Canada to require new assessment of AstraZeneca benefits, risks based on age

By David Ljunggren and Allison Martell

Canada will modify its approval of AstraZeneca’s COVID-19 vaccine to require a new analysis of its benefits and risks based on age, the nation’s drug regulator said on Monday, as a separate federal advisory panel prepared to recommend the vaccine not be given to people under age 55.

The moves follow reports from Europe of rare but serious blood clot issues and bleeding in some people after vaccination, mainly young women. No such cases have been reported in Canada.

Health Canada said in a statement it would add new terms and conditions to the 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.”

The regulator said that information would support its “ongoing evaluation” of the events, and let it determine whether some groups of people are at higher risk.

“Health Canada has been in discussions with AstraZeneca on this evolving issue,” it said. “Health Canada will assess this information when it is received and will determine if additional regulatory actions are necessary.”

It was not immediately clear how long the assessment might take.

The vaccine has two approvals in Canada: One granted to AstraZeneca Canada, and a second for the Serum Institute of India (SII) – which is manufacturing its own version of the vaccine under license – and its Canadian partner Verity Pharmaceuticals.

Separately, the Canadian Broadcasting Corporation reported that Canada’s federal advisory panel on immunization was preparing to recommend that the vaccine not be given to people under age 55 for the time being because of safety concerns.

Many European countries briefly stopped using the Anglo-Swedish firm’s vaccine while investigating the blood clot incidents earlier this month. Canada continued to administer doses, arguing that the benefits of vaccination outweighed potential risks.

Nearly all countries have since resumed use of the AstraZeneca vaccine. But France broke with guidance from the European medical regulator and said on March 19 it should only be given to people aged 55 or older. France said the decision was based on evidence that clotting affected younger people.

In Canada, most AstraZeneca doses have been given to people over age 60, as the country focuses scarce vaccine supplies on people who are most at risk of death and serious illness from COVID-19.

The country is expecting another 1.5 million doses of the AstraZeneca vaccine this week from the United States, which has not yet authorized its use. Canada has ordered more than 20 million doses from AstraZeneca and SII.