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Health Canada adds new warning labels to Astra Zeneca vaccine

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OTTAWA, ON, April 14, 2021 /CNW/ – Health Canada is updating Canadians and healthcare professionals about its ongoing safety review of very rare events of blood clots associated with low levels of blood platelets following immunization with the AstraZeneca and COVISHIELD COVID-19 vaccines.

Health Canada says after a thorough, independent assessment of the currently available scientific data, it has concluded that these very rare events may be linked to use of the vaccine. This is in line with the findings of other regulators.

As a result, the Department has updated warnings in the product information to inform Canadians of the possible side effects and to provide information about the signs and symptoms and when to seek prompt medical attention following vaccination.

Quebec’s Ministry of Health and Social Services confirmed a person in the province experienced an adverse event known as vaccine-induced prothrombotic immune thrombocytopenia (VIPIT). Quebec Health Minister Christian Dubé has identified the individual as a woman, but no other details have been revealed.

The one woman in Quebec has developed a blood clot after receiving the AstraZeneca-Oxford Covishield vaccine, a biologically identical version of the AstraZeneca COVID-19 vaccine manufactured by Serum Institute of India. She is now recovering at home.

Toronto COVID-19 vaccination pop-up clinic at Cloverdale Mall. City of Toronto

This one Quebec case has occurred after about 100,000 vaccinations.

“More than 100,000 people have been vaccinated in the last five days and we’re talking about one case,” said Quebec’s Health Minister Christian Dubé.

Meanwhile, of 20 million doses of AstraZeneca administered in the UK, there were 79 cases of blood clots, and 19 deaths. That’s approximately four cases per million, or one in 250,000, says Health Canada.

“Their is a very low risk that some patients could develop blood clotting with low platelets following the vaccination. The risk of entering the hospital and dying is still much greater than the risk of developing clots following the AstraZeneca COVID-19 vaccine, the benefits of this vaccine surely outweigh any risks,” said Dr. Supriya Sharma, Health Canada’s chief medical advisor.

“We are entering our fourth wave of COVID-19 and it is raging,” said Dr. Supriya Sharma. “Canadians should have no qualms about rolling up their sleeves, AstraZeneca COVID-19 vaccine is safe. If it is available for you take it!”

Based on the review of available data from Europe and from the United Kingdom and AstraZeneca, no specific risk factors have been identified. Therefore, Health Canada says it is not restricting the use of the vaccine in any specific populations at this time.  

Health Canada is adjusting the labelling on the vaccines

Health Canada’s position is that the safety of the AstraZeneca vaccine meets its strict safety standards, and the Department is adjusting the product’s labelling to reflect the available scientific evidence. The results of the ongoing safety assessments have been consistent. The potential risk of these events is very rare, and the benefits of the vaccine in protecting against COVID-19 outweigh its potential risks. Health Canada’s findings are based on a sound and thorough review of all evidence available.

In the very rare event that someone experiences unusual blood clots with low platelets, there are treatments available. Health Canada has now updated warnings in the product information to inform Canadians of the possible side effects and to provide information about the signs and symptoms and when to seek prompt medical attention following vaccination.

Side effects to watch for when taking the AstraZeneca COVID-19 vaccine

  • severe headaches
  • abdominal pain
  • leg pain
  • shortness of breath
  • fever and cold sweats

The National Advisory Committee on Immunization (NACI) is also reviewing the available information to determine whether to maintain or modify its current recommendation not to use the vaccine in people under 55. 

Health Canada reassures Canadians that the AstraZeneca COVID-19 vaccine continues to be safe and effective at protecting them against COVID-19 and encourages people to get immunized with any of the COVID-19 vaccines that are authorized in Canada.

As the COVID-19 vaccine rollout advances in Canada, Health Canada says it will continue to monitor the use of all COVID-19 vaccines closely and examine and assess any new safety concerns. Should any safety issue be confirmed, the Department will take appropriate action.

For further information on COVID-19 vaccines authorized by Health Canada, including post-market updates, please visit Health Canada’s COVID-19 vaccines and treatments portal.

SOURCE Health Canada

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