Canadian health officials on Monday said that they would stop offering AstraZeneca’s COVID-19 vaccine to people under age 55, and require a new analysis of the shot’s risks and benefits based on age and gender.
The moves follow reports from Europe of rare but serious blood clots, bleeding and, in some cases, death after vaccination, mainly in young women. No such cases have been reported in Canada, with about 307,000 AstraZeneca doses administered.
The National Advisory Council of Immunization, an independent expert panel, said that the rate at which the clotting complication happens was not yet clear. So far, 40 percent of people who have developed it have died, but that might fall as more cases are identified and treated early, it said.
“From what is known at this time, there is substantial uncertainty about the benefit of providing AstraZeneca COVID-19 vaccine to adults under 55 years of age,” the council said in a written recommendation.
Older people face a greater risk of hospitalization and death from COVID-19, and the complication seems to be more rare in that age group, the council said, so they could be offered the vaccine “with informed consent.”
In response to the guidance, the Canadian Council of Chief Medical Officers of Health, which includes provincial and federal representatives, said that it would pause giving the vaccine to those under 55.
The council said it considered that Canada had other vaccines available when making the decision. Most of Canada’s supply has so far come from Pfizer Inc and Moderna Inc.
About 11.8 percent of Canada’s population has received at least one dose of a COVID-19 vaccine, according to Reuters’ vaccine tracker.
Separately, Health Canada, the nation’s drug regulator, said that it would add terms and conditions to the AstraZeneca vaccine’s authorizations, including “a requirement that the manufacturers conduct a detailed assessment of the benefits and risks of the vaccine by age and sex in the Canadian context.”
Health Canada said that it had been in talks with AstraZeneca and once it has the requested information, it “will determine if additional regulatory actions are necessary.”
It was not immediately clear how long the assessment might take.
“Patient safety remains the company’s highest priority,” AstraZeneca Canada head of corporate affairs Carlo Mastrangelo said in a statement. “We continue to work closely with Health Canada to share and submit safety data as it becomes available.”
Many European nations briefly stopped using the Anglo-Swedish firm’s vaccine while investigating the blood clot incidents earlier this month, but Canada continued to administer doses.
Nearly all the nations have since resumed use of the vaccine, but France broke with guidance from the European medical regulator and said on March 19 that it should only be given to people aged 55 or older.
France said the decision was based on evidence that the clotting affected younger people.
Canada is expecting a further 1.5 million doses of the AstraZeneca vaccine this week from the US, which has not yet authorized its use. Canada has ordered more than 20 million doses.
COVID-19 cases have been rising in Canada this month.
British Columbia on Monday halted indoor dining and indoor group fitness classes through April 19, as case counts hit an all-time daily high.
Officials said that the measures were a “circuit breaker,” to stop the spread of COVID-19 variants in the province.
British Columbia has identified 270 cases of the P1 variant first identified in Brazil, which officials worry is more resistant to vaccines.
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