Health Canada says it will move forward with administering the Oxford-AstraZeneca COVID-19 vaccine despite at least nine European countries stopping its use.
Health Canada spokesperson Tammy Jarbeau said the agency is aware of reports of adverse events in Europe and would “like to reassure Canadians that the benefits of the vaccine continue to outweigh its risks.”
“Health Canada authorized the vaccine based on a thorough, independent review of the evidence and determined that it meets Canada’s stringent safety, efficacy and quality requirements,” Jarbeau said.
Denmark, Norway and Iceland temporarily suspended the shot on Thursday after reports of blood clots in some people.
However, Health Canada said that there is no indication that the vaccine “caused these events,” and that to date no adverse effects related to the AstraZeneca vaccine have been reported to the agency or the Public Health Agency of Canada (PHAC).
The European Medicines Agency (EMA) is currently investigating the incidents and none of the identified batches under investigation have been shipped to Canada, according to Health Canada.
“This investigation is expected to be completed on an accelerated timeline,” Jarbeau said.
Provinces across Canada reflected Health Canada’s advice that the vaccine is still safe to go ahead with.
“We don’t have any plans to discontinue AstraZeneca at this time,” Ontario Public Health Minister Christine Elliot said Thursday. “We know that several million doses have already been administered around the world with no adverse effects.”
Elliot assured that Health Canada did a thorough review of the vaccine and the province continues to work with the agency to ensure safety.
Quebec’s Public Health Director, Dr. Horacio Arruda, echoed that sentiment. He said Thursday they are following the situation closely, but “at the moment, do not have information that allows us to believe that this vaccine presents more risks than another.”
“If so, rest assured that we will take the appropriate action,” he wrote in a statement.
Alberta’s chief medical officer of health also assured residents the doses offered in Canada are safe.
AstraZeneca Canada spokesperson Carlo Mastrangelo also said the company has completed a new safety review of 10 million patients who received the vaccine and said it uncovered “no evidence of an increased risk of pulmonary embolism or deep vein thrombosis in any defined age group, gender, batch or in any particular country.”
“In fact, the observed number of these types of events are significantly lower in those vaccinated than what would be expected among the general population,” Mastrangelo said.
Denmark’s decision to suspend the vaccine was based on a “precautionary principle” and that it currently has no evidence the vaccine was responsible, according to its health officials.
One person who developed a blood clot after vaccination died 10 days later, Danish officials said, though they could not say whether the patient had any underlying conditions.
Italy has also ordered a precautionary ban on a particular but separate batch of the vaccine after what it described as “serious adverse events.”
Two days earlier, Austria stopped using a batch of AstraZeneca shots after one death and one hospitalization. Denmark officials said the Danish woman who died after immunization was also given a shot from the same batch used in Austria.
However, experts in Canada are quick to emphasize that the potential issue with AstraZeneca seems to stem from a particular batch manufactured in Europe.
Canada’s initial 500,000 doses of the shot have been manufactured by the Serum Institute in India. In total, two million will come through that agreement. A further 20 million doses already secured with AstraZeneca will start to arrive in the spring.
“AZ vaccine has been used on literally millions of people in the UK, India, and other countries. No reports like this have surfaced until now,” said Raywat Deonandan, an epidemiologist and associate professor at the University of Ottawa.
“This suggests that if there is an issue with the vaccine, it’s with this batch of vaccines, and not with the basic formulation itself.”
Bad batches can happen, said Isaac Bogoch, an infectious disease specialist based out of Toronto General Hospital.
“That’s why they collect the lot or batch number, so if there’s an adverse reaction, you can look to see if people who received the same shot from the batch as the person who experienced the reaction had a similar reaction,” he said.
The U.S. Centers for Disease Control and Prevention has a page on its website dedicated to vaccine recalls. While “rarely” issued, a recall can be issued over possible safety concerns before or after any reported injury. Oftentimes, the recall comes from the manufacturer first, over irregularities in vaccine vials, for example, according to the CDC.
Health Canada provides weekly reports on vaccine safety and adverse effects from the shots on its website. Since Canada is only now on the cusp of rolling out AstraZeneca, it is not included in the total 1,591 adverse events related to COVID-19 vaccination as of March 11. That’s out of more than 2,600,000 vaccine doses given out so far.
“Officials are still investigating, though,” Deonandan said of Denmark’s reports. “It’s not conclusive that the clots were, in fact, demonstrably due to the vaccine.”
The news comes as people in parts of Ontario line up outside pharmacies to receive the shot. The province began offering the shots Thursday to people aged 60 to 64 as part of a pilot project.
More than 325 pharmacies in Toronto, Windsor-Essex and Kingston, Frontenac and Lennox & Addington (KFLA) are participating in a pilot program to administer 194,500 doses of the vaccine. About 29,500 doses will be going to family doctors.
Bogoch said the European countries’ decisions “of course needs investigation” but might be “premature” to suggest there’s some interaction with the vaccine and blood clots.
“There have been millions and millions of doses of this vaccine administered to date and to date we have not yet heard about any signal of this happening,” he said.
“But you’re balancing things simultaneously. You want to get it right and don’t want to put anyone in harm’s way, and you still want to maintain trust with the general public.”
Despite the suspensions, Europe’s drug regulator backed the use of AstraZeneca’s vaccine on Thursday, saying its benefits outweigh the risks. Britain, which was among the first in the world to approve AstraZeneca’s vaccine, also encouraged people in the U.K. to continue to get the shot.
Both agencies stressed that it is not confirmed that the reported blood clots in Denmark were caused by the vaccine, adding that the suspension there was precautionary.
Phil Bryan, the safety lead at Britain’s regulatory agency, said more than 11 million doses of the vaccine had been given out across the U.K. so far and that any reports of blood clots were not greater than what would have occurred normally.
“Blood clots can occur naturally and are not uncommon,” he said.
Bogoch said people should find comfort that the reports of blood clots “just haven’t been seen” until after millions of these shots have been doled out around the world, to a variety of age demographics.
“It just means we continue to watch very closely and see what emerges from the investigation,” he said.
“Not even Canada, but look at everywhere else in the world. I don’t think many countries will follow suit unless there’s more evidence that this is a systemic issue rather than a batch issue or a non-issue.”
— with files from Reuters, the Associated Press and the Canadian Press
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