Last checked at 
(Recasts with Health Canada announcement)
By David Ljunggren and Allison Martell
OTTAWA/TORONTO, March 29 (Reuters) - 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.
(Reporting by David Ljunggren and Steve Scherer in Ottawa;
writing by Allison Martell in Toronto
Editing by Paul Simao and Bill Berkrot)
