Statement from Health Canada on AstraZeneca and Janssen COVID-19 vaccines produced at Emergent BioSolutions

April 25, 2021 | Ottawa, ON | Health Canada

Health Canada is aware of the U.S. Food and Drug Administration’s (FDA) recent inspection of the Emergent BioSolutions facility in Baltimore, Maryland, which noted multiple areas of concern. Health Canada would like to reassure Canadians that all AstraZeneca vaccines imported into Canada from this facility are safe and of high quality. Janssen vaccines produced at this site have not entered the country.

Health Canada has verified that the 1.5 million doses of AstraZeneca vaccine imported into Canada from this facility meet quality specifications. The Department reviewed test results of all vaccine lots that came into Canada, as well as the company’s quality control steps implemented throughout the manufacturing process to mitigate potential risks of contamination.

Janssen vaccines anticipated to come into the country next week do not come from this facility.

Whether a drug or vaccine is manufactured domestically or abroad, Health Canada verifies that both the formulation and the facilities that make them comply with Canada’s high standards before approving them for the Canadian market.

Health Canada continues to work with the FDA and to further review the report in detail to determine whether any further actions are required to protect the safety of Canada’s future vaccine supply from this facility.

Canadians can be assured that Health Canada is taking all necessary steps to ensure that any products coming from this facility will only be used if they are safe and effective.