The agency said it had been informed by the European Medicines Agency (EMA) that “several countries in Europe have either temporarily paused the use of specific batches of the AstraZeneca vaccine or use of the AstraZeneca vaccine altogether as a precautionary measure, pending the outcome of the EMA’s investigation,” in an emailed statement to Global News on Sunday.
However, Health Canada noted “none of the identified batches under investigation have been shipped to Canada.”
“To date, no adverse events related to the AstraZeneca COVID-19 vaccine, or the version manufactured by the Serum Institute of India, have been reported to Health Canada or the Public Health Agency of Canada,” they said.
“A careful review of all available safety data of more than 17 million people vaccinated in the European Union and UK with COVID-19 Vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia, in any defined age group, gender, batch or in any particular country,” the statement said.
AstraZeneca’s comments echoed that of Health Canada, who told Global News that it would continue to move forward with administering the vaccine despite the suspensions. The agency said the benefits of the vaccine “continue to outweigh the risks” and that it still “meets Canada’s stringent safety, efficacy and quality requirements.”
Ireland, Denmark, Norway, Iceland and other European countries have temporarily suspended the shot after reports some recipients formed blood clots after vaccination.
Ireland’s deputy chief medical officer said Sunday the country had recommended the suspension of the vaccine’s rollout “out of an abundance of caution” pending further investigation. Similarly, Denmark’s decision to suspend the vaccine on Thursday was based on a “precautionary principle.”
One person who developed a blood clot after vaccination died 10 days later, though health officials there said there is currently no evidence the vaccine was responsible.
Authorities suspect the issues stem from a particular batch of the shot manufactured in Europe.
Earlier, AstraZeneca said there were no confirmed issues related to quality of any of its COVID-19 vaccine batches used across Europe and rest of the world.
Just days before the suspensions, Austria announced it would stop using a batch of AstraZeneca’s vaccine after one person died and another was hospitalized. Denmark officials said the woman who died several days after vaccination was given a shot from the same batch used in Austria.
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.
Canadian experts welcomed the investigation, saying any adverse reaction to vaccines warrants a review, but suggest the suspensions may be “premature” since there’s nothing definitively linking 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,” Isaac Bogoch, an infectious disease expert based out of Toronto General Hospital, told Global News on Thursday.
Dr. Supriya Sharma, Health Canada’s chief medical adviser, also backed the AstraZeneca vaccine on Friday, saying there is no scientific explanation to suggest a link between the vaccine and blood clots so far.
“There’s not a good biological explanation about why a vaccine of this type, injected into a muscle, would cause that kind of adverse event,” said Sharma, in an interview with The Canadian Press.
She added Health Canada has a “really low threshold” for adverse events that could trigger a pause in a vaccine’s use, but that the agency would pause without hesitation if an adverse event met its requirements.
But the reports from Denmark add yet another layer of complexity to a vaccine already embroiled in contention.
The shot has been given different guidelines for use in different countries and jurisdictions. Health Canada has approved the vaccine for people over 18, but the National Advisory Committee on Immunization has recommended the shot not be given to people over the age of 65.
Experts acknowledge more precise data is needed to smooth things out, but stress that the conflicting guidelines don’t mean the shot is unsafe for seniors, nor should it diminish its clear benefits.
“These are our fathers, brothers, sisters, mothers,” said Sharma. “We want to make sure that we’re doing the best for all of them as well.”
— With files from Global News’ Hannah Jackson, the Canadian Press, the Associated Press and Reuters
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