Health Canada says AstraZeneca vaccine safe and effective, will add warning on clots
Posted March 23, 2021 1:54 pm.
OTTAWA – Health Canada is in the process of adding a warning about a rare possible side-effect of blood clots from the Oxford-AstraZeneca vaccine but is still certain the vaccine is safe and effective against COVID-19.
The department’s chief medical adviser Dr. Supriya Sharma says the warning comes on the heels of a similar warning in Europe last week but doesn’t change Health Canada’s analysis that the vaccine’s benefits outweigh its risks.
The European Medicines Agency (EMA) last week amended its authorization of the vaccine to say there is not an overall increase in the risk of blood clots after getting the vaccine.
RELATED: Ontario’s top doctor says to enjoy sun, patios safely as VOC cases rise in province, Toronto
However, the EMA and Health Canada are still analyzing data to see if there is a reason the vaccine may have caused a very small number of blood clots in the vein that drains blood from the brain.
Sharma says the warning in Canada would centre on what to look for, including intense or persistent headaches, shortness of breath, and pain in the legs.
Chief public health officer Dr. Theresa Tam says Canada’s vaccination program is moving much faster than before but warns there has been a 15 percent rise in the number of new cases of COVID-19 in the last week.
The B.1.1.7 variant now accounts for more than 90 percent of cases involving new variants across the country.
Tam says the rise in new variants is leading to higher average hospitalization rates and more severe outcome trends among younger people.
Meantime, one day after AstraZeneca announced advanced trial data that showed its COVID-19 vaccine to be 79 percent effective, U.S. federal health officials are now saying the results from the trial may have used “outdated information.”
The Data and Safety Monitoring Board released a statement early Tuesday morning saying it was concerned that the information included in the trial could paint an inaccurate picture of how effective the shot truly is.
It says it is now completing the validation of the statistical analysis and plans to release more data in the next 48 hours.
