Question Period Note: SAFETY OF THE ASTRAZENECA AND JANSSEN VACCINES

• What is the current status of the AstraZeneca, COVISHIELD and Janssen vaccines in Canada?

KEY MESSAGES
• Health Canada is aware of very rare reports of blood clots with low levels of blood platelets following vaccination with the AstraZeneca, COVISHIELD and Janssen COVID-19 vaccines.
• As of June 11, 2021, there have been 52 cases of these events reviewed by the Public Health Agency of Canada and Health Canada following vaccinations with the AstraZeneca and COVISHIELD vaccines with more than 2.3 million doses of the vaccines administered.
• After a thorough, independent assessment of the currently available scientific data from the manufacturers and international regulatory partners, Health Canada has concluded that these rare events may be linked to use of the AstraZeneca, COVISHIELD and Janssen vaccines. This is in line with the findings of other regulators, such as the European Medicines Agency.
• As a result, Health Canada has updated warnings in the product information for each of these vaccines to inform Canadians of the possible side effects, and has issued risk communications that provide advice to Canadians and healthcare professionals about signs, symptoms and when to seek medical assistance.
• Based on a comprehensive review of these rare events, no specific risk factors have been identified. Therefore, Health Canada is not restricting the use of these vaccines in any specific populations at this time.
• Health Canada continues to review all the available safety data as it becomes available. We will take appropriate action, if required, to protect the health and safety of Canadians.
• The rapid detection of these rare events thanks to ongoing international cooperation with partners like the United States, Europe and the UK shows that Canadians can trust that our post-market monitoring system is working well.

IF PRESSED ON THE EXTENSION OF EXPIRY DATE
• Health Canada approved an extension requested by AstraZeneca to the expiry dates of two lots of the AstraZeneca COVID-19 vaccine by 30 days, from May 31, 2021 to July 1, 2021.
• The approval to extend the shelf life was supported by scientific evidence.
• This change will ensure that provinces and territories are able to use up their existing inventory and provide Canadians access to much needed doses of the vaccine.

IF PRESSED ON OTHER APPROVED VACCINES
• In addition to the AstraZeneca, COVISHIELD and Janssen vaccines, there are two other vaccines authorized for use in Canada – Pfizer and Moderna, which give us additional tools to fight this pandemic as quickly as possible.
• All vaccines in use in Canada are closely monitored through a robust vaccine safety monitoring system.
• Health Canada will continue to work with the Public Health Agency of Canada and international regulators to monitor all COVID 19 vaccines for any potential adverse events.
• While an adverse event may occur soon after immunization, this does not mean that it was caused by the vaccine, which is why such events are carefully reviewed to determine if any action should be taken.
• Should any safety issue be confirmed, the Department will take appropriate action immediately.

BACKGROUND
Summary of Regulatory Actions for AstraZeneca and COVISHIELD Vaccines
On February 26, 2021, Canada authorized 2 manufacturers of the ChAdOx1-S vaccine:
• AstraZeneca (brand name AstraZeneca COVID-19 Vaccine)
• Verity Pharmaceuticals and Serum Institute of India (SII) in collaboration with AstraZeneca (brand name COVISHIELD Vaccine)
AstraZeneca COVID‐19 Vaccine (manufactured by AstraZeneca) and COVISHIELD (manufactured by Serum Institute of India) are ChAdOx1-S recombinant vaccines developed by AstraZeneca and Oxford University. Health Canada reviewed the manufacturing information for these vaccines and found them to be comparable.
The vaccine is approved for people who are 18 years of age and older. It is given by 2 separate intra-muscular injections of 0.5 mL each. The second dose is given 4 to 12 weeks after the first.
Recent Adverse Events for AstraZeneca vaccine
Throughout March, Health Canada has been participating in ongoing assessment of very rare adverse events reported in Europe of thrombosis (blood clots) with thrombocytopenia (low blood platelets) or vaccine-induced immune thrombotic thrombocytopenia (VITT) occurring after immunization with the AstraZeneca vaccine.

In Canada, the provinces have administered over 2.3 million doses of the AstraZeneca or COVISHIELD vaccine. As of June 11, there have been 52 confirmed or suspected reports of VITT in Canada. Based on available evidence to date, PHAC has estimated the rate of these events in Canada could be as high as 1 in 50,000 doses administered.

Following reports of these very rare adverse events in Europe, Health Canada has worked closely with European regulators to review the evidence. A series of statements were issued to keep Canadians informed of the situation.
• March 18, 2021: A statement was issued indicating that the benefits of AstraZeneca vaccines continue to outweigh the benefits
• March 24, 2021: Health Canada communicated about updates to the product monograph and issued guidance for healthcare professionals and vaccine recipients on the potential symptoms to monitor.
• March 29, 2021: Health Canada issued a statement on its issuance of new terms and conditions which require that the manufacturers conduct a detailed assessment of the benefits and risks of the vaccine by age and sex in the Canadian context.
• On April 14, 2021: Health Canada provided an update on the safety review of the AstraZeneca and COVISHIELD COVID-19 vaccines, which concluded that these very rare events may be linked to the vaccine though no risk factors were identified.
• April 19, 2021: Health Canada published a Summary Safety Review that provided an overview of safety information to date.

Health Canada is aware that researchers in Europe have indicated that they have identified a possible cause for these very rare events observed in AstraZeneca COVID-19 vaccine recipients; however, little information is available about this emerging research. Health Canada will be reviewing this evidence when available.

Health Canada is also consulting with scientific experts in Canada and internationally to discuss the very rare events, and continues to be in regular contact with international regulators and the manufacturer of the AstraZeneca vaccine to review all evidence as it becomes available.

On June 11, 2021, the European Medicines Agency advised that people with a previous history of capillary leak syndrome should not receive the AstraZeneca vaccine. The product labelling is being updated. This action results from an assessment of 6 cases of this very rare, serious condition.

Health Canada is evaluating this information. One event of capillary leak syndrome has been reported in Canada.

Summary of Regulatory Actions for Janssen Vaccine

On March 5, 2021, Health Canada authorized the Janssen COVID-19 Vaccine (Ad26.COV2.S).

The Janssen vaccine is approved for people who are 18 years of age and older. A single 0.5mL dose of the vaccine is given by intra-muscular injection.

Recent Adverse Events for Janssen Vaccine

Janssen has provided Health Canada with information on recent reports from the United States, of thromboembolism with thrombocytopenia, and additional cases with other thromboembolic events.

Health Canada has now assessed the available data on these very rare events and has concluded that there is a possible link with use of the Janssen vaccine. As a result, on April 26, 2021, Health Canada made updates to the product monograph to reflect the risk of thrombosis with thrombocytopenia. However, as no specific risk factors for these events have been identified, Health Canada has not implemented specific restrictions on the use of the product.

Health Canada continues to conclude that the benefits of the Janssen vaccine against COVID-19 outweigh the risks of this very rare event.

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