Update - Health Canada issues label change on the AstraZeneca and COVISHIELD COVID-19 vaccines

OTTAWA, ON, June 29, 2021 /CNW/ - 

Summary
Products: AstraZeneca and COVISHIELD COVID-19 vaccines
Issue: Health Canada is updating the product monograph—or label—for the AstraZeneca and COVISHIELD COVID-19/ vaccines to add capillary leak syndrome as a potential side effect, with a warning for patients with a history of capillary leak syndrome to not get the AstraZeneca or COVISHIELD COVID-19 vaccine. The label has also been updated with information about very rare events of blood clots associated with low levels of platelets following immunization.
What to do: Talk to your healthcare professional if you have any questions about the AstraZeneca and COVISHIELD COVID-19 vaccine. If you have previously had capillary leak syndrome, talk to your healthcare professional about your COVID-19 vaccine options. Seek immediate medical attention if you experience symptoms of capillary leak syndrome which would include rapid swelling of the arms and legs and sudden weight gain, which can be accompanied by feeling faint. In addition, seek prompt medical attention if you experience any symptoms that could be thrombosis with thrombocytopenia following vaccination.   

Issue:

Health Canada is updating Canadians and healthcare professionals on its review of very rare reports of capillary leak syndrome following immunization with the AstraZeneca and COVISHIELD COVID-19 vaccines. In line with the labelling updates of other international regulators, the product monograph—or label—for the AstraZeneca and COVISHIELD COVID-19 vaccines will include capillary leak syndrome as a potential side effect. This will include a warning for patients with a history of capillary leak syndrome not to get the AstraZeneca or COVISHIELD COVID-19 vaccine, and information for healthcare professionals. 

Capillary leak syndrome is a very rare, serious condition that causes fluid leakage from small blood vessels (capillaries), resulting in limb swelling, low blood pressure, thickening of the blood and low levels of albumin (an important blood protein) in the blood.

Health Canada recommends that people with a history of capillary leak syndrome not be vaccinated with the AstraZeneca or COVISHIELD COVID-19 vaccine. Individuals should seek prompt medical attention if they experience any symptoms that could be capillary leak syndrome.  Symptoms include rapid swelling of the arms and legs and sudden weight gain, which can be accompanied by feeling faint. If you have questions or you have previously had capillary leak syndrome, talk to your healthcare professional about your COVID-19 vaccine options.

Health Canada and the Public Health Agency of Canada have been monitoring this condition since it was raised as a potential safety concern by the European Medicines Agency in April 2021. Up to and including June 11, 2021, one case of capillary leak syndrome following vaccination with the AstraZeneca or COVISHIELD COVID-19 vaccine has been reported in Canada.  Health Canada and PHAC will continue to monitor for cases of capillary leak syndrome. Health Canada will take further action if necessary.

The labeling changes for capillary leak syndrome were initiated after international reports of this very rare side effect were reviewed in Europe. Of the 78 million doses of the AstraZeneca and COVISHIELD vaccines that have been given in the Europe and the United Kingdom as of May 27, 2021, six cases of capillary leak syndrome were reported following immunization with these vaccines.

In addition, information about blood clots associated with low levels of platelets has been updated on the AstraZeneca and COVISHIELD COVID-19 label. Healthcare professionals are being advised that, while specific risk factors for this condition have not yet been identified, the benefits and risks of vaccination with these vaccines should be considered in patients with previous history of thrombosis, as well as patients with autoimmune disorders (including immune thrombocytopenia). 

It is also recommended to healthcare professionals that patients diagnosed with thrombocytopenia (low platelet count) following vaccination with the AstraZeneca or COVISHIELD COVID-19 vaccine should be evaluated for signs of thrombosis (blood clots). Similarly, patients who present with thrombosis should be evaluated for thrombocytopenia.  

Health Canada reminds anyone who received the AstraZeneca or COVISHIELD COVID-19 vaccine to seek prompt medical attention if they experience any symptoms that could be thrombosis with thrombocytopenia 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 new or worsening symptoms. Canadians are also encouraged to report any adverse events after immunization to their healthcare professionals.

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.

Original Advisory (April 14, 2021): Health Canada provides update on the AstraZeneca and COVISHIELD COVID-19 vaccines

Summary
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.

Issue

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 for the AstraZeneca COVID-19 vaccine and COVISHIELD vaccine 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.

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 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.

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.

Également disponible en français

SOURCE Health Canada

Media Enquiries: Health Canada, [phone], [email protected]; Public Enquiries: [phone], 1-866 225-0709