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 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.
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.
Regardless, Canada says the AstraZeneca COVID-19 vaccine is safe and will continue to be recommended for use.
The reiteration comes as criticism brews in the U.S. over the drugmaker’s analysis of the shot’s efficacy.
The U.S. National Institute for Allergy and Infectious Diseases said on Monday that the board charged with ensuring the accuracy of AstraZeneca’s latest trial said the company may have given an incomplete view of the shot’s effectiveness. The company has since said it will publish up-to-date results from its latest trial within 48 hours.
The data in question was not submitted to Health Canada, senior Health Canada official Marc Berthiaume told reporters. The vaccine was approved in Canada “on the basis of other clinical tests that were examined in detail, showing the efficacy of the vaccine,” he said.
The data is expected to arrive in Canada in the next few weeks, though Canadian officials do not expect any change in the recommendation as a result.
“We will look at the complete data package (from the U.S.) sometime in April, and will assess and communicate the results,” said Sharma.
“The bottom line is: that doesn’t change recommendations on the AstraZeneca vaccine at this time.”
— with files from Reuters and Global News
© 2021 The Canadian Press
