Statement on the European Medicines Agency’s recommended authorization of the AstraZeneca COVID-19 vaccine

Canada NewsWire

OTTAWA, ONJan. 29, 2021 /CNW/ – Health Canada is aware that the European Medicines Agency has recommended granting a conditional marketing authorization for the COVID-19 vaccine manufactured by AstraZeneca and Oxford University.

Health Canada has been reviewing this vaccine in collaboration with the European Medicines Agency (EMA) as part of the EMA OPEN process. This process makes it possible for trusted regulatory authorities outside of the European Union, such as Health Canada, to collaborate and share information throughout the scientific review.

The Department is currently completing its review of the submitted data and expects to make a decision on the authorization of the AstraZeneca vaccine in the coming days. While the Department collaborates with other regulators, it remains committed to conducting an independent and thorough scientific review of all COVID-19 vaccines.

Health Canada has been reviewing AstraZeneca’s vaccine since it was submitted on October 1, 2020, and is expediting the review of all COVID-19 vaccines. This is being done through rolling submissions, where data is being reviewed as it becomes available from the manufacturer. Rolling submissions allow for shorter review times without compromising safety, efficacy and quality, as part of the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19, which was signed on September 16, 2020.

Health Canada is working hard to give Canadians access to COVID-19 vaccines as quickly as possible without compromising its safety, efficacy and quality standards. Protecting the health and safety of Canadians is a top priority.

On December 9, Health Canada authorized the Pfizer-BioNTech COVID-19 vaccine. Health Canada subsequently authorized a second COVID-19 vaccine, on December 23, manufactured by Moderna.