Other safety alerts
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| Canada: Health Canada provides update on the AstraZeneca and COVISHIELD COVID-19 vaccines |
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Health Canada announces that it 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.
After a thorough, independent assessment of the currently available scientific data, Health Canada 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 on the label to inform Canadians and healthcare professions of these possible side effects and to provide information about the signs and symptoms and when to seek prompt medical attention following vaccination.
Minor and temporary adverse events, such as headache, fever, fatigue or pain at the injection site are common after all vaccinations. People should seek medical attention if they experience any persistent, new or worsening symptoms.
Based on Health Canada’s review of available data from Europe and from the United Kingdom and AstraZeneca, no specific risk factors have been identified. Therefore, Health Canada is not restricting the use of the vaccine at this time. Health Canada’s position that the safety of the AstraZeneca vaccine meets its strict safety standards remains valid 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.
As reported this week, the Public Health Agency of Canada has received a report of a case of an individual living in Canada who has experienced a very rare adverse event involving blood clots with low platelets following immunization with COVISHIELD. This is the first reported case in Canada. The person is recovering. This report will be considered as part of the Department’s ongoing safety review of the AstraZeneca and COVISHIELD vaccines and the risk of rare blood clots with low platelets.
If you have received the AstraZeneca or COVISHIELD COVID-19 vaccine, seek prompt medical attention immediately if you have any of the following symptoms four or more days after vaccination:
- shortness of breath
- chest pain
- leg swelling
- persistent abdominal (belly) pain
- neurological symptoms, such as severe and persistent worsening headaches or blurred vision
- skin bruising or tiny blood spots under the skin beyond the site of the injection.
If you experienced rare blood clots with unusual platelets following your first dose of the AstraZeneca or COVISHIELD COVID-19 vaccine, it is not recommended that you receive a second dose of any version of the AstraZeneca vaccine.
Healthcare professionals should be alert to the signs and symptoms of thromboembolism and thrombocytopenia so that they can promptly treat these conditions according to available evidence and clinical guidelines. Healthcare professionals should tell people receiving the vaccine to seek medical attention if they develop symptoms of blood clots, and consider specialist consultation if they suspect their patient has a post-vaccine thrombosis. Healthcare professionals should also report any event potentially related to a vaccine.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../75389a-eng.php
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 11 Mar 2021, with the latest update posted on 13 Apr 2021.
Ends/Thursday, Apr 15, 2021
Issued at HKT 18:00
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