Question Period Note: EMERGENT BIOSOLUTIONS - ASTRAZENECA AND JANSSEN COVID-19 VACCINES

• What is Health Canada doing to ensure that vaccines coming from the Emergent site are safe?

KEY MESSAGES
• Canadians can be assured that Health Canada is taking all necessary steps to ensure that vaccines coming from the Emergent facility are safe and effective before they are distributed in Canada.
• The AstraZeneca vaccines previously imported from this facility were confirmed to meet strict safety and quality requirements prior to distribution in Canada.
• Health Canada has completed its assessment of the recent shipment of Janssen vaccines that were made using an ingredient manufactured by the Emergent facility.
• Due to remaining uncertainties around the quality of the vaccines, Health Canada will not be releasing the shipment.
• Health Canada will continue to verify that all vaccines meet strict quality and safety requirements before they are distributed in Canada.

IF PRESSED ON HEALTH CANADA’S ASSESSMENT OF THE EMERGENT SITE…
• The Emergent BioSolutions facility in Baltimore, Maryland is currently rated as compliant with good manufacturing practices by Health Canada, based on an assessment of an inspection report from the European Medicines Agency (EMA) - Italian Medicines Agency (AIFA).
• The facility is currently authorized by Health Canada to conduct fabricating, packaging, labelling, and testing of vaccine materials. No other product types are authorized for this site.
• To ensure the safety of any future vaccine supply from this facility, Health Canada is planning an onsite inspection, expected to take place this summer. Until this inspection has been completed, Canada will not be accepting any product or ingredients made at this site.

IF PRESSED ON THE SAFETY OF THE ASTRAZENECA VACCINES ALREADY IMPORTED FROM THIS SITE…
• Canadians can be assured that all AstraZeneca vaccines imported into Canada from this facility are safe and of high quality.
• 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.
• As with all vaccines imported into Canada, the AstraZeneca vaccines were only released for distribution once Health Canada was satisfied that they met high quality, safety and efficacy standards.

BACKGROUND
The Emergent BioSolutions facility in Baltimore, Maryland is a manufacturing site for the Janssen vaccine, and previously manufactured AstraZeneca vaccines that were distributed in Canada. In March 2021, the facility was reported to have mixed up the AstraZeneca and Janssen vaccines, resulting in the disposal of millions of doses of the Janssen vaccine. The U.S. Food and Drug Administration (FDA) inspected the facility in April 2021 and found deficiencies with good manufacturing practices (GMPs).
The facility was rated as compliant by Health Canada earlier this year, based on a review of an inspection report from the European Medicines Agency (EMA) - Italian Medicines Agency (AIFA). The 1.5 million doses of AstraZeneca vaccines manufactured by this site and distributed in Canada were determined to meet quality specifications prior to distribution in Canada.
On April 25, 2021 Health Canada issued a statement regarding the FDA recent inspection and reassured Canadians that the Department was reviewing these findings, that it had verified that the AstraZeneca vaccines distributed in Canada from this facility were of high quality and that the Janssen vaccines produced at this facility had not entered Canada. The Department posted an updated statement on April 30th, advising that a drug ingredient used to manufacture the Janssen vaccine imported into Canada on April 28th was made at the Emergent site.
On June 11, 2021, Health Canada issued a statement to communicate that it has concluded its assessment of the quality of the Janssen vaccines shipped to Canada. Due to remaining uncertainties around the quality of the vaccines, Health Canada will not be releasing the vaccines.
Safety, efficacy and quality requirements for vaccines
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.

GMPs are a quality assurance system that is used to ensure that drugs and vaccines are consistently made, packaged, labelled, tested, stored, imported and distributed in a manner that meets high safety, efficacy and quality standards, and are recognized internationally.

All Canadian importers of drug products, including vaccines, must hold a valid Drug Establishment Licence (DEL) for importation. When a drug is fabricated, packaged/labelled, or tested outside of Canada, the foreign building where those activities occur must be listed on the Canadian importer’s DEL to permit the importation of the product.

For the foreign building to be listed on the DEL, the building must be deemed compliant with GMP requirements. To ensure they meet GMP requirements, Health Canada may conduct on-site inspections of domestic or foreign facilities, or may rely on inspections conducted by trusted international regulatory partners, to verify compliance.

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