(Adds details on British Columbia's new restrictions,
vaccination rate)
By David Ljunggren and Allison Martell
OTTAWA/TORONTO, March 29 (Reuters) - Canadian health
officials said on Monday 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 (NACI), an
independent expert panel, said on Monday that the rate at which
the clotting complication happens was not yet clear. So far, 40%
of people who have developed it have died, but that may 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, NACI said, so they can be offered the vaccine
"with informed consent."
In response to NACI's guidance, Canada's Council of Chief
Medical Officers of Health, which includes provincial and
federal representatives, said it would pause the vaccine for
those under 55.
The council said it considered the fact 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.
Some 11.8% of Canada's population has received at least one
dose of a COVID-19 vaccine, according to Reuters' vaccine
tracker. https://graphics.reuters.com/world-coronavirus-tracker-and-maps/vaccination-rollout-and-access/
Separately, Health Canada, the country's drug regulator,
said 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 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,"
Carlo Mastrangelo, AstraZeneca Canada's head of corporate
affairs, said in a statement. "We continue to work closely with
Health Canada to share and submit safety data as it becomes
available."
MORE DOSES EXPECTED
The pause affects both versions of the vaccine approved 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.
Many European countries 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 countries have since resumed use of the 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 the clotting affected younger people.
Canada is expecting a further 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.
COVID-19 cases have been rising in Canada in recent weeks.
On Monday, British Columbia halted indoor dining and indoor
group fitness classes through April 19, as case counts hit an
all-time daily high.
Officials said 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.
(Reporting by David Ljunggren and Allison Martell; Additional
reporting by Steve Scherer in Ottawa and Moira Warburton in
Vancouver; Writing by Allison Martell in Toronto; Editing by
Bill Berkrot and Peter Cooney)