expected to arrive in Canada at end of April 

Procurement Minister Anita Anand says Johnson and Johnson COVID-19 vaccines will begin to arrive in Canada at the end of April. 0:28

More than 3.2 million doses are expected to arrive this week alone, bringing the total number of doses delivered to Canada since vaccinations began in December to 9.5 million.

Almost half of the doses arriving this week come from a shipment of the AstraZeneca-Oxford COVID-19 vaccine that landed today from the United States — one day after provinces suspended its use in people under the age of 55. 

Without counting the Johnson & Johnson doses, Anand said Canada is on track to receive 44 million doses of vaccine by Canada Day.

That amount is more than enough to provide one dose to the 31 million Canadians over the age of 16.

But Trudeau also issued a warning that Canadians need to “stay strong a little longer” as case counts and hospitalizations rise across the country, driven by more transmissible variants of the coronavirus. He asked Canadians not to gather or have parties over the Easter/Passover weekend.

“We’re entering the final stretch of this crisis,” Trudeau said. “I know it’s not easy but, together, we will get through this.”

Provinces limit use of AstraZeneca-Oxford

The promise of more doses this spring comes as some warn that people may be hesitant to take the AstraZeneca-Oxford vaccine because of the confusion caused by changing advice about its safety.

The panel of scientific experts that advises the federal government on immunization policy recommended pausing the use of the AstraZeneca-Oxford vaccine among people under the age of 55 yesterday. It’s a precautionary measure in response to possible links between the vaccine and rare but severe instances of blood clots in some immunized patients — notably younger women.

Dr. Shelley Deeks, the vice-chair of the National Advisory Committee on Immunization (NACI), said the recommendation came after new data from Europe suggested the risk of severe blood clots could be up to one in 100,000 — much higher than the one in one million risk reported before.

Health Canada has ordered AstraZeneca to conduct a study of the risks and benefits of its COVID-19 vaccine across multiple age groups and by sex. NACI’s recommendation will remain in place while that study is completed.

The recommendation marked the third time NACI altered its guidance on the vaccine in the past month. It prompted provinces and territories to suspend the use of the AstraZeneca-Oxford in the under-55 age group.

WATCH: AstraZeneca guidance change ‘precautionary,’ says federal government adviser

Pausing the use of the AstraZeneca vaccine in people under the age of 55 was a precautionary measure, says Dr. Shelley Deeks of the National Advisory Committee on Immunization. Deeks also said that the NACI continues to revise guidance based on evidence. 12:00

Today, Chief Public Health Officer Dr. Theresa Tam said the changing recommendations are the result of evolving science.

“The advice on any medication or vaccine can evolve over time and I think Canadians should be reassured that we have systems in place to detect safety [issues] and then analyze them,” said Tam. 

Tam said some rare events following vaccination only become apparent after millions of vaccines are administered in the real world. She added that all decisions and guidance from public health officials have been shaped by the “data at hand” and that Canadians can be confident in the vaccines that have been approved.

“This is a rapidly moving pandemic and the vaccines are being put in place after very good clinical trials, but we will obviously continue to see data evolve,” said Tam.

“That’s only to make sure that we have the best, most safe and effective vaccines.”

No blood clots linked to the vaccine have been reported in Canada. About 309,000 doses have been given in Canada to date from the initial shipment of 500,000 two weeks ago. Many provinces initially reserved those doses for people in their 50s and early 60s.

WATCH: Trudeau discusses impact AstraZeneca restrictions could have on overall vaccine rollout

The CBC’s Tom Parry asks Prime Minister Justin Trudeau what impact the new AstraZeneca restrictions will have on the rollout of COVID-19 vaccines in Canada. 2:29

Trudeau urged Canadians to accept the first vaccine that becomes available to them.

“The bottom line for Canadians is the right vaccine for you to take is the very first vaccine that you are offered,” he said.

Supply of vaccines unreliable, Ontario’s Premier Ford says

Despite today’s announcement of doses to come, some provinces say they are experiencing a short-term supply crunch. 

In an email on Tuesday afternoon, Ontario Premier Doug Ford’s office said the province is still waiting for a shipment of 225,400 Moderna doses that has been delayed until Apr. 7.

The province also expects to receive 583,400 of the AstraZeneca-Oxford doses that arrived today. But the U.S. manufacturing facilities where they were produced still require Health Canada approval and the doses cannot be used until that approval is granted.

“Our ability to get needles into arms grows by the day, but the supply of vaccines isn’t keeping up with our ability to deliver them,” Ford said today. “We simply don’t have enough vaccines or a guarantee when we will get them.”

In an interview airing on CBC’s Power & Politics this evening, Anand pushed back.

“The claim that we don’t have a steady supply coming into the country is completely false,” said Anand.

“The reality is that supply of vaccine outpaces the administration that the provinces are undertaking, and so as these vaccine deliveries ramp up … we’re going to need the provinces and territories to really ramp up as well.”

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Why Canada is suspending use of AstraZeneca vaccine in people under 55

Canada’s vaccine advisory committee is recommending immediately suspending the use of the AstraZeneca-Oxford COVID-19 vaccine in Canadians under 55 following reports of rare but potentially fatal blood clots in Europe that appear to be connected to the shot.

The National Advisory Committee on Immunization (NACI) updated its guidelines to provinces and territories against the use of the vaccine for younger Canadians on Monday over safety concerns. 

Health Canada said Monday that 300,000 doses of AstraZeneca vaccine have been administered and no cases of the rare blood clotting adverse events have been reported in Canada, but that it was aware of additional cases that have recently been reported in Europe. 

Quebec, Ontario, Alberta, Saskatchewan, ManitobaNewfoundland and Labrador and Prince Edward Island have all suspended the use of the vaccine for anyone below the age of 55. Other provinces and territories are expected to follow. 

Dr. Isaac Bogoch, an infectious diseases physician and member of Ontario’s COVID-19 vaccine task force said that the discovery of a potential connection with the vaccine to blood clots raised a “red flag” that “warrants further exploration.” 

“People should appreciate that not all blood clots are created the same,” he said. “This is a very specific and particular method of blood clotting that likely has an association with the vaccine.” 

Risk of blood clots seems not to affect older age groups: NACI

NACI previously recommended earlier this month that Canadians over 65 not receive the shot, 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.

“This vaccine has had all the ups and downs — it looks like a roller coaster,” said Dr. Caroline Quach, chair of NACI and a pediatric infectious diseases expert. “The problem is because data are evolving, we are also evolving our recommendations.” 

Quach said the risk of rare blood clots appears to only occur in younger populations, which is why NACI recommended suspending the vaccine in those under 55.

“What we’re doing is trying to contrast the risks and benefits,” she said. “So if you have that vaccine versus having to wait for two months while COVID is ramping and you’re at risk of catching it and having complications from it, I think that taking the vaccine is the best option at this point.”

Quach added that the vaccine works well in preventing severe outcomes and death in older populations over 55, particularly in those over 70, and the risk of blood clots does not appear to be present in those age groups. 

WATCH | Canada pauses use of AstraZeneca vaccine in people under 55:

“We are being fully transparent. Maybe it’s too transparent, I don’t know,” says Dr. Caroline Quach-Thahn, Chair of the National Advisory Committee on Immunization. NACI issued guidance for the AstraZeneca vaccine for the third time, now recommending a pause for those under 55. 4:34

“What we need to have is continued confidence in our expert review panel that it’s looking at these vaccines and deciding what is going to be best, safest and most effective for Canadians,” said Alyson Kelvin, an assistant professor at Dalhousie University and virologist at the Canadian Center for Vaccinology in Halifax. 

“This is a new vaccine to a new virus, it’s really important that we’re following all the data as closely as possible and as the vaccines are rolling out, we’re understanding them more and reviewing what the guidance should be.”

Dr. Zain Chagla, an infectious diseases physician at St. Joseph’s Healthcare Hamilton and an associate professor at McMaster University, said NACI is taking a calculated risk by recommending older Canadians still get the vaccine because they are at higher risk of severe outcomes from COVID-19.

“Scientifically, it makes sense,” he said. “This isn’t saying that everyone under 55 is going to get this complication. It’s the slight risk of this complication seems to be more predisposed in this age group. But again, the raw numbers seem to be very, very low.”

What led to Canada’s decision to suspend AstraZeneca

The decision to halt the use of the vaccine in Canadians under 55 comes after the European Medicines Agency (EMA) investigated 25 cases of the rare blood clots out of about 20 million AstraZeneca shots given. It concluded on March 18 that the benefits from the vaccine far outweigh its possible risks, although a definitive link could not be ruled out.

But 18 of the cases in Europe were of an extremely rare type of blood clot called cerebral venous sinus thrombosis (CVST) — where veins that drain blood from the brain are obstructed and can potentially cause fatal bleeding.

The EMA said on March 18 at least nine deaths have been associated with the adverse events in Europe and the agency is continuing to investigate the situation.

Germany’s medical regulator told The Associated Press on Monday it had received reports of 21 cases of rare blood clots in people who had recently received AstraZeneca’s coronavirus vaccine. 

The Paul Ehrlich Institute also said that seven people affected by the blood clots have died. It added that of the 21 cases reported in Germany until March 25, 12 also involved an abnormally low level of platelets in the patients’ blood.


The National Advisory Committee on Immunization (NACI) updated its guidelines against the use of the vaccine for younger Canadians on Monday. (Dado Ruvic/Reuters)

Nineteen of the 21 cases were in women ages 20 to 63, while two were in men ages 36 and 57. During the period covered by the reports, some 2.27 million first doses of the AstraZeneca vaccine were administered in Germany.

“You cannot ignore the blood clots that have been associated with AstraZeneca globally,” said Bogoch. “It’s not entirely clear what the true incidence of this is, but it does appear to be a rare event.” 

What Canadians need to know about the AstraZeneca vaccine

The federal health ministry said it would be requiring both manufacturers, AstraZeneca and India’s Serum Institute, to conduct risk assessments by age and gender — but is requesting more data before deciding whether or not to change authorization of it in Canada. 

Health Canada had previously updated the vaccine’s label with information on the rare blood clotting events.

Canadian health officials said during a press conference Monday the specific syndrome is being called Vaccine-Induced Prothrombotic Immune Thrombocytopenia (VIPIT) and that they are in contact with European officials about it. 


Dr. Isaac Bogoch said that the discovery of a potential connection with the vaccine to blood clots, particularly CVST, raised a ‘red flag’ that ‘warrants further exploration.’ (Cole Burston/The Canadian Press)

“I do understand why Canadians might feel worried,” said Canada’s Deputy Chief Public Health Officer Dr. Howard Njoo.

“What I can say is that the chief medical officers of health of the provinces and territories take vaccine safety very seriously and we want Canadians to have confidence in these vaccines.”

Officials added that Germany’s Paul Ehrlich Institute reported VIPIT has an incidence rate of about one in 100,000, with a mortality rate of about 40 per cent, although more research is needed and that risk is reduced if treated early enough. 

“Where the true rate is, we just don’t know at this point in time,” said NACI Co-Chair Dr. Shelley Deeks. “But we are continuing to follow the data, as it emerges.” 

Symptoms to watch for

The Public Health Agency of Canada released a statement on Monday saying that “there is no cause for concern” for Canadians who have already been vaccinated with AstraZeneca for more than 20 days, but that you should seek immediate medical attention in the rare event you develop the following symptoms four or more days after vaccination:

  • Shortness of breath.
  • Chest pain.
  • Leg swelling.
  • Persistent abdominal pain.
  • Sudden onset of severe or persistent worsening headaches or blurred vision.
  • Skin bruising (other than at the site of vaccination).

PHAC said decisions on the type of second dose that will be offered to those who have been vaccinated with AstraZeneca will be determined based on the “latest evidence and research.” 

Most of the complications in Europe occurred within 14 days of receiving the AstraZeneca shot, and the majority were in women under the age of 55. It’s worth noting that CVST is typically more common in women, particularly during and after pregnancy, while on birth control and hormone replacement therapy.

Germany and Italy resumed vaccinations with the shot on March 19, but France opted to vaccinate only those over 55 with it after discovering several cases of CVST. Denmark and Norway have suspended the use of the vaccine altogether for at least three weeks, while Sweden has resumed the use of the vaccine in those over 65. 

“The real question here is, how common is it, and are there identifiable risk factors for this? That way, we could probably continue to use this vaccine in people with very, very low risks of having a blood clot and selectively vaccinate people who would benefit,” Bogoch said.

“If there is that risk, we would hopefully have better data to support who we could safely and selectively vaccinate with this product.”

Benefits still outweigh risks, says vaccine maker

A spokesperson for AstraZeneca Canada said in a statement the company respects the decision by NACI but stressed that Health Canada’s guidance to health care providers around the use of the vaccine remains unchanged.

“Regulatory authorities in the U.K., European Union, the World Health Organization and Health Canada have concluded that the benefits of using our vaccine to protect people from this deadly virus significantly outweigh the risks across all adult age groups,” the statement read. 
 
“Tens of millions of people have now received our vaccine across the globe. The extensive body of data from two large clinical data sets and real-world evidence demonstrate its effectiveness, reaffirming the role the vaccine can play during this public health crisis.” 

Chagla said NACI’s decision will likely hurt confidence in the vaccine in the eyes of Canadians, especially among those over 55 who may be left “scratching their heads” as to why the vaccine is being recommended for their age group but not younger people. 

“I, unfortunately, envision this vaccine is going to have a limited rollout in Canada moving forward,” he said.

“Even if the dust starts settling, and it’s a completely separate issue or it’s much lower risk than expected, I don’t think you’re going to get many under 55-year-olds to get this vaccine anymore ,and that’s the reality.”

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Immunization committee to recommend provinces stop giving AstraZeneca vaccine to those under 55: sources

Canada’s National Advisory Committee on Immunization (NACI) is expected to recommend today a pause in the use of the AstraZeneca-Oxford COVID-19 vaccine on those under the age of 55 because of safety concerns, sources told CBC News.

The updated guidelines will be issued later today, according to sources who spoke on the condition of anonymity. The expected change comes following reports of rare blood clots in some immunized patients.

Canada is expected to receive 1.5 million doses of this product from the U.S. on Tuesday.

Officials from NACI will provide an update to reporters at 3:10 p.m. ET. CBCNews.ca will carry the remarks live.

Meanwhile, Health Canada — which approved the vaccine for use in Canada in February — said its regulators would be adding “additional terms and conditions on the authorizations” for AstraZeneca and a biologically identical version of the drug manufactured by the Serum Institute of India, which has been branded Covishield.

The manufacturers will be required to conduct a “detailed assessment of the benefits and risks of the vaccine by age and sex in the Canadian context,” information that could lead to “additional regulatory actions.”

“This information will support the ongoing evaluation of these rare blood clotting events, and allow Health Canada to determine if there are specific groups of people who may be at higher risk,” the department said in a press release.

The AstraZeneca shot has not been widely used in people under the age of 55 in this country. Some jurisdictions, such as P.E.I., have been using some of their supply to immunize young people who work in public-facing sectors like grocery and convenience stores. In New Brunswick, the shot was made available to first responders and some teachers last week. 

A spokesperson for P.E.I.’s health department confirmed use of the vaccine had been suspended for those 18 to 29 years of age.

Speaking to reporters in Niagara Falls, Ont., Ontario Premier Doug Ford said today that the province would follow NACI’s guidance and reserve the current supply of AstraZeneca for those in the older cohort.

He said there have been reports of blood clots in younger women in other places.

“I won’t hesitate to cancel that in half a heartbeat. If it’s going to put anyone in harm, we just won’t use it, simple as that,” he said, adding he didn’t want to “roll the dice” by using AstraZeneca on a group that may have an outsized chance of developing complications.

“The guidance from the federal government is that it is safe for people over 55,” Ford said. “I’m talking about younger people taking it, 35 years of age and in that range, that’s where the problem is.”

After a review, the European Union’s drug watchdog, the European Medicines Agency, found the vaccine is not linked to an increase in the overall risk of blood clots.

The EMA said, however, that it could not definitively rule out a link between the vaccine and rare types of blood clots associated with thrombocytopenia, or low levels of blood platelets.

Specifically, it pointed to 18 cases of an extremely rare type of blood clot called cerebral venous sinus thrombosis (CVST), a condition that is much more common in women than men. Most of the cases occurred within 14 days of receiving the AstraZeneca shot, and the majority were in women under the age of 55.

Dr. Joss Reimer, the medical lead on Manitoba’s vaccine implementation task force, said that the province also would pause its deployment of the vaccine among people under 55 because of a “very rare subtype, one specific type of blood clot.”

She said that while there have been no complications reported in Canada, “out of an abundance of caution” Manitoba will restrict the shot to people 55 to 64, for now.

Reimer said it’s not known yet how common this rare blood clot side effect is but early data out of Europe suggest it could be an outcome for 1 out of 100,000 AstraZeneca shots deployed, or even more than that — the science isn’t settled, she said.

“This is a pause while we wait for more information to better understand what’s happened in Europe. This is an important and evidence-based change,” she said, adding this sort of shift is a testament to Canada’s robust vaccine monitoring system.

Reimer said it’s “probably” fine to use the vaccine on all groups — but she’s not comfortable with just “probably” and wants to wait to see more data from Europe.

Last week, the Public Health Agency of Canada said it’s “possible” the vaccine may be associated with “very rare but serious cases of blood clots associated with thrombocytopenia.” Health Canada has maintained that the benefits of the AstraZeneca COVID-19 vaccine continue to outweigh the risks.

Health Canada has said it is aware that researchers in Europe have indicated that they have identified a possible cause for these very rare events, but says little information is available about the findings.

“We have been discussing the rare reports of blood clots and low platelet counts with the European Medicines Agency and other regulators,” Dr. Supriya Sharma, Canada’s chief medical adviser, said on Thursday. “Health Canada will make decisions for Canada based on the science and evidence.

“This is just the latest issue the company has faced over the last three months.

Earlier this year, a number of European countries halted vaccinations in response to questions about the AstraZeneca product’s efficacy in people over the age of 65, only to restart them after new evidence emerged.

After Health Canada approved the shot for all adults, NACI recommended the product be used only on people under the age of 65, citing a dearth of clinical trial data on the vaccine’s effectiveness in older people.

NACI changed course earlier this month after reviewing three “real-world studies,” saying the two-dose viral vector vaccine can and should be used on seniors.

Last week, the U.S. Data and Safety Monitoring Board (DSMB), which keeps an eye on clinical trials, found “outdated information” may have been reported by the company when it released data on U.S. trials. 

Dr. Anthony Fauci, U.S. President Joe Biden’s chief medical adviser and the head of the NIAID, said the monitoring board was surprised by the the better-than-expected efficacy results published by AstraZeneca.

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