Statement
On April 25, 2021, Health Canada issued a statement regarding 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. The Department continues to work with Janssen, AstraZeneca, and the FDA to ensure the facility meets manufacturing standards, and that all vaccine supplies for Canada are of high quality. Since issuing our statement, Health Canada has learned that a drug substance produced at the Emergent site was used in the manufacturing of the initial Janssen vaccines received on April 28 and intended for use in Canada.
Update: Health Canada continues to ensure the quality and safety of vaccines coming into Canada by working with international partners and vaccine manufacturers
April 30, 2021 | Ottawa, ON | Health Canada
On April 25, 2021, Health Canada issued a statement regarding 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. The Department continues to work with Janssen, AstraZeneca, and the FDA to ensure the facility meets manufacturing standards, and that all vaccine supplies for Canada are of high quality. Health Canada remains confident that the 1.5 million doses of AstraZeneca vaccine imported into Canada from this facility meet quality specifications.
Since issuing our statement, Health Canada has learned that a drug substance produced at the Emergent site was used in the manufacturing of the initial Janssen vaccines received on April 28 and intended for use in Canada. The drug substance is the active ingredient that undergoes further processing before becoming the final product (i.e., the vaccine). The final Janssen vaccines were manufactured at a different site located outside of the U.S.
As with all vaccines imported into Canada, the Janssen vaccines will only be released for distribution once Health Canada is satisfied that they meet the Department’s high standards for quality, safety and efficacy. Health Canada is currently working with Janssen and the FDA to obtain all of the information it needs to complete this assessment, prior to releasing the Janssen vaccines for distribution.
Health Canada has rigorous processes in place to continually monitor the quality of vaccines that are administered to Canadians. We will continue to ensure that products coming from the Emergent facility, or any other facility, will only be imported and distributed in Canada if they are of high quality and safe for use.
Contacts
Media Relations
Health Canada
613-957-2983
hc.media.sc@canada.ca