Canada Approves Import of J&J COVID-19 Vaccine Doses Made at Emergent Plant

Vials labeled “COVID-19 Coronavirus Vaccine” and syringe can be seen in front of the Johnson & Johnson logo displayed in this image, taken Feb. 9, 2021. REUTERS/Dado Ruvic/Illustration/File Photo

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Nov 24 (Reuters) – Canada’s health regulator said Wednesday it would allow Johnson & Johnson (JNJ.N) to import its COVID-19 vaccine made at contract manufacturer Emergent BioSolutions Inc’s (EBS.N) factory in the United States.

The decision, Health Canada said, came after it completed an inspection of the facility in Baltimore, Maryland, along with the European Medicines Agency and the South African Health Products Regulatory Authority.

The beleaguered facility has been under regulatory scrutiny since a manufacturing defect earlier this year ruined millions of doses of J&J’s COVID-19 vaccine.

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Canada said in June it would not accept factory-made doses until it completes its own on-site inspection.

The three regulators found the facility in line with good manufacturing practices, Health Canada said Wednesday.

The U.S. Food and Drug Administration halted operations at the facility in April after it emerged that J&J’s vaccine was contaminated with AstraZeneca’s material. (AZN.L) COVID-19 shots, which were also manufactured there at the time.

The FDA inspection had revealed a long list of problems, including peeling paint, sloppy cleanings and poorly trained personnel. read more

The use of many doses of the J&J vaccine made at the Emergent facility has still not been approved by the FDA, although the agency has since authorized the use of batches manufactured before the discontinuation of production.

The FDA, Emergent and J&J did not immediately respond to Reuters’ request for comment.

Earlier on Wednesday, Canada said it had given full approval to the J&J vaccine. read more

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Reporting by Manas Mishra in Bengaluru; Editing by Sriraj Kalluvila

Our standards: The Thomson Reuters Trust Principles.

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