Product: AstraZeneca and COVISHIELD COVID-19 vaccines Issue: Health Canada is updating the AstraZeneca and COVISHIELD COVID-19 vaccine labelling information as it continues its safety review regarding very rare events of blood clots associated with low levels of platelets following immunization. What to do: 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, or skin bruising or tiny blood spots under the skin beyond the site of the injection.
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.
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.
Cases of these very rare events of blood clots associated with low levels of blood platelets following immunization with the AstraZeneca and COVISHIELD COVID-19 vaccines were first reported in Europe in early March. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has estimated the overall risk of these blood clots to be approximately 4 people in a million who receive the vaccine. Reported cases of these adverse events have been seen after the first dose, usually within the first 14 days after immunization.
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.
Health Canada only authorizes a vaccine following a rigorous review of the evidence to determine that it meets the Department's stringent requirements for safety, efficacy and quality. Once a vaccine is on the market, Health Canada and the Public Health Agency of Canada have a strong vaccine safety monitoring system in place that proactively engages healthcare professionals, vaccine manufacturers, the provinces and territories and Indigenous partners. Health Canada examines and assesses any new safety concerns brought to its attention.
Since first being alerted to reports of these adverse events in Europe, Health Canada has taken a number of actions to ensure that the AstraZeneca and the COVISHIELD version continue to be safe and effective.
On March 24, Health Canada updated the product monograph—or label—for the AstraZeneca and COVISHIELD COVID-19 vaccines to provide information on very rare reports of blood clots associated with low levels of blood platelets following immunization with the AstraZeneca vaccine.
On March 29, Health Canada issued Terms and Conditions to AstraZeneca and Verity Pharmaceuticals (the Canadian sponsor for COVISHEILD) requiring additional analysis, including a benefit-risk assessment from AstraZeneca. This information has been provided to Health Canada and was used to inform the latest safety review of the vaccine.
Health Canada has also requested that the manufacturers update the risk management plans for the AstraZeneca and COVISHIELD COVID-19 vaccines to reflect the latest information about this safety issue and to include plans for studies that will address remaining knowledge gaps. The manufacturers are expected to continue to monitor these events closely and report any new information to Health Canada in a timely manner.
As the COVID-19 vaccine rollout continues in Canada, Health Canada continues to monitor the use of all COVID-19 vaccines closely, and to examine and assess any new safety concerns. Should any safety issue be confirmed, the Department will take appropriate action.
What consumers should do
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
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.
Report any adverse events after immunization to your healthcare professional.
What health professionals should do
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 such as shortness of breath, chest pain, leg swelling, persistent abdominal pain;
neurological symptoms such as severe and persistent worsening headaches or blurred vision; or
skin bruising or petechiae beyond the site of vaccination after a few days.
Healthcare professionals should consider specialist consultation if they suspect their patient has a post-vaccine thrombosis.
Healthcare professionals should report any event potentially related to a vaccine. To report a side effect to Health Canada contact your local health unit or visit Health Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.
SOURCE Health Canada
CONTACT: Media Enquiries: Health Canada, (613) 957-2983, firstname.lastname@example.org; Public Enquiries: (613) 957-2991, 1-866 225-0709