Canada to pause Oxford-AstraZeneca shots for under-55s

AZ jab paused for under-55s

UPDATE 11:30 a.m.

Health Canada is demanding that AstraZeneca do a detailed study on the risks and benefits of its COVID-19 vaccine across multiple age groups after getting more reports that patients in Europe developed blood clots following vaccination.

The agency says it has not received any reports of blood clots in Canada to date.

The regulators that review and authorize vaccines are not pulling AstraZeneca's approval in Canada but say regulatory changes could still be made depending on what the results of this study show.

"Health Canada’s guidance issued to health-care practitioners last week still stands, and provides vaccine recipients with information on the signs and symptoms to monitor for following vaccination," a statement from Health Canada issued Monday says.

Last week, the department changed its label on the vaccine to warn about the rare risk of blood clots.

Multiple sources confirm to The Canadian Press that the National Advisory Committee on Immunizations will recommend against the vaccine's use for anyone under the age of 55. They spoke on background because they were not authorized to discuss the move publicly.

NACI provides advice to the provinces on how approved vaccines should be used in the context of the entire number of vaccines available. Provincial governments decide on their own how to use a vaccine, but several announced on Monday plans to stop using it on people under 55, including Prince Edward Island and Quebec.

A briefing with NACI and Health Canada doctors is planned for this afternoon to explain the details to Canadians.

Health Minister Patty Hajdu says Health Canada has been monitoring data very closely following reports of adverse effects in other jurisdictions.

"I can tell you that they'll be updated messaging from Health Canada and NACI regarding onward use of AstraZeneca and who it might be appropriate for," she said, at an unrelated news conference Monday morning.

The AstraZeneca vaccine was approved for all people over 18 on Feb. 26, but NACI then said there weren't enough seniors included in clinical trials to be confident about how the vaccine would perform on people over the age of 65.

Two weeks later, NACI retracted that advice, citing new real-world evidence from the United Kingdom that showed the vaccine was very effective when used on seniors.

This latest recommendation follows reports in Europe that about three dozen patients developed blood clots following immunization with the AstraZeneca vaccine, most of them younger women.

Canada received 500,000 doses of AstraZeneca, made at the Serum Institute of India, but it's not clear how many have been managed to date. Many provinces prioritized their use for people aged 60 to 64, but some focused on younger groups.

ORIGINAL 10:50 a.m.

Health Canada is set to issue new recommendations on the use of the Oxford-AstraZeneca COVID-19 vaccine, Canada's Health Minister said Monday, as Prince Edward Island suspended its use of the shot for those aged 18 to 29.

Patty Hajdu confirmed the federal Health Department and Canada's National Advisory Committee on Immunization would provide an update later Monday.

She told a videoconference that Canada is closely monitoring investigations into possible adverse effects linked to the vaccine that are taking place in several jurisdictions.

"I can tell you that there will be updated messaging from Health Canada and NACI regarding onward use of AstraZeneca and who it might be appropriate for," she said.

Prince Edward Island health officials said in a brief statement the vaccination appointments are on hold pending the updated information from Health Canada and the vaccine committee.

The province announced this month that it would designate its supply of AstraZeneca vaccine for people aged 18 to 29 who work in gas stations and convenience or grocery stores. The move was a response to COVID-19 outbreaks on the Island that were concentrated among young people.

The province said it had received 2,000 doses of the vaccine and they had been distributed to pharmacies across the province to give to the young workers.

The news is the latest setback for a vaccine that has been plagued by questions over its preliminary trial data in the United States, confusion over whether it is safe for seniors and reports that it is linked to blood clots in a small number of people.

It comes as Canada is expected to receive 1.5 million doses of the vaccine from the United States on Tuesday.

Canadian health officials first recommended the AstraZeneca vaccine for those under 65, but on March 16 they adjusted their advice to say that it could also be given to seniors.

Several European countries suspended the use of the vaccine as a precautionary measure earlier this month amid concern that its use could be linked to blood clots in a few patients, although many countries have resumed its use after the European Medicines Agency said it was safe

Health Canada updated its product label for AstraZeneca to warn about blood clotting last week but said reports of those events were nonexistent in Canada and very rare elsewhere.

The label warning followed reports from Europe that the vaccine might cause a rare type of blood clot in the brain in a very small number of patients.

Health Canada's chief medical adviser, Dr. Supriya Sharma, said on March 25 that she agreed with European health authorities that the benefits of the vaccine outweigh any potential risks, and that all four vaccines approved for use in Canada are considered safe.

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