A vial of the Oxford-AstraZeneca COVID-19 vaccine is seen with injection supplies at a clinic in Winnipeg on March 19, 2021. THE CANADIAN PRESS/John Woods

Health Canada confident AstraZeneca vaccine safe and effective against COVID-19

Health Canada confident AstraZeneca vaccine safe and effective against COVID-19

OTTAWA — Health Canada is reassuring Canadians the Oxford-AstraZeneca vaccine is safe and effective, even as it works to add a warning about blood clots and reacts to a new controversy over the company’s preliminary data results in the United States.

The latest vaccine confusion comes as new daily cases of COVID-19 are up 15 per cent across Canada in the last week, prompting some provinces to prepare for new lockdowns or warn they’re coming if people aren’t more careful.

Saskatchewan is sending Regina and some surrounding municipalities back into a full lockdown, banning household guests immediately and putting a stop to indoor dining at restaurants and all other non-essential indoor activities on Sunday.

Regina reported 91 new cases Tuesday, driven by variants of concern.

Quebec Premier François Legault warned some regions in that province to cut back on their in-person contacts or risk new restrictions.

Chief public health officer Dr. Theresa Tam said tightening public health measures might be necessary again, particularly as hospitalizations and critical care patient loads are creeping back up.

“As vaccine delivery begins to ramp up at an accelerated pace, there are hopeful signs for better days ahead,” she said. “However, increasing case counts, a rising proportion of new variant cases and shifting severity trends are cause for continued caution.

In the last week she said an average of 2,100 people were in hospital in Canada being treated for COVID-19 on any given day, including 580 in critical care. That compares to 2,040 in hospital and 550 in ICUs a week ago.

Canada’s vaccine program is accelerating, with more than two million doses expected this week. It’s the most in a single week so far, and could get even bigger if 1.5 million doses of the Oxford-AstraZeneca vaccine arrive from the United States.

But that vaccine is once again in a negative spotlight, this time over accusations within the United States that the company’s preliminary trial results reported Monday were misleading.

It is another blow for a vaccine that has now faced everything from a mistake in dosing during early trials, lower efficacy results than its main competitors, confusion about whether it is effective for seniors, and reports it 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 the U.S. trial issue hasn’t affected Canada’s authorization, which was given Feb. 26 based on trials in the United Kingdom and Brazil.

Those trials showed the vaccine was 62 per cent effective against COVID-19 infections and entirely prevented hospitalizations and deaths.

Monday, the company reported preliminary results from a trial in the United States that appeared stronger, saying it was 79 per cent effective against infection. That report prompted the independent monitoring board overseeing the trial for the U.S. National Institutes of Health to accuse the company of reporting incomplete data to show a better result.

The board members said their analysis pegged the vaccine’s efficacy at between 69 per cent 74 per cent, and said the company’s decision to issue a press release with better results erodes public trust.

AstraZeneca said in a statement Monday’s preliminary report was accurate with data until Feb. 17, and that its analysis of more recent results are consistent with the preliminary report. It said it plans to issue its report on the updated data within 48 hours.

Sharma said it’s not unusual for companies to report preliminary data but said in this case the report came when the company was a lot closer than is typical to knowing what the final data shows. Still, she said, Canada approved the vaccine based on other trials and this doesn’t change those findings.

“At this point in time, we, of course, believe that the benefits of the AstraZeneca vaccine continue to outweigh the risks,” she said.

Health Canada expects to receive the U.S. trial data within the next few weeks and Sharma said it will be reviewed thoroughly and the findings communicated to Canadians.

Health Canada is working on adding a warning to the Canadian label on the vaccine because of the possible, though rare, risk of blood clots.

The European Medicines Agency added such a warning last week after reports that 38 people developed blood clots, out of almost 20 million people who were vaccinated.

The warning says the overall risk of blood clots is not heightened by the vaccine but it may cause a very rare blood clot in the brain. Scientists in Germany and Norway said they believe they have identified the cause as an extreme immune reaction, but said it is treatable and very rare.

Sharma said symptoms would include sudden, intense or persistent headaches, shortness of breath and pain or tenderness in the legs.

But she says there are concerns that this vaccine is suffering in public confidence.

“We’ve said this many times before, that even the most effective vaccine only works if people trust it and agree to receive it,” she said. “It’s like any other reputation — once there’s some doubt that creeps into that reputation, it’s that much more difficult to gain that back.”

More than 3.5 million people in Canada have received at least one dose of vaccine now, and most provinces expect to be able to offer a first dose to every adult by the end of June.

The most positive news on the Canadian COVID-19 front came out of Nunavut Tuesday, which declared itself to be COVID-19 free again, after a lengthy outbreak.

This report by The Canadian Press was first published March 23, 2021.

Mia Rabson, The Canadian Press

vaccines

Get local stories you won't find anywhere else right to your inbox.
Sign up here

Just Posted

Red Deer Rebels forward Arshdeep Bains eyes a loose puck in front of the Medicine Hat Tigers net Saturday night in WHL action at the Centrium. (Photo by ROB WALLATOR/Red Deer Rebels)
Rebels fall short in 12th straight loss

Tigers 5 Rebels 2 (Saturday) Tigers 3 Rebels 2 (Monday) The Red… Continue reading

Red Deer property owners will receive their 2019 property assessment notices in the next few days.  (File photo by Advocate staff)
Red Deer awaiting more details on how federal budget impacts city

The City of Red Deer is awaiting more information on how much… Continue reading

With a ban on sit-in dining once again in place, Las Palmeras owner Andre Lemus is gearing up for more takeout and delivery business. He has also applied to set up an outdoor patio, where dining is allowed under new restrictions. Photo by PAUL COWLEY/Advocate staff
Big interest in outdoor patios in Red Deer as sit-down dining banned again

City of Red Deer has tweaked its patio regulations to make it easier to get a permit

A vial of the Medicago vaccine sits on a surface. CARe Clinic, located in Red Deer, has been selected to participate in the third phase of vaccine study. (Photo courtesy www.medicago.com)
Red Deer clinical research centre participating in plant-based COVID-19 vaccine trial

A Red Deer research centre has been selected to participate in the… Continue reading

Ottawa Senators' Connor Brown, right, scores on Calgary Flames goalie Jacob Markstrom during second-period NHL hockey action in Calgary, Alta., Monday, April 19, 2021. THE CANADIAN PRESS/Jeff McIntosh
Connor Brown scores twice for Ottawa Senators in 4-2 win over Calgary Flames

Connor Brown scores twice for Ottawa Senators in 4-2 win over Calgary Flames

Canada head coach Bev Priestman reacts during the women's international friendly soccer match between England and Canada at Bet365 stadium in Stoke on Trent, England, Tuesday, April 13, 2021. Priestman says her goal is to help Canada move up the Olympic podium after back-to-back bronze medals at the 2012 and 2016 Games. THE CANADIAN PRESS/AP/Rui Vieira
Olympic soccer draw will allow Canadians to start planning on and off the pitch

Olympic soccer draw will allow Canadians to start planning on and off the pitch

Federal government’s extension of CEWS in budget is some good news for CFL franchises

Federal government’s extension of CEWS in budget is some good news for CFL franchises

Canada's Brendan Bottcher dropped a 6-3 decision to Scotland's Bruce Mouat in the men's final of the Humpty's Champions Cup. Bottcher makes a shot against Scotland at the Men's World Curling Championships in Calgary, Alta., Friday, April 9, 2021.THE CANADIAN PRESS/Jeff McIntosh
Mixed results for Canadian teams at Champions Cup as Homan wins, Bottcher loses

Mixed results for Canadian teams at Champions Cup as Homan wins, Bottcher loses

University of Victoria rowing coach Barney Williams is photographed in the stands during the Greater Victoria Invitational at CARSA Performance Gym at the University of Victoria in Victoria, B.C., on Friday, November 29, 2019. The University of Victoria says Williams has resigned effective immediately. THE CANADIAN PRESS/Chad Hipolito
University of Victoria women’s rowing coach resigns by mutual agreement

University of Victoria women’s rowing coach resigns by mutual agreement

Stewart Cink watches his drive down the second fairway during the final round of the RBC Heritage golf tournament in Hilton Head Island, S.C., Sunday, April 18, 2021. (AP Photo/Stephen B. Morton)
Cink coasts to win at Hilton Head for 2nd title of season

Cink coasts to win at Hilton Head for 2nd title of season

The Official UEFA Champions League match balls are on display ahead of the Champions League quarter final second leg soccer match between Liverpool and Real Madrid at Anfield stadium in Liverpool, England, Wednesday, April 14, 2021. (AP Photo/Jon Super)
Threats of expulsion as UEFA confronts Super League rebel 12

Threats of expulsion as UEFA confronts Super League rebel 12

San Jose Sharks center Patrick Marleau (12) motions to the crowd during a break to mark his passing Gordie Howe for most NHL games played in the first period of an NHL hockey game Monday, April 19, 2021, in Las Vegas. (AP Photo/John Locher)
Sharks’ Marleau breaks Howe’s NHL games played record

Sharks’ Marleau breaks Howe’s NHL games played record

Most Read