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

OTTAWA, ON,Jan. 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 andOxford University.HealthCanadahas been reviewing this vaccine in collaboration with the European Medicines Agency (EMA) as part of the EMAOPENprocess. 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.HealthCanadahas been reviewing AstraZeneca’s vaccine since it was submitted onOctober 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 theInterim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19,which was signed onSeptember 16, 2020.HealthCanadais 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.OnDecember 9, Health Canada authorized thePfizer-BioNTechCOVID-19 vaccine. HealthCanadasubsequently authorized a second COVID-19 vaccine, onDecember 23, manufactured byModerna.SOURCE Health CanadaView original content:http://www.newswire.ca/en/releases/archive/January2021/29/c5310.html