Question Period Note: EMERGENT BIOSOLUTIONS - JANSSEN VACCINES

• The Janssen vaccines received on April 28 and intended for use in Canada contained an ingredient that was manufactured at the Emergent site in Baltimore, Maryland, U.S. On June 11, 2021, Health Canada issued a statement to communicate that it concluded its assessment of the quality of the Janssen vaccines shipped to Canada and that due to remaining uncertainties respecting their quality, it would not be releasing the vaccines. In addition, Health Canada communicated that it would not accept any product or ingredients made at this site until it could conduct an inspection and is satisfied with the site’s Good Manufacturing Practices (GMP) status.

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.
• Health Canada completed its assessment of the April 28 shipment of Janssen vaccines that were made using an ingredient manufactured by the Emergent facility. Due to remaining uncertainties about the quality of the vaccines, Health Canada did not release the shipment for distribution in Canada.
• The government secured an alternate supply of Janssen doses. On November 10, approximately 20,000 Janssen doses arrived in Canada for distribution to provinces and territories. Health Canada confirmed these doses came from compliant manufacturing sites in Europe and not from the Emergent facility.
• Health Canada has completed its onsite inspection of the Emergent facility and found it to be compliant with Good Manufacturing Practices. This means that Janssen will be able to import their vaccines that are made with an ingredient manufactured at the Emergent facility.
• As with all vaccines, each lot of the Janssen COVID-19 vaccine that could potentially be imported into Canada will be assessed to confirm that it meets Health Canada’s stringent safety and quality requirements.
IF PRESSED ON HEALTH CANADA’S ASSESSMENT OF THE EMERGENT SITE…

• Based on the concerns identified during the April 2021 U.S. FDA inspection, Health Canada took action to prevent any importation from this facility until such a time as the Department is satisfied that the site meets quality and safety requirements.

• To ensure the safety of any future vaccine supply from this facility, Health Canada conducted an inspection of the Emergent site from October 25th-29th, 2021 and found the site to be compliant with Good Manufacturing Practices. Moving forward, this means that Janssen will be able to import their vaccines that are made with an ingredient manufactured at the Emergent facility.

• Canadians can be assured that any vaccines, whether they come from Emergent or anywhere else, will only be released for distribution once Health Canada is satisfied that they meet the Department’s high standards for quality, safety and efficacy.

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 to reassure Canadians that the Department was reviewing the findings of the FDA inspection, 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 been released for distribution in Canada. The Department posted an updated statement on April 30, 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 noting that due to remaining uncertainties about the quality of the vaccines, it would not be releasing the vaccines. In addition, Health Canada imposed Terms and Conditions on Janssen’s Drug Establishment Licence (DEL) that prevents any importation from this facility until such a time as Health Canada is satisfied of the GMP status of the site. Janssen informed Health Canada that these previously imported vaccines have since been destroyed.

The Canadian government worked with the French government and Janssen to secure an alternative supply of the single dose Janssen vaccine. On November 10, approximately 20,000 Janssen doses arrived in Toronto. Health Canada confirmed that these doses came from compliant manufacturing sites in Europe.

Health Canada conducted an inspection of the Emergent site from October 25-29, 2021 to assess compliance with GMPs. This date was selected to allow time for the company to be ready to run a full production cycle and implement corrective measures to address previous quality concerns. Health Canada has completed assessing its inspection findings and has deemed the Emergent site to be compliant with GMPs. The compliant rating means that, moving forward, Janssen will be able to import their vaccines that are made with an ingredient manufactured at the Emergent facility. Health Canada issued a statement on the results of its inspection on November 24.

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.

KEY FACTS

• Health Canada completed its assessment of the April 28 shipment of Janssen vaccines that were made using an ingredient manufactured by the Emergent facility. Due to remaining uncertainties about the quality of the vaccines, Health Canada did not release the shipment for distribution in Canada.
• The Canadian government worked with the French government and Janssen to secure an alternative supply of the single dose Janssen vaccine. On November 10, approximately 20,000 Janssen doses arrived in Toronto. Health Canada confirmed that these doses came from compliant manufacturing sites in Europe.
• Health Canada inspected the Emergent site from October 25-29, 2021 and found it to be compliant with Good Manufacturing Practices. Moving forward, this means that Janssen will be able to import their vaccines that are made with an ingredient manufactured at the Emergent facility.